Calodis 1000 mg/880 IU effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Calodis 1000 mg / 880 IU effervescent tablets

Calcium / colecalciferol

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Calodis is and what it is 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 elderly individuals.
• As an adjunct to specific therapy for the treatment of osteoporosis (fragile bones) in patients with deficiency or at high risk of combined deficiency of vitamin D and calcium.

2. What you need to know before starting to take Calodis

Do not take Calodis

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6),
• if you have high levels of calcium in your blood (hypercalcemia),
• if you have high levels of calcium in your urine (hypercalciuria),
• if you have overactivity of the parathyroid glands (hyperparathyroidism),
• if you have bone marrow cancer (myeloma),
• if you have cancer that has spread to the bones (bone metastases),
• if you have limited limb movement (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 have excess 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 if you are allergic to peanuts or soy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Calodis:

• Long-term treatment

During long-term treatment, calcium levels in 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 discontinue treatment.

• If you are receiving concomitant treatment with cardiac glycosides (medicines used to treat heart failure and certain heart rhythm disorders) or thiazide diuretics (medicines that increase urine excretion) for heart problems, calcium levels in blood and urine and kidney function should be monitored regularly, especially if you are elderly. Depending on blood levels, your doctor may reduce the dose or discontinue treatment.

• Kidney problems

If you have kidney problems, you should take Calodis with special caution. This is especially important if you are also taking other medicines containing aluminum, as the citric acid in Calodis may increase aluminum absorption. Your blood and urine calcium levels should be monitored. If you have severe kidney problems, use other forms of vitamin D instead of cholecalciferol.

• Taking additional calcium and vitamin D supplements

Medical supervision is required, and your doctor will need to monitor calcium levels in your blood and urine frequently.

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

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

• Immobilization and osteoporosis

In these cases, this medicine should be used with special caution, as it could increase blood calcium levels.

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

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

• When used together with digitalis glycosides (cardiac glycosides derived from the foxglove plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring is necessary, which may include an electrocardiogram to measure the heart's electrical activity (ECG) and a blood test to determine blood calcium levels.
• When administered together with diuretics of the thiazide class (also known as medicines that increase urine excretion), blood calcium levels should be monitored periodically, as thiazides reduce calcium excretion in urine.
• The absorption, and therefore the effectiveness, of certain antibiotics called tetracyclines is reduced when taken at the same time as Calodis. These medicines should be taken at least 2 hours before or 4–6 hours after Calodis.
• The effect of quinolone antibiotics may be reduced if taken simultaneously with calcium. Take quinolone antibiotics at least 2 hours before or 6 hours after taking Calodis.
• Other medicines such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are also affected by interactions. Therefore, these medicines should be taken at least 3 hours before Calodis.
• The largest possible interval should be maintained between administration of cholestyramine (a medicine used to lower high cholesterol) or laxatives such as liquid paraffin, and Calodis, otherwise vitamin D may not be properly absorbed.
• Orlistat (a medicine used to treat obesity) may affect vitamin D absorption. Take Calodis at least 2 hours before or after Orlistat.
• Concomitant administration of Calodis and rifampicin (an antibiotic), phenytoin (a medicine used to treat epilepsy), or barbiturates (hypnotics) may result in reduced effectiveness of vitamin D.
• Concomitant administration of Calodis and glucocorticoids may lead to reduced effectiveness of vitamin D and reduced blood calcium levels.
• Additional calcium and vitamin D supplements should only be taken under medical supervision, and frequent monitoring of calcium levels in blood and urine is required.
• Calcium may reduce the effect of levothyroxine (used to treat thyroid insufficiency). Therefore, take levothyroxine at least 4 hours before or 4 hours after Calodis.
• Calcium may reduce the absorption of iron ranelate, zinc, or strontium. 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 use of Calodis with any antiretroviral integrase inhibitor (such as raltegravir, dolutegravir, elvitegravir, cabotegravir, or any associated combination) may decrease their absorption and therefore their efficacy. Your specialist doctor will advise you on the timing of doses depending on the antiretroviral used.

Taking Calodis with food, drinks, and alcohol

Taking this medicine with foods and drinks containing oxalic acid (a compound found in spinach and rhubarb) or phytic acid (found in wholemeal bread and cereals), and phosphorus found in milk, may reduce the amount of calcium absorbed. You should not take calcium-containing medicines within 2 hours before or after consuming foods high in oxalic acid or phytic acid.

Pregnancy and breastfeeding

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

Pregnancy

Consult your doctor before using this medicine.

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

Lactation

Calodis may be used during breastfeeding. However, calcium and vitamin D3 are excreted in breast milk, and this should be taken into account if additional vitamin D is administered to the infant. Consult your doctor or pharmacist before using this medicine.

Driving and use of machines

No effects on driving or operating machinery have been reported.

Calodis contains sucrose, sodium, lactose, and glucose.

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries. This medicine contains 96.15 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 4.8% of the maximum daily sodium intake recommended for an adult.

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.

This medicine contains glucose (in maltodextrin derived from corn). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.

3. How to take Calodis

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose

For adults and elderly patients: 1 effervescent tablet (1000 mg calcium and 880 IU Vitamin D3) daily.

Use in children and adolescents

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 a long-term treatment. Discuss with your doctor the duration of treatment with Calodis (see also section 2 “Warnings and precautions”).

If you take more Calodis than you should

Contact your doctor or pharmacist immediately if you suspect an overdose. Have the packaging and any remaining tablets available.

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

If you have taken more Calodis than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 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 almost time for your 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 wish to interrupt or discontinue the treatment prematurely, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

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

• Milk-alkali syndrome, which usually occurs only with excessive dosing and is characterized by frequent urination, persistent headache, prolonged loss of appetite, nausea or vomiting, unusual fatigue or weakness, together 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 breathing difficulty and severe skin rash.
• Skin rash, itching, hives
• Feeling unwell (nausea), vomiting, diarrhoea, abdominal pain, constipation, flatulence, bloating (abdominal distension)

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

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

If you have renal impairment, there may be a risk of elevated phosphate levels in the blood, elevated calcium levels in the kidneys, and kidney stones.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 packaging.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This 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 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 IU 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 maltodextrin derived from maize), simeticone emulsion (contains dimethicone and anhydrous colloidal silica), methylcellulose, ?-tocoferol, hydrogenated soybean oil, gelatin, sucrose, corn starch, anhydrous colloidal silica.

Appearance of the product and contents of the pack

Effervescent tablets, cylindrical in shape, white or almost white in colour.

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

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturing Responsible Party

Losan Pharma GmbH

Otto-Hahn-Strasse 13

D-79395 Neuenburg

Germany

Date of the most recent review of this leaflet: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/