Opatanol
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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



 
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1. NAME OF THE MEDICINAL PRODUCT 

 

Opatanol 1 mg/mL eye drops, solution 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

One mL of solution contains 1 mg olopatadine (as hydrochloride). 

 

Excipient(s) with known effect: 

 

Benzalkonium chloride 0.1 mg/ml. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Eye drops, solution (eye drops). 

 

Clear, colourless solution. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis. 

 

4.2 Posology and method of administration 

 

Posology 

 

The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly). 

Treatment may be maintained for up to four months, if considered necessary. 

 

Use in elderly 

No dosage adjustment in elderly patients is necessary. 

 

Paediatric patients 

Opatanol may be used in paediatric patients three years of age and older at the same dose as in adults. 

The safety and efficacy of Opatanol in children aged under 3 years has not been established. No data 

are available. 

 

Use in hepatic and renal impairment 

Olopatadine in the form of eye drops (Opatanol) has not been studied in patients with renal or hepatic 

disease. However, no dosage adjustment is expected to be necessary in hepatic or renal impairment 

(see section 5.2). 

 



 
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Method of administration 

 

For ocular use only. 

 

After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the 

product. To prevent contamination of the dropper tip and solution, care must be taken not to touch the 

eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly 

closed when not in use. 

 

In case of concomitant therapy with other topical ocular medicines, an interval of five minutes should 

be allowed between successive applications. Eye ointments should be administered last. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

4.4 Special warnings and precautions for use 

 

Opatanol is an antiallergic/antihistaminic agent and, although administered topically, is absorbed 

systemically. If signs of serious reactions or hypersensitivity occur, discontinue the use of this 

treatment. 

 

Opatanol contains benzalkonium chloride which may cause eye irritation. 

 

Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative 

keratopathy. Close monitoring is required with frequent or prolonged use in dry eye patients, or in 

conditions where the cornea is compromised. 

 

Contact lenses 

 

Benzalkonium is known to discolour soft contact lenses. Avoid contact with soft contact lenses. 

Patients should be instructed to remove contact lenses prior to administration of the eye drop and wait 

at least15 minutes after instillation before re-inserting contact lenses. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

No interaction studies with other medicinal products have been performed. 

 

In vitro studies have shown that olopatadine did not inhibit metabolic reactions which involve 

cytochrome P-450 isozymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4. These results indicate that 

olopatadine is unlikely to result in metabolic interactions with other concomitantly administered 

active substances. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are no or limited amount of data from the use of ophthalmic olopatadine in pregnant women. 

 

Studies in animals have shown reproductive toxicity following systemic administration (see 

section 5.3). 

 

Olopatadine is not recommended during pregnancy and in women of childbearing potential not using 

contraception. 

 



 
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Breast-feeding 

 

Available data in animals have shown excretion of olopatadine in milk following oral administration 

(for details see section 5.3). 

 

A risk to the newborn/infants cannot be excluded. 

 

Opatanol should not be used during breast-feeding. 

 

Fertility 

 

Studies have not been performed to evaluate the effect of topical ocular administration of olopatadine 

on human fertility. 

 

4.7 Effects on ability to drive and use machines 

 

Opatanol has no or negligible influence on the ability to drive and use machines. 

 

As with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to 

drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision 

clears before driving or using machinery. 

 

4.8 Undesirable effects 

 

Summary of safety profile 

 

In clinical studies involving 1680 patients, Opatanol was administered one to four times daily in both 

eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg. Approximately 

4.5% of patients can be expected to experience adverse reactions associated with the use of Opatanol; 

however, only 1.6% of patients discontinued from the clinical studies due to these adverse reactions. 

No serious ophthalmic or systemic adverse reactions related to Opatanol were reported in clinical 

studies. The most frequent treatment-related adverse reaction was eye pain, reported at an overall 

incidence of 0.7%. 

 



 
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Tabulated list of adverse reactions 

 

The following adverse reactions have been reported during clinical studies and post-marketing data 

and are classified according to the following convention: very common (≥1/10), common 

(≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000)very rare (<1/10,000) 

or not known (cannot be estimated from the available data). Within each frequency grouping, adverse 

reactions are presented in order of decreasing seriousness. 

