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BRIMONIDINE TARTRATE/TIMOLOL 2 MG/ML + 5 MG/ML EYE DROPS SOLUTION

Active substance(s): BRIMONIDINE TARTRATE / TIMOLOL MALEATE / BRIMONIDINE TARTRATE / TIMOLOL MALEATE / BRIMONIDINE TARTRATE / TIMOLOL MALEATE

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Package leaflet: Information for the user
Brimonidine Tartrate/Timolol 2 mg/ml + 5 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 further questions, ask your doctor, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1.
What Brimonidine Tartrate/Timolol Eye Drops, Solution is and what it is used for
2.
What you need to know before you use Brimonidine Tartrate/Timolol Eye Drops, Solution
3.
How to use Brimonidine Tartrate/Timolol Eye Drops, Solution
4.
Possible side effects
5.
How to store Brimonidine Tartrate/Timolol Eye Drops, Solution
6.
Contents of the pack and other information

1.

What Brimonidine Tartrate/Timolol Eye Drops, Solution is and what it is used for

Brimonidine Tartrate/Timolol Eye Drops, Solution is an eye drop that is used to control glaucoma. It
contains two different medicines (brimonidine and timolol) that both reduce high pressure in the eye.
Brimonidine belongs to a group of medicines called alpha-2 adrenergic receptor agonists. Timolol
belongs to a group of medicines called beta-blockers. Brimonidine Tartrate/Timolol is prescribed to
reduce high pressure in the eye when beta-blocker eye drops used alone are not enough.
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. Brimonidine
Tartrate/Timolol works by reducing the production of liquid and increasing the amount of liquid that is
drained. This reduces the pressure inside the eye whilst still continuing to feed the eye.

2.

What you need to know before you use Brimonidine Tartrate/Timolol Eye Drops, Solution

Do not use Brimonidine Tartrate/Timolol eye drops solution
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if you are allergic to brimonidine tartrate, timolol, beta-blockers or any of the other
ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include
swelling of the face, lips and throat, wheeziness, feeling faint, shortness of breath.
itching or redness around the eye.
if you have now or have had in the past respiratory problems such as asthma, or severe chronic
obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in
breathing and/or long-standing cough).
if you have heart problems such as heart beat disorders (unless controlled by a pacemaker) or
heart weakness.
if you are taking monoamine oxidase (MAO) inhibitors or certain other antidepressant
drugs.

Brimonidine Tartrate/Timolol should not be used in children less than 2 years old and should not
usually be used in children aged 2 to 17.

If you think any of these points apply to you, do not use Brimonidine Tartrate/Timolol until you have
talked again to your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Brimonidine Tartrate/Timolol:
if you have now or have had in the past
depression or other psychiatric problems
coronary heart disease (symptoms can include chest pain or tightness, breathlessness or
choking), heart failure, low blood pressure
disturbances of heart rate such as slow heart beat
breathing problems, asthma or chronic obstructive pulmonary disease
poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)
diabetes as timolol may mask signs and symptoms of low blood sugar
overactivity of the thyroid gland as timolol may mask signs and symptoms
kidney or liver problems
tumour of the adrenal gland
eye surgery to lower the pressure in your eye
if you suffer or have suffered from any allergy (e.g. hayfever, eczema) or a severe allergic
reaction be aware that the usual dose of adrenaline used to control a severe reaction may need to
be increased.
Tell your doctor before you have an operation that you are using Brimonidine Tartrate/Timolol as
timolol may change the effects of some medicines used during anaesthesia.
Other medicines and Brimonidine Tartrate/Timolol
Brimonidine Tartrate/Timolol can affect or be affected by other medicines you are using, including
other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use
medicines to lower blood pressure, heart medicine or medicines to treat diabetes. Tell your doctor or
pharmacist if you are taking, have recently taken or might take any other medicines, including
medicines for any condition, even if unrelated to your eye condition, including medicines obtained
without a prescription.
It is particularly important to tell your doctor if you are taking:
pain killers
medicines to help you sleep or for anxiety
medicines to treat high blood pressure (hypertension)
medicines for heart conditions (for example an abnormal heartbeat) such as beta-blockers or
digoxin
another eyedrop used to lower high pressure in the eye (glaucoma)
medicines for depression
medicines to treat severe allergic reactions
medicines that affect some of the hormones in your body, like adrenaline and dopamine
medicines that affect the muscles in your blood vessels
medicines to treat diabetes or high blood sugar
medicines to treat heartburn or stomach ulcers
quinidine (used to treat heart conditions and some types of malaria)
antidepressants known as fluoxetine and paroxetine.
If the dose of any of your current medicines is changed or if you are regularly consuming alcohol you
should tell your doctor.
If you are due to have an anaesthetic, you should tell the doctor or dentist that you are taking
Brimonidine Tartrate/Timolol.

