SEDISLEEP FILM-COATED TABLETS
How to use SEDISLEEP FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
Show originalContents of the leaflet
Introduction
Package Leaflet: Information for the User
Sedisleep Film-Coated Tablets
Dry Extract of Valerian Root
Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.
- Keep this package leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 14 days.
Contents of the Package Leaflet
- What Sedisleep is and what it is used for
- What you need to know before taking Sedisleep
- How to take Sedisleep
- Possible side effects
5 Conservation of Sedisleep
- Contents of the packaging and additional information
1. What Sedisleep is and what it is used for
Sedisleep is a herbal medicine indicated for adults and adolescents over 12 years old for the relief of mild nervous tension and sleep disorders.
2. What you need to know before taking Sedisleep
Do not take Sedisleep:
- if you are allergic to valerian or any of the other components of this medication (listed in section 6).
Warnings and Precautions
Consult your doctor or pharmacist before starting to take Sedisleep.
Children
This medication is not recommended for children under 12 years old due to lack of data.
Taking Sedisleep with other medications
Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
Sedisleep is not recommended if you are taking synthetic sedatives.
Taking Sedisleep with food and beverages
Not applicable.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
Due to the lack of sufficient data to rule out any adverse effects during pregnancy and breastfeeding, the use of this medication is not recommended during these periods.
Driving and Using Machines
Sedisleep is a medication that can cause drowsiness. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced.
3. How to take Sedisleep
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.
The recommended dose for adults, elderly, and adolescents from 12 years old is:
For the relief of mild nervous tension, 1 tablet up to 3 times a day.
For the relief of sleep disorders, 1 tablet half an hour to an hour before bedtime, if necessary, a dose can be taken in the afternoon.
Do not take more than 4 tablets per day.
Use in Children
This medication is not recommended for children under 12 years old.
Tablets should be swallowed whole with a little water. They should not be chewed.
Continuous use for 2 to 4 weeks is recommended to achieve an optimal treatment effect.
If symptoms persist or worsen after 2 weeks of continuous use, consult a doctor.
If you take more Sedisleep than you should
If you have ingested too much Sedisleep, contact your doctor or pharmacist immediately.
Excessive intake of this medication can cause symptoms such as fatigue, abdominal cramps, chest tightness, dizziness, tremors in the hands, and pupil dilation. If these symptoms appear, consult your doctor.
If you forget to take Sedisleep
Do not take a double dose to make up for forgotten doses.
If you stop taking Sedisleep
Stopping the intake of this medication should not cause side effects. However, the symptoms that led you to take this medication may reappear.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medications, this medication can cause side effects, although not everyone experiences them.
Valerian preparations can cause gastrointestinal disorders, such as nausea or abdominal cramps. The frequency of these effects is unknown.
Reporting Side Effects
If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es.
By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Sedisleep
Keep this medication out of sight and reach of children.
Do not use this medication after the expiration date shown on the box after the abbreviation CAD. The expiration date is the last day of the month indicated.
Store in the original packaging to protect it from moisture.
This medication does not require special temperature conditions for storage.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Contents of the Packaging and Additional Information
Composition of Sedisleep
The active ingredient is dry extract of valerian root. Each film-coated tablet contains 500 mg of dry extract of Valeriana officinalisL., radix (equivalent to 2 g - 3 g of valerian root).
Extraction solvent: ethanol 60% (V/V).
The other components are:
Core of the tablet:microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized starch, anhydrous colloidal silica, magnesium stearate.
Film coating:hypromellose, stearic acid, microcrystalline cellulose, black iron oxide.
Appearance of the Product and Contents of the Packaging
Gray, oblong, biconvex film-coated tablets, 18 x 7 mm.
PVC/PE/PVDC/aluminum blisters in packs of 28 or 56 tablets. Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Tilman s.a., Z.I. Sud 15, 5377 Baillonville, Belgium
Local Representative:
NUTRICIÓN MÉDICA, S.L. C/ Arequipa, 1 – 28043 Madrid
This medication is authorized in the Member States of the European Economic Area under the following names:
Belgium, Luxembourg, Cyprus: Sedistress Sleep
Spain: Sedisleep
Finland, Norway, Sweden: Lunixen
Date of the Last Revision of this Package Leaflet:April 2025
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Dosage formTABLET, 500 mg
- ATC codeN05CM09
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to SEDISLEEP FILM-COATED TABLETSDosage form: TABLET, 125 mg dry valerian extractActive substance: Valerianae radixManufacturer: Vemedia Pharma Hispania S.A.Prescription not requiredDosage form: ORAL SOLUTION/SUSPENSION, 94.2 MG/ML valerian rootActive substance: Valerianae radixManufacturer: Vemedia Pharma Hispania S.A.Prescription not requiredDosage form: TABLET, 200 mg/68 mgActive substance: Valerianae radixManufacturer: Vemedia Manufacturing B.V.Prescription not required
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