Calcium/vitamin D3 Rovi 1000 mg/880 IU effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Calcium/Vitamin D3 ROVI 1000 mg / 880 IU effervescent tablets

Calcium carbonate/colecalciferol (Vitamin D3)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Calcio/Vitamin D3 ROVI is and what it is used for
2. What you need to know before taking Calcio/Vitamin D3 ROVI
3. How to take Calcio/Vitamin D3 ROVI
4. Possible side effects
5. How to store Calcio/Vitamin D3 ROVI
6. Contents of the pack and other information

1. What Calcio/Vitamina D3 ROVI is and what it is used for

Calcio/Vitamina D3 ROVI are effervescent tablets. They are available in packs containing 30 tablets.

This medicinal product 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 for vitamin D and calcium supplementation as an adjunct to specific therapy in the treatment of osteoporosis in patients with deficiency or at high risk of combined vitamin D and calcium deficiency.

2. What you should know before starting to take Calcio/Vitamina D3 ROVI

Do not take Calcio/Vitamina D3 ROVI:

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

This medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take Calcio/Vitamina D3 ROVI:

• if you have renal insufficiency (kidneys unable to properly perform their function),
• if you have kidney stones,
• if you have a heart condition, sarcoidosis (inflammation affecting lymph nodes, lungs, liver, eyes, skin, and other tissues), or are being treated with cardiac glycosides (medicines used when the heart is unable to properly perform its function),
• if you are receiving concomitant treatment with other vitamin D-containing products, or are undergoing prolonged or high-dose calcium supplementation. In such cases, your doctor may need to carry out regular clinical monitoring. Your doctor will advise you on how often these checks should be performed.

Taking Calcio/Vitamina D3 ROVI with other medicines:

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. Certain medicines may interact with Calcio/Vitamina D3 ROVI; in such cases it may be necessary to adjust the dose, interrupt treatment with one of the medicines, or leave an interval of at least a few hours between administrations.

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

• Cardiac glycosides (medicines for heart conditions).
• Tetracyclines (certain antibiotics); wait at least 3 hours between administrations.
• Thiazide diuretics (medicines that increase urine output).
• Anticonvulsants.
• Systemic corticosteroids.
• Bisphosphonates and sodium fluoride; wait at least 3 hours between administrations.
• Barbiturates or phenytoin.

Taking Calcio/Vitamina D3 ROVI with food and drinks:

If you take this medicine together with foods or drinks containing oxalic acid (a compound found in spinach and rhubarb) or phytic acid (found in wholemeal bread and cereals), or phosphorus found in milk, interactions may occur. Therefore, it is recommended not to take this medicine within 2 hours after consuming these types of foods.

Pregnancy and breastfeeding:

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

Due to its vitamin D content (880 IU), Calcio/Vitamina D3 ROVI is not recommended during pregnancy and breastfeeding, as the recommended daily dose of vitamin D should not exceed 600 IU/day.

Driving and using machines:

No effects on driving or using machines have been reported.

Calcio/Vitamina D3 ROVI contains sucrose, sodium, lactose, and glucose.

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. This medicine may cause dental caries.

This medicine contains 96.15 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 4.8% of the maximum daily sodium intake recommended for an adult.

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains glucose (in maltodextrin derived from maize). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Calcio/Vitamina D3 ROVI

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

Adults

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

Method and route of administration

This medicine is administered orally.

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

Duration of treatment

Your doctor will indicate how long you should take Calcio/Vitamina D3 ROVI. Do not stop the treatment prematurely.

Follow these instructions unless your doctor has given you different ones. In such cases, it is advisable to request written instructions from your doctor and make sure you have understood them correctly.

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

Remember to take your medicine.

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 Toxicology Information Service, telephone: 91.562.04.20, indicating the medicine and the amount ingested.

Overdose may cause hypervitaminosis D (excess vitamin D) and hypercalcemia (abnormally high blood calcium levels). Symptoms of overdose include: nausea, vomiting, anorexia (eating disorder), abdominal pain, dry mouth or polyuria (increased volume of urine excreted), or irritability, lethargy (excessive tiredness), stupor (reduced 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 make up for missed doses.

If you stop taking Calcio/Vitamina D3 ROVI

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

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

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

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

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

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

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Calcium/Vitamin D3 ROVI

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

Store in the original container to protect it from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Calcio/Vitamina D3 ROVI

• The active substances 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 IU of colecalciferol = vitamin D3).

• The other components (excipients) are: anhydrous citric acid, sodium bicarbonate, lactose monohydrate, povidone, sodium saccharin, sodium cyclamate, macrogol 6000, orange flavour (containing maltodextrin derived from maize), simethicone emulsion, ?-tocoferol, hydrogenated soybean oil, gelatin, sucrose, gluten-free corn starch and silicon dioxide.

Appearance of the product and contents of the container

Effervescent tablets, cylindrical in shape, white or almost white.

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

Manufacturer:

Laboratorios Losan Pharma GMBH

Otto-Hahn-Strasse 13

79395 - Neuenburg

Germany

Date of the most recent revision of this leaflet: June 2022

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