Calcium-sandoz Forte

Leaflet attached to the packaging: patient information

CALCIUM-SANDOZ Forte, 500 mg, effervescent tablets

Calcium

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor or pharmacist.

• This leaflet should be kept in order to read it again if necessary.
• The doctor or pharmacist should be consulted if advice or additional information is needed.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact the doctor.

Table of contents of the leaflet

• 1. What is CALCIUM-SANDOZ Forte and what is it 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 packaging and other information

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

CALCIUM-SANDOZ Forte is a rich source of calcium, which is an essential mineral component
necessary for building and proper functioning of bones.
CALCIUM-SANDOZ Forte is indicated for the prevention and treatment of calcium deficiencies and can be
used in combination with other preparations for the prevention and treatment of a condition called
osteoporosis (bone weakness).
CALCIUM-SANDOZ Forte can also be used in combination with vitamin D for 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 with the blood throughout the body. Calcium plays
a crucial role in the functioning of organs. It is necessary for the proper functioning of nerves, muscles, and heart, as well as for proper blood clotting.
Additionally, calcium also mediates the proper functioning of hormones. To perform these functions, it must be delivered to tissues in the appropriate concentration.

2. Important information before taking CALCIUM-SANDOZ Forte

When not to take CALCIUM-SANDOZ Forte

if the patient has been diagnosed with an allergy (hypersensitivity) to calcium or any of the other
components of the medicine CALCIUM-SANDOZ Forte (see the list of components in section 6 at the end of the leaflet).
if the patient has been diagnosed with an increased amount of calcium in the blood (hypercalcemia).
if the patient has been diagnosed with an increased amount of calcium in the urine (hypercalciuria).
if the patient has kidney diseases, including: kidney stones (nephrolithiasis) and calcium deposition in kidney tissues (renal calcification).

Warnings and precautions

If the patient has kidney disease, the medicine should be taken only after consulting a doctor, especially when taking medicines containing aluminum.
The medicine should not be taken without a doctor's recommendation with medicines containing vitamin D at the same time as CALCIUM-SANDOZ Forte.

CALCIUM-SANDOZ Forte and other medicines

The doctor should be informed about all medicines taken recently, even those that are available without a prescription, as 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, they should 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 taking these medicines.
If the patient is taking one of the antibiotics called tetracyclines, CALCIUM-SANDOZ Forte should be taken at least 2 hours after or 4 to 6 hours before taking the tetracycline.

CALCIUM-SANDOZ Forte with food and drink

CALCIUM-SANDOZ Forte should not be taken within 2 hours of consuming products rich in oxalic acid and phytic acid, such as: spinach, rhubarb, and whole grain cereals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, they should consult a doctor or pharmacist before taking CALCIUM-SANDOZ Forte.
CALCIUM-SANDOZ Forte can be used during pregnancy and breastfeeding if there is a calcium deficiency. The recommended daily dose of calcium (including food and supplements) for pregnant and breastfeeding women is 1000-1300 mg. During pregnancy and breastfeeding, the daily dose of calcium should not exceed 1500 mg.
Calcium passes into breast milk, but this does not cause any side effects in the breastfed child.

Driving and operating machinery

CALCIUM-SANDOZ Forte does not affect the ability to drive vehicles or operate machinery.
CALCIUM-SANDOZ Forte contains aspartame, sodium, sorbitol, benzyl alcohol, sulfur dioxide, and glucose

CALCIUM-SANDOZ Forte can be used in patients with diabetes (1 effervescent tablet contains 0.002 carbohydrate exchange units - CE).
This medicine contains 68.45 mg of sodium (the main component of table salt) in each effervescent tablet.
This corresponds to 3.4% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine contains 180 nanograms of benzyl alcohol in each effervescent tablet. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to small children is associated with a risk of severe side effects, including respiratory disorders (so-called "gasping syndrome"). It should not be given to newborns (up to 4 weeks of age) without a doctor's recommendation. It should not be given to small children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Pregnant or breastfeeding women, as well as patients with liver or kidney disease, should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
This medicine contains 210 nanograms of sulfur dioxide, which may rarely cause severe hypersensitivity reactions and bronchospasm.
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 its 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 some sugars, they should consult a doctor before taking this medicine. It may also have a harmful effect on teeth.

3. How to take CALCIUM-SANDOZ Forte

As with other medicines, the following information should be read carefully to ensure that CALCIUM-SANDOZ Forte is used correctly.
Children: one effervescent tablet (one dose) once or twice a day (which corresponds to 500-1000 mg of calcium).
Adults: one effervescent tablet (one dose) once, twice, or three times a day (which corresponds to 500-1500 mg of calcium)
The effervescent tablet should be dissolved in a glass of water (about 200 ml) and taken immediately after dissolution. The tablets should not be swallowed or chewed.
CALCIUM-SANDOZ Forte can be taken with food or between meals (see the section "Taking CALCIUM-SANDOZ Forte with food and drink").
How long to take CALCIUM-SANDOZ Forte
CALCIUM-SANDOZ Forte can be taken in the recommended doses for as long as the doctor has prescribed. Since CALCIUM-SANDOZ Forte is used to prevent and treat calcium deficiencies, and is used in combination with other preparations to treat and prevent osteoporosis (bone weakness), the treatment will likely be long-term.

Taking a higher dose of CALCIUM-SANDOZ Forte than recommended

Symptoms of an overdose of CALCIUM-SANDOZ Forte may include: nausea, vomiting, thirst, or constipation. If an overdose is suspected, a doctor or pharmacist should be consulted immediately.

Missing a dose of CALCIUM-SANDOZ Forte

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, CALCIUM-SANDOZ Forte can cause side effects, although not everyone will experience them.
Very rare side effects (occurring in less than 1 in 10,000 people):
severe allergic reactions, such as swelling of the face, lips, tongue, and (or) throat, which can cause difficulty swallowing.
If any of these allergic symptoms occur, the use of CALCIUM-SANDOZ Forte should be STOPPEDand a doctor should be consulted immediately.
Rare side effects (occurring in less than 1 in 1,000 people):
nausea, diarrhea, abdominal pain, constipation, bloating, vomiting, itching, redness, and (or) skin burning.
Uncommon side effects (occurring in less than 1 in 100 people):
increased calcium levels in the blood (hypercalcemia) or increased calcium excretion in the urine (hypercalciuria).
If any of the side effects worsen or any side effects not listed in the leaflet occur, the doctor or pharmacist should be informed.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store CALCIUM-SANDOZ Forte

The medicine should be stored out of sight and reach of children.
CALCIUM-SANDOZ Forte should not be taken after the expiry date stated on the carton and tube after the abbreviation "EXP". The expiry date refers to the last day of the given month.
Store in a tightly closed container. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What CALCIUM-SANDOZ Forte contains

The active substances of the medicine are calcium lactogluconate and calcium carbonate.
One 500 mg tablet contains 1132 mg of calcium lactogluconate and 875 mg of calcium carbonate (which corresponds to 500 mg of calcium).
The other ingredients are: anhydrous citric acid, orange flavor [contains: benzyl alcohol, glucose, sorbitol (E 420), and sulfur dioxide (E 220)], aspartame (E 951), macrogol 6000, and sodium bicarbonate.

What CALCIUM-SANDOZ Forte looks like and what the packaging contains

The effervescent tablet is white, round, and has a characteristic orange odor.
CALCIUM-SANDOZ Forte is available in packaging containing 20 effervescent tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
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

To obtain more detailed information about the medicine and its names in the member states

of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Sandoz logo
Date of last revision of the leaflet:07/2024