CALODIS 1000 mg/880 IU EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Calodis 1000 mg / 880 UI Effervescent Tablets

Calcium / Colecalciferol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Calodis and what is it used for

Calodis contains the active substances calcium and vitamin D3.

Calodis is indicated:

• For the prevention and treatment of calcium and vitamin D deficiency states in the elderly.
• As an adjunct to specific therapy for the treatment of osteoporosis (fragile bones) in patients with deficiency or high risk of combined deficiency of vitamin D and calcium.

2. What you need to know before you take Calodis

Do not take Calodis

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of calcium in the blood (hypercalcemia),
• if you have high levels of calcium in the urine (hypercalciuria),
• If you suffer from overactivity of the parathyroid glands (hyperparathyroidism),
• If you suffer from bone marrow cancer (myeloma),
• If you suffer from cancer that has affected the bones (bone metastases),
• if you have limited mobility of the limbs (prolonged immobilization) accompanied by hypercalciuria and/or hypercalcemia,
• if you have kidney stones (nephrolithiasis),
• if you have calcium deposits in the kidneys (nephrocalcinosis),
• if you suffer from an excess of vitamin D (hypervitaminosis D),
• if you have severe kidney problems,
• if you are under 18 years of age.

This medicine contains soybean oil. It should not be used in case of peanut or soy allergy.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Calodis:

• Prolonged treatment

During prolonged treatment, calcium levels in the blood and urine and kidney function should be monitored periodically. This is especially important if you have a tendency to develop kidney stones. Depending on blood levels, your doctor may reduce the dose or stop treatment.

• If you are receiving simultaneous treatment with digitalis glycosides (heart medicines) or thiazide diuretics (medicines that increase urine excretion) for heart problems, in this case, calcium levels in the blood and urine and kidney function should be monitored periodically, especially if you are an elderly patient. Depending on blood levels, your doctor may reduce the dose or stop treatment.
• Kidney problems

If you have kidney problems, you should take Calodis with special care. Especially if you are receiving other medicines that contain aluminum, since the citric acid present in Calodis can increase aluminum absorption. Your calcium levels in blood and urine should be monitored. If you have severe kidney problems, use other forms of vitamin D that are not colecalciferol.

• Additional intake of calcium and vitamin D supplements

Medical supervision is required and your doctor will require frequent monitoring of calcium levels in your blood and urine.

• Sarcoidosis(an immune disorder that can affect the liver, lungs, skin, or lymph nodes)

Be careful when taking Calodis if you suffer from sarcoidosis. There is a risk that the effect of this medicine may become too strong, which can lead to an overdose of calcium in the body. Calcium levels in the blood and urine should be monitored.

• Immobilization and osteoporosis

In these cases, this medicine should be used with special care, as it may increase calcium levels in the blood.

Children and adolescents

Calodis is not indicated for use in children and adolescents under 18 years of age, see section 2 “Do not take Calodis”.

Other medicines and Calodis

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• In case of simultaneous treatment with digitalis glycosides(heart medicines derived from the digitalis plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring is necessary, which may include an electrocardiogram to measure heart activity (ECG) and a blood test to know the calcium level in the blood.
• In case of simultaneous administration of thiazide diuretics(also known as medicines to increase urine excretion), the calcium level in the blood should be monitored periodically, as thiazides reduce calcium excretion in the urine.
• The absorption and, therefore, the efficacy of certain antibiotics called tetracyclinesdecrease with the simultaneous administration of Calodis. These medicines should be taken at least 2 hours before or 4-6 hours after Calodis.
• There may be a reduction in the effect of quinolone antibioticsif taken at the same time as calcium. Take quinolone antibiotics at least 2 hours before or 6 hours after taking Calodis.
• Additionally, other medicines such as sodium fluoride(used to strengthen tooth enamel or treat osteoporosis) and bisphosphonate medicines(used to treat osteoporosis) are affected by interactions. Therefore, these medicines should be taken at least 3 hours before Calodis.
• There should be the widest possible interval between the administration of cholestyramine(a medicine to reduce high cholesterol levels) or laxativessuch as liquid paraffin, and Calodis, otherwise, vitamin D will not be absorbed properly.
• Orlistat(a medicine used to treat obesity) may affect vitamin D absorption. Take Calodis at least 2 hours before or after taking Orlistat.
• Simultaneous administration of Calodis and rifampicin(an antibiotic), phenytoin(a medicine for the treatment of epilepsy), or barbiturates(hypnotics) may lead to a reduction in the effect of vitamin D.
• Simultaneous administration of Calodis and glucocorticoidsmay lead to a reduction in the effect of vitamin D and a reduction in calcium levels in the blood.
• Additional calcium and vitamin D supplementsshould only be administered under medical supervision and frequent monitoring of calcium levels in the blood and urine is required.
• Calcium may reduce the effect of levothyroxine(used to treat thyroid deficiency). For this reason, levothyroxineshould be taken at least 4 hours before or 4 hours after Calodis.
• Calcium may reduce the absorption of iron, zinc, or strontium ranelate. Take these medicines at least 2 hours before or after taking Calodis.
• Calcium may reduce the absorption of estramustine(a medicine used in chemotherapy). Take this medicine at least 2 hours before or after taking Calodis.
• Concomitant administration of Calodis with some antiretroviral integrase inhibitors(such as raltegravir, dolutegravir, elvitegravir, cabotegravir, or any associated combination) may decrease its absorption and, therefore, its efficacy. Your specialist doctor will indicate the frequency of intake depending on the antiretroviral.

