Patient information leaflet

BRIMONIDINE TARTRATE 2 mg/ml eye drops, solution Brimonidine tartrate

Please read this leaflet carefully before you start to take your medicine.

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

•    If you have any further questions, please 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 Brimonidine Tartrate is and what it is used for

2.    Before you use Brimonidine Tartrate

3.    How to use Brimonidine Tartrate

4.    Possible side effects

5.    How to store Brimonidine Tartrate

6.    Further information

1. What Brimonidine Tartrate is and what it is used for

The active ingredient in Brimonidine Tartrate is brimonidine tartrate that is used to reduce pressure within the eye. It can be used either alone or with another eye drop which lowers pressure within the eye for the treatment of glaucoma or ocular hypertension.

2. Before you use Brimonidine Tartrate Do not use this medicine if you are

•    allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of Brimonidine Tartrate

•    taking monoamine oxidase (MAO) inhibitors or certain antidepressants. You must inform your doctor if you are taking any antidepressant medicinal product.

•    breast-feeding

•    infants/babies (from birth until 2 years)

Take special care with this medicine

Consult your doctor before using this medicine if you:

•    suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, heart problems, a disturbed blood supply of the limbs or a blood pressure disorder

•    have or have had kidney or liver problems

•    are pregnant or breast -feeding

•    wear soft (hydrophilic) contact lenses (see section “Important information about some ingredient of Brimonidine Tartrate)

•    regularly consume alcohol.

These eye drops are not recommended for use in children under 12 years of age. If Brimonidine Tartrate was prescribed for a child under 12 years, please clarify with your doctor before using.

Using other medicines

Please tell your doctor if you are using any of following medicines as they may affect your treatment:

•    medicines acting on the central nervous system (opiates, painkillers, sleeping tablets and alcohol)

•    chlorpromazine, methylphenidate or reserpine

•    medicines for treating your high blood pressure or heart

•    medicines for treating a problem with your metabolism

•    isoprenaline or prazosin

•    monoamine oxidase (MAO) inhibitors and other antidepressants.

Please tell your doctor or pharmacist if you are using or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breast-feeding

•    Ask your doctor or pharmacist for advice before taking any medicines.

•    Tell your doctor if you are pregnant or planning to become pregnant

•    This medicine should not be used during pregnancy unless the benefit to the mother outweighs the potential risk to a baby.

•    This medicine should not be used while breast-feeding Driving and using machines

•    This medicine may cause blurred and/or abnormal vision. This effect may seem worse at night or in reduced lighting.

•    This medicine may also cause drowsiness or tiredness in some patients.

If you experience any of these symptoms, do not drive or use machinery until the symptoms are cleared. Important information about some ingredients of Brimonidine Tartrate

This product contains benzalkonium chloride as preservative which may cause irritation and discolour soft contact lenses. If you wear soft contact lenses remove them prior to application and wait at least 15 minutes before reinsertion.

3. How to use Brimonidine Tartrate

Always use this product exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

The usual dose is one drop twice daily, approximately 12 hours apart. If you use it with another eye drops, wait 5-15 minutes before applying the second eye drops.

To be effective it must be used every day.

Children under 12 years

This medicine must not be used in newborns and infants below two years of age.

This medicine is not recommended for use in children (from 2 years until 12 years).

Always wash your hands before applying eye drops. Your prescription label tells you how many drops to use at each dose.

Apply your eye drops in the following way:

1.    Remove protective cap.

2.    Tilt your head back and look at the ceiling.

3.    Gently pull the lower eyelid down until there is a small pocket.

4.    Squeeze the upturned dropper bottle to release a drop into your eye.

5.    Whilst keeping the affected eye closed, press your finger against the corner of the closed eye (the side where the eye meets the nose) and hold for 1 minute.

Avoid touching the dropper tip against your eye or anything else.

Replace and tighten the cap straight after use.

Overdose

If you use more Brimonidine Tartrate than you should Adults

In adults who were instilling more drops than prescribed, the side effects reported were those already known.

Adults who accidentally swallowed brimonidine tartrate experienced decrease in blood pressure, which in some patients was followed by the increase in blood pressure.

