Leaflet: information for the user

Calodis 1000 mg / 880 UI effervescent tablets

Calcium / colecalciferol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Calodis contains the active principles 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.

Do not take Calodis

This medication contains soy oil. It should not be used in case of allergy to peanuts or soy.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Calodis:

• Prolonged treatment

During prolonged treatment, your calcium levels in blood and urine and renal function should be monitored periodically. This is especially important if you are prone to developing kidney stones. Depending on your blood levels, your doctor may reduce the dose or discontinue treatment.

• If you are receiving simultaneous treatment with cardiac glycosides (medications for treating heart failure and certain arrhythmias) or thiazide diuretics (medications that increase urine excretion) for heart problems, your calcium levels in blood and urine and renal function should be monitored periodically, especially if you are an elderly patient. Depending on your blood levels, your doctor may reduce the dose or discontinue treatment.
• Renal problems

If you have kidney problems, you should take Calodis with special care. Especially if you are receiving other medications containing aluminum, as the citric acid present in Calodis may 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 calcium and vitamin D supplements

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

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

You should take special care when taking Calodis if you have sarcoidosis. There is a risk that the effect of this medication may become too strong, leading to a calcium overdose in your body. Your calcium levels in blood and urine should be monitored.

• Immobilization and osteoporosis

In these cases, this medication should be used with special care, as it may increase your calcium levels in 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 medications and Calodis

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• In case of simultaneous treatment with digitalis glycosides (digitalis cardiac glycosides derived from the digitalis plant), arrhythmias may occur. Therefore, strict medical monitoring may be required, including an electrocardiogram to measure heart activity (ECG) and a blood test to determine your calcium levels in blood.
• In case of simultaneous administration of thiazide diuretics (also known as medications that increase urine excretion), your calcium levels in blood should be monitored periodically, as thiazides reduce calcium excretion in urine.
• The absorption and, therefore, the effectiveness of certain tetracycline antibiotics may be reduced with simultaneous administration of Calodis. These medications should be taken at least 2 hours before or 4-6 hours after Calodis.
• There may be a reduction in the effect of quinolone antibiotics if taken at the same time as calcium. Take quinolone antibiotics at least 2 hours before or 6 hours after taking Calodis.
• Additionally, other medications such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are affected by interactions. Therefore, these medications should be taken at least 3 hours before Calodis.
• You should leave the widest possible interval between the administration of colestiramine (a medication for reducing high cholesterol levels) or laxatives such as liquid paraffin, and Calodis, as otherwise, vitamin D will not be absorbed properly.
• Orlistat (a medication used to treat obesity) may affect vitamin D absorption. Take Calodis at least 2 hours before or after taking Orlistat.
• The simultaneous administration of Calodis and rifampicin (an antibiotic), phenytoin (a medication for treating epilepsy), or barbiturates (hypnotics) may lead to a reduction in the effect of vitamin D.
• The simultaneous administration of Calodis and glucocorticoids may lead to a reduction in the effect of vitamin D and a reduction in calcium levels in blood.
• Only additional calcium and vitamin D supplements should be administered under medical supervision, and frequent monitoring of calcium levels in blood and urine will be required.
• Calcium may reduce the effect of levothyroxine (used to treat hypothyroidism). Therefore, take levothyroxine at least 4 hours before or 4 hours after taking Calodis.
• Calcium may reduce the absorption of ranelate iron, zinc, or strontium . Take these medications at least 2 hours before or after taking Calodis.
• Calcium may reduce the absorption of estramustine (a medication used in chemotherapy). Take this medication at least 2 hours before or after taking Calodis.
• The simultaneous administration of Calodis with any antiretroviral integrase inhibitor (such as raltegravir, dolutegravir, elvitegravir, cabotegravir, or any associated combination) may reduce its absorption and, therefore, its effectiveness. Your specialist doctor will indicate the frequency of doses depending on the antiretroviral.

Taking Calodis with food, drinks, and alcohol

If you take this medication together with foods and drinks containing oxalic acid (a compound present in spinach and rhubarb) or phytic acid (present in whole wheat bread and cereals) and the 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 medications containing calcium.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor before using this medication.

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

Lactation

Calodis can be used during lactation. 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 using this medication.

Driving and operating machinery

No effects on driving or operating machinery have been described.

Calodis contains saccharose, sodium, lactose, and glucose.

This medication contains saccharose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication. It may cause tooth decay. This medication contains 96.15 mg of sodium (the main component of table salt/for cooking) in each tablet. This corresponds to 4.8% of the maximum daily sodium intake recommended for an adult.

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication. It may cause tooth decay.

This medication contains glucose (in maltodextrin from corn). If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication. It may cause tooth decay.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. .

The recommended dose is

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

Use in children and adolescents

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

Administration form

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

Treatment duration

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 you have taken an overdose. Have the packaging and any remaining tablets available.

An overdose of Calodis may produce symptoms such as dizziness (nausea), vomiting, excessive thirst, increased urine production, dehydration, or constipation.

If you have taken more Calodis than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 compensate for missed doses.

If you interrupt treatment with Calodis

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

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

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

• Severe allergic reaction: sudden facial swelling, difficulty breathing, and severe skin rash.
• Severe skin rash, itching, urticaria.
• Feeling unwell (nausea), vomiting, diarrhea, abdominal pain, constipation, gas, abdominal distension.

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

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

If you have kidney insufficiency, you may be at risk of having elevated blood phosphate levels, elevated calcium levels in the kidneys, and kidney stones.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging.

Do not use this medication after the expiration date that appears on the box and on the tube after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of calodis

• The active principles are calcium carbonate and colecalciferol (vitamin D 3 ). Each tablet contains 2500 mg of calcium carbonate (equivalent to 1,000 mg of calcium) and 22 ? g of colecalciferol concentrate in powder form (equivalent to 880 UI of vitamin D3).
• The other components (excipients) are: anhydrous citric acid, sodium bicarbonate, lactose monohydrate, povidone, sodium saccharin, sodium cyclamate, macrogol 6000, orange flavor (contains maize-derived maltodextrin), simethicone emulsion (contains dimethicone and anhydrous colloidal silica), methylcellulose, ? -tocopherol, hydrogenated soybean oil, gelatin, sucrose, cornstarch, anhydrous colloidal silica.

Appearance of the product and contents of the packaging

Fizzy, cylindrical tablets, white or off-white in color.

Presented in propylene tubes, each containing 15 effervescent tablets. Each package contains 2 tubes (30 effervescent tablets).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing

Losan Pharma GmbH

Otto-Hahn-Strasse 13

D-79395 Neuenburg

Germany

Last review date of this prospectus: May 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/