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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Brimonidine Hexal is and what it is used for 
2. What you need to know before you use Brimonidine Hexal 
3. How to use Brimonidine Hexal 
4. Possible side effects 
5. How to store Brimonidine Hexal 6. Contents of the pack 
and other information 

What Brimonidine Hexal is and what it is used for

Brimonidine Hexal contains brimonidine tartrate which acts by lowering the pressure in the eyeball.

The eye drops used in adults with glaucoma ( glaucoma ) and ocular hypertension (elevated intraocular pressure) to reduce the increased pressure in the eye that is caused by an accumulation of fluid. The drops can be used either as a single drug or in combination with other eye drops that lower the elevated pressure in the eyeball.

Brimonidine tartrate contained in Brimonidine Hexal 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.

What you need to know before you use Brimonidine Hexal

Do not use Brimonidine Hexal

  • For newborns and toddlers (from birth to 2 years of age).
  • If you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
  • If you are taking certain antidepressants (monoamine oxidase [MAO] inhibitors and certain other antidepressants).

You must tell your doctor if you are taking any medicine for depression.

Warnings and cautions

Talk to your doctor or pharmacist before using Brimonidin Hexal:

  • if you have or have had depression
  • if you have reduced mental capacity
  • if you have heart problems
  • if you have a reduced blood supply to the brain
  • if you have reduced blood supply to your arms and legs
  • if you have low blood pressure problems, especially when getting up
  • if you have or have had kidney or liver problems
  • if you wear soft contact lenses (see section 3)
  • if it is given to a child over 2 years of age as Brimonidine Hexal is not recommended for this age group.

Other medicines and Brimonidine Hexal

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

Tell your doctor if you are taking or have recently taken any of the following:

  • painkillers, sedatives
  • medicines used to treat severe pain or cough or as replacement therapy (opiates)
  • medicines to treat epilepsy or other diseases ( barbiturates )
  • anesthetics
  • medicines to treat heart problems or lower high blood pressure
  • drugs for the treatment of diseases of the nervous system (chlorpromazine, methylphenidate, and reserpine)
  • drugs that act in the same place in the body as brimonidine, e.g. isoprenaline and prazosin
  • monoamine oxidase (MAO) inhibitors and other antidepressants
  • medicine for any other disease, even if it has nothing to do with the eye disease.

Brimonidine Hexal with alcohol

Tell your doctor if you regularly drink alcohol.

Pregnancy and breastfeeding

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.

If you are pregnant or likely to be pregnant, do not use Brimonidine Hexal unless your doctor tells you it is absolutely necessary.

These eye drops should not be used during breast-feeding.

Driving and using machines

These eye drops may cause blurred vision or altered vision. This effect can be aggravated at night or at reduced lighting. Brimonidine Hexal may also cause drowsiness or fatigue in some patients.

If you get any of these symptoms, do not drive or use machines until the symptoms have disappeared.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Brimonidine Hexal contains benzalkonium chloride

This medicine contains 0.05 mg of benzalkonium chloride per ml. 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.

How to use Brimonidine Hexal

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

Dosage and how often to take Brimonidine Hexal

Take 1 drop of Brimonidine Hexal in the affected eye (s) twice daily at approximately 12-hour intervals. If you use it with other eye drops, wait 5-15 minutes before taking the other eye drops.

The eye drops must be taken every day to be effective.

Children under 12 years

Brimonidine Hexal is not recommended for children under 12 years of age. Brimonidine Hexal must not be used in particular for toddlers under 2 years of age.

Method of administration

Brimonidine Hexal is intended for use in the eye (s).

Follow the instructions on the prescription label carefully, and ask your doctor or pharmacist to explain what you do not understand.

Always wash your hands before applying eye drops. Take the drops as follows:

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

Carefully pull the lower eyelid down until a small pocket is formed.

3. Hold the bottle upside down and squeeze until there is a drop in the eye.

4. Keep the eye closed and press the finger towards the corner of the eye (the side where the eye meets the nose) and hold for 1 minute.

Do not allow the drip device to come into contact with the eyes or anything else. Replace and tighten the cover immediately after use.

If you wear soft contact lenses, remove them before using the eye drops and wait 15 minutes after taking the drops before reinserting the lenses. The preservative in these eye drops discolors soft contact lenses.

