Calcichew-D3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium carbonate; Cholecalciferol concentrate (powder form)

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

A12AX

INN (International Name):

Calcium carbonate; Cholecalciferol concentrate (powder form)

Dosage:

1000/800 mg/IU

Pharmaceutical form:

Chewable tablet

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Marketed

Authorization date:

2009-12-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCICHEW-D
3 FORTE DOUBLE STRENGTH 1000 MG/800 IU CHEWABLE TABLETS
calcium/colecalciferol (vitamin D
3
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
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.
-
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 Calcichew-D
3
Forte Double Strength is and what it is used for
2.
What you need to know before you take Calcichew-D
3
Forte Double Strength
3.
How to take Calcichew-D
3
Forte Double Strength
4.
Possible side effects
5.
How to store Calcichew-D
3
Forte Double Strength
6.
Contents of the pack and other information
1.
WHAT CALCICHEW-D
3 FORTE DOUBLE STRENGTH IS AND WHAT IT IS USED FOR
Calcichew-D
3
Forte Double Strength are chewable tablets containing calcium and
vitamin D
3
, which both are
important substances in bone formation. Calcichew-D
3
Forte Double Strength is used in the prevention and
treatment of calcium and vitamin D deficiency in adults with an
identified risk of calcium and vitamin D
deficiency, and as a supplement to specific treatment of osteoporosis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW-D
3 FORTE DOUBLE STRENGTH
DO NOT TAKE CALCICHEW-D
3 FORTE DOUBLE STRENGTH:
-
if you are allergic to calcium, vitamin D, or any of the other
ingredients of this medicine (listed in
section 6).
-
if you have severe kidney problems
-
if you have excessive amounts of calcium in the blood or in the urine.
-
if you have kidney stones.
-
if you have excessive amounts of vitamin D in the bl

Summary of Product characteristics

Health Products Regulatory Authority
30 July 2021
CRN00C48K
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate equivalent to 1000 mg calcium.
Cholecalciferol concentrate (powder form) equivalent to 800 IU (20
microgram) cholecalciferol (vitamin D
3
)
Excipients with known effect:
One tablet contains 88.6 mg isomalt (E953) and 1.5 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Round, white, uncoated and convex tablets of 18 mm. May have small
specks.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D and calcium deficiency in adults
with an identified risk.
Vitamin D and calcium supplement as an adjunct to specific
osteoporosis treatment of patients who are at risk of vitamin D
and calcium deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS INCLUDING ELDERLY_
One tablet, once daily.
SPECIAL PATIENT POPULATIONS
_PAEDIATRIC POPULATION: _
Calcichew-D3 Forte Double Strength 1000mg/800 IU are not intended for
use in children and adolescents.
_IMPAIRED RENAL FUNCTION:_
Calcichew-D3 Forte Double Strength 1000mg/800 IU Chewable Tablets
should not be used in patients with severe renal
impairment (see section 4.3).
_IMPAIRED HEPATIC FUNCTION:_
No dose adjustment is required.
METHOD OF ADMINISTRATION
Oral. The tablet should be chewed or sucked.
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1
- Severe renal impairment (glomerular filtration rate < 30
ml/min/1.73m
2
)
- Diseases and/or conditions resulting in hypercalcaemia and/or
hypercalcuria
Health Products Regulatory Authority
30 July 2021
CRN00C48K
Page 2 of 6
- Renal calculi (nephrolithiasis)
- Hypervitaminosis D
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
During long-term treatment, serum calcium levels should be monit