Coated tablets
extract of root from the taproot
What Sefitude is and what it is used for
Sefitude is herbal medicine for use in mild anxiety and sleep disorders.
Sefitude contains root extract from the taproot.
What you need to know before using Sefitude
Do not use Sefitude
- if you are allergic to turnip root or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Contact a doctor if you do not feel better while using Sefitude.
Children and young people
This medicine is not recommended for children under 12 years of age.
Other drugs and Sefitude
When contacting a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken Sefitude.
Sefitude with food, drink, and alcohol
There are no known effects of taking Sefitude with food or drink.
Pregnancy, breastfeeding, and fertility
In the absence of sufficient information, the use of Sefitude during pregnancy and lactation is not recommended.
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.
Driving and using machines
Sefitude may impair the ability to drive and use machines.
Therefore, if you feel affected, do not drive, or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Sefitude contains sucrose and maltodextrin
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Sefitude
Always take this medicine exactly as described in this leaflet or as directed by your doctor or other healthcare professional. If you are not sure, talk to your doctor, healthcare professional, or pharmacist.
To be swallowed.
The tablets should be swallowed whole with a little water. Do not chew the tablets.
The recommended dose for adults and the elderly are:
In case of mild anxiety: 1 tablet no more than 3 times daily.
In case of sleep disturbances: 1 tablet ½-1 hour before bedtime. If necessary, take 1 tablet earlier in the evening.
The recommended dose for adolescents 12–18 years is:
In case of mild anxiety: 1 tablet no more than 2 times daily.
In case of sleep disturbances: 1 tablet ½-1 hour before bedtime. If necessary, take 1 tablet earlier in the evening.
The maximum daily dose for adolescents 12–18 years is 2 tablets and for adults and the elderly 4 tablets.
Use for children and adolescents
Sefitude is not recommended for children under 12 years of age.
Usage time
This medicine should be taken regularly for 2 to 4 weeks to achieve the best effect.
If you use more Sefitude than you should
Symptoms of overdose (if you have taken more tablets than you should have) are fatigue, abdominal cramps, chest tightness, dizziness, trembling hands, and dilated pupils.
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.
If you forget to use Sefitude
If you forget to take a tablet, take the next dose at the usual time. It does not matter if you forget to take a dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Sefitude
You can stop taking this medicine at any time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with this medicine, gastrointestinal problems (eg nausea and abdominal pain) have been reported (occurring in an unknown number of users).
How to store Sefitude
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 and blister after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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 extracted from the root of the taproot.
- Each coated tablet contains 445 mg of extract (as a dry extract) from Valeriana officinalis L. (turnip root), root, corresponding to 1335-2670 mg of dried turnip root. Extractant: ethanol 70% (V / V).
- The other ingredients are maltodextrin, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, colloidal hydrated silica, talc, sucrose, calcium carbonate, spray-dried acacia rubber, titanium dioxide (E171), shellac, heavy kaolin, refined macro line, refined Rico.
What the medicine looks like and the contents of the pack
Round, white, convex, coated tablets, 11.5–13 mm in diameter.
The coated tablets are packaged in PVC / PVdC / Al blister packs, which are available in packs of 30, 45, or 60 coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Florealis EHF.
Síðumúla 25
108 Reykjavík
Iceland
email info@florealis.com
Manufacturer
Wiewelhove GmbH
Dörnebrink 19
D-49479 Ibbenbüren
Germany