Ideos 500mg/400IU Chewable Tablets

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

CALCIUM, COLECALCIFEROL

Beszerezhető a:

Laboratoire Innotech International 22 Avenue Aristide Briand, Arcueil 94110, France

ATC-kód:

A12AX

INN (nemzetközi neve):

CALCIUM 500 mg COLECALCIFEROL 400 IU

Gyógyszerészeti forma:

CHEWABLE TABLET

Összetétel:

CALCIUM 500 mg COLECALCIFEROL 400 IU

Recept típusa:

OTC

Terápiás terület:

MINERAL SUPPLEMENTS

Engedélyezési státusz:

Authorised

Engedély dátuma:

2006-08-11

Betegtájékoztató

1.3.1. Proposed Product Information Malta
November 2021
PACKAGE LEAFLET
1.3.1. Proposed Product Information Malta
November 2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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 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
IDEOS contains two active substances calcium and vitamin D3 (also
called cholecalciferol). It
belongs to a group of medicines called calcium, combinations with
vitamin D and or other
drugs.
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 indicated in adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IDEOS
1.3.1. Proposed Product Information Malta
November 2021
DO NOT TAKE IDEOS:
-
if you are allergic (hypersensitive) to calcium, vitamin D or any of
the other ingredients
of this medicine (listed in section 6),
-
if you are allergic (hypersensitive) to peanut or soya, due to the
presence of hydrogenated
soya bean oil,
-
if you have abnormal high level of calcium in your blood
(hypercalcaemia),
-
if you have high u

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
IDEOS 500 mg/400 IU, chewable tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 500 mg of calcium as 1250 mg calcium
carbonate and 400 IU of
cholecalciferol (vitamin D
3
) as 4 mg cholecalciferol concentrate (in powder form).
Cholecalciferol concentrate in powder form contains among others
alpha-tocopherol, hydrogenated
soya bean oil, sucrose.
Excipients with known effect:
Each tablet contains 475.0 mg of sorbitol (E420), 1.52 mg of sucrose,
and 0.3 mg of hydrogenated
soybean oil.
For the full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablets
Square, white-grey tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IDEOS is indicated only in adults for:
-
The correction of vitamin D and calcium combined deficiency in elderly
people.
-
Vitamin D and calcium supplementation, as an adjunct to specific
therapy for osteoporosis
treatment in patients with established or at high risk of vitamin D
and calcium combined
deficiencies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
One tablet twice a day.
Paediatric population
There is no relevant use of IDEOS in the paediatric population.
Method of administration
Oral use.
Chew or suck the tablets.
4.3 CONTRAINDICATIONS
-
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
-
This product contains hydrogenated soya bean oil. Patients should not
take this medicinal
product if they are allergic to peanut or soya.
-
Hypercalcaemia,
hypercalciuria,
and
diseases
and/or
conditions,
which
lead
to
hypercalcaemia
and/or
hypercalciuria
(e.g.
myeloma,
bone
metastases,
primary
hyperparathyroidism).
-
Calcium lithiasis, nephrocalcinosis.
-
Severe renal impairment (glomerular filtration rate < 30 ml/min). In
patients with severe
renal impairment, vitamin D3 in the form of cholecalciferol is not
metabolised in the
normal way and other forms of vitamin D3 must be used.
-
Hypervitaminosis D.
4.4 SPECIAL WARNING