Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Calcium carbonate; Colecalciferol

Tilgjengelig fra:

PCO Manufacturing Ltd.

ATC-kode:

A12AA04

INN (International Name):

Calcium carbonate; Colecalciferol

Legemiddelform:

Chewable tablet

Terapeutisk område:

calcium carbonate

Autorisasjon dato:

2022-10-28

Informasjon til brukeren

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCICHEW
®
-D
3 FORTE 500 MG/400 IU
CHEWABLE TABLETS
calcium/colecalciferol
READ ALL OF THIS LEAFLET CAREFULLY 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.
WHAT IS IN THIS LEAFLET:
1.
What Calcichew-D
3
Forte is and what it is used for
2.
What you need to know before you take Calcichew-D
3
Forte
3.
How to take Calcichew-D
3
Forte
4.
Possible side effects
5.
How to store Calcichew-D
3
Forte
6.
Contents of the pack and other information
1 s and what it is used for
1.
WHAT CALCICHEW-D
3 FORTE IS AND WHAT IT IS USED FOR
Calcichew-D
3
Forte Chewable Tablets are lemon flavoured
chewable tablets containing calcium and vitamin D
3
which are
both important substances in bone formation. Both are found in
the diet and vitamin D is also produced in the skin after
exposure to the sun.
Calcichew-D
3
Forte is used to treat and prevent vitamin
D/calcium deficiency, which may occur when 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.
2.
BEFORE YOU TAKE CALCICHEW-D
3 FORTE
DO NOT TAKE CALCICHEW- D
3 FORTE CHEWABLE TABLETS IF YOU:

are allergic to calcium, vitamin D, or any of the other
ingredients of this medicine (listed in section 6)

have severe kidney problems

have a condition that causes excessive amounts of calcium
in your blood or urine (hypercalcaemia or hypercalciuria)
e.g.
o
renal (kidney failure)
o
cancer that has affected y

Preparatomtale

Health Products Regulatory Authority
28 October 2022
CRN00D50V
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate 1250 mg
(equivalent to 500 mg of elemental calcium)
Colecalciferol 400 IU
(equivalent to 10 micrograms vitamin D3).
Excipient(s) with known effect: isomalt (E953) and sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
_Product imported from Spain:_
Round, white, uncoated and convex tablet. May have small specks.
4 CLINICAL PARTICULARS
As per PA2239/013/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/013/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Xylitol (E967)
Povidone
Isomalt (E953)
Flavouring (lemon)
Fatty acid mono- and diglycerides
Sucralose (E955)
Magnesium stearate
Sucrose
Modified maize starch
Triglycerides, medium-chain
Sodium ascorbate
Silica, colloidal anhydrous
Tocopherol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
28 October 2022
CRN00D50V
Page 2 of 2
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 container tightly closed to
protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
White, high density polyethylene bottles.
Bottles of 60 chewable tablets contained in an outer cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
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
PPA0465/156/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28
th
October 2022
10 DATE OF REVISION OF THE TEXT