Calcium carbonate and vitamin d3 Aurobindo

Package leaflet: Information for the patient

Calcium Carbonate and Vitamin D3 Aurobindo 1000 mg + 880 IU effervescent granules

Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Calcio Carbonato e Vitamina D3 Aurobindo is and what it is used for
2. What you need to know before taking Calcio Carbonato e Vitamina D3 Aurobindo
3. How to take Calcio Carbonato e Vitamina D3 Aurobindo
4. Possible side effects
5. How to store Calcio Carbonato e Vitamina D3 Aurobindo
6. Contents of the pack and other information

1. What Calcio Carbonato e Vitamina D3 AurobindoCALCIO is and what it is used for

Calcio Carbonato e Vitamina D3 Aurobindo contains two active substances: calcium carbonate and vitamin D3 (colecalciferol). Calcium is an important element for the proper functioning of the nervous system, muscles, heart, and blood vessels, and is also a fundamental component of bones. Vitamin D3 maintains normal levels of calcium and phosphate in the blood, helping to keep bones strong.

This medicinal product is indicated for the treatment of calcium and vitamin D deficiency in the blood, particularly in elderly individuals or in those who have or are at risk of a disease causing bone weakening (osteoporosis).

2. What you should know before taking Calcio Carbonato e Vitamina D3 Aurobindo

Do not take Calcio Carbonato e Vitamina D3 Aurobindo

• if you are allergic to calcium carbonate, cholecalciferol, or any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria), or suffer from certain bone or parathyroid gland diseases that may increase them (myeloma, bone metastases, primary hyperparathyroidism);
• if you are confined to prolonged bed rest (prolonged immobilization) associated with elevated calcium levels in the blood (hypercalcemia) or urine (hypercalciuria);
• if you have kidney problems (renal failure);
• if you have kidney stones (nephrolithiasis and nephrocalcinosis, calcium lithiasis);
• if you have high levels of vitamin D in your blood (hypervitaminosis D);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if you have high levels of a substance called phenylalanine in your blood (phenylketonuria) (see section “Calcio Carbonato e Vitamina D3 Aurobindo contains aspartame”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Calcio Carbonato e Vitamina D3 Aurobindo.
Take this medicine with caution and inform your doctor in the following cases:

• if your blood or urine calcium levels are high (hypercalcemia, hypercalciuria), or if you have kidney problems (renal failure). In these cases, your doctor may decide to reduce the dose or stop treatment (see section 4 “Possible side effects”);
• if you are taking other medicines or foods containing vitamin D. Your doctor may adjust the dose of this medicine;
• if you are taking supplements containing calcium and/or vitamin D. In this case, your doctor must monitor calcium levels in blood and urine;
• if you suffer from a disease called sarcoidosis, characterized by cough, sometimes with bleeding, and difficulty breathing. In such cases, your doctor must periodically monitor calcium levels in blood and urine.

If you have kidney problems (renal failure), during treatment with this medicine, your doctor must perform specific checks (calcium and phosphate homeostasis), as you may have altered vitamin D metabolism.
If you take Calcio Carbonato e Vitamina D3 Aurobindo for prolonged periods, your doctor must monitor calcium levels in blood and urine and your kidney function (measurement of creatinine levels in blood). These checks are particularly important in elderly patients (see section “Elderly”).

Children and adolescents
This medicine is not recommended for children and adolescents.

Elderly
If you are elderly and are being treated with medicines used for heart conditions (cardiac glycosides) or medicines that increase urine elimination (diuretics), your doctor must carefully monitor calcium levels in blood and urine and your kidney function. These checks are especially necessary if you are taking Calcio Carbonato e Vitamina D3 Aurobindo for prolonged periods.

Other medicines and Calcio Carbonato e Vitamina D3 Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking the following medicines:

• cardiac glycosides for the treatment of certain heart conditions, as the risk of developing heart rhythm disorders (arrhythmia) is higher. In this case, your doctor must monitor your heart activity (electrocardiographic monitoring) and calcium levels in blood;

• bisphosphonates and sodium fluoride for the treatment of certain bone diseases, fluoroquinolones for bacterial infections, as Calcio Carbonato e Vitamina D3 Aurobindo reduces their effectiveness. In these cases, Calcio Carbonato e Vitamina D3 Aurobindo should be taken at least 3 hours after bisphosphonates and sodium fluoride;

• tetracyclines for the treatment of bacterial infections. In this case, tetracyclines should be taken at least 2 hours before or 4–6 hours after taking Calcio Carbonato e Vitamina D3 Aurobindo;

