MICALDEOS 500 MG/1000 IU CHEWABLE TABLETS

2. What you need to know before you take Micaldeos 500 mg / 1000 UI Chewable Tablets

Do not take Micaldeos 500 mg/1000 UI Chewable Tablets

• if you are allergic to calcium, vitamin D3 or any of the other ingredients of this medicine (listed in Section 6)
• if you have high levels of calcium in the blood (hypercalcaemia)
• if you excrete too much calcium in the urine (hypercalciuria)
• if you have overactivity of the parathyroid glands (hyperparathyroidism)
• if you have bone marrow cancer (myeloma)
• if you have cancer that has affected your bones (bone metastases)
• if you have limited mobility of the limbs (prolonged immobilization) accompanied by hypercalcaemia 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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Micaldeos 500 mg/1000 UI Chewable Tablets

• 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 (cardiac glycosides derived from the digitalis plant) or thiazide diuretics (medicines that increase urine excretion) for heart problems, calcium levels in the blood and urine and kidney function should be monitored periodically. Depending on blood levels, your doctor may reduce the dose or stop treatment.
• if you have kidney problems, you should take Micaldeos 500 mg/1000 UI Chewable Tablets with special care. 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.
• only take additional calcium and vitamin D supplements under medical supervision and your doctor will require frequent monitoring of calcium levels in the blood and urine.
• be especially careful when taking Micaldeos 500 mg/1000 UI Chewable Tablets if you have sarcoidosis (an immune disorder that can affect the liver, lungs, skin, or lymph nodes). 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.
• if you are immobilized and have osteoporosis, this medicine should be used with special care, as it may increase calcium levels in the blood.
• before taking Micaldeos 500 mg/1000 UI Chewable Tablets, the amount of calcium and alkali consumed from other sources (food, dietary supplements, and other medicines) such as carbonates should be considered. If calcium-rich products are taken simultaneously with, for example, carbonates, this could lead to the Burnett syndrome. The Burnett syndrome is a calcium metabolic disorder with an increase in calcium levels in the blood (hypercalcaemia), alkalosis (metabolic alkalosis), kidney failure, 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.

Using Micaldeos 500 mg/1000 UI Chewable Tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• In the case of simultaneous treatment with digitalis glycosides (cardiac glycosides derived from the digitalis plant), changes in heart rhythm (cardiac arrhythmias) may occur. Therefore, close medical monitoring is necessary, including an ECG and determination of calcium levels in the blood.
• In the 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 Micaldeos 500 mg/1000 UI Chewable Tablets. These medicines should be taken at least 2 hours before or 4-6 hours after taking Micaldeos 500 mg/1000 UI Chewable Tablets.
• 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 taking Micaldeos 500 mg/1000 UI Chewable Tablets.
• A wide interval should be left between the administration of cholestyramine (a medicine 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 medicine 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 take additional calcium and vitamin D supplements 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 deficiency). For this reason, 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.

You should be aware that oxalic acid (found in spinach and rhubarb) and phytic acid (found 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, breast-feeding, and fertility

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

If you are pregnant, you should not use Micaldeos 500 mg/1000 UI Chewable Tablets.

During pregnancy, the total daily intake of calcium should not exceed 1500 mg and the total daily intake 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 may lead to high levels of calcium in the blood and may have a negative effect on the fetus.

You can take Micaldeos 500 mg/1000 UI Chewable Tablets during breast-feeding. As calcium and vitamin D pass into breast milk, consult your doctor before giving your child other products containing vitamin D. This should be taken into account when additional vitamin D is administered to the child.

Driving and using machines

Micaldeos 500 mg/1000 UI Chewable Tablets have no influence on the ability to drive and use machines.

Micaldeos 500 mg/1000 UI Chewable Tablets contain

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

sorbitol (E420), isomalt (E953), and sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Micaldeos 500 mg / 1000 UI Chewable Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Dose

Adults and the elderly: 1 chewable tablet per day (corresponding to 500 mg of calcium and 1000 IU (International Units) of vitamin D3).

The dose is specifically decided for you by your doctor.

Method of administration

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

Special attention should be paid to ingesting a sufficient daily dose of calcium in the diet (e.g., dairy products, vegetables, mineral water).

Duration of treatment

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

If you take more Micaldeos 500 mg/1000 UI Chewable Tablets than you should

Overdose of Micaldeos 500 mg/1000 UI Chewable Tablets may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine production, decreased body fluids, or constipation. If you suspect an overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Carry this leaflet with you.

If you forget to take Micaldeos 500 mg/1000 UI Chewable Tablets

If you forget to take Micaldeos 500 mg/1000 UI Chewable Tablets, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Micaldeos 500 mg/1000 UI Chewable Tablets

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

If you have any further questions on 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.

Uncommon side effects, may affect up to 1 in 100 people:

• high levels of calcium in the blood (hypercalcaemia) or urine (hypercalciuria).

Rare side effects, may affect up to 1 in 1000 people:

• nausea, diarrhea, abdominal pain, constipation, gas, bloating (abdominal distension).
• skin rash, itching, hives.

Stop taking Micaldeos 500 mg/1000 UI Chewable Tablets and contact a doctor immediatelyif you experience the following allergic reaction (frequency not known as it cannot be estimated from the available data):

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micaldeos 500 mg / 1000 UI Chewable Tablets

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

Do not use this medicine after the expiry date which is stated on the carton and on the tube or on the blister packs after EXP. The expiry date is the last day of the month shown.

For the tube:

Keep the tube tightly closed to protect it from moisture.

Do not store above 30°C.

For the blister packs:

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Micaldeos 500 mg/1000 UI Chewable Tablets

• The active ingredients are calcium and colecalciferol. Each chewable tablet contains 1250 mg of calcium carbonate (equivalent to 500 mg of calcium) and 10 mg of concentrated colecalciferol (in the form of powder) (equivalent to 25 micrograms of colecalciferol = 1000 IU of vitamin D3).
• The other ingredients are isomalt (E953), xylitol, sorbitol (E420), anhydrous citric acid, sodium citrate dihydrate, magnesium stearate, sodium carmellose, orange flavor "CPB" and orange flavor "CVT", hydrated silica colloidal, aspartame (E951), acesulfame potassium, sodium ascorbate, all-rac-alpha-tocopherol, modified corn starch, sucrose, medium-chain triglycerides, and colloidal silicon dioxide.

Appearance and packaging of the product

Micaldeos 500 mg/1000 UI Chewable Tablets are round, white tablets.

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

30 and 90 chewable tablets.

The chewable tablets are presented in aluminum blister packs in the following pack sizes:

30 and 90 chewable tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Procare Health Iberia, S.L.

Avda. Miguel Hernández 21, Bajo

46450 Benifaió (Valencia)

Spain

Manufacturer

HERMES PHARMA GmbH

Georg-Kalb-Straße 5.

82049 Pullach i. Isartal,

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Country Name of the medicinal product

Spain: Micaldeos 500 mg / 1000 UI Chewable Tablets

Date of last revision of this leaflet: October 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)