Leaflet: information for the user

Sedisleep coated tablets

Dried extract ofvalerian root

Read this leaflet carefully before you start taking thismedicine, because it contains important informationfor you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• Ifyou experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

• You should consult a doctor if you get worse or do not improveafter 14 days.

1.What Sedisleep is and what it is used for

2.What you need to knowbeforestarting totake Sedisleep

3.How to take Sedisleep

4.Possible side effects

5Storage of Sedisleep

6.Contents of the pack and additional information

Sedisleep is a plant-based medication indicated for adults and adolescents over 12 years old for the relief of mild nervous tension and sleep disorders.

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 use in children under 12 years due to lack of data.

Taking Sedisleep with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This medication is not recommended if you are taking synthetic sedatives.

Taking Sedisleep with food and drinks

Not applicable.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Lack of sufficient data to rule out any adverse effects during pregnancy and breastfeeding, this medication is not recommended during these periods.

Driving and operating machines

Sedisleep is a medication that can cause drowsiness. Do not drive or operate machines if you feel drowsy or notice that your attention and reaction time are reduced.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose for adults, elderly people, and adolescents 12 years and older is:

For mild nervous tension relief, 1 tablet up to 3 times a day.

For sleep disorder relief, 1 tablet 30 minutes to 1 hour before bedtime, if necessary, a dose can be taken in the afternoon.

Do not take more than 4 tablets a day.

Use in children

This medication is not recommended for use in children under 12 years.

Tablets should be swallowed whole with a little water. They should not be chewed.

It is recommended to use this medication continuously for 2 to 4 weeks to achieve 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 may cause symptoms such as fatigue, abdominal cramps, chest tightness, dizziness, hand tremors, and dilated pupils. If these symptoms appear, consult your doctor.

If you forget to take Sedisleep

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Sedisleep

Stopping this medication should not cause adverse 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Valerian preparations may cause gastrointestinal disturbances, such as nausea or abdominal cramps. The frequency of these effects is unknown.

Reporting 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 prospectus. You may also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter the CAD abbreviation. 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 thrown away through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthepackaging and themedications you no longerneed. In this way, you will help protect the environment.

Composition of Sedisleep

The active principle is the dry extract of valerian root. Each film-coated tablet contains 500 mg of dry extract ofValeriana officinalisL., 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:polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, aluminium lake of indigo carmine (E132), red iron oxide (E172), black iron oxide (E172).

Appearance of the product and content of the packaging

Blue clear film-coated tablets, oblong, biconvex, 18 x 7 mm.

PVC/PE/PVDC/aluminium blisters in packs of 28 or 56 tablets. Some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Tilman s.a., Z.I. Sud 15, 5377 Baillonville, Belgium

Local Representative:

NUTRICIÓN MÉDICA, S.L. C/ Arequipa, 1 – 28043 Madrid

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Belgium, Luxembourg, Cyprus: Sedistress Sleep

Spain: Sedisleep

Finland, Norway, Sweden: Lunixen

Date of the last review of this leaflet:May 2019

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/