Leaflet: information for the user

Sedistress coated tablets

Dried extract of passionflower

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

Follow exactly the instructions for taking the medicine contained in this leaflet or those given by your doctor or pharmacist.

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

• Ifyou experience any side effects, consult your doctor or pharmacist,even if they do not appear in this leaflet. See section 4.

• You should consult a doctor if you get worse or do not improveafter 2 weeks.

1.What Sedistress is and for what it is used

2.What you need to knowbeforestarting totake Sedistress

3.How to take Sedistress

4.Possible side effects

5Storage of Sedistress

6.Contents of the pack and additional information

Sedistress is a medication that containspassionflower extract

Sedistress is a plant-based traditional medication, indicated for adults and adolescents over 12 years old, with the aim of reducing some moderate symptoms of mental stress, such as nervousness, restlessness, or irritability, as well as to facilitate sleep.

This medication is a plant-based traditional medication that must be used following specific indications based exclusively on long-term use.

Do not takeSedistress:

• if you are allergic to passionflower 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.
• Due to insufficient information, Sedistress is not recommended for children under 12 years old, except on medical indication.

Children and adolescents

Sedistress is not recommended for children under 12 years old.

TakingSedistresswith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Sedistress is not recommended to be associated with other calming medications (such as benzodiazepines), except on indication from your doctor or pharmacist.

TakingSedistresswith food and drinks

Not applicable.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to insufficient information to exclude any secondary effects during pregnancy or breastfeeding, it is not recommended to use this medication during these periods.

Driving and operating machines

This medication may cause drowsiness. Do not drive or operate machinery if you feel drowsy or notice that your attention and reaction time are reduced.

Sedistress contains sodium. This medication contains <1>

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The usual doses for adults and adolescents over 12 years old are as follows:

• For transient mental stress relief: 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 help with sleep: 1 or 2 tablets at night, half an hour before bedtime.

Swallow the tablets with a glass of water.

If symptoms worsen or persist after 2 weeks, consult a doctor or pharmacist.

If you take moreSedistressthan you should

If you (or anyone else) have taken a large number of tablets at once or if you think a child has ingested any tablets, contact your doctor or pharmacist immediately, or call the Toxicological Information Service (91 562 04 20).

No cases of overdose have been described.

If you forgot to takeSedistress

Do not take a double dose to make up for the missed doses.

If you interrupt the treatment withSedistress

If you interrupt the treatment with Sedistress before the scheduled time, no side effects should occur.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

No adverse effects were reported.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medications should not be thrown away through drains or trash. Ask your pharmacisthow to dispose ofthepackaging and of themedications that you no longerneed. This way, you will help protect the environment.

Composition ofSedistress

The active principle is the extract of the aerial parts of passionflower (Passiflora incarnataL.). Each tablet contains 200 mg of extract (as dry extract) ofPassiflora incarnataL., aerial parts, corresponding to 700–1000 mg of passionflower.

Extraction solvent: ethanol 60% v/v.

The other components are:

Core:microcrystalline cellulose, povidone, hydrogenated cottonseed oil, sodium carboxymethyl cellulose (type A), anhydrous colloidal silica, tricalcium phosphate.

Covering:polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172).

Excipient used in the extract: maltodextrin.

Appearance of the product and content of the container

Pink, oblong, biconvex coated tablets.

Packed in boxes of 28, 42,98 or 98x1 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Tilman s.a., Z.I. Sud 15, 5377 Baillonville, Belgium

Method of dispensing

Medicine not subject to medical prescription.

This medicine is authorized in the member states of the European Economic Area with the following names:

Belgium, Luxembourg: Sedistress 200

Spain, Greece, Cyprus: Sedistress

Netherlands: Sofytol

Finland, Norway, Sweden: Sedix

France: Anxemil

Revision date of this prospectus:11/2019

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/