Calperos Vita-d3

Package Leaflet: Information for the User

Calperos Vita-D, 500 mg + 2000 IU, chewable tablets
Calcium + Cholecalciferol(Vitamin D)

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

This medicine should always be taken exactly as described in this package leaflet for the patient 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 the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Calperos Vita-D and what is it used for

Calperos Vita-D is a combination of mineral calcium and cholecalciferol, also known as vitamin D. These substances are important in the process of bone formation.
The medicine is used to treat calcium and vitamin D deficiency in adults.

2. Important information before taking Calperos Vita-D

When not to take Calperos Vita-D

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 (hypercalcemia),
if the patient has high levels of calcium in the urine (hypercalciuria),
if the patient has hyperparathyroidism (overactive parathyroid glands),
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 of the limbs (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 Vita-D, the patient should discuss it with their doctor or pharmacist:
If the patient has phenylketonuria (see also section "Calperos Vita-D contains aspartame").
During long-term treatment, the patient's calcium levels in the blood and urine should be regularly checked, as well as their 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 of the medicine or stop the treatment.
If the patient is taking digitalis glycosides (digoxin, digitoxin) or thiazide diuretics for heart problems, they should regularly check their calcium levels in the blood and urine, as well as their kidney function. Depending on the test results, the doctor may reduce the dose of the medicine or stop the treatment.
Calperos Vita-D should be used with caution in patients with kidney function disorders. The patient's calcium levels in the blood and urine should be regularly checked. Patients with severe kidney function disorders should take vitamin D in a different form than vitamin D.
Additional products containing calcium and vitamin D should only be taken under medical supervision. The doctor will recommend regular checks of calcium levels in the blood and urine.
Calperos Vita-D should be used with caution in patients with sarcoidosis (a disorder of the immune system that can affect the liver, lungs, skin, or lymph nodes). There is a risk of excessive action of the medicine, which can lead to calcium overdose. It is necessary to check the calcium levels in the blood and urine.
If the medicine is used in an immobilized patient with osteoporosis, caution should be exercised. There is a possibility of increased calcium levels in the blood.
Before taking Calperos Vita-D, the patient should pay attention to the amount of calcium and alkaline substances (such as carbonates) taken from other sources (such as food, dietary supplements, and other medicines). Taking products rich in calcium with alkaline substances, such as carbonates, can lead to the development of Burnett's syndrome (hypercalcemia and metabolic alkalosis). This is a calcium metabolism disorder associated with an increase in calcium levels in the blood (hypercalcemia), an increase in blood pH (metabolic alkalosis), kidney failure, and calcification of soft tissues. Therefore, additional intake of Calperos Vita-D requires close medical supervision and regular checks of calcium levels in the blood and urine.

Children and adolescents

Calperos Vita-D is not intended for use in children and adolescents under 18 years of age.

Calperos Vita-D and other medicines

The patient should inform 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 (digoxin, digitoxin), cardiac arrhythmias may occur. Therefore, close monitoring of the patient's condition, including ECG and calcium level measurements, is necessary.
If the patient is taking thiazide diuretics, they should regularly check their calcium levels in the blood, as these medicines reduce calcium excretion in the urine.
Taking Calperos Vita-D may reduce the absorption and effectiveness of certain antibiotics (such as tetracyclines) taken at the same time. These antibiotics should be taken at least 2 hours before or 4-6 hours after taking Calperos Vita-D.
The action of other medicines, such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis), may be affected by interactions. Therefore, these medicines should be taken at least 3 hours before taking Calperos Vita-D.
The patient should maintain the longest possible interval between taking cholestyramine (a medicine used to reduce high cholesterol levels) or laxatives, such as liquid paraffin, and taking Calperos Vita-D, due to the possibility of impaired vitamin D absorption.
Concomitant use of Calperos Vita-D and phenytoin (used to treat epilepsy) or barbiturates (sleeping pills) may weaken the action of vitamin D.
Concomitant use of Calperos Vita-D and glucocorticoids (such as cortisone) may weaken the action of vitamin D and reduce calcium levels in the blood.
Additional supplementation with calcium and vitamin D requires close medical supervision and regular checks of calcium levels in the blood and urine.
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 Vita-D.
The action of fluoroquinolone antibiotics may be weakened by concomitant intake of calcium. Fluoroquinolone antibiotics should be taken 2 hours before taking Calperos Vita-D.
Calcium may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least 2 hours before or after taking Calperos Vita-D.

