2 mg / ml eye drops , solution brimonidine tartrate 

1. What Brimonidine Bluefish is and what it is used for

The active substance in Brimonidine Bluefish is brimonidine tartrate, which belongs to a group of medicines called sympathomimetics. It works by lowering the pressure in the eyeball in the disease glaucoma with an open ventricular angle or elevated pressure in the eye. It can either be used as a single drug, or with another eye drop when a single drug is not enough to lower the increased pressure in the eye.

Brimonidine tartrate contained in Brimonidine Bluefish 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 you use Brimonidine Bluefish

Do not use Brimonidine Bluefish

  • if you are allergic to briminodine 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 tell your doctor if you are taking any medicine for depression.
  • to newborns and toddlers (from birth to 2 years of age).

Warnings and cautions

Talk to your doctor or pharmacist before using Brimonidine Bluefish

  • if you have or have previously had depression, impaired mental ability, decreased blood supply to the brain, heart problems, disturbances in the blood supply to the arms and legs, or problems with blood pressure.
  • if you have or have ever had problems with your kidneys or liver.

Children

Brimonidine Bluefish is not recommended for use in children (from 2 years to 12 years).

Other medicines and Brimonidine Bluefish

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 any of the following medicines:

  • painkillers, sedatives, opiates, barbiturates, or if you regularly consume alcohol.
  • anesthetic.
  • medicines to treat heart disease or to lower blood pressure.
  • drugs that may affect metabolisms, such as chlorpromazine, methylphenidate, and reserpine.
  • drugs that act on the same receptor as Brimonidine Bluefish, e.g. isoprenaline and prazosin.
  • monoamine oxidase (MAO) inhibitors and other antidepressants.
  • medicines for other diseases, even when there is no link to your eye disease.
  • or if the dose of one of your other medicines changes.

This may affect your treatment with Brimonidine Bluefish.

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.

Brimonidine Bluefish should not be used if you are breast-feeding.

Driving and using machines

  • Brimonidine Bluefish may cause blurred vision or changes in vision. This effect may appear worse at night or at reduced lighting.
  • Brimonidine Bluefish may also cause drowsiness or fatigue in some patients.
  • If you experience any of these symptoms, do not drive or use machines until the symptoms have subsided.

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 Bluefish contains benzalkonium chloride

This medicine contains 0.05 mg 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.

3. How to use Brimonidine Bluefish

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

Adults

The recommended dose is one drop twice daily in the affected eye (s), at intervals of approximately 12 hours.

User instructions

Brimonidine Bluefish is an eye drop. Always wash your hands before applying eye drops . The pharmacy label indicates how many drops you should take for each dose. If Brimonidine Bluefish is used with other eye drops, wait 5-15 minutes before taking the other type of eye drops.

Take the drops as follows:

1.
2.
3.
4.
  1. Tilt your head back and look at the ceiling.
  2. 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. Release the lower eyelid, close your eyes and at the same time press your finger against the inner corner of the eye (the side where the eye is closest to the nose) for 1 minute.

Avoid getting the tip of the bottle in contact with the eye or anything else.

Replace the cover immediately after use.

Adults

In adults who used more drops than prescribed, the reported side effects were those already known when using Brimonidine Bluefish.

Adults who accidentally swallowed Brimonidine Bluefish experienced a decrease in blood pressure, which in some patients was followed by an increase in blood pressure.

Children

Serious side effects have been reported in children who accidentally swallowed Brimonidine Bluefish. Symptoms included drowsiness, lethargy, low body temperature, pallor, and difficulty breathing. Contact your doctor immediately if this should happen.

Adults and children

If you have accidentally drunk the eye drops or if you have used more Brimonidine Bluefish than you should, contact your doctor immediately.

If you forget to use Brimonidine Bluefish

If you forget to take a dose, take it as soon as you remember. However, you should skip the missed dose if it is almost time for the next dose. Then follow the normal routine.

If you stop using Brimonidine Bluefish

Brimonidine Bluefish must be used every day to be effective. Do not stop using Brimonidine Bluefish 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 following side effects may be seen with the use of Brimonidine Bluefish.

Side effects are those that affect the eye

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

  • Eye irritation (red eyes, burning sensation, stinging sensation, a feeling of having something in the eye, itching, blisters, or white spots in the transparent membrane that covers the surface of the eye)
  • Grumlad syn
  • An allergic reaction in the eye

Common (may affect up to 1 in 10 people):

  • Local irritation ( inflammation and swelling of the eyelid, swelling of the transparent membrane covering the surface of the eye, sticky eyes, aches and increased tear flow)
  • Photosensitivity
  • Abrasion on the surface of the eye and discoloration
  • Dry eyes
  • Whiteness of the translucent membrane covering the surface of the eye
  • Abnormal sight
  • Inflammation of the transparent membrane that covers the surface of the eye

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):

  • Eyelid itching

Side effects are those that affect the body

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

  • Headache
  • Dry mouth
  • Fatigue / drowsiness.

Common (may affect up to 1 in 10 people):

  • Dizziness
  • Cold symptoms
  • Symptoms from the stomach and digestion
  • Taste effect
  • Impotence

Uncommon (may affect up to 1 in 100 people):

  • Depression
  • Palpitations or changes in heart rate
  • Dry nose
  • 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):

  • Insomnia
  • Fainting
  • High blood pressure
  • Low blood pressure

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 Bluefish

  • 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 after EXP. The expiration date is the last day of the specified month.
  • No special storage instructions.
  • The bottle should be discarded 28 days after opening, even if there is a solution left.

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. 1 ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg brimonidine.
  • The other ingredients are benzalkonium chloride, poly (vinyl alcohol), sodium chloride, sodium citrate, citric acid monohydrate, purified water, and sodium hydroxide or hydrochloric acid for pH control.

What the medicine looks like and the contents of the pack

Brimonidine Bluefish is a clear light green/yellow solution. Each bottle contains 5 ml.

Brimonidine Bluefish is available as a pack of 1, 3, and 6 bottles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer 

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

Germany

UAB Santonika

Veiveriu Street 134B

46352 Kaunas

Lithuania

This medicinal product is authorized under the European Economic Area under the names:

Name Member State
Brimonidine Bluefish Iceland
Brimonidine-Bluefish 2 mg/ml eye drops, solution Germany

Muhammad Nadeem

Leave a Reply