1. NAME OF THE MEDICINAL PRODUCT
AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ambroxol hydrochloride ..................................................................................................................... 30 mg
For one scored tablet.
Excipient: lactose.
For a complete list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Scored tablet.
4. CLINICAL DATA
4.1 Therapeutic indications
Treatment of bronchial secretion disorders in adults, particularly during acute bronchial diseases and acute episodes of chronic lung disease.
4.2. Dosage and method of administration
RESERVED FOR ADULTS.
The average dosage of ambroxol hydrochloride is 60 mg to 120 mg per day in two doses, i.e. 1 to 2 tablets twice a day.
4.3. Contraindications
History of hypersensitivity reactions to any of the components.
4.4. Special warnings and precautions for use
The combination of a bronchial mucosifier with a cough suppressant and/or secretion drying (atropic) substances is irrational.
This medicine contains lactose. Its use is not recommended in patients with lactose intolerance.
4.5. Interactions with other medicinal products and other forms of interaction
Not applicable.
4.6. Pregnancy and lactation
Pregnancy
Studies in animals have not shown any teratogenic effect. In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected.
Indeed, to date, substances responsible for malformations in humans have been shown to be teratogenic in animals in well-conducted studies in two species.
Clinically, there are currently no sufficiently relevant data to assess a possible malformative or fetotoxic effect of ambroxol hydrochloride when administered during pregnancy.
Therefore, as a precautionary measure, ambroxol hydrochloride should not be used during pregnancy.
Breastfeeding
The use of this product is not recommended when breastfeeding.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
- Minor gastrointestinal disturbances such as nausea, vomiting, gastralgia may occur, which may resolve rapidly on reduction of the dosage.
- Have been described:
o cases of mucocutaneous reactions such as erythema, rash, pruritus, urticaria;
o very rarely, anaphylactoid manifestations with shock and angioedema, which have had a favourable outcome in the reported cases;
In these cases, treatment must be discontinued.
- Headaches and dizziness have also been described very rarely.
4.9. Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Ambroxol has mucokinetic and expectorant properties.
It stimulates bronchial secretion by its action on the secretory cells and promotes the production of more mobilizable mucus. It increases ciliary activity.
5.2. Pharmacokinetic properties
Ambroxol is well absorbed orally. Peak plasma levels are reached in approximately two hours.
Bioavailability is approximately 70%.
High volumes of distribution indicate significant extravascular distribution.
The elimination half-life averages 7.5 hours. Elimination is predominantly urinary, with two major metabolites excreted as glucuronide conjugate.
5.3. Preclinical safety data
Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Lactose monohydrate, microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A), magnesium stearate.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
No special storage precautions.
6.5. Nature and contents of the outer packaging
20, 30 or 50 scored tablets in blister packs (PVC/PVDC/Aluminium).
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
8. MARKETING AUTHORISATION NUMBER(S)
- 345 918-2 or 34009 345 918 2 2: 30 scored tablets in blister packs (PVC/PVDC/Aluminium).
- 381 354-8 or 34009 381 354 8 0: 20 scored tablets in blister packs (PVC/PVDC/Aluminium).
- 561 504-8 or 34009 561 504 8 9: 50 scored tablets in blister packs (PVC/PVDC/Aluminium).
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
[To be completed by the holder]
10. DATE OF UPDATE OF THE TEXT
[To be completed by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
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