Calcium carbonate and vitamin d3 Doc Generici

Patient information leaflet

CALCIO CARBONATO e VITAMINA D DOC Generici 1000 mg + 880 U.I. effervescent granules

Calcium carbonate and colecalciferol
Equivalent medicine
Read this entire leaflet carefully before taking this medicine, as 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What CALCIO CARBONATO e VITAMINA D3 DOC Generici is and what it is used for
2. What you need to know before taking CALCIO CARBONATO e VITAMINA D3 DOC Generici
3. How to take CALCIO CARBONATO e VITAMINA D3 DOC Generici
4. Possible side effects
5. How to store CALCIO CARBONATO e VITAMINA D3 DOC Generici
6. Contents of the pack and other information

1. What CALCIO CARBONATO e VITAMINA D3 DOC Generici is and what it is used for

CALCIO CARBONATO e VITAMINA D3 DOC Generici contains two active substances: calcium carbonate and vitamin D3 (colecalciferol).
This medicinal product is indicated for the treatment of calcium and vitamin D3 deficiency in the blood in elderly people; in individuals suffering from a disease causing bone weakening (osteoporosis) or those predisposed to this type of deficiency.

2. What you need to know before taking CALCIO CARBONATO e VITAMINA D3 DOC Generici

Do not take CALCIO CARBONATO e VITAMINA D3 DOC Generici

• 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);
• if you are confined to prolonged bed rest (prolonged immobilization) and have elevated calcium levels in your blood (hypercalcemia) or urine (hypercalciuria);
• if you have kidney problems (renal failure);
• if you have kidney stones (nephrolithiasis or calcium lithiasis);
• if you have phenylketonuria, a disease causing increased levels of phenylpyruvate in the urine and phenylalanine in the blood (see section "CALCIO CARBONATO e VITAMINA D3 DOC Generici contains aspartame");
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding");
• if the person to be given the medicine is a child or adolescent under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking CALCIO CARBONATO e VITAMINA D3 DOC Generici:

• if you are taking other medicines, foods, or supplements containing calcium and vitamin D. In this case, your doctor should check calcium levels in your blood and urine once a week;
• if you have kidney problems, even severe ones (severe renal failure). In this case, your doctor may decide to monitor you closely during treatment or prescribe another therapy more suitable for you;
• if you suffer from a disease called sarcoidosis, characterized by coughing, sometimes with bleeding, and difficulty breathing. In such cases, your doctor must periodically check calcium levels in your blood and urine.

Even if you take CALCIO CARBONATO e VITAMINA D3 DOC Generici for prolonged periods, your doctor must check calcium levels in your blood and urine and your kidney function (measurement of creatinine levels in the blood). These checks are particularly important in elderly people (see section “Elderly”).

Children and adolescents
This medicine is contraindicated in children and adolescents.

Elderly
If you are elderly and are being treated with medicines used for heart problems (cardiac glycosides) or medicines that increase urine elimination (diuretics), your doctor must carefully monitor calcium levels in your blood and urine and your kidney function. These checks are necessary especially if you take CALCIO CARBONATO e VITAMINA D3 DOC Generici for prolonged periods.

Other medicines and CALCIO CARBONATO e VITAMINA D3 DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Take CALCIO CARBONATO e VITAMINA D3 DOC Generici with caution and inform your doctor if you are taking the following medicines:

• digitalis, medicines used to treat certain heart conditions, because the risk of developing heart rhythm disturbances (arrhythmia) is higher. In this case, your doctor must monitor your heart activity (electrocardiographic monitoring) and calcium levels in your blood;
• bisphosphonates and sodium fluoride used to treat certain bone diseases, because CALCIO CARBONATO e VITAMINA D3 DOC Generici reduces their effectiveness. In these cases, you must take CALCIO CARBONATO e VITAMINA D3 DOC Generici at least 3 hours before or 3 hours after taking these medicines;
• tetracyclines used to treat bacterial infections. In this case, tetracyclines should be taken at least 3 hours before taking CALCIO CARBONATO e VITAMINA D3 DOC Generici;
• thiazide diuretics, which increase urine elimination (thiazide diuretics), because your doctor must periodically check calcium levels in your blood;
• corticosteroids, used to treat infections and allergies, phenytoin, used to treat epilepsy, and barbiturates, sedative medicines, because they reduce the effectiveness of CALCIO CARBONATO e VITAMINA D3 DOC Generici and it may be necessary to increase the dose.

CALCIO CARBONATO e VITAMINA D3 DOC Generici with food
Interactions may occur with certain foods (e.g., those containing oxalic acid, phosphate, phytic acid, or high fiber content). Take this medicine only after at least two 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, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
CALCIO CARBONATO e VITAMINA D3 DOC Generici is contraindicated during pregnancy.
This medicine must not be taken if you are breastfeeding, as it passes into breast milk.

Driving and using machines
Although no data are available, it is unlikely that CALCIO CARBONATO e VITAMINA D3 DOC Generici affects the ability to drive or use machinery.

CALCIO CARBONATO e VITAMINA D3 DOC Generici contains aspartame and sunset yellow
This medicine contains a source of phenylalanine. It may be harmful if you have phenylketonuria.
This medicine contains sunset yellow, which may cause allergic reactions.

3. How to take CALCIO CARBONATO e VITAMINA D3 DOC Generici

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 effervescent sachet per day.
Dissolve the contents of the sachet in a glass of water and drink immediately.
If you take more CALCIO CARBONATO e VITAMINA D3 DOC Generici than you should
Following an overdose of this medicine, the following symptoms may occur: nausea, vomiting, thirst (polydipsia), excessive need to urinate (polyuria), constipation, fluid loss (dehydration). Due to chronic overdose, calcium deposits may form in organs and in the blood, which could lead to coma and death.
Your doctor will determine the most appropriate treatment depending on the severity of the symptoms.
If you have taken/ingested more than the prescribed amount of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital.
If you forget to take CALCIO CARBONATO e VITAMINA D3 DOC Generici
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody will experience them.
The following adverse reactions may occur:
Frequency not known (frequency cannot be estimated from the available data)

• flatulence;
• constipation;
• nausea;
• stomach pain (gastralgia);
• diarrhoea;
• increased levels of calcium in the urine (hypercalciuria) and in the blood (hypercalcemia), in case of high-dose use;
• increased phosphate levels in the blood (hyperphosphatemia), kidney stones (nephrolithiasis), kidney damage due to accumulation of calcium salts (nephrocalcinosis). This may occur in individuals with kidney problems.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CALCIO CARBONATO e VITAMINA D3 DOC Generici.

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 the container tightly closed, at a temperature not exceeding 25°C, protected 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 DOC Generici 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 (equivalent to 22 \μg of vitamin D).
• The other components are: citric acid, aspartame, sodium saccharin, orange flavouring, maltodextrin, orange yellow S.

Description of the appearance of CALCIO CARBONATO e VITAMINA D3 DOC Generici and contents of the pack
Pack containing 30 effervescent granulate sachets.
Marketing Authorization Holder
DOC Generici Srl – Via Turati 40 – 20121 Milano
Manufacturer
LA.FA.RE. S.r.l. – Via Sac. Benedetto Cozzolino 77 - 80056 Ercolano (NA)