Nervikan film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT:
Nervikán coated tablets
Extract of Valeriana officinalis
Extract of Melissa officinalis
Read the 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.
Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 14 days.
Contents of the leaflet:
- What Nervikán is and what it is used for
- What you need to know before taking Nervikán
- How to take Nervikán
- Possible adverse effects
- How to store Nervikán
- Contents of the pack and other information
1. What Nervikán is and what it is used for
Nervikán belongs to a group of medicines called central nervous system hypnotics and sedatives.
This medicine is indicated for the symptomatic treatment of temporary, mild states of nervousness and occasional difficulty in 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), to the leaves of Melissa officinalis (Lemon balm), or to any of the other components of the medicine (listed in section 6.).
Warnings and precautions:
Do not administer for more than 14 consecutive days without consulting your doctor.
If symptoms worsen or persist for more than 2 weeks, consult your doctor.
Children and adolescents
Nervikán must not be used in children under 12 years of age due to lack of data on safety and efficacy.
Other medicines and Nervikán
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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.
There are no data available on the influence of Nervikán on fertility.
Driving and using machines
This product may affect your ability to drive or operate machinery. If you are affected, do not drive or operate machinery.
Nervikán contains sucrose
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Nervikán contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; essentially "sodium-free".
3. How to take Nervikán
Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Recommended dose:
Adults and children over 12 years:
Nervousness: 1 tablet three times a day.
Sleep induction: 2 tablets 30–60 minutes before bedtime. If necessary, an additional 1 tablet in the afternoon.
Elderly:
Same as for adults.
The tablets should be swallowed whole, without chewing, with plenty of water, preferably after meals.
Use in children and adolescents
Do not administer to children under 12 years of age without consulting a doctor.
If you take more Nervikán than you should
In cases of overdose or accidental ingestion of large quantities, seek medical attention immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Nervikán:
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur. Frequency is unknown.
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 via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Nervikán
Keep this medicine out of the sight and reach of children.
Store in a dry place and below 30°C.
Do not use this medicine after the expiry date indicated on the carton after Exp.: The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point located at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Nervikán:
The active substances 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, colourants: titanium dioxide (E-171), indigo carmine (E-132).
Appearance of the medicinal product and contents of the pack:
Blue tablets. Nervikán is available in cardboard boxes containing 50 and 60 tablets in PVC/PVDC and aluminium blisters.
Marketing Authorisation Holder and Manufacturer:
Dr. Willmar Schwabe GmbH & Co.
Willmar-Schwabe-Straße 4
76227 Karlsruhe / Germany
You can request further information regarding this medicinal product by contacting the local representative of the Marketing Authorisation Holder:
SCHWABE FARMA IBÉRICA, S.A.U.
Avenida de la Industria, 4. Building 2, staircase 1, 2nd floor.
28108 Alcobendas, Madrid.
Date of the most recent review of this leaflet: December 2023.
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/