CALCICHEW-D 500/10 Film Coated Tablet

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)

Mevcut itibaren:

Takeda UK Limited

ATC kodu:

A12AX

INN (International Adı):

CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)

Doz:

500/10

Farmasötik formu:

Film Coated Tablet

Reçete türü:

Product not subject to medical prescription

Terapötik alanı:

Calcium, combinations with other drugs

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2014-01-06

Bilgilendirme broşürü

1 

PACKAGE LEAFLET:  INFORMATION FOR THE USER 
Calcichew-D
3
 Forte 500 mg/400 IU film-coated tablets  
calcium / colecalciferol (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. 

WHAT IS IN THIS LEAFLET:  
1. 
What Calcichew-D
3
 Forte film-coated tablets are and what they are used for 
2. 
What you need to know before you take Calcichew-D
3
 Forte film-coated tablets 
3. 
How to take Calcichew-D
3
 Forte film-coated tablets 
4. 
Possible side effects 
5. 
How to store Calcichew-D
3
 Forte film-coated tablets 
6. 
Contents of the pack and other information 

1. 
WHAT CALCICHEW-D
3
 FORTE FILM-COATED TABLETS IS AND WHAT IT IS USED FOR 

Calcichew-D
3
 Forte film-coated tablets are film-coated tablets
containing calcium and vitamin D3, which 
both are important substances in bone formation. Calcichew-D
3
 Forte film-coated tablets are used in the 
prevention and treatment of calcium and vitamin D deficiency in
the elderly, and as a supplement to specific 
treatment of osteoporosis.  

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW-D
3
 FORTE FILM-COATED TABLETS 

DO NOT TAKE CALCICHEW-D
3
 FORTE FILM-COATED TABLETS: 
- 
if you have excessive amounts of calcium in the blood or in the
urine. 
- 
if you have severe kidney problems 
-  
if you have kidney stones. 
- 
if you have excessive amounts of vitamin D in the blood.   
- 
if you are allergic to calc

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Forte 500 mg / 400 IU Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate equivalent to 500 mg calcium
Cholecalciferol concentrate (powder form) equivalent to 400 IU (10
microgram ) cholecalciferol (vitamin D
3
)
Excipients with known effect:
Sorbitol (E420), 154 mg
Sucrose, 0.7 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, white/off white, film-coated tablets. May have hardly visible
grey spots.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D and calcium deficiency in the
elderly.
Vitamin D and calcium supplement as an adjunct to specific
osteoporosis treatment of patients who are at risk of
vitamin D and calcium deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS AND ELDERLY_
One tablet twice daily.
SPECIAL PATIENT POPULATIONS
_PAEDIATRIC POPULATION:_
Calcichew-D3 Forte 500mg/400 IU Film-coated tablets is not intended
for use in children.
_IMPAIRED RENAL FUNCTION:_
Calcichew-D3 Forte 500mg/400 IU Film-coated tablets should not be used
in patients with severe renal impairment
(see section 4.3).
_IMPAIRED HEPATIC FUNCTION:_
No dose adjustment is required
METHOD OF ADMINISTRATION
Oral. The tablet should be swallowed or chewed.
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