Caltrate 500 mg / 1000 IU, chewable tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Cholecalciferol concentrate ; Calcium carbonate

Tilgjengelig fra:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC-kode:

A12AX

INN (International Name):

Cholecalciferol concentrate ; Calcium carbonate

Dosering :

500 mg/1000 international unit(s)

Legemiddelform:

Chewable tablet

Terapeutisk område:

Calcium, combinations with vitamin D and/or other drugs

Autorisasjon status:

Not marketed

Autorisasjon dato:

2018-06-22

Informasjon til brukeren

Calcium 500 mg / Vitamin D
3
1000 IU, chewable tablets (DE/H/4671/001/DC)
Patient Information Leaflet
EU EXCIPIENTS GUIDELINE
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CALTRATE 500 MG / 1000 IU, CHEWABLE TABLETS
Calcium/Cholecalciferol (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.
-
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 D
3
-supplement and belong to the group of
calcium carbonates and cholecalciferols. 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.
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 D
3
or any of the other ingredients of this medicine

Preparatomtale

Health Products Regulatory Authority
12 March 2021
CRN00C18F
Page 1 of 6
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), 58.149 mg
of sorbitol (E420), 185.00 mg of isomalt (E953), 1.925
mg of sucrose and 0.001 mg of benzyl alcohol
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).
Health Products Regulatory Authority
12 March 2021
CRN00C18F
Page 2 of 6
Method of administration
Oral use.
Caltrate 500 mg / 1000 IU, chewable tablets can be taken at any time,
with or without food. The chewable tablets should be
chewed and