BRIMONIDINE TARTRATE 2 MG / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

1. what brimonidine tartrate 2 mg/ml, eye drops, solution is and what it is used for

Brimonidine tartrate 2 mg/ml, eye drops, solution is used to reduce pressure within the eye.

It can be used either alone, when beta-blocker eye drops are contraindicated, or with another eye drop, when a single medicine is not enough to lower the increased pressure in the eye, in the treatment of open angle glaucoma or ocular hypertension.

The active ingredient in Brimonidine tartrate 2 mg/ml, eye drops, solution is Brimonidine tartrate which works by reducing pressure within the eye ball.

2. what you need to know before you use brimonidine tartrate 2 mg/ml, eye drops, solution

Do not use Brimonidine tartrate 2 mg/ml, eye drops, solution

• if you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
• if you are taking monoamine oxidase (MAO) inhibitors or certain antidepressants. You must inform your doctor if you are taking any antidepressan­t drug.
• ininfants/babies (from birth until 2 years).

Warnings and precautions

Talk to your doctor or pharmacist before using Brimonidine tartrate

2 mg/ml, eye drops, solution

• 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.
• If you have or have had in the past kidney or liver problems.
• If being given to a child between the age of 2 and 12 years because Brimonidine tartrate 2 mg/ml, eye drops, solution is not recommended for use in this age group.

Other medicines and Brimonidine tartrate 2 mg/ml, eye drops, solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

• pain killers, sedatives, opiates, barbiturates or are regularly consuming alcohol
• anesthetics
• to treat a heart condition or to lower blood pressure
• that can affect the metabolism like chlorpromazine, methylphenidate and reserpine
• which work on the same receptor as Brimonidine tartrate 2 mg/ml, eye drops, solution, for example isoprenaline and prazosin
• monoamine oxidase (MAO) inhibitors and other antidepressants
• medicines for any condition, even if unrelated to your eye condition
• or if the dose of any of your current medicines is changed.

These could affect your treatment with Brimonidine tartrate 2 mg/ml, eye drops, solution.

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 using this medicine.

Brimonidine tartrate 2 mg/ml, eye drops, solution should not be used while breast-feeding.

Driving and using machines

• Brimonidine tartrate 2 mg/ml, eye drops, solution may cause blurred or abnormal vision. This effect may seem worse at night or in reduced lighting.
• Brimonidine tartrate 2 mg/ml, eye drops, solution 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.

Brimonidine tartrate 2 mg/ml, eye drops, solution contains benzalkonium chloride

Brimonidine tartrate 2 mg/ml, eye drops, solution contains the preservative benzalkonium chloride. May cause eye irritation. Avoid contact with soft lenses. If you wear soft contact lenses take them out before using these eye drops and then wait 15 minutes after using Brimonidine tartrate 2 mg/ml, eye drops, solution before inserting your lenses. Known to discolour soft contact lenses.

3. how to use brimonidine tartrate 2 mg/ml, 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.

Adults

The usual dose is one drop twice daily in the affected eye(s), approximately 12 hours apart.

Children under 12 years

Brimonidine tartrate 2 mg/ml, eye drops, solution must not be used for infants below 2 years of age.

Brimonidine tartrate 2 mg/ml, eye drops, solution is not recommended for use in children (from 2 years until 12 years).

Instructions for use

Brimonidine tartrate 2 mg/ml, eye drops, solution comes as eye drops. Always wash your hands before applying eye drops. Your prescription label tells you how many drops to use at each dose. If you use Brimonidine tartrate 2 mg/ml, eye drops, solution with another eye drop, wait 5–15 minutes before applying the second eye drop.

• 1. Tilt your head back and look at the ceiling.

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

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

• 4. 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.

If you use more Brimonidine tartrate 2 mg/ml, eye drops, solution than you should

Adults

In adults who were instilling more drops than prescribed, the side effects reported were those already known to occur with Brimonidine tartrate 2 mg/ml, eye drops, solution.

