Jorveza
1 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Jorveza 0.5 mg orodispersible tablets 
Jorveza 1 mg orodispersible tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Jorveza 0.5 mg orodispersible tablets 
 
Each orodispersible tablet contains 0.5 mg of budesonide. 
 
Excipient with known effect 
Each 0.5 mg orodispersible tablet contains 26 mg sodium.  
 
Jorveza 1 mg orodispersible tablets 
 
Each orodispersible tablet contains 1 mg of budesonide. 
 
Excipient with known effect 
Each 1 mg orodispersible tablet contains 26 mg sodium.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Orodispersible tablet 
 
Jorveza 0.5 mg orodispersible tablets 
 
White, round, biplane orodispersible tablets, with a diameter of 7.1 mm and height of 2.2 mm. They 
are debossed with “0.5” on one side. 
 
Jorveza 1 mg orodispersible tablets 
 
White, round, biplane orodispersible tablets, with a diameter of 7.1 mm and height of 2.2 mm. 
  
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years 
of age). 
 
4.2 Posology and method of administration 
 
The treatment with this medicinal product should be initiated by a physician experienced in the 
diagnosis and treatment of eosinophilic esophagitis. 
 
Posology 
 
Induction of remission 
 
The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in the morning and one 1-mg-
tablet in the evening.  



3 
 

 
The usual duration of induction treatment is 6 weeks. For patients who are not appropriately 
responding during 6 weeks the treatment can be extended to up to 12 weeks. 
 
Maintenance of remission 
 
The recommended daily dose is 1 mg budesonide as one 0.5-mg-tablet in the morning and one 0.5-mg-
tablet in the evening or 2 mg budesonide as one 1-mg-tablet in the morning and one 1-mg-tablet in the 
evening, depending on the individual clinical requirement of the patient.   
A maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long standing 
disease history and/or high extent of esophageal inflammation in their acute disease state, see also 
section 5.1. 
 
The duration of maintenance therapy is determined by the treating physician.  
 
Special populations 
 
Renal impairment 
There are currently no data available for patients with renal impairment. Because budesonide is not 
excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with 
the same doses as patients without renal impairment. Budesonide is not recommended for use in 
patients with severe renal impairment. 
 
Hepatic impairment 
During treatment of patients with hepatic impairment with other budesonide containing medicinal 
products, budesonide levels were increased. However, no systematic study investigating different 
levels of hepatic impairment is available. Patients with hepatic impairment should not be treated (see 
sections 4.4 and 5.2). 
 
Paediatric population 
The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been 
established. No data are available. 
 
Method of administration  
 
The orodispersible tablet should be taken immediately once removed from the blister package. 
 
The orodispersible tablet should be taken after a meal. 
It should be placed on the tip of the tongue and gently pressed against the top of the mouth, where it 
will dissolve. This will usually take at least two minutes but can take up to 20 minutes. The 
effervescence process of the tablet starts after Joreveza comes into contact with saliva and stimulates 
the production of further saliva. The dissolved material should be swallowed with saliva little by little 
while the orodispersible tablet disintegrates. The orodispersible tablet should not be taken with liquid 
or food. 
 
There should be at least 30 minutes before eating or drinking or performing oral hygiene. Any oral 
solutions, sprays or chewable tablets should be used at least 30 minutes before or after administration 
of Jorveza. 
 
The orodispersible tablet should not be chewed or swallowed undissolved. These measures ensure 
optimal exposure of the esophageal mucosa to the active substance. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 



4 
 

4.4 Special warnings and precautions for use 
 
Infections 
 
Suppression of the inflammatory response and immune function increases the susceptibility to 
infections and their severity. Symptoms of infections can be atypical or masked.  
 
In clinical studies conducted with Jorveza oral, oropharyngeal and esophageal candida infections have 
been observed with a high frequency (see section 4.8). 
If indicated, symptomatic candidiasis of the mouth and throat can be treated with topical or systemic 
anti-fungal therapy whilst still continuing treatment with Jorveza. 
 
Chickenpox, herpes zoster and measles can have a more serious course in patients treated with 
glucocorticosteroids. In patients who have not had these diseases, the vaccination status should be 
checked, and particular care should be taken to avoid exposure. 
 
Vaccines 
 
The co-administration of live vaccines and glucocorticosteroids should be avoided as this is likely to 
reduce the immune response to vaccines. The antibody response to other vaccines may be diminished. 
 
Special populations 
 
Patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, 
cataract, family history of diabetes or family history of glaucoma may be at higher risk of 
experiencing systemic glucocorticosteroid adverse reactions (see below and section 4.8) and should 
therefore be monitored for the occurrence of such effects. 
 
Reduced liver function may affect the elimination of budesonide, causing higher systemic exposure. 
The risk of adverse reactions (systemic glucocorticosteroid effects) will be increased. However, no 
systematic data are available. Patients with hepatic impairment should therefore not be treated. 
 
Systemic effects of glucocorticosteroids 
 
Systemic effects of glucocorticosteroids (e.g., Cushing’s syndrome, adrenal suppression, growth 
retardation, cataract, glaucoma, decreased bone mineral density and a wide range of psychiatric 
effects) may occur (see also section 4.8). These adverse reactions depend on the duration of treatment, 
concomitant and previous glucocorticosteroid treatment and the individual sensitivity. 
 
Visual disturbance 
 
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents 
with symptoms such as blurred vision or other visual disturbances, the patient should be considered for 
referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma 
or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use 
of systemic and topical corticosteroids. 
 
Others 
 
Glucocorticosteroids may cause suppression of the hypothalamic–pituitary–adrenal (HPA) axis and 
reduce the stress response. When patients are subject to surgery or other stresses, supplementary 
systemic glucocorticosteroid treatment is therefore recommended. 
 
Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see 
section 4.5). 
 



5 
 

Interference with serological testing 
 
Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test 
for diagnosing pituitary insufficiency might show false results (low values).  
 
