Sedisleep film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sedisleep film-coated tablets
Dry extract of valerian root
Read this entire leaflet carefully before starting to take this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or further information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
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You should consult a doctor if your condition worsens or if you do not improve after 14 days.
Contents of the leaflet
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What Sedisleep is and what it is used for
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What you need to know before taking Sedisleep
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How to take Sedisleep
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Possible adverse effects
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Storage of Sedisleep
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Contents of the pack and other information
1. What Sedisleep is and what it is used for
Sedisleep is a herbal medicinal product intended for adults and adolescents over 12 years of age, used for the relief of mild nervous tension and sleep disorders.
2. What you need to know before starting to take Sedisleep
Do not take Sedisleep:
- if you are allergic to valerian or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Sedisleep.
Children
The use of this medicine is not recommended in children under 12 years of age due to lack of data.
Taking Sedisleep with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The use of Sedisleep is not recommended if you are taking synthetic sedatives.
Taking Sedisleep with food and drink
Not applicable.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Due to insufficient data to rule out any adverse effects during pregnancy and breastfeeding, the use of this medicine is not recommended during these periods.
Driving and using machines
Sedisleep is a medicine that may cause drowsiness. Do not drive or operate machinery if you feel sleepy or if your attention and reaction capacity are reduced.
3. How to take Sedisleep
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, elderly patients, and adolescents aged 12 years and older is:
For relief of mild nervous tension: 1 tablet up to 3 times daily.
For relief of sleep disorders: 1 tablet taken half to one hour before bedtime; if necessary, an additional dose may be taken during the afternoon.
Do not take more than 4 tablets per day.
Use in children
This medicine is not recommended for children under 12 years of age.
The tablets should be swallowed whole with a small amount of water. They must not be chewed.
A continuous treatment period of 2 to 4 weeks is recommended to achieve optimal therapeutic 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 taken too much Sedisleep, contact your doctor or pharmacist immediately.
Excessive intake of this medicine may cause symptoms such as fatigue, abdominal cramps, chest tightness, dizziness, hand tremors, and pupillary dilation. If these symptoms occur, consult your doctor.
If you forget to take Sedisleep
Do not take a double dose to make up for missed doses.
If you stop taking Sedisleep
Discontinuation of this medicine should not cause adverse effects. However, the symptoms for which you started taking this medicine may reappear.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Valerian preparations may cause gastrointestinal disturbances, such as nausea or abdominal cramps. It is not known how frequently these effects occur.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es .
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sedisleep
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect it from moisture.
This medicine does not require any special storage conditions regarding temperature.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Sedisleep
The active substance is dry valerian root extract. Each film-coated tablet contains 500 mg of dry extract of Valeriana officinalis L., radix (equivalent to 2 g - 3 g of valerian root).
Extraction solvent: ethanol 60% (V/V).
The other components are:
Tablet core: 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 pack
Grey, 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 commercially available.
Marketing Authorization Holder and Manufacturer
Tilman s.a., Z.I. Sud 15, 5377 Baillonville, Belgium
Local Representative:
NUTRICIÓN MÉDICA, S.L. Arequipa St., 1 – 28043 Madrid, Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Belgium, Luxembourg, Cyprus: Sedistress Sleep
Spain: Sedisleep
Finland, Norway, Sweden: Lunixen
Date of the most recent review of this leaflet: April 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/