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BIMATOPROST/TIMOLOL MYLAN 0.3 MG/ML + 5 MG/ML EYE DROPS SOLUTION

Active substance(s): BIMATOPROST / TIMOLOL MALEATE / BIMATOPROST / TIMOLOL MALEATE

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Package leaflet: Information for the user
BIMATOPROST/TIMOLOL 0.3 mg/ml + 5 mg/ml eye drops, solution
Bimatoprost/timolol

Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
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Keep this leaflet. You may need to read it again.

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If you have any further questions, please ask your doctor or pharmacist.

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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.

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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/TIMOLOL is and what it is used for

2.

What you need to know before you use BIMATOPROST/TIMOLOL

3.

How to use BIMATOPROST/TIMOLOL

4.

Possible side effects

5.

How to store BIMATOPROST/TIMOLOL

6.

Contents of the pack and other information

1.

What BIMATOPROST/TIMOLOL is and what it is used for

BIMATOPROST/TIMOLOL contains two different active substances (bimatoprost and timolol) that both
reduce pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, a prostaglandin
analogue. Timolol belongs to a group of medicines called beta-blockers.
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 and could eventually damage your sight (an illness called glaucoma).
BIMATOPROST/TIMOLOL works by reducing the production of liquid and also increasing the amount of
liquid that is drained. This reduces the pressure inside the eye.
BIMATOPROST/TIMOLOL eye drops are used to treat high pressure in the eye in adults, including the
elderly. This high pressure can lead to glaucoma. Your doctor will prescribe you
BIMATOPROST/TIMOLOL when other eye drops containing beta-blockers or prostaglandin analogues
have not worked sufficiently on their own.

2.

What you need to know before you use BIMATOPROST/TIMOLOL

Do not use BIMATOPROST/TIMOLOL eye drops, solution

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if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of this medicine
(listed in section 6).

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if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive
bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/ or longstanding cough).

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if you have heart problems such as low heart rate, heart block, or heart failure.

Warnings and precautions
Talk to your doctor or pharmacist before using BIMATOPROST/TIMOLOL, if you have now or have had in
the past
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coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart
failure, low blood pressure,

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disturbances of heart rate such as slow heartbeat,

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breathing problems, asthma or chronic obstructive pulmonary disease,

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poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome),

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overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease,

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diabetes as timolol may mask signs and symptoms of low blood sugar,

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severe allergic reactions,

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liver or kidney problems,

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eye surface problems,

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separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye,

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known risk factors for macular oedema (swelling of the retina within the eye leading to worsening
vision), for example, cataract surgery.

Tell your doctor before surgical anaesthesia that you are using BIMATOPROST/TIMOLOL as timolol may
change effects of some medicines used during anaesthesia.
BIMATOPROST/TIMOLOL 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. BIMATOPROST/TIMOLOL may
cause hair growth when in contact with the skin surface.
Children and adolescents
BIMATOPROST/TIMOLOL should not be used in children and teenagers under 18.

Other medicines and BIMATOPROST/TIMOLOL
BIMATOPROST/TIMOLOL can affect or be affected by other medicines you are using, including other eye
drops for the treatment of glaucoma. Please tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. Tell your doctor if you are using or intend to use medicines to
lower blood pressure, heart medicine, medicines to treat diabetes, quinidine (used to treat heart conditions
and some types of malaria) or medicines to treat depression known as fluoxetine and paroxetine.
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. Do not use BIMATOPROST/TIMOLOL if you
are pregnant unless your doctor still recommends it.
Do not use BIMATOPROST/TIMOLOL if you are breast-feeding. Timolol may get into your breast milk.
Ask your doctor for advice before taking any medicine during breast-feeding.

Driving and using machines
BIMATOPROST/TIMOLOL may cause blurred vision in some patients. Do not drive or use machines until
the symptoms have cleared.

BIMATOPROST/TIMOLOL contains Benzalkonium chloride
BIMATOPROST/TIMOLOL contains a preservative called benzalkonium chloride. Benzalkonium chloride
may cause eye irritation and is also known to discolour soft contact lenses. Do not use the drops while your
contact lenses are in your eyes. Wait at least 15 minutes after using the eye drops before putting your lenses
back in your eyes.

3.

How to use BIMATOPROST/TIMOLOL

Always use BIMATOPROST/TIMOLOL exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The usual dose is one drop once a day, either in the morning or in the evening in each eye that needs
treatment. Use at the same time each day.
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.

5.

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 the eye closed, press your finger against the corner of the closed eye (the site where the
eye meets the nose) and hold for 2 minutes. This helps to stop BIMATOPROST/TIMOLOL getting into
the rest of the body.

If a drop misses your eye, try again.
To avoid contamination, 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 BIMATOPROST/TIMOLOL with another eye medicine, leave at least 5 minutes between putting
in BIMATOPROST/TIMOLOL and the other medicine. Use any eye ointment or eye gel last.