Sodium content 
 
Jorveza 0.5 mg and 1 mg orodispersible tablets contain 52 mg of sodium per daily dose, equivalent to 
2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
CYP3A4 inhibitors 
 
Co-treatment with potent CYP3A inhibitors such as ketoconazole, ritonavir, itraconazole, 
clarithromycin, cobicistat and grapefruit juice may cause a marked increase of the plasma 
concentration of budesonide and is expected to increase the risk of systemic adverse reactions. 
Therefore, concomitant use should be avoided unless the benefit outweighs the increased risk of 
systemic corticosteroid adverse reactions, in which case patients should be monitored for systemic 
corticosteroid adverse reactions.  
 
Ketoconazole 200 mg once daily orally increased the plasma concentration of budesonide (3 mg single 
dose) approximately 6-fold during concomitant administration. When ketoconazole was administered 
approximately 12 hours after budesonide, the plasma concentration of budesonide increased 
approximately 3-fold. 
 
Oestrogens, oral contraceptives 
 
Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in 
women also receiving oestrogens or oral contraceptives. No such effect has been observed with 
budesonide and concomitant intake of low-dose combination oral contraceptives. 
 
Cardiac glycosides 
 
The action of glycoside can be potentiated by potassium deficiency which is a potential and known 
adverse reaction of glucocorticoids.  
 
Saluretics  
 
Concommitant use of glucocorticoids may result in enhanced potassium excretion and aggravated 
hypokalaemia. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
Administration during pregnancy should be avoided unless there are compelling reasons for therapy 
with Jorveza. There are few data of pregnancy outcomes after oral administration of budesonide in 
humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies 
indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to 
be higher in the treatment with Jorveza compared to inhaled budesonide. In pregnant animals, 
budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal 
development (see section 5.3). The relevance of this to man has not been established.  
 



6 
 

Breast-feeding 
 
Budesonide is excreted in human milk (data on excretion after inhalative use is available). However, 
only minor effects on the breast-fed child are anticipated after oral use of Jorveza within the 
therapeutic range. A decision must be made whether to discontinue breast-feeding or to 
discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the 
child and the benefit of therapy for the woman. 
 
Fertility 
 
There are no data on the effect of budesonide on human fertility. Fertility was unaffected following 
budesonide treatment in animal studies (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Jorveza has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Fungal infections in the mouth, pharynx and the oesophagus were the most frequently observed 
adverse reactions in clinical studies with Jorveza. In the clinical studies BUL-1/EEA and BUL-2/EER, 
a total of 44 out of 268 patients (16.4%) exposed to Jorveza experienced cases of suspected fungal 
infections associated with clinical symptoms, which were all of mild or moderate intensity. The total 
number of infections (including those diagnosed by endoscopy and histology without symptoms) was 
92, occurring in 72 out of 268 patients (26.9%).  
 
Tabulated list of adverse reactions 
 
Adverse reactions observed in clinical studies with Jorveza are listed in the table below, by MedDRA 
system organ class and frequency. Frequencies are defined as very common (≥ 1/10), common 
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare 
(< 1/10,000) or not known (cannot be estimated from the available data). 
 
MedDRA system 
organ class 

Very common  Common Uncommon 

Infections and 
infestations 

Esophageal 
candidiasis  

Oral and/or 
oropharyngeal candidiasis 

 

Psychiatric disorders   Sleep disorder, anxiety 
Nervous system 
disorders 

 Headache Dizziness, dysgeusia  

Eye disorders   Dry eye  
Vascular disorders   Hypertension 
Respiratory, thoracic 
and mediastinal 
disorders 

  Cough, dry throat,  
oropharyngeal pain   

Gastrointestinal 
disorders 

 Gastroesophageal reflux 
disease, nausea, oral 
paraesthesia, dyspepsia  

Abdominal pain, upper 
abdominal pain, dry 
mouth, dysphagia, erosive 
gastritis, gastric ulcer, 
glossodynia, lip edema 

Skin and 
subcutaneous tissue 
disorders 

  Rash, urticaria 

General disorders 
and administration 

 Fatigue Sensation of foreign body 



7 
 

site conditions 
Investigations  Blood cortisol decreased  

 
The following known adverse reactions of the therapeutic class (corticosteroids, budesonide) could 
also occur with Jorveza (frequency = not known). 
 
MedDRA system organ class Adverse reactions 
Immune system disorders Increased risk of infection 
Endocrine disorders Cushing’s syndrome, adrenal suppression, growth 

retardation in children 
Metabolism and nutrition disorders Hypokalaemia, hyperglycaemia   
Psychiatric disorders Depression, irritability, euphoria, psychomotor 

hyperactivity, aggression 
Nervous system disorders Pseudotumor cerebri including papilloedema in adolescents 
Eye disorders Glaucoma, cataract (including subcapsular cataract), blurred 

vision, central serous chorioretinopathy (CSCR) (see also 
section 4.4) 

Vascular disorders Increased risk of thrombosis, vasculitis (withdrawal 
syndrome after long-term therapy) 

Gastrointestinal disorders Duodenal ulcers, pancreatitis, constipation 
Skin and subcutaneous tissue 
disorders 

Allergic exanthema, petechiae, delayed wound healing, 
contact dermatitis, ecchymosis 

Musculoskeletal and connective 
tissue disorders 

Muscle and joint pain, muscle weakness and twitching, 
osteoporosis, osteonecrosis 

General disorders and administration 
site conditions 

Malaise 

 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
In case of short-term overdose no emergency medical treatment is required. There is no specific 
antidote. Subsequent treatment should be symptomatic and supportive. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, 
corticosteroids acting locally, ATC code: A07EA06 
 
Mechanism of action 
 
Budesonide is a non-halogenated glucocorticosteroid, which acts primarily anti-inflammatory via 
binding to the glucocorticoid receptor. In the treatment of EoE with Jorveza, budesonide inhibits 
antigen-stimulated secretion of many pro-inflammatory signal molecules such as thymic stromal 
lymphopoeitin, interleukin-13 and eotaxin-3 in the esophageal epithelium, which results in a 
significant reduction of the esophageal eosinophilic inflammatory infiltrate. 
 
