Descrizione Clinica
Other Tractana disorders 28cpr riv 200mg
EXTERNAL TRACTANA
active ingredients
Each coated tablet contains 200 mg of dry extract of Passiflora embodied L., herb (equivalent to 700 mg - 1000 mg of passiflora). Extraction solvent: Ethanol 60% V/V. Excipient with known effect: Each tablet contains less than 1mmol (23mg) of sodium, i.e. essentially ‘without sodium’. For the full list of excipients, see paragraph 6.1.Excellent
Compressed core: Microcrystalline cellulose, Povidone, Sodium starch (type A), Hydrogenated cotton oil, Anidra colloidal Silica, Tricalcium Phosphate. Coating: Polyvinyl alcohol, Titanium Dioxide (E171), Macrogol, Talco, Red Iron oxide (E172). Exciting in the extract: maltodextrin.Therapeutic indications
Traditional vegetable medicine indicated to alleviate the mild symptoms of mental stress, such as nervousness, anxiety or irritability and to promote sleep. The product is a traditional vegetable medicinal product to be used for specific indications based solely on long-term use. Tractana is indicated in adults and children over 12 years old.Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.Population
Posology. Adults and children aged 12: - For the relief of transitory mental stress: 1-2 tablets morning and evening. The dosage can be increased according to the indications of the doctor or pharmacist (up to a maximum of 8 tablets per day). - To promote sleep: 1-2 tablets in the evening half an hour before going to sleep. Pediatric population: In the absence of sufficient data, it is not recommended to use in children under the age of 12. Duration of use: If symptoms persist for more than 2 weeks during use of the medicine, consult a doctor or a qualified health professional. Method of administration: Oral use. Take the tablets with plenty of water.Conservation
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from moisture.Warnings
Use in children under 12 years of age has not been validated due to the absence of adequate data. If symptoms worsen during use of the medicine, consult a doctor or a qualified health professional. This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e. essentially ‘without sodium’Interactions
Contemporary use of synthetic sedatives (such as benzodiazepines) is not recommended except if recommended by a doctor or pharmacist. In order to avoid drug interactions, patients must inform their physician or pharmacist of any other ongoing treatments while taking Tractana.Effects
No one known. In case of adverse reactions, consult a doctor or a qualified health professional. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Overdosing
No overdose cases have been reported.Pregnancy and nursing:
The absence of risks during pregnancy or breastfeeding has not been established. A study in an animal species showed reproductive toxicity (see section 5.3). In the absence of sufficient data, use during pregnancy or breastfeeding is not recommended.Fertility:
Fertility data is not available.Source: Farmadati
