Product Information for the User

Calcio/Vitamina D3ROVI 1000 mg / 880 UI effervescent tablets

Calcium carbonate/colecalciferol (Vitamin D3)

Please 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 refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for 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.

Calcio/Vitamina D3ROVI are effervescent tablets. They are presented in containers with 30 tablets.

This medication is an association of calcium and vitamin D that is indicated for the correction of combined vitamin D and calcium deficiency in elderly patients as well as a supplement of vitamin D and calcium as an adjunct to specific therapy for the treatment of osteoporosis in patients with combined vitamin D and calcium deficiency or at high risk of combined deficiency.

Do not take Calcio/Vitamina D3ROVI:

This medication contains soy oil. It should not be used in case of allergy to peanuts or soy.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Calcio/Vitamina D3ROVI:

- if you have renal insufficiency (kidney failure),

- if you have kidney stones,

- if you have heart disease, sarcoidosis (inflammation of lymph nodes, lungs, liver, eyes, skin, and other tissues), or are being treated with cardiac glycosides (medications used when the heart is unable to function properly),

- if you are receiving concurrent treatment with other products containing vitamin D, or are undergoing prolonged or high-dose calcium supplementation. In this case, your doctor may need to perform regular clinical checks. Your doctor will indicate the frequency of these checks.

Taking Calcio/Vitamina D3ROVI with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.Certain medications may interact with Calcio/Vitamina D3ROVI; in these cases, it may be necessary to change the dose, discontinue treatment with one of them, or wait at leastan hour between administration of both.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

Taking Calcio / Vitamina D3ROVI with food and drinks:

If you take this medication with foods and drinks containing oxalic acid (a compound found in spinach and rhubarb) or phytic acid (found in whole wheat bread and cereals) and the phosphorus found in milk may produce interactions, so it is recommended not to take this medication during the 2 hours following the consumption of these types of foods.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the content of vitamin D (880 UI) in Calcio/Vitamina D3ROVI, it is not indicated for use during pregnancy and lactation, as the recommended daily dose of vitamin D should not exceed 600 UI/day.

Driving and operating machinery:

No effects on driving or operating machinery have been described.

Calcio/Vitamina D3ROVI contains saccharose, sodium, lactose, and glucose.

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

This medication contains 96.15 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 4.8% of the maximum daily sodium intake recommended for an adult.

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

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

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

Dose

Adults

The recommended dose is 1 effervescent tablet (1000 mg of calcium and 880 IU of Vitamin D3) per day.

Form and route of administration

This medication is administered orally.

Dissolve the tablet in a glass of water and drink immediately.

Treatment duration

Your doctor will indicate the duration of your treatment with Calcio/Vitamina D3 ROVI. Do not discontinue treatment before.

Follow these instructions unless your doctor has given you different instructions. In these cases, it is advisable to request written instructions from the doctor and ensure you understand them well.

If you estimate that the action of Calcio/Vitamina D3 ROVI is too strong or weak, inform your doctor or pharmacist.

Remember to take your medication.

If you take more Calcio/Vitamina D3 ROVI than you should

If you take more Calcio/Vitamina D3 ROVI than you should, or 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.

Overdose may cause hypervitaminosis D (excess of vitamin D) and hypercalcemia (elevated calcium level in the blood). Symptoms of overdose include: nausea, vomiting, anorexia (eating disorder), abdominal pain, dry mouth, or polyuria (increased urine volume), or irritability, lethargy (excessive fatigue), stupor (decreased response to stimuli), and coma (loss of consciousness) in severe cases.

If you forget to take Calcio/Vitamina D3 ROVI

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Calcio/Vitamina D3 ROVI

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

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

-Infrequent(may affect between 1 and 10 of every 1,000 patients):

• high levels of calcium in the blood (hypercalcemia),
• high levels of calcium in the urine (hypercalciuria).

-Rare(may affect between 1 and 10 of every 10,000 patients):

• constipation,
• flatulence,
• nausea,
• epigastric pain,
• diarrhea.

-Very Rare(may affect fewer than 1 of every 10,000 patients):):

• itching (pruritus),
• skin rash (exanthema),
• hives (urticaria).

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 throughSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store in the original packaging to protect it from moisture.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Calcium/Vitamin D Composition 3 ROVI

-The active principles are: calcium carbonate and colecalciferol concentrate (in powder form). Each tablet contains 2500 mg of calcium carbonate (equivalent to 1,000 mg of calcium) and 22 micrograms of colecalciferol concentrate in powder form (equivalent to 880 UI of colecalciferol = vitamin D 3

-The other components (excipients) are: anhydrous citric acid, sodium bicarbonate, lactose monohydrate, povidone, sodium saccharin, sodium cyclamate, macrogol 6000, orange flavor (contains corn-derived maltodextrin), simethicone emulsion, ? -tocopherol, hydrogenated soybean oil, gelatin, sucrose, cornstarch without gluten, and silicon dioxide.

Appearance of the product and content of the packaging

Effervescent cylindrical tablets, white or off-white in color.

They are presented in polypropylene tubes, each containing 15 effervescent tablets. Each package contains two tubes (30 effervescent tablets).

Marketing Authorization Holder

Laboratorios Farmacéuticos ROVI, S.A.

C/ Julián Camarillo, 35

28037 - Madrid

Spain

Responsible for manufacturing:

Laboratorios Losan Pharma GMBH

Otto-Hahn-Strasse 13

79395 - Neuenburg

Germany

Last review date of this leaflet: June 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)