Gemini 1 ml Sterile eye drops.

u2022 Hayfever, conjunctivitis, allergic conjunctivitis, sore, red or itching eyes.

Adult: Instil 1 drop, 3 or 4 times daily, into the lower eyelid.

Children 2 u2013 12 years: Instil 1 drop daily or twice daily. Contact lenses should be removed before using this medicine. The contact lenses can be placed back 15 minutes afterwards. Not recommended for children under the age of 2 years. If redness or irritation continues, gets worse or lasts for more than 3 days consult your doctor.

u2022 Hypersensitivity to antazoline HCl, tetryzoline HCl or to any of the excipients of GEMINI STERILE EYE DROPS (see section 6.1).

u2022 Patients with dry eyes, especially keratoconjunctivitis sicca

u2022 Patients at a risk of narrow angle glaucoma.

u2022 Patients receiving monoamine oxidase inhibitors or within 14 days of its treatment.

u2022 Not recommended for children under two years of age, due to the greater incidence of systemic absorption and effects.

u2022 Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.

u2022 Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

u2022 Use with caution in patients with increased intra-ocular pressure, hypertension, cardiac irregularities including heart failure, in patients with poorly controlled hypertension and diabetes mellitus, hyperthyroidism or pheochromocytoma and eye infections. Other medications should be chosen in case of chronic recurring allergies.

Interactions with other medicines

No synergic effect can occur due to the low dose. In cases where another ophthalmic treatment is used, allow an interval of 5 minutes between each administration so as not to wash away the active ingredient. Preparations containing tetryzoline may not be used in patients receiving MAO inhibitors until 14 days after the last treatment with such active ingredients (increase in blood pressure resulting from the concomitant use of MAO and tricyclic antidepressants).

Safety and/or efficacy in pregnancy has not been established. No controlled studies are available either in animals, pregnant or nursing women. It is not known whether either active substance of GEMINIu00ae STERILE EYE DROPS passes into breast milk.

This medicine may lead to drowsiness, impaired concentration or blurred vision. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

The undesirable effects listed are based on the MedDRA system organ classes (SOC) classification system. The frequency groupings listed conform to the following convention: Very common (u22651/10); common (u22651/100 to <1/10); uncommon (u22651/1 000 to <1/100); rare (u22651/10 000 to <1/1 000); very rare (<1/10 000) and unknown (cannot be estimated from the available data)

MeDRA System Organ Class Frequency Undesirable effect

Immune system disorder Unknown Hypersensitivity reactions may occur very rarely

Nervous system disorders Less Frequent Headache, drowsiness, tremor, and agitation

Eye disorders Less Frequent Transient irritation may occur immediately after instillation, blurred vision (after systemic absorption), mydriasis, elevation of intraocular pressure, systemic undesirable effects due to absorption, reactive hyperaemia (after discontinuation of the treatment)

Cardiac disorder Less Frequent Tachycardia (particularly in small children), Pectanginous symptoms

Vascular Disorders Less Frequent Hypertension

Skin and subcutaneous tissue disorders Less Frequent Sweating may also occur.

Symptoms

After accidental ingestion, especially in children, overdosage is associated with antimuscarinic, extrapyramidal and CNS stimulation and depression. CNS stimulation causes ataxia, excitement, tremors, psychoses, hallucinations, convulsions, hyperexia may also occur. Deepening coma and cardiorespiratory collapse may follow. CNS depression causes drowsiness, coma, convulsions progressing to respiratory failure or possible cardiovascular collapse.

Treatment

In the event of accidental overdosage following oral ingestion, induce vomiting if the patient is still conscious.