Latanoprost 50 Micrograms/Ml Eye Drops Solution

Package leaflet: Information for the user Latanoprost 50 micrograms/ml Eye Drops Solution

Read all of this leaflet carefully before Other medicines and Latanoprost you start using this medicine because it eye drops contains important information for you. Latanoprost eye drops may interact • Keep this leaflet. You may need to read it with other medicines. Please tell your again. doctor, the doctor treating your child • If you have any further questions, ask or pharmacist if you or your child are your doctor or the doctor treating your using or have used any other medicines child or your pharmacist. including those medicines (or eye • This medicine has been prescribed for drops) obtained without a prescription. you or for your child only. Do not pass it In particular, speak to your doctor or on to others. It may harm them, even if pharmacist if you know that you are their signs of illness are the same as yours. using prostaglandins, prostaglandin • If you or your child get any side effects, analogues or prostaglandin derivatives. talk to your doctor or the doctor treating your child or your pharmacist. This Pregnancy and breast-feeding includes any possible side effects not Do not use Latanoprost eye drops listed in this leaflet. See section 4. if you are pregnant or breast-feeding • The full name of this medicine is unless your doctor considers it necessary. Latanoprost 50micrograms/ml Eye Drops If you are pregnant or breast-feeding, Solution but within the leaflet it will be think you may be pregnant, or are referred to as Latanoprost eye drops. planning to have a baby, ask your doctor for advice before using this medicine.

What is in this leaflet: Driving and using machines 1 What Latanoprost eye drops When you use Latanoprost eye drops are and what they are used for you might have blurred vision, for a short 2 time. If this happens to you, do not drive What you need to know before or use any tools or machines until your you use Latanoprost eye drops vision becomes clear again. 3 How to use Latanoprost eye drops Latanoprost eye drops contain benzalkonium chloride 4 Possible side effects This medicine contains 0.5 mg 5 How to store Latanoprost eye benzalkonium chloride in each 2.5ml drops bottle which is equivalent to 0.2 mg/ml. Benzalkonium chloride may be absorbed 6 Contents of the pack and other by soft contact lenses and may change information the colour of the contact lenses. You should remove contact lenses before 1 What Latanoprost eye drops using this medicine and put them back 15 minutes afterwards. See the are and what they are used for instructions for contact lens wearers in Latanoprost eye drops belong to a group Section 3. of medicines known as prostaglandin analogues. It works by increasing the Benzalkonium chloride may also cause natural outflow of fluid from inside the eye irritation, especially if you have dry eye into the bloodstream. eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel Latanoprost eye drops are used to abnormal eye sensation, stinging or pain treat conditions known as open angle in the eye after using this medicine, talk glaucoma and ocular hypertension to your doctor. in adults. Both of these conditions are linked with an increase in the pressure This medicine contains 9.3mg/ml within your eye, eventually affecting your phosphates which is equivalent to 0.3 eye sight. mg per drop. If you suffer from severe damage to Latanoprost eye drops are also used the clear layer at the front of the eye to treat increased eye pressure and (cornea), phosphates may cause in glaucoma in all ages of children and very rare cases cloudy patches on the babies. cornea due to calcium build-up during treatment. 2 What you need to know before you use Latanoprost eye drops 3 How to use Latanoprost eye Latanoprost eye drops can be used in drops adult men and women (including the Always use this medicine exactly as your elderly) and in children from birth to 18 doctor or the doctor treating your child years of age. Latanoprost eye drops have has told you. You should check with your not been investigated in prematurely doctor or the doctor treating your child born infants (less than 36 weeks or pharmacist if you are not sure. gestation). The recommended dosage for adults Do not use Latanoprost eye drops if (including the elderly) and children is: you are one drop once a day in the affected • allergic (hypersensitive) to latanoprost eye(s). The best time to do this is in the or any of the other ingredients of this evening. medicine (listed in section 6) • pregnant or trying to become Do not use Latanoprost eye drops pregnant more than once a day, because the • breast-feeding . effectiveness of the treatment can be reduced if you administer it more often. Warnings and precautions Use Latanoprost eye drops as instructed Talk to your doctor or the doctor treating by your doctor or by the doctor treating your child or your pharmacist before your child until they tell you to stop. using Latanoprost eye drops or before you give this to your child if you think Contact lens wearers any of the following apply to you or your If you or your child wear contact lenses, child: they should be removed before using Latanoprost eye drops. After using • If you or your child are about to have Latanoprost eye drops you should wait or have had eye surgery (including 15 minutes before putting the contact cataract surgery) lenses back into the eyes. • If you or your child suffer from eye problems (such as eye pain, irritation or Instructions for use: inflammation, blurred vision) 1. Wash your hands and sit or stand • If you or your child suffers from dry comfortably. eyes 2. Twist off the cap. 3. Use your finger to gently pull down If you or your child have severe asthma • the lower eyelid of your affected eye. or the asthma is not well controlled 4. Place the tip of the bottle close to, but • If you or your child wear contact lenses. not touching your eye. You can still use Latanoprost eye drops, 5. Squeeze the bottle gently so that only but follow the instructions for contact one drop goes into your eye, then lens wearers in Section 3 release the lower eyelid. • If you or your child have suffered or are 6. Press a finger against the corner of the currently suffering from a viral infection affected eye by the nose. Hold for 1 of the eye caused by the herpes minute whilst keeping the eye closed. simplex virus (HSV). 7. Repeat in your other eye if your doctor has told you to do this. 8. Replace cap on the bottle.

