


Ask a doctor about a prescription for SEDISTRESS COATED TABLETS
Package Leaflet: Information for the User
Sedistress Coated Tablets
Dry Extract of Passiflora
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.
Contents of the Package Leaflet
5 Conservation of Sedistress
Sedistress is a medication that contains passiflora extract
Sedistress is a traditional herbal medicinal product, indicated for adults and adolescents over 12 years old to reduce some moderate symptoms of mental stress, such as nervousness, restlessness, or irritability, as well as to facilitate sleep.
This medicinal product is a traditional herbal medicinal product that must be used following specific indications based exclusively on long-term use.
Do not take Sedistress:
Warnings and Precautions
Children and Adolescents
The administration of this medication is not recommended for children under 12 years old.
Taking Sedistress with other medications
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
It is not recommended to associate with other calming medications (such as benzodiazepines), except as indicated by your doctor or pharmacist.
Taking Sedistress with food and beverages
Not applicable.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
As there is not enough information to rule out any side effects during pregnancy or breastfeeding, the use of this medication is not advised during these periods.
Driving and Using Machines
This medication can cause drowsiness. Do not drive or use machinery if you feel drowsy or if you notice that your attention and reaction capacity are reduced.
Sedistress contains sodium. This medication contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e., it is essentially sodium-free.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.
The usual doses for adults and adolescents over 12 years old are as follows:
Swallow the tablets with a glass of water.
If your symptoms worsen or persist after 2 weeks, consult a doctor or pharmacist.
If you take more Sedistress than you should
If you (or anyone else) have taken a significant amount of tablets at once or if you think a child has ingested any tablets, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (91 562 04 20).
No cases of overdose have been reported.
If you forget to take Sedistress
Do not take a double dose to make up for forgotten doses.
If you stop treatment with Sedistress
If you stop treatment with Sedistress before planned, no side effects should occur.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medications, this medication can cause side effects, although not everyone experiences them.
No side effects have been reported.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date shown on the box after "CAD". The expiration date is the last day of the month indicated.
This medication does not require any special storage temperature.
Keep in the original packaging to protect it from moisture.
Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
Composition of Sedistress
The active ingredient is the extract of the aerial parts of passiflora (Passiflora incarnataL.). Each tablet contains 200 mg of extract (as dry extract) of Passiflora incarnataL., aerial parts, which corresponds to 700-1000 mg of passiflora.
Extraction solvent: 60% v/v ethanol.
The other components are:
Core:microcrystalline cellulose, pregelatinized starch, magnesium stearate, anhydrous colloidal silica.
Coating:polyvinyl alcohol, calcium carbonate, macrogol, talc, carmine acid (E120).
Excipient used in the extract: maltodextrin.
Appearance of the product and contents of the packaging
Pink to dark pink, oblong, biconvex coated tablets, 18 x 7 mm.
Packaged in boxes of 28, 42, 98, or 98x1 tablets.
Only some packaging sizes may be marketed.
Marketing authorization holder and manufacturer
Tilman s.a., Z.I. Sud 15, 5377 Baillonville, Belgium
Dispensing method
Medication not subject to medical prescription.
This medication is authorized in the Member States of the European Economic Area under the following names:
Belgium, Luxembourg: Sedistress 200
Spain, Greece, Cyprus, Poland: Sedistress
Netherlands: Sofytol
Finland, Norway, Sweden: Sedix
France, Slovenia: Anxemil
Italy: Tractana
Austria: PhytoCalm
Date of the last revision of this package leaflet: 06/2025
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for SEDISTRESS COATED TABLETS – subject to medical assessment and local rules.