Cadelius 600mg/1000 IU ordispersible tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium carbonate; Cholecalciferol

Available from:

Italfarmaco S.A.

ATC code:

A12AX

INN (International Name):

Calcium carbonate; Cholecalciferol

Dosage:

600/1000 mg/IU

Pharmaceutical form:

Orodispersible tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Marketed

Authorization date:

2017-04-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Cadelius 600 mg / 1,000 IU
orodispersible tablets
calcium/cholecalciferol
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for 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 Cadelius is and what it is used for
2.
What you need to know before you take Cadelius
3.
How to take Cadelius
4.
Possible side effects
5.
How to store Cadelius
6.
Contents of the pack and other information
1.
What Cadelius is and what it is used for
Cadelius is used to prevent and treat calcium or vitamin D
3
deficiency in the elderly, and as an
additional treatment in the management of osteoporosis for patients
who are at risk of vitamin D or
calcium deficiency, when a dietary supplement as large as 600 mg/day
of calcium and 1000 IU/day of
Vitamin D
3
is supposed to be adequate.
Cadelius contains calcium and vitamin D
3
which both are important components for the formation of
bone. Vitamin D
3
regulates the uptake and metabolism of calcium as well as the
incorporation of
calcium in bone tissue.
Ask your doctor or pharmacist if you have further questions and always
follow their instructions.
You must talk to a doctor if you do not feel better or if you feel
worse after some days.
2.
What you need to know before you take Cadelius
Do not take Cadelius
-
if you are allergic to the calcium, vitamin D or any of the other
ingredients of this medicine
(listed in section 6)
-
if you have hypercalcaemia (increased levels of calcium in the blood)
or hypercalciuria (increased
levels in the urine)
-
if you have hypervitaminosis D (increased le

Summary of Product characteristics

Health Products Regulatory Authority
29 June 2023
CRN00DP55
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cadelius 600mg/1000 IU ordispersible tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One orodispersible tablet contains:
Calcium carbonate 1500 mg (equivalent to 600 mg calcium)
Cholecalciferol (Vitamin D
3
) 1000 I.U. (equivalent to 0,025 mg)
Excipients with known effect: aspartame (E 951), lactose, partially
hydrogenatedsoya bean oil, sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet
Round flat orodispersible tablets, white to almost white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of calcium and vitamin D deficiency in the
elderly. Vitamin D and calcium supplement in addition to
specific osteoporosis treatment of patients who are at risk of vitamin
D or calcium deficiency, when a dietary supplement as
large 600 mg/day of calcium and 1000 IU/day of Vitamin D3 is supposed
to be adequate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adults and elderly_
One orodispersible tablet per day.
_Dosage in hepatic impairment_
No dose adjustment is required
_Dosage in renal impairment_
Cadelius should not be used in patients with severe renal impairment
(see section 4.3).
_Paediatric population:_
There is no relevant indication for use of Cadelius orodispersible
tablets in children or adolescents
Method of administration:
The tablets may be sucked, they should not be swallowed whole.
The tablets should be taken preferably after meals
The amount of calcium inCadelius is less than the usually recommended
daily intake.
Cadelius is therefore primarily to be used by patients with need of
D-vitamin substitution but with a dietary intake of calcium of
500 mg-1000 mg per day. The patients dietary intake of calcium should
be estimated by the prescriber.
Health Products Regulatory Authority
29 June 2023
CRN00DP55
Page 2 of 6
4.3 CONTRAINDICATIONS

Hypersensitivity to calcium, cholecalciferol or to an