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BRYMONT 2 MG/ML EYE DROPS SOLUTION

Active substance(s): BRIMONIDINE TARTRATE

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912022/03

PACKAGE LEAFLE T: 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)

 

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

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.

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.

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.

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).

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).

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

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.

040/01/Pv01

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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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