Prospect: Information for the user

Calcio / Vitamin D3Aristo 600 mg / 400 U.I. chewable tablets EFG

Read this prospect carefully before starting to take this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Calcio/Vitamin D3Aristo and for what it is used

2.What you need to know before starting to take Calcio/Vitamin D3Aristo

3.How to take Calcio/Vitamin D3Aristo

4.Possible adverse effects

5Storage of Calcio/Vitamin D3Aristo

6.Contents of the package and additional information

Calcio/Vitamina D3Aristo is a calcium and vitamin D supplement.

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 Calcio/Vitamina D3Aristo

• If you are allergic (hypersensitive) to the active principles 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 the blood and urine and renal function should be monitored periodically. This is especially important if you are prone to developing kidney stones. Depending on the 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 the blood and urine and renal function should be monitored periodically, especially if you are an elderly patient. Depending on the 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 the blood and urine should be monitored. If you have severe kidney problems, use other forms of vitamin D that are not colecalciferol.

• Additional supplements of calcium and vitamin D

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

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

You should take special care when taking this medication if you have sarcoidosis. There is a risk that the effect of this medication will become too strong, leading to a calcium overdose in the body. Your calcium levels in the 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 section “Do not take Calcio/Vitamina D3Aristo”

Other medications and Calcio/Vitamina D3Aristo

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

• In the case of simultaneous treatment with digitalis glycosides (digitalis cardiotonic glycosides derived from the plant digitalis), 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 blood calcium levels should be monitored periodically, as thiazides reduce calcium excretion in the urine.
• The absorption and, therefore, the effectiveness of certain antibiotics (designated as tetracyclines) decrease with simultaneous administration of Calcio/Vitamina 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 to treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are affected by interactions. Therefore, these medications should be taken at least 3 hours before Calcio/Vitamina D3.
• You should leave the widest possible interval 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 Calcio/Vitamina D3and 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 Calcio/Vitamina D3and glucocorticoids (e.g., cortisone) may lead to a reduction in the effect of vitamin D and a reduction in blood calcium levels.
• Only additional supplements of calcium and vitamin D should be administered under medical supervision, and frequent monitoring of blood calcium levels and urine is 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 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 two hours before or six hours after taking this medication.

Taking Calcio/Vitamina 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) 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 lactation

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 a deficiency of calcium and vitamin D.

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 D3should not exceed 600 IU (International Units).

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

This medication can be used during lactation. Since calcium and vitamin D pass into breast milk, consult your doctor before giving your child 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.

Calcio/Vitamina D3Aristo contains aspartame (E-951), isomalt (E-953), sorbitol (E-420), and saccharose.

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

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

This medication contains 71 mg of sorbitol in each tablet.

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him 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”.

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 to 2 chewable tablets per day (corresponding to 600 or 1,200 mg of calcium and 400 or 800 IU [International Units] of vitamin D3).

Pregnant women should only take 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 it is not recommended for use in this age group.

Administration form

Oral route.

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 Calcio/Vitamina D3 (see also section 2, Warnings and precautions).

If you take more Calcio/Vitamina D3Aristo than you should

Calcium/Vitamin D3 overdose may cause 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 Calcio/Vitamina D3Aristo

If you forget to take Calcio/Vitamina D3, 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 Calcio/Vitamina D3Aristo

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

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

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

Stop taking Calcio/Vitamina D 3 Aristo and contact a doctor immediately if you experience any of the following severe 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 trash. Deposit 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.

Calcium/Vitamin D Composition3Aristo

-The active principles are calcium and colecalciferol. Each chewable tablet contains 1,500 mg of calcium carbonate (equivalent to 600 mg of calcium) and 4 mg of colecalciferol concentrate (in powder form), equivalent to 400 IU of vitamin D3.

-The other components are: isomalta (E-953), xylitol (E-967), sorbitol (E-420), anhydrous citric acid, sodium dihydrogen citrate, magnesium stearate, sodium caramel, tutti-frutti flavor [flavoring substances, corn maltodextrin, propylene glycol (E-1520), modified corn starch (E-1450) and monosodium citrate (E-331)], hydrated colloidal silica, 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 content of the packaging

Calcio/Vitamina D3Aristo are round and white chewable tablets.

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

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

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

60 chewable tablets.

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for Manufacturing

HERMES PHARMA GmbH

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

Germany

Last review date of this leaflet: September 2021

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