Cadelius 600 mg / 2000 IU orodispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium carbonate; Colecalciferol

Available from:

Italfarmaco S.A.

ATC code:

A12AX

INN (International Name):

Calcium carbonate; Colecalciferol

Dosage:

600 mg+ 2000 international unit(s)

Pharmaceutical form:

Orodispersible tablet

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Not marketed

Authorization date:

2020-08-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Cadelius 600 mg / 2,000 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 treat calcium and vitamin D deficiency in adults.
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 levels of vitamin D in the
blood).
-
if you have kidney stones
-
if you have kidney failure
- if you are pregnant
-
if you are allergic to soya or peanuts.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cadelius
-
if you suffer from sarcoido

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 600 mg / 2000 IU orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 1500 mg calcium carbonate
(equivalent to 600 mg calcium) and 2,000 IU (50 micrograms)
cholecalciferol (vitamin D
3
).
Excipients with known effect
Each orodispersible tablet contains 44.32 mg lactose (as lactose
monohydrate), 8.67 mg aspartame (E951), 7.6 mg sucrose and
1.5 mg partially hydrogenated soybean oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
Round and flat, white or almost white, orodispersible tablet with a
diameter of 19 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cadeliusis indicated in adults for treatment of calcium and vitamin D
deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly_
One orodispersible tablet daily (corresponding to 600 mg of calcium
and 2,000 IU of vitamin D3).
Alternatively, national posology recommendations in treatment of
vitamin D deficiency can be followed.
After first month, lower doses may be considered, dependent upon
desirable serum levels of 25-hydroxycolecalciferol
(25(OH)D), the severity of the disease and the patient´s response to
treatment.
The dose of vitamin D depends on the severity of the disease,
desirable serum levels of 25-hydroxycholecalciferol (25(OH)D)
and patient´s response to treatment.
The amount of calcium in Cadelius is less than the usually recommended
daily intake. Cadelius is therefore to be used primarily
by patients with need of vitamin D substitution but with a dietary
intake of calcium of 500–1,000 mg daily.
Patient's dietary intake of calcium should be estimated by their
prescriber. Mono preparation is necessary for dose adjustment
_Paediatric population_
Cadelius is contraindicated for use in children and adolescents aged 0
– 18 years (see section 4.3).
_Dosage in renal impairment_