Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VALERIANA OFFICINALIS
Phytomed (UK) Ltd
N05CM09
VALERIANA OFFICINALIS
Product not subject to medical prescription
Valerianae radix
Authorised
2017-10-06
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However you still need to use Kiwiherb Valerian carefully to get the best results from it. Keep this leaflet. You may want to read it again. Ask your healthcare professional, e.g. a doctor or pharmacist, if you need more information or advice. If the condition worsens or symptoms do not improve after 2 weeks, a qualified healthcare professional, e.g. a doctor or pharmacist, should be consulted. If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET? 1. What this product is and what it is used for 2. Before you take this product 3. How to take this product 4. Possible side effects 5. How to store this product 6. Further information 1. WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR Kiwiherb Valerian contains Valerian root extract (see section 6 for full details). Kiwiherb Valerian is a Traditional herbal medicinal product for relief of symptoms of mild mental stress and to aid sleep, exclusively based on long standing use. 2. BEFORE YOU TAKE THIS PRODUCT DO NOT TAKE THIS PRODUCT IF YOU ARE: • Allergic to Valerian or any other ingredients in this product (see section 6) • Under 18 years of age • Pregnant or breast feeding • Taking medicines known to interact with alcohol (e.g. metronidazole) • Already taking a medicine for sleep or anxiety TAKING OTHER MEDICINES Tell your healthcare professional, e.g. a doctor or pharmacist, if you are taking any other medicines including herbal medicines or medicines that did not require a prescription. DRIVING AND USING MACHINES This product may cause drowsiness. If affected, do not drive or operate machinery TAKE SPECIAL CARE WITH THIS PRODUCT This product contains alcohol (45% ethanol), i.e. up to 2.25 ml per 5 ml dose, (equivalent to 45 ml beer or 18.8 ml wine), and may be harmful to those suffering from alcoholism. To be taken in Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kiwiherb Valerian Oral Liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains 5ml liquid extract from_ Valeriana officinalis_ radix (corresponding to 2.5 g of valerian root) DER 1:2. Extraction solvent: ethanol 45% v/v. A maximum dose of 15ml contains up to 6.75ml ethanol. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral liquid. A brown liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kiwiherb Valerian is a Traditional herbal medicinal product for relief of symptoms of mild mental stress and to aid sleep, exclusively based on long standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral short term use only Adults and the elderly: To aid sleep: Take two or three 5ml spoonfuls half an hour before bedtime in a small amount of juice or water. To relieve symptoms of mild mental stress: Take one 5ml spoonful up to three times a day in a small amount of juice or water. Maximum daily dose: Three doses per day (total of 15 ml). This product is not recommended in patients less than 18 years. Duration of use: If the condition worsens or symptoms do not improve after 2 weeks, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted 4.3 CONTRAINDICATIONS Hypersensitivity to Valerian or any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The use of this product is not recommended in children and adolescents below the age of 18 years because data is not H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Read the complete document