Adults who accidentally swallowed Brimonidine tartrate 2 mg/ml, eye drops, solution 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 2 mg/ml, eye drops, solution. Signs included sleepiness, floppiness, low body temperature, paleness and breathing difficulties. Should this happen, contact your doctor immediately.

Adults and Children

If Brimonidine tartrate 2 mg/ml, eye drops, solution has been accidentally swallowed or if you have used more Brimonidine tartrate 2 mg/ml, eye drops, solution than you should, please contact your doctor immediately.

If you forget to use Brimonidine tartrate 2 mg/ml, eye drops,

190mm

190mm

solution

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.

Do not take a double dose to make up for a forgotten dose.

If you stop using Brimonidine tartrate 2 mg/ml, eye drops, solution

To be effective Brimonidine tartrate 2 mg/ml, eye drops, solution must be used every day. Do not stop using Brimonidine tartrate 2 mg/ml, eye drops, solution until your doctor tells you to.

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. The chance of having a side effect is described by the following categories:

The following eye side effects may be seen with Brimonidine eye drops:

Affecting the eve

Very common:

• Irritation of the eye (eye redness, burning, stinging, a feeling of something in the eye, itching, follicles or white spots on the see-through layer which covers the surface of the eye)
• Blurred vision
• An allergic reaction in the eye

Common:

• Local irritation (inflammation and swelling of the eyelid, swelling of the see-through layer which covers the surface of the eye, sticky eyes, pain and tearing)
• Sensitivity to light
• Erosion on the surface of the eye and staining
• Eye dryness
• Whitening of the see-through layer which covers the surface of the eye
• Abnormal vision
• Inflammation of the see-through layer which covers the surface of the eye

Very rare:

• Inflammation within the eye
• Reduction in pupil size

Side effects where the occurrence is unknown:

• Itching of eyelids

Affecting the body

Very common:

• Headache
• Dry mouth
• Tiredness/drow­siness

Common:

• Dizziness
• Cold-like symptoms
• Symptoms involving the stomach and digestion
• Abnormal taste
• General weakness

Uncommon:

• Depression
• Palpitations or changes in heart rate
• Dry nose
• General allergic reactions

Rare:

• Shortness of breath

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 via the the Yellow Card Scheme, website. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store brimonidine tartrate 2 mg/ml, eye drops, solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and the box after ‚Exp‘. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine if you notice that the tamper-proof seal on the bottle is broken before first use.

You should throw away the bottle four weeks (28 days) after you first opened it to prevent infections, and use a new bottle.

Do not throw away 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 informationwhat brimonidine tartrate 2 mg/ml, eye drops, solution contains the active substance is brimonidine. one ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine.

• The other ingredients are benzalkonium chloride as a preservative, poly(vinyl alcohol), sodium chloride, sodium citrate, citric acid monohydrate, purified water and sodium hydroxide or hydrochloric acid forpH-adjustment.

What Brimonidine tartrate 2 mg/ml, eye drops, solution looks like and contents of the pack

Brimonidine tartrate 2 mg/ml, eye drops, solution is a clear, greenish-yellow solution, free from any visible particulate matter in a plastic bottle.

Each bottle contains either 2.5 ml, 5 ml or 10 ml of the medicine.

Brimonidine tartrate 2 mg/ml, eye drops, solution is available in packs of 1,3 or 6 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Crescent Pharma Limited

Units 3 & 4, Quidhampton

Business Units,

Polhampton Lane, Overton,

Hampshire RG25 3ED

United Kingdom

Manufacturer:

IMUNAPHARM,a.s.

Jarkova 269/17,

082 22, Sarisske Michal’any

Slovak Republic

Wessling Hungary Kft.

F6tiut56,

1047, Budapest,

Hungary

This leaflet was last revised in 05/2019.

Very rare:

• Sleeplessness
• Faulting
• High blood pressure
• Low blood pressure