Calperos Osteo

Leaflet attached to the packaging: patient information

Calperos Osteo, 1000 mg + 880 IU, chewable tablets
Calcium + Cholecalciferol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Calperos Osteo and what is it used for
• 2. Important information before taking Calperos Osteo
• 3. How to take Calperos Osteo
• 4. Possible side effects
• 5. How to store Calperos Osteo
• 6. Package contents and other information

1. What is Calperos Osteo and what is it used for

Calperos Osteo is a calcium and vitamin D supplement.

The medicine is used

• to prevent and treat calcium and vitamin D deficiency in the elderly;
• as a supplement of vitamin D and calcium in the supportive treatment of osteoporosis (bone fragility).

2. Important information before taking Calperos Osteo

When not to take Calperos Osteo

If the patient is allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6)
If the patient has high blood calcium levels (hypercalcemia).
If the patient excretes large amounts of calcium in the urine (hypercalciuria).
If the patient has hyperparathyroidism (overactive parathyroid gland).
If the patient has bone marrow cancer (multiple myeloma).
If the patient has cancer that has spread to the bones.
If the patient has limited mobility (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria.
If the patient has kidney stones.
If the patient has calcium deposits in the kidneys (nephrocalcinosis).
If the patient is taking too much vitamin D (hypervitaminosis D).
If the patient has severe kidney function disorders.

Warnings and precautions

Before starting treatment with Calperos Osteo, the patient should discuss it with their doctor or pharmacist.
Before taking Calperos Osteo, the patient should pay attention to calcium and alkaline substance intake from other sources (e.g., food, fortified food, or other medicines).
Concomitant administration of high doses of calcium with alkaline substances (such as carbonates) may cause Burnett's syndrome. This is a calcium metabolism disorder caused by an increase in blood calcium levels. It may result from consuming very large amounts of milk and/or calcium carbonate from other sources or taking too many antacids (drugs that neutralize stomach acid). This may cause side effects such as increased blood calcium levels (hypercalcemia), metabolic alkalosis (a metabolic disorder that increases blood pH), kidney failure, and soft tissue calcification (see section 4). Regular blood calcium level checks are necessary.
During long-term treatment, the patient should regularly check their blood and urine calcium levels and kidney function. This is especially important for patients with a tendency to develop kidney stones. Depending on the test results, the doctor may reduce the dose or stop the treatment.
If the patient is taking digitalis glycosides or thiazide diuretics for heart problems, they should regularly check their blood and urine calcium levels and kidney function. Depending on the test results, the doctor may reduce the dose or stop the treatment.
Calperos Osteo should be used with caution in patients with kidney function disorders. The patient should check their blood and urine calcium levels. Patients with severe kidney function disorders should take vitamin D in a form other than cholecalciferol.
Additional calcium and vitamin D supplements should be taken under the strict control of a doctor. The doctor will recommend frequent monitoring of blood and urine calcium levels.
Calperos Osteo should be used with caution in patients with sarcoidosis (an immune system disorder that can affect the liver, lungs, skin, or lymph nodes). There is a risk of excessive medicine action, resulting in calcium overdose. It is necessary to check blood and urine calcium levels.
If the medicine is used in an immobilized patient with osteoporosis, the patient should be cautious. It is possible to increase blood calcium levels.

Children and adolescents

Calperos Osteo is not intended for use in children and adolescents.

Calperos Osteo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is being treated with digitalis glycosides, cardiac arrhythmias may occur. Therefore, it is necessary to closely monitor the patient's condition, including ECG and blood calcium level measurements.
If the patient is taking thiazide diuretics, they should regularly check their blood calcium levels, as these medicines reduce calcium excretion in the urine.
Taking Calperos Osteo may reduce the absorption and thus the effectiveness of certain antibiotics (such as tetracyclines) taken at the same time. The antibiotic should be taken at least 2 hours before or 4 to 6 hours after taking Calperos Osteo.
The action of other medicines, such as fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis), may change due to interactions. For this reason, these medicines should be taken at least 3 hours before taking Calperos Osteo.
The patient should maintain the longest possible interval between taking Calperos Osteo and taking cholestyramine (a medicine used to reduce elevated cholesterol levels) or laxatives (such as liquid paraffin) due to the possibility of impaired vitamin D absorption.
Concomitant use of Calperos Osteo and phenytoin (used to treat epilepsy) or barbiturates (sleeping pills) may weaken the action of vitamin D.
Concomitant use of Calperos Osteo and glucocorticosteroids (such as cortisone) may weaken the action of vitamin D and reduce blood calcium levels.
Taking additional calcium and vitamin D supplements requires close medical supervision and regular monitoring of blood and urine calcium levels.
Calcium may weaken the action of levothyroxine (used to treat hypothyroidism). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after taking Calperos Osteo.
The action of quinolone antibiotics may be weakened by concomitant calcium intake. Antibiotics from this group should be taken 2 hours before or 6 hours after taking Calperos Osteo.

