Calcichew D3 chewable tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Calcium carbonate; Colecalciferol

Beschikbaar vanaf:

Lexon (UK) Ltd

ATC-code:

A12AX

INN (Algemene Internationale Benaming):

Calcium carbonate; Colecalciferol

Dosering:

1.25gram ; 200unit

farmaceutische vorm:

Chewable tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 09060400

Bijsluiter

CALCICHEW - D
3
CHEWABLE TABLETS
(calcium carbonate/colecalciferol
equivalent to 500mg calcium / 200IU colecalciferol)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
This medicine is available without prescription. However, you still
need
to take Calcichew-D
3
Chewable Tablets carefully to get the best results
from it.
*
Always take this medicine exactly as described in this lea flet or as
your
doctor or pharmacist have told you. Keep this leaflet et. 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 leafl
et. See section 4.
IN THIS LEAFLET:
What Calcichew - D
3
Chewable Tablets are and what they are used for
What you need to know before you take Calcichew - D
3
Chewable
Tablets
How to take Calcichew - D
3
Chewable Tablets
Possible side effects
How to store Calcichew - D
3
Chewable Tablets
Contents of the pack and other information
WHAT CALCICHEW - D
3
CHEWABLE TABLETS ARE AND WHAT
THEY ARE USED FOR
Calcichew-D
3
Chewable Tablets are orange fl avoured 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
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 pre-
scribed or recommended for certain bone conditions, for example
osteoporo-
sis, or during pregnancy.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW -
D
3
CHEWABLE TABLETS
DO NOT TAKE CALCICHEW-D
3
CHEWABLE TABLETS IF YOU:
*
are allergic to calcium, vitamin D, or any of the other ingredients of
this
medicine (listed in section 6).
*
ha

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
500 mg/200 IU Chewable Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate
1250mg
(equivalent to 500mg of elemental calcium)
Colecalciferol
200iu
(equivalent to 5 micrograms vitamin D
3
)
Contains isomalt (E953) and sucrose. For a full list of excipients see
section 6.1.
3
PHARMACEUTICAL FORM
Chewable tablet.
Round, white, uncoated and convex tablets. May have small specks.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Calcichew-D
3
Chewable Tablets should be used only as a therapeutic and not
as a food supplement when the diet is deficient or when normal
requirement of
both components is increased.
Calcichew-D
3
Chewable Tablets may be used as an adjunct to specific therapy
for osteoporosis or as a therapeutic supplement in established
osteomalacia,
pregnant patients at high risk of needing such a therapeutic
supplementation or
malnutrition when dietary intake is less than that required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS _
_Adjunctive therapy in osteoporosis: _
One tablet 2-3 times per day
_Calcium and vitamin D deficiency: _
One tablet 2-3 times per day.
SPECIAL PATIENT POPULATIONS
_ELDERLY PATIENTS _
_Adjunctive therapy in osteoporosis _
_Calcium and vitamin D deficiency _
Dosage as for adults.
_PAEDIATRIC POPULATION _
_Calcium and vitamin D deficiency (only) _
One tablet 1-2 times per day.
_IMPAIRED HEPATIC FUNCTION _
No dose adjustment is required.
_IMPAIRED RENAL FUNCTION _
Calcichew-D
3
chewable tablets should not be used in patients with severe renal
impairment (see section 4.3).
METHOD OF ADMINISTRATION
Oral. The tablets should be chewed or sucked.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients
listed in
section 6.1
•
Severe renal impairment (glomerular filtration rate < 30 ml/min)
•
Diseases and/or conditions resulting in hypercalcaemia and/or
hypercalciuria
•
Renal calculi (nephrolithiasis)
•
Hypervitaminosi