 

System Organ Classification Frequency Adverse Reactions 

Infections and infestations Uncommon rhinitis 

Immune system disorders Not known hypersensitivity, swelling face 

Nervous system disorders Common headache, dysgeusia 

 Uncommon dizziness, hypoaesthesia 

 Not known somnolence 

Eye disorders Common eye pain, eye irritation, dry eye, abnormal 

sensation in eyes 

 Uncommon corneal erosion, corneal epithelium defect, 

corneal epithelium disorder, punctate 

keratitis, keratitis, corneal staining, eye 

discharge, photophobia, vision blurred, 

visual acuity reduced, blepharospasm, 

ocular discomfort, eye pruritus, 

conjunctival follicles, conjunctival 

disorder, foreign body sensation in eyes, 

lacrimation increased, erythema of eyelid, 

eyelid oedema, eyelid disorder, ocular 

hyperaemia 

 Not known corneal oedema, eye oedema, eye swelling, 

conjunctivitis, mydriasis, visual 

disturbance, eyelid margin crusting 

Respiratory, thoracic, and 

mediastinal disorders 

Common nasal dryness 

 Not known dyspnoea, sinusitis 

Gastrointestinal disorders Not known nausea, vomiting, 

Skin and subcutaneous tissue 

disorders 

Uncommon dermatitis contact, skin burning sensation, 

dry skin 

 Not known dermatitis, erythema 

General disorders and 

administration site conditions 

Common fatigue 

Not known asthenia, malaise 

 

Cases of corneal calcification have been reported very rarely in association with the use of phosphate 

containing eye drops in some patients with significantly damaged corneas. 

 

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. 

 

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


 
6 

4.9 Overdose 

 

No data are available in humans regarding overdose by accidental or deliberate ingestion. Olopatadine 

has a low order of acute toxicity in animals. Accidental ingestion of the entire contents of a bottle of 

Opatanol would deliver a maximum systemic exposure of 5 mg olopatadine. This exposure would 

result in a final dose of 0.5 mg/kg in a 10 kg infant, assuming 100% absorption. 

 

Prolongation of the QTc interval in dogs was observed only at exposures considered sufficiently in 

excess of the maximum human exposure indicating little relevance to clinical use. A 5 mg oral dose 

was administered twice-daily for 2.5 days to 102 young and elderly male and female healthy 

volunteers with no significant prolongation of QTc interval compared to placebo. The range of peak 

steady-state olopatadine plasma concentrations (35 to 127 ng/ml) seen in this study represents at least 

a 70-fold safety margin for topical olopatadine with respect to effects on cardiac repolarisation. 

 

In the case of overdose, appropriate monitoring and management of the patient should be 

implemented. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: ophthalmologicals; decongestant and antiallergics; other antiallergics, 

ATC code: S01GX 09 

 

Olopatadine is a potent selective antiallergic/antihistaminic agent that exerts its effects through 

multiple distinct mechanisms of action. It antagonises histamine (the primary mediator of allergic 

response in humans) and prevents histamine induced inflammatory cytokine production by human 

conjunctival epithelial cells. Data from in vitro studies suggest that it may act on human conjunctival 

mast cells to inhibit the release of pro-inflammatory mediators. In patients with patent nasolacrimal 

ducts, topical ocular administration of Opatanol was suggested to reduce the nasal signs and 

symptoms that frequently accompany seasonal allergic conjunctivitis. It does not produce a clinically 

significant change in pupil diameter. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Olopatadine is absorbed systemically, as are other topically administered medicinal products. 

However, systemic absorption of topically applied olopatadine is minimal with plasma concentrations 

ranging from below the assay quantitation limit (<0.5 ng/ml) up to 1.3 ng/ml. These concentrations 

are 50-to 200-fold lower than those following well tolerated oral doses. 

 

Elimination 

 

From oral pharmacokinetic studies, the half-life of olopatadine in plasma was approximately eight to 

12 hours, and elimination was predominantly through renal excretion. Approximately 60-70% of the 

dose was recovered in the urine as active substance. Two metabolites, the mono-desmethyl and the N-

oxide, were detected at low concentrations in the urine. 

 

Since olopatadine is excreted in urine primarily as unchanged active substance, impairment of renal 

function alters the pharmacokinetics of olopatadine with peak plasma concentrations 2.3-fold greater 

in patients with severe renal impairment (mean creatinine clearance of 13.0 ml/min) compared to 

healthy adults. Following a 10 mg oral dose in patients undergoing haemodialysis (with no urinary 

output), plasma olopatadine concentrations were significantly lower on the haemodialysis day than on 

the non-haemodialysis day suggesting olopatadine can be removed by haemodialysis. 



