Properties
What is it?
Active ingredient: Acetylcysteine 600 mg. Excipients: Ascorbic acid; anhydrous sodium carbonate; sodium bicarbonate; anhydrous citric acid; sorbitol (695 g per tablet), which is a source of fructose; the medicinal product must not be used in patients with hereditary fructose intolerance; sodium citrate; macrogol 6000; sodium saccharin; lemon flavor. The preparation contains 356.8 mg of sodium, which is equivalent to 17.84% of the maximum daily intake of 2 g of sodium recommended by WHO for adults. The amount of sodium in the maximum daily dose (600 mg acetylcysteine - 3 effervescent tablets of Sputaren 200 mg) is 60.48% of the maximum daily intake of 2 g of sodium recommended by WHO for adults. Sodium content should be considered in the treatment of patients on a sodium-controlled diet (low sodium/low salt). Indications: Acute and chronic diseases of the respiratory system accompanied by impaired mucus production and expectoration. Method of administration: Sputaren effervescent tablets are dissolved in a glass of water and taken orally after meals. The duration of treatment depends on the type and severity of the disease and is determined by the doctor. For the prevention of chronic bronchitis and cystic fibrosis, the preparation Sputaren should be used for a longer period. Dosage: Adults and adolescents from 14 years of age: 1 effervescent tablet per day (600 mg acetylcysteine per day). The preparation should not be used for more than 4-5 days without consulting a doctor. Warning: A slight smell of hydrogen sulfide, which may occur when opening the tube, does not affect the efficacy, tolerability, and safety of the preparation. Contraindications: - Hypersensitivity to acetylcysteine or any of the excipients of the preparation. - Sputaren 600 mg is not recommended for children under 14 years of age due to the high concentration of the active substance. Appropriate dosages of acetylcysteine should be used in these age groups. Special warnings and precautions for use: - Very rare reports of severe skin reactions associated with the use of acetylcysteine (Stevens-Johnson syndrome and Lyell's syndrome) have been reported. In case of skin or mucous membrane changes, the use of the preparation should be discontinued immediately and medical advice should be sought. - Patients with bronchial asthma should be monitored during therapy. In case of bronchospasm, the use of acetylcysteine should be discontinued immediately and appropriate treatment initiated. - The preparation should be used with caution in patients with a history of peptic ulcer, especially when combined with irritant drugs for the gastrointestinal tract. - In patients with histamine intolerance, Sputaren should be used with caution, avoiding long-term therapy, due to the possible influence of acetylcysteine on histamine metabolism and the manifestation of intolerance symptoms (such as headache, runny nose, itching). - The use of acetylcysteine, especially at the beginning of treatment, may lead to thinning of bronchial secretions and an increase in their volume. If the patient is unable to effectively clear sputum, appropriate measures should be taken (such as postural drainage and bronchopulmonary aspiration). Children and adolescents: Mucolytics can cause respiratory disorders in children under 2 years of age due to the physiological characteristics of the respiratory tract in this age group (limited physiological self-cleaning ability). Therefore, mucolytics should not be used in children under 2 years of age. Interactions with other medicinal products and other forms of interaction: Drug interaction studies have only been conducted in adults. - Combination of acetylcysteine with antitussive drugs can lead to suppression of the cough reflex and accumulation of bronchial secretions, so the indications for such combination therapy should be carefully considered. - Activated charcoal can reduce the effect of acetylcysteine. - For safety reasons, it is recommended to maintain an interval of at least 2 hours between the administration of antibiotics and acetylcysteine. This does not apply to cefixime and loracarbef. - The simultaneous use of acetylcysteine and nitroglycerin can enhance the vasodilating effect of nitroglycerin. If combined therapy with acetylcysteine and nitroglycerin is necessary, patients should be monitored for possible hypotension, which can be serious and may be indicated by headache. - The simultaneous administration of acetylcysteine