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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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. Do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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 contains the active substances calcium and vitamin D3 and is a calcium-vitamin D3 supplement.

Calcio/ Vitamina D3 ROVI is used

• to prevent and treat calcium and vitamin D deficiency states in elderly individuals.
• to provide vitamin D and calcium as complementary therapy in osteoporosis (fragile bones).

2. What you need to know before you start taking Calcio/Vitamina D3 ROVI

Do not take Calcio/Vitamina D3 ROVI

• 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 excess vitamin D (hypervitaminosis D),
• if you have severe kidney problems,
• if you are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Calcio/Vitamina D3 ROVI if any of the following apply to you:

• Long-term treatment:

During prolonged treatment, calcium levels in 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 concomitant treatment with cardiac glycosides or thiazide diuretics (medicines that increase urine excretion) for heart problems:

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

• Kidney problems:

If you have kidney problems, you should take Calcio/Vitamina D3 ROVI with special caution, especially if you are also taking other medicines containing aluminum, as the citric acid present in Calcio/Vitamina D3 ROVI may increase aluminum absorption. Your blood and urine calcium levels should be monitored. If you have severe kidney problems, use other forms of vitamin D instead of colecalciferol.

• Taking additional calcium and vitamin D supplements:

Medical supervision is required, and your doctor will need to frequently monitor your blood and urine calcium levels.

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

Take special care when taking Calcio/Vitamina D3 ROVI if you have sarcoidosis. 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.

• Immobilization and osteoporosis:

This medicine should be used with special caution in these cases, as it could increase blood calcium levels.

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”.

Taking Calcio/Vitamina D3 ROVI with other medicines

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

• When taken together with digitalis glycosides (cardiac glycosides derived from the foxglove plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring including ECG and blood calcium level determination is necessary.
• If taken together 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) decrease when taken at the same time as Calcio/Vitamina D3 ROVI. These medicines should be taken at least 2 hours before or 4–6 hours after Calcio/Vitamina D3 ROVI.
• 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 Calcio/Vitamina D3 ROVI.
• The longest possible interval should be left between taking colestyramine (a medicine to reduce high cholesterol levels) or laxatives such as liquid paraffin and Calcio/Vitamina D3 ROVI, as otherwise vitamin D may not be properly absorbed.
• Taking Calcio/Vitamina D3 ROVI together with phenytoin (a medicine used to treat epilepsy) or barbiturates (hypnotics) may reduce the effect of vitamin D.
• Taking Calcio/Vitamina D3 ROVI together with 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 thyroid insufficiency). Therefore, levothyroxine should be taken at least four hours before or four hours after Calcio/Vitamina D3 ROVI.
• 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.

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

You may take Calcio/Vitamina D3 ROVI at any time, with or without food.

Note that oxalic acid (e.g., found in spinach and rhubarb) and phytic acid (e.g., found in whole grains) may reduce the amount of calcium absorbed in the intestine.

Do not take calcium-containing medicines within 2 hours before or after eating foods high in oxalic acid or phytic acid.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you may take Calcio/Vitamina D3 ROVI if you have a deficiency of calcium and vitamin D.

The daily dose should not exceed half a tablet. 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 blood calcium levels and have negative effects on the fetus.

Breastfeeding

Calcio/Vitamina D3 ROVI may be used 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.

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.

Driving and using machines

There are insufficient data regarding the effects of Calcio/Vitamina D3 ROVI on the ability to drive and use machines. However, any influence is considered unlikely.

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

This medicine contains 1 mg of aspartame in each 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 103.57 mg of sorbitol in each chewable tablet.

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

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

This medicine 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, as 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, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

This medicine contains less than 1 mmol of sodium (23 mg) per chewable tablet, i.e., essentially “sodium-free”.

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

3. How to take Calcium/Vitamin 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.

Recommended dose:

Adults and elderly patients: 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). The daily dose of half a tablet must not be exceeded.

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 use.

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

Duration of treatment

Calcium/Vitamin D3 ROVI should be taken as a long-term treatment. Speak with your doctor about the duration of treatment with Calcium/Vitamin D3 ROVI (see also section 2, “Warnings and precautions”).

If you take more Calcium/Vitamin D3 ROVI than you should

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

An overdose of Calcium/Vitamin D3 ROVI may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine output, dehydration, or constipation. In case of suspected overdose, call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 almost time for your 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 stop taking Calcium/Vitamin D3 ROVI

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

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.

The assessment of adverse 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 adverse effects:

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

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

Other reported adverse effects are:

Uncommon adverse effects: may affect up to 1 in 100

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

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

• Nausea, vomiting, diarrhea, abdominal pain, constipation, flatulence, bloating (abdominal distension).
• Skin rash, itching, hives.
• Allergy.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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. Conservation of Calcio/ Vitamina D3 ROVI

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

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

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

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

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

6. Contents of the container and other information

Composition of Calcio/Vitamina D3 ROVI

• The active substances are calcium and colecalciferol. Each chewable tablet contains 2500 mg calcium carbonate (equivalent to 1000 mg calcium) and 8.8 mg concentrated colecalciferol (in powder form) (equivalent to 22 micrograms colecalciferol = 880 IU vitamin D3).

• The other components are isomalt (E-953), xylitol, sorbitol (E-420), anhydrous citric acid, disodium citrate dihydrate, magnesium stearate, sodium croscarmellose, orange flavour “CPB” (containing flavouring substances, benzyl alcohol, propylene glycol, sodium, sorbitol (E-420), mannitol (E-421), maltodextrin (from corn) and gluconolactone (E-575)), orange flavour “CVT” (containing flavouring substances, mannitol (E-421), gluconolactone (E-575), sorbitol (E-420) and medium-chain triglycerides), 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 container

Calcio/Vitamina D3 ROVI are round, white chewable tablets with a smooth surface and a score line to allow the tablet to be divided into equal halves.

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

1 bottle containing 30 chewable tablets.

The chewable tablets are also supplied in aluminum foil blisters in the following pack sizes:

30 chewable tablets.

Marketing Authorization Holder

Laboratorios Farmacéuticos ROVI, 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 up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/