Clinical efficacy and safety 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
https://www.whocc.no/atc_ddd_index/?code=A07
https://www.whocc.no/atc_ddd_index/?code=A07


8 
 

 
In a randomised, placebo-controlled, double-blind phase III clinical study (BUL-1/EEA) including 88 
adult patients with active EoE (randomisation rate: 2:1), 1 mg budesonide given twice daily as an 
orodispersible tablet for 6 weeks induced clinico-pathologic remission (defined as both peak of 
< 16 eosinophils/mm2 high power field in esophageal biopsies and no or only minimal symptoms of 
dysphagia or pain during swallowing) in 34 out of 59 patients (57.6%) versus 0/29 patients (0%) in the 
placebo-group. Open-label extension of the treatment with 1 mg budesonide orodispersible tablet 
twice daily for further 6 weeks in patients without remission in the double-blind phase increased the 
rate of patients with clinico-pathologic remission to 84.7%.  
 
In a randomised, placebo-controlled, double-blind phase III clinical study (BUL-2/EER) including 
204 adult patients with EoE in clinico-pathological remission, patients were randomised to treatment 
with 0.5 mg budesonide twice daily (BID), 1 mg budesonide BID, or placebo (all given as 
orodispersible tablets) for 48 weeks. Primary endpoint was the rate of patients free of treatment failure 
with treatment failure defined as clinical relapse (severity of dysphagia or pain during swallowing 
of ≥4 points on a 0-10 nummerical rating scale, respectively), and/or histological relapse (peak 
of ≥ 48 eosinophils/mm2 high power field), and/or food impaction requiring endoscopic intervention, 
and/or need of an endoscopic dilation, and/or premature withdrawal for any reason. Significantly more 
patients in the 0.5 mg BID (73.5%) group and the 1 mg BID (75.0%) group were free of treatment 
failure at week 48 compared to placebo (4.4%).  
The most stringent secondary endpoint “deep disease remission”, i.e., deep clinical, deep endoscopic 
and histological remission showed a clinically relevant higher efficacy in the 1 mg BID group (52.9%) 
compared to the 0.5 mg BID group (39.7%), indicating that a higher dose of budesonide is of 
advantage to achieve and maintain deep disease remission.  
 
For information about the observed adverse reactions, see section 4.8. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following administration of Jorveza, budesonide is rapidly absorbed. Pharmacokinetic data following 
administration of single doses of 1 mg budesonide to fasted healthy subjects in two different studies 
show a median lag time of 0.17 hours (range 0.00 - 0.52 hours) and a median time to peak plasma 
concentration of 1.00 - 1.22 hours (range 0.50 - 2.00 hours). The mean peak plasma concentration was 
0.44 - 0.49 ng/mL (range 0.18 - 1.05 ng/ml) and the area under the plasma-concentration-time curve 
(AUC0-∞) was 1.50 - 2.23 hr*ng/mL (range 0.81 - 5.14 hr*ng/ml).  
 
Single dose pharmacokinetic data in fasted patients with EoE are available with 4 mg budesonide: 
Median lag-time was 0.00 hours (range 0.00 – 0.17), median time to peak plasma concentration was 
1.00 hour (range 0.67 – 2.00 hours); peak plasma concentration was 2.56 ± 1.36 ng/mL, and AUC0-12 
was 8.96 ± 4.21 hr*ng/mL. 
 
Patients showed a 35% increase in peak plasma concentrations and a 60% increase in AUC0-12 
compared to healthy subjects. 
 
Dose proportionality of the systemic exposure (Cmax and AUC) from 0.5 mg orodispersible tablets to 
1 mg orodispersible tablets has been demonstrated.  
 
Distribution 
 
The apparent volume of distribution following oral administration of 1 mg budesonide to healthy 
subjects was 35.52 ± 14.94 L/kg and 42.46 ± 23.90 L/kg following administration of 4 mg budesonide 
to patients with EoE. Plasma protein binding is on average 85-90%. 
 



9 
 

Biotransformation 
 
Metabolism of budesonide is decreased in EoE patients compared to healthy subjects resulting in 
increased plasma concentrations of budesonide. 
 
Budesonide undergoes extensive biotransformation by CYP3A4 in the mucosa of the small intestine 
and in the liver to metabolites of low glucocorticosteroid activity. The glucocorticosteroid activity of 
the major metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is less than 1% of that of 
budesonide. CYP3A5 does not contribute significantly to the metabolism of budesonide. 
 
Elimination 
 
The median elimination half-life is 2 - 3 hours in healthy subjects (receiving 1 mg budesonide) and 
4 - 5 hours in EoE patients (receiving 4 mg budesonide). Clearance of budesonide is about 13 –
 15 L/hour/kg in healthy subjects and 6.54 ± 4.4 L/hour/kg in EoE patients. Budesonide is eliminated 
only in marginal if any amounts by the kidney. No budesonide, but only budesonide metabolites were 
detected in urine. 
 
Hepatic impairment 
 
A relevant proportion of budesonide is metabolised in the liver by CYP3A4. The systemic exposure of 
budesonide is considerably increased in patients with severely impaired hepatic function. No studies 
have been conducted with Jorveza in patients with impaired liver function.  
 
5.3 Preclinical safety data 
 
Preclinical data in acute, subchronic and chronic toxicological studies with budesonide showed 
atrophies of the thymus gland and adrenal cortex and a reduction especially of lymphocytes. 
 
Budesonide had no mutagenic effects in a number of in vitro and in vivo tests.  
 
A slightly increased number of basophilic hepatic foci were observed in chronic rat studies with 
budesonide, and in carcinogenicity studies, an increased incidence of primary hepatocellular 
neoplasms, astrocytomas (in male rats) and mammary tumours (female rats) were observed. These 
tumours are probably due to the specific steroid receptor action, increased metabolic burden and 
anabolic effects on the liver, effects which are also known from other glucocorticosteroids in rat 
studies and therefore represent a class effect in this species. 
 
Budesonide had no effect on fertility in rats. In pregnant animals, budesonide, like other 
glucocorticosteroids, has been shown to cause foetal death and abnormalities of foetal development 
(smaller litter size, intrauterine growth retardation of foetuses and skeletal abnormalities). Some 
glucocorticoids have been reported to produce cleft palate in animals. The clinical relevance of these 
findings to man has not been established (see section 4.6). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Jorveza 0.5 mg and 1 mg orodispersible tablets 
 
Disodium hydrogen citrate 
Docusate sodium 
Macrogol (6000) 
Magnesium stearate 
Mannitol (E 421) 
Anhydrous monosodium citrate 



10 
 

Povidone (K25) 
Sodium hydrogen carbonate 
Sucralose 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
Do not store above 25 °C. Store in the original package in order to protect from light and moisture. 
 
