Medicine used for cough and cold.
Active substance: acetylcysteine 600 mg.
Excipients: ascorbic acid; anhydrous sodium carbonate; sodium hydrogen carbonate; anhydrous citric acid; sorbitol (695 mg per tablet), which is a source of fructose; patients with hereditary fructose intolerance should not use this medicinal product; sodium citrate; macrogol 6000; sodium saccharin; lemon flavoring.
The product contains 356.8 mg of sodium, which is equivalent to 17.84% of the WHO-recommended maximum daily intake of 2 g of sodium for adults.
The amount of sodium in the maximum daily dose (600 mg acetylcysteine – 3 effervescent tablets of Sputaren 200 mg) corresponds to 60.48% of the WHO-recommended maximum daily intake of 2 g of sodium for adults. The sodium content should be taken into account in patients on a controlled sodium diet (low sodium / low salt diet).
Indications:
Acute and chronic diseases of the respiratory system accompanied by impaired formation and expectoration of sputum.
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 a physician. In chronic bronchitis and cystic fibrosis, for prophylactic purposes, Sputaren should be used for a longer period.
Dosage:
Adults and adolescents from 14 years: 1 effervescent tablet per day (600 mg acetylcysteine per day). The product should not be used for more than 4–5 days without consulting a doctor.
Warning: A slight hydrogen sulfide odor that may appear when opening the tube does not affect the effectiveness, tolerability, or safety of the product.
Contraindications:
- Hypersensitivity to acetylcysteine or any of the excipients.
- Sputaren 600 mg is not recommended for children under 14 years due to the high concentration of the active substance. Appropriate acetylcysteine dosages should be used in these age groups.
Special warnings and precautions for use:
- Very rare cases of severe skin reactions associated with acetylcysteine (Stevens–Johnson syndrome and Lyell’s syndrome) have been reported. If changes in the skin or mucous membranes occur, discontinue use immediately and consult a doctor.
- Patients with bronchial asthma should be monitored during therapy. If bronchospasm develops, acetylcysteine should be discontinued immediately and appropriate treatment initiated.
- Use with caution in patients with a history of peptic ulcer, especially when combined with medicinal products that irritate the gastrointestinal mucosa.
- In patients with histamine intolerance, Sputaren should be used with caution, avoiding long-term therapy, due to the possible effect of acetylcysteine on histamine metabolism and symptoms of intolerance (such as headache, runny nose, itching).
- Acetylcysteine may cause liquefaction of bronchial secretions and an increase in their volume, especially at the beginning of treatment. If the patient cannot effectively expectorate, appropriate measures (such as postural drainage and bronchoaspiration) should be taken.
Children and adolescents:
Mucolytic agents may cause respiratory complications in children under 2 years due to physiological characteristics of the airways (limited 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:
Interaction studies have only been conducted in adults.
- Concomitant use of acetylcysteine with antitussives may suppress the cough reflex and lead to accumulation of bronchial secretions; therefore, such combination therapy should be carefully considered.
- Activated charcoal may reduce the effect of acetylcysteine.
- For safety reasons, it is recommended to maintain at least a 2-hour interval between antibiotics and acetylcysteine. This does not apply to cefixime and loracarbef.
- Concomitant use of acetylcysteine and nitroglycerin may enhance the vasodilatory effect of nitroglycerin. If combined therapy is necessary, patients should be monitored for possible hypotension, which may be severe and indicated by headache.
- Concomitant use of acetylcysteine and carbamazepine may result in subtherapeutic concentrations of carbamazepine.
Effects on laboratory test results:
- Acetylcysteine may affect the results of colorimetric determination of salicylates.
- Acetylcysteine may affect the results of ketone body determination in urine.
- Mixing Sputaren solution with other medicinal products is not recommended.
Pregnancy: Use during pregnancy is not recommended. It may be prescribed only after careful assessment of the risk/benefit ratio.
Breastfeeding:
There is no information on the excretion of acetylcysteine or its metabolites into breast milk. A risk to the breastfed infant cannot be excluded. Use during lactation is possible only after careful evaluation of the benefit/risk ratio.
Fertility: There are no data on the effects of acetylcysteine on human fertility. Animal studies have not shown adverse effects on fertility at therapeutic doses.
Effects on ability to drive and use machines: Sputaren does not affect the ability to drive or operate machinery requiring quick psychomotor reactions.
Adverse reactions:
The most common adverse effects involve the gastrointestinal tract. Hypersensitivity reactions, including anaphylactic shock, anaphylactic/anaphylactoid reactions, bronchospasm, angioedema, rash, and itching, have been reported rarely.
Immune system disorders: uncommon – hypersensitivity reactions; very rare – anaphylactic shock, anaphylactic/anaphylactoid reactions.
Nervous system disorders: uncommon – headache.
Ear and labyrinth disorders: uncommon – tinnitus.
Cardiac disorders: uncommon – tachycardia.
Vascular disorders: very rare – hemorrhage.
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, itching, exanthema.
General disorders and administration site conditions: uncommon – fever; frequency unknown – facial edema.
Investigations: uncommon – hypotension.
Very rare cases of severe skin reactions such as Stevens–Johnson syndrome and Lyell’s syndrome have been reported during acetylcysteine use. In most cases, at least one other suspected medicinal product was involved; however, if skin or mucosal changes occur, medical advice should be sought and acetylcysteine should be discontinued immediately.
Some studies have shown decreased platelet aggregation during acetylcysteine use. The clinical significance of these findings is currently unclear.
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.
Pharmacotherapeutic group: medicines for cough and cold. Mucolytics.
- Acetylcysteine is a derivative of the amino acid cysteine.
- It has mucolytic and expectorant effects. Its action is due to breaking disulfide bonds between mucopolysaccharide chains and depolymerizing mucoproteins in sputum (including purulent sputum), thereby reducing its viscosity.
- An alternative mechanism of action is related to the antioxidant properties of its SH groups, which bind free radicals and neutralize their toxic effects.
- In addition, acetylcysteine promotes glutathione synthesis, which plays an important role in detoxification. This property allows its use in paracetamol overdose.
- Prophylactic use in patients with chronic bronchitis/cystic fibrosis reduces the frequency and severity of bacterial exacerbations.
Shelf life: 3 years from the date of manufacture. Do not use after the expiry date.
Special storage conditions:
- Store protected from moisture and light at a temperature not exceeding 25°C.
- Keep out of reach of children!
- Close the tube tightly after removing a tablet.
Dispensing conditions: over the counter (OTC).
Marketing authorization holder:
World Medicine İlaç San. ve Tic. A.Ş., Turkey
Manufactured by:
PharmaEstica Manufacturing OÜ, Vanapere tee 3, Pringi, Viimsi, 74011 Harju County, Estonia.
