Kiddi" Syrup -

r
-
Kiddi" Syrup -
Carefully read this package insert. It contains important information. You have received this drug either with a doctor's prescription for your personal use, or by the pharmacist or by the druggist
without a medical prescription. So, in order to obtain the greatest
benefit from this medication, you should take it as described in
this package insert or as advised by your physician, your pharmacist, or your druggist.
Please keep this package insert as you may wish to read it again
or refer to it later on.
What Pharmaton kiddi syrup is and what it is used for
Pharmaton kiddi syrup contains vitamins, minerals and lysine.
Lysine is an essential amino acid, which among other functions, is
important for the bone formation. In children, lysine is the amino
acid most often reported to be inadequately supplied.
A poorly balanced or deficient diet may not provide all the necessary vitamins and minerals which are required for children.
Pharmaton Kiddi Syrup covers the increasing demand for vitamins
and the essential amino acid lysine of children and adolescents
during the period of growth in case of loss of appetite, convalescence, physical fatigue as well as to strengthen the resistance,
the performance and concentration.
Before taking pharmaton kiddi syrup
An adequate, varied diet is the most important means of preventing, as far as possible, deficiencies in vitamins and trace
elements. Pharmaton Kiddi Syrup is suitable for diabetics (15 ml
syrup contains 3.6 g carbohydrates).
Do not take Pharrnaton kiddi syrup
• in case of a known disorder of calcium metabolism such as
raised calcium levels in the blood or increased calcium excretion
• in case of hypervitaminosis 0
• in renal insufficiency
• in case of calcium based kidney stones
• in case of phenylketonuria
· ln.rase of care hereditary conditions that may be incompatible
with an excipient of the product
• if you are taking other products that contain vitamin 0
• in case of known hypersensitivity to any ingredient of the compound
Take special care with Pharmaton kiddi syrup
Pharmaton kiddi syrup should not be taken above the recommended dosage and for long periods, except under medical
supervision.
15 ml Pharmaton kiddi syrup contain 2.6 g sorbitol.
Children and adolescents with rare hereditary problems of fructose intolerance shouJd not take this product.
Pharmaton kiddi syrup contains vitamin B6. This substance can
reduce the effects of i-dopa 00 not take Pharmaton kiddi syrup
if you are being treated with t-dopa unless it is under medical
supervision after a careful assessment of the indication.
Inform your doctor, your pharmacist or your druggist if
• you are suffering from other diseases
· you have allergies or
· you take other drugs (including drugs you have bought by
yourself !)
• or are using any medications externally.
Pregnancy and lactation
Pharmaton kiddi syrup is intended for children and adolescents.
--Bo-floHake
PlTarmaten-kiddkyrup--{juriflg- preqnenev-or-when
lactating unless your doctor thinks it is necessary. No systematic
controlled scientific studies have ever been carried out in pregnant women or breastfeeding mothers. As a general precaution,
take as few medicines as possible during pregnancy and breastfeeding or ask your doctor, pharmacist, or druggist for advice,
How to take Pharmaton kiddi syrup
Children aged one to five years: 5 ml daily
Children aged six and adolescents: 10 ml daily
Use the measuring cup provided to measure out the right quantity of syrup in millilitres (ml).
Pharmaton kiddi syrup is best taken with breakfast.
Pharmaton kiddi syrup can also be diluted with water or mixed
with food.
I! has an orange flavour.
Take only the dose recommended in this package insert, or the
dose prescribed by your doctor. If you feel that the effect of this
medicine is too strong or too wrak, please talk to your doctor,
pharmacist, or druggist about it.
NATURAL
HEALTH
PRODUCTS
Possible side effects of Pharmaton kiddi syrup
Hypersensitivity symptoms to the product, such as skin reactions,
have occasionally been reported.
If you notice any side effects not listed in this leaflet, please tell
your doctor, pharmacist, or druggist as they have more detailed
information on the product.
Further information
The yellow discolouration of the urine after taking Pharmaton
Kiddi Syrup is due to the presence of vitamin B2 (natural colour
of the substance) and is harmless.
Pharmaton Kiddi Syrup may show a natural turbidity which is due
to some of the excipients but this does not impair its efficacy.
Shake well before use. After opening, the product must be used
within 30 days. Keep the bottle tightly closed in a dry place out of
the reach of children. 00 not store above 25°C. The product must
not be used after the date indicated with «EXP" on the label
Further information may be obtained from your doctor, your
pharmacist or druggist.
What is in Pharmaton kiddi syrup
15 ml of syrup contains:
Active ingredients:
Lysine hydrochloride
Vitamin B1 hydrochloride
Vitamin B2 sodium phosphate
Vitamin B6 hydrochloride
Vitamin 03
Vitamin Eacetate
Nicotinamide (PP)
Oexpanthenol
Calcium
300.0 mg
~
3.0 m,,--g-l
3.5 mg
"-I
6.0 mg
4001U"'-l
15.0 m-=-g-l
20.0 mg
"-I
10.0 mg
130.0 m-'-g-l
Excipients: Potassium sorbate, Sodium benzoate, Ascorbic acid,
Sorbitol liquid (non crystallizing), Acesulfame K,Macrogolglycerol
hydroxystearate, Orange essence I, Orange essence II, Tangerine
essence, Carmellose sodium, Oisodium edetate, Citric acid
monohydrate, Phosphoric acid concentrated, Aspartame.
Warning: Aspartame contains Phenylalanine
Phenylketonuria.
which cause
Pharmaton kiddi Available pack sizes
Bottles of 100 ml and 200 ml syrup. Not all pack sizes may be
marketed.
Manufactured by
Ginsana SA, Bioggio-Switzerland
On behalf of Boehringer Ingelheim
International GmbH, Germany (under licence of Pharmaton SA)
This package insert was last checked by the competent
health authority for medicines (Swissmedic) in December
2010.
For any information about this medicine, please contact the
local representative of the Marketing Authorisation Holder:
Boehringer Ingelheim
Middle East ErNorth Africa
(Scientific Office) FHLC, P.O.Box-SD512
Oubai Healthcare City, Oubai, UAE.
Tel: +971 (4) 423 0400
Fax: +971 (4) 423 3637
To report any side effect(s):
• Saudi Arabia:
· National Pharmacovigilance Center (NPC)
• Fax: +966-11-205-7662
· Toll-free: 8002490000
• E-mail: [email protected]
· website: www.sfda.gov.sajnpc
· Other countries:
• Please contact the relevant competent authority.