and carbamazepine may lead to sub-therapeutic concentrations of carbamazepine. Effects on laboratory test results: - Acetylcysteine can affect the results of colorimetric methods for determining salicylates. - Acetylcysteine can affect the results of determining ketone bodies in urine. - It is not recommended to mix the prepared solution of Sputaren with other preparations. Pregnancy: The use of the preparation during pregnancy is not recommended. During pregnancy, the preparation can only be prescribed after a strict risk-benefit assessment. Breastfeeding: There is no information on the excretion of acetylcysteine or its metabolites into breast milk. The risk to a breastfed infant cannot be excluded. The use of the preparation during lactation is only possible after a proper assessment of the benefit/risk ratio. Fertility: There is no data on the effect of acetylcysteine on human fertility. In animal studies, therapeutic doses of acetylcysteine did not show any adverse effects on fertility. Ability to drive and use machines: Sputaren does not affect the ability to drive or perform tasks that require rapid psychomotor reactions. Undesirable reactions: - The most common adverse effects are gastrointestinal. Hypersensitivity reactions, including anaphylactic shock, anaphylactic/anaphylactoid reactions, bronchospasm, angioedema, rash, and itching, were rarely observed. Immune system disorders: Uncommon - hypersensitivity reactions; Very rare - anaphylactic shock, anaphylactic/anaphylactoid reaction. Nervous system disorders: Uncommon - headache. Ear and labyrinth disorders: Uncommon - tinnitus. Cardiac disorders: Uncommon - tachycardia. Vascular disorders: Very rare - bleeding. Respiratory, thoracic and mediastinal disorders: Rare - bronchospasm, dyspnea. Gastrointestinal disorders: Uncommon - nausea, diarrhea, stomatitis, abdominal pain, vomiting; Rare - dyspepsia. Skin and subcutaneous tissue disorders: Uncommon - urticaria, angioedema, pruritus, exanthema. General disorders and administration site conditions: Uncommon - fever; Frequency unknown - facial edema. Effects on laboratory and instrumental test results: Uncommon - hypotension. - Very rare cases of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been reported during acetylcysteine administration. In most cases, at least one other suspected drug was involved in the pathogenesis of these syndromes with high probability; however, in case of skin or mucous membrane changes, it is advisable to consult your doctor. In this case, acetylcysteine intake should be discontinued immediately. - Some studies have demonstrated a decrease in platelet aggregation during acetylcysteine use. The clinical significance of these data is currently not determined. Overdose: Overdose may cause gastrointestinal symptoms such as vomiting, nausea, and diarrhea. In breastfed infants, there is a risk of hypersecretion. Treatment: Symptomatic therapy is recommended in case of overdose. Pharmacotherapeutic group: Agents for cough and cold. Mucolytics. - Acetylcysteine is a derivative of the amino acid cysteine. - Acetylcysteine has mucolytic and expectorant effects. Its action is due to the breakdown of disulfide bonds between mucopolysaccharide chains and the depolymerizing effect on the mucoproteins of sputum (including purulent sputum), which reduces its viscosity. - An alternative mechanism of action of acetylcysteine is related to the antioxidant properties of its SH groups, which are capable of binding free radicals and thus neutralizing their toxic effects. - In addition, acetylcysteine promotes increased synthesis of glutathione, which plays an important role in the detoxification of harmful substances. This feature makes it possible to use acetylcysteine in case of paracetamol overdose. - In patients with chronic bronchitis/cystic fibrosis, prophylactic use of acetylcysteine reduces the frequency and severity of bacterial complications. Shelf life: 3 years from the date of manufacture. Do not use after the expiry date. Special storage instructions: - Store in a dry and light-protected place at a temperature not exceeding 25°C. - Keep out of reach of children! - Close the tube tightly after removing the tablet. Pharmacy dispensing conditions: Available without a prescription. Trademark and registration certificate holder: "WORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş.", Turkey. Manufactured by: PharmaEstica Manufacturing OÜ, Vanapere tee 3, Pringi, Viimsi, 74011 Harju county, Estonia.