CALDEOS 1000 mg/880 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Caldeos 1,000 mg / 880 IU Chewable Tablets EFG

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 Caldeos and what is it used for
2. What you need to know before you take Caldeos
3. How to take Caldeos
4. Possible side effects

5 Conservation of Caldeos

1. Package contents and additional information

1. What is Caldeos and what is it used for

Caldeos is a calcium and vitamin D3 supplement.

It is used:

• to prevent and treat calcium and vitamin D deficiency states in the elderly.
• for the intake of vitamin D and calcium as complementary therapy for osteoporosis (fragile bones).

2. What you need to know before you take Caldeos

Do not take Caldeos

• If you are allergic (hypersensitive) to the active substances or 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 excrete too much calcium in the urine (hypercalciuria),
• if you have overactive parathyroid glands (hyperparathyroidism),
• if you have bone marrow cancer (myeloma),
• if you have cancer that has affected the bones (bone metastases),
• if you have limited mobility of the limbs (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria,
• if you have kidney stones (nephrolithiasis),
• if you have calcium deposits in the kidneys (nephrocalcinosis),
• if you have an excess of vitamin D (hypervitaminosis D),
• if you have severe kidney problems.
• if you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if any of the following points apply to you:

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

• Intake of additional calcium and vitamin D supplements

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

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

Be careful when taking this medicine if you have 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 could increase calcium levels in the blood.

Children and adolescents

This medicine is not indicated for use in children or adolescents under 18 years of age. See section "Do not take Caldeos".

Using Caldeos with other medicines

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medicine.

• In case of simultaneous treatment with digitalis glycosides (cardiac glycosides derived from the digitalis plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring is necessary, including an ECG and determination of calcium levels in the blood.
• In case of simultaneous administration of thiazide diuretics (also known as medicines to increase urine excretion), calcium levels 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 tetracyclines) decrease with simultaneous administration of Calcium/Vitamin D3. These medicines should be taken at least 2 hours before or 4-6 hours after Calcium/Vitamin D3.
• Additionally, other medicines such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are affected by interactions. Therefore, these medicines should be taken at least 3 hours before Calcium/Vitamin D3.
• The widest possible interval should be left between the administration of cholestyramine (a medicine to reduce high cholesterol levels) or laxatives such as liquid paraffin and Calcium/Vitamin D3, as otherwise, vitamin D will not be absorbed properly.
• The simultaneous administration of Calcium/Vitamin D3 and phenytoin (a medicine for the treatment of epilepsy) or barbiturates (hypnotics) may lead to a reduction in the effect of vitamin D.
• The simultaneous administration of this medicine and glucocorticoids (e.g., cortisone) may lead to a reduction in the effect of vitamin D and a reduction in calcium levels in the blood.
• Additional calcium and vitamin D supplements should 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, levothyroxine should be taken at least four hours before or four hours after this medicine.
• There may be a reduction in the effect of quinolone antibiotics if taken at the same time as calcium. Take quinolone antibiotics at least two hours before or six hours after taking this medicine.

Using Caldeos with food, drinks, and alcohol

You can take the medicine at any time, with or without food.

You should be aware that oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grains) can reduce the amount of calcium absorbed in the intestine. In the 2 hours before or after eating foods high in oxalic acid or phytic acid, patients should not take medicines containing calcium.

Pregnancy and breastfeeding

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

If you are pregnant, you can take this medicine in case of calcium and vitamin D deficiency.

Do not exceed the daily dose of half a tablet. During pregnancy, the total daily amount of calcium should not exceed 1,500 mg and the total daily amount of vitamin D3 should not exceed 600 IU (International Units).

Long-term overdose of calcium and vitamin D during pregnancy should be avoided as it can lead to high levels of calcium in the blood and may have a negative effect on the fetus.

This medicine can be used during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor before giving your child other products that contain vitamin D.

Driving and using machines

There is not enough information available on the effects of this medicine on the ability to drive and use machines. However, the influence seems unlikely.

Caldeos contains aspartame (E-951), isomalt (E-953), sorbitol (E-420), and sucrose.

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This medicine contains isomalt, sorbitol, and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Caldeos

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

Dose

Unless your doctor tells you otherwise, the recommended dose is:

Adults and elderly: 1 chewable tablet per day (corresponding to 1,000 mg of calcium and 800 IU [International Units] of vitamin D3).

Pregnant women can take only half a chewable tablet per day (corresponding to 500 mg of calcium and 440 IU [International Units] of vitamin D3). Do not exceed the daily dose of half a tablet.

Use in children and adolescents

This medicine is not indicated for use in children or adolescents under 18 years of age. See section "Do not take Caldeos".

Method of administration

Oral use.

The tablet can be divided into equal doses.

The tablet should be chewed before swallowing. It can be taken at any time, with or without food.

Duration of treatment

This medicine should be taken as prolonged treatment. Talk to your doctor about the duration of treatment with Calcium/Vitamin D3 (see also section 2, Warnings and precautions).

If you take more Caldeos than you should

Overdose of Calcium/Vitamin D3 can cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine production, decreased body fluids, or constipation.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Caldeos

If you forget to take the Calcium/Vitamin D3 tablet, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Caldeos

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

If you have any other questions about 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 Caldeos and contact a doctor immediately if you experience any of the following side effects:

Very rare:May affect up to 1 in 10,000 people

• Allergic reaction.
• Swelling of the face, lips, tongue, or throat with sudden difficulty breathing and severe skin rash.

Other reported side effects are:

Rare side effects:May affect up to 1 in 1,000 people

• Nausea, vomiting, diarrhea, abdominal pain, constipation, gas, bloating (abdominal distension).
• Skin rash, itching, urticaria.
• Allergy.

Uncommon side effects:May affect up to 1 in 100 people

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Caldeos

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

For tubes:

Keep the container perfectly closed to protect it from moisture.

For aluminum strips:

Store in the original container to protect it from light and moisture.

Do not use this medicine after the expiration date that appears on the container after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Caldeos

• The active ingredients are calcium and colecalciferol. Each chewable tablet contains 2,500 mg of calcium carbonate (equivalent to 1,000 mg of calcium) and 8.8 mg of concentrated colecalciferol (in powder form), equivalent to 880 IU of vitamin D3.
• The other ingredients are: isomalt (E-953), xylitol (E-967), sorbitol (E-420), anhydrous citric acid, sodium dihydrogen citrate, magnesium stearate, sodium carmellose, orange flavor (CPB-239), orange flavor (CVT-255) (both flavors contain sorbitol E-420 and corn maltodextrin), aspartame (E-951), acesulfame potassium, sodium ascorbate, all-rac-alpha-tocopherol, modified corn starch, sucrose, medium-chain triglycerides, and colloidal silicon dioxide.

Appearance of the product and package contents

Caldeos are round, white tablets with a smooth surface and a score line to break the tablet.

The chewable tablets are presented in polypropylene tubes with a polyethylene cap and desiccant in the following package size:

30 chewable tablets.

The chewable tablets are presented in aluminum/paper thermo-sealed strips in the following package size:

30 chewable tablets.

Not all package sizes may be marketed.

Marketing authorization holder

Procare Health Iberia, S.L.

Avda. Miguel Hernández 21, Bajo

46450 Benifaió (Valencia) Spain

Manufacturer

Hermes Arzneimittel GmbH

Georg-Kalb-Straße 5-8

82049 Pullach i. Isartal

Germany

Date of last revision of this leaflet: March 2017

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/