6.5 Nature and contents of container  
 
Alu/Alu-blister. 
 
Jorveza 0.5 mg orodispersible tablets 
 
Pack sizes of 20, 60, 90, 100 or 200 orodispersible tablets.  
 
Jorveza 1 mg orodispersible tablets 
 
Pack sizes of 20, 30, 60, 90, 100 or 200 orodispersible tablets.  
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Dr. Falk Pharma GmbH 
Leinenweberstr. 5 
79108 Freiburg 
Germany 
Tel.: +49 (0)761 1514-0 
Fax: +49 (0)761 1514-321 
E-mail: zentrale@drfalkpharma.de 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Jorveza 1 mg orodispersible tablets 
 
EU/1/17/1254/001 
EU/1/17/1254/002 
EU/1/17/1254/003 
EU/1/17/1254/004 
EU/1/17/1254/005 
EU/1/17/1254/006  



11 
 

 
Jorveza 0.5 mg orodispersible tablets 
 
EU/1/17/1254/007 
EU/1/17/1254/008 
EU/1/17/1254/009 
EU/1/17/1254/010 
EU/1/17/1254/011 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 08 January 2018 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


12 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 



13 
 

A.  MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Dr. Falk Pharma GmbH 
Leinenweberstrasse 5 
79108 Freiburg 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 



14 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



15 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



16 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON – 0.5 MG  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Jorveza 0.5 mg orodispersible tablets 
budesonide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each orodispersible tablet contains 0.5 mg budesonide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sodium. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
orodispersible tablet 
 
20 orodispersible tablets 
60 orodispersible tablets 
90 orodispersible tablets 
100 orodispersible tablets 
200 orodispersible tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Do not chew or swallow.  
Use as directed by the physician. 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 



17 
 

 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. Store in the original package in order to protect from light and moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Dr. Falk Pharma GmbH 
Leinenweberstr. 5 
79108 Freiburg 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1254/007 (20 orodispersible tablets) 
EU/1/17/1254/008 (60 orodispersible tablets) 
EU/1/17/1254/009 (90 orodispersible tablets) 
EU/1/17/1254/010 (100 orodispersible tablets) 
EU/1/17/1254/011 (200 orodispersible tablets) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Jorveza 0.5mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN  
NN  



18 
 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS – 0.5 MG  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Jorveza 0.5 mg orodispersible tablets 
budesonide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Dr. Falk Pharma GmbH 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



19 
 

 
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON – 1 MG  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Jorveza 1 mg orodispersible tablets 
budesonide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each orodispersible tablet contains 1 mg budesonide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sodium. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
orodispersible tablet 
 
20 orodispersible tablets 
30 orodispersible tablets 
60 orodispersible tablets 
90 orodispersible tablets 
100 orodispersible tablets 
200 orodispersible tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Do not chew or swallow. Use as directed by the physician. 
Read the package leaflet before use. 
Oral use. 
 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 



20 
 

EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. Store in the original package in order to protect from light and moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Dr. Falk Pharma GmbH 
Leinenweberstr. 5 
79108 Freiburg 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1254/001 (20 orodispersible tablets) 
EU/1/17/1254/002 (30 orodispersible tablets) 
EU/1/17/1254/003 (60 orodispersible tablets) 
EU/1/17/1254/004 (90 orodispersible tablets) 
EU/1/17/1254/005 (100 orodispersible tablets) 
EU/1/17/1254/006 (200 orodispersible tablets) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Jorveza 1mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 



21 
 

SN 
NN 
 



22 
 

 
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS – 1 MG  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Jorveza 1 mg orodispersible tablets 
budesonide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Dr. Falk Pharma GmbH 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



23 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



24 
 

Package leaflet: Information for the patient 
Jorveza 0.5 mg orodispersible tablets 
Jorveza 1 mg orodispersible tablets 

budesonide 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Jorveza is and what it is used for 
2. What you need to know before you take Jorveza 
3. How to take Jorveza 
4. Possible side effects 
5. How to store Jorveza 
6. Contents of the pack and other information 
 
 
1. What Jorveza is and what it is used for 
 
Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation. 
 
It is used in adults (older than 18 years of age) to treat eosinophilic oesophagitis, which is an 
inflammatory condition of the gullet (food pipe) that causes problems with swallowing food. 
 
 
2. What you need to know before you take Jorveza 
 
Do not take Jorveza 
− if you are allergic to budesonide or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
Talk to your doctor or pharmacist before taking Jorveza if you have: 
− tuberculosis 
− high blood pressure 
− diabetes, or if somebody in your family has diabetes 
− weakening of the bones (osteoporosis) 
− ulcers in the stomach or first part of the small intestine (peptic ulcer) 
− increased pressure in your eye (which can cause glaucoma) or eye problems such as clouding of 

the lens (cataracts) or if somebody in your family has glaucoma 
− liver disease. 
 
If you have any of the conditions mentioned above you may be at increased risk of side effects. Your 
doctor will decide on the appropriate measures and if it is still all right for you to take this medicine. 
 
Jorveza may cause typical side effects of corticosteroid medicines and may affect all parts of the body, 
particularly when you take this medicine at high doses and over a long time (see section 4). 
 
Further precautions during treatment with Jorveza 
− Contact your doctor if you get blurred vision or have other problems with your vision. 



25 
 

 
Take the following precautions during treatment with Jorveza because your immune system may be 
weakened: 
− Tell your doctor if you get fungal infections in the mouth, throat and gullet or if you think you 

have any infection during treatment with this medicine. Symptoms of fungal infection can be 
white spots in the mouth and throat and difficulty in swallowing. The symptoms of some 
infections can be unusual or less noticeable. 

− Keep away from people who have chickenpox or herpes zoster (shingles) if you have not had 
these infections. The effects of these illnesses can be much more severe during treatment with 
this medicine. If you do come into contact with chickenpox or shingles, see your doctor straight 
away. Please also report your vaccination status to your doctor. 

− Tell your doctor if you have not yet had measles and/or if and when you have received your last 
vaccination for this disease. 