If you use more BIMATOPROST/TIMOLOL than you should
If you use more BIMATOPROST/TIMOLOL 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/TIMOLOL
If you forget to use BIMATOPROST/TIMOLOL, use a single drop as soon as you remember, and then go
back to your regular routine. Do not use a double dose to make up for a forgotten dose.

If you stop using BIMATOPROST/TIMOLOL
BIMATOPROST/TIMOLOL should be used every day to work properly.
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. You can usually
carry on taking the drops, unless the effects are serious. If you’re worried, talk to a doctor or pharmacist. Do
not stop using BIMATOPROST/TIMOLOL without speaking to your doctor.
The following side effects may be seen with BIMATOPROST/TIMOLOL:
Very common side effects (may affect more than 1 in 10people)
Affecting the eye
redness.
Common side effects (may affect up to 1 in 10 people)
Affecting the eye
burning,
itching,
stinging,
irritation of the conjunctiva (see-through layer of the eye),
sensitivity to light,
eye pain, sticky eyes, dry eyes, a feeling of something in the eye,
small breaks in the surface of the eye with or without inflammation,
difficulty in seeing clearly,
redness and itching of the eyelids,
hair growing around the eye,
darkening of the eyelids,
darker skin colour around the eyes,
longer eyelashes,
eye irritation,
watery eyes,
swollen eyelids,
reduced vision.

Affecting other parts of the body
runny nose,
dizziness,
headache.
Uncommon side effects (may affect up to 1 in 100 people)
Affecting the eye
abnormal sensation in the eye,
iris inflammation,
swollen conjunctiva (see-through layer of the eye),
painful eyelids,
tired eyes,
in-growing eyelashes,
darkening of iris colour,
eyes appear sunken,
eyelid has moved away from the surface of the eye,
darkening of eyelashes.
Affecting other parts of the body
shortness of breath.
Side effects where the frequency is not known (frequency cannot be estimated from the available data)
Affecting the eye
cystoid macular oedema (swelling of the retina within the eye leading to worsening vision),
eye swelling,
blurred vision.
Affecting other parts of the body
difficulty breathing / wheezing,
symptoms of allergic reaction (swelling, redness of the eye and rash of the skin),
changes in your taste sensation,
slowing of heart rate,
difficulty sleeping,
nightmare,
asthma,
hair loss,
tiredness.
Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost and so
may possibly be seen with BIMATOPROST/TIMOLOL. Like other medicines applied into eyes, timolol is
absorbed into the blood. This may cause similar side effects as seen with ”intravenous” and /or “oral” betablocking agents. The chance of having side effects after using eye drops is lower than when medicines are
for example, taken by mouth or injected. Listed side effects include reactions seen within bimatoprost and
timolol when used for treating eye conditions:
severe allergic reactions with swelling and difficulty breathing which could be life-threatening;
low blood sugar,
depression; memory loss,
fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased muscle
weakness); tingling sensation,
decreased sensation of your eye surface; double vision; drooping eyelid; separation of one of the layers
within the eyeball after surgery to reduce the pressure in the eye; inflammation of the surface of the eye,
bleeding in the back of the eye (retinal bleeding), inflammation within the eye, increased blinking,
heart failure; irregularity or stopping of the heartbeat; slow or fast heartbeat; too much fluid, mainly
water, accumulating in the body; chest pain,

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low blood pressure; high blood pressure; swelling or coldness of your hands, feet and extremities,
caused by constriction of your blood vessels,
cough, worsening of asthma, worsening of the lung disease called chronic obstructive pulmonary
disease (COPD),
diarrhoea; stomach pain; feeling and being sick; indigestion; dry mouth,
red scaly patches on skin; skin rash,
muscle pain,
reduced sexual urge; sexual dysfunction,
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 the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety
of this medicine.
5.

How to store BIMATOPROST/TIMOLOL

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 medicine does not require any special storage conditions.
Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you must
throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you remember,
write down the date that you opened it in the space on the carton.
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.

6.

Contents of the pack and other information

What BIMATOPROST/TIMOLOL contains
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The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol maleate
6.8 mg/ml.

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The other ingredients are benzalkonium chloride (a preservative), sodium chloride, disodium phosphate
heptahydrate, citric acid monohydrate and purified water. Small amounts of hydrochloric acid or sodium
hydroxide may be added to bring the solution to the correct pH (acidity) level.

What BIMATOPROST/TIMOLOL looks like and contents of the pack
BIMATOPROST/TIMOLOL is a colourless to slightly yellow solution in a plastic bottle.

Each pack contains either1 plastic bottle or 3 plastic bottles each with a screw-cap.
Each bottle is about half full and contains 3 milliliters of solution.
This is enough for 4 weeks’ usage.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
S.C. ROMPHARM COMPANY S.R.L., Eroilor Street, no. 1A, Otopeni 075100, Ilov, Romania
This leaflet was last revised in
07/06/2017

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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