• orlistat for the treatment of obesity, ion-exchange resins such as cholestyramine used to reduce cholesterol levels in blood, laxatives such as liquid paraffin which increase fecal elimination, phenytoin and barbiturates for the treatment of epilepsy,
  as they may reduce the effectiveness of Calcio Carbonato e Vitamina D3 Aurobindo;

• thiazide diuretics which increase urine elimination (thiazide diuretics), as your doctor must periodically monitor calcium levels in blood and urine;

• corticosteroids for the treatment of infections and allergies, as they reduce the effectiveness of Calcio Carbonato e Vitamina D3 Aurobindo and a higher dose may be needed;

• medicines containing iron, zinc, and strontium ranelate, as Calcio Carbonato e Vitamina D3 Aurobindo reduces their effectiveness. In this case, these products should be taken at least 2 hours apart from Calcio Carbonato e Vitamina D3 Aurobindo;

• estramustine for the treatment of prostate cancer and hormones used for thyroid disorders (thyroid hormones such as levothyroxine), as it is recommended to take Calcio Carbonato e Vitamina D3 Aurobindo at least 2 hours after taking these medicines.

Calcio Carbonato e Vitamina D3 Aurobindo with food
Take this medicine only after at least 2 hours have passed since consuming foods such as spinach, rhubarb, and whole grains.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Calcio Carbonato e Vitamina D3 Aurobindo must not be used during pregnancy or while breastfeeding.
Vitamin D and its derivatives pass into breast milk. Your doctor should consider this information if additional vitamin D is to be given to your baby.

Driving and using machines
Although no data are available, it is unlikely that Calcio Carbonato e Vitamina D3 Aurobindo affects the ability to drive or use machines.

Calcio Carbonato e Vitamina D3 Aurobindo contains aspartame
This medicine contains aspartame, a source of phenylalanine. It may be harmful if you have phenylketonuria.

3. How to take Calcium Carbonate and Vitamin D3 Aurobindo

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 sachet per day.
Take the medicine preferably after meals.
Pour the contents of the sachet into a glass, add a generous amount
of water, stir, and then drink the resulting solution immediately.

If you take more Calcium Carbonate and Vitamin D3 Aurobindo than you should
After taking an excessive dose of this medicine, calcium levels in the blood (hypercalcemia) or in the urine (hypercalciuria) may increase, as well as vitamin levels (hypervitaminosis). This may lead to the following symptoms: loss of appetite (anorexia), nausea, vomiting, thirst, even excessive thirst (polydipsia), excessive need to urinate (polyuria), constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, bone pain, kidney stones (nephrocalcinosis, kidney stones), and in more severe cases, disturbances in the heart rhythm (cardiac arrhythmias). If you take this medicine in high doses for prolonged periods (chronic overdose), increased calcium levels in the blood (hypercalcemia) may occur, which could lead to irreversible kidney damage, calcification of soft tissues, profound unconsciousness (coma), and death.
Your doctor will determine the most appropriate treatment depending on the severity of symptoms.
In case of accidental ingestion or overdose of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital without delay. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D, and cardiac glycosides should also be discontinued.

If you forget to take Calcium Carbonate and Vitamin D3 Aurobindo
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:

Uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the urine (hypercalciuria) and in the blood (hypercalcemia).

Rare (may affect up to 1 in 1,000 people)

• constipation;
• flatulence;
• nausea;
• stomach pain (gastralgia);
• diarrhoea;
• itching;
• skin irritations (rash, urticaria);
  allergic reactions (hypersensitivity).

Additionally, in people with kidney problems (renal impairment), there is a higher risk of changes in specific blood test results (hyperphosphataemia) and kidney stones (nephrolithiasis and nephrocalcinosis). See section “Warnings and precautions”.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calcium Carbonate and Vitamin D3 Aurobindo

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 packaging after
“EXP.”.
The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Calcio Carbonato e Vitamina D3 Aurobindo contains

• The active substances are calcium carbonate and colecalciferol. Each sachet contains 2500 mg of calcium carbonate (equivalent to 1000 mg of calcium) and 880 IU of colecalciferol (vitamin D3).
• The other components are: citric acid, aspartame, sodium saccharin, orange flavour, maltodextrin, orange yellow S.

Description of the appearance of Calcio Carbonato e Vitamina D3 Aurobindo and contents of the
pack
Pack containing 30 effervescent granulate sachets.
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l., Via San Giuseppe 102, 21047 Saronno (VA)
Manufacturer
LA.FA.RE. S.r.L. - Via Sac. Benedetto Cozzolino, 77 - 80056 Ercolano (NA)