− If you need to be vaccinated please speak to your doctor first. 
− If you know that you are due to have an operation please tell your doctor that you are taking 

Jorveza. 
 
Jorveza could affect the results of adrenal function tests (ACTH stimulation test) ordered by your 
doctor or in hospital. Tell your doctors that you are taking Jorveza before you have any tests. 
 
Children and adolescents 
Jorveza should not be used in children and adolescents under 18 years of age. The use of this medicine 
in children younger than 18 years of age has not yet been studied. 
 
Other medicines and Jorveza 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Some of these medicines may increase the effects of Jorveza and your doctor may wish to 
monitor you carefully if you are taking these medicines.  
In particular: 
− ketoconazole or itraconazole (to treat fungal infections) 
− clarithromycin, an antibiotic medicine used to treat infections 
− ritonavir and cobicistat (to treat HIV infections) 
− oestrogens (used for hormone replacement therapy or contraception) 
− cardiac glycosides such as digoxin (medicines used to treat heart conditions) 
− diuretics (to remove excess fluid from the body). 
 
Jorveza with food and drink 
You should not drink grapefruit juice whilst you are taking this medicine as this can worsen its side 
effects. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Do not take this medicine during pregnancy without checking with your doctor first. 
 
Do not take this medicine if you are breast-feeding unless you have checked with your doctor. 
Budesonide passes in small amounts into the breast milk. Your doctor will help you decide whether 
you should continue treatment and not breast-feed or if you should stop treatment over the period your 
baby is being breast-fed. 
 
Driving and using machines 
Jorveza is not expected to affect your ability to drive or use machines. 
 



26 
 

Jorveza contains sodium 
This medicine contains 52 mg sodium (main component of cooking/table salt) per daily dose. This is 
equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult. 
 
 
3. How to take Jorveza 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose for treatment of acute episodes is two 1 mg orodispersible tablets (2 mg 
budesonide) per day. Take one 1 mg orodispersible tablet in the morning and one 1 mg orodispersible 
tablet in the evening. 
 
The recommended dose for prevention of further episodes is two 0.5 mg orodispersible tablets (1 mg 
budesonide) per day or two 1 mg orodispersible tablets (2 mg budesonide) per day, depending on your 
body’s response to the treatment. Take one orodispersible tablet in the morning and one orodispersible 
tablet in the evening.  
 
Method of administration 
Take the orodispersible tablet immediately once removed from the blister package.  
 
Take the orodispersible tablet after a meal. 
 
Place the orodispersible tablet on the tip of your tongue and close your mouth. Press it gently against 
the roof of your mouth with your tongue until it has dissolved completely (this usually takes at least 
two minutes but may take up to 20 minutes). Swallow the dissolved material with saliva little by little, 
as the orodispersible tablet breaks up. 
Do NOT take any liquid with the orodispersible tablet. 
 
Do not chew or swallow the undissolved orodispersible tablet. 
 
Do not eat, drink, brush your teeth or rinse your mouth for at least 30 minutes after you have taken the 
orodispersible tablet. Do not use any oral solutions, sprays or chewable tablets for at least 30 minutes 
before or after administration of the orodispersible tablet. This will ensure that your medicine works 
properly.  
 
Kidney and liver problems  
If you have any problem with your kidney or liver, talk to your doctor. If you have a kidney problem, 
your doctor will decide if Jorveza is suitable for you. In case your kidney problems are severe, you 
should not take Jorveza. If you have any liver disease, you should not take Jorveza. 
 
Duration of treatment 
Initially, your treatment should last about 6 to 12 weeks.  
After treatment of the acute episode, your doctor will decide how long and with which dose you are to 
continue the treatment, depending on your condition and your response to the treatment. 
 
If you take more Jorveza than you should 
If you have taken too many orodispersible tablets on one occasion, take your next dose as prescribed. 
Do not take a smaller amount. Contact a doctor if you are in doubt. Take the carton and this leaflet 
with you if possible. 
 
If you forget to take Jorveza 
If you miss a dose, just take the next dose at the usual time. Do not take a double dose to make up for a 
forgotten dose. 
 



27 
 

If you stop taking Jorveza 
Speak to your doctor if you want to interrupt or end your treatment early. It is important that you do 
not stop taking your medicine without talking to your doctor. Keep taking your medicine until your 
doctor tells you to stop, even if you feel better. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The following side effects have been reported during the use of Jorveza: 
 
Very common: may affect more than 1 in 10 people 
− fungal infections in the gullet (which can cause pain or discomfort when swallowing) 
 
Common: may affect up to 1 in 10 people 
− headache 
− fungal infections in the mouth and throat (symptoms can be white spots) 
− heartburn 
− indigestion 
− feeling sick (nausea) 
− tingling or numbness in your mouth 
− tiredness 
− decreased amount of the hormone cortisol in your blood. 
 
Uncommon: may affect up to 1 in 100 people 
− difficulty in sleeping   
− anxiety 
− dizziness 
− taste disorder  
− dry eyes 
− high blood pressure 
− cough, dry throat  
− abdominal pain, upper abdominal pain 
− difficulty swallowing 
− inflammation of the stomach, ulcers in the stomach 
− burning tongue, swelling of the lips, dry mouth 
− rash, itching rash 
− sensation of foreign body  
− pain in the mouth or throat. 
 
The following side effects have been reported and are typical with medicines similar to Jorveza 
(corticosteroids), and can therefore also occur with this medicine. The frequency of these events is 
currently not known:  
− increased risk of infection 
− Cushing’s syndrome, which is associated with too much corticosteroid and causes roundness of 

the face, weight gain, high blood sugar, build-up of fluid in the tissues (e.g. swollen legs), 
reduced potassium level in the blood (hypokalaemia), irregular periods in women, unwanted 
body hair in women, impotence, stretch marks on the skin, acne. 

