Calcichew-D3 Forte Chewable Tablets, calcium carbonate / colecalciferol equivalent to 500mg Calcium / 400 IU colecalciferol

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Cholecalciferol; Calcium carbonate

Sẵn có từ:

Imbat Limited

Mã ATC:

A12AX

INN (Tên quốc tế):

Cholecalciferol; Calcium carbonate

Liều dùng:

500mg/400IU mg/IU

Dạng dược phẩm:

Chewable tablet

Loại thuốc theo toa:

Product not subject to medical prescription

Khu trị liệu:

Calcium, combinations with vitamin D and/or other drugs

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2012-09-28

Tờ rơi thông tin

Base Label - 175mm
Height - 60mm
Front Cover - 115mm
Page 20 - 95mm
Height - 60mm
Doncaster Pharmaceuticals
20pp Kleerformat
02/02/2012
60x175mm
60x115mm(folded)
RNC
Page 17 - 95mm
Page 4 - 95mm
Height - 60mm
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Page 5 - 95mm
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Height - 60mm
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Height - 60mm
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Each tablet contains 1250mg calcium carbonate (equivalent to 500mg
calcium) and 400IU colecalciferol (equivalent to 10 micrograms vitamin
D3)
Also contains sorbitol (E420), isomalt (E953), sucrose and aspartame
(E951)
Please read the patient information leaflet for further information
For oral administration
Adults and the elderly: 2 chewable tablets a day, preferably one
tablet
morning and evening
The tablets should be chewed or sucked
Keep out of the sight and reach of children
Do not store above 30°C. Store in the original package to protect
from
moisture
Manufactured by Nycomed Pharma AS, Drammensveien 852,
N-1385 Asker, Norway
Procured from within the EU by the PPA holder: Imbat Ltd, Unit L2,
North Ring Business Park, Santry, Dublin 9
Repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, South Yorkshire, DN3 1QR, UK
PPA No: 1151/155/1
ECMA No: 08557/0029
* Registered trademark
PATIENT INFORMATION LEAFLET CALCICHEW*-D3 FORTE CHEWABLE TABLETS calcium carbonate / colecalciferol
equivalent to 500mg calcium / 400IU colecalciferol
Your medicine is available using the name Calcichew-D3 Forte
Chewable Tablets but will be referred to as Calcichew-D3 Forte
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Calcichew-D3 Forte carefully to get the best results
from it.
People with diets and lifestyles that mean they will obtain less than
the
recommended intake of calcium and vitamin D are at risk of weakened
bones. Prolonged lack of adequate calcium an

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Forte Chewable Tablets, calcium carbonate / colecalciferol equivalent
to 500mg Calcium / 400 IU
colecalciferol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate 1250 mg
(equivalent to 500 mg of elemental calcium)
Colecalciferol 400 IU
(equivalent to 10 micrograms vitamin D3)
Contains sorbitol 390mg, isomalt 49.90mg, aspartame 1mg and sucrose
0.77mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
_Product imported from the UK_
Round, white, uncoated and convex tablet. May have small specks.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcichew-D
3
Forte Chewable Tablets should only be used as a therapeutic supplement
when the diet is deficient.
It
should not be used as a food supplement.
The prophylaxis and treatment of combined vitamin D and calcium
deficiency particularly in housebound and
institutionalised elderly subjects.
The supplementation of vitamin D and calcium as an adjunct to specific
therapy for osteoporosis or as a therapeutic
supplement in established osteomalacia, pregnant patients at high risk
of deficiency or malnutrition when dietary intake
is less than that required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
_Adults and elderly:_ 2 chewable tablets per day, preferably one
tablet morning and evening.
The tablet may be chewed or sucked.
_Dosage in hepatic impairment:_
No dose adjustment is required.
_Dosage in renal impairment:_
Calcichew-D
3
Forte chewable tablets should not be used in patients with severe
renal impairment.
Calcichew-D
3
Forte chewable tablets are not intended for use in children.
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