Nervomix forte
Poland
Table of Contents
Patient Information Leaflet
NERVOMIX Forte, hard capsules
(Valerianae radix, Lupuli strobilus, Melissae folium, Hyperici herba)
Please read all of this leaflet carefully before taking this medicine, because it
contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or
as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If your symptoms do not improve or if you feel worse, consult your doctor.
Table of Contents
- What Nervomix Forte is and what it is used for
- Important information before taking Nervomix Forte
- How to take Nervomix Forte
- Possible side effects
- How to store Nervomix Forte
- Contents of the pack and other information
1. What Nervomix Forte is and what it is used for
Nervomix Forte is a herbal medicinal product with calming properties that facilitate sleep. Its active ingredients help relieve emotional tension and promote sleep onset.
This product is intended for traditional use in the indications mentioned, and its efficacy is based solely on long-term use and experience.
Indications
Traditionally used for temporary states of nervous unrest and sleep onset disorders.
2. Important information before using 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 does not tolerate valerian.
Warnings and precautions
During treatment, avoid exposure to ultraviolet radiation (sunbathing,
solarium). St. John's wort herb contained in the medicine may cause photosensitivity,
especially in individuals with fair skin.
If symptoms persist or worsen during treatment, consult a doctor.
Children and adolescents
Use in children under 12 years of age is not recommended.
Nervomix Forte and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken,
as well as any medicines you plan to use.
Do not take together with other sedatives or with theophylline, cyclosporine,
warfarin, digoxin, oral contraceptives, and alcohol.
If you are taking any of the listed medicines or other prescription medicines,
consult your doctor or pharmacist before using Nervomix Forte.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or
is planning to have a child, she should consult a doctor or pharmacist before
using this medicine.
This medicine should not be used during pregnancy and breastfeeding.
Driving and operating machinery
This medicine may impair psycho-physical performance and the ability to drive
mechanical vehicles or operate moving machinery. Therefore, it is not recommended
to take the medicine before driving or operating machinery.
3. How to use Nervomix Forte
This medicine should always be taken exactly as described in the patient leaflet or
as directed by a doctor or pharmacist. In case of doubt, consult a doctor
or pharmacist.
Recommended dose
Adults and adolescents from 12 years of age: 2–4 capsules three times daily, depending on symptom severity, taken with at least 1/2 glass of liquid; do not chew.
Do not exceed a total daily dose of 12 capsules.
As an aid to sleep, take a single dose (2–4 capsules) half an hour to one hour before bedtime.
Children under 12 years of age: Not recommended.
Duration of use:
Do not use for longer than 3 weeks.
If symptoms persist or worsen during treatment, consult a doctor.
Overdose of Nervomix Forte:
Due to the presence of St. John's wort herb, taking more than the recommended dose may
cause photosensitivity, especially in individuals with fair skin.
Missed dose of Nervomix Forte:
Missing a dose does not affect the course of ongoing treatment.
Do not take a double dose to make up for a missed dose.
4. Possible adverse effects
Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
Adverse effects occur rarely at recommended doses. Occasionally, symptoms of intolerance to valerian root, gastrointestinal disturbances, feeling of fatigue, or light sensitivity in fair-skinned individuals may occur – in such cases, discontinue use of the product.
If symptoms do not resolve, consult a doctor.
Reporting adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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: [email protected]
Reporting adverse effects helps to gather further information on the safety of using this medicine.
5. How to store Nervomix Forte
Keep the medicine out of sight and reach of children.
Store in a dry place at a temperature not exceeding 25 °C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
6. Contents of the pack and other information
What Nervomix Forte contains
- The active substances are: Valerianae radix, Lupuli strobilus, Melissae folium, Hyperici herba. Each capsule contains respectively: Valerianae radix 210 mg, Lupuli strobilus 52.5 mg, Melissae folium 52.5 mg, Hyperici herba 35 mg.
- Other ingredients: titanium dioxide E 171, erythrosine E 127, indigo carmine E 132, gelatin.
What Nervomix Forte looks like and contents of the pack
Hard capsules
The capsules are packed in PVC/PVDC blisters lidded with Al foil, placed in a cardboard box.
The pack contains 20 or 60 hard capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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