Package leaflet: Information for the user

Valeriana Vemedia 450 mg coated tablets

Dry extract of root of Valeriana officinalis (3-6:1)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 14 days.

Contents of this leaflet:

What Valeriana Vemedia is and what it is used for
What you need to know before taking Valeriana Vemedia
How to take Valeriana Vemedia
Possible side effects
How to store Valeriana Vemedia
Contents of the pack and other information

1. What Valeriana Vemedia is and what it is used for

Valeriana Vemedia is a herbal medicinal product for the relief of mild nervous tension and sleep disturbances.
Valeriana Vemedia is indicated in adults and children over 12 years of age.

2. What you should know before taking Valeriana Vemedia

Do not take Valeriana Vemedia
if you are allergic to valerian or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Consult your doctor if symptoms persist for more than 2 weeks or worsen.

Children
The use of Valeriana Vemedia is not recommended in children under 12 years of age.

Other medicines and Valeriana Vemedia
Do not take Valeriana Vemedia together with medicines that cause drowsiness (e.g. synthetic sedatives).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Valeriana Vemedia with food and drinks
Taking Valeriana Vemedia with or without food does not affect the medicine's effect in any way.
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Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Valeriana Vemedia during pregnancy or breastfeeding. There are no safety data available on the use of Valeriana Vemedia during pregnancy or breastfeeding.
Consult your doctor or pharmacist before taking any medicine.

Driving and use of machinery
Valeriana Vemedia may cause drowsiness. Do not drive or operate tools or machinery if you experience this effect.

Valeriana Vemedia contains glucose and sucrose
Valeriana Vemedia contains glucose (103 mg per tablet) and sucrose (268 mg per tablet).
If your doctor has diagnosed you with an intolerance to certain sugars, please contact him/her before taking this medicine.

Valeriana Vemedia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Valeriana Vemedia

For oral use.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults and children over 12 years of age is:

For relief of mild nervous tension: 1 tablet three times a day.
For sleep disturbances: 1 tablet between half an hour and one hour before going to bed; if necessary, an additional tablet may be taken earlier in the evening.

Maximum daily dose: 4 tablets.
Use in children
Valeriana Vemedia is not recommended for children under 12 years of age.
The tablets should be swallowed whole with a little water. Do not chew the tablets.
If symptoms persist after 2 weeks of treatment, consult your doctor.
If you take more Valeriana Vemedia than you should
Contact your doctor or pharmacist if you have taken more than the recommended dose and bring this leaflet with you. Generally, no adverse effects occur if you take 1 or 2 tablets more than the recommended dose.
Symptoms of overdose (which may occur if you take more tablets than recommended) include: fatigue, abdominal cramps, chest tightness, dizziness, hand tremors, and pupil dilation (mydriasis).
If you forget to take Valeriana Vemedia
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If you forget to take a tablet, continue your treatment by taking the next tablet at the usual time. It is not a problem if you have missed one dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Valeriana Vemedia
You may stop taking this medicine at any time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
During treatment with this medicine, gastrointestinal symptoms may occur, for example nausea or abdominal pain. The frequency of such side effects is unknown.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valeriana Vemedia

Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after "Scad."
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Valeriana Vemedia contains

The active substance is dried extract of the root of Valeriana officinalis. Each coated tablet contains 450 mg of dried extract (DER 3-6:1) of Valeriana officinalis L., root (equivalent to 1350-2700 mg of valerian root). Extraction solvent: ethanol 70% (V/V).
The other components are: Tablet core: liquid glucose (dried by spray-drying), anhydrous colloidal silica, powdered cellulose, croscarmellose sodium, stearic acid and talc. Tablet coating: sucrose, talc, calcium carbonate (E 170), acacia, tragacanth gum, titanium dioxide (E 171), liquid glucose (dried by spray-drying), Capol 600 T.S. (containing white beeswax, carnauba wax and shellac).

Description of the appearance of Valeriana Vemedia and package contents
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Valeriana Vemedia is a white, shiny, round, biconvex coated tablet. The tablets are supplied in PVC/PVDC-Alu blisters and available in packs of 10, 20, 30, 40 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
NL-1112 AX Diemen
The Netherlands

Marketing Authorization Holder in Italy
Vemedia Pharma S.r.l – Parma

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Vemedia Valeriaan 450 mg, omhulde tabletten
France: VALERIANE VEMEDIA, comprimé enrobé
Italy: Valeriana Vemedia 450 mg compresse rivestite
Greece: Valemarex 450 mg, επικαλυμμένα δισκία
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