2 mg/ml eye drops, solution 
Brimonidine tartrate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to 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. See section 4.

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 other ingredients information

1. What Brymont is and what it is used for

This medicine contains eye drops. One bottle contains 5 ml of medicine.

The active substance in Brymont is brimonidine tartrate.

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

Brimonidine tartrate found in Brymont may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Brymont

Do not use Brymont

  • if you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of Brymont (listed in section 6)
  • if you are taking monoamine oxidase inhibitors ( MAOIs ), such as phenelzine or isocarboxazid, which are commonly used to treat depression
  • if you are taking tricyclic antidepressants (eg amitriptyline or imipramine) or mianserin, which are commonly used to treat depression
  • if you are breast-feeding or planning to breast-feed
  • to infants or toddlers (newborns up to two years of age).

Warnings and cautions

Talk to your doctor before using Brymont if you

  • suffers from or has suffered from depression, decreased blood supply to the brain, heart problems, blood pressure problems, or disturbances in the blood supply to the extremities (arms and legs)
  • have or have had kidney or liver problems
  • wears soft contact lenses

Children and adolescents under 17 years of age

Brymont must not be used for small children under 2 years of age.

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

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

Other drugs and Brymont

Before you use Brymont, tell your doctor or pharmacist if you have any other eye diseases. Also tell if you are taking, or have recently taken any other medicines, such as:

  • analgesics (eg those containing a combination of paracetamol and codeine ), tranquilizers (tablets against stress or to sleep, such as diazepam, alprazolam), opiates (e.g. morphine), barbiturate s (eg phenobarbitol), or if you regularly drink alcohol
  • medicines to treat depression (eg fluoxetine, paroxetine, or venlafaxine ), medicines to treat heart problems (eg digoxin ) or to lower blood pressure (eg bendrofluazide, atenolol, lisinopril, or reserpine)
  • prazosin; drugs often used to treat an enlarged prostate
  • chlorpromazine and methylphenidate; which is often used to treat certain nervous disorders

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Also, tell if any dose of any of your current medicines is changing.

Pregnancy and breastfeeding 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 this medicine. Brymont should be used during pregnancy only if your doctor tells you to.

Do not use this medicine if you are breast-feeding or planning to breast-feed your baby.

Driving and using machines

Brymont may cause drowsiness and fatigue in some patients. It can also cause blurred vision and/or visual disturbances. Such side effects can be worse at night or in poor lighting. Do not drive or use any tools or machines until the side effects have disappeared.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Brymont contains benzalkonium chloride

This medicine contains 0.05 mg benzalkonium chloride per ml equivalent to 0.25 mg / 5 ml bottle. Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.

3. How to use Brymont

Always use Brymont exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Avoid contact with soft contact lenses. If you wear soft contact lenses, remove them before administering Brymont. Then wait at least 15 minutes before inserting them again.

The recommended dose is 1 drop in the affected eye twice daily at 12-hour intervals, e.g. 1 time in the morning and once in the evening.

If you are taking any other ophthalmic medicines, leave at least 5-15 minutes between applications of the eye medicines.

Use for children and adolescents

Brymont must not be used for small children under 2 years of age.

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

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

User instructions

Brymont should only be used as eye drops. Do not swallow.

Always wash your hands before using eye drops. Apply a drop of Brymont to the affected eye (s) as follows:

  1. Lean your head back and look at the ceiling.
  2. Gently pull the lower eyelid down until a small pocket is formed.
  3. Squeeze the inverted bottle to drip a drop into the eye.
  4. Close your eyes and press a finger to the corner of your eye (where the eye and nose meet) and hold for a minute.
  5. Screw on the lid immediately after use.

The drip tip should not come into contact with anything, not even the eye, as it may damage the eye and contaminate the eye drops.

If you have dropped too many drops of Brymont in the eye, it will probably not lead to any injury. Administer the next dose at the usual time. If you swallow the medicine, contact a doctor immediately as the drops may cause low blood pressure, high blood pressure, decreased consciousness, slower heart rate, decreased muscle tension, reduced breathing, and low body temperature, which may require hospitalization.

If you forget to use Brymont

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, continue with the next dose as planned. Dose one should not exceed 1 drop twice daily in the eye (s) being treated.

If you stop using Brymont

Do not stop taking 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 Brymont and contact a doctor immediately if the following symptoms occur (general allergic reaction ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • rash or difficulty breathing

Very common: may affect more than 1 user in 10:

  • allergic reaction in the eye, or white spots on the surface of the eye, blurred vision, redness of the eyes, burning, tingling, a feeling of having something in the eye or itching
  • headache, dry mouth, and fatigue/drowsiness

Common: may affect up to 1 in 10 users:

  • changes in the surface of the eye, redness, swelling, pain and tenderness of the eye or eyelid, abnormal vision, sticky eyes, photosensitivity, irritation *, dryness, tears or whitening of the surface of the eye* Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor
  • dizziness, cold symptoms, gastrointestinal symptoms, abnormal taste in the mouth, or a general feeling of weakness

Uncommon: may affect up to 1 in 100 people:

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

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

  • shortness of breath

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

  • inflammation of the eye or a decrease in pupil size
  • insomnia, fainting, and high or low blood pressure

Some side effects may be caused by allergies to certain ingredients in Brymont.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. How to store Brymont

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

Do not use if the protective seal on the bottle has been broken before first use.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

The packaging is stable for 28 days after opening and must then be discarded even if the bottle is not empty.

Do not store above 25 ° C.

Store the bottle in the outer carton in order to protect it from light

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. Contents of the packaging and other information

Content declaration

  • The active substance is brimonidine tartrate, 2.0 mg/ml, which corresponds to brimonidine, 1.3 mg/ml.
  • The other ingredients are benzalkonium chloride ( preservative ), polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, water for injections, hydrochloric acid for pH adjustment or sodium hydroxide for adjustment.

What the medicine looks like and the contents of the pack

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Blumont Pharma Ltd., 23 Moortown Close, Grantham, NG31 9GG, UK

Local representative: Astimex pharma AB, Isafjordsgatan 36,164 40 Kista,


Manufacturer:

Farmigea SpA

Via GB Oliva, 6/8

56121 Pisa, Italy

Muhammad Nadeem

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