SOLUCIS SCIR 200ML 10%

FOR USE IN THE MANUFACTURE OF FOODSTUFFS

active ingredients

SOLUCIS 50 mg/ml Syrup 100 ml of syrup contain: Active ingredient Carbocysteine 5 g. Excipients with known effects: methyl para-hydroxybenzoate; ethyl para-hydroxybenzoate; propile para-hydroxybenzoate; sucrose, sodium, benzoate sodium. For the full list of excipients, see paragraph 6.1 SOLUCIS 100 mg/ml Syrup 100 ml of syrup contain: Active ingredient Carbocysteine 10 g. Excipients with known effects: methyl para-hydroxybenzoate; ethyl para-hydroxybenzoate; propile para-hydroxybenzoate; sucrose, sodium, benzoate sodium. For the full list of excipients, see paragraph 6.1

Excellent

Sodium benzoate; sodium hydroxide; methyl para-hydroxybenzoate; ethyl para-hydroxybenzoate; propile para-hydroxybenzoate; sucrose; aromas: caramel, vanillin, bur caramel; purified water.

Therapeutic indications

Mucolitic, fluidizing in the acute and chronic affections of the respiratory system.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Gastro-duodenal ulcer. Pregnancy and nursing. SOLUCIS 50 mg/ml Syrup: The drug is contraindicated in children under or equal to 5 years of age.

Population

SOLUCIS 50 mg/ml Syrup. Adults: 1 tablespoon 3 times a day. Children over 5 years: 1 teaspoon coffee 2-3 times a day in relation to age. SOLUCIS 100 mg/ml Syrup. Use of the medicine is reserved for adults: 1 tablespoon 2 times a day, morning and evening. Duration of recommended treatment. Acute respiratory tract affections: 8 to 10 days. Chronic and recurring Ball Affections O.R.L. or bronchial: from 10 days to 3 weeks several times a year.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Gastrointestinal bleeding: Cases of gastrointestinal bleeding were reported with the use of carbocysteine. It is recommended caution in the elderly, in patients with a history of gastroduodenal ulcers or in patients taking concomitant drugs known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, the patient must stop treatment with carboxysteine. Asthmatic and debilitated patients: It is recommended to take specific precautions in patients with severe respiratory failure, in patients with asthma and with a history of bronchospasm, as well as in debilitated patients. The use of carboxysteine causes a decrease in the viscosity of the mucus and an increase in the removal of the mucus, both through the ciliar activity of the epithelium, and through the reflex of the cough. Therefore, an increase in cough and inspectorate is expected. The use of antitussive medicines inhibits cough reflex and increases the risk of airway obstruction, due to an increase in mucus accumulation in the respiratory tract. Concurrent use of this medicine with sedative medications of cough and/or medicines that inhibit bronchial secretion (e.g. anti-muscarinic medicines) is not recommended. The increase in the expectation that can be seen in the first days of treatment is reduced quickly. SOLUCIS contains: methyl para-hydroxybenzoate; ethyl para-hydroxybenzoate; para-hydroxybenzoate propile that can cause allergic reactions (also delayed). SOLUCIS contains 6.3 g sucrose for 15 ml syrup (1 tablespoon) and 2.1 g sucrose for 5 ml syrup (1 teaspoon). Patients with rare hereditary problems of fructose intolerance, or glucose-galactosis mal absorption, or insufficiency of isomaltase sucrasis, should not take this medicine. The daily posology of 3 tablespoons per day (equal to 45 ml of syrup) contains 18.9 grams of sucrose, while the posology of 3 teaspoons per day (equal to 15 ml of syrup) contains 6.3 g of sucrose. Please note that in case of diabetes or hypocaloric diets. SOLUCIS 100 mg/ml contains 192,4 mg sodium for 15 ml syrup (1 tablespoon) equivalent to 10% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The maximum daily dose of SOLUCIS 100 mg/ml is equivalent to 20% of the maximum daily intake recommended by the WHO with the diet of an adult; SOLUCIS 100 mg/ml is therefore considered to be high in sodium. This aspect should be particularly taken into consideration for those who follow a low salt diet. SOLUCIS 50 mg/ml contains 97.4 mg of sodium for 15 ml (1 tablespoon) and 32.5 mg for 5 ml (1 teaspoon) equivalent respectively to 5% and 1.6% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult.

Interactions

They are not known in literature medical interactions and incompatibility with other drugs.

Effects

Undesirable effects are classified by systems and organs and by frequency. The frequencies are defined as: very common (≥ 1/10); common (≥ 1/100, Skin and subcutaneous tissue pathologies. Frequency not noted: Steven-Johnson syndrome, bollous dermatitis, multiform erythema, toxic rash. Gastrointestinal diseases. Unknown frequency: gastrointestinal bleeding. It may also occur the appearance of dizziness and digestive phenomena such as gastralgia, nausea and diarrhea. In these cases it is necessary to reduce posology or stop therapy. In addition, allergic rashes and anaphylactic reactions, fixed erythema may occur. In such cases stop treatment and consult your doctor to establish suitable therapy. 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: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Symptoms due to overdose include: headaches, nausea, diarrhea, gastralgia. In the case of overdose cause vomiting and possibly practice gastric lavender.

Pregnancy: Although the active ingredient is neither teratogenic nor mutagenic and has not shown any adverse effects on the reproductive function in the animal, data on its use in human pregnancy are not available. Therefore the use of the medicinal product is contraindicated in pregnancy. Nursing: Since there is no data on the passage of carboxysteine in breast milk, the use of the medicine is contraindicated during breastfeeding.

Source: Farmadati