Package leaflet: Information for the user

Sedistress Forte, 500 mg, coated tablets
Passiflorae herbae extractum siccum
Please read this leaflet carefully before taking this medicine because it contains important
information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 weeks, or if you feel worse, consult your doctor.

Contents of the leaflet

What Sedistress Forte is and what it is used for
Important information before taking Sedistress Forte
How to take Sedistress Forte
Possible side effects
How to store Sedistress Forte
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 dry extract of passionflower herb (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 an aid to help with sleep onset.
This product is a traditional herbal medicinal product intended for use in specific indications based exclusively on its long-standing use.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.

2. Important information before taking Sedistress Forte

When not to take Sedistress Forte

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

Warnings and precautions
Before starting to take Sedistress Forte, discuss this with your doctor or pharmacist.
Children and adolescents
Use of this medicine is not recommended in children under 12 years of age.
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PACKAGE LEAFLET
Sedistress Forte and other medicines
You must tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use with other sedative medicines (such as benzodiazepines) is not recommended. If the patient is taking other sedative medicines, consult a doctor or pharmacist before starting treatment with this medicinal product.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient data to exclude harmful effects during pregnancy and breastfeeding, use of this medicine is not recommended during these periods.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery. If such effects are observed, the patient should not drive or operate machinery.

3. How to take Sedistress Forte

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose for adults and adolescents over 12 years of age:

To relieve short-term mental stress: 1 to 2 tablets per day.
To aid sleep: 1 tablet in the evening, half an hour before bedtime. If necessary, a second tablet may be taken later.

The dose may be increased after consultation with a doctor or pharmacist (up to a maximum of 3 tablets per day).
Swallow the tablets with plenty of water.
If symptoms worsen, do not improve, or persist for more than 2 weeks, consult your doctor or pharmacist.
Taking more Sedistress Forte than recommended
If a person (or someone else) has taken a large number of tablets at the same time, or if a child has swallowed one tablet, contact a doctor or pharmacist immediately.
No cases of overdose have been reported.
Missing a dose of Sedistress Forte
Do not take a double dose to make up for a missed tablet.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
No adverse reactions have been reported to date.
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PACKAGE LEAFLET
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Sedistress Forte

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the "EXP" mark.
The expiry date refers to the last day of the stated month.
No special storage temperature requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

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

Tablet core: maltodextrin, microcrystalline cellulose, pregelatinized corn starch, colloidal hydrated silica, magnesium stearate.
Tablet coating: Sub-coating: hypromellose 15mPas, hypromellose 3mPas, polydextrose (E1200), calcium carbonate, medium-chain triglycerides. Top-coating: polyvinyl alcohol, calcium carbonate, macrogol 3350, talc, carmine (E120).

What Sedistress Forte looks like and contents of the pack
Sedistress Forte is a pink to dark pink, elongated coated tablet, 19 x 9 mm in size. Sedistress Forte is packaged in blisters made of PVC/PE/PVDC/Aluminum or in unit-dose blisters made of PVC/PE/PVDC/Aluminum and is available in pack sizes containing 14, 28, 56, 98 tablets or 100 x 1 tablet.
Not all pack sizes may be marketed.

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PACKAGE LEAFLET

Marketing Authorisation Holder and Manufacturer
Tilman SA
Z.I. Sud 15
5377 Baillonville
Belgium
Tel: +32 84 320 360

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Salveo Poland Sp. z o.o.
Okrężna 83, 83a lok.5
02-933 Warsaw, Poland
Tel: +48 22 121 13 05
[email protected]

This medicinal product is authorised 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
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