912022/03

PACKAGE LEAFLET: INFORMATION FOR THE USER

BRYMONT® 2 mg/ml EYE DROPS, SOLUTION

Brimonidine tartrate

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. Do not pass it on to others. It may harm them, even if their symptoms 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 Brymont is and what it is used for

2.    What you need to know before you use Brymont

3.    How to use Brymont

4.    Possible side effects

5.    How to store Brymont

6.    Contents of the pack and further information

1.    WHAT BRYMONT IS AND WHAT IT IS USED FOR

It is an eye drop and each bottle contains 5 ml of the medicine.

The active ingredient in Brymont is Brimonidine tartrate.

Brymont is used to reduce pressure within the eye in glaucoma or ocular hypertension (raised pressure in the eye).

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE BRYMONT

Do not use Brymont

-    if you are allergic (hypersensitive) to brimonidine tartrate or to any of the other ingredients in Brymont (listed in section 6)

-    if you are taking monoamine oxidase inhibitors (MAOIs) e.g. phenelzine or isocarboxazid, often used to treat depression

-    if you are taking tricyclic anti-depressants (e.g. amitriptyline, imipramine) or mianserin, often used to treat depression

-    if you are breast feeding or intend to breast feed

-    in infants or babies (from birth until 2 years)

Warnings and Precautions

Talk to your doctor before using Brymont if you:

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

-    have, or have had in the past, kidney or liver problems

-    wear soft (hydrophilic) contact lenses

Children and Adolescents under 17 years

Brymont should not be used in infants below 2 years of age.

Brymont is not recommended for use in children (from 2 years until 12 years)

No clinical studies have been performed with Brymont in adolescents (12 to 17 years)

Other medicines and Brymont

Before using Brymont, please tell your doctor or pharmacist if you have any other eye disorder. Also, if you are taking, have recently taken, or might take any other medicines, in particular:

-    pain killers (e.g. co-codamol), sedatives (tablets for stress or to help you sleep e.g. diazepam, alprazolam), opiates (e.g. morphine), barbiturates (e.g. phenobarbital), or you are regularly taking alcohol.

-    medicines to treat depression (e.g. fluoxetine, paroxetine or venlafaxine), to treat a heart condition (e.g. digoxin) or to lower blood pressure (e.g. bendrofluazide, atenolol, lisinopril or reserpine).

-    prazosin, a medicine often used to treat enlarged prostate

-    chlorpromazine and methylphenidate, often used to treat certain nervous disorders.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine for any condition, including medicines obtained without any prescription, or if the dose of any of your current medicines is changed.

Pregnancy and 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 taking any medicine. Brymont should be used in pregnancy only if specifically recommended by a doctor.

Do not use if you are breast feeding or intend to breast feed.

Driving and using machines

Brymont may cause drowsiness or tiredness in some patients. It can also cause blurred / abnormal vision; these effects may seem worse at night or in reduced lighting. Wait until these effects have cleared before driving or using machines.

Brymont contains

The preservative benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses.

3.    HOW TO USE BRYMONT

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

Avoid contact with soft lenses. If you wear soft contact lenses, remove them prior to the application of Brymont and then wait at least 15 minutes before reinsertion.

The usual dose is one drop twice daily in the affected eye(s), approximately 12 hours apart e.g. once in the morning and once in the evening.

If you use it with another eye drop, please wait 5-15 minutes before applying the second eye drop.

Use in Children and Adolescents under 17 years

Brymont should not be used in infants below 2 years of age.

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

No clinical studies have been performed with Brymont in adolescents (12 to 17 years).

Instructions for use:

Brymont is for use as eye drops only; do not swallow.

Always wash your hands before applying eye drops. Apply one drop of Brymont in each affected eye in the following way:

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.

5.    Replace and tighten the cap immediately after use.

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

If you use more Brymont than you should:

If you have instilled too many drops of Brymont in your eye(s), it is unlikely to cause you any harm. Apply your next dose at the usual time. If it has been swallowed, contact your doctor immediately since it may cause low blood pressure, high blood pressure, reduced consciousness, slow heart rate, decreased muscle tone, suppression of your breathing and low body temperature which may require hospital treatment.

If you forget to use Brymont:

If you forget a dose, apply it as soon as you have realised it. However, if it is almost time for your next dose, treatment should continue with the next dose as planned. The dose should not exceed one drop 2 times daily in the affected eye(s).

If you stop using Brymont:

Do not stop using this medicine without talking to your doctor first.

4. POSSIBLE SIDE EFFECTS

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

Stop using Bymont and immediately contact your doctor

if you get any of the following symptoms (general allergic reaction):

•    swollen face, tongue or throat

•    difficulties in swallowing

•    rash or breathing difficulties

Very common: may affect more than 1 in 10 people

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

•    Headache, dry mouth, and tiredness/drowsiness

Common: may affect up to 1 in 10 people

•    Changes to the surface of the eye, redness, swelling, pain and tenderness of the eye orthe eyelid, abnormal vision, sticky eyes, sensitivity to light, irritation, dryness, tears, or whitening of the front of the eye

•    Dizziness, cold-like symptoms, gastro-intestinal symptoms, abnormal taste or general weakness

Uncommon: may affect up to 1 in 100 people

•    Depression, palpitations (thumping sensation in the heart), changes in heart rate or dry nose, and general allergic reactions

Rare: may affect up to 1 in 1,000 people

•    Shortness of breath

Very rare: may affect up to 1 in 10,000 people

•    Inflammation inside the eye or a reduction in pupil size

•    Sleeplessness, fainting and high or low blood pressure

Some of these effects may be due to an allergy to any of the ingredients of Brymont 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 Yellow Card Scheme Website: 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 B RYMONT

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

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

Do not use Brymont after the expiry date, which is stated on the label of the bottle and on the carton after Exp.

The expiry date refers to the last day of that month

Do not use the same bottle 28 days after first opening, even if the bottle is not empty.

Do not store the bottle at a temperature above 25°C.Keep bottle in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Brymont contains

-    The active ingredient in Brymont is brimonidine tartrate 2.0 mg/ml which is equivalent to brimonidine 1.3 mg/ml.

-    The other ingredients are benzalkonium chloride (preservative), polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, water for injection, and sodium hydroxide or hydrochloric acid (to adjust pH).

What Brymont looks like and contents of the pack

Brymont is a clear greenish-yellow to light greenish-yellow solution in a plastic bottle containing 5 ml of the solution.

Brymont is available in packs of 1, 2 or 3 bottles.

Not all pack sizes may be marketed in every country.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Blumont Pharma Ltd., 23 Moortown Close, Grantham, NG31 9GG United Kingdom Manufacturer:

Farmigea S.p.A - Via G.B. Oliva, 6/8 - 56121 Pisa, Italy

Hard to see or read this leaflet? Call 01476 978568 for help.

This leaflet was last revised on 01.2016

040/01/Pv01