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BIMATOPROST TEVA 0.3 MG/ML EYE DROPS SOLUTION

Active substance(s): BIMATOPROST / BIMATOPROST

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Teva Pharmaceuticals Europe B.V
Effective Date: TBD

REG0208816

Version 0.3
Approved

Package leaflet: Information for the user
Bimatoprost 0.3 mg/ml Eye Drops, Solution
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
1.

What Bimatoprost is and what it is used for

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

Do not use Bimatoprost:
- 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.
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 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.

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Date of Print: 24-Apr-2017

Valid for 7 days from date of print

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Teva Pharmaceuticals Europe B.V
Effective Date: TBD

REG0208816

Version 0.3
Approved

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 or have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
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 chloride
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. A preservative in Bimatoprost called benzalkonium chloride may cause eye irritation
and can discolour soft contact lenses.
3.

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.

2.

3.

4.

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.

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Teva Pharmaceuticals Europe B.V
Effective Date: TBD

REG0208816

Version 0.3
Approved

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
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.
If you stop using Bimatoprost
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 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
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Effective Date: TBD

REG0208816

Version 0.3
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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 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.
5.

How to store Bimatoprost

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.

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Date of Print: 24-Apr-2017

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Teva Pharmaceuticals Europe B.V
Effective Date: TBD

REG0208816

Version 0.3
Approved

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 contains
The active substance is bimatoprost. One ml of solution contains 0.3 mg bimatoprost. One drop
contains approximately 7.5 micrograms bimatoprost.
The other ingredients are benzalkonium chloride (preservative), citric acid monohydrate, disodium
phosphate heptahydrate, sodium chloride, sodium hydroxide or hydrochloric acid (for pHadjustment) and purified water.
What Bimatoprost looks like and contents of the pack
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 3 millilitres of solution. This is enough
for 4 weeks’ usage.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limted, Eastbourne, BN22 9AG, UK
Manufacturer
S.C. ROMPHARM COMPANY S.R.L., Eroilor Street, no. 1A, Otopeni, Ilfov, 075100, Romania
This leaflet was last revised in 03/2017
PL 00289/2069

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Date of Print: 24-Apr-2017

Valid for 7 days from date of print

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Expand Transcript

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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