Package leaflet: information for the patient

Biprolast, 2 mg/ml, eye drops, solution
brimonidini tartras
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Biprolast is and what it is used for
Important information before using Biprolast
How to use Biprolast
Possible side effects
How to store Biprolast
Further information

1. What Biprolast is and what it is used for
Biprolast is used to reduce intraocular pressure.
Biprolast may be used as monotherapy in patients for whom treatment with β-adrenergic receptor-blocking eye drops is contraindicated, or as an adjunctive therapy together with other eye drops when intraocular pressure is not sufficiently controlled with single-agent therapy in the treatment of open-angle glaucoma or ocular hypertension.
The active substance in Biprolast is brimonidine tartrate, which reduces intraocular pressure.

2. Important information before using Biprolast

When not to use Biprolast

if the patient is allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of Biprolast;
if the patient is taking monoamine oxidase inhibitors (MAOIs) or certain antidepressant medicines. Inform your doctor if you are taking any antidepressant medications;
in breastfeeding women;
in newborns and infants (from birth to 2 years of age).

Warnings and precautions
Before using this medicine, inform your doctor:

if the patient suffers or has previously suffered from depression, has impaired mental function, cerebrovascular disorders, heart disorders, peripheral circulation disorders, or hypotension;
if the patient has or has previously had kidney or liver function disorders;
if Biprolast is to be used in children aged 2 to 12 years, as Biprolast is not recommended in this age group.

Biprolast and other medicines
Tell your doctor or pharmacist if you are currently taking, or have recently taken, any other medicines, including those obtained without a prescription.
Inform your doctor if you are taking any of the following medicines:
ꞏ analgesics, sedatives, opioid analgesics, barbiturates, or regularly consuming alcohol;
ꞏ anaesthetics;
ꞏ medicines affecting blood circulation or lowering arterial blood pressure;
ꞏ medicines affecting metabolism, e.g. chlorpromazine, methylphenidate, reserpine;
ꞏ medicines acting on the same receptor as Biprolast, e.g. isoprenaline, prazosin;
ꞏ monoamine oxidase inhibitors (MAOIs) and other antidepressants;
ꞏ other medicines, even if their use is not related to eye disease;
ꞏ or if the doses of currently used medicines have changed.
All of the above factors may affect therapy with Biprolast.

Pregnancy and breastfeeding
Before using any medicine, consult your doctor or pharmacist.
Inform your doctor if you become pregnant or are planning a pregnancy.
Do not breastfeed during treatment with Biprolast.

Driving and operating machinery
After instillation of Biprolast eye drops, vision may become blurred or disturbed. These symptoms may be particularly troublesome at night or in dim light.
In some patients, Biprolast may cause drowsiness or fatigue.
Do not drive or operate machinery until these symptoms have resolved.

Important information about certain ingredients of Biprolast
The medicine contains 0.05 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Soft contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye occur, such as stinging or pain after using the medicine, contact your doctor.

3. How to use Biprolast

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are unsure,
you should consult your doctor or pharmacist.
Use in adults
The usual dose of Biprolast is one drop into each affected eye, administered twice daily, approximately 12 hours apart.
Use in children under 12 years of age
Biprolast should not be used in children under 2 years of age.
The use of Biprolast is not recommended in children (2–12 years of age).
Method of administration
Biprolast should only be administered as eye drops.
Wash your hands before instilling the drops.
Use the drops exactly as prescribed by your doctor.
If you are using Biprolast together with other eye drops, you should wait at least 5–15 minutes between administering Biprolast and the other eye drops.
Avoid touching the eye or any other surface with the dropper tip. The dropper may become contaminated with bacteria that could cause an infection leading to serious eye damage, and even loss of vision.
To instill the drops, follow these steps:

Wash your hands.
Tilt your head backward and look upward.
Gently pull down the lower eyelid to form a small pocket.
Squeeze the inverted dropper bottle to release one drop into the pocket.
Close your eye and, at the same time, press gently with your finger on the tear duct (at the inner corner of the eye) for about 1 minute.
Immediately after use, replace and tighten the cap on the bottle.

Use of a higher than recommended dose of Biprolast
Adults
In adults who received more drops than recommended, the adverse reactions reported were consistent with those currently known to occur following the use of Biprolast.
In adults who accidentally swallowed Biprolast, a drop in blood pressure was observed, followed in some patients by an increase in blood pressure.
Children
Severe adverse reactions have been reported in children who accidentally swallowed Biprolast.
The following symptoms were observed: drowsiness, reduced muscle tone, decreased body temperature, pallor, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately.
Adults and children
If Biprolast is swallowed or a higher than recommended dose is used, contact your doctor immediately.
Missed dose of Biprolast
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed dose.
Stopping Biprolast treatment
For treatment to be effective, the medicine should be used every day. Do not stop using Biprolast without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If allergic reactions occur, including urticaria, facial swelling, swelling of the lips, tongue and/or throat, which
may cause difficulty in breathing or swallowing, or other serious adverse effects occur, stop using Biprolast and
contact your doctor immediately.
The likelihood of occurrence of adverse 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 adverse effects related to the eyes may occur:
Very common: eye irritation (eye redness, burning and stinging, sensation of foreign body, itching, granules or white spots on the conjunctiva), blurred vision, allergic reactions of the eye;
Common: local irritation (inflammation and swelling of eyelids, swelling of conjunctiva, presence of discharge in the conjunctival sac, eye pain and lacrimation), photophobia, corneal erosion and corneal spots, dry eye, blanching of conjunctiva, visual disturbance, conjunctivitis;
Very rare: inflammation of internal parts of the eye, miosis;
Frequency unknown: eyelid itching

The following general adverse effects affecting the whole body may occur:
Very common: headache, dry mouth, feeling of fatigue and (or) drowsiness;
Common: dizziness, flu-like symptoms, gastrointestinal symptoms, taste disturbances, general weakness;
Uncommon: depression, palpitations or cardiac arrhythmias, dry nose, generalized allergic reactions;
Rare: dyspnoea;
Very rare: insomnia, fainting, hypertension or hypotension;
Frequency unknown: skin reactions including skin redness, facial swelling, itching, rash and blood vessel dilation.

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

5. How to store Biprolast

Keep this 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 specified month.
Biprolast may be stored for up to 28 days after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Biprolast contains

The active substance is brimonidine tartrate. 1 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, 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 supplied in a 5 ml bottle with a dropper, in packs containing 1 or 3 bottles.
Marketing Authorisation 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 authorised for sale in the European Economic Area under the following names:
Poland: Biprolast