FLUTOXIL SCIR FL 250ML 4MG/5ML

FLUTOXIL 4 MG/5 ML

active ingredients

5 ml of syrup contain: Active ingredient: bromexine hydrochloride 4 mg (equivalent to bromexin 3,65 mg). For excipients see par. 6.1.

Excellent

Tartaric acid, benzoic acid, sodium carmellose, glycerol, liquid sorbitol, ethanol (96%), all fruit aroma, sodium hydroxide, purified water

Therapeutic indications

FLUTOXIL is indicated in the treatment of secretion turbs in acute and chronic respiratory affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. In case of hereditary conditions that can be compatible with one of the excipients (see 4.4). There are no absolute contraindications, but in patients with gastroduodenal ulcer, it is recommended to use it after consulting the doctor. Contraindicated during breastfeeding (see par. 4.6)

Population

We recommend the following dosages unless otherwise prescribed: Adults: 1-2 teaspoons (5-10 ml) 3 times a day (= 24 mg die) In adults, at the beginning of treatment, it may be necessary to increase the total daily dose up to 48 mg (60 ml) divided into three times. Children: 1⁄2 – 1 teaspoon (2.5 – 5 ml) 3 times a day (= 12 mg die) It is recommended to take the drug after meals. The syrup is administered to diabetics and children, it does not contain fructose, nor sucrose. Do not exceed the recommended doses.

Conservation

This medicine does not require any special condition of conservation

Warnings

Treatment with FLUTOXIL entails an increase in bronchial secretion (this promotes expectation). Very rarely, at the same time as the administration of mucolitic substances such as bromexin, severe lesions of the skin were observed such as Stevens Johnson syndrome and Lyell syndrome. Most of these could be explained by the severity of underlying diseases or other medications taken simultaneously. If new lesions of the skin or mucous membrane occur, precautionally stop the treatment with bromexin during subsequent investigations. Do not use for protracted treatments. After short period of treatment without appreciable results conduct further investigations. The medicinal product contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interactions

Clinical interactions with other medicines have not been reported.

Effects

Cases of diarrhea, nausea, vomiting and other mild gastrointestinal disorders have been reported. There were also cases of allergic reactions including skin rash, hives, bronchospasm, angioedema and anaphylaxis. In such cases stop treatment.

Overdosing

No overdose symptoms have ever been reported. In case of overdose, symptomatic treatment is recommended.

Use the product in cases of actual need under the direct control of the doctor. The results of preclinical studies and clinical use of FLUTOXIL showed no adverse effects in pregnancy. However, it is necessary to observe the usual precautions regarding the administration of pregnant drugs, particularly in the first quarter. As the drug passes into breast milk avoid administration in case of breastfeeding.

Source: Farmadati