Taking Calodis with food, drinks, and alcohol

If you take this medicine together with foods and drinks that contain oxalic acid (a compound found in spinach and rhubarb) or phytic acid (found in whole wheat bread and cereals) and phosphorus found in milk, it may reduce the amount of calcium absorbed. In the 2 hours before or after eating foods with high oxalic acid or phytic acid content, you should not take medicines that contain calcium.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Consult your doctor before using this medicine.

Due to the content of vitamin D (880 UI) in Calodis, its use is not recommended during pregnancy since the recommended daily dose of vitamin D should not exceed 600 UI/day. However, the use of Calodis in pregnant women with established nutritional deficiency of calcium and vitamin D is under medical discretion.

Breastfeeding

Calodis can be used during breastfeeding. However, calcium and vitamin D3 pass into breast milk, and this should be taken into account if additional vitamin D is administered to the child. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No effects on driving or using machines have been described.

Calodis contains sucrose, sodium, lactose, and glucose.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. It may cause tooth decay. This medicine contains 96.15 mg of sodium (main component of table/cooking salt) per effervescent tablet. This is equivalent to 4.8% of the maximum recommended daily intake of sodium for an adult.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. It may cause tooth decay.

This medicine contains glucose (in maltodextrin from corn). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. It may cause tooth decay.

3. How to take Calodis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is

In adults and elderly patients, it is 1 effervescent tablet (1000 mg of calcium and 880 UI of Vitamin D3) per day.

Use in children and adolescents

It is not indicated for use in children and adolescents under 18 years of age (see section 2 “Do not take Calodis”).

Method of administration

This medicine is administered orally. Dissolve the tablet in a glass of water and drink immediately.

Duration of treatment

Calodis should be taken as prolonged treatment. Talk to your doctor about the duration of treatment with Calodis (see also section 2 “Warnings and precautions”).

If you take more Calodis than you should

Consult your doctor or pharmacist immediately if you suspect that you are suffering from an overdose. Have the package and any remaining tablets available.

Overdose of Calodis may cause symptoms such as feeling dizzy (nausea), vomiting, thirst or excessive thirst, increased urine production, dehydration, or constipation.

If you have taken more Calodis than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Calodis

If you forget to take Calodis, take it as soon as you remember unless it is time to take the next dose. In that case, take the next dose as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Calodis

If you want to stop or suspend treatment prematurely, consult your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Calodis and consult a doctor immediately if you experience any of the following serious side effects:

Very rare (may affect up to 1 in 10,000 patients):

• Milk-alkali syndrome, which usually occurs only in case of excessive dosing and consists of frequent urination, persistent headache, lasting loss of appetite, nausea or vomiting, fatigue or unusual weakness along with elevated calcium levels in the blood and kidney problems.

Rare (may affect up to 1 in 1,000 patients):

• Severe allergic reaction: swelling of the face, lips, tongue, or throat with sudden difficulty breathing and severe skin rash.
• skin rash, itching, hives
• feeling unwell (nausea), vomiting, diarrhea, abdominal pain, constipation, gas, bloating (abdominal distension)

Uncommon (may affect up to 1 in 100 patients):

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

If you have kidney failure, there may be a risk of having high phosphate levels in the blood, high calcium levels in the kidneys, and kidney stones.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calodis

Keep this medicine out of the sight and reach of children.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton and on the tube after EXP. The expiry date is the last day of the month stated.

Medicines should 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

Composition of Calodis

• The active substances are calcium carbonate and colecalciferol (vitamin D3). Each effervescent tablet contains 2500 mg of calcium carbonate (equivalent to 1000 mg of calcium) and 22 μg of colecalciferol concentrate in powder form (equivalent to 880 UI of vitamin D3).
• The other ingredients (excipients) are: anhydrous citric acid, sodium bicarbonate, lactose monohydrate, povidone, sodium saccharin, sodium cyclamate, macrogol 6000, orange flavor (contains maltodextrin from corn), simethicone emulsion (contains dimethicone and anhydrous colloidal silica), methylcellulose, α-tocopherol, hydrogenated soybean oil, gelatin, sucrose, corn starch, anhydrous colloidal silica.

Appearance of the product and pack contents

Effervescent tablets, cylindrical, white or off-white.

It is presented in propylene tubes, each containing 15 effervescent tablets. Each pack contains 2 tubes (30 effervescent tablets).

Marketing authorization holder and manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer

Losan Pharma GmbH

Otto-Hahn-Strasse 13

D-79395 Neuenburg

Germany

Date of last revision of this leaflet: May 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/