Caltrate 600 mg/400 IU, Film-coated Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Calcium carbonate; Cholecalciferol concentrate

Доступна з:

Haleon Ireland Limited

Код атс:

A12AX

ІПН (Міжнародна Ім'я):

Calcium carbonate; Cholecalciferol concentrate

Дозування:

600 mg/400 international unit(s)

Фармацевтична форма:

Film-coated tablet

Терапевтична области:

Calcium, combinations with vitamin D and/or other drugs

Статус Авторизація:

Marketed

Дата Авторизація:

2009-04-24

інформаційний буклет

(NON-PRESCRIPTION) PACKAGE LEAFLET: INFORMATION FOR THE USER
CALTRATE 600MG/400 IU, FILM-COATED TABLET
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, film-
coated tablet 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 (cholecalciferol)or any of
the other ingredients of
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 high
levels of calcium in the urine (

Характеристики продукта

Health Products Regulatory Authority
26 April 2023
CRN00CJLT
Page 1 of 7
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 associated with 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
For oral use.
Calcium should be provided from the diet or from other sources for
additional calcium requirements.
The calcium dose should be calculated based on elemental calcium daily
needs for the different ages and metabolic situations
and the amount of calcium in food.
The necessary daily intake of cholecalciferol will depend on the
different metabolic situations.
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
RENAL IMPAIRMENT
Dose adjustment may be needed (see section 4.4).
HEPATIC INSUFFICIENCY
The dose does not require adjustment.
Health Products Regulatory Authority
26 April 2023
CRN00