CALVIDIN® 600 mg/400 I.U. chewable tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium carbonate; Cholecalciferol

Available from:

Mylan IRE Healthcare Limited

ATC code:

A12AX

INN (International Name):

Calcium carbonate; Cholecalciferol

Dosage:

600/400IU Base Milligrams

Pharmaceutical form:

Chewable tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Marketed

Authorization date:

2000-11-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CALVIDIN
600 MG/400 I.U. CHEWABLE TABLETS
Calcium carbonate and Cholecalciferol
For adults only.
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. Always take this
medicine exactly as
described in this leaflet or as your doctor or pharmacist have 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 CALVIDIN 600 mg/400 I.U. chewable tablets is and what it is
used for
2. What you need to know before you take CALVIDIN 600 mg/400 I.U.
chewable tablets
3. How to take CALVIDIN 600 mg/400 I.U. chewable tablets
4. Possible side effects
5. How to store CALVIDIN 600 mg/400 I.U. chewable tablets
6. Contents of the pack and other information
1.
WHAT CALVIDIN 600 MG/400 I.U. CHEWABLE TABLETS IS AND WHAT IT IS USED
FOR
This medicine contains two active substances calcium and vitamin D3.
Calcium is an
important constituent of bone and vitamin D3 helps the absorption of
calcium by the intestine
and its deposition in the bones.
It is used:

in the correction of vitamin D and calcium deficiencies in the elderly

in combination with osteoporosis treatment where vitamin D and calcium
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 CALVIDIN 600 MG/400 I.U.
CHEWABLE
TABLETS
DO NOT TAKE CALVIDIN 600 MG/400 I.U. CHEWABLE TABLETS

If you are allergic to calcium, vitamin D or any of the other
ingredients of this
medicine (listed in section 6)

If you have an abnormally high level of calcium in the blood
(hypercalcaemia) and/or
excessive loss of calcium in urine (hyperc

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2021
CRN009ZV8
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CALVIDIN® 600 mg/400 I.U. chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Calcium carbonate 1500 mg
equivalent to elemental calcium 600 mg
Cholecalciferol concentrate (powder form) 4 mg
equivalent to vitamin D
3
10 µg(400 I. U.)
Excipient with known effect:
Sucrose 1,54 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Chewable tablet
White biplane tablets with a snap grove and the letters C/D.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Correction of combined vitamin D and calcium deficiencies in the
elderly.
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 a high risk
of such deficiency.
CALVIDIN
®
is indicated in adults aged 18 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND ELDERLY
One chewable tablet twice a day [e. g. one tablet in the morning and
one tablet in the evening (equivalent to 1200 mg of
calcium and 800 I.U. of vitamin D
3
)]. Dose reduction should be considered as necessary following the
monitoring of calcium
levels as indicated in section 4.4 and 4.5.
PREGNANT WOMEN
One chewable tablet a day (see section 4.6).
PAEDIATRIC POPULATION
There is no relevant use of CALVIDIN
®
in children or adolescents.
POSOLOGY IN CASES OF HEPATIC INSUFFICIENCY
The dose does not require adjustment.
POSOLOGY IN CASES OF RENAL INSUFFICIENCY
Dosage in renal impairment: CALVIDIN
®
chewable tablets should not be used in patients with severe renal
impairment.
Health Products Regulatory Authority
12 January 2021
CRN009ZV8
Page 2 of 7
Method of administration
The tablets are chewed and then swallowed with a little liquid.
In exceptional cases (e.g. patients disabled) the tablets can, after
consulting a doctor, be sucked.
4.3 CONTRAINDICATIONS
- Hyper