Brimonidine Biogaran 2 mg/ml Ögondroppar, lösning

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

brimonidintartrat

Dostępny od:

BIOGARAN

Kod ATC:

S01EA05

INN (International Nazwa):

brimonidine tartrate

Dawkowanie:

2 mg/ml

Forma farmaceutyczna:

Ögondroppar, lösning

Skład:

brimonidintartrat 2 mg Aktiv substans; bensalkoniumklorid Hjälpämne

Typ recepty:

Receptbelagt

Podsumowanie produktu:

Förpacknings: Flaska, 5 ml; Flaska, 3 x 5 ml; Flaska, 6 x 5 ml

Status autoryzacji:

Avregistrerad

Data autoryzacji:

2017-10-25

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRIMONIDINE BIOGARAN
2 MG/ML EYE DROPS, SOLUTION
brimonidine tartrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. 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 pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Brimonidine Biogaran is and what it is used for
2.
What you need to know before you use Brimonidine Biogaran
3.
How to use Brimonidine Biogaran
4.
Possible side effects
5.
How to store Brimonidine Biogaran
6.
Contents of the pack and other information
1.
WHAT BRIMONIDINE BIOGARAN IS AND WHAT IT IS USED FOR
The active ingredient in Brimonidine Biogaran is brimonidine tartrate
which belongs to a group of
medicines called sympathomimetics. It works by reducing pressure
within the eyeball in the
conditions open angle glaucoma or ocular hypertension. It can be used
either alone or with another eye
drop, if a single medicine is not enough to lower the increased
pressure in the eye.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRIMONIDINE BIOGARAN
DO NOT USE BRIMONIDINE BIOGARAN:

If you are allergic to brimonidine 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
inform your doctor if you are taking any antidepressant drug.

In infants/babies (from birth until 2 years).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Brimonidine Biogaran

If you suffer or have suffered from depression, reduced mental
capacity, reduced blood supply
to the brain, heart problems, a disturbed blood supply of the limbs o

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brimonidine Biogaran 2 mg/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 2.0 mg brimonidine tartrate, equivalent to
1.3 mg of brimonidine.
Excipient(s) with known effect: Contains benzalkonium chloride 0.05
mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear and slightly greenish-yellow solution, pH 5.5-6.5, and
osmolality 275-350 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure (IOP) in patients with open
angle glaucoma or ocular
hypertension.

As monotherapy in patients in whom topical beta-blocker therapy is
contraindicated.

As adjunctive therapy to other intraocular pressure lowering
medications when the target IOP is
not achieved with a single agent (see Section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage in adults (including the elderly) _
The recommended dose is one drop of brimonidine tartrate 2 mg/ml eye
drops, solution in the affected
eye(s) twice daily, approximately 12 hours apart. No dosage adjustment
is required for the use in
elderly patients.
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal
sac be compressed at the medial canthus (punctal occlusion) for one
minute. This should be
performed immediately following the instillation of each drop.
If more than one topical ophthalmic drug is to be used, the different
drugs should be instilled 5-15
minutes apart.
Use in renal and hepatic impairment:
Brimonidine tartrate 2 mg/ml eye drops, solution has not been studied
in patients with hepatic or renal
impairment (see section 4.4).
_Paediatric population_
No clinical studies have been performed in adolescents (12 to 17
years).
2
Brimonidine tartrate 2 mg/ml eye drops, solution is not recommended
for use in children below 12
years and is contraindicated in neonates and infants (less than 2
years o