CALCIO/VITAMIN D3 ROVI 1000 mg/880 IU EFFERVESCENT TABLETS

Introduction

Package Leaflet: Information for the User

Calcium/Vitamin D33ROVI 1000 mg / 880 UI Effervescent Tablets

Calcium Carbonate/Colecalciferol (Vitamin D3)

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

-Keep this package leaflet, as you may need to read it again.

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

-This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Calcium/Vitamin D3 ROVI and what is it used for
2. What you need to know before taking Calcium/Vitamin D3 ROVI
3. How to take Calcium/Vitamin D3 ROVI
4. Possible side effects
5. Storage of Calcium/Vitamin D3 ROVI
6. Package Contents and Additional Information

1. What is Calcium/Vitamin D3 ROVI and what is it used for

Calcium/Vitamin D3 ROVI are effervescent tablets. They come in packs of 30 tablets.

This medication is a combination of calcium and vitamin D, 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 deficiency or at high risk of combined vitamin D and calcium deficiency.

2. What you need to know before taking Calcium/Vitamin D3 ROVI

Do not take Calcium/Vitamin D3ROVI:

• if you are allergic to the active substances or to any of the other components of this medication (listed in section 6),
• if you have hypercalcemia (abnormally high calcium levels in the blood),
• if you have hypercalciuria (excessive elimination of calcium in the urine),
• if you have kidney stones, tissue calcification (deposits of calcium salts in tissues),
• if you have chronic kidney disease,
• if you have prolonged immobilization accompanied by hypercalciuria and/or hypercalcemia.

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

Warnings and Precautions:

Consult your doctor or pharmacist before starting to take Calcium/Vitamin D3 ROVI:

• if you have kidney failure (inability of the kidneys to function properly),
• 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 there is an inability of the heart to function properly),
• if you are receiving combined treatment with other products containing vitamin D, or are undergoing prolonged or high-dose treatment with calcium supplements. In this case, your doctor may need to perform regular clinical checks. Your doctor will indicate the frequency of these checks.

Taking Calcium/Vitamin D3ROVI with other medications:

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. Certain medications may interfere with Calcium/Vitamin D3 ROVI; in these cases, it may be necessary to change the dose, interrupt treatment with one of them, or wait at least a few hours between administration of both.

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

• Cardiac glycosides (heart medications).
• Tetracyclines (certain antibiotics), wait for an interval of at least 3 hours.
• Thiazide diuretics (medications that increase urine elimination).
• Anticonvulsants.
• Systemic corticosteroids.
• Bisphosphonates and sodium fluoride, wait for an interval of 3 hours.
• Barbiturates or phenytoin.

Taking Calcium / Vitamin D3ROVI with food and beverages:

If you take this medication with foods and beverages that contain oxalic acid (a compound found in spinach and rhubarb) or phytic acid (found in whole wheat bread and cereals) and phosphorus found in milk, interactions may occur, so it is recommended not to take this medication during the 2 hours following consumption of this type of food.

Pregnancy and Breastfeeding

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

Due to the content of vitamin D (880 UI) in Calcium/Vitamin D3 ROVI, its use is not recommended during pregnancy and breastfeeding, as the recommended daily dose of vitamin D should not exceed 600 UI/day.

Driving and Using Machines:

No effects on driving or using machines have been reported.

Calcium/Vitamin D3ROVI contains sucrose, sodium, lactose, and glucose.

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 cavities.

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

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

3. How to take Calcium/Vitamin D3 ROVI

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

Dose

Adults

The recommended dose is 1 effervescent tablet (1000 mg of calcium and 880 UI 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.

Duration of Treatment

Your doctor will indicate the duration of your treatment with Calcium / Vitamin D3 ROVI. Do not stop treatment before.

Follow these instructions unless your doctor has given you different instructions. In these cases, it is advisable to ask the doctor for the instructions in writing and make sure you have understood them well.

If you think the effect of Calcium/Vitamin D3 ROVI is too strong or too weak, tell your doctor or pharmacist.

Remember to take your medication.

If you take more Calcium/Vitamin D3ROVI than you should

If you take more Calcium/Vitamin D3 ROVI than you should, or in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

Overdose can cause hypervitaminosis D (excess of vitamin D) and hypercalcemia (abnormally high calcium levels in the blood). The symptoms in case of overdose are: nausea, vomiting, anorexia (eating disorder), abdominal pain, dry mouth, or polyuria (increased volume of urine eliminated), or irritability, lethargy (excessive tiredness), stupor (decreased response to stimuli), and coma (loss of consciousness) in severe cases.

If you forget to take Calcium/Vitamin D3ROVI

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Calcium/Vitamin D3ROVI

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

-Uncommon(may affect between 1 and 10 in every 1,000 patients):

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

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

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

-Very Rare(may affect less than 1 in every 10,000 patients):

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

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5. Storage of Calcium/Vitamin D3 ROVI

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

Store in the original package to protect it from moisture.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Calcium/Vitamin D3ROVI

-The active substances are: calcium carbonate and colecalciferol concentrate (in powder form). Each tablet contains 2500 mg of calcium carbonate (equivalent to 1000 mg of calcium) and 22 micrograms of colecalciferol concentrate in powder form (equivalent to 880 UI of colecalciferol = vitamin D3).

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

Appearance of the Product and Package Contents

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

They come 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

Manufacturer:

Laboratorios Losan Pharma GMBH

Otto-Hahn-Strasse 13

79395 - Neuenburg

Germany

Date of the Last Revision of this Package Leaflet:June 2022

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