PATIENT INFORMATION LEAFLET:

Nervikán coated tablets

Extract ofValeriana officinalis

Extract ofMelissa officinalis

Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the administration instructions contained in this leaflet or those given 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.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You must consult a doctor if your condition worsens or does not improve after 14 days.

1. What isNervikánand what it is used for

2. What you need to know before starting to takeNervikán

3. How to takeNervikán

4. Possible side effects

5. Storage ofNervikán

6. Contents of the pack and additional information

Nervikánbelongs to the group of medications known as central nervous system hypnotics and sedatives.

This medication is indicated for the symptomatic treatment of temporary and mild states of nervousness and occasional difficulty falling asleep of nervous origin.

Consult a doctor if symptoms worsen or do not improve after 14 days.

Do not take Nervikán

If you are allergic to the root ofValeriana officinalis(Valerian), the leaves ofMelissa officinalis(Melissa) or any of the other components of the medication (listed in section 6).

Warnings and precautions:

Do not administer for more than 14 consecutive days without consulting a doctor.

If symptoms worsen or persist for more than 2 weeks, consult your doctor.

Children and adolescents

Nervikánshould not be used in children under 12 years due to a lack of data on safety and efficacy.

Other medications and Nervikán

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

As a general precaution, and due to the lack of data on its use during pregnancy and breastfeeding, its use is not recommended in these situations.

No data are available on the influence of Nervikán on fertility.

Driving and operating machinery

This product may affect your ability to drive or operate machinery. If affected, do not drive or operate machinery.

Nervikán contains saccharose

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Nervikán contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; essentially "sodium-free".

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

This medication is taken orally.

The recommended dose is:

Adults and children over 12 years:

Anxiety: 1 tablet 3 times a day

Sleep inducer: 2 tablets 30 – 60 minutes before bedtime. If necessary, 1 tablet more in the afternoon.

Seniors:

The same as for adults.

The tablets should be swallowed whole, without chewing and with plenty of water, preferably after meals.

Use in children and adolescents

Do not administer to children under 12 years without consulting a doctor.

If you take more Nervikán than you should

In cases of overdose or accidental ingestion of large quantities, go to a medical center immediately or call the Toxicological Information Service at tel.: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Nervikán:

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

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

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may appear. Frequency 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 can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. http://www.notificaram.es. Reporting adverse effects can help provide more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in a dry place and below 30° C.

Do not use this medication after the expiration date that appears on the box after Expiration Date:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Nervikán:

The active principles are, per each tablet:

160 mg of dry extract, obtained with 70% v/v ethanol, of Valeriana officinalis root (Valeriana) equivalent to 480 – 960 mg of dry Valeriana root, and

80 mg of dry extract, obtained with 36% v/v ethanol, of Melissa officinalis leaves (Melisa), equivalent to 320 – 480 mg of dry Melisa leaves.

The other components (excipients) are: sucrose, anhydrous colloidal silica, crospovidone, hydrogenated ricin oil, microcrystalline cellulose, magnesium stearate, talc, hypromellose, stearic acid, vanilla, sodium saccharin, simethicone, methylcellulose, sorbic acid, colorants: titanium dioxide (E-171), indigo carmine (E-132).

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Appearance of the product and content of the packaging:

Blue tablets. Nervikán is presented in cardboard boxes containing 50 tablets in PVC/PVDC and aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing:

Dr. Willmar Schwabe GmbH & Co.

Willmar-Schwabe-Stra?e 4

76227 Karlsruhe / Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

SCHWABE FARMA IBÉRICA, S.A.U.

Avenida de la Industria, 4. Edificio 2, escalera 1, 2nd floor.

28108 Alcobendas, Madrid.

Last review date of this leaflet: December 2023.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/