− slowed growth in children 
− mood changes, such as depression, irritability or euphoria 
− restlessness with increased physical activity, aggression 



28 
 

− increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic 
disk) in adolescents  

− blurred vision 
− increased risk of blood clots, inflammation of the blood vessels (which can happen when the 

medicine is stopped after long-term use) 
− constipation, ulcers in the small intestine  
− inflammation of the pancreas, which causes severe pain in the belly and back 
− rash, red spots from bleeding in the skin, delayed wound healing, skin reactions such as contact 

dermatitis, bruising 
− muscle and joint pain, muscle weakness, muscle twitching 
− weakening of the bones (osteoporosis), bone damage due to poor circulation of blood 

(osteonecrosis) 
− general feeling of being ill. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Jorveza 
 
Keep this medicine out of the sight and reach of children. 
 
Do not take this medicine after the expiry date which is stated on the carton and blister after “EXP”. 
The expiry date refers to the last day of that month. 
 
Do not store above 25 °C. Store in the original package in order to protect from light and moisture. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Jorveza contains  
 
Jorveza 0.5 mg orodispersible tablet 
 
- The active substance is budesonide. Each orodispersible tablet contains 0.5 mg of budesonide. 

 
- The other ingredients are disodium hydrogen citrate, docusate sodium, macrogol (6000), 

magnesium stearate, mannitol (E 421), anhydrous monosodium citrate, povidone (K25), sodium 
hydrogen carbonate and sucralose (see also section 2, ”Jorveza contains sodium”).  

 
Jorveza 1 mg orodispersible tablet 
 
- The active substance is budesonide. Each orodispersible tablet contains 1 mg of budesonide. 
 
- The other ingredients are disodium hydrogen citrate, docusate sodium, macrogol (6000), 

magnesium stearate, mannitol (E 421), anhydrous monosodium citrate, povidone (K25), sodium 
hydrogen carbonate and sucralose (see also section 2, ”Jorveza contains sodium”). 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


29 
 

What Jorveza looks like and contents of the pack 
 
Jorveza 0.5 mg orodispersible tablet 
 
Jorveza 0.5 mg orodispersible tablets are white, round, biplane. They are debossed with “0.5” on one 
side. They come in blisters in packs with 20, 60, 90, 100 or 200 orodispersible tablets.   
 
Jorveza 1 mg orodispersible tablet 
 
Jorveza 1 mg orodispersible tablets are white, round, biplane. They come in blisters in packs with 20, 
30, 60, 90, 100 or 200 orodispersible tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Dr. Falk Pharma GmbH 
Leinenweberstr. 5 
79108 Freiburg 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Dr. Falk Pharma Benelux 
Tél/Tel: +31-(0)76-5244200 
info@drfalkpharma-benelux.eu 
 

Lietuva 
UAB Morfėjus 
Tel: +370 5 2796328 
biuras@morfejus.lt 
 

България 
Dr. Falk Pharma GmbH 
Teл: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

Luxembourg/Luxemburg 
Dr. Falk Pharma Benelux 
Tél/Tel: +31-(0)76-5244200 
info@drfalkpharma-benelux.eu 
 

Česká republika 
Ewopharma, spol. s r. o. 
Tel: +420 267 311 613 
info@ewopharma.cz 

Magyarország 
Medicons Kft. 
Tel: +36 23 444 773 
central@medicons.hu 

Danmark 
Vifor Pharma Nordiska AB 
Tlf: +46 8 5580 6600 
info.nordic@viforpharma.com 
 

Malta 
Dr. Falk Pharma GmbH 
Tel: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

Deutschland 
Dr. Falk Pharma GmbH 
Tel: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

Nederland 
Dr. Falk Pharma Benelux 
Tel: +31-(0)76-5244200 
info@drfalkpharma-benelux.eu 
 

Eesti 
Dr. Falk Pharma GmbH 
Tel: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

Norge 
Vifor Pharma Nordiska AB 
Tlf: +46 8 5580 6600 
info.nordic@viforpharma.com 
 

Ελλάδα 
GALENICA A.E 
Tηλ: +30 210 52 81 700 

Österreich 
Dr. Falk Pharma Österreich GmbH 
Tel: +43 (1) 577 3516 0 

mailto:info@drfalkpharma-benelux.eu
mailto:biuras@morfejus.lt
mailto:zentrale@drfalkpharma.de
mailto:info@drfalkpharma-benelux.eu
mailto:info@ewopharma.cz
mailto:central@medicons.hu
mailto:info.nordic@viforpharma.com
mailto:zentrale@drfalkpharma.de
mailto:zentrale@drfalkpharma.de
mailto:info@drfalkpharma-benelux.eu
mailto:zentrale@drfalkpharma.de
mailto:info.nordic@viforpharma.com


30 
 

contact@galenica.gr 
 

office@drfalkpharma.at 
 

España 
Dr. Falk Pharma España 
Tel: +34 91 372 95 08 
drfalkpharma@drfalkpharma.es  
 

Polska 
Dr. Falk Pharma GmbH 
Tel: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

France 
Dr. Falk Pharma GmbH 
Tél: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

Portugal 
Dr. Falk Pharma Portugal, Sociedade Unipessoal 
Lda. 
Tel: +351 21 412 61 70 
farmacovigilancia@drfalkpharma.pt 
 

Hrvatska 
Würth d.o.o.  
Tel: +385 1 4650358 
wurth@zg.t-com.hr 
 
Ireland 
Dr. Falk Pharma GmbH 
Tel: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

România 
Dr. Falk Pharma GmbH 
Tel: +49 761 1514 0 
zentrale@drfalkpharma.de 
 
Slovenija 
Ewopharma d.o.o. 
Tel: + 386 (0) 590 848 40 
info@ewopharma.si  
 

Ísland 
Dr. Falk Pharma GmbH 
Sími: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

Slovenská republika 
Dr. Falk Pharma GmbH 
Tel: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

Italia 
Dr. Falk Pharma GmbH 
Tel: +49 761 1514 0 
zentrale@drfalkpharma.de 
 

Suomi/Finland 
Vifor Pharma Nordiska AB 
Puh/Tel: +46 8 5580 6600 
info.nordic@viforpharma.com 
 

Κύπρος 
THESPIS PHARMACEUTICAL Ltd  
Τηλ: +357 22677710 
pharmacovigilance@thespispharma.com 

Sverige 
Vifor Pharma Nordiska AB 
Tel: +46 8 5580 6600 
info.nordic@viforpharma.com 
 

