Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VALERIANA OFFICINALIS WORTEL, DROOG EXTRACT (ETHANOL-WATER 70-30) (3-6 = 1)
Sandoz B.V.
N05CM09
VALERIANA OFFICINALIS ROOT DRY EXTRACT (ETHANOL-WATER 70-30) (3-6 = 1)
Omhulde tablet
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Oraal gebruik
Valerianae radix
Hulpstoffen:
2016-06-14
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 Baca dokumen lengkapnya
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 Baca dokumen lengkapnya