 
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Studies comparing the pharmacokinetics of 10 mg oral doses of olopatadine in young (mean age 

21 years) and elderly (mean age 74 years) showed no significant differences in the plasma 

concentrations (AUC), protein binding or urinary excretion of unchanged parent drug and metabolites. 

 

A renal impairment study after oral dosing of olopatadine has been performed in patients with severe 

renal impairment. The results indicate that a somewhat higher plasma concentration can be expected 

with Opatanol in this population. Since plasma concentrations following topical ocular dosing of 

olopatadine are 50-to 200-fold lower than after well-tolerated oral doses, dose adjustment is not 

expected to be necessary in the elderly or in the renally impaired population. Liver metabolism is a 

minor route of elimination. Dose adjustment is not expected to be necessary with hepatic impairment. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety, 

pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to 

reproduction. 

 

Studies in animals have shown reduced growth of nursing pups of dams receiving systemic doses of 

olopatadine well in excess of the maximum level recommended for human ocular use. Olopatadine 

has been detected in the milk of nursing rats following oral administration. 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Benzalkonium chloride 

sodium chloride 

disodium phosphate dodecahydrate (E339) 

hydrochloric acid (E507) (to adjust pH) 

sodium hydroxide (E524) (to adjust pH) 

purified water 

 

6.2 Incompatibilities 

 

In the absence of compatibility studies, this medicinal product must not be mixed with other 

medicinal products. 

 

6.3 Shelf-life 

 

3 years. 

 

Shelf-life after first opening 

 

Discard four weeks after first opening. 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and content of container 

 

5 ml opaque low density polyethylene bottles with polypropylene screw caps (DROP-TAINER). 

 

Cartons containing 1 or 3 bottles. Not all pack sizes may be marketed. 

 



 
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6.6 Special precautions for disposal 

 

No special requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBERS 

 

EU/1/02/217/001-002 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 17 May 2002 

Date of latest renewal: 22 May 2007 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

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/


 
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ANNEX II 

 

A. MANUFACTURER(S) 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 



 
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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Names and addresses of the manufacturer(s) responsible for batch release 

 

S.A. Alcon-Couvreur N.V. 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

or 

 

Alcon Cusí, S.A. 

Camil Fabra 58 

08320 El Masnou 

Barcelona 

Spain 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription. 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic Safety Update Reports 
 

The requirements for submission of periodic safety update reports 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) 

 

Not applicable. 

 



 
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ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



 
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A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

BOX OF 1 BOTTLE + BOX OF 3 BOTTLES 

1. NAME OF THE MEDICINAL PRODUCT

Opatanol 1 mg/mL eye drops, solution 

olopatadine 

2. STATEMENT OF ACTIVE SUBSTANCE

1 mL of solution contains 1 mg olopatadine (as hydrochloride). 

3. LIST OF EXCIPIENTS

Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, hydrochloric 

acid/sodium hydroxide and purified water. 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 

1 x 5 mL 

3 x 5 mL 

5. METHOD AND ROUTE OF ADMINISTRATION

Read the package leaflet before use. 

For ocular 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 

Discard four weeks after first opening. 

Opened: 

Opened (1): 

Opened (2): 

Opened (3): 



 
14 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 

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 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBERS 

 

EU/1/02/217/001 1 x5 ml 

EU/1/02/217/002 3 x 5 ml 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Opatanol 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 



 
15 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

BOTTLE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 

 

Opatanol 1 mg/mL eye drops 

olopatadine 

For ocular use. 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

 

3. EXPIRY DATE 

 

EXP 

Discard four weeks after first opening. 

Opened: 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

5 mL 

 

 

6 OTHER 

 



 
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B. PACKAGE LEAFLET 



 
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Package leaflet: Information for the user 

 

Opatanol 1 mg/mL eye drops, solution 

olopatadine 

 

Read all of this leaflet carefully before you start using 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 Opatanol is and what it is used for 

2. What you need to know before you use Opatanol 

3. How to use Opatanol 

4. Possible side effects 

5. How to store Opatanol 

6. Contents of the pack and other information 

 

1. What OPATANOL is and what it is used for 

 

Opatanol is used for the treatment of signs and symptoms of seasonal allergic conjunctivitis. 

 

Allergic conjunctivitis. Some materials (allergens) like pollens, house dust or animal fur may cause 

allergic reactions resulting in itching, redness as well as swelling of the surface of your eye. 

 

Opatanol is a medicine for treatment of allergic conditions of the eye. It works by reducing the 

intensity of the allergic reaction. 