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Latanoprost Eye Drops 50mcg/0.005% 2.5ml Vial Drops PIL - UK

approved for print/date Item number: BBBB0882 Colours Non Printing Colours 1. Black 1. Originator: C.Grant Dimensions: 135 x 440 2. 2. Origination Date: 08/03/2021 Min Body Text Size: 8.5pt Revision Date: 27/04/2021 Supplier: Siegfried 3. 3. Revised By: M.Doak 4. 5. Proof Round Technical Date sent: 08/03/2021 6. 04 Approval Date received: 16/03/2021 [email protected]

FMD info NA (not a carton)  No  Yes  Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 If you use Latanoprost eye drops with • Skin reactions on the eyelids, other eye drops darkening of the skin of the eyelids. Wait at least 5 minutes between using • Worsening of asthma. Latanoprost eye drops and using other • Developing a viral infection of the eye eye drops. caused by the herpes simplex virus (HSV). If you use more Latanoprost eye drops • Fluid filled area within the coloured than you should part of the eye (iris cyst). If you put too many drops into the eye, it • Drug reaction inflammation to may lead to some minor irritation in the the membranes around the eye eye and the eyes may water and turn red. (pseudopemphigoid of ocular This should pass, but if you are worried conjunctiva). contact your doctor or the doctor treating your child for advice. • Severe itching of the skin. Contact your doctor as soon as possible if you or your child swallows Latanoprost Very rare (may affect up to 1 in 10,000 eye drops accidentally. people): • Worsening of angina in patients who If you forget to use Latanoprost eye also have heart disease, sunken eye drops appearance (eye sulcus deepening). Carry on with the usual dosage at the usual time. Do not use a double dose to In very rare cases, some patients with make up for the dose you have forgotten. severe damage to the clear layer at If you are unsure about anything, talk to the front of the eye (the cornea) have your doctor or pharmacist. developed cloudy patches on the cornea due to calcium build-up during If you stop using Latanoprost eye treatment. drops You should speak to your doctor or the Additional side effects in children doctor treating your child if you want to Side effects seen more often in children stop using Latanoprost eye drops. compared to adults are runny itchy nose and fever. If you have any further questions on the use of this medicine, ask your doctor or Reporting of side effects pharmacist. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this 4 Possible side effects leaflet. You can also report side effects Like all medicines, this medicine directly via the Yellow Card Scheme at: can cause side effects, although not www.mhra.gov.uk/yellowcard or search everybody gets them. for MHRA Yellow Card in the Google Play or Apple App Store. The following are known side effects of By reporting side effects you can help using Latanoprost eye drops: provide more information on the safety of this medicine. Very common (may affect more than 1 in 10 people): • A gradual change in your eye colour 5 How to store Latanoprost eye by increasing the amount of brown drops pigment in the coloured part of the eye Keep this medicine out of the sight and known as the iris. If you have mixed- reach of children. colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are Do not use this medicine after the expiry more likely to see this change than if date which is stated on the label after you have eyes of one colour (blue, grey, EXP. The expiry date refers to the last day green or brown eyes). Any changes of that month. in your eye colour may take years to develop although it is normally seen Keep