Mucofortin effervescent tablets 600mg 10 pieces

MUCOFORTIN 10 effervescent tablets

Acetylcysteinum 600 mg

OTC

• Dilutes respiratory secretions
• Facilitates expectoration

Mucofortin product description

Mucofortin is used short-term as a medication to thin respiratory secretions and facilitate expectoration in patients with symptoms of cold-related infection.

1 effervescent tablet once daily.

Use at least 4 hours before bedtime.

Oral administration.

The drug should not be used in children and adolescents under 18 years of age.

Manufacturer:
Natur Produkt Pharma Sp. z o.o.

30 Podstoczysko Street

07-300 Ostrów Mazowiecka

Distributor:

Natur Produkt Zdrovit Sp. z o.o.

31 Nocznickiego St., 01-918 Warsaw

Mucofortin, 600 mg, effervescent tablets. One effervescent tablet contains 600 mg of acetylcysteine. Excipients of known effect: One effervescent tablet contains: 682.2 mg isomalt, 39.9 mg aspartame, 669.9 mg sodium bicarbonate (equivalent to 183.4 mg sodium).

MUCOFORTIN - Indications for use.

Mucofortin medicinal product is used short-term as a drug to thin respiratory secretions and facilitate their expectoration in patients with symptoms of infection associated with the common cold.

MUCOFORTIN - Dosage and method of administration.

Adults 600 mg of acetylcysteine (1 effervescent tablet) once daily. The product should not be used for more than 5 days without consulting a doctor. Children and adolescents (under 18 years of age) Due to the amount of active ingredient, Mucofortin should not be used in children and adolescents under 18 years of age. Method of administration: oral administration. Dissolve the effervescent tablet in half a glass of water and drink immediately after dissolving. The solution is clear and colorless.

MUCOFORTIN - Caution.

Use at least 4 hours before bedtime due to the possibility of retention of dilute secretions in the bronchi. During treatment, it is recommended to take increased amounts of fluids. Contraindications: hypersensitivity to the active substance or to any of the excipients, asthmatic condition, phenylketonuria, children under 2 years of age - because the active substance: acetylcysteine may cause airway obstruction in children under 2 years of age. Special warnings and precautions for use: patients with bronchial asthma must be closely monitored during treatment with acetylcysteine due to the possibility of bronchospasm. If bronchospasm occurs, acetylcysteine should be discontinued immediately. In elderly patients or those with respiratory failure, special care should be taken due to decreased ability to expectorate secretions. Patients with expectoration problems should additionally receive respiratory physiotherapy (e.g., positioning drainage). Mucolytic drugs can cause airway obstruction in children under 2 years of age. Due to the physiological characteristics of the airways in this age group, the ability to expectorate may be limited. Therefore, mucolytic drugs should not be used in children under 2 years of age. On the other hand, due to the amount of active substance, Mucofortin medicinal product should not be used in children and adolescents under the age of 18 years. Caution is recommended when using the product in patients with a history of gastric or duodenal ulcers, especially if other drugs with known irritating effects on the gastric mucosa are used at the same time. Severe skin side effects, i.e. Stevens-Johnson syndrome and Lyell's syndrome, have been reported very rarely during the use of acetylcysteine. Patients should be advised to discontinue acetylcysteine immediately and seek immediate medical attention if skin or mucous membrane lesions occur. Caution should be exercised in patients with histamine intolerance and long-term use of acetylcysteine should be avoided in these patients, as acetylcysteine affects histamine metabolism and may cause intolerance symptoms (e.g. headache, nasopharyngitis, pruritus). If concomitant use of acetylcysteine and orally administered antibiotics is necessary, these drugs should be taken at least 2 hours apart (see section 4.5). This drug contains 183.4 mg of sodium in each effervescent tablet, which corresponds to 9.17% of the maximum WHO recommended 2 g daily sodium intake in adults. The product contains aspartame, which is a source of phenylalanine. It may be harmful to patients with phenylketonuria. The product contains isomalt, which is hydrolyzed in the body to glucose, mannitol and sorbitol. Patients with glucose-galactose malabsorption syndrome should not take this medicinal product. Do not use this medicinal product in patients with rare hereditary fructose intolerance.

MUCOFORTIN - Side effects.

Uncommon: oral mucositis, vomiting, diarrhea, abdominal pain, nausea, headache, tinnitus, hypersensitivity reactions, tachycardia, urticaria, rash, angioedema, pruritus, fever, hypotension, rare: indigestion, bronchospasm, dyspnea; very rare: anaphylactic shock, anaphylactic or pseudo-anaphylactic reactions, hemorrhage; unknown frequency: facial edema. There are very rare reports of Stevens-Johnson syndrome and the development of Lyell's syndrome after treatment with acetylcysteine. In most cases, at least one additional drug product has been used in a patient who has developed lesions on the skin and mucous membranes. If any new lesions develop on the skin or mucous membranes, treatment with acetylcysteine should be stopped immediately. Reduced platelet aggregation in the presence of acetylcysteine has been observed in the course of various studies, but it is currently not possible to determine the clinical significance of this phenomenon.

Entity responsible: Natur Produkt Pharma Sp. z o.o. 30 Podstoczysko Street, 07-300 Ostrów Mazowiecka.

Marketing authorization number: 21925.

Drug issued without a prescription