Micaldeos 500 mg/1000 IU chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Micaldeos 500 mg/1000 IU chewable tablets

Calcium carbonate / Colecalciferol (Vitamin D3)

Read the entire 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could 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 Micaldeos 500 mg/1000 IU chewable tablets are and what they are used for
2. What you need to know before taking Micaldeos 500 mg/1000 IU chewable tablets
3. How to take Micaldeos 500 mg/1000 IU chewable tablets
4. Possible side effects
5. How to store Micaldeos 500 mg/1000 IU chewable tablets
6. Contents of the pack and other information

1. What Micaldeos 500 mg / 1000 IU chewable tablets are and what they are used for

Micaldeos 500 mg/1000 IU chewable tablets is a calcium-vitamin D3 supplement.

It is used

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

• to provide vitamin D and calcium as complementary therapy in osteoporosis (fragile bones) in patients at risk of vitamin D and calcium deficiency.

2. What you need to know before taking Micaldeos 500 mg / 1000 IU chewable tablets

Do not take Micaldeos 500 mg/1000 IU 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 your blood (hypercalcemia)
• if you excrete too much 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 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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Micaldeos 500 mg/1000 IU chewable tablets

• during long-term treatment, calcium levels in blood and urine and kidney 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 stop treatment.
• if you are receiving concomitant treatment with cardiac glycosides or thiazide diuretics (medicines that increase urine excretion) for heart problems, calcium levels in 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 IU 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 instead of colecalciferol.
• take additional calcium and vitamin D supplements only under medical supervision, and your doctor will require frequent monitoring of calcium levels in blood and urine.
• take special care when taking Micaldeos 500 mg/1000 IU chewable tablets if you have sarcoidosis (an immune disorder that may affect the liver, lungs, skin, or lymph nodes). There is a risk that the effect of this medicine may become too strong, which could lead to calcium overdose in the body. Calcium levels in blood and urine should be monitored.
• if you are immobilized and have osteoporosis, this medicine should be used with special care, as it could increase calcium levels in the blood.
• before taking Micaldeos 500 mg/1000 IU chewable tablets, consider the amount of calcium and alkali consumed from other sources (foods, dietary supplements, and other medicines), such as carbonates. If calcium-rich products are taken simultaneously with, for example, carbonates, this could cause Burnett syndrome. Burnett syndrome is a metabolic calcium disorder characterized by increased calcium levels in the blood (hypercalcemia), alkalosis (metabolic alkalosis), kidney failure, and soft tissue calcification. Therefore, additional intake of Micaldeos 500 mg/1000 IU chewable tablets requires strict medical supervision, with frequent monitoring of calcium levels in blood and urine.

Children and adolescents

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

Taking Micaldeos 500 mg/1000 IU chewable tablets with other medicines

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

• When taken at the same time as digitalis glycosides (cardiac glycosides derived from the digitalis plant), changes in heart rhythm (cardiac arrhythmias) may occur. Therefore, close medical monitoring, including ECG and blood calcium level determination, is necessary.
• When taken 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) are reduced when taken at the same time as Micaldeos 500 mg/1000 IU chewable tablets. These medicines should be taken at least 2 hours before or 4–6 hours after taking Micaldeos 500 mg/1000 IU chewable tablets.
• In addition, 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 IU chewable tablets.
• The interval between administration of colestyramine (a medicine to lower high cholesterol levels) or laxatives such as liquid paraffin and Micaldeos 500 mg/1000 IU chewable tablets should be as long as possible, otherwise vitamin D will not be properly absorbed.
• Taking Micaldeos 500 mg/1000 IU chewable tablets together with phenytoin (a medicine used to treat epilepsy) or barbiturates (hypnotics) may reduce the effect of vitamin D.
• Taking Micaldeos 500 mg/1000 IU chewable tablets together with glucocorticoids (e.g., cortisone) may reduce the effect of vitamin D and lower 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 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 IU chewable tablets.
• The effect of quinolone antibiotics may be reduced 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 IU chewable tablets.

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

You may take Micaldeos 500 mg/1000 IU 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) may reduce the amount of calcium absorbed in the intestine. Patients should not take calcium-containing medicines within 2 hours before or after eating foods high in oxalic acid or phytic acid.

Pregnancy, breastfeeding, and fertility

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.

You should not use Micaldeos 500 mg/1000 IU chewable tablets if you are pregnant.

During pregnancy, the total daily calcium intake 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 cause high calcium levels in the blood and may have a negative effect on the fetus.

You may take Micaldeos 500 mg/1000 IU chewable tablets during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor beforehand if your child is receiving other products containing vitamin D. This should be taken into account when giving additional vitamin D to the child.

Driving and using machines

Micaldeos 500 mg/1000 IU chewable tablets have no influence on the ability to drive and use machines.

Micaldeos 500 mg/1000 IU chewable tablets contain

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

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

3. How to take Micaldeos 500 mg / 1000 IU chewable tablets

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

Dosage

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

The dosage has been specifically determined for you by your doctor.

Method of administration

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

Special attention should be paid to consuming an adequate daily dietary intake of calcium (e.g. dairy products, vegetables, mineral water).

Duration of treatment

Micaldeos 500 mg/1000 IU chewable tablets should be taken as a long-term treatment. Discuss with your doctor the duration of treatment with this medicine (see also section 2, Warnings and precautions).

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

An overdose of Micaldeos 500 mg/1000 IU chewable tablets may cause symptoms such as nausea, vomiting, thirst or excessive drowsiness, increased urine output, dehydration, or constipation. If an overdose is suspected, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Take this leaflet with you.

If you forget to take Micaldeos 500 mg/1000 IU chewable tablets

If you forget to take Micaldeos 500 mg/1000 IU chewable tablets, take it as soon as you remember. Do not take a double dose to make up for missed doses.

If you stop treatment with Micaldeos 500 mg/1000 IU chewable tablets

If you wish to interrupt or discontinue treatment prematurely, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Uncommon adverse effects, may affect 1 in 100 people:

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

Rare adverse effects, may affect 1 in 1000 people:

• feeling sick (nausea), diarrhoea, stomach pain, constipation, gas, bloating (abdominal distension).
• skin rash, itching, hives.

Stop taking Micaldeos 500 mg/1000 IU chewable tablets and contact a doctor immediately if 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 breathing difficulty and severe skin rash.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Micaldeos 500 mg / 1000 IU chewable tablets

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

Do not use this medicine after the expiry date stated on the box, on the bottle, or on the aluminum foil strips after EXP. The expiry date refers to the last day of the month indicated.

For the bottle:

Keep the bottle tightly closed to protect it from moisture.

Do not store above 30°C.

For the strips:

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Micaldeos 500 mg/1000 IU chewable tablets

• The active substances 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 powder form) (equivalent to 25 micrograms of colecalciferol = 1000 IU of vitamin D3).
• The other components are isomalt (E953), xylitol, sorbitol (E420), anhydrous citric acid, disodium citrate dihydrate, magnesium stearate, sodium carmellose, orange flavour “CPB” and orange flavour “CVT”, colloidal hydrated silica, aspartame (E951), potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol, modified maize starch, sucrose, medium-chain triglycerides and colloidal silicon dioxide.

Appearance of the product and contents of the container

Micaldeos 500 mg/1000 IU 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 also presented in aluminum foil blisters in the following pack sizes:

30 and 90 chewable tablets.

Only some pack sizes may be commercially available.

Marketing Authorization 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country Name of the medicinal product

Spain: Micaldeos 500 mg / 1000 IU chewable tablets

Date of the most recent review of this leaflet: October 2020

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