the bottle in the outer carton in within 8 months of treatment. The order to protect from light. colour change may be permanent and may be more noticeable if you Before opening the bottle: use Latanoprost eye drops in only one Store in a refrigerator (2°C – 8°C). This eye. There appears to be no problems medicinal product should also be kept associated with the change in eye refrigerated during transport from the colour. The eye colour change does not manufacturer to the pharmacy. It is not continue after Latanoprost eye drops necessary for you to keep it refrigerated treatment is stopped. during transport e.g. from the pharmacy • Redness of the eye. to your home. • Eye irritation (a feeling of burning, grittiness, itching, stinging or the After first opening the bottle: sensation of a foreign body in the eye). Do not store above 25°C and use within If you experience eye irritation severe four weeks. enough to make your eyes water excessively, or make you consider Do not throw away any medicines stopping this medicine, talk to your via wastewater or household waste. doctor, pharmacist or nurse promptly Ask your pharmacist how to throw (within a week). You may need your away medicines you no longer use. treatment to be reviewed to ensure These measures will help protect the you keep receiving appropriate environment. treatment for your condition. • A gradual change to eyelashes of the 6 Contents of the pack and other treated eye and the fine hairs around information the treated eye, seen mostly in people What Latanoprost eye drops contain of Japanese origin. These changes • The active substance is latanoprost. involve an increase of the colour One ml of eye drop solution contains (darkening), length, thickness and 50 micrograms latanoprost. One drop number of your eye lashes. contains approximately 1.5 micrograms latanoprost. Common (may affect up to 1 in 10 people): • The other ingredients are • Irritation or disruption to the surface benzalkonium chloride, sodium of the eye, eyelid inflammation dihydrogen phosphate monohydrate, (blepharitis), eye pain and light sensitivity disodium hydrogen phosphate, (photophobia), conjunctivitis. sodium chloride, purified water.

Uncommon (may affect up to 1 in 100 What Latanoprost eye drops look like people): and contents of the pack • Eyelid swelling, dryness of the eye, Latanoprost is a clear, colourless eye inflammation or irritation of the surface drop solution in a plastic bottle with of the eye (keratitis), blurred vision. a dropper and plastic cap. Each bottle • Inflammation of the coloured part of contains 2.5 ml eye drops solution, the eye (uveitis). corresponding to approximately 80 • Skin rash. drops of solution. • Headache, dizziness. • Chest pain (angina); awareness of heart Latanoprost eye drops are available in rhythm (palpitations). packs of 1 bottle. • Asthma and shortness of breath (dyspnoea). Marketing Authorisation Holder • Muscle pain, joint pain. Accord, Barnstaple, EX32 8NS, UK Swelling of the retina (macular • Manufacturers oedema). HBM Pharma s. r. o. Sklabinská 30, 036 80 Martin Rare (may affect up to 1 in 1,000 people): Slovak Republic • Inflammation of the iris (iritis); symptoms of swelling or scratching/ Jadran Galenski Laboratorij d.d. damage to the surface of the eye, Svilno 20, Rijeka, 51000, Croatia swelling around the eye (periorbital oedema) misdirected eyelashes or an This leaflet was last revised in April 2021 extra row of eyelashes, scarring of the surface of the eye, fluid filled area within the coloured part of the eye (iris cyst).

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Latanoprost Eye Drops 50mcg/0.005% 2.5ml Vial Drops PIL - UK