COMBIGAN 2MG/ML + 5MG/ML EYE DROPS SOLUTION

Active substance: TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

COMBIGAN® 2mg/ml + 5mg/ml EYE DROPS, SOLUTION
(brimonidine tartrate and timolol)
This product is available using the above name but will be referred to as Combigan throughout the following leaflet:
Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

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

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Combigan is and what it is used for
2. Before you use Combigan
3. How to use Combigan
4. Possible side effects
5. How to store Combigan
6. Further information
1. WHAT COMBIGAN IS AND WHAT IT IS USED FOR
Combigan 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. Combigan 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. Combigan 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. BEFORE YOU USE COMBIGAN
Do not use Combigan eye drops solution
• if you are allergic (hypersensitive) to brimonidine tartrate, timolol, beta-blockers or any of the other
ingredients of Combigan. 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, 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 low heart rate, heart failure, heart beat disorders (unless controlled by a
pacemaker).
• if you are taking monoamine oxidase (MAO) inhibitors or certain other antidepressant drugs.
Combigan should not be used in children less than 2 years old and should not usually be used in children aged 2 to
nd
17.
If you think any of these points apply to you, do not use Combigan until you have talked again to your doctor.
Take special care with Combigan
Before you take this medicine, tell your doctor
• if you have now or have had in the past
− 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 levels
− over activity 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 the doctor before you have an operation that you are using Combigan, as the timolol may change effects of
some medicines during anaesthesia.
Using other medicines
Combigan 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 or have recently taken any other
medicines, including medicines for any condition, even if unrelated to your eye condition, including medicines
obtained without a prescription.
There are a number of medicines which may interfere with Combigan, so 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, digoxin or quinidine
(used to treat heart conditions and some types of malaria)
• medicines to treat diabetes or high blood sugar
• medicines for depression such as fluxetine and paroxetine
• another eye drop used to lower high pressure in the eye (glaucoma)
• 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 heartburn or stomach ulcers
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 Combigan.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant or
planning to become pregnant.
Do not use Combigan if you are pregnant unless your doctor considers it necessary.
Do not use Combigan if you are breast-feeding. Timolol may get into your milk. Ask your doctor for advice before
taking any medicine during breast-feeding.
Driving and Using Machines
Combigan 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.
Important information about some of the ingredients of Combigan
Contact Lenses
• Do not use Combigan while your contact lenses are in your eyes. Wait at least 15 minutes after using Combigan
before putting your lenses back in.
• A preservative in Combigan (benzalkonium chloride) may cause eye irritation and is also known to discolour soft
contact lenses.
3. HOW TO USE COMBIGAN
Always use Combigan exactly as your doctor has told you. You should check with your doctor or pharmacist if you
are not sure. Combigan must not be used in infants below 2 years of age. Combigan should not usually be used in
children and adolescents (from 2 to 17 years).
The usual dose is one drop of Combigan, 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 Combigan, leave at least 5 minutes between using Combigan 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.
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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.
Keep the eye closed and press your finger against the corner of your eye (the side where your eye meets your
nose) for two minute. This helps stop Combigan 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 screw-cap back on
to close the bottle, straight after you have used it.
If you use more Combigan than you should
Adults
If you use more Combigan 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 Combigan) as part of medical treatment for glaucoma. Signs include sleepiness, floppiness, low body
temperature, paleness and breathing difficulties. Should this happen, contact your doctor immediately.
Adults and Children
If Combigan has been accidentally swallowed then you should contact your doctor immediately.
If you forget to use Combigan
If you forget to use Combigan, 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 take a double dose to make up for a forgotten dose.
If you stop using Combigan
