KATARFLUID AD OS SOL 200ML

KATARFLUID 5 G/100 ML ADULTATION

active ingredients

100 ml oral solution contain 5 g carbocysteine. Excipients with known effects: sodium; methyl phydroxybenzoate; propile p-hydroxybenzoate; sorbitol sol. 70%. For the full list of excipients, see paragraph 6.1.

Excellent

Citrate sodium; methyl phydroxybenzoate; propile p-hydroxybenzoate; sodium hydroxide; sorbitol sol. 70%; banana aroma; 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 listed in paragraph 6.1. Gastro-duodenal ulcer. Pregnancy and nursing.

Population

Population. Adults: 2-3 tablespoons per day. These doses can be increased according to the doctor. The use of the product is reserved for adults.

Conservation

Store at a temperature not exceeding 25°C.

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, there is an increase in cough and inspectorate. The use of antitussive medicines inhibits cough reflex and increases the risk of airway obstruction, due to an increase in mucus accumulation in 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. Information on excipients: This medicine contains 105 mg of sodium per dose (one tablespoon), equivalent to 5,25% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. This medicine contains sorbitol. Patients with hereditary fructose intolerance should not be given this medicine. This medicine contains p-hydroxybenzoate of methyl and p-hydroxybenzoate of propile. They can cause allergic reactions (also delayed).

Interactions

They are not known, at the present state of knowledge, incompatibility or between the administration of carbocysteine and the most common drugs of use in the treatment of the diseases of the upper and lower airways, nor with foods.

Effects

The side effects are listed according to the following frequency classification: very common (≥ 1/10), common (≥ 1/100, Immune system disorders: Anaphylactic reaction. Gastrointestinal diseases: Diarrhea, nausea, gastricgia. In such cases it is recommended to reduce posology. Do not note: gastrointestinal bleeding (in this case interrupt treatment and consult your doctor to establish suitable therapy). Pathologies of skin and subcutaneous tissue. Note: Steven-Johnson syndrome, bullying dermatitis, multiform erythema, toxic rash, (in such cases stop treatment and consult your doctor to establish suitable therapy). In addition, allergic rashes and anaphylactic reactions, fixed erythema may occur. Ear and labyrinth pathologies: Vertigo. It can also occur bronchial obstruction with unknown frequency. 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 the address https://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 followed by specific support therapy.

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. Since no data on the passage of carboxysteine in breast milk are available, the use of the medicinal product is contraindicated during feeding.

Source: Farmadati