Sedistress Forte

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

Sedistress Forte is a traditional herbal medicinal product containing dry extract of passion flower (Passiflora incarnata L.). Sedistress Forte is a traditional herbal medicinal product used in adults and adolescents over 12 years of age to relieve mild symptoms of mental stress, such as nervousness, anxiety or irritability, and as a medicine to facilitate sleep. The product is a traditional herbal medicinal product intended for use in specified indications resulting solely from its long-term use. If after 14 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Sedistress Forte

When not to take Sedistress Forte

• if the patient is allergic to passion flower or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Sedistress Forte, the patient should discuss it with their doctor or pharmacist.

Children and adolescents

The use of this medicine in children under 12 years of age is not recommended.
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LEAFLET

Sedistress Forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take. It is not recommended to take Sedistress Forte with other sedative medicines (such as benzodiazepines). If the patient is taking other sedative medicines, they should consult their doctor or pharmacist before starting to take this medicinal product.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Due to the lack of sufficient data to rule out a harmful effect during pregnancy and breastfeeding, the use of this medicine is not recommended during this period.

Driving and using machines

This medicine may affect the patient's ability to drive and use machines. If the patient experiences any effect, they should not drive or operate machinery.

3. How to take Sedistress Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The recommended dose for adults and adolescents over 12 years of age is:

• Relief of short-term mental stress: 1 to 2 tablets per day.
• Facilitating sleep: 1 tablet in the evening, 30 minutes before bedtime. If necessary, a second tablet can be taken later.

The dose may be increased after consulting a doctor or pharmacist (up to a maximum of 3 tablets per day). The patient should swallow the tablets with a large amount of water. If the symptoms worsen or do not improve, or if they persist for more than 2 weeks, the patient should consult their doctor or pharmacist.

Taking a higher dose of Sedistress Forte than recommended

If the patient (or someone else) has taken a large number of tablets at the same time, or if a child has swallowed a tablet, they should contact a doctor or pharmacist. No cases of overdose have been reported.

Missing a dose of Sedistress Forte

The patient should not take a double dose to make up for a missed tablet. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sedistress Forte can cause side effects, although not everybody gets them. No side effects have been reported so far.
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LEAFLET

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

• Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sedistress Forte

The medicine should be stored out of sight and reach of children. The medicine should not be used after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated. There are no special storage precautions for the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Sedistress Forte contains

Each film-coated tablet contains 500 mg of extract (in the form of dry extract) of Passiflora incarnata L., herba (passion flower), corresponding to 2000 mg - 3000 mg of passion flower. Extraction solvent: ethanol 70% V/V. The other ingredients are:

• Core of the tablet: maltodextrin, microcrystalline cellulose, maize starch, colloidal silicon dioxide, magnesium stearate.
• Coating of the tablet: Sub-coating:hypromellose 15mPas, hypromellose 3mPas, polydextrose (E1200), calcium carbonate, triglycerides of medium-chain fatty acids. Top-coating:polyvinyl alcohol, calcium carbonate, macrogol 3350, talc, carmine (E120).

What Sedistress Forte looks like and contents of the packaging

Sedistress Forte is a pink to dark pink, elongated, film-coated tablet with dimensions of 19 x 9 mm. Sedistress Forte is packaged in PVC/PE/PVDC/Aluminium blisters or unit-dose blisters of PVC/PE/PVDC/Aluminium and is available in packs of 14, 28, 56, 98 tablets or 100 x 1 tablet. Not all pack sizes may be marketed.
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Marketing authorization holder and manufacturer

Tilman SA, Z.I. Sud 15, 5377 Baillonville, Belgium, Tel: +32 84 320 360. For further information about this medicine, the patient should contact the local representative of the marketing authorization holder: Salveo Poland Sp. z o.o., Okrężna 83, 83a lok.5, 02-933 Warsaw, Poland, Tel: +48 22 121 13 05, office-pol@salveo-pharma.com

This medicine is authorized for marketing in the Member States of the European

Economic Area under the following names:

Cyprus, Bulgaria:Sedistress 500
Romania, Malta:Sedistress 500 mg
Spain, Greece, Poland, Belgium, Luxembourg:Sedistress Forte
France:Anxemil 500 mg
Portugal, Croatia:Sedistress
Italy:Tractamed
Sweden, Norway, Denmark:Sedix forte
Finland:Sedizin
Czech Republic:Blossomin
Slovakia:Zenaxal
Slovenia:Anxemil STR

Date of last revision of the leaflet:

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