Latvija 
UAB Morfėjus 
Tel: +370 5 2796328 
biuras@morfejus.lt 

United Kingdom 
Dr. Falk Pharma UK Ltd 
Tel: + 44 (0) 1628 536600 
office@drfalkpharma.co.uk  

 
 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 

mailto:contact@galenica.gr
mailto:office@drfalkpharma.at
mailto:drfalkpharma@drfalkpharma.es
mailto:zentrale@drfalkpharma.de
mailto:zentrale@drfalkpharma.de
mailto:farmacovigilancia@drfalkpharma.pt
mailto:wurth@zg.t-com.hr
mailto:zentrale@drfalkpharma.de
mailto:zentrale@drfalkpharma.de
mailto:info@ewopharma.si
mailto:zentrale@drfalkpharma.de
mailto:zentrale@drfalkpharma.de
mailto:zentrale@drfalkpharma.de
mailto:info.nordic@viforpharma.com
mailto:info.nordic@viforpharma.com
mailto:biuras@morfejus.lt
mailto:office@drfalkpharma.co.uk
http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A.  MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what jorveza is and what it is used for', 'Section_Content': 'jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation. it is used in adults (older than 18 years of age) to treat eosinophilic oesophagitis, which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food.', 'Entity_Recognition': [{'Text': 'jorveza', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 0, 'EndOffset': 7, 'Score': 0.8399120569229126, 'Text': 'jorveza', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'the active substance budesonide', 'Type': 'TREATMENT', 'BeginOffset': 17, 'EndOffset': 48}, {'Text': 'a corticosteroid medicine', 'Type': 'TREATMENT', 'BeginOffset': 50, 'EndOffset': 75}, {'Id': 3, 'BeginOffset': 89, 'EndOffset': 101, 'Score': 0.9851239323616028, 'Text': 'inflammation', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9252356290817261}]}, {'Id': 8, 'BeginOffset': 136, 'EndOffset': 138, 'Score': 0.7319510579109192, 'Text': '18', 'Category': 'PROTECTED_HEALTH_INFORMATION', 'Type': 'AGE', 'Traits': []}, {'Id': 4, 'BeginOffset': 162, 'EndOffset': 187, 'Score': 0.933968186378479, 'Text': 'eosinophilic oesophagitis', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.926817774772644}]}, {'Text': 'an inflammatory condition', 'Type': 'PROBLEM', 'BeginOffset': 198, 'EndOffset': 223}, {'Id': 6, 'BeginOffset': 276, 'EndOffset': 291, 'Score': 0.47514525055885315, 'Text': 'swallowing food', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6775901317596436}]}]}
{'Title': '2. what you need to know before you take jorveza', 'Section_Content': 'do not take jorveza − if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6). warnings and precautions talk to your doctor or pharmacist before taking jorveza if you have: − tuberculosis − high blood pressure − diabetes, or if somebody in your family has diabetes − weakening of the bones (osteoporosis) − ulcers in the stomach or first part of the small intestine (peptic ulcer) − increased pressure in your eye (which can cause glaucoma) or eye problems such as clouding of the lens (cataracts) or if somebody in your family has glaucoma − liver disease. if you have any of the conditions mentioned above you may be at increased risk of side effects. your doctor will decide on the appropriate measures and if it is still all right for you to take this medicine. jorveza may cause typical side effects of corticosteroid medicines and may affect all parts of the body, particularly when you take this medicine at high doses and over a long time (see section 4). further precautions during treatment with jorveza − contact your doctor if you get blurred vision or have other problems with your vision. take the following precautions during treatment with jorveza because your immune system may be weakened: − tell your doctor if you get fungal infections in the mouth, throat and gullet or if you think you have any infection during treatment with this medicine. symptoms of fungal infection can be white spots in the mouth and throat and difficulty in swallowing. the symptoms of some infections can be unusual or less noticeable. − keep away from people who have chickenpox or herpes zoster (shingles) if you have not had these infections. the effects of these illnesses can be much more severe during treatment with this medicine. if you do come into contact with chickenpox or shingles, see your doctor straight away. please also report your vaccination status to your doctor. − tell your doctor if you have not yet had measles and/or if and when you have received your last vaccination for this disease. − if you need to be vaccinated please speak to your doctor first. − if you know that you are due to have an operation please tell your doctor that you are taking jorveza. jorveza could affect the results of adrenal function tests (acth stimulation test) ordered by your doctor or in hospital. tell your doctors that you are taking jorveza before you have any tests. children and adolescents jorveza should not be used in children and adolescents under 18 years of age. the use of this medicine in children younger than 18 years of age has not yet been studied. other medicines and jorveza tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. some of these medicines may increase the effects of jorveza and your doctor may wish to monitor you carefully if you are taking these medicines. in particular: − ketoconazole or itraconazole (to treat fungal infections) − clarithromycin, an antibiotic medicine used to treat infections − ritonavir and cobicistat (to treat hiv infections) − oestrogens (used for hormone replacement therapy or contraception) − cardiac glycosides such as digoxin (medicines used to treat heart conditions) − diuretics (to remove excess fluid from the body). jorveza with food and drink you should not drink grapefruit juice whilst you are taking this medicine as this can worsen its side effects. pregnancy and breast-feeding if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. do not take this medicine during pregnancy without checking with your doctor first. do not take this medicine if you are breast-feeding unless you have checked with your doctor. budesonide passes in small amounts into the breast milk. your doctor will help you decide whether you should continue treatment and not breast-feed or if you should stop treatment over the period your baby is being breast-fed. driving and using machines jorveza is not expected to affect your ability to drive or use machines. jorveza contains sodium this medicine contains 52 mg sodium (main component of cooking/table salt) per daily dose. this is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.', 'Entity_Recognition': [{'Text': 'jorveza', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 13, 'BeginOffset': 12, 'EndOffset': 19, 'Score': 0.991391658782959, 'Text': 'jorveza', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.8592298626899719}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 33, 'EndOffset': 41}, {'Id': 14, 'BeginOffset': 45, 'EndOffset': 55, 'Score': 0.9981356859207153, 'Text': 'budesonide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this 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{'Title': '3. how to take jorveza', 'Section_Content': "always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. the recommended dose for treatment of acute episodes is two 1 mg orodispersible tablets (2 mg budesonide) per day. take one 1 mg orodispersible tablet in the morning and one 1 mg orodispersible tablet in the evening. the recommended dose for prevention of further episodes is two 0.5 mg orodispersible