BIMATOPROST 0.1 mg/ml EYE DROPS, SOLUTION

Package leaflet: Information for the user

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    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.

What is in this leaflet:

1.    What Bimatoprost is and what it is used for

2.    What you need to know before you use Bimatoprost

3.    How to use Bimatoprost

4.    Possible side effects

5.    How to store Bimatoprost

6.    Contents of the pack and other information

OH What Bimatoprost is and what it is used for

Bimatoprost Eye Drops, Solution contains bimatoprost. Bimatoprost is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

Bimatoprost eye drops are used to reduce high pressure in the eye in adults. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.

How Bimatoprost works

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.

2 What you need to know before you use Bimatoprost

Do not use Bimatoprost if you:

• are allergic (hypersensitive) to bimatoprost or any of the other ingredients of this medicine (listed in section 6)

• have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride.

Warnings and precautions

Talk to your doctor or pharmacist before using Bimatoprost if you:

• have any breathing problems • have liver or kidney problems • have had a cataract surgery in the past

• have dry eye

• have or have had any problems with your cornea (front transparent part of the eye)

• wear contact lenses (see section "Bimatoprost contains benzalkonium" below)

• have or have had low blood pressure or low heart rate • have had a viral infection or inflammation of the eye.

Bimatoprost may 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 over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye.

Children and adolescents

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

Other medicines and Bimatoprost

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Bimatoprost can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma (for example a prostaglandin analogue). Talk to your doctor as they may need to monitor the pressure in your eye(s) during treatment.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

Bimatoprost contains benzalkonium

A preservative in Bimatoprost called benzalkonium chloride may cause eye irritation and can discolour soft contact lenses. Do not use the drops when you are wearing your lenses. Wait 15 minutes after using the drops before you put your lenses back in.

How to use Bimatoprost

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Bimatoprost should only be applied to the eye. The recommended dose is one drop of Bimatoprost in the evening, once daily in each eye that needs treatment.

If you use Bimatoprost with another eye medicine, wait at least five minutes between using Bimatoprost 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. 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.

5. Whilst keeping your eye closed, press a finger against the corner of the affected eye by the nose and hold for 1 minute.

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

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

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 take a double dose to make up for a forgotten dose.

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 By reporting side effects you can help provide more information on the safety of this medicine.

How to store Bimatoprost

Keep this medicine out of the sight and reach of children.

Store below 30°C.

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 protect the environment.

^ Contents of the pack and other information

What Bimatoprost contains

•    The active substance is bimatoprost. One ml of solution contains 0.1 mg bimatoprost.

•    The other ingredients are benzalkonium chloride (preservative), sodium chloride, disodium phosphate, anhydrous (E339), citric acid anhydrous (E330) and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the level of acid (pH levels) normal.

What Bimatoprost looks like and contents of the pack

Bimatoprost is a clear/colourless to slightly yellow eye drop 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 3 millilitres of eye drops solution. This is enough for 4 weeks usage. Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne,

BN22 9AG, UK

Manufacturer

Teva Pharmaceutical Works Private Limited Company Tancsics Mihaly ut 82.

H-2100 Godollo,

Hungary

This leaflet was last revised in 05/2015.

PL 00289/1884

30213-A 140 x 420 3-xxxxxxxx/A