SEDISTRESS COATED TABLETS

Introduction

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.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

• You should consult a doctor if your symptoms worsen or do not improve after 2 weeks.

Contents of the Package Leaflet

1. What Sedistress is and what it is used for
2. What you need to know before taking Sedistress
3. How to take Sedistress
4. Possible side effects

5 Conservation of Sedistress

1. Contents of the packaging and additional information

1. What Sedistress is and what it is used for

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.

2. What you need to know before taking Sedistress

Do not take Sedistress:

• if you are allergic to passiflora or any of the other components of this medication (listed in section 6).

Warnings and Precautions

• Consult your doctor or pharmacist before starting to take Sedistress.
• Lack of sufficient information means that the administration of Sedistress is not recommended for children under 12 years old, except in cases of medical indication.

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.

3. How to take Sedistress

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:

• For relief of transient mental stress: 1 or 2 tablets in the morning and evening. The dose may be increased, after consulting your doctor or pharmacist (maximum 8 tablets per day).
• To facilitate sleep: 1 or 2 tablets at night, 30 minutes before bedtime.

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.

4. Possible side effects

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.

5. Conservation of Sedistress

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.

6. Contents of the packaging and additional information

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/