 

 

2. What you need to know before you use Opatanol 

 

Do not use Opatanol 

 If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this 

medicine (listed in section 6). 

 You should not use OPATANOL if you are breast-feeding. 

 

Warnings and precautions 

Talk to your doctor or pharmacist before using Opatanol. 

 

You should remove contact lenses that are in your eyes before using Opatanol. 

 

Children 

Do not use Opatanol in children under the age of 3 years. Do not give this medicine to children under 

the ages of 3 years because there is no data to indicate that it is safe and work in children under 

3 years. 

 



 
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Other medicines and Opatanol 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

If you are using other eye drops or eye ointment medicines, leave at least 5 minutes between each 

medicine. Eye ointments should be administered last. 

 

Pregnancy, breast-feeding and fertility 

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 using this medicine. 

 

You should not use Opatanol if you are breast-feeding, ask your doctor for advice before using this 

medicine. 

 

Driving and using machines 

You may find that your vision is blurred for a time just after you use Opatanol. Do not drive or use 

machines until this has worn off. 

 

Opatanol contains Benzalkonium chloride 

 

This medicine contains 0.5 mg benzalkonium chloride in each 5 ml which is equivalent to 0.1 mg/ml. 

 

The preservative in Opatanol, benzalkonium chloride, may be absorbed by soft contact lenses and 

may change the colour of the contact lenses. You should remove contact lenses before using this 

medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye 

irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the 

eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to 

your doctor. 

 

 

3. How to use Opatanol 

 

Always use 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 is one drop in the eye or eyes, twice a day, morning and evening. 

 

Use this much unless your doctor tells you to do differently. Only use Opatanol in both eyes if your 

doctor told you to. Use it for as long as your doctor told you to. 

 

Opatanol should only be used as an eye drop. 

 

TURN THE PAGE FOR MORE ADVICE. 

 

Now turn over. 

 



 
19 

How to use Opatanol (continued) 

  
 1 2 

 

How much to use 

see side 1 

 

 Get the Opatanol bottle and a mirror. 

 Wash your hands. 

 Take the bottle and twist off the cap. 

 After cap is removed, if the tamper evident snap collar is loose, remove before using the 

product. 

 Hold the bottle, pointing down, between your thumb and middle finger. 

 Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between 

the eyelid and your eye. The drop will go in here (picture 1). 

 Bring the bottle tip close to the eye. Use the mirror if it helps. 

 Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could 

infect the drops left in the bottle. 

 Gently press on the base of the bottle to release one drop of Opatanol at a time. 

 Don’t squeeze the bottle, it is designed so that just a gentle press on the bottom is needed 

(picture 2). 

 If you use drops in both eyes, repeat the steps for your other eye. 

 Put the bottle cap back on firmly immediately after use. 

 

If a drop misses your eye, try again. 

 

If you use more Opatanol than you should 

Rinse it all out with warm water. Do not put in any more drops until it’s time for your next regular 

dose. 

 

If you forget to use Opatanol 

Use a single drop as soon as you remember, and then go back to your regular dosing routine. 

However, if it is almost time for your next dose, skip the missed dose before going back to your 

regular dosing routine. Do not use a double dose to make up for the one missed. 

 

If you stop using Opatanol 

Do not stop using this medicine without first speaking to your doctor. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 



 
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4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

The following side effects have been seen with Opatanol: 

 

Common (may affect up to 1 in 10 people) 

Effects in the eye: 

Eye pain, eye irritation, dry eye, abnormal eye sensation, eye discomfort. 

 

General side effects 

Headache, fatigue, dry nose, bad taste. 

 

Uncommon (may affect up to 1 in 100 people) 

Effects in the eye 

Blurred, reduced, or abnormal vision, corneal disorder, eye surface inflammation with or without 

surface damage, inflammation or infection of the conjunctiva, eye discharge, sensitivity to light, 

increased tear production, itchy eye, redness of the eye, eyelid abnormality, itching, redness, swelling, 

or crusting of the eyelid. 

 

General side effects 

Abnormal or decreased sensation, dizziness, runny nose, dry skin, skin inflammation. 

 

Not known (frequency cannot be estimated from the available data) 

Effects in the eye 

Eye swelling, corneal swelling, change in pupil size. 

 

General side effects 

Shortness of breath, increased allergic symptoms, facial swelling, drowsiness, generalized weakness, 

nausea, vomiting, sinus infection, skin redness and itching. 

