KETOVITE

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

THIAMINE HYDROCHLORIDE ; RIBOFLAVIN ; PYRIDOXINE HYDROCHLORIDE ; NICOTINAMIDE ; CALCIUM PANTOTHENATE ; ASCORBIC ACID ; INOSITOL ; BIOTIN ; FOLIC ACID ; MENADIOL DIACETATE ; TOCOPHERYL ACETATE

Beschikbaar vanaf:

Essential Pharmaceuticals Limited

ATC-code:

A11EX

INN (Algemene Internationale Benaming):

THIAMINE HYDROCHLORIDE ; RIBOFLAVIN ; PYRIDOXINE HYDROCHLORIDE ; NICOTINAMIDE ; CALCIUM PANTOTHENATE ; ASCORBIC ACID ; INOSITOL ; BIOTIN ; FOLIC ACID ; MENADIOL DIACETATE ; TOCOPHERYL ACETATE

Dosering:

0 %v/v

farmaceutische vorm:

Tablets

Prescription-type:

Product not subject to medical prescription

Therapeutisch gebied:

Vitamin B-complex, other combinations

Autorisatie-status:

Marketed

Autorisatie datum:

1988-03-07

Bijsluiter

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

Productkenmerken

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
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