Leaflet: information for the user

Micaldeos 500 mg/1000 IU chewable tablets

Calcium carbonate / Colecalciferol (Vitamin D3)

Read this leaflet carefully before you start taking the medicine, as 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 Micaldeos500 mg/1000 IU chewable tablets are and what they are used for

2.What you need to know before you start taking Micaldeos500 mg/1000 IU chewable tablets

3.How to take Micaldeos500 mg/1000 IU chewable tablets

4.Possible side effects

5.Storage of Micaldeos500 mg/1000 IU chewable tablets

6.Contents of the pack and additional informationl

Micaldeos 500 mg/1000 UI chewable tabletsis a calcium-vitamin D3 supplement.

It is used

• to prevent and treat calcium and vitamin D deficiency states in the elderly.

for the supply of vitamin D and calcium as a complementary therapy for osteoporosis (fragile bones) in patients at risk of vitamin D and calcium deficiency.

Do not take Micaldeos 500 mg/1000 UI chewable tablets

-if you are allergic to calcium, vitamin D3, or 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 a cancer that has affected your bones (bone metastases)

-if you have prolonged immobility 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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Micaldeos 500 mg/1000 UI chewable tablets

-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 concurrent treatment with cardiac glycosides 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. Depending on your blood levels, your doctor may reduce the dose or discontinue treatment.

-if you have kidney problems, you should take Micaldeos 500 mg/1000 UI chewable tablets with special care. 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.

-Only take additional calcium and vitamin D supplements under medical supervision, and your doctor will require frequent monitoring of your calcium levels in blood and urine.

-Be especially careful when taking Micaldeos 500 mg/1000 UI chewable tablets if you have sarcoidosis (an immunological disorder that can affect the liver, lungs, skin, or lymph nodes). 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.

-if you are immobilized and have osteoporosis, this medication should be used with special care, as it may increase your calcium levels in the blood.

-Before taking Micaldeos 500 mg/1000 UI chewable tablets, consider the amount of calcium and alkalinity consumed from other sources (foods, dietary supplements, and other medications), such as carbonates. If you take high-calcium products simultaneously with, for example, carbonates, this may cause Burnett syndrome. Burnett syndrome is a metabolic disorder of calcium with increased calcium levels in the blood (hypercalcemia), metabolic alkalosis, renal insufficiency, and calcification of soft tissues. Therefore, additional intake of Micaldeos 500 mg/1000 UI chewable tablets requires strict medical supervision, with frequent monitoring of calcium levels in blood and urine.

Children and adolescents

Micaldeos 500 mg/1000 UI chewable tablets are not indicated for use in children and adolescents.

Use of Micaldeos 500 mg/1000 UI chewable tablets with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

-in the case of concurrent treatment with digitalis glycosides (digitalis cardiac glycosides derived from the plant digitalis), changes in heart rhythm (cardiac arrhythmias) may occur. Therefore, close medical monitoring, including an ECG and determination of calcium levels in blood, is necessary.

-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 Micaldeos 500 mg/1000 UI chewable tablets. These medications should be taken at least 2 hours before or 4-6 hours after taking Micaldeos 500 mg/1000 UI chewable tablets.

-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 taking Micaldeos 500 mg/1000 UI chewable tablets.

-Leave the widest possible interval between the administration of cholestyramine (a medication to reduce high cholesterol levels) or laxatives such as liquid paraffin and Micaldeos 500 mg/1000 UI chewable tablets, as otherwise, vitamin D will not be absorbed properly.

-Simultaneous administration of Micaldeos 500 mg/1000 UI chewable tablets and phenytoin (a medication for the treatment of epilepsy) or barbiturates (hypnotics) may lead to a reduction in the effect of vitamin D.

-Simultaneous administration of Micaldeos 500 mg/1000 UI chewable tablets 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.

-Only administer additional calcium and vitamin D supplements 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, levothyroxine should be taken at least four hours before or four hours after taking Micaldeos 500 mg/1000 UI chewable tablets.

-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 Micaldeos 500 mg/1000 UI chewable tablets.

Taking Micaldeos 500 mg/1000 UI chewable tablets with food and drinks

You can take Micaldeos 500 mg/1000 UI chewable tablets 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, lactation, and fertility

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.

Do not use Micaldeos 500 mg/1000 UI chewable tablets if you are pregnant.

