ALFA-AMYLASE BGR CONSEIL 3000 U CEIP Cpr enr Plq/18x1

Alfa-amylase.....................................................................................................................................3000 U.CEIP*

For one film-coated tablet.

*Equivalent to 2142,9 European Pharmacopoeia units.

Excipient(s) with known effect: 1,24 mg yellow orange S (E110), 110,23 mg sucrose, 353 mg sorbitol.

Adjunctive treatment of congestive states of the oropharynx.

N.B.: 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, medical advice should be sought.

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

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

This medicine must not be used for prolonged periods 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.

Excipients

This medicine contains sucrose. Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) must not take this medicine.

This medicine contains 353 mg of sorbitol per tablet. Patients with hereditary fructose intolerance (HFI) must not take/receive this medicine.

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

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

Pregnancy

There are no teratogenesis 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, use of ALFA-AMYLASE BGR CONSEIL should be avoided during breastfeeding.

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

Adverse 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: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported.

Pharmacotherapeutic class: Enzymes with anti-inflammatory action, ATC code: R02A

18 months.

Store at a temperature not exceeding 25°C.

No special requirements.