CALCIO/VITAMIN D3 ROVI 500 MG/1000 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Calcium/Vitamin D3ROVI 500 mg/1000 UI Chewable Tablets

calcium carbonate / colecalciferol (Vitamin D3)

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets are and what they are used for
2. What you need to know before you take Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets
3. How to take Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets
4. Possible side effects
5. Storage of Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets

1. Contents of the pack and further information

1. What Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets are and what they are used for

Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets are a calcium-vitamin D3 supplement.

They are used

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

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

2. What you need to know before you take Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets

Do not take Calcium/Vitamin D3ROVI 500 mg/1000 UI 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 the blood (hypercalcaemia)
• if you excrete too much calcium in the urine (hypercalciuria)
• if you have overactivity of the parathyroid glands (hyperparathyroidism)
• if you have bone marrow cancer (myeloma)
• if you have cancer that has affected the bones (bone metastases)
• if you have limited mobility of the limbs (prolonged immobilization) accompanied by hypercalcaemia 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

Consult your doctor or pharmacist before starting to take Calcium/Vitamin D3ROVI 500 mg/1000 UI Chewable Tablets

• during prolonged treatment, calcium levels in the blood and urine and kidney function should be monitored periodically. This is especially important if you have a tendency to develop kidney stones. Depending on blood levels, your doctor may reduce the dose or stop treatment.
• if you are receiving simultaneous treatment with digitalis glycosides (cardiac glycosides derived from the digitalis plant) or thiazide diuretics (also known as medications to increase urine excretion) for heart problems, calcium levels in the blood and urine and kidney function should be monitored periodically. Depending on blood levels, your doctor may reduce the dose or stop treatment.
• if you have kidney problems, you should take Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets with special care. Your calcium levels in the blood and urine should be monitored. If you have severe kidney problems, use other forms of vitamin D that are not colecalciferol.
• you should only take additional calcium and vitamin D supplements under medical supervision and your doctor will require frequent monitoring of calcium levels in the blood and urine.
• you should be especially careful when taking Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets if you have sarcoidosis (an immune disorder that can affect the liver, lungs, skin, or lymph nodes). There is a risk that the effect of this medicine may become too strong, which can lead to an overdose of calcium in the body. Calcium levels in the blood and urine should be monitored.
• if you are immobilized and have osteoporosis, this medicine should be used with special care, as it may increase calcium levels in the blood.
• before taking Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets, you should consider the amount of calcium and alkali consumed from other sources (food, dietary supplements, and other medications), such as carbonates. If you take products rich in calcium simultaneously with, for example, carbonates, this could cause Burnett's syndrome. Burnett's syndrome is a calcium metabolic disorder with an increase in calcium levels in the blood (hypercalcaemia), alkalosis (metabolic alkalosis), kidney failure, and calcification of soft tissues. Therefore, additional intake of Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets requires strict medical supervision, with frequent monitoring of calcium levels in the blood and urine.

Children and adolescents

Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets are not indicated for use in children and adolescents.

Using Calcium/Vitamin D3ROVI 500 mg/1000 UI Chewable Tablets with other medicines

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

• In case of simultaneous treatment with digitalis glycosides (cardiac glycosides derived from the digitalis plant), changes in heart rhythm (cardiac arrhythmias) may occur. Therefore, close medical monitoring is necessary, including an ECG and determination of calcium levels in the blood.
• In case of simultaneous administration of thiazide diuretics (also known as medications to increase urine excretion), calcium levels in the blood should be monitored periodically, as thiazides reduce calcium excretion in the urine.
• The absorption and, therefore, the efficacy of certain antibiotics (called tetracyclines) decrease with simultaneous administration of Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets. These medications should be taken at least 2 hours before or 4-6 hours after taking Calcium/Vitamin D3 ROVI 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 taking Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets.
• You should leave the widest possible interval between the administration of cholestyramine (a medication to reduce high cholesterol levels) or laxatives such as liquid paraffin and Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets, as otherwise, vitamin D may not be absorbed properly.
• Simultaneous administration of Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets and phenytoin (a medication for the treatment of epilepsy) or barbiturates (hypnotics) may lead to a reduction in the effect of vitamin D.
• Simultaneous administration of Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets and glucocorticoids (e.g., cortisone) may lead to a reduction in the effect of vitamin D and a reduction in calcium levels in the blood.
• You should only take additional calcium and vitamin D supplements under medical supervision and your doctor will require frequent monitoring of calcium levels in the blood and urine.
• Calcium may reduce the effect of levothyroxine (used to treat thyroid deficiency). For this reason, you should take levothyroxine at least four hours before or four hours after taking Calcium/Vitamin D3 ROVI 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. You should take quinolone antibiotics at least two hours before or six hours after taking Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets.

