IDEOS 500mg/400 IU Chewable Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Cholecalciferol; Calcium carbonate

Beschikbaar vanaf:

Laboratoire Innotech International

ATC-code:

A12AX

INN (Algemene Internationale Benaming):

Cholecalciferol; Calcium carbonate

Dosering:

500 mg/400 international unit(s)

farmaceutische vorm:

Chewable tablet

Prescription-type:

Product not subject to medical prescription

Therapeutisch gebied:

Calcium, combinations with vitamin D and/or other drugs

Autorisatie-status:

Marketed

Autorisatie datum:

1996-01-08

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IDÉOS 500MG/400 IU CHEWABLE TABLETS
CALCIUM / VITAMIN D
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 IDEOS is and what it is used for
2. What you need to know before you take IDEOS
3. How to take IDEOS
4. Possible side effects
5. How to store IDEOS
6. Contents of the pack and other information
1. WHAT IDEOS IS AND WHAT IT IS USED FOR
This medicine provides calcium and vitamin D3 (also called
cholecalciferol) to the body.
This medicine is used:

in case of vitamin D and calcium deficiency in the elderly.

in association with some treatments of osteoporosis (a condition where
bone mass decreases and
bone brittleness increases), when there is deficiency or a risk of
deficiency in vitamin D and
calcium.
This medicine is intended for use in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IDEOS
DO NOT TAKE IDEOS:
- If you are allergic (hypersensitive) to calcium or vitamin D or any
of the other ingredients of this
medicine (listed in section 6).
- if you are allergic (hypersensitive) to peanut or soya (this product
contains soybean oil),
- if you have high calcium levels in your blood (hypercalcaemia),
- If you have high levels of calcium in your urine (hypercalciuria),
- If you have a condition that leads to hypercalcaemia and/or
hypercalciuria (e.g. overactive
parathyroid glands, a disease of the bone marrow, a malignant bone
tumor, bone metastases),
- If you are suffering from kidney disease (kidney failure),
- If

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
IDEOS 500mg/400 IU Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS PER TABLET:
Calcium carbonate
.........................................................
1250 mg
(equivalent to 500 mg of elemental calcium)
Cholecalciferol (vitamin D
3
) .............................................
400 IU
(equivalent to 10 µg)
Excipients with known effects: 475mg sorbitol, 1.52mg sucrose, 0.3mg
hydrogenated soya bean oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Chewable tablets.
Greyish white, square, tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-Vitamin D and calcium deficiency correction in the elderly.
-Vitamin D and calcium supplementation as an adjunct to specific
therapy for osteoporosis in patients with established,
or at high risk of vitamin D and calcium combined deficiencies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adults only.
Oral use.
Chew or suck the tablets.
One tablet, twice a day.
4.3 CONTRAINDICATIONS
-Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
-Hypercalcaemia, as a result of hyperparathyroidism (primary or
secondary), hypercalciuria, calcium lithiasis, tissue
calcifications (nephrocalcinosis)
-Vitamin D overdose
-Myeloma and bone metastases
-Renal insufficiency (creatinine clearance < 20 ml/min)
-This product contains partially hydrogenated soybean oil. Patients
should not take this medicinal product if they are
allergic to peanut or soya.
Idéos tablets are also contra-indicated in patients where prolonged
immobilisation is accompanied by hypercalcaemia
and/or hypercalciuria. In these cases, treatment should only be
resumed when the patient becomes mobile.
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