Sedogelat

Sedogelat Forte film-coated tablets

Sedogelat Forte is a traditional herbal medicinal product used for restlessness and nervous sleep disorders.

Application

What is Sedogelat Forte and what is it used for?

Sedogelat Forte is a traditional herbal medicinal product containing dry extracts of valerian root and lemon balm leaves.

Sedogelat Forte is used for restlessness and nervous sleep disorders.

The use of this traditional herbal medicinal product in the aforementioned
areas of application is based exclusively on many years of use.

If you do not feel better or even worse after 2 weeks, consult your doctor.

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How is it applied?

What is Sedogelat and what is it used for?

Sedogelat Forte is a traditional herbal medicinal product used for restlessness and nervous disorders of falling asleep and sleeping through.

This medicinal product is a traditional herbal medicinal product registered exclusively on the basis of long-standing use for the above-mentioned indications.

This medicine is used in adults and adolescents aged 12 years and over.

If you do not feel better or even worse after 2 weeks, consult your doctor.

What should you pay attention to before taking it?

What should you watch out for when taking Sedogelat?

Sedogelat Forte must not be used
- if you are allergic to valerian, lemon balm or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Sedogelat Forte.

Children
Use in children under 12 years of age is not recommended as insufficient data are available.
Use Sedogelat Forte with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor for advice before taking this medicine.

Since there are insufficient data, the use during pregnancy and breastfeeding cannot be recommended.

Driving and ability to operate machinery

Caution: this medicinal product may impair reactions and driving ability.
Affected persons should not actively participate in road traffic, operate machinery or perform or participate in dangerous activities.

Sedogelat Forte contains glucose syrup
Please only take Sedogelat Forte after consulting your doctor if you are known to suffer from a sugar intolerance.

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How should the medicine be taken?

How to take Sedogelat?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

adults and adolescents aged 12 years and over
For restlessness: 1-2 film-coated tablets 3 to 4 times daily.
For sleep disorders: 1- 2 film-coated tablets half an hour to an hour before bedtime.
Do not take more than 8 film-coated tablets daily.

Children
Use in children under 12 years of age is not recommended as insufficient data are available.

How to use
To take
Take the film-coated tablets unchewed with a little water.

Duration of use

If you do not feel better or even worse after 2 weeks, consult your doctor.

If you have used a larger amount of Sedogelat Forte than you should

The following has been observed with a dose of approx. 20 g valerian root (which would correspond to approx. 54 film-coated tablets): Fatigue, abdominal cramps, chest tightness, drowsiness, trembling of the hands and pupil dilation. These complaints had subsided after 24 hours. In case of significant overdose, you must consult a doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Sedogelat?

Do not store above 30 °C.

Keep this medicine out of the reach of children.
You must not use this medicine after the expiry date which is stated on the outer carton after "Use by:" and on the blister after "Expiry date:". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

HOW TO STORE SEDOGELATE FORTE?

Do not store above 30°C.

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after (use by:). The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Sedogelat Forte contains
- The active ingredients are: Dry extracts of valerian root and lemon balm leaves

1 film-coated tablet contains:
72 mg dry extract of valerian root (Valerianae radix, drug extract ratio 3-6:1, extracting agent: 70% ethanol V/V)
72 mg dry extract of lemon balm leaves (Melissae folium, drug extract ratio 4-6:1, extracting agent: 30% methanol V/V).

- The other ingredients are: Glucose syrup (spray-dried), microcrystalline cellulose, carboxymethyl starch - sodium (type A), highly dispersed silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose, stearic acid, Betadex, iron oxide yellow (E172), iron oxide red (E172) and vegetable charcoal (E153).

What Sedogelat Forte looks like and contents of the pack

Sedogelat Forte are brown, round film-coated tablets, domed on both sides, and are available in PVC/PE/PVDC aluminium blister packs of 30 and 60. Not all package sizes may be placed on the market.