CALCIO 1000 mg + 880 U.i. Granulki Musujące
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Treść ulotki
- Calcio Carbonato e Vitamina D3 Aurobindo 1000 mg + 880 U.I. effervescent granules
- What is Calcio Carbonato e Vitamina D3 AurobindoCALCIO and what is it used for
- What you need to know before taking Calcium Carbonate and Vitamin D3 Aurobindo
- How to take Calcio Carbonato e Vitamina D3 Aurobindo
- Possible side effects
- How to store Calcio Carbonato e Vitamina D3 Aurobindo
- Contents of the pack and other information
Calcio Carbonato e Vitamina D3 Aurobindo 1000 mg + 880 U.I. effervescent granules
Generic medicine
Read this 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is Calcio Carbonato e Vitamina D3 AurobindoCALCIO and what is it used for
Calcio Carbonato e Vitamina D3 Aurobindo contains two active ingredients: calcium carbonate and
vitamin D3 (cholecalciferol). Calcium is an important element for the correct 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,
contributing to making bones strong.
This medicine is indicated for the treatment of calcium and vitamin D deficiency in the blood,
particularly in elderly people or those who suffer from or are at risk of a disease that causes a
weakening of the bones (osteoporosis).
2. What you need to know before taking Calcium Carbonate and Vitamin D3 Aurobindo
Do not take Calcium Carbonate and Vitamin 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 the blood (hypercalcemia) or in the urine (hypercalciuria) or suffer from certain bone diseases or parathyroid gland diseases that can increase them (myeloma and bone metastases, primary hyperparathyroidism);
- if you are confined to bed for a long period (prolonged immobilization) accompanied by high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria);
- if you suffer from kidney problems (renal insufficiency);
- if you have kidney stones (nephrolithiasis and nephrocalcinosis, calcium lithiasis);
- if you have high levels of vitamin D in the blood (hypervitaminosis D);
- if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
- if you have high amounts of a substance called phenylalanine in your blood (phenylketonuria) (see section “Calcium Carbonate and Vitamin D3 Aurobindo contains aspartame”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Calcium Carbonate and Vitamin D3
Aurobindo.
Take this medicine with caution and inform your doctor in the following cases:
- if the levels of calcium in your blood or urine are high (hypercalcemia, hypercalciuria), or if you suffer from kidney problems (renal insufficiency). In these cases, your doctor may decide to reduce the dose of medicine to be taken or to stop treatment (see section 4 “Possible side effects”).;
- if you are taking other medicines or foods that contain vitamin D. The doctor may adjust the dose of the medicine;
- if you are taking supplements that contain calcium and/or vitamin D. In this case, the doctor must check the levels of calcium in the blood and urine;
- if you suffer from a disease called sarcoidosis, characterized by cough, associated with bleeding, and difficulty breathing. In this case, the doctor must periodically check the levels of calcium in the blood and urine.
If you suffer from kidney disorders (renal insufficiency), during treatment with this medicine,
your doctor must subject you to specific checks (calcium and phosphate homeostasis), as you may
experience an altered vitamin D metabolism.
If you take Calcium Carbonate and Vitamin D3 Aurobindo for prolonged periods of time, your doctor
must check the levels of calcium in the blood and urine and the function of your kidneys (measurement
of creatinine levels in the blood). These checks are particularly important in
elderly people (See section “Elderly”).
Children and adolescents
This medicine is not recommended in children and adolescents.
Elderly
If you are elderly and are being treated with medicines used for heart problems (cardiac glycosides) or
that facilitate the elimination of urine (diuretics), your doctor must carefully check
the levels of calcium in the blood and urine and the function of your kidneys. These checks are
necessary especially if you take Calcium Carbonate and Vitamin D3 Aurobindo for prolonged
periods of time.
Other medicines and Calcium Carbonate and Vitamin D3 Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Tell your doctor if you are taking the following medicines:
- cardiac glycosides for the treatment of some heart problems, as the risk of developing heart rhythm disturbances (arrhythmia) is greater. In this case, the doctor must check your heart activity (electrocardiographic monitoring) and the levels of calcium in the blood;
- bisphosphonates and sodium fluoride for the treatment of some bone diseases, fluoroquinolones for infections caused by bacteria, as Calcium Carbonate and Vitamin D3 Aurobindo reduces their effectiveness. In these cases, you must take Calcium Carbonate and Vitamin D3 Aurobindo at least 3 hours after taking bisphosphonates and sodium fluoride;
- tetracyclines for the treatment of infections caused by bacteria. In this case, tetracyclines must be taken at least 2 hours before or 4-6 hours after taking Calcium Carbonate and Vitamin D3 Aurobindo;
- orlistat for the treatment of obesity, ion exchange resins, such as cholestyramine, used to reduce cholesterol levels in the blood, laxatives, such as paraffin oil, which
increase the elimination of feces, phenytoin and barbiturates for the treatment of epilepsy,
as they can reduce the effectiveness of Calcium Carbonate and Vitamin D3 Aurobindo;
- thiazide diuretics that facilitate the elimination of urine, as your doctor needs to periodically check the levels of calcium in the blood and urine;
- corticosteroids for the treatment of infections and allergies, as they reduce the effectiveness of Calcium Carbonate and Vitamin D3 Aurobindo and it may be necessary to increase the dose;
- medicines that contain iron, zinc and strontium ranelate, as Calcium Carbonate and Vitamin D3 Aurobindo reduces their effectiveness. In this case, you must take these products at least 2 hours apart from Calcium Carbonate and Vitamin 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 Calcium Carbonate and Vitamin D3 Aurobindo after at least 2 hours have passed since taking these medicines.