Taking Calcium/Vitamin D3ROVI 500 mg/1000 UI Chewable Tablets with food and drinks

You can take Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets at any time, with or without food.

You should 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, you should not use Calcium/Vitamin D3 ROVI 500 mg/1000 UI 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 cause high levels of calcium in the blood and may have a negative effect on the fetus.

You can take Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets during breastfeeding. As calcium and vitamin D pass into breast milk, consult your doctor before giving your child other products containing vitamin D. You should take into account when additional vitamin D is administered to the child.

Driving and using machines

Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets have no influence on the ability to drive and use machines.

Calcium/Vitamin D3ROVI 500 mg/1000 UI 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 in each chewable tablet. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains 49.62 mg of sorbitol in each chewable tablet.

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

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

This medicine 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 can 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 can accumulate in the body and cause adverse effects (metabolic acidosis).

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

3. How to take Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dose

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

The dose is specifically decided for you by your doctor.

Method of administration

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

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

Duration of treatment

Calcium/Vitamin 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 medicine (see also section 2. Warnings and precautions).

If you take more Calcium/Vitamin D3ROVI 500 mg/1000 UI Chewable Tablets than you should

Overdose of Calcium/Vitamin D3 ROVI 500 mg/1000 UI Chewable Tablets may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine production, decreased body fluids, or constipation. If you suspect an overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Bring this leaflet with you.

If you forget to take Calcium/Vitamin D3ROVI 500 mg/1000 UI Chewable Tablets

If you forget to take Calcium/Vitamin 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 Calcium/Vitamin D3ROVI 500 mg/1000 UI Chewable TabletsIf you want to stop or suspend treatment prematurely, consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects, may affect up to 1 in 100 people:

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

Rare side effects, may affect up to 1 in 1000 people:

• nausea, diarrhea, abdominal pain, constipation, gas, bloating (abdominal distension).
• skin rash, itching, urticaria.

Stop taking Calcium / Vitamin D3ROVI 500 mg / 1000 UI Chewable Tablets and contact a doctor immediatelyif you experience the following allergic reaction (frequency not known, as 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calcium/Vitamin D3 ROVI 500 mg / 1000 UI Chewable Tablets

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

Do not use this medicine after the expiry date which is stated on the carton and on the tube or on the blister strips after EXP. The expiry date is the last day of the month stated.

For the tube:

Keep the tube tightly closed to protect it from moisture.

Do not store above 30°C.

For the blister strips:

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Calcium/Vitamin D3 Composition3ROVI 500 mg/1000 UI Chewable Tablets

• The active ingredients 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 UI of vitamin D3).
• The other components are isomalt (E-953), xylitol, sorbitol (E-420), anhydrous citric acid, sodium citrate dihydrate, magnesium stearate, sodium carmellose, 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), acesulfame potassium, sodium ascorbate, all-rac-alpha-tocopherol, modified corn starch, sucrose, medium-chain triglycerides, and colloidal silicon dioxide.

Product Appearance and Container Content

Calcium/Vitamin D3 ROVI 500 mg / 1000 UI chewable tablets are 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 marketed.

Marketing Authorization Holder

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Manufacturer

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