ACTIGRIP COUGH MUCOL * FL 150ML

ACTIGRIP COUGH MUCOL * FL 150ML

Therapeutic indications

ACTIGRIP MUCOLITIC COUGH is indicated to help dissolve phlegm and the small bronchial secretions associated with fat cough, for use in adults and adolescents over 12 years of age.

Dosage and method of use

DosageAdults and adolescents over 12 years:10 ml (200 mg of guaifenesin) 4 times a day. Maximum daily dose: 40 ml (800 mg of guaifenesin)Pediatric populationThe safety and efficacy of ACTIGRIP COUGH MUCOLYTIC in children under 12 years of age has not yet been established. No data are available.Elderly people:As for adults.Hepatic / renal impairmentUse caution in case of severe hepatic and renal impairment. If the cough persists for more than 7 days, tends to recur or is accompanied by fever, rash or persistent headache, consult a doctor. Method of administration: oral.

Contraindications

Hypersensitivity to the active substances, or to any of the excipients listed in section 6.1.

Side effects

The following side effects may be associated with the use of guaifenesin:Disorders of the immune system: hypersensitivity reactions, including itching, hives, rash (frequency - not known).Gastrointestinal disorders: pain in the upper abdomen, diarrhea, nausea, vomiting (frequency - not known).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospettareazione-avversa.”.

Special warnings

This product should not be used for persistent or chronic cough, such as occurs with asthma, or where the cough is accompanied by excessive secretions, unless directed by a physician. A persistent cough can be a sign of a serious condition. If the cough persists for more than 7 days, tends to recur or is accompanied by fever, rash or persistent headache, consult a doctor. Use caution when using the product in the presence of severe renal or hepatic insufficiency. Concomitant use of cough suppressants is not recommended. Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this drug. This product contains 4.7% vol. Ethanol (alcohol), i.e. up to 400 mg per serving, equivalent to approximately 10 ml of beer or 4 ml of wine per 10 ml serving. This can be harmful to people with alcoholism. The ethanol content should be considered for pregnant or breastfeeding women, children and high-risk groups such as patients with liver or kidney disease or epilepsy. This product contains Ponceau 4R red dye (E124) which may cause allergic reactions. This product contains 17.6 mg of sodium per 10 ml dose. This should be taken into consideration by individuals on a controlled sodium diet

Pregnancy and breastfeeding

Pregnancy There are no or limited amounts of data on the use of guaifenesin in pregnant women. There are insufficient studies regarding reproductive toxicity in animals (see section 5.3). ACTIGRIP MUCOLITIC COUGH is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive methods. Feeding time Guaifenesin is excreted in breast milk in small quantities. There is insufficient information on the effect of guaifenesin in newborns / infants. A decision must be made to discontinue breastfeeding or to discontinue / abstain from ACTIGRIP COUGH MUCOLITIC therapy based on the benefit of breastfeeding for the child and the benefit of therapy for the woman. Fertility Insufficient information is available to determine whether guaifenesin can impair fertility.

Expiration and retention

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

Interactions with other drugs

If urine is collected within 24 hours of taking a dose of this product, a metabolite of guaifenesin may cause color interference with laboratory determinations of urinary 5-hydroxyindolacetic acid (5-HIAA) and vanillylmandelic acid (VMA ). Expectorant drugs such as guaifenesin should not be combined with cough suppressants in the treatment of cough, as this combination is inadequate and patients may be exposed to unnecessary side effects. No interaction studies have been performed revealing an interaction with guaifenesin.

Overdose

Symptoms and signs of overdose may include gastrointestinal discomfort, nausea and sleepiness. If taken in excessive quantities, guaifenesin can cause kidney stones. Management Treatment should be symptomatic and supportive.

Active principles

This product contains 20 mg of guaifenesin in each ml (100 mg in 5 ml). Excipients with known effect (mg per ml): ethanol 39.7 mg ponceau 4R (E124) 0.05 mg sodium 1.8 mg glucose fructose Macrogol glycerol hydroxystearate 40 For a full list of excipients, see section 6.1.

Excipients

Xanthan gum Sodium chloride Sodium saccharin Ammonium glycyrized Sodium benzoate (E211) Citric acid anhydrous Sodium citrate Macrogol glycerol hydroxystearate 40 Levomenthol Raspberry flavor F2126 (includes ethanol, glucose and fructose) Caramel (E150) (includes glucose (E124eau) 4 Glycerol Macrogol 1500 Propylene glycol 96% ethanol Purified water