Calcium Sandoz + Vitamin C

Leaflet accompanying the packaging: patient information

Calcium Sandoz + Vitamin C

260 mg of calcium ions + 1000 mg of vitamin C, effervescent tablets

Calcii lactogluconas + Calcii carbonas + Acidum ascorbicum

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 directed by a doctor or pharmacist. Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Calcium Sandoz + Vitamin C and what is it used for
• 2. Important information before taking Calcium Sandoz + Vitamin C
• 3. How to take Calcium Sandoz + Vitamin C
• 4. Possible side effects
• 5. How to store Calcium Sandoz + Vitamin C
• 6. Contents of the packaging and other information

1. What is Calcium Sandoz + Vitamin C and what is it used for

Calcium is a basic mineral component that affects the maintenance of electrolyte balance in the body, necessary for its proper functioning. Calcium is an essential component of bone tissue and is necessary for its proper development, as well as for the proper functioning of the nervous system, muscles, heart, and proper blood coagulation. Calcium also acts as a mediator in hormone action, and by reducing the permeability of blood vessel walls, it has anti-edema and anti-exudative effects.
Ascorbic acid (vitamin C) belongs to the group of water-soluble vitamins and plays an important role in biological processes. It participates in oxidation and reduction processes, is necessary for the production of collagen, cartilage, dentin, elastin, tissue repair, and detoxification of the body. High doses of vitamin C (up to 1 g per day) are effective in the prevention and treatment of upper respiratory tract infections.
Deficiencies in calcium and ascorbic acid can be the result of improper nutrition or increased demand by the body (see: Indications).

Indications

• Increased demand for calcium and vitamin C:
• during a period of decreased immunity,
• during infectious diseases,
• during the recovery period.
• Treatment of calcium and vitamin C deficiency.
• Supportive treatment for colds and flu.
• In smokers.

2. Important information before taking Calcium Sandoz + Vitamin C

When not to take Calcium Sandoz + Vitamin C

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has been diagnosed with diseases and/or disorders that cause increased calcium levels in the blood (hypercalcemia) and/or increased excretion of calcium in the urine (hypercalciuria),
• if the patient has kidney calcification or kidney stones (including oxalate stones),
• if the patient has been diagnosed with sideroblastic anemia, hemochromatosis (a disease involving excessive absorption of iron from food, with the possibility of damage to internal organs), or congenital deficiency of glucose-6-phosphate dehydrogenase enzyme in red blood cells.

Warnings and precautions

Patients with kidney function disorders can take Calcium Sandoz + Vitamin C only under medical supervision. The doctor will recommend monitoring calcium and phosphate levels in the blood.
Due to the high content of ascorbic acid (vitamin C) in the medicine, it is not recommended for people with severe or terminal kidney failure (patients undergoing dialysis), with recurring kidney calcification or a tendency to form kidney stones.
People who have been found to have increased excretion of oxalates in the urine should be cautious when taking this medicine.
If the patient is taking large doses of calcium, especially if they are also taking vitamin D, and are taking antacids (such as calcium carbonate) and/or consuming large amounts of dairy products, they should monitor their blood calcium levels and kidney function due to the possibility of hypercalcemia (elevated calcium levels in the blood), milk-alkali syndrome (a condition caused by excessive consumption of calcium and easily absorbable antacids in the stomach - e.g., milk, calcium carbonate), and the risk of kidney function disorders.
In the case of mild hypercalciuria (too much calcium in the urine) or if kidney stones have formed in the past, it is recommended to monitor the amount of calcium excreted in the urine and to increase fluid intake. If necessary, the dose of the medicine can be reduced or its use discontinued.
It is not recommended to take vitamin C during radio- and/or chemotherapy.
A daily dose of ascorbic acid (vitamin C) above 1 g may distort the results of blood and urine tests (glucose, uric acid, creatinine, inorganic phosphates), as well as tests for hidden blood in the stool.
Calcium Sandoz + Vitamin C contains citric acid, so patients with severe kidney function disorders, especially those taking aluminum-containing medications, should not take this medicine.
Patients with diabetes should consider that one effervescent tablet of Calcium Sandoz + Vitamin C contains 2.0 g of sugar.
If the patient has previously been diagnosed with intolerance to certain sugars, they should inform their doctor before taking the medicine.
Calcium Sandoz + Vitamin C contains 275.5 mg of sodium (the main component of table salt) in each tablet. This corresponds to 13.8% of the maximum recommended daily sodium intake in the diet for adults.

Calcium Sandoz + Vitamin C and other medicines

Calcium

• When taking Calcium Sandoz + Vitamin C, you should avoid taking doses of vitamin D and its derivatives above 400 IU per day, unless the doctor recommends otherwise.
• Calcium may reduce the absorption of certain medicines (estramustine [a medicine that destroys cancer cells], etidronate [a medicine used in bone diseases], phenytoin [an antiepileptic medicine], antibacterial medicines from the quinolone group or medicines containing fluorine). In such cases, you should maintain at least a 3-hour interval between taking Calcium Sandoz + Vitamin C and the mentioned medicines.
• Calcium may reduce the absorption of tetracycline antibiotics taken simultaneously. Therefore, tetracyclines should be administered at least 2 hours before or 4 to 6 hours after taking Calcium Sandoz + Vitamin C.
• The amount of calcium absorbed from the gastrointestinal tract may decrease when consuming certain foods, such as spinach, rhubarb, bran, and cereal products.
• Calcium in doses above 1000 mg taken with vitamin D or its derivatives may weaken the effect of concurrently administered verapamil and other calcium channel antagonists (medicines used to treat irregular heart rhythm, chest pain, or high blood pressure).
• In patients treated with cardiac glycosides (heart medicines), oral administration of large doses of calcium may increase the risk of irregular heart rhythm.
• Certain diuretic medicines may reduce calcium excretion, leading to hypercalcemia.
• If the patient is taking corticosteroids with systemic effects, it may be necessary to increase the dose of calcium. Consult a doctor.
• Calcium may reduce the absorption of bisphosphonates (medicines used to treat osteoporosis) and sodium fluoride from the gastrointestinal tract. Therefore, oral bisphosphonates should be taken at least 3 hours before taking calcium.

