Leaflet: information for the user

Calcio/ Vitamin D3ROVI 1000 mg/880 UI chewable tablets

Read this leaflet carefully before you start taking this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isCalcio/Vitamin D3ROVIand what it is used for

2. What you need to know before starting to takeCalcio/Vitamin D3ROVI

3. How to takeCalcio/Vitamin D3ROVI

4. Possible side effects

5. Storage ofCalcio/Vitamin D3ROVI

6. Contents of the pack and additional information

Calcio/ Vitamin D3ROVI contains the active principles of calcium and vitamin D3and is a calcium-vitamin D3supplement.

Calcio/ Vitamin D3ROVI is used

• to prevent and treat calcium and vitamin D deficiency states in older adults.
• to provide vitamin D and calcium as a complementary therapy for osteoporosis (fragile bones).

Do not take Calcio/ Vitamin DD3ROVI

• if you are allergic to calcium, vitamin D3, or any of the other components of this medication (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 hyperactivity of the parathyroid glands (hyperparathyroidism),
• if you have bone cancer (myeloma),
• if you have cancer that has affected your bones (bone metastases),
• if you have limited mobility of your limbs (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria,
• if you have kidney stones (nephrolithiasis),
• if you have calcium deposits in your kidneys (nephrocalcinosis),
• if you have excessive vitamin D (hypervitaminosis D),
• if you have severe kidney problems,
• if you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Calcio/Vitamin D3 ROVI if any of the following points affect you:

• Prolonged treatment:

During prolonged treatment, your calcium levels in the blood and urine and renal function should be monitored periodically. This is especially important if you are prone to developing kidney stones. Depending on the blood levels, your doctor may reduce the dose or discontinue treatment.

• If you are receiving simultaneous treatment with cardiac glycosides or thiazide diuretics (medications that increase urine excretion) for heart problems:

In this case, your calcium levels in the blood and urine and renal function should be monitored periodically, especially if you are an elderly patient. Depending on the blood levels, your doctor may reduce the dose or discontinue treatment.

• Kidney problems:

If you have kidney problems, you should take Calcio/Vitamin D3 ROVI with special care, especially if you are receiving other medications containing aluminum, as the citric acid present in Calcio/Vitamin D3 ROVI may increase aluminum absorption. 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.

• Additional supplements of calcium and vitamin D:

Medical supervision is required, and your doctor will require frequent monitoring of your calcium levels in your blood and urine.

• Sarcoidosis (an immunological disorder that can affect the liver, lungs, skin, or lymph nodes):

You should take special care when taking Calcio/Vitamin D3 ROVI if you have sarcoidosis. There is a risk that the effect of this medication may become too strong, leading to a calcium overdose in the body. Your calcium levels in the blood and urine should be monitored.

• Immobility and osteoporosis:

In these cases, this medication should be used with special care, as it may increase blood calcium levels.

Children and adolescents

Calcio/Vitamin D3 ROVI is not indicated for use in children or adolescents under 18 years of age. See the section “Do not take Calcio/Vitamin D3 ROVI”.

Use of Calcio/Vitamin D3 ROVI with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• In the case of simultaneous treatment with cardiac glycosides (digitalis-derived cardiac glycosides), arrhythmias may occur. Therefore, strict medical monitoring is required, including an ECG and determination of calcium levels in the blood.
• In the case of simultaneous administration of thiazide diuretics (also known as medications that increase urine excretion), your 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 (designated as tetracyclines) decrease with simultaneous administration of Calcio/Vitamin D3 ROVI. These medications should be taken at least 2 hours before or 4-6 hours after Calcio/Vitamin D3 ROVI.
• 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 Calcio/Vitamin D3 ROVI.
• 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 Calcio/Vitamin D3 ROVI, as otherwise, vitamin D will not be absorbed properly.
• The simultaneous administration of Calcio/Vitamin D3 ROVI and phenytoin (a medication for the treatment of epilepsy) or barbiturates (hypnotics) may lead to a reduction in the effect of vitamin D.

• The simultaneous administration of Calcio/Vitamin D3 ROVI 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.
• Only additional supplements of calcium and vitamin D should be administered under medical supervision, and frequent monitoring of calcium levels in the blood and urine 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/Vitamin D3 ROVI.
• There may be a reduction in the effect of quinolone antibiotics if taken at the same time as calcium. Take quinolone antibiotics at least two hours before or six hours after taking Calcio/Vitamin D3 ROVI.

Taking Calcio/Vitamin D3 ROVI with food, drinks, and alcohol

You can take Calcio/Vitamin D3 ROVI at any time, with or without food.

You should be aware that oxalic acid (e.g., present in spinach and rhubarb) and phytic acid (e.g., present in whole grains) may 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, you should not take medications containing calcium.

Pregnancy and lactation

Pregnancy

If you are pregnant, you can take Calcio/Vitamin D3 ROVI if you have a calcium and vitamin D deficiency.

Do not exceed the daily dose of half a tablet. During pregnancy, the total daily dose of calcium should not exceed 1500 mg, and the total daily dose of vitamin D3 should not exceed 600 IU (International Units).

