Calcium carbonate vitamin d3 Eg

ANNEX
The changes concerning the medicinal product Calcio Carbonato Vitamina D3 EG, with
application code N1B/2015/2657, referred to in this notification, are reported below.
The current PATIENT LEAFLET is amended as follows:
Package leaflet: Information for the user

CALCIO CARBONATO VITAMINA D3 EG 1000 mg + 880 I.U. 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, because it could 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 VITAMINA D3 EG is and what it is used for
2. What you need to know before taking CALCIO CARBONATO VITAMINA D3 EG
3. How to take CALCIO CARBONATO VITAMINA D3 EG
4. Possible side effects
5. How to store CALCIO CARBONATO VITAMINA D3 EG
6. Contents of the pack and other information

1. What CALCIO CARBONATO VITAMINA D3 EG is and what it is used for

CALCIO CARBONATO VITAMINA D3 EG 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 helps maintain normal levels of calcium and phosphate in the blood, contributing to strong bones.
This medicinal product is indicated for the treatment of calcium and vitamin D3 deficiency in the blood in elderly people or in patients suffering from a disease causing bone weakening (osteoporosis) who are already undergoing treatment, or in patients at high risk of such deficiency.

2. What you should know before taking CALCIO CARBONATO VITAMINA D3 EG

Do not take CALCIO CARBONATO VITAMINA D3 EG

• 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 levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
• if you have kidney problems (renal failure);
• if you have kidney stones (nephrolithiasis, calcium lithiasis);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);
• if you have phenylketonuria, a disease causing increased levels of phenylalanine in the blood (See section “CALCIO CARBONATO VITAMINA D3 EG contains aspartame”).

Warnings and precautions
Talk to your doctor or pharmacist before taking CALCIO CARBONATO VITAMINA D3 EG.
Take this medicine with caution and inform your doctor in the following cases:

• if your calcium levels in blood or urine are high (hypercalcemia, hypercalciuria). In this case, your doctor may decide whether to reduce the dose or discontinue treatment;
• if you have kidney problems (renal failure). In such cases, your doctor may decide to monitor you during treatment, prescribe a more suitable therapy, or, if necessary, discontinue treatment;
• if you are taking other medicines, foods, or supplements containing calcium and vitamin D. In this case, your doctor must periodically monitor calcium levels in your blood and urine;
• if you suffer from a disease called sarcoidosis, characterized by coughing with bleeding and difficulty breathing. In this case, your doctor must periodically monitor calcium levels in your blood and urine.

If you take CALCIO CARBONATO VITAMINA D3 EG for prolonged periods, your doctor must monitor calcium levels in your blood and urine and your kidney function (measurement of creatinine levels in blood). These checks are particularly important if you are elderly or already being treated with diuretics or cardiac glycosides.

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

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

• digitalis for the treatment of certain heart conditions, as the risk of developing heart rhythm disorders (arrhythmias) is higher. In this case, your doctor must monitor your heart activity (electrocardiographic monitoring) and calcium levels in blood;
• phenytoin or barbiturates, medicines used to treat seizures, as they may reduce the effect of vitamin D3;
• bisphosphonates and sodium fluoride used to treat certain bone diseases, as CALCIO CARBONATO VITAMINA D3 EG reduces their effectiveness. In these cases, CALCIO CARBONATO VITAMINA D3 EG should be taken at least 3 hours after these medicines;
• tetracyclines used to treat bacterial infections. In this case, tetracyclines should be taken at least 3 hours before taking CALCIO CARBONATO VITAMINA D3 EG;
• thiazide diuretics, which promote urine elimination (thiazide diuretics), as your doctor must periodically monitor calcium levels in blood;
• corticosteroids used to treat infections and allergies, as they reduce the effectiveness of CALCIO CARBONATO VITAMINA D3 EG and a higher dose may be required.

CALCIO CARBONATO VITAMINA D3 EG with food
Interactions may occur with 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.

Pregnancy
Do not take CALCIO CARBONATO VITAMINA D3 EG if you are pregnant.

Breastfeeding
Since CALCIO CARBONATO VITAMINA D3 EG passes into breast milk, do not take it if you are breastfeeding.

Driving and using machines
Although no data are available, it is unlikely that CALCIO CARBONATO VITAMINA D3 EG affects your ability to drive or operate machinery.

CALCIO CARBONATO VITAMINA D3 EG contains aspartame
This medicine contains a source of phenylalanine. It may be harmful if you have phenylketonuria.

CALCIO CARBONATO VITAMINA D3 EG contains sunset yellow FCF (E110)
It may cause allergic reactions.

3. How to take CALCIO CARBONATO VITAMINA D3 EG

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.
Dissolve the contents of the sachet in a glass of water, stir and drink immediately.
Take this medicine preferably after meals.
If you take more CALCIO CARBONATO VITAMINA D3 EG than you should
If you have taken or ingested an excessive amount of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital.
Following an overdose of this medicine, the following symptoms may occur: nausea, vomiting, thirst (polydipsia), excessive need to urinate (polyuria), constipation, fluid loss (dehydration), and formation of calcium deposits in organs and in the blood.
The doctor will determine the most appropriate treatment depending on the severity of the symptoms.
If you forget to take CALCIO CARBONATO VITAMINA D3 EG
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 can cause side effects, although not everybody will experience them.
The following side effects 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);
• Increased levels of phosphate in the blood (hyperphosphatemia), kidney stones (nephrolithiasis and nephrocalcinosis) in patients with kidney problems.

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/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CALCIO CARBONATO VITAMINA D3 EG

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 and protect from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CALCIO CARBONATO VITAMINA D3 EG 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 I.U. of colecalciferol.
• The other components are: citric acid, aspartame, sodium saccharin, orange flavour, maltodextrin, orange yellow S (E110).

Description of the appearance of CALCIO CARBONATO VITAMINA D3 EG and contents of the pack
Carton pack containing 30 sachets.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 20136 – MILAN
Manufacturer
E-Pharma Trento S.p.A. Frazione Ravina Via Provina, 2 – 38123 Trento (TN)