Ascorbic acid (vitamin C)

• Vitamin C should not be taken with antacids and medicines containing iron and/or copper salts.
• Vitamin C in doses above 1 g per day may reduce the effectiveness of tricyclic antidepressant medicines, increase the effect and toxicity of oral anticoagulant medicines and sulfonamides, and increase the serum concentration of concurrently taken estrogens.
• Vitamin C may cause increased absorption of aluminum (e.g., contained in antacids) from the gastrointestinal tract. You should avoid combining vitamin C with such medicines, especially in patients with kidney failure.
• Vitamin C increases iron absorption from the gastrointestinal tract.
• Vitamin C in large doses (>200 mg) should not be taken simultaneously with deferoxamine (a medicine used in iron overdose).

Due to the content of citric acid, patients with severe kidney function disorders, especially those taking aluminum-containing medications, should not take Calcium Sandoz + Vitamin C.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Calcium Sandoz + Vitamin C can be taken during pregnancy and breastfeeding only after consulting a doctor.

Driving and operating machines

Calcium Sandoz + Vitamin C does not affect the ability to drive and operate machines.

3. How to take Calcium Sandoz + Vitamin C

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The effervescent tablet should be dissolved in a glass of water.
Adults and children over 7 years old:1 effervescent tablet once a day.
Children from 3 to 7 years old:½ effervescent tablet once a day.
Infants:as directed by a doctor.

Taking a higher dose of Calcium Sandoz + Vitamin C than recommended

Overdose may cause increased calcium levels in the blood and urine, with symptoms such as loss of appetite, nausea, vomiting, excessive thirst, increased urine production, dehydration, and constipation, abdominal pain, muscle weakness, fatigue, mental disorders, bone pain, kidney calcification, kidney stones, and heart rhythm disorders (in severe cases). Long-term intake of higher doses of the medicine may cause kidney damage and calcification of soft tissues. Very high calcium levels can cause coma and be life-threatening. After taking large amounts of calcium and alkaline substances, the so-called milk-alkali syndrome may occur (symptoms: frequent urination, persistent headache, persistent loss of appetite, nausea or vomiting, unusual feeling of fatigue or weakness, hypercalcemia, alkalosis, and kidney function disorders).
High doses of vitamin C may cause diarrhea (osmotic diarrhea) and related symptoms.
Vitamin C overdose may contribute to excessive iron overload in patients with iron storage diseases (e.g., sideroblastic anemia, hemochromatosis) and may cause hemolysis in patients with congenital glucose-6-phosphate dehydrogenase deficiency.
In case of accidental overdose of the medicine during the intake of large doses of vitamin D, drink plenty of water and consult a doctor.

Missing a dose of Calcium Sandoz + Vitamin C

Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Uncommon (may occur in less than 1 in 100 people): increased calcium levels in the blood (hypercalcemia), increased excretion of calcium in the urine (hypercalciuria).
Rare (may occur in less than 1 in 1000 people): hypersensitivity reactions, bloating, constipation, diarrhea, nausea, vomiting, abdominal pain, indigestion.
Very rare (may occur in less than 1 in 10,000 people): generalized allergic reactions (anaphylactic reaction, facial edema, angioedema), milk-alkali syndrome, usually occurring only after overdose (symptoms: frequent urination, persistent headache, persistent loss of appetite, nausea or vomiting, unusual feeling of fatigue or weakness, hypercalcemia, alkalosis, and kidney function disorders), headache, dizziness, rash, itching, urticaria, fatigue.
Frequency not known (frequency cannot be estimated from the available data): kidney stones (formation of stones in the urinary tract after prolonged treatment with high doses of calcium and vitamin C).
Reporting side effects
If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. 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 + Vitamin C

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Keep the tube tightly closed.
Do not use the medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
Make sure the container is properly closed after each effervescent tablet is removed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Calcium Sandoz + Vitamin C contains

The active substances are: calcium lactogluconate, calcium carbonate, and ascorbic acid.
One effervescent tablet contains: 1.0 g of calcium lactogluconate + 0.327 g of calcium carbonate (equivalent to 260 mg or 6.5 mmol of ionized calcium) and 1.0 g of ascorbic acid.
Other ingredients are: sodium saccharin, macrogol 4000, sucrose, sodium bicarbonate, anhydrous citric acid, beta-carotene, bitter flavor (Grade PO 430/02), lemon flavor (Grade

• 987.323 PO5.51).

What Calcium Sandoz + Vitamin C looks like and what the packaging contains

Yellowish, orange-speckled, round, flat effervescent tablets, placed in a polypropylene tube with a polyethylene cap, which contains a desiccant.
The packaging contains 10 effervescent tablets.

Marketing authorization holder:

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer

Delpharm Orleans
5, Avenue de Concyr
45 071, Orléans La Source Cedex 02
France
Lek S.A.
Domaniewska 50 C
02-672 Warsaw
Lek S.A.
Podlipie 16
95-010 Stryków
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben, Germany
To obtain more detailed information, please contact:
Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
tel. (22) 209 70 00
Date of last update of the leaflet:04/2022