If you use more Brimonidine Hexal than you should

Adults

There is limited experience with overdose of Brimonidine Hexal in adults. This is unlikely when given as eye drops. In the cases reported, the symptoms have generally been those already listed as side effects. Adults who inadvertently swallow brimonidine experienced a drop in blood pressure, which in some patients was followed by an increase in blood pressure.

Children

Several cases of overdose have been reported in children receiving brimonidine Hexal as part of medical treatment for glaucoma ( glaucoma ). Symptoms include temporary coma or decreased consciousness, fatigue, drowsiness, lethargy, slow heartbeat, low body temperature, paleness, and difficulty breathing. Contact a doctor immediately if any of these symptoms occur.

Adults and children

For other alpha-2 agonist s, a group of drugs also brimonidine belong, oral (oral) of dosages reported to cause symptoms such as low blood pressure, weakness, vomiting, lethargy, drowsiness, slow heart rate, irregular heartbeat, contraction of the pupil are, weakness in the body, low body temperature, difficulty breathing and cramps. Brimonidine Hexal may cause similar symptoms.

Brimonidine Hexal is for eye application only. If you or a child accidentally swallows these eye drops or uses more than you or your child should, contact a doctor immediately.

If you forget to use Brimonidine Hexal

If you forget to use this medicine, take it as soon as you remember. If it is almost time for your next dose, do not take the drops but wait until the usual time and follow the normal routine.

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

If you stop using Brimonidine Hexal

You must use Brimonidine Hexal every day for it to be effective. Do not stop using this medicine 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.

Some of the side effects in the eye/eyes may be due to allergy to the active substance or any of the other ingredients (see the end of section 2 and section 6).

You may experience the following side effects that affect your eyes:

Very common  (may affect more than 1 user in 10)

  • an allergic reaction in the eye
  • blisters or white spots on the conjunctiva that cover the surface of the eye
  • cloudy vision
  • Red eyes
  • burning sensation, stinging sensation, feeling of having something in the eye
  • itching

Common  (may affect up to 1 in 10 people)

  • changes in the surface of the eye
  • eyelid inflammation
  • conjunctivitis
  • visual disturbances
  • sticky eyes
  • swelling of the eyelid or conjunctiva
  • photosensitivity
  • irritation
  • red eyelids
  • pain in the eye
  • dry eyes
  • abrasion on the surface of the eye and discoloration
  • tears
  • whitening of the conjunctiva

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

  • inflammation of the eye
  • reduced pupil size

Has been reported (occurs in an unknown number of users)

  • inflammation inside the eye that causes pain and redness
  • eyelid itching

You may experience the following side effects that affect the rest of your body :

Very common  (may affect more than 1 user in 10)

  • headache
  • fatigue / drowsiness
  • dry mouth

Common  (may affect up to 1 in 10 people)

  • dizziness
  • symptoms of the gastrointestinal tract
  • cold symptoms
  • general weakness
  • general allergic reactions

Uncommon  (may affect up to 1 in 100 people)

  • Depression
  • palpitation
  • changes in heart rate
  • dryness of the nose
  • sore throat
  • nausea
  • taste influence
  • dermatitis with rash
  • thirst

Rare  (may affect up to 1 in 1,000 people)

  • shortness of breath
  • seasonal allergy
  • high or low blood pressure
  • impact on the voice
  • cough
  • nasal congestion
  • dry throat

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

  • fainting
  • insomnia

Has been reported (occurs in an unknown number of users)

  • skin reactions including redness, swelling of the face, itching, rash, and dilation of blood vessels

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 Brimonidine Hexal

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

This medicine does not require any special storage conditions.

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

After first opening: used within 28 days.

Do not use this medicine if the warranty seal on the bottle is broken before first use.

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. Each ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
  • The other ingredients are benzalkonium chloride, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water and sodium hydroxide, and hydrochloric acid for pH control.

What the medicine looks like and the contents of the pack

Clear, slightly greenish-yellow solution.

The eye drops are packaged in a white low-density polyethylene (LDPE) drip bottle with a transparent low-density polyethylene (LDPE) drip device (which produces about 35 microliters) and a white high-density polyethylene (HDPE) drip device cap and placed in a carton.

Pack sizes:

1×5 ml, 3×5 ml, 6x5ml

1×10 ml, 3×10 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Hexal A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Pharma Stulln GmbH, Werksstrasse 3, 9251 Stulln, Germany

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

UAB Santonikas, 134B Veiveriu Street, 46353 Kaunas, Lithuania

Muhammad Nadeem

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