Eurocal D3: detailed information

Package leaflet: Information for the user

Eurocal D3 500 mg + 440 IU Effervescent Granules

Calcium carbonate + Colecalciferol
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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Eurocal D3 is and what it is used for

Eurocal D3 contains the active substances calcium carbonate (a mineral salt) and colecalciferol (vitamin D3).
Eurocal D3 is indicated for the treatment of vitamin D and calcium deficiencies in elderly patients.
Eurocal D3 is also indicated for the treatment of osteoporosis (a disease causing thinning of the bones, leading to fractures) in patients at risk of concomitant deficiency of vitamin D and calcium.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Eurocal D3

Do not take Eurocal D3

If you are allergic to calcium carbonate, colecalciferol, or any of the other ingredients of this medicine (listed in section 6).
If you are immobilized for a prolonged period, especially in combination with high levels of calcium in urine or blood.
If you suffer from kidney stones.
If blood tests have shown high levels of calcium in your blood.
If urine tests have shown high levels of calcium.

Eurocal D3 must not be used in children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Eurocal D3.

During long-term treatment, it is advisable to monitor serum and urinary calcium levels as well as renal function. It is recommended to reduce or temporarily discontinue treatment if urinary calcium excretion exceeds 7.5 mmol in 24 hours (300 mg in 24 hours).
If you are taking concomitant treatment with digitalis, bisphosphonates, sodium fluoride, thiazide diuretics, or tetracyclines: see section "Other medicines and Eurocal D3".
Take into account the vitamin D dose per dosage unit (440 IU) and any other prescribed vitamin D supplements.
Additional administration of vitamin D or calcium should be carried out under strict medical supervision. In such cases, weekly monitoring of serum and urinary calcium levels is absolutely necessary.
This medicine should be prescribed with caution if you have sarcoidosis (a chronic inflammatory disease affecting multiple organs), due to the possible increase in vitamin D levels. In such patients, monitoring of blood and urine calcium levels is required.
This medicine should be used with caution if you have renal insufficiency, and effects on calcium and phosphate concentrations should be monitored.

Children
Eurocal D3 must not be used in children.
Other medicines and EUROCAL D3
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
This is particularly important if you are already taking:

Heart medications such as digoxin or other cardiac glycosides.
Tetracycline antibiotics such as doxycycline, demeclocycline, etc.
Thiazides, medications used to increase urine elimination, also known as diuretics.
Medications for bone disorders, such as bisphosphonates and sodium fluoride.
Medications for epilepsy, such as phenytoin and barbiturates.
Medications for treating inflammation, such as steroids.
Estramustine, a medicine used in the treatment of cancer.
Levothyroxine, a thyroid hormone used to treat thyroid disorders.
Medicines containing strontium.

Eurocal D3 with food and drink
Foods containing oxalic acid (e.g. spinach, rhubarb, beans), phosphates (e.g. ham, sausages, and spreadable cheese), or phytic acid (e.g. raw beans, seeds, nuts, bran, cereals, soy protein isolates) may reduce calcium absorption. You should not take Eurocal D3 within two hours after consuming foods rich in oxalic acid or phytic acid.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnant or breastfeeding women may take Eurocal D3 500 mg + 440 IU provided that the daily intake does not exceed 1500 mg of calcium and 600 IU of vitamin D3.
Driving and using machines
Eurocal D3 is not expected to affect your ability to drive or use machinery.
EUROCAL D3 contains:

Sorbitol If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Sucrose If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Potassium Contains 81.5 mg of potassium per dose. This should be taken into consideration in patients with reduced renal function or those on a low-potassium diet.
Vegetable oils Do not use this medicine if you are allergic to peanuts or soy.
Sodium This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.

3. How to take EUROCAL D3

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 or 2 sachets per day. Your doctor or pharmacist will tell you how many sachets you need to take each day.
Pour the contents of the sachet into a glass, add a large amount of water, mix, and immediately drink the solution.
Use in children
EUROCAL D3 must not be used in children.
If you take more EUROCAL D3 than you should
Do not exceed the recommended dose. If you take too much medicine, stop taking calcium and vitamin D, start rehydration, and immediately contact your doctor or go to the nearest emergency department (if possible, bring the package with you).
Symptoms of overdose may include nausea, vomiting, thirst, polydipsia (excessive thirst), polyuria (frequent urination), constipation.
In addition, you may develop milk-alkali syndrome (characterized by high levels of calcium in the blood). This condition may occur if you take too much medicine. Contact your doctor immediately or proceed as described above, as your kidneys may no longer function properly. Symptoms include frequent urge to urinate, persistent headache, persistent loss of appetite, nausea or vomiting, unusual tiredness or weakness. Blood tests may show hypercalcemia (high levels of calcium in the blood) and alkalosis (blood pH higher than normal).
If you forget to take EUROCAL D3
If you forget a dose, take the next dose as soon as you remember, and continue taking the medicine as before. Do not take a double dose to make up for a forgotten 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 gets them.
For all the side effects listed below, the frequency cannot be determined from the available data:

Sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if affecting the whole body) must be reported to the doctor immediately.
Dental lesions
Constipation
Flatulence (passing gas from the intestine)
Nausea
Stomach pain
Diarrhoea
Itching, skin rash
Kidney stones
Formation of calcium deposits in the kidneys
Milk-alkali syndrome (characterised by frequent urge to urinate, persistent headache, persistent loss of appetite, nausea or vomiting, unusual tiredness or weakness, usually observed in cases of overdose)

Some additional side effects may only be detected by a doctor, including:

Excessive urinary excretion of calcium, detected by urine analysis
Exceptionally high calcium levels, detected by blood analysis
Exceptionally high potassium levels, detected by blood analysis

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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 Eurocal D3

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Eurocal D3 contains

The active substances are calcium carbonate and colecalciferol. Each 4 g sachet contains 1250 mg of calcium carbonate (equivalent to 500 mg of calcium or 12.5 mmol of calcium) and 440 IU of colecalciferol (equivalent to 11 µg of Vitamin D3). The amount of sodium per sachet is 5 mg or 0.22 mmol.
The other components are: citric acid, malic acid, gluconolactone, maltodextrin, sodium cyclamate, sodium saccharin, lemon flavour (containing: sorbitol, mannitol, D-gluconolactone, dextrin, gum arabic, lemon essence), rice starch, potassium carbonate, α-tocopherol, vegetable oils, gelatin, sucrose, maize starch.

Description of the appearance of Eurocal D3 and package contents
Sachets (paper/aluminum/polyethylene) of 4 g;
Eurocal D3 500 mg / 440 IU, effervescent granules - 30 sachets
Eurocal D3 500 mg / 440 IU, effervescent granules - 46 sachets
Marketing Authorisation Holder and Manufacturer
Amdipharm Ltd - 3 Burlington Road - Dublin 4 Temple Chambers - Ireland

Package leaflet: Information for the user

Eurocal D3 1000 mg + 880 IU Effervescent Granules

effervescent
calcium carbonate + colecalciferol
Please 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Eurocal D3 is and what it is used for

Eurocal D3 contains the active substances calcium carbonate (a mineral salt) and colecalciferol (vitamin D3).
Eurocal D3 is indicated for the treatment of vitamin D and calcium deficiency in elderly patients.
Eurocal D3 is also indicated for the treatment of osteoporosis (a disease causing thinning of the bones with resulting fractures) in patients at risk of concomitant deficiency of vitamin D and calcium.
If you do not feel better or if you feel worse, talk to your doctor.

2. What you need to know before taking Eurocal D3

Do not take Eurocal D3

If you are allergic to calcium carbonate, colecalciferol, or any of the other ingredients of this medicine (listed in section 6).
If you are immobilized for prolonged periods, especially in association with high levels of calcium in urine or blood.
If you suffer from kidney stones.
If blood tests have shown high levels of calcium in your blood.
If urine tests have shown high levels of calcium.
If you are pregnant or breastfeeding.

Eurocal D3 must not be used in children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Eurocal D3.

If treatment is prolonged, it is advisable to monitor serum and urinary calcium levels and renal function. It is recommended to reduce or temporarily discontinue treatment if urinary calcium excretion exceeds 7.5 mmol in 24 hours (300 mg in 24 hours).
If you are concurrently taking digitalis, bisphosphonates, sodium fluoride, thiazide diuretics, or tetracyclines: see section "Other medicines and Eurocal D3".
If you are taking vitamin D from other sources, take into account the vitamin D dose per dosage unit (880 IU).
If you are receiving additional vitamin D or calcium supplementation, this must be done under strict medical supervision. In such cases, weekly monitoring of serum and urinary calcium levels is absolutely necessary.
If you have sarcoidosis (a chronic inflammatory disease affecting multiple organs), due to the potential increase in vitamin D levels. In such patients, monitoring of blood and urine calcium levels is required.
If you have renal impairment, effects on calcium and phosphate concentrations must be monitored.

Children
Eurocal D3 must not be used in children.
Other medicines and EUROCAL D3
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are already taking:

Heart medications such as digoxin or other cardiac glycosides.
Tetracycline antibiotics such as doxycycline, demeclocycline, etc.
Thiazides, medicines used to increase urine elimination, also known as diuretics.
Medicines for bone disorders such as bisphosphonates and sodium fluoride.
Medicines for epilepsy, such as phenytoin and barbiturates.
Medicines for treating inflammation, such as steroids.
Estramustine, a medicine used in the treatment of cancer.
Levothyroxine, a thyroid hormone used to treat thyroid disorders.
Medicines containing strontium.

