CALCICHEW-D 500mg/400IU mg/IU Tablets Chewable

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

CALCIUM CARBONATE, COLECALCIFEROL

Tilgængelig fra:

Takeda UK Limited

ATC-kode:

A12AX

INN (International Name):

CALCIUM CARBONATE, COLECALCIFEROL

Dosering:

500mg/400IU mg/IU

Lægemiddelform:

Tablets Chewable

Recept type:

Product not subject to medical prescription

Terapeutisk område:

Calcium, combinations with other drugs

Autorisation status:

Transfer Pending

Autorisation dato:

2014-01-06

Indlægsseddel

PATIENT INFORMATION LEAFLET
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.
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.
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 your bones

have excessive amounts of vitamin D in your blood


Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Forte 500 mg/400 IU Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect: isomalt (E953) 49.90 mg and sucrose 0.77
mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Round, white, uncoated and convex tablet.
May have small specks.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcichew-D
3
Forte Chewable Tablets should only be used as a therapeutic supplement
when the diet is deficient.
It
should not be used as a food supplement.
The prophylaxis and treatment of combined vitamin D and calcium
deficiency particularly in housebound and
institutionalised elderly subjects.
The supplementation of vitamin D and calcium as an adjunct to specific
therapy for osteoporosis or as a therapeutic
supplement in established osteomalacia, pregnant patients at high risk
of deficiency or malnutrition when dietary intake
is less than that required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS AND ELDERLY_
One tablet twice daily.
SPECIAL PATIENT POPULATIONS
_PAEDIATRIC POPULATION:_
Calcichew-D
3
Forte Chewable Tablets are not intended for use in children.
Per tablet:
Calcium carbonate
1250
mg
(equivalent to 500 mg of elemental calcium)
Colecalciferol
400
IU
(equivalent to 10 micrograms vitamin D
3
)
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