Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Devil's claw extract (as dry root)
Lamberts Healthcare Limited
Devil's claw extract (as dry root)
.
Film-coated tablet
Product not subject to medical prescription
Not marketed
2018-03-16
PACKAGE LEAFLET: INFORMATION FOR THE USER LAMBERTS ® DEVILS CLAW TABLETS Devils Claw Root Extract 8003 EI 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, pharmacist or nurse has told 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, pharmacist or nurse. 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 4 weeks. WHAT IS IN THIS LEAFLET 1. What this traditional herbal medicine is and what it is used for 2. What you need to know before you take this traditional herbal medicine 3. How to take this traditional herbal medicine 4. Possible side effects 5. How to store this traditional herbal medicine 6. Contents of the pack and other information 1. WHAT THIS TRADITIONAL HERBAL MEDICINE IS AND WHAT IT IS USED FOR This is a traditional herbal medicine containing Devils Claw root extract. Lamberts® Devils Claw Tablets is a traditional herbal medicinal product for the relief of minor joint pain in adults over 18 years of age, exclusively based upon long- standing use. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS TRADITIONAL HERBAL MEDICINE DO NOT TAKE THIS TRADITIONAL HERBAL MEDICINE IF YOU: • have ever had or have a stomach ulcer or duodenal ulcer • are pregnant or breastfeeding. • are under 18 years of age. • are allergic to Devil’s Claw or any of the other ingredients (see section 6) WARNINGS AND PRECAUTIONS Talk to a qualified healthcare professional, e.g. your doctor or pharmacist, before taking this traditional herbal medicine: If your symptoms worsen or do not improve after 4 weeks If your joint pain is accompanied by swelling of the joint, redness or fever If you have heart problems and want to take this t Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamberts Devils Claw Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each fim-coated tablet contains 450 mg of dry extract from_ Harpagophytum procumbens_ D.C. and/or _H. zeyheri_ L. Decne radix (devil’s claw root). (Equivalent to 1575 – 2250 mg of Devil’s claw root) Extraction solvent: ethanol 60 % v/v For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Small, green oval film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used for the relief of minor joint pain in adults over 18 years of age, exclusively based on long-standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral short-term use only. For adults and the elderly, take one tablet twice a day (in the morning and in the evening). The safety of Lamberts Devils Claw Tablets in children and adolescents under the age of 18 years has not been established as no data are available. Do not exceed the stated dose. Tablets should be swallowed whole with some water or other liquid If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare professional e.g. a doctor or pharmacist should be consulted. 4.3 CONTRAINDICATIONS Patients with active gastric or duodenal ulcer. The safety of Lamberts Devils Claw Tablets in children and adolescents under 18 years of age has not been established as no data are available. Do not use in case of known hypersensitivity to the active substance or any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If the symptoms worsen during the use of the medicinal product or if symptoms persist for more than 4 weeks, a qualified healthcare professional e.g. a doctor or a pharmacist should be consulted. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Izlasiet visu dokumentu