Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Inositol nicotinate
Genus Pharmaceuticals Ltd
C04AC03
Inositol nicotinate
750mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060400
PACKAGE LEAFLET: INFORMATION FOR THE USER HEXOPAL FORTE 750MG TABLETS (INOSITOL NICOTINATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Hexopal Forte 750mg Tablets are and what they are used for 2. Before you use Hexopal Forte 750mg Tablets 3. How to use Hexopal Forte 750mg Tablets 4. Possible side-effects 5. How to store Hexopal Forte 750mg Tablets 6. Further information 1. WHAT HEXOPAL FORTE 750MG TABLETS ARE AND WHAT THEY ARE USED FOR Hexopal Forte 750mg Tablets contain inositol nicotinate, which works by relaxing the blood vessels. Hexopal Forte 750mg Tablets are used to treat intermittent claudication (pain in the legs whilst walking) and Raynaud’s phenomemon (fingers and toes which go white and bloodless in the cold). 2. BEFORE YOU USE HEXOPAL FORTE 750MG TABLETS DO NOT USE HEXOPAL FORTE 750MG TABLETS IF YOU: • are allergic (hypersensitive) to inositol nicotinate or any of the other ingredients of Hexopal Forte 750mg Tablets (see section 6 – Further information for details) • have recently had a heart attack or stroke TAKE SPECIAL CARE WITH HEXOPAL FORTE 750MG TABLETS IF YOU HAVE: • poor circulation to the brain (cardiovascular insufficiency) • chest pains (unstable angina). USING OTHER MEDICINES The risk of bleeding can be increased when taken with warfarin. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. PREGNANCY AND BREAST-FEEDING Hexopal should not usually be used during pregnancy. If you are pregnant or planning to become pregnant Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hexopal Forte 750mg Tablets Inositol Nicotinate 750mg Tablets BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Inositol Nicotinate BP 750 mg. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Hexopal is indicated for the symptomatic relief of severe intermittent claudication and Raynauds phenomenon. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Adults: The usual dose is 3g daily (two Hexopal Forte Tablets twice daily). The dose of Hexopal may be increased up to 4g daily if necessary. Oral administration. 4.3. CONTRAINDICATIONS Use in patients who have suffered a recent myocardial infarction or are in the acute phase of a cerebrovascular accident. Use in patients hypersensitive to the active ingredient. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should be used with caution in the presence of cerebrovascular insufficiency or unstable angina. Ingredients with specified warnings This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The risk of bleeding can be increased when concomitantly taken with warfarin. 4.6. PREGNANCY AND LACTATION There is no evidence of the safety of Hexopal in human pregnancy nor is there any evidence from animal work that it is free from hazard. The use of Hexopal in pregnancy should therefore be avoided unless there is no safer alternative. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8. UNDESIRABLE EFFECTS Nicotinic acid can cause myalgia, the risk of myalgia due to intake of lipid- lowering agents, especially statins, can be increased. Uncommon side effects include flushing, dizziness, headache, nausea, vomiting, syncope, paraesthesia, rash, oedema, and postural hypotension. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal pr Lestu allt skjalið