Product Information for the User

Calcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets

calcium carbonate / colecalciferol (Vitamin D3)

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 product information. See section 4.

6. Contents of the pack and additional information

Calcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletsis a calcium-vitamin D3supplement.

It is used

• to prevent and treat calcium and vitamin D deficiency states in the elderly.

- as a supplement of vitamin D and calcium as a complementary therapy for osteoporosis (fragile bones) in patients at risk of vitamin D and calcium deficiency.

Do not take Calcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets

-if you are allergic to calcium, vitamin D3, 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 a cancer that has affected your bones (bone metastases)

-if you have prolonged immobility 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

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets

-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, your calcium levels in blood and urine and renal function should be monitored periodically. Depending on your blood levels, your doctor may reduce the dose or discontinue treatment.

-If you have kidney problems, you should takeCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletswith special care. 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.

-Only take additional calcium and vitamin D supplements under medical supervision, and your doctor will require frequent monitoring of your calcium levels in blood and urine.

-Be especially careful when takingCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletsif you have sarcoidosis (an immunological disorder that can affect the liver, lungs, skin, or lymph nodes). 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.

-If you are immobile and have osteoporosis, this medication should be used with special care, as it may increase your blood calcium levels.

-Before takingCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets, consider the amount of calcium and alkali consumed from other sources (foods, dietary supplements, and other medications), such as carbonates. If you take high-calcium products simultaneously with, for example, carbonates, this may cause Burnett syndrome. Burnett syndrome is a metabolic disorder of calcium with increased blood calcium levels (hypercalcemia), metabolic alkalosis, renal insufficiency, and calcification of soft tissues. Therefore, additional intake of Calcio / Vitamina D3 ROVI 500 mg / 1000 UI chewable tablets requires strict medical supervision, with frequent monitoring of blood and urine calcium levels.

Children and adolescents

Calcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletsis not indicated for use in children and adolescents.

Use of Calcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets with 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 digital glycosides (cardiac glycosides derived from the digitalis plant), changes in heart rhythm (cardiac arrhythmias) may occur. Therefore, close medical monitoring, including an ECG and determination of blood calcium levels, is necessary.

-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 urine.

-The absorption and, therefore, the effectiveness of certain antibiotics (designated tetracyclines) decrease with simultaneous administration ofCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets. These medications should be taken at least 2 hours before or 4-6 hours after taking Calcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets.

-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 takingCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets.

-Leave the widest possible interval between the administration of cholestyramine (a medication to reduce high cholesterol levels) or laxatives such as liquid paraffin andCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets, as otherwise, vitamin D will not be absorbed properly.

-The simultaneous administration ofCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletsand phenytoin (a medication for the treatment of epilepsy) or barbiturates (hypnotics) may lead to a reduction in the effect of vitamin D.

-The simultaneous administration ofCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletsand glucocorticoids (e.g., cortisone) may lead to a reduction in the effect of vitamin D and a reduction in blood calcium levels.

-Only additional calcium and vitamin D supplements should be administered under medical supervision, and frequent monitoring of blood and urine calcium levels will be 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 takingCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets.

-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 takingCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets.

Taking Calcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets with food and drinks

You can takeCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletsat any time, with or without food.

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, lactation, 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.

Do not useCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletsif you are pregnant.

During pregnancy, your daily total calcium intake should not exceed 1500mg, and your daily total vitamin D3intake should not exceed 600UI (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.

You can takeCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletsduring lactation. As calcium and vitamin D pass into breast milk, consult your doctor before giving your child other products containing vitamin D. Be aware that when administering additional vitamin D to the child, this should be taken into account.

Driving and operating machines

The influence ofCalcio/Vitamina D3ROVI 500 mg/1000 UI chewable tabletson your ability to drive and operate machines is negligible.

Calcio/Vitamina D3ROVI 500 mg/1000 UI chewable tablets contains aspartame (E-951), sorbitol (E-420), isomalt (E-953), sucrose, benzyl alcohol, and sodium.

This medication contains 0.50 mg of aspartame in each chewable 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 49.62 mg of sorbitol in each chewable tablet.

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

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

This medication contains 0.011 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. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis). Consult your doctor or pharmacist 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).

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

Adults and elderly people: 1 chewable tablet per day (corresponding to 500 mg of calcium and 1000 UI (International Units) of vitamin D3).

The dose is specifically decided for you by your doctor.

Administration form

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

Special attention should be paid to ingesting a daily dose of sufficient calcium in the diet (e.g. dairy products, vegetables, mineral water).

Treatment duration

Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets should be taken as prolonged treatment. Talk to your doctor about the duration of treatment with this medication (see also section 2. Warnings and precautions).

If you take more Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets than you should

The overdose of Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets may produce symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine excretion, decreased body fluids or constipation. In case of suspected overdose, contact your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring this leaflet with you.

If you forgot to take Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets

If you forgot to take Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets, take it as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tabletsIf you want to interrupt or prematurely suspend treatment, consult your doctor.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Adverse effects that are infrequent, may affect 1 in 100 people:

-high levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria).

Adverse effects that are rare, may affect 1 in 1,000 people:

-nausea, diarrhea, abdominal pain, constipation, gas, abdominal distension.

-skin rash, itching, urticaria.

Stop taking Calcio / Vitamina D3ROVI 500 mg / 1000 UI chewable tablets and contact a doctor immediatelyif you experience the following allergic reaction (frequency unknown since it cannot be estimated from the available data):

-swelling of the face, lips, tongue, or throat with sudden difficulty breathing and severe skin rash.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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.

Do not usethis medicationafter the expiration date that appears on the box and on the tube or on the aluminum foil strips after CAD. The expiration date is the last day of the month indicated.

For the tube:

Keep the tube perfectly closed to protect it from moisture.

Do not store at a temperature above 30° C.

For the strips:

Do not store at a temperature above 30° C.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and unused medications at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Calcium/Vitamin D Composition3ROVI 500 mg/1000 UI Chewable Tablets

• The active principles are calcium andcolecalciferol. Each chewable tablet contains 1250mg of calcium carbonate (equivalent to 500mg of calcium) and 10mg of colecalciferol concentrate (in the form of powder) (equivalent to 25micrograms of colecalciferol = 1000UI of vitaminD3).
• The other components are isomalta (E-953), xylitol, sorbitol (E-420), anhydrous citric acid, sodium citrate dihydrate, magnesium stearate, sodium carmelose, orange flavor “CPB” (which contains flavoring substances, mannitol (E-421), maltodextrin, gluconolactone (E-575), sorbitol (E-420), benzyl alcohol, propylene glycol, and sodium), orange flavor “CVT” (which contains flavoring substances, mannitol (E-421), gluconolactone (E-575), sorbitol (E-420), and medium-chain triglycerides), hydrated colloidal silica, aspartame (E-951), potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol,modified cornstarch,sucrose,medium-chain triglycerides,andcolloidal silicon dioxide.

Appearance of the product and contents of the package

Calcium/Vitamin D3ROVI 500 mg / 1000 UI chewable tabletsare round, white tablets.

The chewable tablets are presented in polypropylene tubes with polyethylene caps containing a desiccant in the following package sizes:

30 and 90 chewable tablets.

The chewable tablets are presented in aluminum foil strips in the following package sizes:

30 and 90 chewable tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Responsible for manufacturing

HERMES PHARMA GmbH

Georg-Kalb-Straße 5

82049 Pullach i. Isartal

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2020

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