Adcal-D3 Lemon chewable tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Calcium carbonate; Colecalciferol

可用日期:

Kyowa Kirin International UK NewCo Ltd

ATC代码:

A12AX

INN（国际名称）:

Calcium carbonate; Colecalciferol

剂量:

1.5gram ; 400unit

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: 5038903000365 5038903000372

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADCAL-D
3
®
LEMON CHEWABLE TABLETS
Calcium carbonate (1500 mg) and Vitamin D
3
(400 I.U.)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Adcal-D
3
Lemon is and what it is used for
2.
What you need to know before you take Adcal-D
3
Lemon
3.
How to take Adcal-D
3
Lemon
4.
Possible side effects
5.
How to store Adcal-D
3
Lemon
6.
Contents of the pack and other information
1.
WHAT ADCAL-D
3 LEMON
IS AND WHAT IT IS USED FOR
Adcal-D
3
Lemon contains calcium and vitamin D
3
which are both essential for healthy bones and
teeth.
Adcal-D
3
Lemon provides extra calcium and vitamin D
3
to your diet. It is therefore used in
conditions where your body’s calcium and vitamin D levels need to be
increased.
Adcal-D
3
Lemon can be prescribed by doctors for certain bone conditions, for
example, osteoporosis.
Studies show that taking calcium and vitamin D
3
over a long time can prevent hip and other non-
vertebral bone fractures in later life.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCAL-D
3 LEMON
DO NOT TAKE ADCAL-D
3 LEMON:
−
if you are allergic to calcium carbonate, vitamin D
3
or any of the other ingredients of this
medicine (listed in section 6).
−
if you are allergic to peanut or soya. Adcal-D
3
Lemon contains soya oil.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Adcal-D
3
Lemon.
Tell your doctor or pharmacist if you:
−
Have high levels of calcium in your blood (hypercalcaemia) or high
levels of calcium in your
urine (hypercalciuria

产品特点

OBJECT 1
ADCAL D3 LEMON CHEWABLE TABLETS
Summary of Product Characteristics Updated 28-Apr-2017 | Kyowa Kirin
Ltd
1. Name of the medicinal product
Adcal-D
3
®
Lemon Chewable tablets
2. Qualitative and quantitative composition
Per tablet:
Calcium carbonate: 1500 mg, equivalent to 600 mg of elemental calcium
Colecalciferol: 400 IU, equivalent to 10 μg vitamin D
3
This product also contains sucrose (part of the vitamin D
3
concentrate: approximately 1.7 milligrams per
tablet) and soya oil (also part of the vitamin D
3
concentrate: approximately 0.3 milligrams per tablet).
For full list of excipients see 6.1
3. Pharmaceutical form
Chewable tablet
4. Clinical particulars
4.1 Therapeutic indications
As an adjunct to specific therapy for osteoporosis and in situations
requiring therapeutic supplementation
of malnutrition e.g. in pregnancy and established vitamin D dependent
osteomalacia.
The prevention and treatment of calcium deficiency/vitamin D
deficiency especially in the housebound
and institutionalised elderly subjects. Deficiency of the active
moieties is indicated by raised levels of
PTH, lowered 25-hydroxy vitamin D and raised alkaline phosphatase
levels which are associated with
increased bone loss.
4.2 Posology and method of administration
Oral.
_Adults and Elderly and Children above 12 years of age:_
2 chewable tablets per day, preferably one tablet each morning and
evening.
_Children:_
Not recommended for children under 12 years.
4.3 Contraindications
Absolute contraindications are hypercalcaemia resulting for example
from myeloma, bone metastases or
other malignant bone disease, sarcoidosis; primary hyperparathyroidism
and vitamin D overdosage.
Severe renal failure. Hypersensitivity to any of the tablet
ingredients.
Relative contraindications are osteoporosis due to prolonged
immobilisation, renal stones, severe
hypercalciuria.
Adcal-D
3
Lemon contains a small quantity of soya oil and is therefore
contraindicated in patients who are
allergic to peanuts or soya.
4.4 Special warnings and precautions for us