Package leaflet: Information for the user

Bimatoprost Pharmathen 0.3 mg/ml, eye drops, solution

Bimatoprost

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 Pharmathen is and what it is used for

2.    What you need to know before you use Bimatoprost Pharmathen

3.    How to use Bimatoprost Pharmathen

4.    Possible side effects

5.    How to store Bimatoprost Pharmathen

6.    Contents of the pack and other information

1. What Bimatoprost Pharmathen is and what it is used for

Bimatoprost Pharmathen is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

Bimatoprost Pharmathen 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.

2. What you need to know before you use Bimatoprost Pharmathen Do not use Bimatoprost Pharmathen:

-    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.

Warnings and precautions

Talk to your doctor or pharmacist before using Bimatoprost Pharmathen.

Talk to your doctor:

-    if you have any breathing problems;

-    if you have liver or kidney problems;

-    if you have had a cataract surgery in the past;

-    if you have dry eye;

-    if you have or have had any problems with your cornea (front transparent part of the eye);

-    if you wear contact lenses (see “Bimatoprost Pharmathen contains benzalkonium chloride”);

-    if you have or have had low blood pressure or low heart rate;

-    if you have had a viral infection or inflammation of the eye.

Bimatoprost Pharmathen 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

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

Other medicines and Bimatoprost Pharmathen

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

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

Pregnancy and breast-feeding

If you are pregnant or breast feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not breast-feed while using Bimatoprost Pharmathen as this medicine may get into breast milk.

Driving and using machines

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

Bimatoprost Pharmathen contains benzalkonium chloride

May cause eye irritation.

Avoid contact with soft contact lenses.

Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

3. How to use Bimatoprost Pharmathen

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

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

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

• Take the container (picture 1) out of the carton box.

(picture 2).

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Wash your hands. Tilt your head back and look at the ceiling

•    Gently pull down the lower eyelid until there is a small pocket (picture 3).

•    Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment (picture 4).

•    Let go of the lower lid, and close your eye for 30 seconds (picture 5).

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 Pharmathen than you should

If you use more Bimatoprost Pharmathen 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 Pharmathen

If you forget to use Bimatoprost Pharmathen, 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 Bimatoprost Pharmathen

Bimatoprost Pharmathen should be used every day to work properly. If you stop using Bimatoprost Pharmathen 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.

4. Possible side effects

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

Very common: may affect more than 1 in 10 people Affecting the eye:

•    Longer eyelashes (up to 45% of people)

•    Slight redness (up to 44% of people)

•    Itchiness (up to 14% of people)

Common: may affect up to 1 in 10 people Affecting the eye:

•    An allergic reaction in the eye

•    Tired eyes

•    Sensitivity to light

•    Darker skin colour around the eye

•    Darker eyelashes

•    Pain

•    A feeling that something is in your eye

•    Sticky eyes

•    Darker iris colour

•    Difficulty in seeing clearly

•    Irritation

•    Burning

•    Inflamed, red and itchy eyelids

•    Tears

•    Dryness

•    Worsening of vision

•    Blurred vision

• Swelling of the see-through layer which covers the surface of the eye

•    Small breaks in the surface of the eye, with or without inflammation

Affecting the body:

•    Headaches

•    An increase in blood-test results that show how your liver is working

•    Increased blood pressure

Uncommon: may affect up to 1 in 100 people Affecting the eye:

•    Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)

•    Inflammation within the eye

•    Retinal bleeding

•    Swollen eyelids

•    Eyelid twitching

•    Eyelid shrinking, moving away from surface of the eye

•    Skin redness around the eye

Affecting the body:

•    Nausea

•    Dizziness

•    Weakness

•    Hair growth around the eye

Not known: frequency cannot be estimated from the available data Affecting the eye:

•    Eyes appear sunken

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)

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 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

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

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

5. How to store Bimatoprost Pharmathen

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.

This medicinal product does not require any special storage conditions.

After first opening of the container, the product may be stored for 4 weeks. 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 use this medicine if you notice the tamper-proof seal on the bottle neck is broken before you first use it.

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.

6. Contents of the pack and other information

What Bimatoprost Pharmathen contains

-    The active substance is bimatoprost. One ml of solution contains 0.3 mg bimatoprost.

-    The other ingredients are benzalkonium chloride (preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and water for injection. Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the level of acid (pH levels) normal.

What Bimatoprost Pharmathen looks like and contents of the pack

Bimatoprost Pharmathen is a clear, colourless solution free from visible particles in a white opaque low density polyethylene vial for eye drops containing 3 ml of the ophthalmic solution sealed with a white opaque LDPE plug applicator and a white HDPE/LDPE cap with a tamper-proof seal.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pharmathen S.A.

6 Dervenakion Street

Pallini 15351

Athens, Greece

Tel: 0030 210 66 04 300

Fax: 0030 210 66 66 749

Email: info@pharmathen.com

Manufacturer:

BALKANPHARMA-RAZGRAD AD 68 Aprilsko vastanie Blvd.,

Razgrad,

7200

Bulgaria

Telephone: +359 84 613 318 Fax: +359 84 634 272 E-Mail: office@antibiotic.bg

or

Pharmathen S.A.

6 Dervenakion Street Pallini 15351 Athens, Greece Tel: 0030 210 66 04 300 Fax: 0030 210 66 66 749 Email: info@pharmathen.com

This medicinal product is authorised in the Member States of the EEA under the following names:

Danmark Bimatoprost Pharmathen Deutschland Bimatoprost Pharmathen United Kingdom Bimatoprost Pharmathen Italia Bimatoprost Pharmathen Espana Bimatoprost Pharmathen Romania Bimatoprost Pharmathen Kunpoq Bimatoprost Pharmathen EAAaSa Bimatoprost Pharmathen Polska Bimatoprost Genoptim

For any information about this medicine, please contact the local representative of the marketing authorisation holder.

Danmark/Deutschland/United Kingdom/Italia/Espana/Romama/Ronpog/E^MSa Pharmathen S.A.

+30 2106604300

Polska

Synoptis Pharma Sp. z o.o.

+48 22 321 62 40

This leaflet was last revised in 24/02/2016

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