PACKAGE LEAFLET: INFORMATION FOR THE USER D03227 Adults (including the elderly) 5. How to store Pilocarpine The usual dose is two drops three times Eye Drops Pilocarpine Eye Drops 1.0%, 2.0% and 4.0% w/v daily. Keep this medicine out of the sight and Pilocarpine Hydrochloride reach of children (Referred to as Pilocarpine Eye Drops in this leaflet) Use in children Lowest available dose and concentration Make sure the container is properly should be used at the start of the closed after each use. treatment for children under 18 years of age. Your doctor might increase the Store Pilocarpine Eye Drops in their dose up to the maximum recommended original container to protect from Read all of this leaflet carefully before you start using this medicine because adult dosage of the 2 % Pilocarpine eye moisture and away from direct light. it contains important information for you. drops depending on the response and Store below 25°C. • Keep this leaflet. You may need to read it again. tolerability. • If you have any further questions, please ask your doctor or pharmacist. Do not use Pilocarpine Eye Drops after • This medicine has been prescribed for you. Do not pass it onto others. It may If you use more Pilocarpine Eye Drops the expiry date which is printed on the harm them, even if their signs of illness are the same as yours. than you should label. The expiry date refers to the last • If you get any of the side effects, talk to your doctor or pharmacist. This includes If you are at all concerned that you have day of that month. any possible side effects not listed in this leaflet. See section 4. used or been given too much of this What is in this leaflet: • (medicines used to medicine please tell your doctor. Dispose of this medicine 28 days after treat serious mental disorders) e.g. opening. 1. What Pilocarpine Eye Drops are and . what are they used for If you swallow any Pilocarpine Eye • medicines used to treat high blood Medicines should not be disposed of 2. What you need to know before you Drops pressure (adrenergic blockers) such as via waste water or household waste. use Pilocarpine Eye Drops Pilocarpine Eye Drops are for external . use only. If you have swallowed or you Ask your pharmacist how to dispose of 3. How to use Pilocarpine Eye Drops medicines no longer required. These 4. Possible side effects suspect someone else has swallowed If you have any doubts about measures will help to protect the 5. How to store Pilocarpine Eye Drops any Pilocarpine Eye Drops, contact whether you should use this medicine environment. 6. Contents of the pack and other your doctor or go to the accident talk to your doctor or pharmacist. information and emergency department of your local hospital at once. Always take the container and this leaflet with you if 6. Contents of the pack and Pilocarpine Eye Drops with food,drink other information 1. What Pilocarpine Eye Drops and possible, even if empty. are and what are they used You are advised not to drink alcohol What Pilocarpine Eye Drops contain for during your treatment with Pilocarpine If you forget to take Pilocarpine Eye The active substance is Pilocarpine Eye Drops. Drops hydrochloride 1.0%, 2.0% or 4.0% w/v Pilocarpine Hydrochloride belongs to a group of medicines called miotics, , breast-feeding and If you miss a dose of Pilocarpine The other ingredients are benzalkonium these medicines affect muscles in the and purified water. eye causing the pupil of the eye to get fertility Eye Drops, use them as soon as you smaller. If you are pregnant or breast feeding, remember unless it is nearly time for think you may be pregnant or are the next dose, then carry on using it as What Pilocarpine Eye Drops look like Pilocarpine Eye Drops are used to treat planning to have a baby, ask your doctor before. Do not take a double dose to and contents of the pack certain forms of (an increase for advice before taking this medicine. make up for one you have missed. Pilocarpine Eye Drops are a clear, in the pressure within the eye) and to colourless and sterile solution supplied reverse the effect of drugs that cause the Driving and using machines If you stop using Pilocarpine Eye in a plastic dropper bottle. Each bottle pupil of the eye to get bigger. Pilocarpine Eye Drops can cause Drops contains 10ml of the solution. difficulty in adapting to the dark. You should not drive or use machinery in You should keep using Pilocarpine Eye Marketing Authorisation Holder: 2. What you need to know poor light. The eye drops may also cause Drops for as long as your doctor has Martindale Pharmaceuticals Ltd before you use Pilocarpine blurred vision. If this happens, you asked. Your treatment is helping your T/a Martindale Pharma Eye Drops should not drive or operate machinery condition, even if you have not noticed Bampton Road until you can see clearly. a difference in how you feel. Should you Harold Hill Do not use Pilocarpine Eye Drops if: need to stop your treatment, your doctor Romford Essex RM3 8UG UK • you are allergic (hypersensitive) Pilocarpine eye drops contains will advise you how to do this. to Pilocarpine or any of the other benzalkonium Manufacturers: ingredients in this medicine, which are This medicine contains benzalkonium If you have any further questions on the Tubilux Pharma S.p.A. listed in section 6 of this leaflet. chloride which may cause eye irritation use of the medicine, ask your doctor or Via Costarica 20/22 • you are suffering from inflammation of and is known to discolour soft contact pharmacist. 