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Each tablet contains 30 mg Ambroxol HCl. Each teaspoon (=5 mL) elixir contains 15 mg Ambroxol HCl. Each teaspoon (5 mL) elixir forte contains 30 mg Ambroxol HCl. ACTIONS : Silopect possesses mucokinetic and secretolytic properties. It promotes the removal of tenacious secretions in the respiratory tract and reduced mucus stasis. Expectoration of mucus is facilitated and breathing is eased considerably. Mucus secretion is normalized during Silopect treatment. Cough and sputum volume are often significantly reduced. The film – like secretion on the surface of the respiratory mucous can thus perform its normal protective function. Long term use is possible because of the good tolerability of the preparation. INDICATIONS : Acute and chronic disorders of the respiratory tract associated with abnormal bronchial secretions, particularly in exacerbations of chronic bronchitis, asthmatic bronchitis and bronchial asthmat; pre-and post-operative treatment. DOSAGE & ADMINISTRATION : Unless otherwise prescribed. Tablet : Adult : 1 tab 3 times daily. In long term therapy, the dose may be reduced to twice daily. The tablet should be taken after meals with liquid. Elixir forte (30 mg / 5mL) : Adult and children > 12 years : First 2-3 day,10 mL (2 teaspoon) 2 times daily. The following day : 1 teaspoon (= 5 mL), 3 times daily. Children 6-12 years: 7.5 mL (11/2 teaspoon) 2 times daily. 4-6 years: 5mL (1teaspoon) 2 times daily. 2-4 years : 3.75 mL (3/4 teaspoon) 2 times daily. 1-2 years: 2.5 mL (1/2 teaspoon) 2 times daily. Elixir (15 mg/5mL): Adult and Children > 12 years: 10 mL (2 teaspoon) 3 times daily, for the first 2-3 days. Later, 5 mL (1teaspoon) 3 times daily . Children 5-12 years: 5 mL (1teaspoon) 2-3 times daily. 2-5 years : 2.5 mL (1/2 teaspoon) 3 times daily <2years : 2.5 mL (1/2 teaspoon) 2 times daily. Silopect Elixirs should be taken after meals. The previous regimen are suitable for the therapy of acute respiratory tract disorders and for the initial treatment of chronic conditions up to 14 days. In longer treatment, the dose can be halved. OVERDOSAGE : No symptoms of over dosage have been reported in man to date. If they occur. Symptomatic treatment should be provided. CONTRAINDICATIONS : There are no known contraindications. PRECAUTIONS : Use in pregnancy : Pre clinical studies have show no hazard, but safety during human pregnancy has not yet been established. The usual precautions regarding the use of drugs at this time, especially during the 1st trimester should be observed. Use in lactation : Safety during lactation has not yet been established. SIDE EFFECTS : Silopect is generally well tolerated. Mild gastrointestinal side effects have occasionally been reported. Allergic reactions have occurred rarely, some of the affected patients also showed allergic reactions to other substances. INTERATIONS : The combination of Silopect with other drugs is possible. This refers particularly to preparations used as standard medication for bronchitis syndrome (cardiac glycosides, corticosteroids, bronchospasmolytics, diuretics and antibiotics. PACKING : Tablet 30 mg. Box of 10x10’s. Reg.No.DKL9421007510A1 Elixir forte 30 mg/5mL. Bottle of 60 ml. Reg.No.DKL9421007634B1 Elixir 15 mg/5mL. Bottle of 100 mL. Reg.No.DKL9421007634A1. On medical prescription only. |
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