Calperos 1000

Leaflet attached to the packaging: patient information

CALPEROS 500

Calcium carbonate
200 mg of calcium ions, hard capsules

CALPEROS 1000 Calcium carbonate

400 mg of calcium ions, hard capsules

You should carefully read the contents of the leaflet 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 your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If after 14 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is CALPEROS and what is it used for

CALPEROS 500 and CALPEROS 1000 contain calcium carbonate, which is a source of ionized calcium for the body.
Calcium is an element involved in the formation and mineralization of bone tissue throughout a person's life. It conditions proper nerve conduction and muscle excitability. It maintains the body's electrolyte balance and also affects the functioning of the heart muscle. It participates in the blood coagulation process. It affects the activity of a number of enzymes and also plays the role of a transmitter, thanks to which chemical, physical, or hormonal stimuli are transformed into a specific biological effect. Due to its property of reducing the permeability of blood vessel walls, calcium acts anti-inflammatory, anti-edematous, and anti-allergic.
The calcium carbonate contained in the CALPEROS preparations helps to cover the daily demand for calcium, reduces calcium loss from the bone system in women during the peri- and postmenopausal period, as well as in all people in old age. It prevents the occurrence of bone changes in the course of chronic kidney failure. It has a soothing effect on allergic reactions on the skin and mucous membranes.
Indications for use are:

• states of increased demand for calcium: period of intense growth in children and adolescents, as well as during pregnancy and lactation;
• improper nutrition with calcium-poor products;
• disturbances in calcium reabsorption from renal tubules;
• reduced calcium levels in the blood with elevated phosphorus levels in patients with chronic kidney failure undergoing dialysis and prevention of increased neuromuscular excitability;
• prophylactically in the prevention and supplementally in the comprehensive treatment of osteoporosis;
• states after long-term immobilization and the period of convalescence after bone fractures;
• supportively in the treatment of colds and allergic diseases.

2. Important information before taking CALPEROS

When not to take CALPEROS:

• with increased calcium levels in the blood and excessive excretion of calcium in the urine, e.g. in hyperthyroidism, parathyroidism, overdose of vitamin D, decalcifying tumors such as multiple myeloma and tumors metastasizing to bone, in severe untreated kidney failure;
• in kidney stones;
• while being treated with cardiac glycosides;
• in severe hypercalciuria (urine with an excessive amount of excreted calcium).

Warnings and precautions

In the case of chronic kidney failure, it is necessary to control calcium and phosphorus levels in the blood during the use of the medicine.
When using high doses, especially with concurrent use of vitamin D preparations, the risk of elevated calcium levels in the blood with subsequent kidney damage cannot be excluded, so in such patients, it is necessary to control calcium levels in blood serum and kidney function.
Patients treated with cardiac glycosides should consult a doctor before using calcium preparations, as the concurrent use of both medicines may enhance the effect of glycosides on the heart and cause a risk of rhythm disturbances.
During treatment with high doses, especially when taking vitamin D, thiazide diuretics, and (or) calcium-containing medicines or food products (such as milk), there is a risk of hypercalcemia (too high calcium levels in the blood) with subsequent kidney function disorder or milk-alkali syndrome. This risk also applies to pregnant women taking high doses of calcium and patients with impaired kidney function. In these patients, it is necessary to control calcium levels in serum and monitor kidney function.

Taking CALPEROS with food and drink

It is recommended to take the medicine during a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
During pregnancy, the demand for calcium increases. When using therapeutic doses, no risk to the fetus has been demonstrated.
Breastfeeding
During breastfeeding, the demand for calcium increases. When using therapeutic doses, no risk to the infant has been demonstrated.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