Eurocal D3 with food and drink
Foods containing oxalic acid (e.g. spinach, rhubarb, beans), phosphates (e.g. ham, sausages, and spreadable cheese), or phytic acid (e.g. raw beans, seeds, nuts, bran, cereals, soy protein isolates) may reduce calcium absorption. You should not take Eurocal D3 within two hours after consuming foods rich in oxalic acid or phytic acid.
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.
Due to the high dose of vitamin D, this medicine is not recommended during pregnancy and breastfeeding.
Driving and using machines
Eurocal D3 is not expected to affect your ability to drive or operate machinery.
EUROCAL D3 contains:

Sorbitol. This medicine contains 1.13 mg of sorbitol per sachet.
Sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. It may be harmful to teeth.
Potassium. This medicine contains 4.18 mmol (or 163.15 mg) of potassium per sachet. This should be taken into account in individuals with impaired renal function or those on a low-potassium diet.
Sodium. This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially 'sodium-free'.

3. How to take EUROCAL D3

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 sachet per day. Your doctor or pharmacist will tell you
how many sachets you need to take each day.
Empty the contents of the sachet into a glass, add a large amount of water, stir,
and drink the solution immediately.
Use in children
Eurocal D3 must not be used in children.
If you take more EUROCAL D3 than you should
Do not exceed the recommended dose. If you take too much medicine, stop taking
calcium and vitamin D, proceed with rehydration, and contact your doctor immediately or go
to the nearest emergency room (if possible, bring the package with you).
Symptoms of overdose may include nausea, vomiting, polydipsia (excessive thirst), polyuria
(frequent urination), constipation.
In addition, you may develop milk-alkali syndrome (characterized by high levels
of calcium in the blood). This condition may occur if you take too much medicine.
Contact your doctor immediately or act as described above, as your kidneys may
no longer function properly. Symptoms are: frequent urge to urinate, persistent headache,
persistent loss of appetite, nausea or vomiting, unusual tiredness or weakness. Blood tests
may show hypercalcemia (high levels of calcium in the blood) and alkalosis (blood pH higher
than normal).
If you forget to take EUROCAL D3
If you forget a dose, take the next dose as soon as you remember, and continue taking the
medicine as before. Do not take a double dose to make up for a forgotten 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 get them.
Tell your doctor immediately if you experience sudden breathlessness, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if widespread throughout the body).

For all the side effects listed below, frequency cannot be determined from the available data:

Dental lesions
Constipation
Flatulence (passing gas from the intestine)
Nausea
Stomach pain
Diarrhoea
Itching, skin rash
Kidney stones
Formation of calcium deposits in the kidneys
Milk-alkali syndrome (characterised by frequent urge to urinate, persistent headache, persistent loss of appetite, nausea or vomiting, unusual fatigue or weakness, usually observed in cases of overdose)

Some additional side effects may only be detected by your doctor, including:

Excessive urinary excretion of calcium, detected by urine analysis
Exceptionally high calcium levels, detected by blood analysis
Exceptionally high potassium levels, detected by blood analysis

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the following 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 Eurocal D3

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the
last day of that month.
Do not store above 25°C.
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 Eurocal D3 contains

The active substances are calcium carbonate and colecalciferol. One 8 g sachet contains 2500 mg of calcium carbonate (equivalent to 1000 mg of calcium or 25 mmol of calcium) and 880 IU of colecalciferol (equivalent to 22 µg of Vitamin D3). The amount of sodium per sachet is 10 mg or 0,44 mmol.
The other components are: citric acid, malic acid, gluconolactone, maltodextrin, sodium cyclamate, sodium saccharinate, lemon flavour (containing: sorbitol, mannitol, D-gluconolactone,

dextrin, gum arabic, lemon essence), rice starch, potassium carbonate, α-tocopherol, oils
vegetables, gelatin, sucrose, corn starch.
Description of the appearance of Eurocal D3 and contents of the pack
Sachets (paper/aluminium/polyethylene) of 8 g;
EUROCAL D3 1000 mg/880 IU, effervescent granules - 30 sachets
EUROCAL D3 1000 mg/880 IU, effervescent granules - 46 sachets
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Amdipharm Ltd - 3 Burlington Road - Dublin 4 Temple Chambers - Ireland
Manufacturer
Hermes Pharma Ges.m.b.H.
Schwimmschulweg 1a
9400 Wolfsberg
Austria