SEDISTRESS FORTE FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sedistress Forte Coated Tablets

Dry extract of passionflower

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

5 Conservation of Sedistress Forte

1. Contents of the packaging and additional information

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

Sedistress Forte is a traditional herbal medicinal product containing passionflower extract (Passiflora incarnataL.).

Sedistress Forte is a traditional herbal medicinal product indicated for adults and adolescents over 12 years of age to reduce 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 and should be used following specific instructions based exclusively on long-term use.

You should consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Sedistress Forte

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 medicinal product is not recommended for children under 12 years of age.

Taking Sedistress Forte with other medications

Inform 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 sedative medications (such as benzodiazepines). If you are taking other sedative 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

As there is not enough information to exclude any side effects during pregnancy or breastfeeding, the use of this medicinal product is not recommended during these periods.

Driving and using machines

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

3. How to take Sedistress Forte

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 of age are as follows:

• For relief of transient mental stress: 1 or 2 tablets per day.
• To facilitate sleep: 1 tablet at night, 30 minutes before bedtime. If necessary, 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 your symptoms worsen or persist after 2 weeks, consult your doctor or pharmacist.

If you take more Sedistress Forte 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 Forte

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

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 will experience 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 for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Sedistress Forte

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated 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 from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Sedistress Forte

The active ingredient is the dry extract of the aerial parts of passionflower (Passiflora incarnataL.). Each tablet contains 500 mg of extract (as dry extract) of Passiflora incarnataL., herb (equivalent to 2,000 - 3,000 mg) of passionflower.

Extraction solvent: ethanol 70% V/V.

The other components are:

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

Appearance of the product and packaging contents

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

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

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of the last revision of this package leaflet: January 2024.

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es