Biprolast

Leaflet attached to the packaging: patient information

Biprolast, 2 mg/ml, eye drops, solution

Brimonidine tartrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Biprolast and what is it used for
• 2. Important information before using Biprolast
• 3. How to use Biprolast
• 4. Possible side effects
• 5. How to store Biprolast
• 6. Other information

1. What is Biprolast and what is it used for

Biprolast is used to lower the pressure inside the eye.
Biprolast may be used as a single medication in patients for whom treatment with eye drops blocking β-adrenergic receptors is contraindicated, or as a supplementary medication in combination with other eye drops when the intraocular pressure is not sufficiently lowered using single medications in the treatment of open-angle glaucoma or ocular hypertension.
The active substance of Biprolast is brimonidine tartrate, which reduces the pressure inside the eye.

2. Important information before using Biprolast

When not to use Biprolast

• in breastfeeding women;
• in newborns and infants (from birth to 2 years).

Warnings and precautions

Before using this medicine, the doctor should be informed:

Biprolast and other medicines

Tell the doctor or pharmacist about all medicines being taken or have been taken recently, including those obtained without a prescription.
Inform the doctor if the following medicines are being used:
• painkillers, sedatives, opioid painkillers, barbiturates, and regular alcohol consumption;
• anesthetics;
• medicines affecting blood circulation or lowering blood pressure;
• medicines affecting metabolism, such as chlorpromazine, methylphenidate, reserpine;
• medicines acting on the same receptor as Biprolast, e.g., isoprenaline, prazosin;
• monoamine oxidase inhibitors (MAOIs) and other antidepressants;
• other medicines, even if their use is not related to eye disease;
• or if the doses of currently used medicines have changed.
All these factors may affect therapy with Biprolast.

Pregnancy and breastfeeding

Before using any medicine, consult a doctor or pharmacist.
Inform the doctor if the patient becomes pregnant or plans to become pregnant.
Do not breastfeed while using Biprolast.

Driving and operating machinery

After instilling Biprolast, vision may become blurred or disturbed. These symptoms may be particularly troublesome at night or in low light.
In some patients, Biprolast may cause drowsiness or fatigue.
Do not drive or operate machinery until the above symptoms have resolved.

Important information about some ingredients of Biprolast

The medicine contains 0.05 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color.
Remove contact lenses before instillation and wait at least 15 minutes before reinserting.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye).
If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, consult a doctor.

3. How to use Biprolast

This medicine should always be used as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Use in adults

The usual dose of Biprolast is one drop into each affected eye, administered twice a day, approximately 12 hours apart.

Use in children under 12 years

Do not use Biprolast in children under 2 years.
Biprolast is not recommended for use in children (2-12 years).
Method of administration
Biprolast should only be instilled into the eyes.
Wash your hands before instillation.
Administer the drops as directed by the doctor.
If using Biprolast with other eye drops, wait at least 5-15 minutes between instilling Biprolast and administering other drops.
Avoid touching the eye or anything else with the dropper tip, as it may become contaminated with bacteria that can cause infection leading to serious eye damage or vision loss.
Instill the medicine as follows:

• 1. Wash your hands.
• 2. Tilt your head back and look up.
• 3. Gently pull down the lower eyelid to form a small pocket.
• 4. Squeeze the inverted dropper and release one drop of solution into the pocket.
• 5. Close your eye and press the tear duct in the inner corner of the eye for about 1 minute.
• 6. Immediately after use, replace the cap and tighten the bottle.

Using more than the recommended dose of Biprolast

Adults
In adults who received more drops than recommended, the reported side effects were those currently known to occur with Biprolast.
In adults who accidentally ingested Biprolast, a decrease in blood pressure occurred, followed by an increase in blood pressure in some patients.
Children
Severe side effects have been reported in children who accidentally ingested Biprolast.
The following symptoms were observed: drowsiness, decreased muscle tone, decreased body temperature, pallor, and breathing difficulties.
If the above symptoms occur, consult a doctor immediately.
Adults and children
In case of ingestion or use of more than the recommended dose of Biprolast, consult a doctor immediately.

Missing a dose of Biprolast

If a dose is missed, it should be administered as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the previously established schedule. Do not use a double dose to make up for the missed dose.

Stopping use of Biprolast

To ensure effective treatment, the medicine should be used every day. Do not stop using the medicine without consulting a doctor.
In case of further doubts about using the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If allergic reactions occur, including hives, face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, or other serious side effects occur, stop using Biprolast and consult a doctor immediately.
The likelihood of side effects is described below:

Very common: occurs in more than 1 in 10 patients

Common: occurs in less than 1 in 10 patients

Uncommon: occurs in less than 1 in 100 patients

Rare: occurs in less than 1 in 1000 patients

Very rare: occurs in less than 1 in 10,000 patients

The following local side effects related to the eye may occur:

Very common:eye irritation (eye redness, burning, stinging, foreign body sensation, itching, lumps or white spots on the conjunctiva), blurred vision, eye allergic reactions;
Common:local irritation (lid inflammation and swelling, conjunctival edema, discharge in the conjunctival sac, eye pain, and tearing), light sensitivity, corneal erosion and spots on the cornea, dry eye, conjunctival blanching, vision disturbance, conjunctivitis;
Very rare:inflammation of the inner parts of the eye, miosis.
Frequency not known: eyelid itching

The following general side effects related to the whole body may occur:

Very common:headache, dry mouth, feeling tired and/or sleepy;
Common:dizziness, flu-like symptoms, gastrointestinal symptoms, taste disturbances, general weakness;
Uncommon:depression, heart palpitations or arrhythmias, nasal dryness, generalized allergic reactions;
Rare:shortness of breath;
Very rare:insomnia, fainting, hypertension or hypotension;
Frequency not known:skin reactions including redness, facial swelling, itching, rash, and vasodilation.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Biprolast

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
Biprolast, after first opening, can be stored for a maximum of 28 days.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Biprolast contains

• The active substance of Biprolast is brimonidine tartrate. 1 ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The medicine also contains benzalkonium chloride, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water, sodium hydroxide 1M, and hydrochloric acid 1M (to adjust pH).

What Biprolast looks like and contents of the pack

Biprolast is a clear, slightly yellowish-green solution. The eye drops are available in a 5 ml bottle with a dropper in a pack of 1 or 3 bottles.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Famar Anonymous Industrial Single Member
Company of Pharmaceuticals and Cosmetics
63, Agiou Dimitriou street
17564 Alimos, Attica
Greece
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Poland:
Biprolast
Date of leaflet approval:07.2024