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COMBIGAN EYE DROPS

Active substance(s): BRIMONIDINE TARTRATE / TIMOLOL MALEATE

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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.
You should only use one bottle at a time.
Do not take your eye drops after the expiry date which is stated on the carton/label 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.

6. Further information
What Combigan eye drops contains
The active substance in Combigan is brimonidine tartrate and timolol.
One millilitre of solution contains 2milligrams of brimonidine tartrate and timolol maleate
equivalent to 5milligrams of timolol.
The other ingredients are benzalkonium chloride (a preservative), sodium phosphate
monobasic monohydrate, sodium phosphate dibasic heptahydrate 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 eye drops looks like and contents of the pack
Combigan eye drops are a clear, greenish-yellow eye drop solution in a plastic bottle with a
screw-cap.
Each bottle is about half full and contains 5 ml of solution.
Manufactured by: Allergan Pharmaceuticals Ireland, Castlebar Road, Westport Co. Mayo,
Ireland.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, UK.
®

Combigan eye drops; PL 18799/2498
Leaflet revision: 27.10.2015

Package Leaflet: InformatIon for the User
®

Combigan eye drops
(brimonidine tartrate and timolol)

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 of the side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Combigan eye drops but will be referred to as Combigan
throughout this leaflet.
In this leaflet:
1. What Combigan is and what it is used for
2. What you need to know before you use Combigan
3. How to use Combigan
4. Possible side effects
5. How to store Combigan
6. Contents of the pack and other 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.

POM

2. What you need to know 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 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, 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 17.
If you think any of these points apply to you, do not use Combigan until you have talked
again to your doctor.
Warnings and precautions
Talk to your doctor before using Combigan
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.
Other medicines and Combigan
Combigan can affect or be affected by other medicines you are using, including
other eye drops for the treatment of glaucoma. Tell your doctor or pharmacist if you are
taking have recently taken or might take 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 heart beat) 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 fluoxetine 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
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
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. 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 recommended 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. Gently pull down the lower eyelid until there is a small pocket.
2. Turn the bottle upside down and squeeze it to release one drop into each eye that
needs treatment.
3. Let go of the lower lid, and close your eye.
4. 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, this medicine 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
Affecting the eye
Very common: (may affect more than 1 in 10 people):
Eye redness or burning.

Common (may affect up to 1 in 10 people):
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 (may affect up to 1 in 100 people):
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 (frequency cannot be estimated from the available data):
Blurred vision
Affecting the body:
Common: (may affect up to 1 in 10 people):
High blood pressure
Depression
Sleepiness
Headache
Dry mouth
General weakness
Uncommon (may affect up to 1 in 100 people):
Heart failure
Irregular heart rate
Light-headedness
Fainting
Dry nose
Taste disturbance
Nausea
Diarrhoea
Not know (frequency cannot be estimated from the available data):
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 Comgiban, 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 heart beat, 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
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, pharmacist or nurse. 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.

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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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