Kalcipos-D forte 500 mg/800 IU film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium; Cholecalciferol

Available from:

Viatris Healthcare Limited

ATC code:

A12AX

INN (International Name):

Calcium; Cholecalciferol

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Marketed

Authorization date:

2012-05-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
KALCIPOS-D FORTE 500 MG/800 IU FILM-COATED TABLETS
calcium/cholecalciferol (vitamin D
3
)
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 forte is and what it is used for
2.
What you need to know before you take Kalcipos-D forte
3.
How to take Kalcipos-D forte
4.
Possible side effects
5.
How to store Kalcipos-D forte
6.
Contents of the pack and other information
1.
WHAT KALCIPOS-D FORTE IS AND WHAT IT IS USED FOR
Kalcipos-D forte 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 forte 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 personnel if you have
further questions and always follow
their instructions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KALCIPOS-D FORTE
DO NOT TAKE KALCIPOS-D FORTE
-
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, choleca

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2023
CRN00DWLZ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kalcipos-D forte 500 mg/800 IU film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains calcium carbonate equivalent to 500
mg calcium, cholecalciferol (Vitamin D
3
) 800 IU (20
microgram).
Excipients with known effect: sucrose 1.8 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet. White, oval, engraved R150, 8.5 x 19 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 forte film-coated tablets is indicated in adults aged 18
years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and older people_
One film-coated tablet (500 mg/800 IU) daily.
The amount of calcium in Kalcipos-D forte is less than the usually
recommended daily intake.
Kalcipos-D forte 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 forte should not be used in patients with severe renal
impairment (see section 4.3).
_Paediatric population_
There is no relevant use of Kalcipos-D forte film-coated tablets in
children or adolescents.
Method of administration
Tablets shall be swallowed with water, whole, crushed or divided.
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.

S