Ca-C 1000 Sandoz

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE, CALCIUM LACTOGLUCONATE, ASCORBIC ACID

Available from:

Novartis Consumer Health UK Limited Park View, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, United Kingdom

ATC code:

A11GB01

INN (International Name):

CALCIUM CARBONATE 0.327 g CALCIUM LACTOGLUCONATE 1 g ASCORBIC ACID 1 g

Pharmaceutical form:

EFFERVESCENT TABLET

Composition:

CALCIUM CARBONATE 0.327 g CALCIUM LACTOGLUCONATE 1 g ASCORBIC ACID 1 g

Prescription type:

OTC

Therapeutic area:

VITAMINS

Authorization status:

Withdrawn

Authorization date:

2007-04-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT/USER
CALCIUM C 1000 SANDOZ
1000MG EFFERVESCENT TABLETS
Calcium lactate gluconate + calcium carbonate + vitamin C
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has
told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you or your child gets any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet.

You must talk to a doctor if you or your child does not feel better or
feels worse.
WHAT IS IN THIS LEAFLET
1
What Calcium C is and what it is used for
2
What you need to know before you use Calcium C
3
How to use Calcium C
4
Possible side effects
5
How to store Calcium C
6
Contents of the pack and other information
1
WHAT CALCIUM C IS AND WHAT IT IS USED FOR
Calcium C contains three active ingredients, two are calcium salts
(calcium lactate gluconate and
calcium carbonate) and the third is ascorbic acid (vitamin C).
Calcium is an essential mineral, necessary for bone formation and
maintenance. Calcium also
plays an important role in the way the body functions. It is essential
for nerve, muscle and heart
function as well as for clotting of blood. In addition, it mediates
the action of many hormones.
To carry out these various roles, calcium must be available to the
appropriate tissues in the
proper concentration.
Vitamin C plays an important role in biochemical processes. It is also
needed for collagen
formation (found in bone, cartilage, skin, and other tissues) and
tissue repair.
High doses of vitamin C are found to be effective in the prevention
and treatment of upper
respiratory tract infections.
Calcium C is used when you or your child has:
Calcium and vitamin C deficiency, which can be the result of poor
nutrition or may occur due to
an increase in requirem

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calcium C 1000 Sandoz 1000mg effervescent tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet (orange flavor) contains:
1.0g calcium lactate-gluconate and 0.327g calcium carbonate
(equivalent to 260 mg or
6.5 mmol ionizable calcium)
1.0
g ascorbic acid (vitamin C)
Excipient(s): sodium and sucrose.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Effervescent tablet
CALCIUM C (ORANGE)
Yellowish mottled orange circular flat effervescent tablet with
beveled edge and odor of
lemon.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Increased demand for calcium and ascorbic acid, e.g. in pregnancy and
lactation,
during
periods
of
rapid
growth
(childhood,
adolescence),
in
old
age,
during
infectious disease and convalescence

Treatment of calcium and ascorbic acid deficiency

Adjuvant in colds and influenza
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 7 years of age and older: 1 effervescent tablet
daily
Children 3 to 7 years: ½ effervescent tablet daily
Infants:_ _as prescribed by the physician
The effervescent tablet should be dissolved in a glass of water
(approx. 200 ml) and drunk
immediately. Calcium C effervescent tablet may be taken with or
without food.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Diseases and/or conditions resulting in hypercalcemia and/or
hypercalciuria.
Nephrocalcinosis or 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 dosage 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