Caltrate 600 mg/400 IU, Film-coated Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Calcium carbonate; Cholecalciferol concentrate

Boleh didapati daripada:

Pfizer Healthcare Ireland

Kod ATC:

A12AX

INN (Nama Antarabangsa):

Calcium carbonate; Cholecalciferol concentrate

Dos:

600 mg/400 international unit(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Calcium, combinations with vitamin D and/or other drugs

Status kebenaran:

Marketed

Tarikh kebenaran:

2009-04-24

Risalah maklumat

(NON-PRESCRIPTION) PACKAGE LEAFLET: INFORMATION FOR THE USER
CALTRATE 600MG/400 IU, FILM-COATED TABLETS
CALCIUM (AS CARBONATE) AND CHOLECALCIFEROL (VITAMIN D
3
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Caltrate 600
mg/400 IU, film-coated tablets carefully to get the best results from
it. Always take this medicine
exactly as described in this leaflet or as your doctor or pharmacist
has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

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.

You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Caltrate is and what it is used for
2.
What you need to know before you take Caltrate
3.
How to take Caltrate
4.
Possible side effects
5.
How to store Caltrate
6.
Contents of the pack and other information
1. WHAT CALTRATE IS AND WHAT IT IS USED FOR
This medicine contains two active substances calcium and vitamin D
3
. Calcium is an important
constituent of bone and vitamin D
3
helps the absorption of calcium by the intestine and its
deposition in the bones.
It is used:

In the correction of calcium and vitamin D deficiencies in older
people,

In combination with osteoporosis treatments where calcium and vitamin
D levels are too
low or where there is a high risk of them being too low.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALTRATE
DO NOT TAKE CALTRATE

If you are allergic to calcium, vitamin D or any of the other
ingredients in Caltrate in particular
soya bean oil or peanut (listed in section 6).

If you are suffering from kidney failure

If you have an abnormally high level of calcium in the blood
(hypercalcaemia) and/or
excessive loss of calcium in the urine (hypercalci

Ciri produk

Health Products Regulatory Authority
05 November 2019
CRN009FS0
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caltrate 600 mg/400 IU, Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
600 mg of calcium (as calcium carbonate)
10 micrograms of cholecalciferol (equivalent to 400 I.U. vitamin D
3
)
Excipients with known effect: sucrose, partially hydrogenated soya
bean oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Capsule-shaped grey/beige tablets. One side is scored and engraved
with “D” on the left and “600” on the right of the score.
The other side is engraved with “Caltrate”.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Correction of combined vitamin D and calcium deficiencies in older
people.
Supply of vitamin D and calcium as an adjunct to specific treatments
for osteoporosis, in patients where combined vitamin D
and calcium deficiencies have been diagnosed or those at high risk of
such deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and Older People
One tablet twice a day (e.g. one tablet in the morning and one tablet
in the evening). Dose reduction should be considered as
necessary following the monitoring of calcium levels as indicated in
section 4.4 and 4.5.
Paediatric population
No data are available
Pregnant women
One tablet a day (see section 4.6).
Hepatic insufficiency
The dose does not require adjustment.
METHOD OF ADMINISTRATION
The tablet should be swallowed with a large glass of water.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
05 November 2019
CRN009FS0
Page 2 of 6
- Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
- The product contains partially hydrogenated soya bean oil and is
contraindicated for patients hypersensitive to peanut or
soya.
- Renal failure.
- Hypercalciuria an