Calperos osteo

Package leaflet: Information for the patient

Calperos Osteo, 1000 mg + 880 IU, chewable and suckable tablets
Calcium + Cholecalciferolum
Please read all of this leaflet carefully before taking the medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Calperos Osteo is and what it is used for
2. What you need to know before taking Calperos Osteo
3. How to take Calperos Osteo
4. Possible side effects
5. How to store Calperos Osteo
6. Contents of the pack and other information

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

Calperos Osteo is a calcium and vitamin D supplement.
The medicine is used

• for the prevention and treatment of calcium and vitamin D deficiency in elderly people;
• as a supplement of vitamin D and calcium in the supportive treatment of osteoporosis (bone fragility).

2. Important information before using Calperos Osteo

When not to use 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 levels of calcium in the blood (hypercalcaemia).
If the patient excretes large amounts of calcium in the urine (hypercalciuria).
If the patient has hyperparathyroidism.
If the patient suffers from multiple myeloma (a type of bone marrow cancer).
If the patient has cancer that has spread to the bones.
If the patient has limited limb mobility (prolonged immobilisation) associated with
hypercalcaemia and/or hypercalciuria.
If the patient has kidney stones (nephrolithiasis).
If calcium deposits (nephrocalcinosis) have been detected in the patient's kidneys.
If the patient is taking excessive amounts of vitamin D (hypervitaminosis D).
If the patient has severe kidney function disorders.

Warnings and precautions
Before starting treatment with Calperos Osteo, discuss this with your doctor or pharmacist.
Before taking Calperos Osteo, consider calcium and alkaline substance intake from other sources (e.g. food, fortified foods, or other medicines).
Concomitant administration of high doses of calcium with alkaline substances
(such as carbonates) may lead to the occurrence of milk-alkali syndrome. This is a calcium metabolism disorder caused by elevated calcium levels in the blood. It may result from consuming very large amounts of milk and/or calcium carbonate from other sources, or from taking excessive amounts of acid-neutralising medicines (antacids). This may lead to adverse effects such as increased calcium levels in the blood (hypercalcaemia), metabolic alkalosis (a metabolic disorder causing increased blood pH), kidney failure, or soft tissue calcification (see section 4). Regular monitoring of blood calcium levels is necessary.
During long-term treatment, blood and urine calcium levels and kidney function should be regularly monitored. This is particularly important for patients prone to developing kidney stones. Depending on test results, the doctor may reduce the dose or discontinue treatment.
If the patient is simultaneously taking cardiac glycosides (digitalis) or thiazide diuretics for heart problems, blood and urine calcium levels and kidney function should be regularly monitored. Depending on test results, the doctor may reduce the dose or discontinue treatment.
Calperos Osteo should be used with particular caution in patients with kidney function disorders. Blood and urine calcium levels should be checked. 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 only under strict medical supervision. Your doctor will recommend frequent monitoring of blood and urine calcium levels.
Calperos Osteo should be used with particular caution in patients with sarcoidosis (an immune system disorder that may affect the liver, lungs, skin, or lymph nodes). There is a risk of excessive drug effect and, consequently, calcium overdose. Monitoring of blood and urine calcium levels is necessary.
If Calperos Osteo is used in an immobilised patient with osteoporosis, particular caution is required. Increased blood calcium levels may occur.

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

Calperos Osteo and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
If the patient is being treated simultaneously with cardiac glycosides (digitalis), heart rhythm disturbances may occur. Therefore, close monitoring of the patient's condition, including ECG and blood calcium level measurements, is necessary.
If the patient is taking thiazide diuretics at the same time, blood calcium levels should be monitored regularly, as these drugs reduce calcium excretion in urine.
Taking Calperos Osteo may reduce the absorption and thus the effectiveness of certain antibiotics (tetracyclines) taken simultaneously. The antibiotic should be taken at least 2 hours before or 4 to 6 hours after taking Calperos Osteo.
The effect of other medicines, such as fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used in the treatment of osteoporosis), may also be altered due to interactions. Therefore, these medicines should be taken at least 3 hours before taking Calperos Osteo.
A sufficiently long interval should be maintained between taking Calperos Osteo and cholestyramine (a medicine used to reduce elevated cholesterol levels) or laxatives (such as liquid paraffin) due to the risk of impaired vitamin D absorption.
Concomitant use of Calperos Osteo and phenytoin (used to treat epilepsy) or barbiturates (sleeping pills) may reduce the effectiveness of vitamin D.
Concomitant use of Calperos Osteo and glucocorticosteroids (e.g. cortisone) may reduce the effectiveness of vitamin D and decrease blood calcium levels.
Taking additional calcium and vitamin D supplements requires strict medical supervision and regular monitoring of blood and urine calcium levels.
Calcium may reduce the effectiveness of levothyroxine (used to treat hypothyroidism). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after taking Calperos Osteo.
The effect of quinolone antibiotics may be reduced by concomitant calcium intake. Antibiotics of this group should be taken 2 hours before or 6 hours after taking Calperos Osteo.

