Leaflet: Information for the user

Caldeos 1.000 mg / 880 U.I. chewable tablets EFG

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 only, and you must 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.

1.What Caldeos is and what it is used for

2.What you need to know before you start taking Caldeos

3.How to take Caldeos

4.Possible side effects

5Storage of Caldeos

6.Contents of the pack and additional information

Caldeos is a calcium and vitamin D supplement3.

It is used:

• to prevent and treat calcium and vitamin D deficiency states in elderly individuals.
• to provide vitamin D and calcium as a complementary therapy for osteoporosis (fragile bones).

Do not take Caldeos

• If you are allergic (hypersensitive) to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you have high levels of calcium in your blood (hypercalcemia),
• If you excrete too much calcium in your urine (hypercalciuria),
• If you have hyperactivity of the parathyroid glands (hyperparathyroidism),
• If you have bone cancer (myeloma),
• If you have cancer that has affected your bones (bone metastases),
• If you have limited mobility of your limbs (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria,
• If you have kidney stones (nephrolithiasis),
• If you have calcium deposits in your kidneys (nephrocalcinosis),
• If you have excessive 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 medication if any of the following points affect you:

• 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 blood levels, your doctor may reduce the dose or discontinue treatment.

• If you are receiving simultaneous treatment with cardiac glycosides or thiazide diuretics (medications that increase urine excretion) for heart problems.

In this case, your calcium levels in blood and urine and renal function should be monitored periodically, especially if you are an elderly patient. Depending on blood levels, your doctor may reduce the dose or discontinue treatment.

• Kidney problems

If you have kidney problems, you should take this medication with special care. Especially if you are receiving other medications containing aluminum, as the citric acid present in this medication 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 do not contain colecalciferol.

• Additional calcium and vitamin D supplements

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

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

Be especially careful when taking this medication if you have sarcoidosis. There is a risk that the effect of this medication may become too strong, leading to a calcium overdose in the 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 blood calcium levels.

Children and adolescents

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

Use of Caldeos with other medications

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

• In the case of simultaneous treatment with digitalis glycosides (digitalis-derived cardiac glycosides), arrhythmias may occur. Therefore, strict medical monitoring is required, including an ECG and determination of blood calcium levels.
• In the 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 efficacy of certain antibiotics (designated tetracyclines) are reduced with simultaneous administration of Calcium/Vitamin D3. These medications should be taken at least 2 hours before or 4-6 hours after Calcium/Vitamin D3.
• 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 Calcium/Vitamin D3.
• Leave the widest possible interval between the administration of cholestyramine (a medication to reduce high cholesterol levels) or laxatives such as liquid paraffin and Calcium/Vitamin D3, as otherwise, vitamin D will not be absorbed properly.
• Simultaneous administration of Calcium/Vitamin D3and phenytoin (a medication for epilepsy treatment) or barbiturates (hypnotics) may lead to a reduction in the effect of vitamin D.
• Simultaneous administration of this medication and glucocorticoids (e.g., cortisone) may lead to a reduction in the effect of vitamin D and a reduction in blood calcium levels.
• Only additional calcium and vitamin D supplements should be administered 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 hypothyroidism). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after this medication.
• 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 this medication.

Use of Caldeos with food, drinks, and alcohol

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

Be aware that oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grains) may 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 medications containing calcium.

Pregnancy and breastfeeding

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

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

Do not exceed the daily dose of half a tablet. During pregnancy, the total daily dose of calcium should not exceed 1,500 mg and the total daily dose of vitamin D3should not exceed 600 IU (International Units).

Avoid long-term calcium and vitamin D overdose during pregnancy as it may cause high calcium levels in the blood and have a negative effect on the fetus.

This medication can be used during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor before taking this medication if your child is receiving other products containing vitamin D.

Driving and operating machinery

No sufficient data is available regarding the effects of this medication on the ability to drive and operate machinery. However, the influence appears to be unlikely.

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

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

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

Follow exactly the administration instructions for this medication as 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 people: 1 chewable tablet per day (corresponding to 1,000 mg of calcium and 800 IU [International Units] of vitamin D3).

Pregnant women may 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 half a tablet per day.

Use in children and adolescents

This medication is not indicated for use in children or adolescents under 18 years of age. See the section “Do not take Caldeos”.

Administration form

Oral route.

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.

Treatment duration

This medication 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 may produce symptoms such as nausea, vomiting, excessive thirst, increased urine output, 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 medication 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 the missed dose.

If you interrupt treatment with Caldeos

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

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

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

Stop taking Caldos and contact a doctor immediately if you experience any of the following adverse 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 adverse effects are:

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

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

Uncommon adverse effects:May affect 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 phosphates in the blood, high levels of calcium 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 of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication 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 medication after the expiration date that appears on the container after “CAD”. The expiration date is the last day of the month indicated.

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

Composition of Caldeos

- The active principles 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 U.I. of vitamin D3. 3 .

- The other components are: isomalta (E-953), xylitol (E-967), sorbitol (E-420), anhydrous citric acid, sodium dihydrogen citrate, magnesium stearate, sodium carmelose, orange aroma (CPB-239), orange aroma (CVT-255) (the two aromas contain sorbitol E-420 and corn dextrin), aspartame (E-951), potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol, modified corn starch, sucrose, medium-chain triglycerides, and colloidal silicon dioxide.

Appearance of the product and contents of the packaging

Caldeos are round, white, smooth tablets with a groove for breaking the tablet.

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

30 chewable tablets.

The chewable tablets are presented in aluminum/paper thermosealed strips in the following packaging size:

30 chewable tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Procare Health Iberia, S.L.

Avda. Miguel Hernández 21, Bajo

46450 Benifaió (Valencia) Spain

Responsible for Manufacturing

Hermes Arzneimittel GmbH

Georg-Kalb-Straße 5-8

82049 Pullach i. Isartal

Germany

Last review date of this leaflet: March 2017

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