 

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the 

cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment. 

 

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 Opatanol 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the bottle and the box after ‘EXP’. 

The expiry date refers to the last day of the month. 

 

This medicine does not require any special storage conditions. 

 

You should throw away the bottle four weeks after you first opened it to prevent infections, and use a 

new bottle. Write down the date you opened it in the space on each bottle label and box. 

 

Do not throw away 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. 

 

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


 
21 

 

6 Content of the pack and other information 

 

What Opatanol contains 

- The active substance is olopatadine. Each mL of solution contains 1 mg of olopatadine (as 

hydrochloride). 

- The other ingredients are benzalkonium chloride, sodium chloride, disodium phosphate 

dodecahydrate (E339), hydrochloric acid (E507) and/or sodium hydroxide (E524) and purified 

water. 

 

What Opatanol looks like and contents of the pack 

Opatanol is a clear and colourless liquid (a solution) supplied in a pack containing either one 5 ml 

bottle or three 5 ml plastic bottles with screw caps. 

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

S.A. Alcon-Couvreur N.V. 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

Alcon Cusí, S.A. 

Camil Fabra 58 

08320 El Masnou 

Spain 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

Lietuva 

SIA „Novartis Baltics“ Lietuvos filialas 

Tel: +370 5 269 16 50 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

Nederland 

Novartis Pharma B.V. 

Tel: +31 26 37 82 111 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 



 
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Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: + 421 2 5542 5439 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

This leaflet was last revised in 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.emea.europa.eu/ 

 

