Calcichew 500 mg chewable tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Calcium

Disponible desde:

PCO Manufacturing Ltd.

Código ATC:

A12AA; A12AA04

Designación común internacional (DCI):

Calcium

Dosis:

500 milligram(s)

formulario farmacéutico:

Chewable tablet

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Calcium; calcium carbonate

Estado de Autorización:

Authorised

Fecha de autorización:

2005-12-02

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCICHEW
® 500 MG CHEWABLE TABLETS
calcium
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.
−
You must talk to a doctor if you do not feel better or if you feel
worse after two weeks.
−
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.
IN THIS LEAFLET:
1.
What Calcichew 500 mg is and what it is used for
2.
What you need to know before you take Calcichew 500 mg
3.
How to take Calcichew 500 mg
4.
Possible side-effects
5.
How to store Calcichew 500mg
6.
Contents of the pack and other information
1.
WHAT CALCICHEW 500 MG IS AND WHAT IT IS USED FOR
Calcichew 500 mg Chewable Tablets are orange flavoured
chewable tablets containing the active ingredient calcium. Calcium
is found in the diet and is an important substance in bone formation.
Calcichew 500 mg is used to treat and prevent calcium deficiency
which may occur if your diet or lifestyle does not provide enough, or
when body requirements are increased. This medicine may also be
prescribed or recommended for certain bone conditions, for
example osteoporosis, or during pregnancy. It may also be given to
patients receiving kidney dialysis to remove the phosphate from the
blood that cannot be removed by dialysis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW 500 MG
DO NOT TAKE CALCICHEW 500 MG CHEWABLE TABLETS IF YOU:
•
are allergic (hypersensitive) to calcium or any of the other
ingredients of this medicine (listed in section 6)_ _
•
have a condition that causes excessive amounts of calcium in
your blood or urine (hypercalcaemia or hypercalciuria)
•
have kidney stones.
WARNINGS AND PRECAUTIONS
TALK

Ficha técnica

Health Products Regulatory Authority
27 May 2022
CRN00CVR7
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew 500 mg chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1250 mg calcium carbonate, equivalent to 500 mg
elemental calcium.
Excipient(s) with known effect
Isomalt (E953)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet.
_ _
_Product imported from Greece and Spain:_
White, round chewable tablets with orange flavour.
4 CLINICAL PARTICULARS
As per PA2239/013/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/013/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Xylitol (E967)
Povidone
Flavouring (orange)
Magnesium stearate
Sucralose (E955)
Isomalt (E953)
Monoglycerides and diglycerides of fatty acids
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Keep the bottle tightly closed in order to protect from moisture.
Health Products Regulatory Authority
27 May 2022
CRN00CVR7
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Bottles of 60 chewable tablets contained in an outer cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/156/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 02 December 2005
Date of last renewal: 02 December 2010
10 DATE OF REVISION OF THE TEXT
May 2022