Children

Serious side effects were reported in children who accidentally swallowed brimonidine tartrate. Signs included sleepiness, floppiness, low body temperature, paleness and breathing difficulties. Should this happen, contact your doctor immediately.

Adults and Children

If this medicine has been accidentally swallowed or if you have used more product than you should, please contact your doctor immediately.

If you forget to use Brimonidine Tartrate

If you forget to take a dose, apply it as soon as you remember. If, however, it is almost time for your next dose, you should omit the missed dose altogether and then follow your normal routine.

If you stop using Brimonidine Tartrate

As you suffer from glaucoma or ocular hypertension, if you stop using this medicine your ocular pressure will rise to the values prior the treatment and your vision might be damaged with time. Inform your doctor if you need to interrupt the treatment.

If you have any further question on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Brimonidine Tartrate can cause side effects, although not everybody gets them.

If you experience a rare (affect less than 1 in 1,000) but serious allergic reaction (difficulty breathing, closing of the throat, swelling of the lips, tongue, or face or hives, ocular allergic reactions) to brimonidine, stop using the medication and contact your doctor immediately.

Please tell your doctor if you notice any of the following side effects:

Very common (occur in more than 1 user in 10):

•    an allergic reaction in the eye, follicles or white spots on the conjunctiva, blurred vision, eye redness, burning, stinging, a feeling of something in the eye or itching

•    headache, tiredness, drowsiness and dry mouth.

Common (occur in 1 to 10 users in 100):

•    local irritation (inflammation and swelling of the eyelid, swelling of the conjunctiva, sticky eyes, pain and tearing), sensitivity to light, erosion on the surface of the eye and staining, eye dryness, whitening of the conjunctiva, abnormal vision, inflammation of the conjunctiva

•    dizziness, gastrointestinal symptoms, general weakness

•    cold-like symptoms or abnormal taste.

Uncommon (occur in 1 to 10 users in 1,000):

•    depression

•    palpitations or changes in heart rate or dry nose

•    general allergic reactions.

Rare (occur in 1 to 10 users in 10,000):

•    shortness of breath.

Very rare (occur in less than 1 user in 10,000):

•    eye inflammation or a reduction in pupil size

Some of these effects may be due to an allergy to the active ingredient or any of the other ingredients

• fainting, high or low blood pressure or sleeplessness.

Side effects where the occurrence is unknown:

Skin reactions including redness, face swelling, itching, rash and widening of blood vessels.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5. How to store Brimonidine Tartrate

Keep the bottle in a safe place out of the reach and sight of children.

No special storage conditions are required.

Do not use the bottle if the tamper-proof seal on the bottle is broken before first use.

The product should not be used after the expiry date (this is printed on both the bottle label and on the carton the bottle is packed in).

Discard the bottle 28 days after opening, even if there is solution remaining.

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 Brimonidine Tartrate contains

•    The active substance is brimonidine tartrate

•    1 ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine.

The other ingredients are benzalkonium chloride as a preservative, polyvinyl alcohol, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, purified water and sodium hydroxide or hydrochloric acid to adjust pH.

What Brimonidine Tartrate looks like and contents of the pack

A plastic dropper bottle with screw cap contains 5 ml of clear, light greenish-yellow solution.

Pack sizes: 1 x 5 ml 3 x 5 ml 6 x 5 ml

Not all packaging sizes may be marketed.

Marketing Authorisation Holder

Medicom Healthcare Limited

235 Hunts Pond Road

Titchfield Common

Fareham

Hants

PO14 4PJ

Manufacturer

TUBILUX PHARMA S.p.A.

Via Costarica 20/22 00071 Pomezia (RM)

ITALY

This medicinal product is authorized in the Member States of the EEA under the following names:

Italy

Brimonidina Tubilux Pharma 2 mg/ml collirio, soluzione Germany

Brimo-Vision 2 mg/ml Augentropfen Spain

Brimonidina cinfa 2 mg/ml colirio en solucion UK

Brimonidine Tartrate 2 mg/ml eye drops solution This leaflet was last revised in October 2015