CALPEROS and other medicines

Thiazide diuretics increase calcium reabsorption, reduce the amount of calcium ions excreted in the urine, and create a risk of elevated calcium levels in the blood. In cases of concurrent use, it is necessary to control calcium levels in blood serum.
Concurrently administered systemic corticosteroids reduce calcium absorption and may require an increase in its dose.
Orally administered calcium salts reduce the absorption of tetracycline antibiotics and fluorine compounds from the gastrointestinal tract. These medicines should be administered at an interval of 2 hours.
Calcium compounds may also cause reduced absorption of quinolones, some cephalosporin antibiotics, and iron preparations.
Calcium preparations may enhance the effect and thus increase the toxicity of cardiac glycosides. Therefore, during concurrent use of these medicines, it is necessary to control heart function (electrocardiogram) and calcium levels in the blood.
Bisphosphonates or sodium fluoride should be administered at least 3 hours before taking calcium, due to reduced absorption from the gastrointestinal tract in the case of concurrent use.
During concurrent use of vitamin D or its derivatives in doses above 400 IU/day, calcium absorption from the gastrointestinal tract increases significantly, and hypercalcemia may occur.
During combined treatment with vitamin D and CALPEROS, it is necessary to systematically check calcium levels.
The medicine weakens the effect of verapamil and other calcium channel blockers.
Oxalic acid (found in large quantities in spinach and rhubarb) and phytic acid (found in whole grains) may reduce calcium absorption due to the formation of insoluble calcium salts. Patients should not take calcium preparations within 2 hours of consuming foods with high oxalic acid or phytic acid content.
Thiazide diuretics may increase the risk of hypercalcemia (too high calcium levels in the blood).

CALPEROS contains indigo carmine

The medicine may cause allergic reactions.

3. How to take CALPEROS

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
The dose is usually determined based on the daily demand, which is as follows:

Usually, the following dosing is used:
CALPEROS 500: 1 to 2 hard capsules (from 200 mg to 400 mg of calcium) 2 to 3 times a day;
CALPEROS 1000: 1 hard capsule (400 mg of calcium) 1 to 3 times a day.
You should not take more than 1200 mg of calcium ions per day, i.e. no more than 6 hard capsules of CALPEROS 500 or 3 hard capsules of CALPEROS 1000.

Use in children and adolescents

Children over 7 years old and adolescents:
1 hard capsule of CALPEROS 500 (200 mg of calcium) up to 3 times a day.
It is recommended to take the medicine during a meal.

Taking a higher dose of CALPEROS than recommended

There are no reports of cases of acute poisoning with the medicine.
Overdosing on the medicine, especially in patients taking higher-than-therapeutic doses of vitamin D or its derivatives, may lead to elevated calcium levels in the blood. The following may occur: loss of appetite, excessive thirst, nausea, vomiting, constipation, muscle weakness, fatigue, impaired consciousness, polyuria, bone pain, kidney calcification, kidney stones, and in severe cases, cardiac arrhythmias.
Milk-alkali syndrome: it may lead to metastatic calcification.
Treatment of overdose: Calcium administration should be discontinued. Thiazide diuretics, lithium, vitamin A, and cardiac glycosides should not be administered. You should consult a doctor. The doctor will perform gastric lavage, hydrate the patient, and depending on the severity of the overdose, will use one or more medicines (loop diuretics, bisphosphonates, calcitonin, corticosteroids). The levels of electrolytes in the blood, kidney function, and urine excretion will be monitored, and in severe cases, heart function will also be monitored.

Missing a dose of CALPEROS:

The next dose should be taken at the scheduled time.
You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:

• uncommon: occurring in 1 to 10 out of 1000 patients;
• rare: occurring in 1 to 10 out of 10,000 patients.

Metabolic and nutritional disorders
Uncommon: elevated calcium levels in the blood, excessive excretion of calcium in the urine.
Frequency not known: milk-alkali syndrome, usually observed only in the case of overdose (see section "Taking a higher dose of CALPEROS than recommended"). Milk-alkali syndrome is usually reversible after discontinuation of the medicine and special treatment (diuretic action induced by physiological saline solution, pamidronic acid).
Gastrointestinal disorders
Rare: constipation, bloating with gas, nausea, abdominal pain, diarrhea.
Skin and subcutaneous tissue disorders
Rare: itching, rash, urticaria.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store CALPEROS

The medicine should be stored out of sight and reach of children.
Do not store above 25°C, protect from moisture.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste containers. You should 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 CALPEROS contains

One hard capsule of CALPEROS 500 contains 200 mg of calcium ions in the form of 500 mg of calcium carbonate.
One hard capsule of CALPEROS 1000 contains 400 mg of calcium ions in the form of 1000 mg of calcium carbonate.
Excipients: magnesium stearate, talc.
Composition of the gelatin capsule: titanium dioxide (E 171), indigo carmine (E 132), gelatin.

What CALPEROS looks like and what the packaging contains

Available packaging

CALPEROS 500:

• 15 hard capsules or 30 hard capsules (blister packs);
• 200 hard capsules (HDPE bottle with PP cap);

CALPEROS 1000:

• 30 hard capsules or 100 hard capsules (blister packs);
• 100 hard capsules (HDPE bottle with PP cap).

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow
Date of last revision of the leaflet:June 2025