00071 Pomezia (RM) the coloured part of the eye (acute iritis lenses. ITALY or anterior uveitis). • you are suffering from eye disorders Soft contact lenses must not be worn 4. Possible side effects such as narrow angle glaucoma or Marketing Authorisation numbers: during treatment with Pilocarpine Eye Like all medicines, this medicine Pilocarpine Eye Drops 1.0% w/v PL secondary glaucoma. Drops. • you are wearing soft contact lenses. can cause side effects, although not 00156/0079 everyone gets them. Pilocarpine Eye Drops 2.0% w/v PL 00156/0080 Warnings and precautions: 3. How to use Pilocarpine Eye Common side effects (may affect 1 and Pilocarpine Eye Drops 4.0% w/v PL Talk to your doctor or pharmacists before Drops 10 in every 100 patients): 00156/0078 taking Pilocarpine eye drops if Always use Pilocarpine Eye Drops exactly • itching, smarting and a burning • you are suffering from any heart as your doctor has told you. Always sensation around the eye This leaflet was last revised in:04/2016 problems. complete a course of treatment. Do not • a red skin rash with itching (urticaria) • you have . stop because you feel better. • swelling, redness or soreness of the • you have Parkinson’s disease. eyelid • you have problems in passing urine. Pilocarpine Eye Drops are for external • swelling of the front of the eye • you have high blood pressure. use only. (conjunctiva) • you have a stomach ulcer. • temporarily blurred vision • you are pregnant or are breast-feeding. Instructions for use • temporary short sightedness • difficulty in seeing in poor light If you are unsure about how to use 1. Before opening a new bottle of Pilocarpine Eye Drops, please check • enlargement of the veins in the eye Pilocarpine Eye Drops talk to your doctor • headache and brow ache (especially or pharmacist. that the safety strip on the front of the bottle is unbroken. in young patients at the beginning of 2. Tear off the safety strip to break the treatment). Children seal. • bleeding within the front of the eye Pilocarpine should be given at the 3. Wash your hands well before use. • detachment of the retina (the inner lowest available dose at the start of the 4. Remove the outer cap. If you are surface of the eye) treatment for children under 18 years of putting in the eye drops yourself, you age. should use a mirror. Rare may affect up to 1 in 1,000 people: 5. Tilt your head back and look up at • feeling sick (nausea) Eye tests the ceiling. • being sick () Your doctor may want to check your 6. Pull the lower lid of the eye out to • diarrhoea eyes before and during your therapy form a small pocket between your • increase in particularly if you have had any eye eyelid and your eye. • increased flow of tears disorders. If you have not had your eyes 7. Hold the container between the • trembling or shaking checked recently, tell your doctor. thumb and middle finger of the • wheezing and breathing difficulties other hand, turn the bottle upside • change in blood pressure or changes in the way your heart beats Other medicines and Pilocarpine down near to the eye, try not to touch the eye with the nozzle. Please tell your doctor or pharmacist if With long term use it is possible that you are taking or have recently taken any 8. Apply enough pressure to the bottle to release one to two drops, as the lens of your eye may change shape other medicines, including medicines resulting in changes to your vision. obtained without a prescription. directed by your doctor. 9. Blink your eye a few times. You may not know if you have some of Some medicines can interfere with your 10. If you think that you have missed your eye, then insert another drop. the side effects. Your doctor will detect treatment. Tell your doctor if you are them during examinations. taking any of the following: 11. Repeat steps 5-10 above for your • antihistamines (medicines used to treat other eye if you have been told to ). use Pilocarpine Eye Drops in both Reporting of side effects • anticholinesterases, (such as eyes. Reporting suspected adverse reactions ) which are medicines that 12. Replace the outer cap on the after authorisation of the medicinal affect the muscles and are used to treat bottle, trying not to touch the product is important. It allows continued diseases like myasthenia gravis. applicator tip with anything, monitoring of the benefit/risk balance • medicines used to make the pupil including the eye or your fingers. of the medicinal product. Healthcare larger and dry up the saliva in your 13. Wash your hands. professionals are asked to report any mouth, such as and suspected adverse reactions via the phenylephrine. Always use this medicine exactly as Yellow Card Scheme Website: http:// • medicines used to treat Parkinson’s described in this leaflet or as your doctor www.mhra.gov.uk/yellowcard. disease, drugs such has told you. Check with your doctor or as , and pharmacist if you are not sure. . • antidepressants including tricyclic Your doctor will decide how much antidepressants (such as ) you need based on the severity of and monoamine oxidase inhibitors your condition and your response to (MAOI’s), a type of medicine used to treatment. treat severe depression. Continued overleaf D03227

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100mm Measurement Verification Bar