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. Do not use Brimonidine
Tartrate/Timolol if you are pregnant unless your doctor considers it necessary.
Do not use Brimonidine Tartrate/Timolol if you are breast-feeding. Timolol may get into your milk.
Driving and using machines
Brimonidine Tartrate/Timolol may cause drowsiness, tiredness or blurred vision in some patients. Do
not drive or use any tools or machines until the symptoms have cleared. If you experience any
problems, talk to your doctor.
Brimonidine Tartrate/Timolol contains benzalkonium chloride.
Contact lenses
Do not use Brimonidine Tartrate/Timolol while your contact lenses are in your eyes. Wait at
least 15 minutes after using Brimonidine Tartrate/Timolol before putting your lenses back in.
A preservative in Brimonidine Tartrate/Timolol (benzalkonium chloride) may cause eye
irritation and is also known to discolour soft contact lenses.

3.

How to use Brimonidine Tartrate/Timolol Eye Drops, Solution

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Use in children and adolescents
Brimonidine Tartrate/Timolol must not be used in infants below 2 years of age. Brimonidine
Tartrate/Timolol should not usually be used in children and adolescents (from 2 to 17 years).
Use in adults (including the elderly)
The recommended dose is one drop of Brimonidine Tartrate/Timolol, twice a day about 12 hours
apart. Do not change the dose or stop taking it without speaking to your doctor.
If you have other eye drops as well as Brimonidine Tartrate/Timolol, leave at least 5 minutes
between using Brimonidine Tartrate/Timolol and the other eye drops.
Instructions for use
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first begin
to use it.
Wash your hands before opening the bottle. Tilt your head back and look at the ceiling.
1.
2.
3.
4.

Gently pull down the lower eyelid until there is a small pocket.
Turn the bottle upside down and squeeze it to release one drop into each eye that needs
treatment.
Let go of the lower lid, and close your eye.
After using Brimonidine Tartrate/Timolol, press a finger into the corner of your eye, by the nose
(as in the picture below) for 2 minutes. This helps to stop 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 screwcap back on to close the bottle, straight after you have used it.
If you use more Brimonidine Tartrate/Timolol than you should
Adults
If you use more Brimonidine Tartrate/Timolol than you should, it is unlikely to cause you any harm.
Put your next drop in at the usual time. If you are worried, talk to your doctor or pharmacist.
Babies and children
Several cases of overdose have been reported in babies and children receiving brimonidine (one of the
ingredients of Brimonidine Tartrate/Timolol Eye Drops, Solution) as part of medical treatment for
glaucoma. Signs include sleepiness, floppiness, low body temperature and breathing difficulties.
Should this happen, contact your doctor immediately.
Adults and children
If Brimonidine Tartrate/Timolol has been accidentally swallowed then you should contact your doctor
immediately.
If you forget to use Brimonidine Tartrate/Timolol
If you forget to use Brimonidine Tartrate/Timolol, use a single drop in each eye that needs treatment
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 Brimonidine Tartrate/Timolol
Brimonidine Tartrate/Timolol should be used every day to work properly.
If you have any further questions on the use of this product, 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 Brimonidine Tartrate/Timolol without speaking to your
doctor.
If you experience any of the following side effects, please contact your doctor immediately:
Heart failure (eg. chest pain) or irregular heart rate
Increased or decreased heart rate or low blood pressure
The following side effects may be seen with Brimonidine Tartrate/Timolol.
Very common (may affect more than 1 in 10 people):
Eye redness or burning.
Common (may affect up to 1 in 10 people):
Stinging, an allergic reaction in the eye or on the skin around the eye, small breaks in the surface of
the eye (with or without inflammation), high blood pressure, swelling and redness of the eyelid,
irritation, or a feeling of something in the eye, dry eyes, depression, headache, itching of the eye and

