देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
THIAMINE HYDROCHLORIDE ; RIBOFLAVIN ; PYRIDOXINE HYDROCHLORIDE ; NICOTINAMIDE ; CALCIUM PANTOTHENATE ; ASCORBIC ACID ; INOSITOL ; BIOTIN ; FOLIC ACID ; MENADIOL DIACETATE ; TOCOPHERYL ACETATE
Essential Pharmaceuticals Limited
A11EX
THIAMINE HYDROCHLORIDE ; RIBOFLAVIN ; PYRIDOXINE HYDROCHLORIDE ; NICOTINAMIDE ; CALCIUM PANTOTHENATE ; ASCORBIC ACID ; INOSITOL ; BIOTIN ; FOLIC ACID ; MENADIOL DIACETATE ; TOCOPHERYL ACETATE
0 %v/v
Tablets
Product not subject to medical prescription
Vitamin B-complex, other combinations
Marketed
1988-03-07
4. Possible side effects Like all medicines, this product can cause side effects, although not everybody gets them. The following side effect has been reported but the frequency cannot be estimated from the available information (frequency not known): • severe allergic reaction (anaphylactic reaction). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. EXP Lot P 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 digest one of the essential amino acids) • in other disorders of starch, sugar or amino acid metabolism • in patients who are on restricted, specialised or synthetic diets. Ketovite Tablets are a multivitamin preparation, intended for use at the same time as Ketovite Liquid. 2. What you need to know before you take Ketovite Tablets Do not take Ketovite Tablets पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ketovite Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains; For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Yellow tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vitamin 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For adults, children over 4 years, and the elderly: One tablet three times daily, 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 The recommended dose should not be exceeded without medical advice. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Pyridoxine may increase the peripheral metabolism of levodopa reducing therapeutic efficiency in patients with 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 all-rac-Alpha-Tocopheryl acetate 5.0 mg Inositol 50.0 mg Biotin 0.17 mg Folic acid 0.25 mg Acetomenaphthone 0.50 mg 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _1_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _8_ _ पूरा दस्तावेज़ पढ़ें