Tractana 28 coated tablets

Tractana 28 coated tablets is a herbal medicine, formulated to relieve mild symptoms of mental stress such as nervousness, anxiety and irritability, as well as promoting sleep . Each tablet contains 200 mg of dry extract of Passiflora incarnata L., an active ingredient known for its calming properties. This product is indicated for adults and children over 12 years of age, based on a traditional use consolidated over time. Tractana is a natural solution for those seeking support in managing daily stress and improving the quality of night-time rest. The tablets are coated to ensure easy administration and better tolerability. Passionflower and sleep are the key words that define the effectiveness of this product in promoting mental and physical well-being.

ACTIVE INGREDIENTS

Active ingredients in Tractana 28 coated tablets - What is the active ingredient in Tractana 28 coated tablets?

Each coated tablet contains 200 mg of dry extract of Passiflora incarnata L., herba (equivalent to 700 mg - 1000 mg of passionflower). Extraction solvent: Ethanol 60% V/V. Excipient with known effect: Each tablet contains less than 1 mmol sodium (23 mg), that is to say essentially 'sodium-free'. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Tractana 28 coated tablets - What does Tractana 28 coated tablets contain?

Tablet core: Microcrystalline cellulose, Povidone, Sodium starch glycolate (type A), Hydrogenated cottonseed oil, Colloidal anhydrous silica, Tricalcium phosphate. Coating: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc, Red iron oxide (E172). Excipient in the extract: maltodextrin.

DIRECTIONS

Therapeutic indications Tractana 28 coated tablets - Why is Tractana 28 coated tablets used? What is it used for?

Traditional herbal medicine indicated to relieve mild symptoms of mental stress, such as nervousness, anxiety or irritability and to promote sleep. The product is a traditional herbal medicine to be used for specific indications based exclusively on long-standing use. Tractana is indicated in adults and children over 12 years of age.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Tractana 28 coated tablets - When should Tractana 28 coated tablets not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Quantity and method of taking Tractana 28 coated tablets - How to take Tractana 28 coated tablets?

Dosage. Adults and children over 12 years of age: - For the relief of transient mental stress: 1-2 tablets morning and evening. The dosage may be increased as directed by your doctor or pharmacist (up to a maximum of 8 tablets per day). - To aid sleep: 1-2 tablets in the evening half an hour before going to sleep. Paediatric population: In the absence of sufficient data, use in children under 12 years of age is not recommended. Duration of use: If symptoms persist for more than 2 weeks during use of the medicine, consult a doctor or qualified healthcare professional. Method of administration: Oral use. Take the tablets with plenty of water.

CONSERVATION

Storage Tractana 28 coated tablets - How to store Tractana 28 coated tablets?

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

WARNINGS

Warnings Tractana 28 coated tablets - About Tractana 28 coated tablets it is important to know that:

Use in children under 12 years of age has not been validated due to the lack of adequate data. If symptoms worsen while using the medicine, consult a doctor or qualified healthcare professional. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'

INTERACTIONS

Interactions Tractana 28 coated tablets - Which medicines or foods can modify the effect of Tractana 28 coated tablets?

The concomitant use of synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor or pharmacist. To avoid drug interactions, patients should inform their doctor or pharmacist of any other treatments they are taking while taking Tractana.

SIDE EFFECTS

Like all medicines, Tractana 28 coated tablets can cause side effects - What are the side effects of Tractana 28 coated tablets?

None known. In case of adverse reactions, consult a doctor or a qualified healthcare professional. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Tractana 28 coated tablets - What are the risks of Tractana 28 coated tablets in case of overdose?

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Tractana 28 coated tablets.

Pregnancy and lactation: The absence of risk during pregnancy or lactation has not been established. One study in one animal species has shown reproductive toxicity (see section 5.3). In the absence of sufficient data, use during pregnancy or lactation is not recommended. Fertility: No data on fertility are available.

DRIVING AND USE OF MACHINERY

Taking Tractana 28 coated tablets before driving or using machines - Does Tractana 28 coated tablets affect driving or using machines?

May impair ability to drive and use machines. Affected patients should not drive or use machines.