Sedix 200 mg coated tablets
What Sedix Is And What It Is Used For
Sedix tablets is a traditional herbal medicine used for mild symptoms of nervous tension such as
- Anxiety
- Irritability
- Temporary insomnia
The indications for traditional herbal sedix tablets are based solely on experience with long-term use.
What You Need To Know Before You Take Sedix
Do Not Take:
- If you are allergic to passion flower or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions
- In the absence of adequate data, the use of Sedix tablets in children under 12 years of age is not recommended.
Children And Young People
This medicine is not recommended for children under 12 years of age.
Other Medicines And Sedix
In case of contact with a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken this over-the-counter medicine.
Concomitant use of Sedix and synthetic sedatives (eg benzodiazepines ) is not recommended unless co-administration has been prescribed by a physician.
Pregnancy And Breastfeeding
Due to insufficient experience, Sedix should not be used during pregnancy and lactation.
Driving and Using Machines
This medicine may impair the ability to drive or use machines. If you feel affected, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or other healthcare professional.
Sedix contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet and is essential ‘sodium-free’.
How To Take Sedix
Always take this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults and adolescents over 12 years of age is:
- For mild symptoms of nervous tension: 1 to 2 tablets morning and evening. Dose one can be increased according to your doctor’s prescription (maximum 8 tablets per day).
- In case of difficulty sleeping: 1 to 2 tablets in the evening, half an hour before bedtime.
Swallow the tablet with a large glass of water.
If your symptoms worsen or do not improve after 2 weeks, you should contact a doctor.
If You Take More Sedix Than You Should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
No case of overdose has been reported.
If You Forget To Take Sedix
Do not take a double dose to make up for a forgotten dose.
If You Stop Taking Sedix
No adverse effects are expected upon discontinuation of treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Sedix Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported.
How To Store Sedix
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
- No special temperature instructions.
- Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Content Declaration
- The active substance is passion flower extract, ( Passiflora incarnata L.), an herb.
- 1 tablet contains 200 mg of dry extract of Passiflora incarnata L. (passion flower), corresponding to 700 mg – 1000 mg of dried passion flower herb.
- Extractant: Ethanol 60% v / v.
- Other ingredients are:
What The Medicine Looks Like And The Contents Of The Pack
- Sedix is a pink, oblong, biconvex coated tablet.
- Sedix is available in packs of 28, 42, or 98 tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Tilman said, ZI Sud 15, 5377 Baillonville, Belgium
Local representative :
Sana Pharma Medical AS, Philip Pedersens vei 20, 1366 Lysaker, Norway
This medicinal product is registered under the European Economic Area under the names:
Belgium, Luxembourg: Sedistress 200
Spain, Greece, Cyprus, Poland: Sedistress
France, Slovenia: Anxemil
Netherlands: Sofytol
Finland, Norway, Sweden: Sedix
Italy: Tatiana
Austria: PhytoCalm