ALFA-AMYLASE BIOGARAN CONSEIL 3000 U CEIP Cpr enr Plq/18

Film-coated tablet.

Box of 18, under 1 blister.

For a coated tablet:

Alfa-amylase: 3 000 U.CEIP*

* Equivalent to 2 142,9 European Pharmacopoeia units.

Excipients with known effect: orange yellow S (E110), sucrose, sorbitol.

Adjunctive treatment of congestive states of the oropharynx.

NB: In the presence of general clinical signs of bacterial infection, systemic antibiotic therapy should be considered.

Reserved for adults.

A syrup form, more suitable for children, is available.

Dosage

1 tablet 3 times a day during meals.

Method of administration

Swallow the tablet, without chewing it, with a glass of water.

If there is no improvement after 5 days of treatment, it is necessary to seek medical advice.

Hypersensitivity to alpha-amylase or to any of the excipients listed in the section Composition.

Special warnings

This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.

This medicine contains sorbitol. Its use is not recommended in patients with fructose intolerance (a rare hereditary disease).

This medicine contains an azo colouring agent (E110, orange yellow S) and may cause allergic reactions.

Precautions for use

If other symptoms appear (severe sore throat, headache, nausea, vomiting...) or if associated fever occurs, the course of action should be reassessed.

This medicine should not be used for a prolonged period, beyond 5 days, without medical advice.

Hypersensitivity : Hypersensitivity reactions, including anaphylactic-type reactions and anaphylactic shock, may occur from the first dose (see section Adverse effects) and may be life-threatening. In these cases, administration of alpha-amylase must be stopped immediately and appropriate medical treatment must be initiated.

The data available to date do not suggest the existence of clinically significant interactions.

Pregnancy

There are no teratogenicity data in animals.

In clinical practice, no malformative or foetotoxic effect has appeared to date. However, follow-up of pregnancies exposed to this medicine is insufficient to rule out any risk.

Consequently, as a precautionary measure, it is preferable not to use this medicine during pregnancy.

Breast-feeding

In the absence of data on the passage of alpha-amylase into breast milk, the use of ALFA-AMYLASE BIOGARAN CONSEIL should be avoided during breastfeeding.

ALFA-AMYLASE BIOGARAN CONSEIL has no effect on the ability to drive vehicles and use machines.

Undesirable effects are classified by organ system and by frequency as follows: very common (> 1/100, < 1/10); uncommon (> 1/1 000, < 1/100); rare (> 1/10 000, < 1/1 000); very rare (< 1/10 000) and frequency not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Frequency not known: angioedema, urticaria, pruritus, skin rash, maculopapular rash.

Immune system disorders

Frequency not known: hypersensitivity, anaphylactic reaction, anaphylactic shock (see section Warnings and precautions).

Respiratory, thoracic and mediastinal disorders

Frequency not known: bronchospasm.

Gastrointestinal disorders

Frequency not known: nausea, vomiting

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr.

No cases of overdose have been reported.

Pharmacotherapeutic class: Anti-inflammatory enzyme, ATC code: R02A.

18 months.

Store at a temperature not exceeding 25 °C.

No special requirements.