Lumigan
(Bimatoprost)

What Lumigan is and what it is used for

LUMIGAN is an antiglaucoma preparation. It belongs to a group of medicines called prostamides. LUMIGAN eye drops are used to reduce high pressure in the eye. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure. Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

How to take Lumigan

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. LUMIGAN should only be applied to the eye. The recommended dose is one drop of LUMIGAN in the evening, once daily in each eye that needs treatment. If you use LUMIGAN with another eye medicine, wait at least five minutes between using LUMIGAN and the other eye medicine. Do not use more than once a day as the effectiveness of treatment may be reduced. Instructions for use: You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it. 1. Wash your hands. Tilt your head back and look at the ceiling. 2. Gently pull down the lower eyelid until there is a small pocket. 3 3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment. 4. Let go of the lower lid, and close your eye for 30 seconds. Wipe off any excess that runs down the cheek. If a drop misses your eye, try again. To help prevent infections and avoid eye injury, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it. If you use more LUMIGAN 0.1 mg/ml than you should If you use more LUMIGAN than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist. If you forget to use LUMIGAN 0.1 mg/ml If you forget to use LUMIGAN, use a single drop as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose. If you stop using LUMIGAN 0.1 mg/ml LUMIGAN should be used every day to work properly. If you stop using LUMIGAN the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

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

Very common side effects These may affect one or more users in 10 Affecting the eye
• Slight redness (up to 29 % of people)

Common side effects These may affect 1 to 9 users in 100 Affecting the eye
• Small breaks in the surface of the eye, with or without inflammation
• Irritation
• Itchy eyes
• Longer eyelashes
• Irritation, when drop is put in the eye
• Eye pain Affecting the skin
• Red and itchy eyelids
• Darker skin colour around the eye
• Hair growth around the eye

Uncommon side effects These may affect 1 to 9 users in 1000 Affecting the eye
• Darker Iris colour
• Tired eye
• Swelling of the surface of the eye 4
• Blurred vision
• Loss of eye lashes Affecting the skin
• Dry skin
• Crusting on the edge of the eyelid
• Swelling of the eyelid
• Itching Affecting the body
• Headache
• Feeling of sickness Side effects where the frequency is not known Affecting the eye
• Macular oedema (swelling of the retina at the back of the eye which may lead to worsening vision)
• Darker eyelid colour
• Eyes appear sunken
• Dryness
• Sticky eyes
• A feeling that something is in your eye
• Swelling of the eye
• Increasing tears Affecting the body
• Asthma
• Worsening of asthma
• Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin) In addition to the side effects for LUMIGAN 0.1 mg/ml, the following side effects have been seen with another medicine containing a higher strength of bimatoprost (0.3 mg/ml):
• Dizziness
• Ocular burning
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty in seeing clearly
• Worsening of vision
• Swelling of the see-through layer that covers the eye
• Sensitivity to light
• Tears
• Darker eyelashes
• Retinal bleeding
• Inflammation within the eye
• Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
• Eyelid twitching
• Eyelid shrinking, moving away from surface of the eye
• Skin redness around the eye
• Increased blood pressure
• Weakness
• An increase in blood-test results that show how your liver is working 5

Other side effects reported with eye drops containing phosphates 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 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: UK Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of the medicine.

How to Store Lumigan

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 label and the carton after EXP. The expiry date refers to the last day of that month. You must throw away the bottle at the latest four weeks after you first opened it, even if there are still some drops left. This will prevent infections. To help you remember, write down the date you opened it in the space on the box. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.