Sedistress Forte film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sedistress Forte coated tablets

Dry extract of passionflower

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

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

Contents of the 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 adverse effects

5. Storage of Sedistress Forte

6. Contents of the pack and other information

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

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

Sedistress Forte 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 and must be used in accordance with specific instructions based exclusively on long-term use.

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

2. What you need to know before starting to take Sedistress Forte

Do not take Sedistress Forte:

• if you are allergic to passionflower or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Sedistress Forte.

Children and adolescents

Administration of this medicine is not recommended for children under 12 years of age.

Taking Sedistress Forte with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Combination with other sedative drugs (such as benzodiazepines, for example) is not recommended. If you are taking other sedative medicines, consult your doctor or pharmacist before starting to use this medicine.

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 rule out any adverse effects during pregnancy or breastfeeding, the use of this medicine is not advised during these periods.

Driving and using machines

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

3. How to take Sedistress Forte

Follow exactly the dosage instructions 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 per day.
• To aid sleep: 1 tablet at night, half an hour before bedtime. If needed, a second tablet may be taken later.

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

Take the tablets with a large glass of water.

If 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 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 Forte

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

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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sedistress Forte

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.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sedistress Forte

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

Extraction solvent: ethanol 70% V/V.

The other components are:

• Core: maltodextrin, microcrystalline cellulose, pregelatinized corn starch, colloidal hydrated silica, magnesium stearate.
• Coating: Lower layer: hypromellose (15 mPas / 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 contents of the pack

Oblong, film-coated tablets, pink to dark pink in colour (19x9 mm).

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Date of the most recent revision of this leaflet: January 2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es