Leaflet: information for the user

Sedistress Forte 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.

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

• You must consult a doctor if you get worse or do not improve after 2 weeks.

1.What Sedistress Forte is and what it is used for

2.What you need to know before you start taking Sedistress Forte

3.How to take Sedistress Forte

4.Possible side effects

5Storage of Sedistress Forte

6.Contents of the pack and additional information

Sedistress Forte is a traditional herbal medicine that containspassionflower extract (Passiflora incarnataL).

Sedistress Forte is a traditional herbal medicine, indicated for adults and adolescents over 12 years old, in order to reduce moderate symptoms of mental stress, such as nervousness, restlessness or irritability, as well as to facilitate sleep.

This medication is a traditional herbal medicine and should be used following specific indications based exclusively on long-term use.

You should consult a doctor if it worsens or does not improve after 14 days.

Do not takeSedistress Forte:

• 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 Forte.

Children and adolescents

This medication is not recommended for children under 12 years old.

Taking Sedistress Forte with other medications

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

This medication is not recommended to be taken with other calming medications (such as benzodiazepines). If you are taking other calming medications, consult your doctor or pharmacist before starting to use this medication.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

This medication may cause drowsiness. If this occurs, do not drive or operate machinery.

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 temporary mental stress relief: 1 or 2 tablets per day.
• To help with sleep: 1 tablet at night, half an hour before bedtime. If needed, a second tablet can be taken later.

The dose may be increased following the instructions of your doctor or pharmacist (up to a maximum of 3 tablets per day).

Swallow the tablets with a large glass of water.

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

If you take moreSedistress Fortethan 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 Toxicology Information Service (91 562 04 20).

No cases of overdose have been described.

If you forgot to takeSedistress Forte

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

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.

Medicines should not be thrown away through drains or trash.Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose ofthe containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sedistress Forte

The active principle is the dry extract of the aerial parts of passionflower ( Passiflora incarnata L.). Each tablet contains 500 mg of extract (as dry extract) of Passiflora incarnata L., herb (equivalent to 2,000 – 3,000 mg) of Passiflora.

Extraction solvent: ethanol 70% V/V.

The other components are:

• Core: maltodextrin, microcrystalline cellulose, pregelatinized cornstarch, hydrated colloidal silica, magnesium stearate.
• Coating: Lower layer : hypromellose (15mPas /3 mPas) , polydextrose (E1200), calcium carbonate, medium-chain triglycerides. Upper layer : poly(vinyl alcohol), calcium carbonate, macrogol 3350, talc, carmine acid (E120).

Appearance of the product and content of the packaging

Oblong coated tablets, pink to dark pink in color (19x9 mm).

Packed in PVC/LDPE/PVDC/aluminum blisters and available in boxes of 14, 28, 56, 98 tablets or 100 single-dose tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

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

Date of the last review of this leaflet: January 2024.

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