Patient Information Leaflet: Information for the User

Calcio carbonato + Vitamina D3 ABC 1000 mg / 880 IU effervescent granules

Calcium carbonate and colecalciferol
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist, or nurse has told you to do.

Keep this leaflet. You may need to read it again.
If you need more information or advice, contact your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

What Calcio carbonato + Vitamina D3 ABC is and what it is used for
What you need to know before taking Calcio carbonato + Vitamina D3 ABC
How to take Calcio carbonato + Vitamina D3 ABC
Possible side effects
How to store Calcio carbonato + Vitamina D3 ABC
Contents of the pack and other information

1. What Calcio carbonato + vitamina D3 ABC is and what it is used for

Calcio carbonato + vitamina D3 ABC contains the active substances calcium carbonate and colecalciferol (vitamin D3).
This medicinal product is used for the treatment of calcium and vitamin D deficiency in the elderly. It is also used in combination with osteoporosis therapies in patients with deficiency or at high risk of concomitant deficiency of vitamin D and calcium.

2. What you need to know before taking Calcio carbonato + vitamina D3 ABC

Do not take Calcio carbonato + vitamina D3 ABC

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you have diseases and/or are prone to conditions that may lead to high levels of calcium in the urine (hypercalciuria) or in the blood (hypercalcemia);
if the level of vitamin D in your blood is too high (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Calcio carbonato + vitamina D3 ABC

if you have impaired kidney function or if you are prone to developing kidney stones. Your treatment should be closely monitored if your kidneys are not functioning properly to ensure adequate calcium levels in your blood;
if you have sarcoidosis (an inflammatory disease of unknown origin, characterized by the formation of granulomas in various organs);
if you are an immobilized patient suffering from osteoporosis; if you are taking other medicines containing vitamin D or calcium carbonate.

If you are undergoing long-term treatment, your doctor may periodically wish to check calcium levels in your blood and request a urine sample to monitor kidney function. Based on the results, your doctor may reduce the dosage or decide to discontinue treatment.

Children and adolescents
This medicine is not intended for use in children.

Other medicines and Calcio carbonato + vitamina D3 ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Consult your doctor if you are taking any of the following medicines:

heart medications such as digoxin or other cardiac glycosides;
bisphosphonates or sodium fluoride (medicines used to treat bone disorders);
thiazide diuretics;
phenytoin or barbiturates (medicines used to treat epilepsy);
glucocorticosteroids;
tetracycline antibiotics (tetracyclines);
other medicines containing vitamin D or calcium.

Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least two hours before or after Calcio carbonato + vitamina D3 ABC.

Calcio carbonato + vitamina D3 ABC with food and alcohol
This medicine may interact with certain foods containing oxalic acid (e.g. spinach and rhubarb), phosphates (e.g. bran), or phytic acid (e.g. whole grains), as these may reduce the absorption of calcium contained in Calcio carbonato + vitamina D3 ABC.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Due to its high vitamin D content, this dosage is not recommended during pregnancy and breastfeeding.
In pregnant women, excessive intake of calcium and vitamin D must be avoided, as persistent hypercalcemia is associated with adverse effects on fetal development.
Calcio carbonato + vitamina D3 ABC may be used during breastfeeding, but your doctor should be informed, as calcium and vitamin D pass into breast milk.
This should be taken into account when administering vitamin D supplements to the infant.

Driving and using machines
Calcio carbonato + vitamina D3 ABC is not expected to affect your ability to drive or operate machinery.

Calcio carbonato + vitamina D3 ABC contains aspartame
This medicine contains 40 mg of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.

Calcio carbonato + vitamina D3 ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.

Calcio carbonato + vitamina D3 ABC contains Sunset Yellow FCF (E110)
May cause allergic reactions.

3. How to take Calcio carbonato + vitamina D3 ABC

Take this medicine exactly as described in this leaflet, or as your doctor, pharmacist, or nurse has told you. If you are unsure, consult your doctor, pharmacist, or nurse.

Adults
Empty the contents of the sachet into a glass, add a generous amount of water, stir and drink immediately after effervescence has finished, preferably after meals. The recommended dose is one sachet per day.
Your doctor or pharmacist will tell you how many sachets to take each day.

If you take more Calcio carbonato + vitamina D3 ABC than you should
Taking an excessive dose of this medicine may cause the following symptoms: nausea, vomiting, intense thirst, increased frequency of urination, constipation.
If any of these adverse effects occur, contact your doctor immediately and take the necessary precautionary measures.

If you forget to take Calcio carbonato + vitamina D3 ABC
Do not take a double dose to make up for the missed dose.

If you stop taking Calcio carbonato + vitamina D3 ABC
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may experience an allergic reaction. If you develop skin rash, itching, difficulty breathing, or
swelling of the face, lips, throat or tongue, you must stop taking this medicine immediately and
seek urgent medical assistance.

Uncommon (may affect up to 1 in 100 people)

High blood calcium levels (hypercalcemia). Symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, extreme thirst, increased need to urinate, muscle weakness, drowsiness, and confusion;
Increased calcium levels in urine (hypercalciuria).

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

Constipation, flatulence, nausea, abdominal pain, diarrhoea;
Itching, rash, and urticaria.

Not known (frequency cannot be estimated from the available data)

Hypersensitivity reactions such as angioedema or laryngeal edema;
Milk-alkali syndrome, associated with high blood calcium levels (hypercalcemia), elevated blood pH (alkalosis), and renal failure.

Additionally, in people with kidney problems (renal failure), there is a higher risk of abnormal results in specific blood tests (hyperphosphatemia) and kidney stones (nephrolithiasis and nephrocalcinosis).
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 website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calcium carbonate + vitamin D3 ABC

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.
Keep the container tightly closed and store it at a temperature below 25 °C 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 + vitamina D3 ABC 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 flavour, maltodextrin, orange yellow S.
Description of the appearance of Calcio carbonato + vitamina D3 ABC and contents of the pack
Pack containing 30 effervescent granulate sachets.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino
Manufacturer
LA. FA. RE. S.r.l. – Via Sac. Benedetto Cozzolino, 77 – 80056 Ercolano (NA)