Calcium-sandoz forte

Package leaflet: Information for the patient

CALCIUM-SANDOZ Forte, 500 mg, effervescent tablets
Calcium
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• Consult your doctor or pharmacist if you need advice or further information.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, you should contact your doctor.

Contents of the leaflet

1. What CALCIUM-SANDOZ Forte is and what it is used for
2. Important information before taking CALCIUM-SANDOZ Forte
3. How to take CALCIUM-SANDOZ Forte
4. Possible side effects
5. How to store CALCIUM-SANDOZ Forte
6. Contents of the pack and other information

1. What CALCIUM-SANDOZ Forte is and what it is used for

CALCIUM-SANDOZ Forte is a rich source of calcium, which is a fundamental mineral component necessary for the formation and proper functioning of bones.
CALCIUM-SANDOZ Forte is indicated for the prevention and treatment of calcium deficiency and may be used concomitantly with other agents for the prevention and treatment of a condition known as osteoporosis (bone weakening).
CALCIUM-SANDOZ Forte may also be used concomitantly with vitamin D in the treatment of rickets (softening of growing bones in children) and osteomalacia (softening of bones in adults).
Calcium is absorbed in the small intestine and distributed throughout the body via the bloodstream. Calcium plays an essential role in organ function. It is necessary for the proper functioning of nerves, muscles, and the heart, as well as for normal blood coagulation. Additionally, calcium is involved in the proper functioning of hormones. To fulfill these functions, calcium must be delivered to tissues in appropriate concentrations.

2. Important information before using CALCIUM-SANDOZ Forte

When not to use CALCIUM-SANDOZ Forte
if the patient is allergic (hypersensitive) to calcium or any of the other ingredients of CALCIUM-SANDOZ Forte (see the list of ingredients in section 6 at the end of the leaflet).
if the patient has increased calcium levels in the blood (hypercalcemia).
if the patient has increased calcium levels in the urine (hypercalciuria).
if the patient has kidney diseases, including kidney stones (nephrolithiasis) and deposition of calcium in kidney tissues (nephrocalcinosis).

Warnings and precautions
If the patient has kidney disease, the medicine should be used only after consultation with a doctor, especially when taking medications containing aluminium.
Do not use vitamin D-containing medications together with CALCIUM-SANDOZ Forte without medical advice.

CALCIUM-SANDOZ Forte and other medicines
You must tell your doctor about all medicines you have recently taken, even those available without a prescription, because calcium may interact with other medicines taken at the same time.
If the patient is taking or has recently taken cardiac glycosides, thiazide diuretics, or corticosteroids, follow the doctor's instructions.
If the patient is taking oral bisphosphonates or sodium fluoride, CALCIUM-SANDOZ Forte should be taken at least 3 hours after these medicines.
If the patient is taking one of the group of antibiotics called tetracyclines, CALCIUM-SANDOZ Forte should be taken at least 2 hours after or 4 to 6 hours before taking tetracycline.

CALCIUM-SANDOZ Forte with food and drink
Do not take CALCIUM-SANDOZ Forte within 2 hours of consuming foods rich in oxalic and phytic acid, such as spinach, rhubarb, and whole grain cereals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using CALCIUM-SANDOZ Forte.
CALCIUM-SANDOZ Forte may be used during pregnancy and breastfeeding when calcium deficiency occurs. The recommended daily calcium intake (including food and supplements) for pregnant and breastfeeding women is 1000–1300 mg. During pregnancy and breastfeeding, the daily calcium intake should not exceed 1500 mg.
Calcium passes into breast milk, but this does not cause any adverse effects in the breastfed infant.

Driving and operating machinery
CALCIUM-SANDOZ Forte has no effect on the ability to drive motor vehicles or operate machinery.