Calcium Carbonate and Vitamin D3 Aurobindo with food
Take this medicine only after 2 hours have passed since ingesting foods such as
spinach, rhubarb and whole grains.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Calcium Carbonate and Vitamin D3 Aurobindo should not be used if you are pregnant or if you
are breastfeeding with breast milk.
Vitamin D and its derivatives pass into breast milk. The doctor must consider this
information in case of additional vitamin D administration to your baby.
Driving and operating machinery
Although no data are available, it is unlikely that Calcium Carbonate and Vitamin D3
Aurobindo will impair the ability to drive vehicles or operate machinery.
Calcium Carbonate and Vitamin D3 Aurobindo contains aspartame
This medicine contains aspartame, a source of phenylalanine. It may be harmful if you
have phenylketonuria.
3. How to take Calcio Carbonato e Vitamina D3 Aurobindo
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask 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 large amount of water, mix and then drink the resulting solution immediately
If you take more Calcio Carbonato e Vitamina D3 Aurobindo than you should
Following the intake of an excessive dose of this medicine, an increase in calcium levels in the blood (hypercalcemia) or in the urine (hypercalciuria) and hypervitaminosis (increased levels of vitamins) may occur. The following symptoms may therefore manifest: loss of appetite (anorexia), nausea, vomiting, thirst, even intense (polydipsia), excessive need to urinate (polyuria), constipation (constipation), abdominal pain, muscle weakness, fatigue, mental disorders, bone pain, kidney stones (nephrocalcinosis, kidney stones) and, in more severe cases, disturbances of the heart rhythm (cardiac arrhythmias). If you take this medicine at high doses and for long periods of time (chronic overdose), an increase in calcium levels in the blood (hypercalcemia) may occur, which can lead to irreversible kidney damage and calcification of soft tissues and cause a profound state of unconsciousness (coma) and death.
The doctor will establish the most appropriate therapy based on the severity of the symptoms.
In case of ingestion/intake of an excessive amount of this medicine, stop the treatment and immediately consult your doctor or the nearest hospital. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued.
If you forget to take Calcio Carbonato e Vitamina D3 Aurobindo
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody 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);
- diarrhea;
- itching;
- skin irritations (rash, urticaria). allergic reactions (hypersensitivity),
In addition, in people with kidney problems (kidney damage) there is an increased risk of an alteration of the
results of specific blood tests (hyperphosphatemia) and of stones at the level of the kidneys (nephrolithiasis
and nephrocalcinosis). See the paragraph “Warnings and precautions”.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at: 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 Calcio Carbonato e Vitamina D3 Aurobindo
Keep this medicine out of the sight and reach of children.
Do not take this medicine afterthe expiry datethat is stated on thepack after
“EXP.”.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in 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
WhatCalcio Carbonato e Vitamina D3 Aurobindo contains
- The active ingredients are calcium carbonate and cholecalciferol. Each sachet contains 2500 mg of calcium carbonate (equivalent to 1000 mg of calcium) and 880 I.U. of cholecalciferol (vitamin D3).
- The other ingredients are: citric acid, aspartame, sodium saccharin, orange flavour, maltodextrin, Sunset Yellow FCF.
Description of the appearance of Calcio Carbonato e Vitamina D3 Aurobindo and pack contents
Pack of 30 sachets of effervescent granules.
Marketing Authorisation 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)
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- Kraj rejestracji
- Postać farmaceutycznaEffervescent granules, 1000 MG + 880 U.I.
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KALKIO KARBONATO E VITAMINA D3 AUROBINDOPostać farmaceutyczna: Coated tablet, 1000 MGSubstancja czynna: calcium carbonateProducent: THERAMEX IRELAND LIMITEDWymaga receptyPostać farmaceutyczna: Injectable solution, 10 %Substancja czynna: calcium gluconateProducent: B. BRAUN MELSUNGEN AGWymaga receptyPostać farmaceutyczna: Injectable solution, 500 MG/5 MLSubstancja czynna: calcium gluconateWymaga recepty
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