Sedistress coated tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sedistress coated tablets
Dry extract of passionflower
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
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You should consult a doctor if you worsen or do not improve after 2 weeks.
Contents of the leaflet
- What Sedistress is and what it is used for
- What you need to know before taking Sedistress
- How to take Sedistress
- Possible adverse effects
- Storage of Sedistress
- Contents of the pack and other information
1. What Sedistress is and what it is used for
Sedistress is a medication containing passionflower extract.
Sedistress is a traditional herbal medicinal product indicated for adults and adolescents over 12 years of age to relieve mild symptoms of mental stress, such as nervousness, restlessness, or irritability, as well as to aid sleep.
This medicine is a traditional herbal medicinal product to be used according to specific guidelines based exclusively on long-term use.
2. What you need to know before taking this medicine
Do not take Sedistress:
- if you are allergic to passionflower or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- Consult your doctor or pharmacist before starting to take Sedistress.
- Due to insufficient data, administration of Sedistress is not recommended in children under 12 years of age, except on medical advice.
Children and adolescents
Administration of this medicine is not recommended in children under 12 years of age.
Taking Sedistress with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Concomitant use with other sedative drugs (such as benzodiazepines) is not recommended, unless specifically advised by your doctor or pharmacist.
Taking Sedistress with food and drinks
Not applicable.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Due to insufficient data to exclude any adverse effects during pregnancy or breastfeeding, use of this medicine is not recommended during these periods.
Driving and using machines
This medicine may cause drowsiness. Do not drive or operate machinery if you feel sleepy or if your attention and reaction capacity are impaired.
Sedistress contains sodium. This medicine contains <1 mmol of sodium (23 mg) per coated tablet, i.e. essentially sodium-free.
3. How to take Sedistress
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The usual doses for adults and adolescents over 12 years of age are as follows:
- For relief of transient mental stress: 1 or 2 tablets in the morning and in the afternoon. The dose may be increased, after consulting your doctor or pharmacist (maximum 8 tablets per day).
- To aid sleep: 1 or 2 tablets at night, half an hour before going to bed.
Take the tablets with a glass of water.
If 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 large number of tablets at once, or if you suspect that 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 taking Sedistress
If you stop treatment with Sedistress earlier than expected, no side effects should occur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
No adverse effects were reported.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sedistress
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect it from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Sedistress
The active substance is the extract from the aerial parts of passionflower (Passiflora incarnata L.). Each tablet contains 200 mg of extract (as dry extract) from Passiflora incarnata L., aerial parts, corresponding to 700–1000 mg of passionflower.
Extraction solvent: ethanol 60% v/v.
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.
Nature of the product and pack contents
Film-coated tablets, pink to dark pink, oblong, biconvex, 18 x 7 mm.
Packaged in boxes containing 28, 42, 98 or 98x1 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Tilman s.a., Z.I. Sud 15, 5377 Baillonville, Belgium
Method of dispensing
Medicinal product not subject to medical prescription.
This medicinal product is authorized in the European Economic Area member states 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 most recent review of this leaflet: 06/2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/