Tetramil 0.3% + 0.05% 10 ml eye drops solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

In allergic and inflammatory states of the conjunctiva accompanied by photophobia, tearing, foreign body sensation, pain.

ACTIVE INGREDIENTS

100 ml of solution contains: Active ingredients: Pheniramine maleate 0.30 g. Tetrizoline hydrochloride 0.05 g. For excipients see par. 6.1.

EXCIPIENTS

Multi-dose bottle Boric acid; borax; sodium ethylmercurythiosalicylate; sodium carboxymethylcellulose; water for injections. Single-dose container Boric acid; borax; water for injections.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity towards the components of the product or other substances closely related from a chemical point of view; in particular towards xylometazoline, oxymetazoline, tetrizoline. Narrow/closed-angle glaucoma or other serious eye diseases. Contraindicated in children under twelve years of age. Generally contraindicated during pregnancy and breastfeeding (see par. 4.6). Contraindicated in simultaneous treatment with monoamine oxidase inhibitor drugs (tranylcypromine, phenelzine, pargyline) (see par. 4.5).

DOSAGE

Instill 1-2 drops 2-3 times a day into the affected eye. Do not exceed the recommended doses. Carefully follow the recommended doses. A higher dosage of the product, even if taken topically and for a short period of time, can give rise to serious systemic effects.

CONSERVATION

None in particular.

WARNINGS

The product, although presenting very little systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, cardiac disorders, and hyperglycemia (diabetes). If symptoms persist or worsen after a short period of treatment, invite the patient to consult a doctor. In any case, the product must not be used for more than 4 consecutive days, unless otherwise prescribed by a doctor, given the possibility that unwanted effects may otherwise occur. The product, if accidentally ingested or if used for long periods at excessive doses, can cause toxic phenomena. Infections, pus, foreign bodies in the eye, mechanical, chemical or heat damage require medical intervention. The use of topical products, especially if prolonged, can give rise to sensitization phenomena. In this case it is necessary to interrupt treatment and institute appropriate therapy. The multi-dose bottle contains merthiolate as a preservative which can give rise to sensitization reactions, and must not be applied while wearing contact lenses (in the case of contact lens wearers, wear them only 15 minutes after using the product). In these cases it is possible to use the single-dose container which does not contain preservatives.

INTERACTIONS

The concomitant use of monoamine oxidase inhibitor drugs can lead to the onset of serious hypertensive crises.

SIDE EFFECTS

The use of the product can sometimes cause pupillary dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, headache. In children, if accidentally ingested, the preparation can cause even profound drowsiness and hypotonia. Rarely, hypersensitivity phenomena may occur. In this case it is necessary to interrupt the treatment and institute suitable therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena. Accidental ingestion of the drug, especially in children, can cause central nervous system depression: marked sedation (severe drowsiness), coma. If this occurs, use gastric lavage and general supportive measures.

PREGNANCY AND BREASTFEEDING

During pregnancy and breastfeeding, use only if clearly necessary, under the direct supervision of a doctor.

EFFECTS ON DRIVING ABILITY

No effects are described.