During pregnancy, the total daily amount of calcium should not exceed 1500 mg, and the total daily amount of vitamin D3 should not exceed 600 UI (International Units).

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

You can take Micaldeos 500 mg/1000 UI chewable tablets during lactation. As calcium and vitamin D pass into breast milk, consult your doctor before giving your child other products containing vitamin D. Be aware when administering additional vitamin D to the child.

Driving and operating machinery

The influence of Micaldeos 500 mg/1000 UI chewable tablets on your ability to drive and operate machinery is negligible.

Micaldeos 500 mg/1000 UI chewable tablets contain

• aspartame (E951), this medication may be harmful to individuals with phenylketonuria because it contains a source of phenylalanine.

sorbitol (E420), isomalt (E953), 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 or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

Adults and elderly people: 1 chewable tablet per day (corresponds to 500 mg of calcium and 1000 UI (International Units) of vitamin D3).

The dose is specifically decided for you by your doctor.

Administration form

You must chew the tablet before swallowing it. It can be taken at any time, with or without food.

You should pay special attention to ingesting a daily dose of sufficient calcium in your diet (e.g. dairy products, vegetables, mineral water).

Treatment duration

Micaldeos 500 mg/1000 UI chewable tablets should be taken as prolonged treatment. Talk to your doctor about the duration of treatment with this medication (see also section 2, Warnings and precautions).

If you take more Micaldeos 500 mg/1000 UI chewable tablets than you should

An overdose of Micaldeos 500 mg/1000 UI chewable tablets may produce symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine excretion, decreased body fluids or constipation. In case of suspected overdose, contact your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring this leaflet with you.

If you forgot to take Micaldeos 500 mg/1000 UI chewable tablets

If you forgot to take Micaldeos 500 mg/1000 UI chewable tablets, take it as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Micaldeos 500 mg/1000 UI chewable tablets

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

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

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

Adverse effects that are infrequent, may affect 1 in 100 people:

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

Adverse effects that are rare, may affect 1 in 1000 people:

-nausea, diarrhea, abdominal pain, constipation, gas, abdominal distension.

-skin rash, itching, urticaria.

Stop taking Micaldeos 500 mg/1000 UI chewable tablets and contact a doctor immediatelyif you experience the following allergic reaction (frequency unknown since it cannot be estimated from available data):

-swelling of the face, lips, tongue, or throat with sudden difficulty breathing and severe skin rash.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

Do not usethis medicationafter the expiration date that appears on the box and on the tube or on the aluminum foil strips after CAD. The expiration date is the last day of the month indicated.

For the tube:

Keep the tube perfectly closed to protect it from moisture.

Do not store at a temperature above 30° C.

For the strips:

Do not store at a temperature above 30° C.

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 pointat the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Micaldeos 500 mg/1000 UI chewable tablets

• The active principles are calcium andcolecalciferol. Each chewable tablet contains 1250mg of calcium carbonate (equivalent to 500mg of calcium) and 10mg of colecalciferol concentrate (in the form of powder) (equivalent to 25micrograms of colecalciferol = 1000UI of vitaminD3).
• The other components are isomalta (E953), xylitol, sorbitol (E420), anhydrous citric acid, sodium citrate dihydrate, magnesium stearate, sodium carmellose, orange flavor “CPB” and orange flavor “CVT”, hydrated colloidal silica, aspartame (E951), potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol,modified cornstarch,sucrose,medium-chain triglycerides,andcolloidal silicon dioxide.

Appearance of the product and contents of the package

Micaldeos 500 mg/1000 UI chewable tabletsare round, white tablets.

The chewable tablets are presented in polypropylene tubes with polyethylene caps containing a desiccant in the following package sizes:

30 and 90 chewable tablets.

The chewable tablets are presented in aluminum foil strips in the following package sizes:

30 and 90 chewable tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Procare Health Iberia, S.L.

Miguel Hernández Avenue 21, Ground Floor

46450 Benifaió (Valencia)

Spain

Responsible for manufacturing

HERMES PHARMA GmbH

Georg-Kalb-Straße 5.

82049 Pullachi. Isartal,

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Pai´sMedicinal product name

Spain:Micaldeos 500 mg / 1000 UI chewable tablets

Last revision date of this leaflet: October 2020

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/)