Calcium/vitamin D3 Rovi 500 mg/1000 IU chewable tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the user

Calcium/Vitamin D3 ROVI 500 mg/1000 IU chewable 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, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it 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/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets are and what they are used for

2. What you need to know before taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets

3. How to take Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets

4. Possible adverse effects

5. How to store Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets

6. Contents of the pack and other information

1. What Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets is and what it is used for

Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets is a calcium-vitamin D3 supplement.

It is used

• for the prevention and treatment of calcium and vitamin D deficiency states in elderly individuals.

• to provide vitamin D and calcium as complementary therapy in osteoporosis (fragile bones) in patients at risk of vitamin D and calcium deficiency.

2. What you need to know before taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets

Do not take Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets

• if you are allergic to calcium, vitamin D3, or any of the other ingredients of this medicine (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 overactivity of the parathyroid glands (hyperparathyroidism)
• if you have bone marrow cancer (myeloma)
• if you have cancer that has spread to the bones (bone metastases)
• if you have limited limb movement (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria
• if you have kidney stones (nephrolithiasis)
• if you have calcium deposits in the kidneys (nephrocalcinosis)
• if you have an excess of vitamin D (hypervitaminosis D)
• if you have severe kidney problems

Warnings and precautions

Talk to your doctor or pharmacist before taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets

• during long-term treatment, calcium levels in blood and urine and kidney function should be monitored regularly. This is especially important if you are prone to developing kidney stones. Depending on blood levels, your doctor may reduce the dose or discontinue treatment.
• if you are receiving concomitant treatment with cardiac glycosides or thiazide diuretics (medicines that increase urine excretion) for heart problems, calcium levels in blood and urine and kidney function should be monitored regularly. Depending on blood levels, your doctor may reduce the dose or discontinue treatment.
• if you have kidney problems, you should take Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets with special caution. Your blood and urine calcium levels 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 calcium levels in blood and urine.
• take special care when taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets if you have sarcoidosis (an immune disorder that may affect the liver, lungs, skin, or lymph nodes). There is a risk that the effect of this medicine may become too strong, leading to calcium overdose in the body. Blood and urine calcium levels should be monitored.
• if you are immobilized and have osteoporosis, this medicine should be used with special care, as it could increase blood calcium levels.
• before taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets, consider the amount of calcium and alkali consumed from other sources (foods, dietary supplements, and other medicines), such as carbonates. If calcium-rich products are taken simultaneously with, for example, carbonates, this could cause Burnett syndrome. Burnett syndrome is a metabolic calcium disorder characterized by increased blood calcium levels (hypercalcemia), alkalemia (metabolic alkalosis), kidney failure, and soft tissue calcification. Therefore, additional intake of Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets requires strict medical supervision with frequent monitoring of blood and urine calcium levels.

Children and adolescents

Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets are not indicated for use in children and adolescents.

Taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• When taken together with digitalis glycosides (cardiac glycosides derived from the foxglove plant), changes in heart rhythm (cardiac arrhythmias) may occur. Therefore, close medical monitoring, including ECG and blood calcium level determination, is necessary.
• If taken simultaneously with diuretics of the thiazide class (also known as medicines that increase urine excretion), blood calcium levels should be monitored periodically, as thiazides reduce calcium excretion in urine.
• The absorption, and therefore the effectiveness, of certain antibiotics (called tetracyclines) is reduced when taken at the same time as Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets. These medicines should be taken at least 2 hours before or 4–6 hours after taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets.
• Other medicines such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are also affected by interactions. Therefore, these medicines should be taken at least 3 hours before taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets.
• The interval between administration of colestyramine (a medicine used to lower high cholesterol levels) or laxatives such as liquid paraffin and Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets should be as long as possible, as otherwise vitamin D may not be properly absorbed.
• Simultaneous administration of Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets and phenytoin (a medicine used to treat epilepsy) or barbiturates (hypnotics) may reduce the effect of vitamin D.
• Simultaneous administration of Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets and glucocorticoids (e.g., cortisone) may reduce the effect of vitamin D and lower blood calcium levels.
• Additional calcium and vitamin D supplements should only be taken 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 Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets.
• The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics at least two hours before or six hours after taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets.

Taking Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets with food and drink

You may take Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets at any time, with or without food.

Please note that oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) may reduce the amount of calcium absorbed in the intestine. Patients should not take calcium-containing medicines within 2 hours before or after consuming foods high in oxalic acid or phytic acid.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, you should not use Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets.

