Agobrim 0,2 % Eye Drops

AGOBRIM EYE DROPS is indicated for the lowering of intraocular pressure in patients with open angle glaucoma or ocular hypertension.

The recommended dose is one drop of AGOBRIM EYE DROPS in the affected eye(s) twice daily, approximately 12 hours apart. AGOBRIM EYE DROPS may be used concomitantly with other topical ophthalmic medicinal products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the product should be administered at least 5 minutes apart.

Method of administration: Ocular use.

AGOBRIM EYE DROPS is contraindicated in patients who have exhibited a hypersensitivity to brimonidine tartrate, benzalkonium chloride or to any of the excipients listed in section 6.1. AGOBRIM EYE DROPS is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy. Safety and efficacy of AGOBRIM EYE DROPS in children younger than 2 years of age has not been established. However due to potentially serious adverse central nervous system effects, including apnoea and lethargy, reported in infants treated with topical brimonidine tartrate, the use of AGOBRIM EYE DROPS is not recommended for use in paediatric patients under the age of two. (see section 4.8).

Paediatric population: Children of 2 years of age and above, especially those in the 2-7 age range and/or weighing u2264 20 Kg, should be treated with caution and closely monitored due to the high incidence and severity of somnolence (see section 4.8).

Cardiac disorders: Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease.

Eye disorders: If allergic reactions are observed, treatment with AGOBRIM EYE DROPS should be discontinued. Delayed ocular hypersensitivity reactions have been reported with brimonidine, as contained in AGOBRIM EYE DROPS, with some reported to be associated with an increase in IOP. The use of AGOBRIM EYE DROPS may result in dry eyes and therefore should be used with caution in patients with dry eye syndrome.

Vascular disorders: Brimonidine, as contained in AGOBRIM EYE DROPS should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangitis obliterans.

Hepatic and renal insufficiency: Brimonidine, as contained in AGOBRIM EYE DROPS has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.

Benzalkonium chloride: The preservative in AGOBRIM EYE DROPS, benzalkonium chloride, may cause eye irritation, symptoms of dry eyes, and may affect the tear film and corneal surface. Patients should remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Patients should avoid contact with soft contact lenses. AGOBRIM EYE DROPS should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

AGOBRIM EYE DROPS is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on antidepressants which affect noradrenergic transmission (e.g., tricyclic antidepressants and miaserin), (see section 4.3). Although specific medicine interactions studies have not been conducted with AGOBRIM EYE DROPS, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. There is no information available regarding the level of circulating catecholamines after AGOBRIM EYE DROPS administration. Caution, however, is advised in patients taking medications which can affect the metabolism and uptake of circulating amines e.g., chlorpromazine, methylphenidate, reserpine and tricyclic antidepressants may affect the metabolism and uptake of circulating amines. After the application of AGOBRIM EYE DROPS, insignificant decreases in blood pressure were noted in some patients. Caution is advised when using medicines such as antihypertensives and/or cardiac glycosides (i.e digoxin) concomitantly with AGOBRIM EYE DROPS. Caution is advised when initiating (or changing the dose of) a concomitant systemic agent (irrespective of pharmaceutical form) which may interact with u03b1-adrenergic agonists or interfere with their activity i.e., agonists or antagonists of the adrenergic receptor e.g. (isoprenaline, prazosin, beta-blockers, anti-hypertensives). Alpha-agonists, as a class, may reduce pulse and blood pressure.

Pregnancy: The safety of use during human pregnancy has not been established. AGOBRIM EYE DROPS should not be used during pregnancy.

Breast-feeding: It is not known if brimonidine is excreted in human milk. AGOBRIM EYE DROPS should not be used by women nursing infants.

Fertility: No data is available.

AGOBRIM EYE DROPS may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery. AGOBRIM EYE DROPS may cause blurred and/or abnormal vision, which may impair the ability to drive or to use machinery, especially at night or in reduced lighting. The patient should wait until these symptoms have cleared before driving or using machinery.

The most reported ADRs are oral dryness, ocular hyperaemia, and burning/stinging. They are usually transient and not commonly of a severity requiring discontinuation of treatment. Adverse reactions reported are included in the table below.

a. Tabulated list of adverse reactions

• Skin and subcutaneous tissue disorders
• Eyelid erythema,
• Eyelid oedema,
• Rash
• Frequent
• Eye Pruritus,
• Vasodilatation
• Frequency not known

• Allergic reactions

• Insomnia, depression, anxiety, syncope.

• Headache,
• Dizziness

• Conjunctival hyperaemia, Eye pruritus, Allergic conjunctivitis.
• Burning sensation,
• Stinging, foreign body sensation,
• Follicular conjunctivitis,
• Photophobia,
• Eye pain,
• Eye dryness,
• Conjunctival oedema,
• Blepharitis,
• Eye irritation,
• Eye discharge,
• Conjunctival haemorrhage.
• Conjunctival folliculosis,
• Conjunctivitis,
• Epiphora,
• Visual field defects, visual disturbances,
• Worsened visual acuity,
• Superficial punctate keratopathy,
• Vitreous floaters.

• Palpitations

• Hypertension

• Cough, dyspnoea

• Sinusitis,
• Sinus infection,
• Flu syndrome,
• Bronchitis,
• Rhinitis

• Asthenia

• Hypotonia in infants

Treatment, in the event of an oral overdose, includes supportive and symptomatic therapy. A patent airway should be maintained.