ACTIGRIP TOSSE MUCOL FL 150ML

ACTIGRIP TOSSE MUCOLITICAL "20 MG/ML ORAL FUTURE, GUSTO MENTOLO

active ingredients

This product contains 20 mg of sheathfenesin in every ml (100 mg in 5 ml). Excipients with known effects (mg per ml): ethanol 39,7 mg ponceau 4R (E124) 0.05 mg sodium 1,8 mg fructose glucose Macrogol glycerol hydroxystearate 40 For the full list of excipients, see paragraph 6.1.

Excellent

Xanthan gum Sodium chloride Sodium saccharin Glycyrized ammonium Sodium benzoate (E211) Citric acid anidro Sodium citrate Macrogol glicerol hydroxystearate 40 Levomentolo Raspberry Aroma F2126 (including ethanol, glucose and fructose)Caramello (E15012) (including glucose) Ponceau 4R

Therapeutic indications

ACTIGRIP TOSSE MUCOLITICO is indicated to help dissolve catarror and the exigue bronchial secretions associated with fatty cough, for use in adults and adolescents over the age of 12.

Contraindications

Hypersensitivity to active ingredients, or any of the excipients listed in the paragraph 6.1.

Population

Population Adults and teenagers over 12 years: 10 ml (200 mg of sheathfenesine) 4 times a day. Maximum daily dose: 40 ml (800 mg of sheathfenesin) Pediatric population The safety and effectiveness of ACTIGRIP TOSSE MUCOLITICO in children under 12 years has not yet been established. Data is not available. Seniors: Like adults. Hepatic/renal Comprogation Use caution in case of severe liver and kidney failure. If the cough persists for more than 7 days, it tends to relapse or is accompanied by fever, rash or persistent headache, consult a doctor. Method of administration: oral.

Conservation

Do not store at temperature above 25°C. Store in the original container protected from light.

Warnings

This product should not be used for persistent or chronic cough, as it happens with asthma, or where the cough is accompanied by excessive secretions, unless indicated by a doctor. A persistent cough can be a sign of a serious condition. If the cough persists for more than 7 days, it tends to relapse or is accompanied by fever, rash or persistent headache, consult a doctor. Use caution in case of use of the product in the presence of severe kidney or liver failure. Concurrent use of cough suppressants is not recommended. Patients with rare hereditary problems of fructose intolerance or glucose-galactose mal absorption should not take this medication. This product contains 4.7 vol.% ethanol (alcohol), i.e. up to 400 mg per dose, equivalent to about 10 ml of beer or 4 ml of wine per dose of 10 ml. This can be harmful to subjects suffering from alcoholism. Ethanol content should be taken into account for pregnant women or breast-feeding, for children and high-risk groups such as patients with liver or kidney disease or epilepsy. This product contains the red dye Ponceau 4R (E124) which can cause allergic reactions. This product contains 17,6 mg sodium per dose of 10 ml. This must be taken into account by subjects who follow a controlled sodium diet

Interactions

If the urine is collected within 24 hours of taking a dose of this product, a metabolite of sheathphenhexin may cause a chromatic interference with the laboratory determinations of 5hydroxyndolacetic urinary (5-HIAA) and vanillylmandelic acid (VMA). Expectant drugs such as sheathfenesine should not be associated with cough suppressants in the treatment of cough itself, as this association is inadequate and patients may be exposed to unnecessary unwanted effects. No interaction studies have been carried out which reveal an interaction with sheathfenesine.

Effects

The following side effects can be associated with the use of sheathfenesin: Immune system pathologies: hypersensitivity reactions, including itching, hives, rash (frequency - unknown). Gastrointestinal diseases: pain in the upper part of the abdomen, diarrhea, nausea, vomiting (frequency - not known). 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 “http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospettareazione-avversa.”.

Overdosing

Symptoms and signs of overdose can include gastrointestinal discomfort, nausea and drowsiness. If assumed in excessive quantities, sheathfenesin may cause kidney computation. Management Treatment should be symptomatic and supportive.

Pregnancy They are not available, or are present in limited quantities, data on the use of sheathfenesin in pregnant women. There are no sufficient studies on reproductive toxicity on animals (see paragraph 5.3). ACTIGRIP TOSSE MUCOLITICO is not recommended during pregnancy and in potentially fertile women who do not use contraceptive methods. Food Sheathfenesin is excreted in breast milk in small quantities. There is insufficient information on the effect of sheathfenesin in infants/in infants. A decision must be taken on suspending breastfeeding or suspension/abstenance from treatment with ACTIGRIP TOSSE MUCOLITICO according to the benefit of breastfeeding for the child and that of therapy for women. Fertility There is no sufficient information available to determine whether sheathfenesin can reduce fertility.

Source: Farmadati