Taking Calperos Vita-D with food and drink

Calperos Vita-D can be taken at any time, preferably with a meal.
The patient should remember that oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grain products) can reduce the amount of calcium absorbed in the intestine.
Medicines containing calcium should be taken with a 2-hour interval from consuming foods high in oxalic acid 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 Vita-D should not be taken during pregnancy.
The total daily intake of calcium should not exceed 1500 mg, and the total daily intake of vitamin D should not exceed 600 IU (international units) during pregnancy.
The patient should avoid prolonged overdose of calcium and vitamin D during pregnancy, as this can lead to high levels of calcium in the blood and may have an adverse effect on the unborn child.
Breastfeeding
Calperos Vita-D should not be taken during breastfeeding. Due to the high content of vitamin D in Calperos Vita-D, the risk to the child cannot be ruled out.
Both calcium and vitamin D pass into breast milk, so the patient should consult their doctor about whether to stop breastfeeding or stop taking Calperos Vita-D.
Alternatively, the treatment can be changed to other calcium and vitamin D medicines with lower doses of vitamin D.

Driving and using machines

Calperos Vita-D does not affect the ability to drive and use machines.

Calperos Vita-D contains aspartame

This medicine contains 0.5 mg of aspartame in each chewable 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 impaired excretion.

Calperos Vita-D contains sorbitol, isomalt, and sucrose

This medicine contains up to 49.42 mg of sorbitol, 185 mg of isomalt, and 3.85 mg of sucrose in each chewable tablet. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine may have a harmful effect on teeth.

Calperos Vita-D contains sodium

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

Calperos Vita-D contains benzyl alcohol

This medicine contains 0.016 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 consult their doctor before taking the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (such as metabolic acidosis).

3. How to take Calperos Vita-D

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dosage

Adults, including the elderly, take 1 chewable tablet per day, which corresponds to 500 mg of calcium and 2000 IU (international units) of vitamin D.
Before taking Calperos Vita-D, it may be necessary to take a medicine containing a higher dose of vitamin D without calcium to achieve the desired level of vitamin D. The doctor will initiate such treatment depending on the severity of the disease and the patient's response to treatment.

Children and adolescents

Due to the high content of vitamin D, Calperos Vita-D is not intended for use in children and adolescents under 18 years of age.

Method of administration

The tablet should be chewed and then swallowed. It can be taken at any time, preferably with a meal.
The patient should pay attention to adequate daily calcium intake in their diet (i.e., in dairy products, vegetables, and mineral water), as Calperos Vita-D provides only about half of the daily required calcium intake.

Duration of treatment

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

Taking more than the recommended dose of Calperos Vita-D

Overdose of Calperos Vita-D may cause symptoms such as nausea, vomiting, increased thirst, increased urine production, dehydration, or constipation.
If an overdose is suspected, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Calperos Vita-D

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

Stopping treatment with Calperos Vita-D

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

4. Possible side effects

Like all medicines, Calperos Vita-D can cause side effects, although not everybody gets them.
The assessment of side effects is based on the following frequency:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data

Stop taking Calperos Vita-D and consult a doctor immediately

in case of an allergic reaction (with unknown frequency): swelling of the face, lips, tongue, or throat with sudden difficulty breathing and severe rash.
Other reported side effects:
Uncommon:

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

Rare:

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

Frequency not known:

• Burnett's syndrome (hypercalcemia and metabolic alkalosis).

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.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 Calperos Vita-D

The medicine should be stored out of sight and reach of children.
The medicine should not be taken 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.
The tablets should be stored in the original packaging to protect them from light.
The container should be stored tightly closed to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Calperos Vita-D contains

The active substances of the medicine are calcium and cholecalciferol (vitamin D).
Each chewable tablet contains 500 mg of calcium (in the form of calcium carbonate) and 50 micrograms of cholecalciferol equivalent to 2000 IU of vitamin D (in the form of cholecalciferol concentrate powder).
The other ingredients are: isomalt (E 953), xylitol (E 967), sorbitol (E 420), citric acid, sodium citrate, magnesium stearate, sodium carmellose, orange flavor "CPB" (containing natural flavoring substances, mannitol, maltodextrin, gluconolactone, sorbitol, propylene glycol, benzyl alcohol), orange flavor "CVT" (containing flavoring substances, mannitol, maltodextrin, gluconolactone, sorbitol, and saturated fatty acid triglycerides), colloidal silica, aspartame (E 951), acesulfame potassium (E 950), sodium ascorbate, all-rac-α-tocopherol, modified corn starch, sucrose, saturated fatty acid triglycerides, anhydrous colloidal silica.

What Calperos Vita-D looks like and contents of the pack

Calperos Vita-D is a round, white, chewable tablet with a diameter of 18 mm.
The tablets are available in polypropylene containers with polyethylene caps containing a desiccant, in the following pack sizes: 30 chewable tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
To obtain more detailed information on the medicine, the patient should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw
Phone: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany
Hermes Pharma GmbH
Hans-Urmiller Ring 52
82515 Wolfratshausen
Germany

Date of last revision of the leaflet: June 2023