Avoid long-term overdosing on calcium and vitamin D during pregnancy, as it may lead to high calcium levels in the blood and have a negative effect on the fetus.

Lactation

Calcio/Vitamin D3 ROVI can be used during lactation. Since calcium and vitamin D pass into breast milk, consult your doctor if your child is receiving other products containing vitamin D.

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

Driving and operating machinery

No sufficient data is available regarding the effects of Calcio/Vitamin D3 ROVI on the ability to drive and operate machinery. However, the influence appears to be unlikely.

Calcio/Vitamin D3 ROVI contains aspartame (E-951), sorbitol (E-420), isomalt (E-953), saccharose, benzyl alcohol, and sodium.

This medication contains 1 mg of aspartame in each chewable tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains 103.57 mg of sorbitol in each chewable tablet.

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

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

This medication contains 0.023 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 your body and cause adverse effects (metabolic acidosis).

This medication contains less than 1 mmol of sodium (23 mg) per chewable tablet, which is essentially “sodium-free”.

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

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

The recommended dose is:

Adults and elderly people: 1 chewable tablet per day (corresponding to 1000 mg of calcium and 880 IU [International Units] of vitamin D3).

Pregnant women may take only half a chewable tablet per day (corresponding to 500 mg of calcium and 440 IU [International Units] of vitamin D3). Do not exceed the daily dose of half a tablet.

Use in children and adolescents

Calcio/ Vitamina D3 ROVI is not indicated for use in children or adolescents under 18 years of age.

See section “Do not take Calcio/ Vitamina D3 ROVI”.

Administration form

Oral route.

The tablet must be chewed before swallowing. You can take Calcio/ Vitamina D3 ROVI at any time, with or without food.

Treatment duration

Calcio/ Vitamina D3 ROVI should be taken as prolonged treatment. Talk to your doctor about the duration of treatment with Calcio/ Vitamina D3 ROVI (see also section 2, “Warnings and precautions”).

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

Consult your doctor or pharmacist immediately if you suspect you have taken an overdose. Have the packaging and any remaining chewable tablets available.

An overdose of Calcio/ Vitamina D3 ROVI may produce symptoms such as: nausea, vomiting, excessive thirst, increased urine production, decreased body fluids, or constipation. In case of suspected overdose, call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Calcio/ Vitamina D3 ROVI

If you forgot to take Calcio/ Vitamina D3 ROVI, take it as soon as you remember, unless it is time to take the next dose. In that case, take the next dose as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Calcio/ Vitamina D3 ROVI

If you want to interrupt or prematurely discontinue treatment, consult your doctor.

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

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

The evaluation of side effects is based on the following frequencies:

Stop taking Calcio/ Vitamina D3ROVI and contact a doctor immediately if you experience any of the following severe side effects:

Very rare:May affect up to 1 in 10,000 users

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

Other reported side effects are:

Uncommon side effects:May affect 1 in 100 users

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

Rare side effects:May affect up to 1 in 1,000 users

• nausea, vomiting, diarrhea, abdominal pain, constipation, gas, bloating.
• skin rash, itching, urticaria.
• allergy.

If you have kidney failure, you may be at risk of having high levels of phosphates in the blood, high levels of calcium in the kidneys, and kidney stones.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the tube or on the aluminum foil strips after CAD. The expiration date is the last day of the month indicated.

For the tube: Keep the container perfectly closed to protect it from moisture.

For the strips: This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.of the pharmacy.

Composition of Calcium/ Vitamin D 3 ROVI

• The active principles are calcium and colecalciferol. Each chewable tablet contains 2500 mg of calcium carbonate (equivalent to 1000 mg of calcium) and 8.8 mg of concentrated colecalciferol (in powder form) (equivalent to 22 micrograms of colecalciferol = 880 UI of vitamin D 3 .

• The other components are isomalta (E-953), xylitol, sorbitol (E-420), anhydrous citric acid, sodium citrate dihydrate, magnesium stearate, sodium croscarmellose, orange flavor “CPB” (containing flavoring agents, benzyl alcohol, propylene glycol, sodium, sorbitol (E-420), mannitol (E-421), maltodextrin (derived from corn) and gluconolactone (E-575)), orange flavor “CVT” (containing flavoring agents, mannitol (E-421), gluconolactone (E-575), sorbitol (E-420) and medium-chain triglycerides), aspartame (E-951), potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol, modified cornstarch, sucrose, medium-chain triglycerides and colloidal silicon dioxide.

Appearance of the product and contents of the packaging

Calcio/ Vitamina D 3 ROVI are round, white tablets with a smooth surface and a groove for breaking the tablet. The tablet can be divided into two equal halves.

The chewable tablets are presented in polypropylene tubes with polyethylene caps containing a desiccant in the following packaging sizes:

1 tube of 30 chewable tablets.

The chewable tablets are presented in aluminum foil strips in the following packaging sizes:

30 chewable tablets.

Holder of the marketing authorization

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Responsible for manufacturing

HERMES PHARMA GmbH

Hans-Urmiller- Ring 52

82515 Wolfratshausen

Germany

This leaflet has been revised in: April 2017

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