MUCOBROXOL Syrup (2016)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

MUCOBROXOL Syrup, 15mg/5ml.

2. Qualitative and quantitative composition

Each 5ml MUCOBROXOL Syrup contains 15mg Ambroxol Hydrochloride Ph. Eur.

3. Pharmaceutical form

Syrup.

4.1. Therapeutic indications

MUCOBROXOL Syrup is indicated for acute and chronic disorders of the respiratory tract associated with abnormal bronchial secretions, particularly in exacerbations of chronic bronchitis, asthmatic and ...

4.2. Posology and method of administration

Route of administration Oral. Posology Children under 2 years: 2.5ml twice daily. Children 2-5 years: 2.5ml 3 times daily. Children 5-12 years: 5ml 3 times daily. Adults and children ...

4.3. Contraindications

MUCOBROXOL Syrup may not be given in cases of hypersensitivity to ambroxol or any of the other ingredients listed in the list of excipients.

4.4. Special warnings and precautions for use

In the case of disturbed brochomotoricity and excessive amount of secretion (e.g. in the rare malignant ciliary syndrome), because of possible secretory congestion MUCOBROXOL Syrup should be used with ...

4.5. Interaction with other medicinal products and other forms of interaction

With the combined use of MUCOBROXOL Syrup and antitussives (cough preparations) a dangerous congestion of the secretions can occur due to the suppressed coughing reflex, so that special care should be ...

4.6. Pregnancy and lactation

Ambroxol hydrochloride crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal evelopment, parturition or postnatal ...

4.7. Effects on ability to drive and use machines

There is no evidence for an effect on the ability to drive and use machines. Studies on the effects on the ability to drive and use machines have not been performed.

4.8. Undesirable effects

The following frequencies are the basis for assessing undesirable effects: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), ...

4.9. Overdose

No specific overdose symptoms have been reported in man to date. Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the known side effects of Mucobroxol ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Respiratory ATC code: R05CB06 Ambroxol is an active N-desmethyl metabolite of bromhexine. Ambroxol stimulates, by means of a direct attack on the gland cells, the ...

5.2. Pharmacokinetic properties

Ambroxol is rapidly and almost completely absorbed after oral administration in humans. Tmax after oral administration is 1–3 hours. Due to a first-pass metabolism, the absolute bioavailability ...

5.3. Preclinical safety data

Ambroxol hydrochloride has a low index for acute toxicity. In repeat-dose studies, oral doses of 150 mg/kg/day (mouse, 4 weeks), 50 mg/kg/day (rat, 52 and 78 weeks), 40 mg/kg/day (rabbit, 26 weeks) and ...

6.1. List of excipients

Glycerol Ph. Eur. Liquid Sorbitol (Non-crystallising) Ph. Eur. Benzoic Acid Ph. Eur. Hydroxyethyl Cellulose Ph. Eur. Raspberry Aroma Purified Water Ph. Eur.

6.2. Incompatibilities

None known to date.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

To be stored at or below 25°C in the packaging that it comes in, protected from light.

6.5. Nature and contents of container

Cartoned Amber glass bottle with screw cap. Available in 100ml or 200ml.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

MUNDIPHARMA PHARMACEUTICALS LTD., 13, Othellos str., Dhali Industrial Zone, P.O. Box 23661, 1685 Nicosia, Cyprus Telephone number: +357 22815656 Fax Number: +357 22487833 E-mail: info@Mundipharma.com.cy ...

8. Marketing authorization number(s)

19999

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 6th July 2006

10. Date of revision of the text

02/2016

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