Kalcipos-D 500mg/800 IU chewable Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

CALCIUM CARBONATE, COLECALCIFEROL

Tilgængelig fra:

Meda AB Box 906, SE-170 09 Solna, Sweden

ATC-kode:

A12AX

INN (International Name):

CALCIUM CARBONATE 500 mg COLECALCIFEROL 800 IU

Lægemiddelform:

CHEWABLE TABLET

Sammensætning:

CALCIUM CARBONATE 500 mg COLECALCIFEROL 800 IU

Recept type:

POM

Terapeutisk område:

MINERAL SUPPLEMENTS

Autorisation status:

Withdrawn

Autorisation dato:

2012-03-22

Indlægsseddel

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5 PACKAGE LEAFLET: INFORMATION FOR THE USER
KALCIPOS-D 500 MG/800 IU CHEWABLE TABLETS
CALCIUM/CHOLECALCIFEROL (VITAMIN D3)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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 Kalcipos-D is and what it is used for
2.
What you need to know before you take Kalcipos-D
3.
How to take Kalcipos-D
4.
Possible side effects
5.
How to store Kalcipos-D
6.
Contents of the pack and other information
1.
WHAT KALCIPOS-D IS AND WHAT IT IS USED FOR
Kalcipos-D is used to prevent and treat calcium and vitamin D
3
deficiency in the elderly, and
as an additional treatment in the management of osteoporosis, when a
risk of deficiency of
calcium and vitamin D
3
is suspected.
Kalcipos-D contains calcium and vitamin D
3
which both are important components for the
formation of bone. Vitamin D
3
regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in bone tissue.
Ask your doctor, pharmacist or other health personal if you have
further questions and always
follow their instructions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KALCIPOS-D
DO NOT TAKE KALCIPOS-D
-
if you have hypercalcaemia (increased levels of calcium in the blood)
or
hypercalciuria (increased levels in the urine).
-
if you have kidney stones
-
if you have calcium depositions in the kidneys
-
if you have hypervitaminosis D (increased levels of vitamin D in the
blood).
-
if you have severely impaired kidney function/kidney failure
-
if you are allergic to calcium, cholecalciferol (Vitamin D) or any of
the other ingredients
o

Produktets egenskaber

1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kalcipos-D 500 mg/ 800 IU chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains calcium carbonate equivalent to 500 mg
calcium,
cholecalciferol (Vitamin D3) 800 IU (20 microgram).
Excipients with known effect: glucose 200 mg and sucrose 1.8 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
White to off white, round, engraved R 152 on one side, diameter 17 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of calcium and vitamin D deficiency in the
elderly. Vitamin D and
calcium supplement in addition to specific osteoporosis treatment of
patients who are at risk
of vitamin D and calcium deficiency.
Kalcipos-D chewable tablets is indicated in adults aged 18 years and
over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and older people _
One chewable tablet (500 mg/800 IU) daily.
The amount of calcium in Kalcipos-D is less than the usually
recommended daily intake.
Kalcipos-D is therefore primarily to be used by patients with need of
D-vitamin substitution
but with a dietary intake of calcium of 500 mg-1000 mg per day. The
patients dietary intake
of calcium should be estimated by the prescriber.
_ _
_Patients with hepatic impairment _
No dose adjustment is required.
_Patients with renal impairment _
Kalcipos-D should not be used in patients with severe renal impairment
(see section 4.3).
_Paediatric population _
There is no relevant use of Kalcipos-D chewable tablets in children or
adolescents.
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Method of administration
Tablet can be chewed or slowly melted in the mouth.
4.3
CONTRAINDICATIONS
•
Hypercalciuria and hypercalcaemia and diseases and/or conditions which
lead to
hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases,
primary
hyperparathyroidism).
•
Nephrolithiasis.
•
Nephrocalcinosis.
•
Hypervitaminosis D.
•
Severe renal impairment and renal failure.
•
Hypersensitivity to the