Adcal 1500mg chewable tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:

Calcium carbonate

Available from:

Kyowa Kirin International UK NewCo Ltd

ATC code:

A12AA04

INN (International Name):

Calcium carbonate

Dosage:

1.5gram

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09050101; GTIN: 5038903000136

Patient Information leaflet

                                Package Leaflet: Information for the patient
Adcal
®
1500 mg
Chewable Tablets
Calcium carbonate
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 is and what it is used for
2.
What you need to know before you take Adcal
3.
How to take Adcal
4.
Possible side effects
5.
How to store Adcal
6.
Contents of the pack and other information
1.
What Adcal is and what it is used for
Adcal
contains
calcium
which
is
essential
for
healthy
bones
and
teeth. Adcal provides extra calcium to your diet. It is therefore used
in
conditions where your body’s calcium levels need to be increased.
Adcal
can be prescribed by doctors for certain bone conditions.
2.
Before you take Adcal
Do not take Adcal:
●
If
you
are
allergic
to
calcium
carbonate
or
any
of
the
other
ingredients of this medicine (listed in Section 6).
●
If you have a higher than normal level of calcium in your blood
(hypercalcaemia).
●
If you have very high levels of calcium in your urine
(severe hypercalciuria).
●
If you have severe kidney failure and are not being treated by renal
dialysis.
●
If you have kidney stones.
●
If you have osteoporosis due to long-term immobility.
Warnings and precautions
Talk to your doctor or pharmacist before taking Adcal.
Tell your doctor or pharmacist if you:
●
have higher than normal levels of calcium in your urine
(mild to moderate hypercalciuria).
●
have mild to moderate problems with your kidneys.
●
have
previously
been
told
by
your
doctor
that
you
have
an
intolerance to some sugars.
●
are taking a
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Adcal 1500mg Chewable Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate: 1500mg
equivalent to 600mg of elemental calcium
3
PHARMACEUTICAL FORM
Chewable Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adcal is a chewable tablet recommended as a supplementary source of
calcium when
normal requirements are high and in the correction of calcium
deficiency in the diet.
They can be used in osteoporosis therapy as an adjunct to more
specific conventional
treatments. Adcal chewable tablets can be used as a phosphate binding
agent in the
management of renal failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
_Adults, elderly and children _
Dietary deficiency and as an adjunct in osteoporosis therapy; 2
chewable tablets per
day, preferably one tablet each morning and evening.
For use in binding phosphate in the management of renal failure in
patients on renal
dialysis, the dose should be adjusted for the individual patient and
is dependent on the
serum phosphate level.
The tablets should be chewed, not swallowed whole and taken just prior
to, during or
immediately following a meal.
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
untreated by
renal dialysis. Hypersensitivity to any of the tablet ingredients.
Relative contra-indications are osteoporosis due to prolonged
immobilisation, renal
stones, severe hypercalciuria.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with mild to moderate renal failure or mild hypercalciuria
should be
supervised carefully. Periodic checks of plasma calcium levels and
urinary calcium
excretion should be made in patients with mild to moderate renal
failure or mild
hypercalciuria.
Urinary calcium excretion should also be measured. In patients with a
history of
renal stones urinary calc
                                
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