Calci-D 1000mg/1,000unit chewable tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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下载 资料单张 (PIL)
05-07-2018
下载 产品特点 (SPC)
05-07-2018

有效成分:

Colecalciferol; Calcium carbonate

可用日期:

Forum Health Products Ltd

ATC代码:

A12AX

INN(国际名称):

Colecalciferol; Calcium carbonate

剂量:

1000unit ; 2.5gram

药物剂型:

Chewable tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 09060400; GTIN: 5391512453220

资料单张

                                WHAT IS IN THIS LEAFLET
1. What CALCI-D is and what it is
used for
2. What you need to know before you
take CALCI-D
3. How to take CALCI-D
4. Possible side effects
5. How to store CALCI-D
6. Contents of the pack and other
information
1. WHAT CALCI-D IS AND WHAT IT
IS USED FOR
CALCI-D chewable tablets contain two
active substances, calcium carbonate
and colecalciferol (vitamin D3). Both
calcium and vitamin D3 are found in
the diet and vitamin D is also produced
in the skin after exposure to the sun.
CALCI-D chewable tablets may be
prescribed by doctors to treat and
prevent vitamin D/calcium deficiency.
CALCI-D is used:
•
in the correction of calcium and
vitamin D deficiencies in the elderly,
•
in combination with osteoporosis
treatments where calcium and vitamin
D levels are too low or where there is
a high risk of them being too low.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CALCI-D
DO NOT TAKE CALCI-D:
•
If you are allergic to calcium
carbonate or colecalciferol (vitamin
D3) or any of the other ingredients of
this medicine (listed in section 6);
•
if you are inactive and have high
levels of calcium in your blood
(hypercalcaemia) or urine
(hypercalciuria);
•
if you have calcium deposits in the
tissues of your body;
•
if you have serious kidney problems;
•
if you have kidney stones or calcium
stones in general;
•
if you have abnormally high levels of
vitamin D;
•
if you are less than 18 year of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before taking CALCI-D.
Take special care with CALCI-D if
you:
•
if you have had kidney stones or other
kidney problems (your doctor will
need to monitor your treatment
carefully if your kidneys are not
working properly to make sure you do
not build up too much calcium in your
blood)
•
if you stay in bed for a long period
(months) and if you have osteoporosis
(brittle bones) because you may have
high levels of calcium in your blood
•
if you are taking any other medicines
containing calcium or vitamin D (your
doctor or your pharmacist will 
                                
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产品特点

                                OBJECT 1
CALCI-D 1000 MG /1000 IU CHEWABLE TABLETS
Summary of Product Characteristics Updated 09-Mar-2016 | Consilient
Health Ltd
1. Name of the medicinal product
CALCI-D 1000 mg /1000 IU chewable tablets
2. Qualitative and quantitative composition
One tablet contains:
calcium carbonate
colecalciferol (Vitamin D3)
2500 mg (equivalent to 1000 mg calcium)
1000 I.U. (equivalent to 0.025 mg)
Excipients with known effect: sucrose, isomaltitol (E953).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet
The chewable tablet has a round shape and is white to almost white
with a break mark.
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Correction of calcium and Vitamin D deficiency in the elderly.
CALCI-D may be used as an adjunct to specific therapy for
osteoporosis, in patients with either
established vitamin D and calcium combined deficiencies or in those
patients at high risk of needing such
therapeutic supplements.
4.2 Posology and method of administration
Posology
Adults and elderly: 1 tablet/day for oral use
The tablets may be chewed or sucked, they should not be swallowed
whole.
It is advisable to take the preparation during the evening meal.
Paediatric population: There is no relevant use of CALCI-D chewable
tablets in the paediatric population.
Dosage in pregnant women: One half- tablet a day (see section 4.6).
Patients with hepatic dysfunction: No dosage adjustment is required.
Patients with renal dysfunction: CALCI-D should not be used in
patients with severe renal dysfunction.
4.3 Contraindications
- Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1.
- Hypercalcaemia (>10.5 mg/dl), hypercalciuria (300 mg or 7.5 mmol/24
hours), severe renal
insufficiency, nephrolithiasis, nephrocalcinosus, calcification of
tissues, diseases and/or conditions
resulting in hypercalciurea and/or hypercalcaemia.
- Hypervitaminosis D.
4.4 Special warnings and precautions for use
- During long-term treatmen
                                
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