Sedistress

Package Leaflet: Information for the User

Sedistress, Coated Tablets

Extract of passion flower
Passiflorae herbae extractum siccum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 2 weeks there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What Sedistress is and what it is used for
• 2. Important information before taking Sedistress
• 3. How to take Sedistress
• 4. Possible side effects
• 5. How to store Sedistress
• 6. 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 an extract of passion flower.
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, worrying or irritability, and as a sleep aid.
This product is a traditional herbal medicinal product intended for use in specified indications exclusively based on long-standing use.

2. Important information before taking Sedistress

When not to take Sedistress

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

Warnings and precautions

Before taking Sedistress, discuss it with your doctor or pharmacist.

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

Children and adolescents

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

Sedistress with other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take.
It is not recommended to take Sedistress with other sedative medicines (such as benzodiazepines) without the advice of a doctor or pharmacist.

Sedistress with food and drink

Not applicable.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Due to the lack of sufficient data to exclude a harmful effect during pregnancy and breastfeeding, this medicine is not recommended during this period.

Driving and using machines

This medicine may affect your ability to drive or use machines. It is not recommended to drive or use machines.

Sedistress contains sodium:

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Sedistress

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Recommended dose for adults and adolescents over 12 years of age:

• Relief of short-term mental stress: 1 to 2 tablets in the morning and evening. The dose may be increased according to the doctor's or pharmacist's advice (up to 8 tablets per day).
• As a sleep aid: 1 to 2 tablets in the evening, 30 minutes 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 one of the tablets, contact your doctor or pharmacist.
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 Sedistress should not cause any side effects.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to:
Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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 this medicine.

5. How to store Sedistress

Keep the 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 month.
There are no special storage instructions for this medicine.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sedistress contains

The active substance is passion flower extract (Passiflorae herbae extractum siccum
).
One tablet contains 200 mg of extract (in the form of dry extract) from passion flower Passiflora incarnataL. (which corresponds to 700 mg - 1000 mg of passion flower).
Extraction solvent: ethanol 60% V/V.
The other ingredients are:

• Core: microcrystalline cellulose, povidone K30, sodium carboxymethylcellulose (Type A), hydrogenated cottonseed oil, colloidal anhydrous silica, calcium phosphate.
• Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172).
• Auxiliary substances used in the extract are maltodextrin.

What Sedistress looks like and contents of the pack

Sedistress is a pink, elongated, biconvex, coated tablet.
Sedistress is available in packs of 28, 42 or 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Tilman SA
Z.I. Sud 15
5377 Baillonville
Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium, Luxembourg:
Sedistress 200
Spain, Greece, Cyprus, Poland:
Sedistress
France:
Anxemil
Finland, Norway, Sweden:
Sedix
Netherlands:
Sofytol
Date of last revision of the leaflet:05.05.2020