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

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

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Combigan® 2mg/ml + 5mg/ml eye drops, solution
(Brimonidine tartrate and timolol maleate)
Your medicine is known by the above name, but will be referred to as
Combigan throughout this:
Patient Information Leaflet
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 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.

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
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 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 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 breastfeeding.
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 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 minutes. 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.

- 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

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 (e.g. 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

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.

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 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.
• If the medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
• Do not throw away any medicine via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

Affecting the body:

6) Content of the pack and other information

Common (may affect up to 1 in 10 people):
• High blood pressure
• Depression
• Sleepiness
• Headache
• Dry mouth
• General weakness

What Combigan contains:
• The active substances are brimonidine tartrate and timolol.
• Each 1ml of solution contains 2mg brimonidine tartrate and timolol
maleate equivalent to 5mg 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).

Uncommon (may affect up to 1 in 100 people:
• Heart failure
• Irregular heart rate
• Light-headedness
• Fainting
• Dry nose
• Taste disturbance
• Nausea
• Diarrhoea

What Combigan looks like and contents of the pack
Combigan is a clear, greenish-yellow eye drop solution in a plastic bottle
with a nozzle and a screw cap.
Each bottle is about half full and contains 5 ml of solution.
Combigan is available in packs of 1 x5ml bottle and 3 x 5ml bottles.
PL 10383/2156

POM

Not known (frequency cannot be estimated from the available data)
• Increased or decreased heart rate
• Low blood pressure
• Face redness

Who makes and repackages your medicine
Your medicine is manufactured by Allergan Pharmaceuticals Ireland,
Castlebar Road, Westport, Co Mayo, Ireland. Procured from within the EU
and repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

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.

Leaflet date: 23.03.2016

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

Combigan is a registered trademark of Allergan Inc., USA.

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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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