Adiaval 1.000 mg/880 ui chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Adiaval 1,000 mg / 880 IU chewable tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Adiaval is and what it is used for

2. What you need to know before taking Adiaval

3. How to take Adiaval

4. Possible adverse effects

5. Storage of Adiaval

6. Contents of the container and other information

1. What Adiaval is and what it is used for

Adiaval is a calcium and vitamin D3 supplement.

It is used:

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

2. What you need to know before taking Adiaval

Do not take Adiaval

• If you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine (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 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 (nephrocalcinoses),
• 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

Talk to your doctor or pharmacist before taking this medicine if any of the following apply to you:

• Long-term treatment

During prolonged treatment, blood and urine calcium levels 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 discontinue treatment.

• If you are receiving concomitant treatment with cardiac glycosides or thiazide diuretics (medicines 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 elderly. Depending on blood levels, your doctor may reduce the dose or discontinue treatment.

• Kidney problems

If you have kidney problems, you should take this medicine with special caution. Especially if you are taking other medicines containing aluminium, as the citric acid present in this medicine may increase aluminium absorption. Your blood and urine calcium levels should be monitored. If you have severe kidney problems, use other forms of vitamin D instead of cholecalciferol.

• Taking additional calcium and vitamin D supplements

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

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

Take special care when taking this medicine if you have sarcoidosis. There is a risk that the effect of this medicine may become too strong, leading to calcium overdose in the body. Blood and urine calcium levels should be monitored.

• Immobilization and osteoporosis

In these cases, this medicine should be used with special caution, as it could increase blood calcium levels.

Children and adolescents

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

Taking Adiaval with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

• When used concomitantly with digitalis glycosides (cardiotonic glycosides derived from the foxglove plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring including ECG and measurement of blood calcium levels is necessary.
• When administered simultaneously with diuretics of the thiazide class (also known as medicines to increase urine excretion), blood calcium levels should be monitored periodically, as thiazides reduce calcium excretion in the urine.
• The absorption, and therefore the effectiveness, of certain antibiotics (called tetracyclines) is reduced when taken at the same time as Adiaval. These medicines should be taken at least 2 hours before or 4–6 hours after Adiaval.
• Other medicines such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are also affected by interactions. Therefore, these medicines should be taken at least 3 hours before Adiaval.
• The longest possible interval should be left between the administration of colestyramine (a medicine to lower high cholesterol levels) or laxatives such as liquid paraffin and this medicine, otherwise vitamin D will not be properly absorbed.
• Simultaneous administration of Adiaval and phenytoin (a medicine for the treatment of epilepsy) or barbiturates (hypnotics) may reduce the effect of vitamin D.
• Simultaneous administration of Adiaval and glucocorticoids (e.g., cortisone) may reduce the effect of vitamin D and reduce blood calcium levels.
• Additional calcium and vitamin D supplements should only be taken 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 insufficiency). Therefore, levothyroxine should be taken at least four hours before or four hours after this medicine.
• 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 this medicine.

Taking Adiaval with food, drinks and alcohol

You may take the medicine 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

If you are pregnant, you may take this medicine if you have a deficiency of calcium and vitamin D.

The daily dose should not exceed half a tablet. During pregnancy, the total daily intake of calcium should not exceed 1,500 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 blood calcium levels and may have a negative effect on the fetus.

This medicine may be used during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor before use if your child is receiving other products containing vitamin D.

See the section “Adiaval contains aspartame (E-951), sorbitol (E-420), isomalt (E-953), sucrose and benzyl alcohol” for information on the effects of benzyl alcohol on pregnancy and breastfeeding.

Driving and using machines

There are insufficient data regarding the effects of this medicine on the ability to drive and use machines. However, any influence seems unlikely.

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

This medicine contains 1.00 mg of aspartame (E951) in each chewable tablet. Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains 119.32 mg of sorbitol (E420) in each chewable tablet.

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

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

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

3. How to take Adiaval

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

Dosage

Unless otherwise instructed by your doctor, the recommended dose is:

Adults and elderly patients: 1 chewable tablet per day (corresponding to 1,000 mg of calcium and 800 IU [International Units] of vitamin D3).

Pregnant women may take only half a chewable tablet per day (corresponding to 500 mg of calcium and 440 IU [International Units] of vitamin D3). The daily dose of half a tablet must not be exceeded.

Use in children and adolescents

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

Method of administration

Oral use.

The tablet may be divided into equal doses.

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

Duration of treatment

This medicine should be taken as a long-term treatment. Talk to your doctor about the duration of treatment with Adiaval (see also section 2, Warnings and precautions).

If you take more Adiaval than you should

Overdose of Adiaval may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine output, dehydration, or constipation.

In case of overdose or accidental ingestion, consult 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.

If you forget to take Adiaval

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

If you stop taking Adiaval

If you wish to interrupt or discontinue the 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 everybody gets them.

Stop taking Adiaval and contact a doctor immediately if you experience any of the following 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 breathing difficulty and severe skin rash.

Other reported adverse effects are:

Rare adverse effects: May affect up to 1 in 1,000 people

• Nausea, vomiting, diarrhoea, abdominal pain, constipation, flatulence, bloating (abdominal distension).
• Skin rash, itching, urticaria.
• Allergy.

Uncommon adverse effects: May affect up to 1 in 100 people

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

If you have renal impairment, there may be a risk of elevated phosphate levels in the blood, elevated calcium levels in the kidneys, and kidney stones.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Adiaval

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

For tubes:

Keep the container tightly closed to protect it from moisture.

For aluminum strips:

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

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adiaval

• The active substances are calcium and colecalciferol. Each chewable tablet contains 2,500 mg calcium carbonate (equivalent to 1,000 mg calcium) and 8.8 mg concentrated colecalciferol (in powder form), equivalent to 880 IU of vitamin D3.
• The other components are: isomalt (E-953), xylitol (E-967), sorbitol (E-420), anhydrous citric acid, sodium dihydrogen citrate, magnesium stearate, sodium carmellose, orange flavour (CPB-239) (containing sorbitol E-420, corn maltodextrin, propylene glycol and benzyl alcohol), orange flavour (CVT-255) (containing sorbitol E-420 and corn maltodextrin), aspartame (E-951), potassium acesulfame, sodium ascorbate, modified corn starch, sucrose, medium-chain triglycerides and colloidal silicon dioxide.

Appearance of the product and contents of the pack

Adiaval are round, white tablets with a smooth surface and a break line to divide the tablet.

The chewable tablets are available in polypropylene bottles with a polyethylene cap containing a desiccant, in the following pack size:

30 chewable tablets.

The chewable tablets are also available in heat-sealed aluminum/paper strips in the following pack size:

30 chewable tablets.

Only certain pack 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 most recent revision of this leaflet: November 2021

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/