Package Insert: Information for the Patient

Osvical D 600 mg/400 IUEffervescent Granules

Calcium, pidolato/Colecalciferol (Vitamin D3)

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Osvical D is a calcium and vitamin D supplement.

Osvical D 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 Osvical D

• if you are allergic to the active ingredients or 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 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 Osvical D, especially if you are affected by any of the following points:

• Prolonged treatment

During prolonged treatment, your calcium levels in blood and urine and renal function should be monitored periodically. This is especially important if you are prone to developing kidney stones. Depending on your 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.

Monitoring of calcium levels in blood and urine and renal function should be performed periodically, especially if you are an elderly patient. Depending on your 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 ifyou are receiving other medications containing aluminum, as the citric acid present in this medication may 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.

• Additional calcium and vitamin D supplements

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

• Immobilization and osteoporosis

In these cases, this medication should be used with special care, as it may increase your 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 “Do not take Osvical D”).

Osvical D and other medications

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-derived cardiac glycosides), arrhythmias may occur. Therefore, strict medical monitoring should be performed, including an ECG and determination of calcium levels in blood.
• In the case of simultaneous administration of thiazide diuretics (also known as medications that increase urine excretion), your calcium levels in blood should be monitored periodically, as thiazides reduce calcium excretion in urine.
• The absorption and, therefore, the efficacy of certain antibiotics (designated as tetracyclines) decrease with simultaneous administration of Osvical D. These medications should be taken at least 2 hours before or 4 to 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 Osvical D.
• 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 Osvical Dand phenytoin (a medication for the treatment of epilepsy) or barbiturates (hypnotics) may lead to a reduction of the effect of vitamin D.
• Simultaneous administration of Osvical Dand glucocorticoids (e.g., cortisone) may lead to a reduction of the effect of vitamin D and a reduction of calcium levels in the blood.
• Only additional calcium and vitamin D supplements should be administered under medical supervision, and frequent monitoring of calcium levels in blood and urine should be required.
• Calcium may reduce the effect of levothyroxine (used to treat hypothyroidism). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after this medication.
• There may be a reduction of 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.
• Calcium salts may decrease the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least 2 hours before or after Osvical D lemon flavor.
• Orlistat (used to treat obesity) may alter the absorption of fat-soluble vitamins, such as vitamin D3.

Taking Osvical D with 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) 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist 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 packet. 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 levels of calcium in the blood and 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 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.

Osvical D contains aspartame

This medication contains 30 mg of aspartame in each packet.

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.

Osvical D contains yellow-orange S

It may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Osvical D contains sodium

Consult your doctor or pharmacist if you need 2 or more packets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

Osvical D contains glucose

This medication contains glucose (from maltodextrin and dextrin). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Osvical D contains sorbitol

This medication contains 0.4 mg of sorbitol (E420) in each packet, equivalent to 0.05 mg/g.

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 sachets 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 1 sachet per day. Do not exceed the daily dose of 1 sachet.

Use in children and adolescents

The safety and efficacy of this medication have not been established in children, so it is not recommended for use in this age group.

Administration form

Oral route.

Dissolve the contents of the sachet in a glass of tap water. Osvical D can be taken at any time, with or without food.

Treatment duration

Osvical D should be taken as prolonged treatment. Talk to your doctor about the duration of your treatment with Osvical D (see also section 2 “Warnings and precautions”).

If you take more Osvical D than you should

Osvical D overdose may cause symptoms such as nausea, vomiting, 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Osvical D

If you forget to take Osvical D, take it as soon as you remember. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Osvical D

If you want to interrupt or 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 Osvical D 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:

Less common adverse effects (may affect up to 1 in 100 people)

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

Rare adverse 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.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Milk-alkali syndrome (also known as Burnett syndrome, which generally only appears when excessive amounts of calcium have been ingested). Symptoms include frequent and urgent need to urinate, headache, loss of appetite, nausea or vomiting, fatigue or weakness, along with high levels of calcium in the blood and kidney function alterations.

If you have kidney insufficiency, there may be a risk of having elevated levels of phosphates in the blood, elevated 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 for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box, after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE point of your 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.

Composition of Osvical D

• The active principles are pidolato calcium and colecalciferol. Each sachet contains 4,500 mg of pidolato calcium (equivalent to 600 mg of calcium) and 4 mg of colecalciferol (vitamin D3) (equivalent to 400 UI of vitamin D3).
• The other components are: aspartame (E951), sodium bicarbonate, anhydrous sodium carbonate, anhydrous citric acid, sodium citrate anhydrous, orange aroma (contains natural aromas, wheat maltodextrin and pea starch dextrin), lemon aroma [contains natural aromas, mannitol (E421), D-glucono-1,5-lactone (E575), wheat maltodextrin and/or potato maltodextrin and sorbitol (E420)], yellow-orange S (E110), povidone 30.

Appearance of the product and contents of the packaging

Orange-colored granule with orange flavor and smell.

Osvical D is presented in the form of sachets, in containers with 60 sachets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet:June 2018.

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/.