Alphagan 0.2% eye drops

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Brimonidine tartrate

Disponible des:

AbbVie Ltd

Codi ATC:

S01EA05

Designació comuna internacional (DCI):

Brimonidine tartrate

Dosis:

2mg/1ml

formulario farmacéutico:

Eye drops

Vía de administración:

Ocular

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 11060000; GTIN: 5016007908091

Informació per a l'usuari

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALPHAGAN
® EYE DROPS
BRIMONIDINE TARTRATE 0.2% EYE DROPS
(brimonidine tartrate)
Your medicine is avaliable using one of the above names but will
be referred to as Alphagan throughout the leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE.

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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
IN THIS LEAFLET:
1.
What Alphagan is and what it is used for
2.
Before you use Alphagan
3.
How to use Alphagan
4.
Possible side effects
5.
How to store Alphagan
6.
Further information
1.
WHAT ALPHAGAN IS AND WHAT IT IS USED FOR
Alphagan is used to reduce pressure within the eye.
It can be used either alone, when beta-blocker eye drops are
contraindicated, or with another eye drop, when a single medicine
is not enough to lower the increased pressure in the eye, in the
treatment of open angle glaucoma or ocular hypertension. The
active ingredient in Alphagan is brimonidine tartrate, which works
by reducing pressure within the eyeball.
2.
BEFORE YOU USE ALPHAGAN
DO NOT USE ALPHAGAN

If you are allergic (hypersensitive) to brimonidine tartrate or
any of the other ingredients of Alphagan.

If you are taking monoamine oxidase (MAO) inhibitors or
certain antidepressants. You must inform your doctor if you
are taking any antidepressant drug.

If you are breast-feeding.

In infants/babies (from birth until 2 years).
TAKE SPECIAL CARE WITH ALPHAGAN
Before you take this medicine, tell your doctor:

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 or a blood
pressure disorder.
�

Fitxa tècnica

OBJECT 1
ALPHAGAN
Summary of Product Characteristics Updated 24-Jul-2014 | Allergan Ltd
1. Name of the medicinal product
Alphagan 0.2% w/v (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): Contains benzalkonium chloride 0.05 mg/ml. For a full
list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
Clear, greenish-yellow to light greenish-yellow solution.
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
_Recommended dosage in adults (including the elderly)_
The recommended dose is one drop of Alphagan 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_
Alphagan has not been studied in patients with hepatic or renal
impairment (see section 4.4).
_Use in paediatric subjects_
No clinical studies have been performed in adolescents (12 to 17
years).
Alphagan is not recommended for use in children below 12 years and is
contraindicated in neonates and
infants (less than 2 years of age) (see sections 4.3, 4.4 and 4.9). It
is known that severe adverse reactions
can occur in neonates. The safety and efficac