http://www.emea.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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 opatanol is and what it is used for', 'Section_Content': 'opatanol is used for the treatment of signs and symptoms of seasonal allergic conjunctivitis. allergic conjunctivitis. some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye. opatanol is a medicine for treatment of allergic conditions of the eye. it works by reducing the intensity of the allergic reaction.', 'Entity_Recognition': [{'Text': 'opatanol', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 2, 'BeginOffset': 0, 'EndOffset': 8, 'Score': 0.9817423224449158, 'Text': 'opatanol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'signs', 'Type': 'PROBLEM', 'BeginOffset': 38, 'EndOffset': 43}, {'Text': 'symptoms', 'Type': 'PROBLEM', 'BeginOffset': 48, 'EndOffset': 56}, {'Id': 4, 'BeginOffset': 60, 'EndOffset': 92, 'Score': 0.6532711982727051, 'Text': 'seasonal allergic conjunctivitis', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.6421136260032654}]}, {'Id': 5, 'BeginOffset': 94, 'EndOffset': 117, 'Score': 0.9348219633102417, 'Text': 'allergic conjunctivitis', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.7457378506660461}]}, {'Text': 'some materials (allergens', 'Type': 'PROBLEM', 'BeginOffset': 119, 'EndOffset': 144}, {'Id': 6, 'BeginOffset': 195, 'EndOffset': 213, 'Score': 0.9673033952713013, 'Text': 'allergic reactions', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6581825613975525}, {'Name': 'DIAGNOSIS', 'Score': 0.49333828687667847}]}, {'Id': 7, 'BeginOffset': 227, 'EndOffset': 234, 'Score': 0.9982085227966309, 'Text': 'itching', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7885017395019531}]}, {'Id': 8, 'BeginOffset': 236, 'EndOffset': 243, 'Score': 0.9926119446754456, 'Text': 'redness', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8127105236053467}]}, {'Id': 9, 'BeginOffset': 255, 'EndOffset': 263, 'Score': 0.9837729334831238, 'Text': 'swelling', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7789077758789062}], 'Attributes': [{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.979381263256073, 'RelationshipScore': 0.999448835849762, 'RelationshipType': 'SYSTEM_ORGAN_SITE', 'Id': 0, 'BeginOffset': 287, 'EndOffset': 290, 'Text': 'eye', 'Category': 'ANATOMY', 'Traits': []}]}, {'Id': 0, 'BeginOffset': 287, 'EndOffset': 290, 'Score': 0.979381263256073, 'Text': 'eye', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 3, 'BeginOffset': 292, 'EndOffset': 300, 'Score': 0.9247405529022217, 'Text': 'opatanol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a medicine', 'Type': 'TREATMENT', 'BeginOffset': 304, 'EndOffset': 314}, {'Text': 'allergic conditions of the eye', 'Type': 'PROBLEM', 'BeginOffset': 332, 'EndOffset': 362}, {'Text': 'the allergic reaction', 'Type': 'PROBLEM', 'BeginOffset': 402, 'EndOffset': 423}]}
{'Title': '2. what you need to know before you use opatanol', 'Section_Content': 'do not use opatanol if you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6). you should not use opatanol if you are breast-feeding. warnings and precautions talk to your doctor or pharmacist before using opatanol. you should remove contact lenses that are in your eyes before using opatanol. children do not use opatanol in children under the age of 3 years. do not give this medicine to children under the ages of 3 years because there is no data to indicate that it is safe and work in children under 3 years. other medicines and opatanol tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. if you are using other eye drops or eye ointment medicines, leave at least 5 minutes between each medicine. eye ointments should be administered last. pregnancy, breast-feeding and fertility 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 using this medicine. you should not use opatanol if you are breast-feeding, ask your doctor for advice before using this medicine. driving and using machines you may find that your vision is blurred for a time just after you use opatanol. do not drive or use machines until this has worn off. opatanol contains benzalkonium chloride this medicine contains 0.5 mg benzalkonium chloride in each 5 ml which is equivalent to 0.1 mg/ml. the preservative in opatanol, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses. you should remove contact lenses before using this medicine and put them back 15 minutes afterwards. benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). if you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.', 'Entity_Recognition': [{'Text': 'opatanol', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 11, 'BeginOffset': 11, 'EndOffset': 19, 'Score': 0.9781540632247925, 'Text': 'opatanol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.8687958717346191}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 31, 'EndOffset': 39}, {'Id': 29, 'BeginOffset': 41, 'EndOffset': 55, 'Score': 0.6214120984077454, 'Text': 'hypersensitive', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': []}, {'Id': 12, 'BeginOffset': 60, 'EndOffset': 71, 'Score': 0.996772825717926, 'Text': 'olopatadine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 107, 'EndOffset': 120}, {'Id': 13, 'BeginOffset': 163, 'EndOffset': 171, 'Score': 0.9646956920623779, 'Text': 'opatanol', 'Category': 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{'Title': '3. how to use opatanol', 'Section_Content': "always use 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 is one drop in the eye or eyes, twice a day, morning and evening. use this much unless your doctor tells you to do differently. only use opatanol in both eyes if your doctor told you to. use it for as long as your doctor told you to. opatanol should only be used as an eye drop. turn the page for more advice. now turn over. how to use opatanol (continued) 1 2 how much to use see side 1 get the opatanol bottle and a mirror. wash your hands. take the bottle and twist off the cap. after cap is removed, if the tamper evident snap collar is loose, remove before using the product. hold the bottle, pointing down, between your thumb and middle finger. tilt your head back. pull down your eyelid with a clean finger, until there is a 'pocket' between the eyelid and your eye. the drop will go in here (picture 1). bring the bottle tip close to the eye. use the mirror if it helps. don't touch your eye or eyelid, surrounding areas or other surfaces with the dropper. it could infect the drops left in the bottle. gently press on the base of the bottle to release one drop of opatanol at a time. don't squeeze the bottle, it is designed so that just a gentle press on the bottom is needed (picture 2). if you use drops in both eyes, repeat the steps for your other eye. put the bottle cap back on firmly immediately after use. if a drop misses your eye, try again. if you use more opatanol than you should rinse it all out with warm water. do not put in any more drops until it's time for your next regular dose. if you forget to use opatanol use a single drop as soon as you remember, and then go back to your regular dosing routine. however, if it is almost time for your next dose, skip the missed dose before going back to your regular dosing routine. do not use a double dose to make up 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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 seen with opatanol: common (may affect up to 1 in 10 people) effects in the eye: eye pain, eye irritation, dry eye, abnormal eye sensation, eye discomfort. general side effects headache, fatigue, dry nose, bad taste. uncommon (may affect up to 1 in 100 people) effects in the eye blurred, reduced, or abnormal vision, corneal disorder, eye surface inflammation with or without surface damage, inflammation or infection of the conjunctiva, eye discharge, sensitivity to light, increased tear production, itchy eye, redness of the eye, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid. general side effects abnormal or decreased sensation, dizziness, runny nose, dry skin, skin inflammation. not known (frequency cannot be estimated from the available data) effects in the eye eye swelling, corneal swelling, change in pupil size. general side effects shortness of breath, increased allergic symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinus infection, skin redness and itching. in very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment. 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': 'opatanol', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 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{'Title': '5. how to store opatanol', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': None, 'Entity_Recognition': None}