Combigan 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, Combigan can cause side effects, although not everybody gets them.
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 chance of having a side effect is described by the following categories:
Not known
Frequency cannot be estimated from the available data
Very common
Occurs in more than 1 out of 10 patients
Common
Occurs in fewer than 1 out of 10 patients
Uncommon
Occurs in fewer than 1 out of 100 patients
The following side effects may be seen with Combigan.
Affecting the eye
Very common: Eye redness or burning.
Common:
• Stinging or pain in the eye
• Allergic reaction in the eye or on the skin around the eye,
• Small breaks in the surface of the eye (with or without inflammation)
• Swelling, redness or inflammation of the eyelid
• Irritation, or a feeling of something in the eye
• Itching of the eye and eyelid
• Follicles or white spots on the see through layer which covers the surface of the eye
• Vision disturbance
• Tearing
• Eye dryness
• Sticky eyes
Uncommon:
• Difficulty in seeing clearly
• Swelling or inflammation of the see-through layer which covers the surface of the eye
• Tired eyes
• Sensitivity to light
• Eyelid pain
• Whitening of the see-through layer which covers the surface of the eyes
• Swelling or areas of inflammation under the surface of the eye
• Floaters in front of the eyes
Not known
• Blurred vision
Affecting the body:
Common:
• High blood pressure
• Depression
• Sleepiness
• Headache
• Dry mouth
• General weakness
Uncommon:
• Heart failure
• Irregular heart rate
• Light-headedness
• Fainting
• Dry nose
• Taste disturbance
• Nausea
• Diarrhoea
Not known:
• Increased or decreased heart rate
• Low blood pressure
• Face redness
Some of these effects may be due to an allergy to any of the ingredients. Additional side effects have been seen
with brimonidine or timolol and therefore may potentially occur with Combigan.
The following additional side effects have been seen with brimonidine:
- inflammation within eye, small pupils, difficulty sleeping cold-like symptoms shortness of breath, symptoms
involving the stomach and digestion, general allergic reactions, skin reactions including redness, face
swelling itching rash and widening of blood vessels.
Like other medicines applied into eyes, Combigan (brimonidine/timolol) is absorbed into the blood. Absorption of
timolol, a beta blocker component of Combigan, may cause similar side effects as seen with intravenous” and /or
“oral” beta-blocking agents. 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:
- Generalised 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), localised and generalised rash, itchiness, severe sudden life threatening allergic reaction
- Low-blood glucose levels
- Difficulty in sleeping (insomnia), nightmares, memory loss
- Stroke, reduced blood supply to the brain, increased signs and symptoms of myasthenia gravis (muscle
disorder), unusual sensations (like pins and needles).
- 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, corneal erosion (damage
to the front layer of the eyeball), drooping of the upper eyelid (making the eye half closed), double vision
- Chest pain, oedema (fluid build up), changes in the rhythm or speed of the heartbeat, a type of heart rhythm
disorder, heart attack, heart failure,
- Raynaud’s phenomenon, cold hands and feet
- Constriction of the airways in the lung (predominantly in patients with pre-existing disease) difficulty
breathing, cough
- Indigestion, 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
- Sexual dysfunction, decreased libido
- Muscle weakness/tiredness
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE COMBIGAN
• Keep out of the sight and reach of children.
• Keep the bottle in the outer carton to protect it from light.
• Do not use Combigan 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.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will help to protect the environment.
• If your medicine become discoloured or show signs of any deterioration, you should seek the advice of your
pharmacist.
6. FURTHER INFORMATION
What Combigan contains
• The active substances are brimonidine tartrate and timolol.
• Each ml of solution contains 2mg of brimonidine tartrate and timolol maleate equivalent to 5mg of timolol.
• The other ingredients are benzalkonium chloride (a preservative), sodium phosphate dibasic heptahydrate, sodium
phosphate monobasic monohydrate and purified water. 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 Combigan looks like and contents of the pack
Combigan is a clear, greenish-yellow eye drop solution in a plastic bottle with a screw-cap. Each bottle contains
5ml of solution.
®
POM
PL No: 15814/1054
COMBIGAN 2mg/ml + 5mg/ml EYE DROPS, SOLUTION
Manufactured by Allergan Pharmaceuticals Ireland, Westport, County Mayo, Ireland. Procured from within the EU
and repackaged by OPD Laboratories Ltd., Unit 6 Colonial way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 18.10.2013.
Combigan is a Trade Mark of the Allergan, Inc.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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