CALCIUM-SANDOZ Forte contains aspartame, sodium, sorbitol, benzyl alcohol, sulfur dioxide, and glucose
CALCIUM-SANDOZ Forte may be used by patients with diabetes (1 effervescent tablet contains 0.002 carbohydrate exchange units - WW).
This medicine contains 68.45 mg of sodium (main component of table salt) in each effervescent tablet. This corresponds to 3.4% of the maximum recommended daily sodium intake in the diet of adults.
This medicine contains 180 nanograms of benzyl alcohol in each effervescent tablet. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with a risk of severe adverse reactions, including respiratory disturbances (so-called "gasping syndrome"). Do not administer to newborns (up to 4 weeks of age) without medical advice. Do not administer to young children (under 3 years of age) for longer than one week without medical advice or consultation with a pharmacist.
Pregnant or breastfeeding women, as well as patients with liver or kidney disease, should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
This medicine contains 210 nanograms of sulfur dioxide, which rarely may cause severe hypersensitivity reactions and bronchoconstriction.
This medicine contains 30 mg of aspartame (E 951) in each effervescent tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
This medicine contains 630 micrograms of sorbitol in each effervescent tablet.
This medicine contains glucose. If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine. It may also have harmful effects on teeth.

3. How to use CALCIUM-SANDOZ Forte

As with any medicine, you should carefully read the following information to
ensure that CALCIUM-SANDOZ Forte is used correctly.
Children: one effervescent tablet (one dose) once or twice daily (corresponding to 500–1000 mg
of calcium).
Adults: one effervescent tablet (one dose) once, twice, or three times daily (corresponding to
500–1500 mg of calcium).
The effervescent tablet must be dissolved in a glass of water (approximately 200 ml) and taken
immediately after dissolving. The tablets must not be swallowed or chewed.
CALCIUM-SANDOZ Forte may be taken with meals or between meals (see section "Taking
CALCIUM-SANDOZ Forte with food and drink").
How long to take CALCIUM-SANDOZ Forte
CALCIUM-SANDOZ Forte, at the recommended doses, may be taken for as long as advised by
your doctor. Since CALCIUM-SANDOZ Forte is used for the prevention and treatment of calcium
deficiency, and is often used together with other medications for the treatment and prevention of
osteoporosis (weakening of the bones), treatment will likely be long-term.
Taking more CALCIUM-SANDOZ Forte than recommended
Symptoms of overdose may include: nausea, vomiting, thirst, or constipation. If overdose is
suspected, seek immediate medical advice from a doctor or pharmacist.
If you forget to take CALCIUM-SANDOZ Forte
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, CALCIUM-SANDOZ Forte may cause side effects, although not
everyone will experience them.
Very rare side effects (occurring in fewer than 1 in 10,000 people):
severe allergic reactions such as swelling of the face, lips, tongue and (or) throat, which may cause
difficulty in swallowing.
If any of these allergic symptoms occur, you must STOP taking CALCIUM-SANDOZ Forte and
seek immediate medical advice from a doctor.
Rare side effects (occurring in fewer than 1 in 1,000 people):
nausea, diarrhoea, abdominal pain, constipation, bloating, vomiting, itching, redness and (or)
burning of the skin.
Uncommon side effects (occurring in fewer than 1 in 100 people):
increased calcium levels in the blood (hypercalcaemia) or increased excretion of calcium
in the urine (hypercalciuria).
If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your
doctor or pharmacist.
Reporting of side effects
If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or
nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, additional information on the safety of the medicine can be collected.

5. How to store CALCIUM-SANDOZ Forte

Keep this medicine out of the sight and reach of children.
Do not use CALCIUM-SANDOZ Forte after the expiry date stated on the carton and tube after the abbreviation "EXP". The expiry date refers to the last day of the specified month.
Store in a tightly closed container. Keep in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What CALCIUM-SANDOZ Forte contains
The active substances in the medicine are calcium lactogluconate and calcium carbonate.
One 500 mg tablet contains 1132 mg of calcium lactogluconate and 875 mg of calcium carbonate (corresponding to 500 mg of calcium).
The other ingredients are: anhydrous citric acid, orange flavour [containing: benzyl alcohol, glucose, sorbitol (E 420) and sulphur dioxide (E 220)], aspartame (E 951), macrogol 6000 and sodium hydrogen carbonate.

What CALCIUM-SANDOZ Forte looks like and contents of the pack
The effervescent tablet is white, round, and has a characteristic orange odour.
CALCIUM-SANDOZ Forte is available in packs containing 20 effervescent tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
DELPHARM ORLEANS
5, Avenue de Concyr
F-45071 Orléans La Source Cedex 02
France
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben, Germany
Haleon Germany GmbH
Barthstrasse 4
80339 Munich, Germany

For further information about the medicine and its trade names in the European Economic Area countries,
please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00