eyelid, blurred vision, sleepiness, dry mouth, general weakness or an increase in blood-test results that
show how your liver is working.
Uncommon (may affect up to 1 in 100 people):
Congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to
fluid build-up), irregular heart rate, light-headedness, fainting, dizziness, dry nose or taste
disturbances, white spots under the eyelid or sensitivity to light.
Not known (frequency cannot be estimated from the available data):
Increased or decreased heart rate or low blood pressure
Some of these effects may be due to an allergy to any of the ingredients.
The following side effects have been seen with brimonidine or timolol and so may possibly be seen
with Brimonidine Tartrate/Timolol Eye Drops, Solution . Like other medicines applied into the eyes,
timolol is absorbed into the blood. This may cause similar side effects to those seen with intravenous
and/or oral beta-blocking agents. The incidence of side effects after topical ophthalmic administration
is lower than when medicines are, for example, taken by mouth or injected. Listed side effects include
reactions seen within the class of beta-blockers when used for treating eye conditions.
Generalized allergic reactions including swelling beneath the skin that can occur in areas such
as the face and limbs, and can obstruct the airway which may cause difficulty swallowing or
breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden lifethreatening allergic reaction.
Low blood glucose levels
Difficulty sleeping (insomnia), nightmares, memory loss
Stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia
gravis (muscle disorder), unusual sensations like pins and needles
Inflammation of the eyelid, inflammation in the cornea, detachment of the layer below the retina
that contains blood vessels following filtration surgery which may cause visual disturbances,
decreased corneal sensitivity, drooping of the upper eyelid (making the eye stay half closed),
double vision, inflammation of the iris, small pupils
Chest pain, palpitations, oedema (fluid build-up), heart attack, heart failure
Raynaud's phenomenon, cold hands and feet
Constriction of the airways in the lungs (predominantly in patients with pre-existing disease),
difficulty breathing, cough
Nausea, indigestion, diarrhoea, abdominal pain, vomiting
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of
psoriasis, skin rash
Muscle pain not caused by exercise, muscle weakness/tiredness
Sexual dysfunction, decreased libido
Ringing in the ears, cold-like symptoms.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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 Brimonidine Tartrate/Timolol Eye Drops, Solution

Keep this medicine out of the sight and reach of children.
Store below 30°C. Keep the bottle in the outer carton to protect it from light.
After first opening of the bottle, use within 28 days.
You should only use one bottle at a time.
Do not use this medicine after the expiry date which is stated on the label of the bottle and the carton
after EXP. The expiry date refers to the last day of that month.

You must throw away the bottle four weeks after you first opened it, even if there are still some drops
left. This will help to prevent infections. 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 Brimonidine Tartrate/Timolol Eye Drops, Solution contains
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The active substances are brimonidine tartrate and timolol.
One millilitre of solution contains 2 milligrams of brimonidine tartrate and timolol maleate
equivalent to 5 milligrams of timolol.
The other ingredients are benzalkonium chloride (a preservative), sodium dihydrogen phosphate
dihydrate, disodium phosphate dihydrate and water for injections. Small amounts of
hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH (a
measure of the acidity or alkalinity of the solution).

What Brimonidine Tartrate/Timolol Eye Drops, Solution looks like and contents of the pack
Brimonidine Tartrate/Timolol Eye Drops, Solution is a clear, greenish-yellow eye drop solution in a
plastic bottle with a screwcap. Each bottle is about half full and contains 5 ml of solution. Packs are
available containing either 1, 3, 5, 6 or 10 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Gyógyszergyár Zrt.
Gödöllő, Táncsics Mihály út 82.
Debrecen
H-2100
Hungary

This leaflet was last revised in 10/2016
PL 00289/2019
* Only the actual site of batch release will appear on the printed version of the leaflet

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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