NERVIKAN COMPRESSED COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT:

Nervikán coated tablets

Extract ofValeriana officinalis

Extract ofMelissa officinalis

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:

1. What Nervikán is and what it is used for
2. What you need to know before taking Nervikán
3. How to take Nervikán
4. Possible side effects
5. Storage of Nervikán
6. Package contents and additional information

1. What Nervikán is and what it is used for

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

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

You should consult a doctor if your condition worsens or does not improve after 14 days.

2. What you need to know before taking Nervikán

Do not take Nervikán

If you are allergic to the root of Valeriana officinalis(Valerian), the leaves of Melissa officinalis(Lemon balm), 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 of age due to the lack of data on safety and efficacy.

Other medications and Nervikán

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

Pregnancy, breastfeeding, and fertility

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.

As a general precaution, and since there is no data on its use during pregnancy and breastfeeding, its use is not recommended in these situations.

There is no data on the influence of Nervikán on fertility.

Driving and using machines

This product may affect your ability to drive or use machines. If you are affected, do not drive or use machines.

Nervikán contains sucrose

This medication contains sucrose. If your doctor has told you 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; it is essentially "sodium-free".

3. How to take Nervikán

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

This medication is for oral use.

The recommended dose is:

Adults and children over 12 years:

Nervousness: 1 tablet 3 times a day

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

Elderly:

Same as adults.

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 Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Nervikán:

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Gastrointestinal symptoms (e.g., nausea, abdominal cramps) may appear. The frequency is unknown.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications. http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Nervikán

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 shown on the box after "Expiration Date:". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Nervikán:

The active ingredients are, per tablet:

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

80 mg of dry extract, obtained with 36% v/v ethanol, from the leaves of Melissa officinalis(Lemon balm), equivalent to 320-480 mg of dry Lemon balm leaves.

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

Appearance of the product and package contents:

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

Marketing authorization holder and manufacturer:

Dr. Willmar Schwabe GmbH & Co.

Willmar-Schwabe-Straße 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, 2ª planta.

28108 Alcobendas, Madrid.

Date of the last revision of this package leaflet: December 2023.

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/