Adcal-D3 Lemon chewable tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Calcium carbonate; Colecalciferol

Доступна с:

Mawdsley-Brooks & Company Ltd

код АТС:

A12AX

ИНН (Международная Имя):

Calcium carbonate; Colecalciferol

дозировка:

1.5gram ; 400unit

Фармацевтическая форма:

Chewable tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 09060400

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADCAL-D
3
® LEMON CHEWABLE TABLETS
Calcium carbonate (1500 mg) and Vitamin D
3
(400 I.U.)
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).
If you are unsure your doctor will advise you.
-
Have problems with your kidneys, for example kidney stones.
-
Have sarcoidosis (inflammation that produces lumps of cells in various
organs in the body), your doctor will be able
to tell you if you do.
-
Have previously been told by your doctor that you have an intolerance
to some sugars.
-
Are taking any other medication, even those you may have bought for
yourself without prescription.
OTHER MEDICINES AND ADCAL-D
3 LEMON
Tell your doctor if you are taking calcium supplements or antacids for
indigestion, digitalis drugs (eg. Lanoxin), diuretics
or corticosteroids.
If you are taking thyroxine, bisphosphonates, iron or fluoride
medicines, tetracycline or quinolone antibiotics make sure
your doctor knows this. When taking these medicines leave a peri

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Adcal-D
3
Lemon Chewable tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate: 1500mg, equivalent to 600mg of elemental calcium.
Colecalciferol: 400iu, equivalent to 10
μ
g vitamin D3.
This
product
also
contains
sucrose
(part
of
the
vitamin
D3
concentrate:
approximately 1.7 milligrams per tablet) and soya oil (also part of
the vitamin
D3 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 contra-indications 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 contra-indications 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 USE
Patients with mild to moderate renal failure or mild hypercalciuri