During pregnancy, the total daily intake of calcium should not exceed 1500 mg and the total daily intake of vitamin D3 should not exceed 600 IU (International Units).

Long-term overdose of calcium and vitamin D during pregnancy should be avoided, as it may lead to high blood calcium levels and may have a negative effect on the fetus.

You may take Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor beforehand if your child is receiving other products containing vitamin D. This should be taken into account when giving additional vitamin D to the child.

Driving and using machines

Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets have no influence on the ability to drive and use machines.

Calcio/Vitamina D3 ROVI 500 mg/1000 IU chewable tablets contain aspartame (E-951), sorbitol (E-420), isomalt (E-953), sucrose, benzyl alcohol, and sodium.

This medicine contains 0.50 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains 49.62 mg of sorbitol per chewable tablet.

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

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

This medicine contains 0.011 mg of benzyl alcohol per 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 the body and cause adverse effects (metabolic acidosis).

This medicine contains less than 23 mg of sodium (1 mmol) per chewable tablet; hence, it is essentially “sodium-free.”

3. How to take Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets

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 and elderly patients: 1 chewable tablet per day (corresponds to 500 mg of calcium and 1000 IU (International Units) of vitamin D3).

The dosage has been specifically determined for you by your doctor.

Method of administration

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

Special attention should be paid to consuming an adequate daily intake of calcium through the diet (e.g. dairy products, vegetables, mineral water).

Duration of treatment

Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets should be taken as a long-term treatment. Discuss with your doctor the duration of treatment with this medicine (see also section 2. Warnings and precautions).

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

An overdose of Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine output, dehydration, or constipation. If an overdose is suspected, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Bring this leaflet with you.

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

If you forget 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 make up for forgotten doses.

If you stop taking Calcio/Vitamina D3 ROVI 500 mg/1000 UI chewable tablets If you wish to interrupt or discontinue the treatment prematurely, consult your doctor.

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

4. Possible adverse effects

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

Uncommon adverse effects, may affect 1 in every 100 people:

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

Rare adverse effects, may affect 1 in every 1,000 people:

• feeling sick (nausea), diarrhoea, stomach pain, constipation, flatulence, bloating (abdominal distension).
• skin rash, itching, hives.

Stop taking Calcium / Vitamin D3ROVI 500 mg / 1000 IU chewable tablets and contact a doctor immediately if you experience the following allergic reaction (frequency not known since it cannot be estimated from available data):

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Calcio/Vitamina D3 ROVI 500 mg / 1000 IU chewable tablets

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

Do not use this medicine after the expiry date stated on the carton, on the bottle, or on the aluminum foil strips after EXP. The expiry date refers to the last day of the month indicated.

For the bottle:

Keep the bottle tightly closed to protect it from moisture.

Do not store above 30°C.

For the foil strips:

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Calcium/Vitamin D3 ROVI 500 mg/1000 IU chewable tablets

• The active substances are calcium and colecalciferol. Each chewable tablet contains 1250 mg of calcium carbonate (equivalent to 500 mg of calcium) and 10 mg of concentrated colecalciferol (in powder form) (equivalent to 25 micrograms of colecalciferol = 1000 IU of vitamin D3).
• The other components are isomalt (E-953), xylitol, sorbitol (E-420), anhydrous citric acid, disodium citrate dihydrate, magnesium stearate, sodium carmellose, orange flavour “CPB” (containing flavouring substances, mannitol (E-421), maltodextrin, glucono-delta-lactone (E-575), sorbitol (E-420), benzyl alcohol, propylene glycol and sodium), orange flavour “CVT” (containing flavouring substances, mannitol (E-421), glucono-delta-lactone (E-575), sorbitol (E-420) and medium-chain triglycerides), colloidal hydrated silica, aspartame (E-951), acesulfame potassium, sodium ascorbate, modified maize starch, sucrose, medium-chain triglycerides and colloidal silicon dioxide.

Appearance of the product and contents of the pack

Calcium/Vitamin D3 ROVI 500 mg / 1000 IU chewable tablets are round, white tablets.

The chewable tablets are available in polypropylene tubes with polyethylene caps containing a desiccant, in the following pack sizes:

30 and 90 chewable tablets.

The chewable tablets are also available in aluminium foil blisters in the following pack sizes:

30 and 90 chewable tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Manufacturer 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 under the following names:

Date of the last revision of this leaflet: February 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)