Calperos Osteo with food and drink

Calperos Osteo can be taken at any time, regardless of meals. However, the patient should remember that oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grain products) may reduce the amount of calcium absorbed in the intestine. Calcium-containing medicines should be taken with a 2-hour interval from consuming products containing oxalic or phytic acid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Calperos Osteo can be used in pregnant women with calcium and vitamin D deficiency. The daily dose should not exceed half a tablet. During pregnancy, the total daily amount of calcium should not exceed 1500 mg, and the total daily amount of vitamin D should not exceed 600 IU (international units).
The patient should avoid long-term calcium and vitamin D overdose during pregnancy due to the possibility of high blood calcium levels and adverse effects on the unborn child.
Breastfeeding
Calperos Osteo can be used during breastfeeding. Both calcium and vitamin D pass into breast milk, so the patient should ask their doctor if their child is also taking other products containing vitamin D.

Driving and using machines

Calperos Osteo does not affect the ability to drive and use machines.
Calperos Osteo contains aspartame, glucose, sodium, sorbitol, isomalt, sucrose, and benzyl alcohol
Aspartame (E 951)
This medicine contains 1.00 mg of aspartame in each chewable tablet.
Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
Glucose
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The glucose contained in the medicine may have a harmful effect on teeth.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, which means the medicine is considered "sodium-free".
Sorbitol (E 420)
The medicine contains 103.57 mg of sorbitol in each chewable tablet.
Isomalt (E 953)
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Sucrose
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The medicine may have a harmful effect on teeth.
Benzyl alcohol
This medicine contains 0.023 mg of benzyl alcohol in each chewable tablet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women and patients with liver or kidney disease should contact their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

3. How to take Calperos Osteo

Calperos Osteo should always be taken strictly according to the doctor's or pharmacist's recommendations. If the patient has any doubts, they should consult their doctor or pharmacist.

Dosage

If the doctor has not recommended otherwise, the recommended dosage is:
Adults and the elderly
Adults and the elderly take 1 chewable tablet per day (which corresponds to 1000 mg of calcium and 880 IU (international units) of vitamin D).
Pregnant women
Pregnant women take only half a chewable tablet (which corresponds to 500 mg of calcium and 440 IU (international units) of vitamin D). The daily dose should not exceed half a tablet.

Method of administration

The tablet should be chewed and then swallowed. It can be taken at any time, regardless of meals.

Duration of treatment

Calperos Osteo should be taken for a longer period. The patient should consult their doctor about this (see also section 2 "Warnings and precautions").

Taking a higher dose of Calperos Osteo than recommended

Overdosing on Calperos Osteo may cause the following symptoms: nausea, vomiting, increased thirst, increased urine excretion, dehydration, or constipation.
If there is a suspicion of overdose, the patient should immediately contact their doctor or pharmacist.

Missing a dose of Calperos Osteo

If the patient forgets to take a tablet, they should take it as soon as they remember.
However, the patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Calperos Osteo

If the patient plans to stop or prematurely end the treatment, they should discuss it with their doctor or pharmacist.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Calperos Osteo can cause side effects, although not everybody gets them.
In case of the following allergic reaction (frequency not known), the patient should immediately stop taking Calperos Osteo and consult their doctor:

• -facial, lip, tongue, or throat swelling with sudden breathing difficulties and severe rash.

Other reported side effects:
Uncommon: may affect up to 1 in 100 people

• high blood calcium levels (hypercalcemia) or high urine calcium levels (hypercalciuria).

Rare: may affect up to 1 in 1000 people:

• nausea, diarrhea, abdominal pain, constipation, gas, bloating (feeling of abdominal distension)
• rash, itching, urticaria

Unknown (frequency cannot be estimated from the available data)

• If the patient has kidney function disorders, they may be at risk of increased phosphate levels in the blood, kidney stone formation, and increased calcium deposition in the kidneys.
• Calcium metabolism disorder (Burnett's syndrome) characterized by increased blood calcium levels (hypercalcemia), low blood acid levels (metabolic alkalosis), kidney failure, and soft tissue calcification.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be collected on the safety of the medicine.

5. How to store Calperos Osteo

This medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "Expiry Date (EXP):". The expiry date refers to the last day of the month.
Container:
Store the container tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Calperos Osteo contains

• The active substances of the medicine are calcium and cholecalciferol. One tablet contains 1000 mg of calcium in the form of 2500 mg of calcium carbonate and 880 IU (22 micrograms) of cholecalciferol (vitamin D) in the form of 8.8 mg of cholecalciferol concentrate (powder).
• Other ingredients are: isomalt (E953), xylitol, sorbitol (E420), citric acid, sodium dihydrogen citrate, magnesium stearate, sodium carmellose, orange flavor "CPB" (flavoring substance identical to natural), mannitol (E 421), maltodextrin (contains glucose), gluconolactone, sorbitol (E 420), sodium, propylene glycol, benzyl alcohol), orange flavor "CVT" (flavoring substance identical to natural, mannitol (E 421), gluconolactone, sorbitol (E 420), medium-chain triglycerides), aspartame (E951), acesulfame potassium, sodium ascorbate, all-rac-α-tocopherol, corn starch modified, sucrose, medium-chain triglycerides, and colloidal silica anhydrous.

What Calperos Osteo looks like and what the package contains

The tablets are round, white, with a smooth surface, and have a line to facilitate division. The tablet can be divided into halves.
The chewable tablets are available in polypropylene containers with polyethylene caps containing a desiccant, in the following package sizes: 30, 60, 90 chewable tablets.

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 Kraków
HERMES PHARMA GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany

Date of last revision of the leaflet: July 2021