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Package leaflet
Information for use, please, read carefully!
BRIMONAL® 0.2%
(Brimonidi tartras)
Drug form: Eye drops, solution.
Marketing authorisation holder:
UNIMED PHARMA, JSC, Bratislava, Slovak Republic.
Composition:
Active substance:
Brimonidini tartras (brimonidine tartrate) 2 mg in one mL of solution.
1 mL = 23 drops.
Excipients:
Benzalkonii chloridum (benzalkonium chloride – a preservative), natrii chloridum
(sodium chloride), hypromellosum (hypromellose), acidum tartaricum (tartaric acid),
natrii tartras dihydricus (sodium tartrate), natrii hydroxidum (sodium hydroxide – to
adjust pH), aqua purificata (purified water).
Pharmacotherapeutic group: Ophthalmic, anti-glaucoma agent.
Characteristics: Active substance brimonidine tartrate is a selective agonist of
alpha-2 adrenergic receptors that decreases pressure in the eye.
Indications: BRIMONAL® 0.2% is used to lower increased intraocular pressure in
glaucoma or in ocular hypertension without glaucoma (increased pressure in the
eyeball). Preparation may be applied alone, or together with other eye drops that
reduce intraocular pressure (mainly with beta-blockers). The preparation is indended
to be used by adults.
Contraindications: BRIMONAL® 0.2% must not be used in hypersensitivity to the
active substance, or to any of the other ingredients of the preparation. Patients
receiving some drugs for therapy of depression (monoaminoxidase inhibitors, tricyclic
and tetracyclic antidepressants) have to avoid this preparation.
BRIMONAL® 0.2% must not be applied to children and teenagers under 18
years of age, and to breast-feeding mothers.
Safety of the use of the preparation during human pregnancy has not been
established to date. BRIMONAL® 0.2% should not be used in pregnancy unless the
potential benefit of the preparation for a mother outweighs the potential risk for a
developing foetus.
Undesirable effects:
After application of BRIMONAL® 0.2% some local (ocular) or systemic undesirable
effects may occur.
Local unwanted possible effects include: sensation of burning, stinging and
tingling in the eye, feeling that something is in the eye, feeling of dryness in the eye,
painful eyes. Blurred vision, excessive production of tears and increased discharge
from eyes may develop as well. Moreover, eye and eyelid redness, paleness of
conjunctiva, swelling of eyelids or conjunctiva may be present. Nodules may develop
on the conjunctiva. Some of above undesirable effects might be associated with
hypersensitivity to one of ingredients of the preparation.
Systemic possible undesirable effects include: feeling of dry mouth, dryness of
nasal mucosa, headache, tiredness, drowsiness, dizziness, upset stomach, unusual
change in taste, general weakness, depressions and pounding heartbeat.
If you notice above mentioned undesirable effects, or any other unusual
reactions, please inform your doctor.
Interactions: The effects of BRIMONAL® 0.2% and those of other drugs used
simultaneously may interact with each other. Your doctor should therefore be
informed about all drugs you are currently taking or you intend to take, either those
on medical prescription, or over-the-counter products. Should another doctor
prescribes you a new drug, inform him/her that you use BRIMONAL ® 10% eye drops,
solution.
Preparation may potentiate inhibiting effect of sleeping pills, medications with
calming effects, some pain-relievers and alcohol. It may enhance the effect of bloodpressure-lowering drugs.
If you receive also other ophthalmic agents, discuss the suitability of their
concomitant use with your ophthalmologist.
Dosage: Actual dosage and duration of therapy must be determined by a
doctor. If not indicated otherwise, one drop twice a day is recommended, applied 12
hours apart. If you use BRIMONAL® 0.2% together with other eye drops, keep 5-15minute interval before instillation of the other drug. If you miss one dose, apply it as
soon as you remember. If it is time for the next regularly scheduled dose, skip the
missed dose and continue your regular dosing schedule.
Special warnings: BRIMONAL® 0.2% may inducre tiredness and/or drowsiness
which may impair the ability to drive motor vehicles and operate machinery.
Preparation may enhance inhibiting action of alcohol.
A preservative benzalkonium chloride present in this preparation may be
absorbed by soft contact lenses, therefore wait at least 15 minutes after using
BRIMOVAL® 0.2% to put in your lenses.
In case of overdosage or incidental ingestion of the drug by a child seek
medical attention immediately.
Tell your doctor if you are pregnant or breast-feeding a baby before using this
medication.
Precautions: Preparation must not be used after the expiry date shown on the pack.
Use an open bottle within 28 days. Tighten the cap of the bottle after instillation right
away.
Package: 1 x 5 mL, 1 x 10 mL, 3 x 5 mL.
Storage: Do not refrigerate/freeze. Protect to light. To be stored at temperature below
25°C. Keep out of reach of children.
Date of last text revision: April 2005
Oriešková 11, 821 05 Bratislava
Slovak Republic