Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
DEVILS CLAW SECONDARY ROOTS
Laboratoires ARKOPHARMA
DEVILS CLAW SECONDARY ROOTS
.
Capsule, hard
Product not subject to medical prescription
Not marketed
2012-03-23
1 PACKAGE LEAFLET_RV16 2 PACKAGE LEAFLET: INFORMATION FOR THE USER HARPADOL HARD CAPSULES _Devil’s Claw Root 435 mg_ _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 _ _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. _ - _You must talk to a doctor if you feel worse or do not feel better after 4 weeks._ _ _ WHAT IS IN THIS LEAFLET. 1. What HARPADOL is and what it is used for. 2. What you need to know before you take HARPADOL. 3. How to take HARPADOL. 4. Possible side effects. 5. How to store HARPADOL. 6. Contents of the pack and other information. 1. WHAT HARPADOL IS AND WHAT IT IS USED FOR. Harpadol contains the active substance Devil's claw root ( _Harpagophytum procumbens D.C. and / or _ _H. zeyheri L. Decne)._ Harpadol is a traditional herbal medicinal product for the relief of minor joint pain in adults over 18 years of age, exclusively based on longstanding use. You must talk to a doctor if you feel worse or do not feel better after 4 weeks. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HARPADOL. DO NOT TAKE HARPADOL: If you are allergic to Devil’s claw (also known as Harpagophytum) or any of the ingredients of this product. If you are pregnant or breast-feeding. If you are under 18 years. WARNINGS AND PRECAUTIONS : Talk to your doctor or pharmacist before taking Harpadol. Talk to your doctor: if you have other symptoms such as swelling, redness of a joint, or fever in addition to joint pain. if new symptoms develop or if your symptoms worsen or last for more than 4 weeks if you have an ulcer (either a gastric and/or duodenal ulcer). _ _ if you have heart disease. CHILDREN AND ADOLESCEN Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Harpadol Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 435 mg_ Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne (devil's claw root)._ For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule (capsule). Translucent colourless capsules filled with brown/yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product 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 Use Adults and the elderly: One capsule to be taken 3 times daily with a large glass of water. Duration of use For oral short-term use only If the condition worsens, new symptoms develop or symptoms persist during the use of Harpadol, or for more than four weeks, a doctor should be consulted. The safety of Harpadol in children and adolescents under 18 years of age has not yet been established as no data are available. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Pregnancy and breast-feeding. The safety of Harpadol in children and adolescents under 18 years of age has not yet been established as no data are available. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Articular pain accompanied by swelling of joint, redness or fever should be examined by a doctor. As a general precaution, patients with gastric or duodenal ulcers should not use Harpadol. Some studies in animals have shown at high concentrations of Devil’s claw, possible calcium antagonistic effects similar to verapamil, caution should be taken when Devil’s claw is administered to patients with cardiac disorders. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Preberite celoten dokument