Ketovite Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Riboflavin; Biotin; Thiamine hydrochloride; Acetomenaphthone; Nicotinamide; Pyridoxine hydrochloride; Ascorbic acid; Folic acid; Tocopherol acetate; Inositol; Calcium pantothenate

Pieejams no:

Essential Pharmaceuticals Limited

ATĶ kods:

A11EX

SNN (starptautisko nepatentēto nosaukumu):

Riboflavin; Biotin; Thiamine hydrochloride; Acetomenaphthone; Nicotinamide; Pyridoxine hydrochloride; Ascorbic acid; Folic acid; Tocopherol acetate; Inositol; Calcium pantothenate

Deva:

0 percent volume/volume

Zāļu forma:

Tablet

Ārstniecības joma:

Vitamin B-complex, other combinations

Autorizācija statuss:

Not marketed

Autorizācija datums:

2012-05-25

Lietošanas instrukcija

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.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have 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. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse.
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:
• if you are allergic to any of the ingredients of the tablets
(listed in section 6).
Warnings and precautions
• Ketovite Tablets contains 0.17 mg biotin per tablet. If you are
about to undergo laboratory
testing you must tell your doctor or the laboratory personnel that you
are taking or have
recently taken Ketovite Tablets, because biotin may affect results of
such

Produkta apraksts

Health Products Regulatory Authority
20 August 2020
CRN009W45
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ketovite Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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
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.
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
Health Products Regulatory Authority
20 August 2020
CRN009W45
Page 2 of 4
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