Ideos 500 mg/400 IU Chewable Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cholecalciferol; Calcium carbonate

Available from:

PCO Manufacturing Ltd.

ATC code:

A12AX

INN (International Name):

Cholecalciferol; Calcium carbonate

Dosage:

500 mg/400 international unit(s)

Pharmaceutical form:

Chewable tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Authorised

Authorization date:

2004-06-11

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IDEOS
® 500 MG/400 IU
CHEWABLE TABLETS
calcium / 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 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 D
3
(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 dis

Summary of Product characteristics

Health Products Regulatory Authority
13 August 2019
CRN00925H
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ideos 500 mg/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 D3) …………………………………..
400 IU
(equivalent to 10 microgram(s))
Excipients with known effects: sorbitol, sucrose, hydrogenated soybean
oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablets.
_Product imported from Spain & Greece:_
Greyish white square chewable tablets, with a lemon flavour.
4 CLINICAL PARTICULARS
As per PA1033/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1033/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Product imported from Spain:
Xylitol (E967)
Sorbitol (E420)
Povidone
Lemon flavouring*
Magnesium stearate
*Composition of the lemon flavouring (essential oils of lemon, orange,
litsea cubeba, maltodextrin, acacia gum, sodium citrate)
The vitamin D3 concentrate may contain sucrose and soyabean oil.
Product imported from Greece:
Xylitol (E967)
Sorbitol (E420)
Povidone
Lemon flavouring*
Magnesium stearate
*Composition of the lemon flavouring (flavouring preparations, natural
flavouring substances, maldodextrin, acacia, sodium
citrate, citric acid, butylated hydroxyanisole)
Excipients in Vitamin D3 concentrate (cholecalciferol):
alpha-tocopherol, partially hydrogenated soyabean oil, gelatin,
sucrose,
maize starch.
Health Products Regulatory Authority
13 August 2019
CRN00925H
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C. Store in the original container.
6.5 NATURE AND CONTENTS OF CONTAINER
4 x Polypropylen