Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
OPATANOL 1mg/ml eye drops solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Olopatadine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 take it
e 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. 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. 1
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. Opatanol contains Disodium Phosphate Dodecahydrate This medicine contains 16.72 mg phosphates (in 63.05 mg disodium phosphate dodecahydrate) in each bottle of 5 ml, which is equivalent to 3.34 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment. 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.
How to take it
Opatanol (continued)
1
2
How much to use 2
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. 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.
3
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store 5.
How to store it
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. 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.
4
Marketing Authorisation Holder and Manufacturer Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place, 195 Wood Lane London, W12 7FQ United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370 This leaflet was last revised in 02/2025 Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.emea.europa.eu/
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Frequently asked questions about OPATANOL 1mg/ml eye drops solution
How do I take OPATANOL 1mg/ml eye drops solution?
OPATANOL 1mg/ml eye drops solution comes as eye drops containing 1mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in OPATANOL 1mg/ml eye drops solution?
The active substance in OPATANOL 1mg/ml eye drops solution is olopatadine hydrochloride.
Are there equivalent medicines to OPATANOL 1mg/ml eye drops solution?
Medicines with the same active substance, strength and form include: Olopatadine 1 mg/ml Eye drops, Solution. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for OPATANOL 1mg/ml eye drops solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get OPATANOL 1mg/ml eye drops solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: olopatadine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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).
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.
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%.
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:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
💬 Ask about this leaflet
Ask anything about OPATANOL 1mg/ml eye drops solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.