SANDOCAL EFFERVESCENT 1000 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CALCIUM LACTOGLUCONATE, CALCIUM CARBONATE

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC code:

A12AA06

INN (International Name):

CALCIUM LACTOGLUCONATE, CALCIUM CARBONATE

Dosage:

1000 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Calcium

Authorization status:

Authorised

Authorization date:

2016-07-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SANDOCAL® 1000
EFFERVESCENT TABLETS
CALCIUM
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Sandocal carefully to
get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Sandocal is and what it is used for
2. Before you take Sandocal
3. How to take Sandocal
4. Possible side effects
5. How to store Sandocal
6. Further information
1. WHAT SANDOCAL IS AND WHAT IT IS USED FOR
Sandocal contains a rich source of calcium which is an essential
mineral, necessary for bone
formation and maintenance.
Sandocal is used in the prevention and treatment of calcium
deficiency, and may be used, with other
medicines, to prevent and treat a condition called osteoporosis
(weakening of the bones).
Sandocal is also used, together with vitamin D3, for the treatment of
rickets (softening of growing
bones in children) and osteomalacia (softening of adults bones).
Calcium is absorbed from the intestine and distributed throughout the
body in the blood.
Calcium plays an important role in several body functions. It is
essential for nerve, muscle and heart
function as well as for the clotting of blood.
In addition, it is necessary for many hormones to work properly in the
body. To carry out these
various roles, calcium must be available in the appropriate
concentration.
2. BEFORE YOU TAKE SANDOCAL
DO NOT TAKE SANDOCAL...
• If you are allergic to calcium and any of the other ingredients of
Sandocal (_see the list of _
_ingredients in section 6 at the end of the leaflet_).
• If you are suffering from raised levels of blood calcium
(hypercalcaemia);
• If you are suffering from increased calcium in your urine
(hypercalciuria)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sandocal 1000 Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet of 1000 mg contains:
2263 mg of calcium lactate gluconate and 1750 mg of calcium carbonate
(equivalent to 1000mg or 25mmol of
calcium).
Excipients:
3323mg of citric acid anhydrous (fine granulate), 30mg of aspartame (E
951), 500 mg of sodium hydrogen carbonate,
30 mg of Orange flavour powder (containing sorbitol (E 420) and
dextrose).
For a full list of excipients, see section 6.1
.
3 PHARMACEUTICAL FORM
Effervescent tablet
White, circular, flat faced, bevelled edge effervescent tablets with
an orange odour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
o
Prevention and treatment of calcium deficiency
o
Calcium supplement as an adjunct to specific therapy in the prevention
and treatment of
osteoporosis
o
Rickets and osteomalacia, in addition to vitamin D3 therapy
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: 500 – 1500 mg per day
Children: 500 – 1000 mg per day
The effervescent tablets should be dissolved in a glass of water
(approx. 200 ml) and drunk immediately. Sandocal
effervescent tablet may be taken with or without food.
4.3 CONTRAINDICATIONS
o
Hypersensitivity to the active substances or to any of the excipients
of the effervescent tablet
o
Diseases and/or conditions resulting in hypercalcaemia and/or
hypercalciuria
o
Nephrocalcinosis, nephrolithiasis
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For patients with mild hypercalciuria (exceeding 300 mg/24 hours or
7.5 mmol/24 hours), or with a history of urinary
calculi, monitoring of calcium excretion in the urine is required. If
necessary, the calcium dose should be reduced or
therapy should be discontinued. An increased fluid intake is
recommended for patients prone to formation of calculi in
the urinary tract.
In patients with impaired renal function, calcium salts should be
taken under medical supervision with monitoring of
calcium and phosphate serum levels.
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