Mucosolvan syrup

Mucosolvan syrup 30 mg/5 ml is an expectorant which is used to thin the mucus in acute and chronic bronchial and lung diseases where thick, tenacious mucus is a problem.

 Before you take Mucosolvan syrup 30 mg/5 ml

Do not take Mucosolvan syrup 30 mg/5ml:

if you are hypersensitive (allergic) to the active substance (ambroxol hydrochloride) or to any of the other ingredients of Mucosolvan syrup 30 mg/5 ml.

Special care must be taken with Mucosolvan syrup 30 mg/5 ml in the following circumstances:

in a very small number of cases, there have been reports of severe skin reactions such as Stevens-Jo-hnson syndrome and toxic epidermal necrolysis (TEN) occurring in temporal association with the use of expectorants such as ambroxol hydrochloride. Most of these cases were attributable to the underlying disease and/or to other medication being taken concomitantly. In addition, during the early phase of Stevens-Johnson syndrome or TEN, patients may initially experience non-specific influenza-like symptoms such as fever, joint pain, rhinitis, cough and sore throat. Because of these non-specific influenza-like initial symptoms, symptomatic treatment with cough and cold medications, which is inappropriate, may be started. If new skin or mucosal lesions appear, therefore, medical advice should be sought immediately and the use of ambroxol hydrochloride discontinued.

Patients with impaired kidney or liver function If you have impaired kidney function or severe liver disease, you must not take Mucosolvan cou-gh syrup 30 mg/5 ml except on medical advice. With ambroxol. as with any medicine which is broken down in the liver and then eliminated via the kidneys, accumulation of the breakdown products which are formed in the liver can be expected to occur in patients with severely impaired kidney function.

In some rare bronchial diseases which are associated with excessive accumulation of secretions (such as primary ciliary dyskinesia), Mucosolvan syrup 30 mg/5 ml should only be used under medical supervision because of the risk that secretions may accumulate.

Use in children

Mucosolvan syrup 30 mg/5 ml must not be used in children under 2 years of age except on medical advice.

Taking other medicines

  • Please tell your doctor or pharmacist if you are taking/ using or have recently taken/used any other me-dicines, including medicines obtained without a prescription.
  • Ambroxol and cough suppressants
  • Simultaneous use of Mucosolvan syrup 30 mg/5 ml and cough suppressants may lead to the development of a dangerous accumulation of secretions owing to reduction of the cough reflex and should be undertaken only after careful risk-benefit assessment.

Pregnancy and breast-feeding

Pregnancy

Ambroxol passes through the placenta to the unborn child. You should not take this medicine while you are pregnant, especially during the first 3 months.

Breast-feeding

Ambroxol has been shown to pass into breast milk in animal studies. Use while breast-feeding is not recommended.

How to take Mucosolvan syrup 30 mg/5 ml

Always take Mucosolvan syrup 30 mg/5 ml exactly as described in this package leaflet. You should check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by the doctor, the recommended doses are as follows:

Children from 2 to 5 years of age 1.25 ml three times daily (equivalent to 22.5 mg ambroxol
hydrochloride per day)

Children from 6 to 12 years of age: 2.5 ml two to three times daily (equivalent to 30-45 mg ambroxol hydrochloride per day).

Adults and adolescents over 12 years of age: The usual dosage is 5 ml three times daily (equivalent to 90 mg ambroxol hydrochloride per day) for the first 2-3 days and 5 ml twice daily (equivalent to 60 mg ambroxol hydrochloride per day) thereafter.

For adults and adolescents over 12 years of age, the therapeutic effect may be enhanced by increasing the dosage to 10 ml twice daily (equivalent to 120 mg ambroxol hydrochloride per day).

Route and method of administration and duration of treatment

  • Mucosolvan syrup 30 mg/5 ml is for oral use.
  • Mucosolvan syrup 30 mg/5 ml can be taken with or without food and is dispensed with the aid of the measuring cup provided.
  • Please clean the measuring cup after each use by rinsing with warm water.
  • You should contact a doctor if your symptoms worsen or do not improve after 4-5 days.
  • If you feel that the effect of Mucosolvan syrup 30 mg/5 ml is too strong or too weak, talk to your doctor or pharmacist.

If you take more Mucosolvan syrup 30 mg/5 ml than you should:

No specific symptoms of overdose have been reported to date. The symptoms observed in cases of accidental overdose or medication error are consistent with the side effects which may occur at recommended doses (see section 4). In case of overdose, please consult a doctor as symptomatic treatment may be required.

If you forget to take Mucosolvan syrup 30 mg/5 ml:

If you forget to take Mucosolvan syrup 30 mg/5 ml or take too small a dose, wait until it is time to take your next dose and then continue taking Mucosolvan syrup 30 mg/5 ml as described in the dosage instructions above.

If you stop taking Mucosolvan syrup 30 mg/5 ml:

If you stop treatment early, your symptoms may get worse.

Possible side effects

Like all medicines, Mucosolvan syrup 30 mg/5 ml can have side effects although not everybody gets them.

Side effects

  • Immune system disorders/Skin and subcutaneous tissue disorders: Skin rash, urticaria (nettle rash)
  • Nervous system disorders: Taste disturbances.
  • Gastrointestinal disorders: Nausea, feeling of numbness in the mouth
  • Respiratory, thoracic and mediastinal disorders: Feeling of numbness in the throat.
  • Renal and urinary disorders: Very rare: Difficulty urinating
  • General disorders and administration site conditions: Uncommon: Fever, mucous membrane reactions

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