LIERRE GRIMPANT BIOGARAN CONSEIL édulcoré au maltitol liquide S buv sans sucre Fl/100ml

Climbing ivy (Hedera helix L.) (dry extract of leaf of).......................................................................0,700 g

Extraction solvent: ethanol 30% V/V

Drug / extract ratio: 4-8 : 1

For 100 ml of drinkable solution.

Excipient(s) with known effect: sodium benzoate, liquid maltitol, propylene glycol.

Herbal medicine used as an expectorant in cases of productive cough.

This medicine is indicated in adults, adolescents and children over 2 years.

Dosage

Aadolescents, Adults and elderly people :

7,5 ml 2 times a day (corresponding to 105 mg of dry extract of climbing ivy leaf)

Paediatric population

Children aged 6 to 11 years 

5 ml 2 times a day (corresponding to 70 mg of dry extract of climbing ivy leaf)

Children aged 2 to 5 years 

2,5 ml 2 times a day (corresponding to 35 mg of dry extract of climbing ivy leaf)

Child under 2 years

This medicine is contraindicated in children under 2 years (see section Contraindications).

Method of administration

Oral use.

Use the enclosed measuring cup to measure the exact dose.

Duration of treatment

One week.

If symptoms persist after one week of treatment, a doctor or pharmacist should be consulted.

• Hypersensitivity to the active substance or to plants of the family Araliaceae or to any of the excipients mentioned in section Composition.
• Children under 2 years due to the risk of worsening respiratory symptoms.

In case of dyspnoea, fever or purulent expectorations, a doctor or pharmacist should be consulted.

Concomitant use with opioid antitussives such as codeine or dextromethorphan is not recommended without medical advice.

The greatest caution is recommended in patients suffering from gastritis or gastric ulcer.

This medicine contains liquid maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Paediatric population

Persistent or recurrent cough in children aged 2 to 4 years requires a medical diagnosis before starting treatment.

No interaction has been reported.

Pregnancy

There are no or few data on the use of dry ivy leaf extract in pregnant women. Animal studies are insufficient with regard to reproductive toxicity (see section Preclinical safety). In the absence of sufficient safety data, use during pregnancy is not recommended.

Breast-feeding

It is not known whether the constituents or metabolites of dry ivy leaf extract are excreted in breast milk. A risk to newborns/infants cannot be excluded. In the absence of sufficient safety data, use during breast-feeding is not recommended.

Fertility

No data are available concerning effects on fertility.

The effects on the ability to drive vehicles and use machines have not been studied.

Frequency not determinable (cannot be estimated from available data):

•  Gastrointestinal disorders:

Nausea, vomiting or diarrhoea have been observed.

•  Immune system disorders:

Allergic reactions (urticaria, skin rashes, dyspnoea, Quincke's oedema) have been observed.

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

An overdose may cause nausea, vomiting, diarrhoea and agitation.

One case of a 4-year-old child who developed aggressiveness and diarrhoea after accidental ingestion of a climbing ivy extract corresponding to 1,8 g of plant material has been reported.

Pharmacotherapeutic class: expectorants, ATC code: R05CA12

The mechanism of action is not known.

No data available.

The positive result obtained in the Ames test performed on the climbing ivy leaf extract contained in LIERRE GRIMPANT BIOGARAN CONSEIL SANS SUCRE could be attributed to the presence of flavonoids, and is therefore of no genotoxic relevance in humans.

No carcinogenesis study or reproductive toxicity study has been performed.

3 years.

After first opening of the bottle, the oral solution should be used within 14 days.

No special precautions for storage.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.