ADIAVAL 1000 mg/880 IU CHEWABLE TABLETS

2. What you need to know before taking Adiaval

Do not takeAdiaval

• If you are allergic (hypersensitive) to the active ingredients 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 overactive 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, blood and urine calcium levels 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 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, blood and urine calcium levels 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 discontinue 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 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 blood and urine calcium levels.

• 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. Blood and urine calcium levels should be monitored.

• Immobility 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 Adiaval”.

UsingAdiavalwith other medications

Tell your doctor or pharmacist that you are using or have recently used or may need to use 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 blood calcium levels.
• In the case of simultaneous administration of thiazide diuretics (also known as medications to increase urine excretion), blood calcium levels 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 Adiaval. These medications should be taken at least 2 hours before or 4-6 hours after Adiaval.
• 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 Adiaval.
• 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 may not be absorbed properly.
• Simultaneous administration of Adiaval 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 Adiaval and glucocorticoids (e.g., cortisone) may lead to a reduction in the effect of vitamin D and a reduction in blood calcium levels.
• Additional calcium and vitamin D supplements should only be administered under medical supervision, and frequent monitoring of blood and urine calcium levels 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.

UsingAdiavalwith food, drinks, and alcohol

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 half a 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 can cause high blood calcium levels 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.

See the section Adiaval contains aspartame (E-951), sorbitol (E-420), isomalt (E-953), sucrose, and benzyl alcohol to see the effect of benzyl alcohol on pregnancy and breastfeeding.

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 seems unlikely.

Adiavalcontains aspartame (E-951), sorbitol (E-420), isomalt (E-953), sucrose, and benzyl alcohol.

This medication contains 1.00 mg of aspartame (E951) per chewable 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 119.32 mg of sorbitol (E420) per chewable tablet.

This medication contains isomalt and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may harm your teeth.

This medication contains 0.023 mg of benzyl alcohol per chewable tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding or have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis). Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems ("gasping syndrome") in children. Do not give this medication to your newborn (up to 4 weeks of age) unless your doctor has recommended it. This medication should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist has indicated it.

This medication contains less than 23 mg of sodium (1mmol) per chewable tablet; it is essentially “sodium-free”.

3. How to take Adiaval

Follow the administration instructions of this medication exactly 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: 1 chewable tablet per day (corresponding to 1,000 mg of calcium and 800 IU of vitamin D3).

Pregnant women can take only half a chewable tablet per day (corresponding to 500 mg of calcium and 440 IU of vitamin D3). Do not exceed the daily dose of half a tablet.

Use in children and adolescents

This medication is not indicated for use in children or adolescents under 18 years of age. See section “Do not take Adiaval”.

Method of administration

Oral route.

The tablet can be divided into equal doses.

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 Adiaval (see also section 2, Warnings and precautions).

If you take moreAdiavalthan you should

Overdose of Adiaval 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 takeAdiaval

If you forget to take the Adiaval tablet, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment withAdiaval

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

If you have any other questions about the use of this product, 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 takingAdiavaland contact a doctor immediately if you experience any of the following 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, urticaria.
• 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 Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Adiaval

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 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 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 ofAdiaval

• The active ingredients are calcium and colecalciferol. Each chewable tablet contains 2,500 mg of calcium carbonate (equivalent to 1,000 mg of calcium) and 8.8 mg of concentrated colecalciferol (in powder form), equivalent to 880 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, orange flavor (CPB-239) (contains sorbitol E-420, corn maltodextrin, propylene glycol, and benzyl alcohol), orange flavor (CVT-255) (contains sorbitol E-420 and corn maltodextrin), 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

Adiaval are round, white, smooth-surfaced tablets with a score line to break the tablet.

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

30 chewable tablets.

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

30 chewable tablets.

Not all package sizes may be marketed.

Marketing authorization holder

LACER, S.A.

Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

Manufacturer

HERMES PHARMA GmbH

Georg-Kalb-Straße 5

82049

Pullach i. Isartal

Germany

Date of the last revision of this package leaflet: November 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/