Nervomix Forte

Leaflet attached to the packaging: patient information

NERVOMIX Forte, hard capsules

(Valerianae radix, Lupuli strobilus, Melissae folium, Hyperici herba)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

• 1. What is Nervomix Forte and what is it used for
• 2. Important information before taking Nervomix Forte
• 3. How to take Nervomix Forte
• 4. Possible side effects
• 5. How to store Nervomix Forte
• 6. Package contents and other information

1. What is Nervomix Forte and what is it used for

A herbal product with a calming effect, facilitating sleep. The active substances contained in it soothe emotional tension states and facilitate sleep. The product is intended for traditional use in the indicated indications and its effectiveness is based solely on a long period of use and experience.

Indications for use

Traditionally used in transient states of nervous overexcitement, sleep disorders.

2. Important information before taking Nervomix Forte

When not to take Nervomix Forte

• -if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• -if the person is intolerant to valerian.

Warnings and precautions

During treatment with the medicine, exposure to ultraviolet radiation (sunbathing, solarium) should be avoided. The St. John's Wort herb contained in the medicine may cause hypersensitivity to light, especially in people with fair skin. If the symptoms persist during treatment with the medicine or worsen, the doctor should be consulted.

Children and adolescents

The use of the preparation is not recommended in children under 12 years of age.

Nervomix Forte and other medicines

The doctor or pharmacist should be informed about all medicines taken by the patient currently or recently, as well as about medicines that the patient plans to take. Do not take with other sedative medicines and with theophylline, cyclosporine, warfarin, digoxin, oral contraceptives, and alcohol. In the case of taking the mentioned medicines or other prescription medicines, the doctor or pharmacist should be consulted before taking Nervomix Forte.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine. The preparation should not be used during pregnancy and breastfeeding.

Driving and operating machinery

The preparation may impair psychophysical fitness, the ability to drive vehicles and operate machinery in motion, so it is not recommended to take the preparation before planned driving or operating machinery.

3. How to take Nervomix Forte

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.

Recommended dose

Adults and adolescents from 12 years of age: 2-4 capsules 3 times a day, depending on the severity of symptoms, with at least 1/2 glass of liquid, without chewing. Do not take more than a total of 12 capsules in 24 hours. As a means of facilitating sleep, a single dose (2-4 capsules) should be taken 30 minutes to 1 hour before sleep. Children under 12 years of age: The use of the preparation is not recommended.

Duration of treatment:

It is not recommended to use the preparation for more than 3 weeks. If the symptoms persist during treatment with the medicine or worsen, the doctor should be consulted. Taking a higher dose of Nervomix Forte than recommended: Due to the content of St. John's Wort, taking a higher dose of the medicine may cause hypersensitivity to light, especially in people with fair skin.

Missing a dose of Nervomix Forte

Missing a dose of the medicine has no effect on the course of the therapy. A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. At the recommended doses, side effects are rare. Occasionally, symptoms of intolerance to valerian root, gastrointestinal disorders, fatigue, hypersensitivity to light in people with fair skin may occur - in this case, the use of the preparation should be discontinued. If the symptoms do not disappear, the doctor should be consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nervomix Forte

The medicine should be stored out of sight and reach of children. Store in a dry room at a temperature not exceeding 25°C. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.

6. Package contents and other information

What Nervomix Forte contains

• The active substances of the medicine are: Valerianae radix, Lupuli strobilus, Melissae folium, Hyperici herba.One capsule contains respectively: Valerianae radix210 mg, Lupuli strobilus52.5 mg, Melissae folium52.5 mg, Hyperici herba35 mg.
• Other ingredients are: titanium dioxide E 171, erythrosine E 127, indigo carmine E 132, gelatin.

What Nervomix Forte looks like and what the package contains

Hard capsules. The capsules are packaged in PVC/PVDC blisters covered with Al foil in a cardboard box. The package contains 20 or 60 hard capsules.

Responsible entity and manufacturer

Responsible entity

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Date of last update of the leaflet: