Caltrate 500 mg / 1000 IU, chewable tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Calcium carbonate; Cholecalciferol concentrate

Disponible desde:

Pfizer Healthcare Ireland

Código ATC:

A12AX

Designación común internacional (DCI):

Calcium carbonate; Cholecalciferol concentrate

Dosis:

500 mg/1000 international unit(s)

formulario farmacéutico:

Chewable tablet

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Calcium, combinations with vitamin D and/or other drugs

Fecha de autorización:

2018-06-22

Información para el usuario

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.
-
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 500 mg / 1000 IU, chewable tablets are and what they are
used for.
2.
What you need to know before you take Caltrate 500 mg / 1000 IU,
chewable tablets.
3.
How to take Caltrate 500 mg / 1000 IU, chewable tablets.
4.
Possible side effects.
5.
How to store Caltrate 500 mg / 1000 IU, chewable tablets.
6.
Contents of the pack and other information.
1.
WHAT CALTRATE 500 MG / 1000 IU, CHEWABLE TABLETS ARE AND WHAT THEY ARE
USED FOR
Caltrate 500 mg / 1000 IU, chewable tablets are a calcium-vitamin
D3-supplement and belong to the group of
calcium carbonates and cholecalciferols. Calcium is an important
constituent of Bone and Vitamin D3 helps the
absorption of Calcium by the intestine and its deposition in the
bones.
Caltrate 500 mg / 1000 IU, chewable tablets ARE USED
-
to prevent and treat a lack of calcium and vitamin D in the elderly.
-
for vitamin D- and calcium supplementation as supportive treatment of
osteoporosis (brittle bones).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALTRATE 500 MG / 1000 IU,
CHEWABLE TABLETS
DO NOT TAKE CALTRATE 500 MG / 1000 IU, CHEWABLE TABLETS
-
if you are allergic to calcium, vitamin D3 or any of the other
ingredients of this medicine (listed in section 6).
-
if you have high levels of calcium in your blood (hypercalcaemia).
-
if you have high levels of calcium in your urine (hypercalciuria).
-
if you suffer from overactive parathyroid glands
(hyperparathyroidism).
-
if you suffer fro

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caltrate 500 mg / 1000 IU, chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
500 mg calcium (as calcium carbonate).
25 micrograms cholecalciferol (vitamin D
3
, equivalent to 1000 IU) as cholecalciferol concentrate powder form.
Excipients with known effect:
Each chewable tablet
contains 0.50 mg of
aspartame (E951),
58.14 mg of
sorbitol
(E420),
185.00 mg of
isomalt
(E953) and 1.925 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable, round, white tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Caltrate 500 mg / 1000 IU, chewable tablets are indicated:
-
for the prevention and treatment of vitamin D and calcium deficiency
in the elderly
-
as 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 and elderly_
1 chewable tablet daily (corresponding to 500 mg of calcium and 1000
IU of vitamin D
3
).
_Patients with hepatic impairment_
No dose adjustment is required.
_Patients with renal impairment_
Caltrate 500 mg / 1000 IU, chewable tablets should not be used in
patients with severe renal impairment (see section
4.3).
_Pregnancy_
During pregnancy the daily intake should not
exceed 1,500 mg of calcium and 600 I.U.
of vitamin D
3
.
Therefore,
Caltrate 500 mg / 1000 IU chewable tablets should not be used during
pregnancy (see section 4.6).
_Paediatric population_
Caltrate 500 mg / 1000 IU, chewable tablets are not intended for use
in children or adolescents (see section 4.3).
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