tablets (1 mg budesonide) per day or two 1 mg orodispersible tablets (2 mg budesonide) per day, depending on your body's response to the treatment. take one orodispersible tablet in the morning and one orodispersible tablet in the evening. method of administration take the orodispersible tablet immediately once removed from the blister package. take the orodispersible tablet after a meal. place the orodispersible tablet on the tip of your tongue and close your mouth. press it gently against the roof of your mouth with your tongue until it has dissolved completely (this usually takes at least two minutes but may take up to 20 minutes). swallow the dissolved material with saliva little by little, as the orodispersible tablet breaks up. do not take any liquid with the orodispersible tablet. do not chew or swallow the undissolved orodispersible tablet. do not eat, drink, brush your teeth or rinse your mouth for at least 30 minutes after you have taken the orodispersible tablet. do not use any oral solutions, sprays or chewable tablets for at least 30 minutes before or after administration of the orodispersible tablet. this will ensure that your medicine works properly. kidney and liver problems if you have any problem with your kidney or liver, talk to your doctor. if you have a kidney problem, your doctor will decide if jorveza is suitable for you. in case your kidney problems are severe, you should not take jorveza. if you have any liver disease, you should not take jorveza. duration of treatment initially, your treatment should last about 6 to 12 weeks. after treatment of the acute episode, your doctor will decide how long and with which dose you are to continue the treatment, depending on your condition and your response to the treatment. if you take more jorveza than you should if you have taken too many orodispersible tablets on one occasion, take your next dose as prescribed. do not take a smaller amount. contact a doctor if you are in doubt. take the carton and this leaflet with you if possible. if you forget to take jorveza if you miss a dose, just take the next dose at the usual time. do not take a double dose to make up for a forgotten dose. if you stop taking jorveza speak to your doctor if you want to interrupt or end your treatment early. it is important that you do not stop taking your medicine without talking to your doctor. keep taking your medicine until your doctor tells you to stop, even if you feel better. if you have any further questions on the 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{'Title': '4. possible side effects', 'Section_Content': "like all medicines, this medicine can cause side effects, although not everybody gets them. the following side effects have been reported during the use of jorveza: very common: may affect more than 1 in 10 people − fungal infections in the gullet (which can cause pain or discomfort when swallowing) common: may affect up to 1 in 10 people − headache − fungal infections in the mouth and throat (symptoms can be white spots) − heartburn − indigestion − feeling sick (nausea) − tingling or numbness in your mouth − tiredness − decreased amount of the hormone cortisol in your blood. uncommon: may affect up to 1 in 100 people − difficulty in sleeping − anxiety − dizziness − taste disorder − dry eyes − high blood pressure − cough, dry throat − abdominal pain, upper abdominal pain − difficulty swallowing − inflammation of the stomach, ulcers in the stomach − burning tongue, swelling of the lips, dry mouth − rash, itching rash − sensation of foreign body − pain in the mouth or throat. the following side effects have been reported and are typical with medicines similar to jorveza (corticosteroids), and can therefore also occur with this medicine. the frequency of these events is currently not known: − increased risk of infection − cushing's syndrome, which is associated with too much corticosteroid and causes roundness of the face, weight gain, high blood sugar, build-up of fluid in the tissues (e.g. swollen legs), reduced potassium level in the blood (hypokalaemia), irregular periods in women, unwanted body hair in women, impotence, stretch marks on the skin, acne. − slowed growth in children − mood changes, such as depression, irritability or euphoria − restlessness with increased physical activity, aggression 28 − increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disk) in adolescents − blurred vision − increased risk of blood clots, inflammation of the blood vessels (which can happen when the medicine is stopped after long-term use) − constipation, ulcers in the small intestine − inflammation of the pancreas, which causes severe pain in the belly and back − rash, red spots from bleeding in the skin, delayed wound healing, skin reactions such as contact dermatitis, bruising − muscle and joint pain, muscle weakness, muscle twitching − weakening of the bones (osteoporosis), bone damage due to poor circulation of blood (osteonecrosis) − general feeling of being ill. reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.", 'Entity_Recognition': [{'Text': 'jorveza', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 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{'Title': '5. how to store jorveza', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not take this medicine after the expiry date which is stated on the carton and blister after "exp". the expiry date refers to the last day of that month. do not store above 25 . store in the original package in order to protect from light and moisture. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what jorveza contains jorveza 0.5 mg orodispersible tablet - the active substance is budesonide. each orodispersible tablet contains 0.5 mg of budesonide. - the other ingredients are disodium hydrogen citrate, docusate sodium, macrogol (6000), magnesium stearate, mannitol (e 421), anhydrous monosodium citrate, povidone (k25), sodium hydrogen carbonate and sucralose (see also section 2, "jorveza contains sodium"). jorveza 1 mg orodispersible tablet - the active substance is budesonide. each orodispersible tablet contains 1 mg of budesonide. - the other ingredients are disodium hydrogen citrate, docusate sodium, macrogol (6000), magnesium stearate, mannitol (e 421), anhydrous monosodium citrate, povidone (k25), sodium hydrogen carbonate and sucralose (see also section 2, "jorveza contains sodium"). what jorveza looks like and contents of the pack jorveza 0.5 mg orodispersible tablet jorveza 0.5 mg orodispersible tablets are white, round, biplane. they are debossed with "0.5" on one side. they come in blisters in packs with 20, 60, 90, 100 or 200 orodispersible tablets. jorveza 1 mg orodispersible tablet jorveza 1 mg orodispersible tablets are white, round, biplane. they come in blisters in packs with 20, 30, 60, 90, 100 or 200 orodispersible tablets. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'jorveza', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'what jorveza', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 12}, {'Id': 1, 'BeginOffset': 22, 'EndOffset': 29, 'Score': 0.9950428009033203, 'Text': 'jorveza', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.705279529094696, 'RelationshipScore': 0.9985817670822144, 'RelationshipType': 'STRENGTH', 'Id': 2, 'BeginOffset': 30, 'EndOffset': 36, 'Text': '0.5 mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 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