Kalcipos-D forte 500 mg/800 IU chewable 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:

Chewable tablet

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Marketed

Authorization date:

2010-05-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
KALCIPOS-D FORTE 500 MG/800 IU CHEWABLE 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 personal 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, cholecalcif

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 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 forte 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 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 patient's 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 chewable tablets in
children or adolescents.
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.

Hypervitami