Calperos Osteo with food and drink
Calperos Osteo may be taken at any time, regardless of meals. Note 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 at least 2 hours apart from consuming products containing oxalic or phytic acid.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Calperos Osteo may be used in pregnant women with calcium and vitamin D deficiency. The daily dose must not exceed half a tablet. During pregnancy, the total daily calcium intake should not exceed 1500 mg, and the total daily vitamin D intake should not exceed 600 IU (international units).
Prolonged calcium and vitamin D overdose during pregnancy should be avoided due to the risk of high blood calcium levels and adverse effects on the unborn child.

Breastfeeding
Calperos Osteo may be used during breastfeeding. Both calcium and vitamin D pass into human milk; therefore, consult your doctor to determine whether the infant is receiving other vitamin D-containing products.

Driving and operating machinery
Calperos Osteo does not affect the ability to drive or operate machinery.

Calperos Osteo contains aspartame, glucose, sodium, sorbitol, isomalt, sucrose, and benzyl alcohol

Aspartame (E 951)
This medicine contains 1.00 mg of aspartame per chewable tablet.
Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

Glucose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. The glucose contained in the medicine may have harmful effects on teeth.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, meaning the medicine is considered "sodium-free".

Sorbitol (E 420)
The medicine contains 103.57 mg of sorbitol per chewable tablet.

Isomalt (E 953)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. The medicine may have harmful effects on teeth.

Benzyl alcohol
This medicine contains 0.023 mg of benzyl alcohol per chewable tablet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women and 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 (metabolic acidosis).

3. How to use Calperos Osteo

Calperos Osteo should always be used exactly as directed by a doctor or pharmacist. In case of
doubt, consult a doctor or pharmacist.
Dosage
Unless otherwise prescribed by a doctor, the recommended dosage is as follows:
Adults and elderly patients
Adults and elderly patients should take 1 chewable tablet daily (corresponding to 1000 mg of
calcium and 880 IU (International Units) of vitamin D).
Pregnant women
Pregnant women should take only half a chewable tablet (corresponding to 500 mg of calcium and 440 IU (International Units) of vitamin D). The daily dose of half a tablet must not be exceeded.
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 prolonged period. Consult your doctor regarding this (see also section 2 "Warnings and precautions").
Use of more than the recommended dose of Calperos Osteo
Overdose of Calperos Osteo may cause the following symptoms: nausea, vomiting, increased thirst, increased urination, fluid deficiency in the body, or constipation.
If an overdose is suspected, contact a doctor or pharmacist immediately.
Missed dose of Calperos Osteo
If a patient forgets to take a tablet, they should take it as soon as they remember.
However, a double dose should not be taken to make up for the missed tablet.
Stopping Calperos Osteo treatment
If a patient plans to discontinue or prematurely end treatment, they should discuss this with a doctor or pharmacist.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the following allergic reaction occurs (frequency unknown), you must immediately stop using Calperos Osteo and consult a doctor:

• swelling of the face, lips, tongue, or throat, with sudden breathing difficulties and severe rash.

Other reported adverse reactions:
Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 people:

• nausea, diarrhoea, abdominal pain, constipation, flatulence, bloating (feeling of abdominal fullness)
• rash, itching, urticaria

Unknown frequency (cannot be estimated from available data)

• In patients with impaired kidney function, increased levels of phosphates in blood, kidney stone formation, and increased calcium deposition in the kidneys may occur.
• Disorders of calcium metabolism (Burnett's syndrome), characterized by elevated calcium levels in blood (hypercalcemia), abnormally low acid levels in blood (metabolic alkalosis), kidney failure, and calcification of soft tissues.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Calperos Osteo

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton, container, and
blister after: "Expiry date (EXP):". The expiry date refers to the last day of the stated month.
Container:
Keep the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Calperos Osteo contains

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

What Calperos Osteo looks like and contents of the pack
The tablets are round, white, with a smooth surface and a dividing line to facilitate splitting. The tablet can be divided into two equal parts.
Chewable tablets are available in polypropylene tablet containers with polyethylene caps containing a desiccant, in the following pack sizes: 30, 60, 90 chewable tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53 Street
00-113 Warsaw
Tel: (22) 345 93 00

Manufacturer
Teva Operations Poland Sp. z o.o.
Mogilska 80 Street
31-546 Kraków

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