Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ascorbic acid; Riboflavin; Thiamine hydrochloride; Pyridoxine hydrochloride; Nicotinamide; Calcium pantothenate; Alpha tocopheryl acetate; Inositol; Biotin; Folic acid; Acetomenaphthone
Essential Pharmaceuticals Ltd
A11EX
Ascorbic acid; Riboflavin; Thiamine hydrochloride; Pyridoxine hydrochloride; Nicotinamide; Calcium pantothenate; Alpha tocopheryl acetate; Inositol; Biotin; Folic acid; Acetomenaphthone
16.6mg ; 1mg ; 1mg ; 330microgram ; 3.3mg ; 1.16mg ; 5mg ; 50mg ; 170microgram ; 250microgram ; 500microgram
Oral tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 09060700; GTIN: 5015001128009
EACH TABLET CONTAINS: Thiamine Hydrochloride 1.0 mg, Riboflavin 1.0 mg, Pyridoxine Hydrochloride 0.33 mg, Nicotinamide 3.3 mg, Calcium Pantothenate 1.16 mg, Ascorbic Acid 16.6 mg, Alpha Tocopheryl acetate 5.0 mg, Inositol 50.0 mg, Biotin 0.17 mg, Folic Acid 0.25 mg, Acetomenaphthone 0.5 mg. DOSAGE: Tablets to be taken orally and as directed by a medical practitioner. Do not exceed the stated dose. Store in a refrigerator (2°C-8°C) . Read teh package leaflet before use. Keep out of the sight and reach of children. Essential Pharmaceuticals Ltd, Egham, Surrey, TW20 8RB, UK. PL 41094/0001 KETOVITE TABLETS Vitamin supplement SUGAR FREE 100 tablets FOR USE IN RESTRICTED OR THERAPEUTIC DIETS To obtain complete vitamin supplement use with Ketovite Liquid KetTab-PL-UK-2 POM Package leaflet: Information for the user Ketovite Tablets Multivitamin preparation Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • 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. What is in this leaflet 1. What Ketovite Tablets are and what they are used for 2. What you need to know before you take Ketovite Tablets 3. How to take Ketovite Tablets 4. Possible side effects 5. How to store Ketovite Tablets 6. Contents of the pack and other information 1. What Ketovite Tablets are and what they are used for Ketovite Tablets are a therapeutic vitamin supplement for the prevention of vitamin deficiency. It is used in conditions such as: • galactosaemia (a disorder of milk sugar digestion) • disaccharide intolerance (a reaction to sugars such as sucrose, lactose and maltose) • phenylketonuria (an inability to Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ketovite Tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Thiamine hydrochloride BP 1.0 mg Riboflavin BP 1.0 mg Pyridoxine hydrochloride 0.33 mg Nicotinamide BP 3.3 mg Calcium pantothenate PhEur 1.16 mg Ascorbic acid BP 16.6 mg Acetomenaphthone BP 1973 0.5 mg Alpha-tocopheryl acetate BP 5.0 mg Inositol NF XII 50.0 mg Biotin USP 0.17 mg Folic acid BP 0.25 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a therapeutic supplement for the prevention of vitamin deficiency in conditions such as galactosaemia, disaccharide intolerance, phenylketonuria and other disorders of carbohydrate or amino acid metabolism, as well as in patients who are on restricted, specialised or synthetic diets. In order to achieve complete vitamin supplementation Ketovite Tablets should be used in conjunction with Ketovite Liquid. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _For Adults, Children and the Elderly:_ One tablet three times a day, by oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Interference with clinical laboratory tests Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results, depending on the assay. The risk of interference is higher in children and patients with renal impairment and increases with higher doses. When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves’ disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin). Alternative tests not susceptible to biotin Olvassa el a teljes dokumentumot