AMBROXOL BIOGARAN CONSEIL 30 mg, 20 scored tablets

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.