Descrizione Clinica
ICTALMA “400 MG TISANA”
active ingredients
A bag of g 1.2 contains: Active ingredient: Valerian root 400 mg. For the full list of excipients, see paragraph 6.1.Excellent
Chamomile, holy, green anise, peppermint and melissa.Therapeutic indications
Clear sedative, also to favor the night rest.Contraindications
Hypersensitivity to the active ingredient or any of the components.Population
1-2 filter bags three times a day. The bag must be infusion for a few minutes in a quantity of water equal to the content of a cup. Infusion can be assumed hot or cold and correct with sugar and any orange or lemon peel, to taste. Do not exceed the recommended doses. Pediatric population. Use in children under 12 years of age is not recommended, since data on the effectiveness and safety of the medicine in pediatrics are not available.Conservation
Store the product in a cool and dry environment.Warnings
As data on the effectiveness and safety of the drug in pediatrics are not available, the use of this medicine is not recommended in children under the age of 12. If symptoms worsen after two weeks of continuous treatment, it is recommended to consult a doctor.Interactions
Only limited data on drug interactions with other medicines are available. A clinically relevant interaction with metabolized drugs from CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 has not been observed. However, probably, valerian extracts can enhance depressive effects on the central nervous system induced by other substances, such as barbituric and chlorromazine; deduced that the concomitant use of TICALMA with psychopharmaceutical, barbitural or sedatives requires a diagnosis and medical control. ICTALMA can be enhanced by concurrent consumption of alcohol; alcohol consumption must therefore be avoided.Effects
Gastro-intestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of preparations based on di root of valerian. The frequency is not known. If other adverse reactions do not occur, a doctor or pharmacist should be consulted. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address “www.agenziafarmaco.gov.it/it/responsabili”.Overdosing
The root of valerian at a dose of about 20 g causes slight symptoms (affactication, abdominal cramps, slight vertigo sensation, thoracic oppression, tremors to the hands and midriasis) that disappear in 24 hours. If the symptoms appear, proper treatment must be established. Due to high overdose, it is likely to admit depressing effects on the central nervous system.Safety during pregnancy and nursing has not been established. As a precautionary measure, due to lack of data, use during pregnancy and nursing is not recommended.
Source: Farmadati
