CALCIO/VITAMIN D3 ARISTO 600 MG/400 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Calcium / Vitamin D3Aristo 600 mg / 400 IU chewable tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Calcium/Vitamin D3 Aristo and what is it used for
2. What you need to know before taking Calcium/Vitamin D3 Aristo
3. How to take Calcium/Vitamin D3 Aristo
4. Possible side effects

5 Conservation of Calcium/Vitamin D3 Aristo

1. Package contents and additional information

1. What is Calcium/Vitamin D3 Aristo and what is it used for

Calcium/Vitamin D3 Aristo is a calcium and vitamin D supplement.

It is used:

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

2. What you need to know before taking Calcium/Vitamin D3 Aristo

Do not take Calcium/Vitamin D3Aristo

• If you are allergic (hypersensitive) to the active substances or to any of the other components of this medication (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 hyperactivity of the 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 medication 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 suspend treatment.

• If you are receiving simultaneous treatment with digitalis glycosides (cardiac glycosides derived from the digitalis plant) or thiazide diuretics (also known as medications to 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 suspend treatment.

• Kidney problems

If you have kidney problems, you should take this medication with special care. Especially if you are receiving other medications that contain aluminum, as the citric acid present in this medication 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.

• Taking 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 medication if you have sarcoidosis. There is a risk that the effect of this medication 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.

• Immobility and osteoporosis

In these cases, this medication should be used with special care, as it may increase calcium levels in the blood.

Children and adolescents

This medication is not indicated for use in children or adolescents under 18 years of age. See section "Do not take Calcium/Vitamin D3 Aristo"

Other medications and Calcium/Vitamin D3Aristo

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

• In the 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 the case of simultaneous administration of thiazide diuretics (also known as medications 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 medications should be taken at least 2 hours before or 4-6 hours after this medication.
• 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.
• As large a gap as possible should be left between the administration of cholestyramine (a medication to reduce high cholesterol levels) or laxatives such as liquid paraffin and this medication, as otherwise, vitamin D will not be absorbed properly.
• Simultaneous administration of Calcium/Vitamin D3 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 Calcium/Vitamin D3 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 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.

Taking Calcium/Vitamin D3Aristo with food and drinks

You can take the medication 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 medications containing calcium.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan 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 one 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 may cause high levels of calcium in the blood and may 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 giving your child other products containing vitamin D.

Driving and using machines

There is not enough data on the effects of this medication on the ability to drive and use machines. However, the influence appears to be unlikely.

Calcium/Vitamin D3Aristo contains aspartame (E-951), isomalt (E-953), sorbitol (E-420), and sucrose.

This medication contains 0.60 mg of aspartame (E-951) per tablet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medication contains isomalt (E-953). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 71 mg of sorbitol per tablet.

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Calcium/Vitamin D3 Aristo

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dose

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

Adults and elderly people: 1 to 2 chewable tablets per day (corresponding to 600 or 1,200 mg of calcium and 400 or 800 IU of vitamin D3).

Pregnant women can take only one chewable tablet per day. Do not exceed the daily dose of one tablet.

Use in children and adolescents

The safety and efficacy of this medication have not been established in the pediatric population, so its use is not recommended in this age group.

Method of administration

Oral route.

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

Duration of treatment

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 Calcium/Vitamin D3Aristo 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 medication and the amount ingested.

If you forget to take Calcium/Vitamin D3Aristo

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

If you interrupt treatment with Calcium/Vitamin D3Aristo

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking Calcium/Vitamin D3Aristo and contact a doctor immediately if you experience any of the following serious 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, hives.
• 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, there may be a risk of elevated phosphate levels in the blood, elevated calcium levels in the kidneys, and kidney stones.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Calcium/Vitamin D3 Aristo

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/paper strips:

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

Do not use this medication after the expiration date shown on the container after "CAD". The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Calcium/Vitamin D3Aristo

• The active ingredients are calcium and colecalciferol. Each chewable tablet contains 1,500 mg of calcium carbonate (equivalent to 600 mg of calcium) and 4 mg of concentrated colecalciferol (in powder form), equivalent to 400 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, tutti-frutti flavor [flavoring substances, corn maltodextrin, propylene glycol (E-1520), modified corn starch (E-1450), and sodium citrate (E-331)], colloidal hydrated silica, 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

Calcium/Vitamin D3 Aristo are round, white tablets.

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

60 chewable tablets, in two tubes of 30 tablets each.

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

60 chewable tablets.

Not all package sizes may be marketed.

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

HERMES PHARMA GmbH

Hans-Urmiller-Ring, 52 - Wolfrathausen - D-82515

Germany

Date of last revision of this package leaflet: September 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/