CALCICHEW-D 500/1000 mg/IU Tablets Chewable

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, ALL-RAC ALPHA-TOCOPHEROL, MEDIUM CHAIN TRIGLYCERIDES, MODIFIED MAIZE STARCH, SUCROSE, SODIUM ASCORBATE, SILICA COLLOIDAL ANHYDROUS

Boleh didapati daripada:

Takeda UK Limited

Kod ATC:

A12AX

INN (Nama Antarabangsa):

CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, ALL-RAC ALPHA-TOCOPHEROL, MEDIUM CHAIN TRIGLYCERID

Dos:

500/1000 mg/IU

Borang farmaseutikal:

Tablets Chewable

Laluan pentadbiran:

Oral use

Unit dalam pakej:

Pack sizes: 30, 60, 90, 100 and 120 tablets

Jenis preskripsi:

Product not subject to medical prescription

Kumpulan terapeutik:

Mineral supplements

Kawasan terapeutik:

Calcium, combinations with other drugs

Tanda-tanda terapeutik:

Prevention and treatment of vitamin D and calcium deficiency. Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency

Status kebenaran:

Authorised

Tarikh kebenaran:

2015-07-10

Risalah maklumat

1

PACKAGE LEAFLET: INFORMATION FOR THE USER 

CALCICHEW-D
3
 EXTRA 500 MG/1000 IU CHEWABLE TABLETS 
calcium/cholecalciferol (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
 Extra is and what it is used for 
2. 
What you need to know before you take Calcichew-D
3
 Extra 
3. 
How to take Calcichew-D
3
 Extra 
4. 
Possible side effects 
5. 
How to store Calcichew-D
3
 Extra 
6. 
Contents of the pack and other information 

1. 
WHAT CALCICHEW-D
3
 EXTRA IS AND WHAT IT IS USED FOR 

Calcichew-D
3
 Extra are chewable tablets containing calcium and vitamin D
3
, which both are 
important substances in bone formation. Calcichew-D
3
 Extra is used in the prevention and treatment 
of calcium and vitamin D deficiency, and as a supplement to
specific treatment of osteoporosis. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW-D
3
 EXTRA 

DO NOT TAKE CALCICHEW-D
3
 EXTRA: 
- 
if you are allergic to calcium, vitamin D or any of the
other ingredients of this medicine (listed 
in section 6) 
- 
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 

WARNINGS AND PRECAUTIONS 
Talk to your doctor or pharmacist before taking Calcichew-D
3
 Extra 
- 
if you are on lo

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Extra 500 mg/1000 IU chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate equivalent to 500 mg calcium
Cholecalciferol concentrate (powder form) equivalent to 1000 IU (25
microgram) cholecalciferol (vitamin D
3
)
Excipient(s) with known effect:
One tablet contains 1 mg aspartame (E951), 49.9 mg isomalt (E953)
(contained in the flavour), 390 mg sorbitol (E420)
and 1.75 mg sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Round, white, uncoated and convex tablets of 16 mm. May have small
specks.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D and calcium deficiency.
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 once daily.
The amount of calcium in Calcichew-D
3
Extra is lower than the recommended daily intake. Calcichew-D
3
Extra is
therefore primarily to be used by patients with need of D-vitamin
supplementation, but who have some dietary intake
of calcium.
SPECIAL PATIENT POPULATIONS
_Paediatric population:_
Calcichew-D
3
Extra tablets are not intended for use in children or adolescents.
_Impaired renal function_
Calcichew-D
3
Extra should not be used in patients with severe renal impairment (see
section 4.3).
_Impaired hepatic function_
No dose adjustment is required
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