TETRAMIL COLL FL10ML 0.3+0.05%

T AND T R A M I L 0.3%+0.05% COLLIRIC, DEOLUTION

active ingredients

100 ml of solution contain: Active ingredients: Feniramina maleato g 0,30. Tetrizolina hydrochloride g 0.05. For excipients v. par. 6.1.

Excellent

Multi-dose bottle Boric acid; borax; etylmercuryosalicylate sodium; sodium carbossimetilcellulose; water for injectable preparations. Single-dose container Boric acid; borax; water for injectable preparations.

Therapeutic indications

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

Contraindications

Hypersensitivity to the components of the product or other substances closely related to the chemical; in particular towards xilometazolina, oximetazolina, tetrizolina. Glaucoma at a narrow/closed angle or other severe eye diseases. Contraindicated in children under twelve years. Generally contraindicated during pregnancy and nursing (see par. 4.6). Contraindicated in the contemporary treatment with inhibiting drugs of monoaminoxydase (tranilcipromine, fenelzina, pargilina) (see par. 4.5).

Population

Instill in the affected eye 1–2 drops 2–3 times a day. Do not exceed the recommended doses. Strictly stick to the recommended doses. A higher dose of the product even if taken in a topical way and for a short period of time can give rise to serious systemic effects.

Conservation

None in particular.

Warnings

The product, while presenting a very low systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, heart disorders, and hyperglycemia (diabetes). In case of persisting or aggravating symptoms after a short period of treatment invite the patient to consult the doctor. In any case, the product should not be used for more than 4 consecutive days, except for a different prescription, given the possibility that they may occur otherwise, side effects. The product, if accidentally ingested or used for long periods at excessive doses, can determine toxic phenomena. Infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage, require medical intervention. Prolonged use of topical products can lead to awareness-raising. In this case it is necessary to stop treatment and establish suitable therapy. The multidose bottle contains mertiolate as a preservative that can give rise to awareness reactions, and should not be applied while wearing contact lenses (in the case of contact lens wearers, wear the same only 15 minutes after the use of the product). In these cases you can use the monodose container that does not contain preservatives.

Interactions

Concurrent intake of monoaminoxydase inhibitor drugs can lead to severe hypertensive crisis.

Effects

The use of the product can sometimes determine pupilal dilation, systemic effects from absorption (hypertension, heart disorders, hyperglycemia), increased blood pressure, nausea, headache. In children if accidentally ingested, the preparation can determine even deep sopore, and hypotonia. Rarely, phenomena of hypersensitivity can occur. In this case it is necessary to stop the treatment and establish suitable therapy. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

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

In pregnancy and during breastfeeding, use only in case of actual need, under the direct control of the doctor.

Source: Farmadati