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BIMATOPROST PHARMATHEN 0.1 MG/ML EYE DROPS SOLUTION

Active substance(s): BIMATOPROST

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Package leaflet: Information for the user
Bimatoprost Pharmathen 0.1 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;
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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:
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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.



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Wash your hands. Tilt your head back and look at the ceiling (picture 2).



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.

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Very common: may affect more than 1 in 10 people
Affecting the eye:
 Slight redness (up to 29 % of people)
Common: may affect up to 1 in 10 people
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: may affect up to 1 in 100 people
Uncommon: may affect up to 1 in 100 people
Affecting the eye:
 Darker iris colour
 Tired eye
 Swelling of the surface of the eye
 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
Not known: frequency cannot be estimated from the available data
Affecting the eye:
 Macular oedema (swelling of the retina at the back of the eye)
 Darker eyelid colour
 Eyes appear sunken
 Dryness
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 Bimatoprost Pharmathen, the following side effects have
been seen with another medicine containing a higher strength of bimatoprost (0.3 mg/ml):
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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
A feeling that something is in your eye
Sensitivity to light
Tears
Sticky eyes
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

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.
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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 0.1 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
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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
España Bimatoprost Pharmathen
România Bimatoprost Pharmathen
Κύπρος Bimatoprost Pharmathen
Eλλάδα 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/España/România/Κύπρος/Eλλάδα
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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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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