Medicinal Products

ALPHAGAN 0.2% (2 mg / mL)

Generic drug of the therapeutic class: Ophthalmology
Active ingredients: Brimonidine tartrate
laboratory: Allergan

Eye drops in solution
Dropper bottle of 5 ml
All forms

Indication

Reduced high intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

· As monotherapy in patients with contraindication to local beta-blockers.

· In combination with other treatments that decrease intraocular pressure in the case where monotherapy does not achieve target IOP (see section 5.1 ).

Dosage 0.2% ALPHAGAN (2 mg / mL) Eye drops in solution 5 ml dropper bottle

Recommended dosage in adults (including elderly patients)

The recommended dosage is one drop of Alphagan twice a day in the affected eye (s), both instillations being spaced approximately 12 hours apart. The use of eye drops in elderly patients does not require any dose adjustment.

As is the case with all eye drops, in order to reduce possible systemic absorption, it is recommended to compress the lacrimal sac at the internal canthus (occlusion point) for one minute. This must be done immediately after instillation of each drop.

When using several ophthalmic products for local use, the instillations of the different products should be spaced for 5 to 15 minutes.

Use in case of renal or hepatic insufficiency

Alphagan has not been studied in patients with renal or hepatic impairment (see section 4.4 ).

Use in children:

It has not been conducted clinical studies in adolescents (12 to 17 years).

Alphagan is not recommended for children under 12 years of age and is contraindicated in neonates and infants (under 2 years of age) (see sections 4.3). Contraindications, Special warnings and precautions for use, Overdose ). Severe adverse effects have been reported in neonates. In children, the safety and efficacy of Alphagan have not been established.

Against indications

· Hypersensitivity to the active substance or to any of the excipients,

· Neonates, and infants (see section 4.8 ),

· Patients receiving monoamine amine oxidase inhibitor (MAOI) and antidepressant patients with noradrenergic transmission (eg tricyclic antidepressants and mianserin).

Alphagan side effects 0.2%

The most commonly reported adverse events are dry mouth, ocular hyperemia, burning sensations, tingling sensation, occurring in 22 to 25% of patients. They are usually transient and rarely severe enough to require stopping treatment.

In clinical studies, symptoms of allergic reactions occurred in 12.7% of patients (resulting in discontinuation of treatment in 11.5% of patients) and occurred within 3 to 9 months of treatment in the majority of patients .

In each category, adverse effects are presented in descending order of severity. To classify the frequency of adverse reactions the following terminologies were used: very common (³ 1/10); frequent (³ 1/100, <1/10); infrequent (³ 1/1000, <1/100); rare (³ 1/10 000, <1/1 000); very rare (<1 / 10, 000), not known (can not be estimated based on available data).

Cardiac disorders

Uncommon: palpitations / arrhythmia (including bradycardia and tachycardia).

Nervous system disorders

Very common: headache, drowsiness.

Frequent: dizziness, abnormal taste.

Very rare: syncope.

Eye disorders

Very frequent:

· Eye irritation (hyperemia, burning and tingling, pruritus, foreign body sensation, conjunctival follicles).

· blurry vision.

Allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis, ocular allergic reaction and follicular conjunctivitis.

Frequent

· Local irritation (hyperemia and edema of the eyelid, blepharitis, conjunctival edema and secretions, eye pain and tearing).

· Photophobia.

· Erosion and corneal staining.

· Dry eye.

· Conjunctival whitening.

· Abnormal vision

· Conjunctivitis.

Very rare:

· Iritis.

· Myosis.

Respiratory, thoracic and mediastinal disorders

Frequent: symptoms of the upper respiratory tract.

Uncommon: nasal dryness.

Rare: dyspnea.

Gastrointestinal disorders

Very common: oral dryness.

Common: gastrointestinal symptoms

Vascular disorders

Very rare: hypertension, hypotension.

General disorders and administration site conditions

Very common: tiredness.

Frequent: asthenia.

Immune system disorders

Uncommon: systemic allergic reactions.

Psychiatric disorders

Uncommon: depression.

Very rare: insomnia.

The following side effects have been reported after the marketing of Alphagan. Knowing that they were reported on the basis of spontaneous notifications, an estimate of their frequency could not be made.

Frequency unknown:

Eye disorders

· Irido-cyclite (anterior uveitis).

· Eyelid pruritus.

Skin and subcutaneous tissue disorders

· Skin reaction including erythema, facial edema, pruritus, rash and vasodilation.

In cases where brimonidine has been used in the medical treatment of congenital glaucoma, symptoms of brimonidine overdose such as loss of consciousness, lethargy, somnolence, hypotension, hypotonia, bradycardia, hypothermia, cyanosis, pallor, Respiratory depression and apnea have been reported in neonates and infants who received brimonidine (see section 4.3 ).

In a 3-month, 3-month, phase 3 study in children aged 2 to 7 years with uncontrolled beta-blocker glaucoma, a significant (55%) prevalence of somnolence was reported with Alphagan association. In 8% of children, it was severe and led to discontinuation of treatment in 13% of cases. The incidence of sleepiness decreased with increasing age, being minimal in the 7-year age group (25%) but was more weight-related, occurring more frequently in children of weight less than or equal to 20 kg (63%) than for those weighing more than 20 kg (25%) (see section Warnings and precautions for use ).

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