TRIOFAN Nasal drops / spray Ref.[115930] Active ingredients: Carbocisteine Xylometazoline

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: The Star Medicines Importers Co. Ltd., 10, Loukis Akritas Str., 3030 Limassol, Tel: 25 371 056

4.3. Contraindications

Hypersensitivity to xylometazoline or to any other componets.

After surgery around the head/face area exposing the durra mater.

Dry nasal mucous membranes (rhinitis sicca).

Closed–angle glaucoma.

Do not use the drops and spray for adults, for children under 6 years.

4.4. Special warnings and precautions for use

Triofan must not be used for more than 5-7 days without medical advice. A prolonged and continues use can cause a drug-induced congestion of the nasal mucous membranes, whose symptoms are very close to those of a cold.

Triofan is to be used with caution by patients suffering from hyperthyroidism, cardiovascular diseases, hypertension and diabetes mellitus.

Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.

Triofan, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.

Do not exceed the recommended dosage.

4.5. Interaction with other medicinal products and other forms of interaction

With normal use of Triofan, the interaction with tricyclic antidepressants and MAO inhibitors is negligible.

4.6. Pregnancy and lactation

No controlled studies have been carried out in pregnant women or animals. In view of its vasoconstrictor properties, it is advisable to take the precaution of not using Triofan during pregnancy.

Triofan should be used with caution during lactation.

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

Occasionally: A transient burning sensation in the nose and throat. Local irritation, dryness of the nasal mucosa, nausea, headache and insomnia.

Isolated cases: Systemic sympathomimetic reactions, transient visual disturbances and allergic reactions with dyspnea and angioedema of the nasal mucosa.

Uncommon: Epistaxis

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel: +357 22608607, Fax: +357 22608669, website: www.moh.gov.cy/phs.

6.2. Incompatibilities

None known.

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