Valeriaan Sandoz, omhulde tabletten

Land: Nederländerna

Språk: nederländska

Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiva substanser:

VALERIANA OFFICINALIS WORTEL, DROOG EXTRACT (ETHANOL-WATER 70-30) (3-6 = 1)

Tillgänglig från:

Sandoz B.V.

ATC-kod:

N05CM09

INN (International namn):

VALERIANA OFFICINALIS ROOT DRY EXTRACT (ETHANOL-WATER 70-30) (3-6 = 1)

Läkemedelsform:

Omhulde tablet

Sammansättning:

, , , , , , ,

Administreringssätt:

Oraal gebruik

Terapiområde:

Valerianae radix

Produktsammanfattning:

Hulpstoffen:

Tillstånd datum:

2016-06-14

Bipacksedel

v3
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALERIAAN SANDOZ, OMHULDE TABLETTEN
Dry extract of valerian root (3-6:1)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 told to you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse after 14
days of continuous use.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is a herbal medicine which is used for the
relief of
sleep disorders (like insomnia or difficulty in falling asleep) and
mild nervous
tension (like mental strain, restlessness and irritability).
You must talk to a doctor if you do not feel better or if you feel
worse after using
[Nationally completed name] for 14 days continuously.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]

if you are allergic to valerian extract or any of the other
ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking [Nationally completed
name].
CHILDREN AND ADOLESCENTS
The use of [Nationally completed name] is not recommended in children
under 12
years of age, as there is little experience available in this age
group.
v3
OTHER MEDICINES AND [NATIONALLY COMPLETED NAME]
Tell your doctor or p

Produktens egenskaper

SANDOZ
Business use only
Page 1 of 5
1.3.1 spc-label-pl - common-spc - 6,786
(NL/H/3418/001/DC)
20160601
VALERIANA OFFICINALIS 445 MG COATED TABLET
722-2395.00
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VALERIAAN SANDOZ OMHULDE TABLET
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 445 mg of extract (as dry extract) from
_Valeriana officinalis_
L. s.l., radix
(valerian root) (3-6:1),
Extraction solvent Ethanol 70% (V/V)
Excipient with known effect: 95.6 mg Sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
coated tablet
round, white convex coated tablets
with a diameter of 12 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Herbal medicinal product for the relief of sleep disorders and mild
nervous tension.
Valeriaan Sandoz is indicated in adolescents over 12 years of age,
adults and elderly.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adolescents over 12 years of age, adults and elderly _
For relief of mild nervous tension one coated tablet up to 3 times
daily.
For relief of sleep disorders, a single coated tablet half to one hour
before bedtime with an earlier
dose during the evening if necessary.
Maximum daily dose: 4 coated tablets
Duration of use:
Because of its gradual onset of efficacy valerian root is not suitable
for acute interventional
treatment of mild nervous tension or sleep disorders. To achieve an
optimal treatment effect,
continued use over 2 – 4 weeks is recommended.
If symptoms persist or worsen after 2 weeks of continued use, a doctor
should be consulted.
_Paediatric population _
The safety and efficacy of Valerian coated tablet in children under 12
years of age have not yet been
established. No data are available.
Method of administration
SANDOZ
Business use only
Page 2 of 5
1.3.1 spc-label-pl - common-spc - 6,786
(NL/H/3418/001/DC)
20160601
VALERIANA OFFICINALIS 445 MG COATED TABLET
722-2395.00
For oral use.
The coated tablets should be taken with a sufficient amount of cold
liquid (preferably a g