Bimatoprost 0.1 mg/ml eye drops, solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Bimatoprost 0.1 mg/ml is and what it is used for
2. What you need to know before you use Bimatoprost 0.1 mg/ml
3. How to use Bimatoprost 0.1 mg/ml
4. Possible side effects
5. How to store Bimatoprost 0.1 mg/ml
6. Contents of the pack and other information

• if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).
• if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride.

Talk to your doctor or pharmacist before using Bimatoprost 0.1 mg/ml. Talk to your doctor, if:

• you have any breathing problems
• you have liver or kidney problems
• you have had a cataract surgery in the past
• you have dry eye
• you have or have had any problems with your cornea (front transparent part of the eye)
• you wear contact lenses (see “Bimatoprost 0.1 mg/ml contains benzalkonium chloride”)
• you have or have had low blood pressure or low heart rate
• you have had a viral infection or inflammation of the eye

During treatment, Bimatoprost may cause a loss of fat around the eye, which may cause your eyelid crease to deepen, your eye to appear sunken (enophthalmos), your upper eyelid to droop (ptosis), the skin around your eye to tighten (involution of dermatochalasis) and the lower white part of your eye to become more visible (inferior scleral show). The changes are typically mild, but if pronounced, they can affect your field of vision. The changes may disappear if you stop taking Bimatoprost. Bimatoprost may also cause your eyelashes to darken and grow and cause the skin around the eyelid to darken too. The colour of your iris may also go darker. These changes may be permanent. The change may be more noticeable if you are only treating one eye.

Bimatoprost has not been tested in children under the age of 18 and therefore should not be used by patients under 18 years.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 taking this medicine.

Bimatoprost may get into breast milk so you should not breast-feed while you are taking Bimatoprost.

Your sight may become blurred for a short time just after using Bimatoprost. You should not drive or use machines until your sight is clear again.

This medicine contains 0.2 mg benzalkonium chloride in each 1 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.

This medicine contains 0.95 mg in each 1 ml.

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. 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 Bimatoprost 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 Bimatoprost, use a single drop as soon as you remember, and then go back to your regular routine. Do not put two drops to make up for a forgotten drop.

Bimatoprost should be used every day to work properly. If you stop using Bimatoprost the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.

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.

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 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.

• The active substance is bimatoprost. One ml of solution contains 0.1 mg bimatoprost. One drop contains approximately 2.5 micrograms bimatoprost.
• The other ingredients are benzalkonium chloride (preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, sodium hydroxide or hydrochloric acid (for pH-adjustment) and purified water.

Bimatoprost is a clear, colourless solution in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap. Each bottle is approximately half full and contains either 2.5 millilitres or 3 millilitres of solution. This is enough for 4 weeks’ usage.

Not all pack sizes may be marketed.

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