Addera D3

Adiaval it is a calcium and vitamin D supplement3.

It is used:

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

Follow exactly the instructions for taking this medicine as directed 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 the elderly: 1 chewable tablet daily (corresponds to 1,000 mg of calcium and 800 IU [international units] of vitamin D3).

Pregnant women may take only half a chewable tablet a day (corresponding to 500 mg of calcium and 440 IU [international units] of vitamin D3). The daily dose of half a tablet should 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 can 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 of which I should

Overdose of Adiaval symptoms such as vomiting (nausea), vomiting, excessive thirst or thirst, increased amount of urine excreted, decreased body fluids, or constipation may occur.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the toxicological information service, Phone: 91 562 04 20, indicating the drug and the amount ingested.

If you forgot to take Adiaval

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

If you stop taking Adiaval

If you want to stop or stop treatment prematurely, talk to your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone suffers from them.

Stop taking Adiaval and contact a doctor immediately if you have any of the following side effects:

Very rare: It can affect up to 1 in 10,000 people

• Allergic reaction.
• Swelling of the face, lips, tongue or throat with sudden respiratory distress and severe skin rash.

Other side effects reported are:

Rare side effects: It can affect up to 1 in 1,000 people

• Vomiting( nausea), vomiting, diarrhea, abdominal pain, constipation, gas, bloating (bloating).
• Skin rash, itching, hives.
• Allergy.

Uncommon side 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 elevated levels of phosphates in your blood, elevated levels of calcium in your kidneys, and kidney stones.

Reporting of adverse effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish system of Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. by reporting adverse effects you can help provide more information about the safety of this medication.

Do not take Adiaval

• If you are allergic (hypersensitive) to the active substances 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 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 your bones (bone metastases),
• if you have limitation of 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 suffer from an excess of vitamin D (hypervitaminosis D),
• if you have serious kidney problems.
• if you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if any of the following affects 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 the blood levels, the doctor may reduce the dose or stop treatment.

• If you are receiving simultaneous treatment with cardiotonic 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 an elderly patient. Depending on the blood levels, the doctor may reduce the dose or stop treatment.

• Kidney problems

If you have kidney problems, you should take this medicine with special care. Especially if you are receiving other medicines containing aluminum, since the citric acid present in this medicine can increase the absorption of aluminum. You should be monitored for calcium levels in your blood and urine. If you have severe kidney problems, Use forms of vitamin D other than cholecalciferol.

• Taking additional calcium and vitamin D supplements

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

• Sarcoidosis (an immune disorder that can 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 drug will become too strong, which can lead to an overdose of calcium in the body. Blood and urine calcium levels should be monitored.

• Immobilization and osteoporosis

In these cases, this drug should be used with special care, as it could increase the level of calcium in the blood.

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”.

Use of Adiaval with other medicines

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medicines.

• In case of simultaneous treatment with digitalis glycosides (cardiotonic glycosides derived from the digital plant), cardiac arrhythmias may occur. Therefore, it is necessary to conduct strict medical monitoring that includes an ECG and determination of the level of calcium in the blood.
• In case of simultaneous administration of diuretics of the drug class of thiazides (also known as drugs to increase urine excretion), the level of calcium in the blood should be monitored periodically, since thiazides reduce the excretion of calcium in the urine.
• The absorption and therefore effectiveness of certain antibiotics (called tetracyclines) decreases with the simultaneous administration of Adiaval. These medications should be taken at least 2 hours before or 4-6 hours after Adiaval.
• In addition, other drugs 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 drugs should be taken at least 3 hours before Adiaval
• The widest possible interval should be left between administration of Cholestyramine (a medicine to reduce high cholesterol levels) or laxatives such as liquid paraffin and this medicine, as otherwise vitamin D will not be absorbed properly.
• Simultaneous administration of Adiaval and phenytoin (a drug for the treatment of epilepsy) or barbiturates (hypnotics) can lead to a reduction in the effect of vitamin D.
• Simultaneous administration of Adiaval and glucocorticoids (e.g. cortisone) may result in a reduction in the effect of vitamin D and a reduction in the level of calcium in the blood.
• Only additional calcium and vitamin D supplements should be administered under medical supervision and frequent monitoring of blood and urine calcium levels should be required.
• Calcium can reduce the effect of Levothyroxine (it is used to treat thyroid insufficiency). For this reason, levothyroxine should be taken at least four hours before or four hours after this medicine.
• There may be a reduction in the effect of quinolone antibiotics if they are taken at the same time as calcium. Take quinolone antibiotics at least two hours before or six hours after taking this medication.

Use of Adiaval with food, drinks and alcohol

You can take the drug at any time, with or without food.

You should keep in mind that oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grains) can reduce the amount of calcium that is absorbed in the intestine. Within 2 hours before or after eating foods high in oxalic acid or phytic acid, patients should not take calcium-containing drugs.

Pregnancy and lactation

If you are pregnant or breast-feeding, or think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine.

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

The daily dose of half a tablet should not be exceeded. During pregnancy, the total daily amount of calcium should not exceed 1,500 mg and the total daily amount of vitamin D3 it must not exceed UI 600 (international units).

Long-term overdose of calcium and vitamin D during pregnancy should be avoided as it can cause high levels of calcium in the blood and can have a negative effect on the fetus.

This drug can be used during breastfeeding. Since calcium and vitamin D pass into breast milk, check with your doctor first if your child receives other products that contain vitamin D.

Driving and using machines

Insufficient data are available on the effects of this medicinal product on the ability to drive and use machines.However, the influence seems unlikely.

Adiaval it contains aspartame (e-951), isomalta (e-953), sorbitol (e-420) and sucrose.

This drug can be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This drug contains isomalta, sorbitol and sucrose. If your doctor has told you that you have an intolerance to certain sugars, check with him before taking this medicine.