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.
Olopatadine 1 mg/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
Olopatadine Eye drops, Solution 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. Olopatadine Eye drops, Solution 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 Olopatadine Eye drops, Solution
Do not use Olopatadine Eye drops, Solution: • •
If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6). You should not use Olopatadine Eye drops, Solution if you are breast-feeding.
Warning and precautions Talk to your doctor, pharmacist before taking Olopatadine Eye drops, Solution. You should remove contact lenses that are in your eyes before using Olopatadine Eye drops, Solution.
Children •
Do not use Olopatadine Eye drops, Solution 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 Olopatadine eye drops 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 Olopatadine Eye drops, Solution 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 Olopatadine Eye drops, Solution. Do not drive or use machines until this has worn off. Olopatadine Eye drops, Solution contains Benzalkonium chloride This medicine contains 0.1 mg benzalkonium chloride in each ml. 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 take it
Olopatadine eye drops
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 Olopatadine Eye drops, Solution in both eyes if your doctor told you to. Use it for as long as your doctor told you to.
Olopatadine Eye drops, Solution should only be used as an eye drop.
INSTRUCTIONS FOR USE
Using the dropperbottle for the first time: Opening the dropper bottle before first use
1. Check to make sure that the tamper evident ring between the dropper bottle and the cap is not broken (See Fig. 1). You must not use the bottle if the tamper evident ring on the bottle neck is broken.
2. Before opening the bottle for the first time, tear off the tamper evident ring to break the seal (See Fig. 2).
3. To open the dropper bottle, remove the cap by turning it in the counterclockwise direction (See Fig. 3).
4. Tighten the cap on the container after every use (Fig. 4). Using your eye drops
• •
Wash your hands. 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 dropper 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 dropper bottle. Gently press on the base of the dropper bottle to release one drop of Olopatadine eye drops at a time. Don't squeeze the dropper 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 dropper bottle cap back on firmly immediately after use.
If a drop misses your eye, try again.
If you use more Olopatadine Eye drops, Solution 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 Olopatadine Eye drops, Solution 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 Olopatadine Eye drops, Solution 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 Olopatadine Eye drops, Solution 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Olopatadine Eye drops, Solution
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 waste water 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 Olopatadine Eye drops, Solution 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 anhydrous (E339), water for injections, hydrochloric acid (E507) and/or sodium hydroxide (E524) (for pH adjustment). What Olopatadine Eye drops, Solution looks like and contents of the pack Olopatadine Eye drops, Solution is a clear colourless solution practically free from particles supplied in a pack containing either one 5 ml plastic dropper bottle or three 5 ml dropper bottles with screw caps. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Brown and Burk UK Ltd. 5 Marryat Close, Hounslow West, Middlesex, TW4 5DQ United Kingdom
This leaflet was last revised in 04/2019
Frequently asked questions about Olopatadine 1 mg/ml Eye drops, Solution
How do I take Olopatadine 1 mg/ml Eye drops, Solution?
Olopatadine 1 mg/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 Olopatadine 1 mg/ml Eye drops, Solution?
The active substance in Olopatadine 1 mg/ml Eye drops, Solution is olopatadine hydrochloride.
Are there equivalent medicines to Olopatadine 1 mg/ml Eye drops, Solution?
Medicines with the same active substance, strength and form include: OPATANOL 1mg/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 Olopatadine 1 mg/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 Olopatadine 1 mg/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 Olopatadine Eye drops, Solution 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.
Elderly
No dosage adjustment in elderly patients is necessary.
Paediatric population
Olopatadine may be used in paediatric patients three years of age and older at the same dose as in adults. The safety and efficacy of Olopatadine in children aged under 3 years has not been established. No data are available.
Hepatic and renal impairment
Olopatadine in the form of eye drops 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
Olopatadine 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.
Olopatadine contains benzalkonium chloride which may cause eye irritation, especially if patients have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If patients feel abnormal eye sensation, stinging or pain in the eye after using this medicine, seek medical attention immediately.
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 chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should be instructed to remove contact lenses before using this medicine and put them back 15 minutes afterwards.
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 new-born/infants cannot be excluded.
Olopatadine Eye drops, solution 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
Olopatadine Eye drops, solution 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, olopatadine 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 olopatadine; 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 olopatadine 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, lacrimatioincreased, 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 Yellow Card Scheme at: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 Olopatadine Eye drops, solution 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 Olopatadine 1 mg/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.