Patient Information Leaflet

Sedistress, coated tablets
Passionflower herb extract
Passiflorae herbae extractum siccum
Please read this leaflet carefully before taking this medicine, because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has advised.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell 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 is and what it is used for
Important information before taking Sedistress
How to take Sedistress
Possible side effects
How to store Sedistress
Contents of the pack and other information

1. What Sedistress is and what it is used for

Sedistress is a traditional herbal medicinal product containing passionflower herb extract.
Sedistress 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, worry or irritability, and as an aid to help sleep.
This product is a traditional herbal medicinal product for use in specified indications solely based on long-standing use.

2. Important information before taking Sedistress

When not to take Sedistress

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

Warnings and precautions
Before starting Sedistress, discuss this with your doctor or pharmacist.

Due to lack of sufficient data, Sedistress is not recommended for use in children under 12 years of age.

Children and adolescents
Use of this medicine is not recommended in children under 12 years of age.
Sedistress and other medicines
You must tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use with other sedative medicines (such as benzodiazepines) is not recommended without medical advice from a doctor or pharmacist.
Sedistress with food and drink
Not applicable.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Due to lack of sufficient data, to exclude potential 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. It is not advisable to drive or operate machinery.
Sedistress contains sodium:
This medicine contains less than 1 mmol of sodium ions (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Sedistress

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

For relief of short-term mental stress: 1 to 2 tablets in the morning and in the evening. The dose may be increased according to the advice of a doctor or pharmacist (up to a maximum of 8 tablets per day).
As a sleep aid: 1 to 2 tablets in the evening, half an hour before bedtime.

Swallow the tablets with a large amount of water.
If symptoms worsen or do not improve after 2 weeks, consult your doctor or pharmacist.
Taking more Sedistress than recommended
If you have taken a large number of tablets at once, or if a child has swallowed any of the tablets, contact your doctor or pharmacist immediately.
No cases of overdose have been reported.
Missing a dose of Sedistress
Do not take a double dose to make up for a missed tablet.
Stopping Sedistress
Stopping treatment with Sedistress should not cause any adverse effects.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
No adverse reactions have been reported to date.
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 Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 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 helps provide more information on the safety of the medicine.

5. How to store Sedistress

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.
There are no special requirements regarding the storage temperature of this medicine.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Sedistress contains
The active substance in Sedistress is a dry extract of passionflower herb (Passiflorae herbae extractum siccum).
Each tablet contains 200 mg of extract (in the form of dry extract) from Passiflora incarnata L. herb (equivalent to 700 mg – 1000 mg of passionflower flowers).
Extraction solvent: ethanol 60% V/V.
Other ingredients are:

Tablet core: microcrystalline cellulose, pregelatinized starch, magnesium stearate, colloidal anhydrous silica.
Coating: polyvinyl alcohol, calcium carbonate, macrogol 3350, talc, carmine (E120).
Excipients used in the extract: maltodextrin.

What Sedistress looks like and contents of the pack
Sedistress is in the form of pink to dark pink, elongated, biconvex tablets, 18 x 7 mm in size.
Sedistress is available in cardboard boxes containing 28, 42, 98 or 100x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Tilman SA
Z.I. Sud 15
5377 Baillonville
Belgium
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium, Luxembourg: Sedistress 200
Spain, Greece, Cyprus, Poland: Sedistress
France, Slovenia: Anxemil
Finland, Norway, Sweden: Sedix
Netherlands: Sofytol
Austria: PhytoCalm
Italy: Tractana