CALCIO/VITAMIN D3 ROVI 1000 MG/880 IU CHEWABLE TABLETS

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

Do not take Calcium/ VitaminD3ROVI

• 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 the blood (hypercalcemia),
• if you excrete too much calcium in the urine (hypercalciuria),
• if you have hyperactivity 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 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,
• if you are under 18 years of age.

Warnings and Precautions

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

• Prolonged treatment:

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 discontinue treatment.

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

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

• Kidney problems:

If you have kidney problems, you should take Calcium/ Vitamin D3 ROVI with special care, especially if you are receiving other medications that contain aluminum, as the citric acid present in Calcium/ 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.

• Intake of additional calcium and vitamin D supplements:

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

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

Be careful when taking Calcium/ Vitamin D3 ROVI if you have sarcoidosis. There is a risk that the effect of this medication 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.

• Immobilization and osteoporosis:

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

Children and Adolescents

Calcium/ Vitamin D3 ROVI is not indicated for use in children or adolescents under 18 years of age. See section "Do not take Calcium/ Vitamin D3 ROVI".

Using Calcium/ Vitamin D3 ROVI with Other Medications

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

• In the case of simultaneous treatment with digitalis glycosides (cardiac glycosides derived from the digitalis plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring, including an ECG and determination of calcium levels in the blood, is necessary.
• In the 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 the simultaneous administration of Calcium/ Vitamin D3 ROVI. These medications should be taken at least 2 hours before or 4-6 hours after Calcium/ 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 Calcium/ Vitamin D3 ROVI.
• The interval between the administration of cholestyramine (a medication to reduce high cholesterol levels) or laxatives such as liquid paraffin and Calcium/ Vitamin D3 ROVI should be as long as possible, as otherwise, vitamin D may not be absorbed properly.
• The simultaneous administration of Calcium/ 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 Calcium/ 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.
• Additional calcium and vitamin D supplements should only be administered under medical supervision, and frequent monitoring of calcium levels in the blood and urine is required.
• Calcium may reduce the effect of levothyroxine (used to treat thyroid deficiency). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after Calcium/ 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 2 hours before or 6 hours after taking Calcium/ Vitamin D3 ROVI.

Taking Calcium/ Vitamin D3 ROVI with Food, Drinks, and Alcohol

You can take Calcium/ 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) 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, you should not take medications containing calcium.

Pregnancy and Breastfeeding

Pregnancy

If you are pregnant, you can take Calcium/ 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 amount of calcium should not exceed 1500 mg, and the total daily amount 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 have a negative effect on the fetus.

Breastfeeding

Calcium/ Vitamin D3 ROVI can be used during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor before taking this medication if your child is receiving other products containing vitamin D.

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.

Driving and Using Machines

There is no sufficient data on the effects of Calcium/ Vitamin D3 ROVI on the ability to drive and use machines. However, the influence appears to be unlikely.

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

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

This medication contains 103.57 mg of sorbitol per 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 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 tooth decay.

This medication contains 0.023 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 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 medication contains less than 1 mmol of sodium (23 mg) per chewable tablet, which is essentially "sodium-free".

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 for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

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

Pregnant women can 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

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

See section "Do not take Calcium/ Vitamin D3 ROVI".

Method of Administration

Oral route.

The tablet should be chewed before swallowing. You can take Calcium/ Vitamin D3 ROVI at any time, with or without food.

Duration of Treatment

Calcium/ Vitamin D3 ROVI should be taken as prolonged treatment. Discuss the duration of treatment with Calcium/ Vitamin D3 ROVI with your doctor (see also section 2, "Warnings and Precautions").

If You Take More Calcium/ Vitamin D3 ROVI Than You Should

Consult your doctor or pharmacist immediately if you suspect an overdose. Have the package and any remaining tablets available.

Overdose of Calcium/ Vitamin D3 ROVI may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine production, decreased body fluids, or constipation. In case of suspected overdose, call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If You Forget to Take Calcium/ Vitamin D3 ROVI

If you forget to take Calcium/ Vitamin 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 make up for forgotten doses.

If You Interrupt Treatment with Calcium/ Vitamin D3 ROVI

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

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.

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

Stop taking Calcium/ Vitamin D3 ROVI and contact a doctor immediately if you experience any of the following serious side effects:

Very rare:may affect up to 1 in 10,000

• 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 up to 1 in 100

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

Rare side effects:may affect up to 1 in 1,000

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

If you have kidney failure, there may be a risk of elevated phosphate levels in the blood, elevated calcium levels in the kidneys, and kidney stones.

If you experience any side effect that is severe or not listed in this package leaflet, tell 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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Calcium/ Vitamin D3 ROVI

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

Do not use this medication after the expiration date shown on the box and tube or on the aluminum foil strips after the expiration date. 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.

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

6. Container Content and Additional Information

Calcium/ Vitamin D3 Composition3ROVI

• The active ingredients 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 IU of vitamin D3).

• The other components are isomalt (E-953), xylitol, sorbitol (E-420), anhydrous citric acid, sodium citrate dihydrate, magnesium stearate, sodium croscarmellose, orange flavor "CPB" (which contains flavoring substances, benzyl alcohol, propylene glycol, sodium, sorbitol (E-420), mannitol (E-421), maltodextrin (derived from corn) and gluconolactone (E-575)), orange flavor "CVT" (which contains flavoring substances, 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 corn starch, sucrose, medium-chain triglycerides and colloidal silicon dioxide.

Product Appearance and Container Content

Calcium/ Vitamin D3 ROVI are round, white tablets with a smooth surface and a score line to break the tablet. The tablet can be divided into two equal halves.

The chewable tablets are presented in polypropylene tubes with polyethylene caps that contain a desiccant in the following package sizes:

1 tube of 30 chewable tablets.

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

30 chewable tablets.

Marketing Authorization Holder

ROVI Pharmaceutical Laboratories, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Manufacturer

HERMES PHARMA GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

This leaflet was last revised in: April 2017

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