EUROCAL 1000 mg /880 Iu Effervescent Granules

Зміст інструкції

1. Eurocal D3 500 mg + 440 U.I. Effervescent Granules
   1. What is Eurocal D3 and what it is used for
   2. What you need to know before taking Eurocal D3
   3. How to take EUROCAL D3
   4. Possible side effects
   5. How to store Eurocal D3
   6. Contents of the pack and other information
2. Eurocal D3 1000 mg + 880 U.I. Granulato
   1. What is Eurocal D3 and what is it used for
   2. What you need to know before taking Eurocal D3
   3. How to take EUROCAL D3
   4. Possible side effects
   5. How to store Eurocal D3
   6. Package contents and other

Eurocal D3 500 mg + 440 U.I. Effervescent Granules

Calcium carbonate + Cholecalciferol

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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 Eurocal D3 is and what it is used for
• 2. What you need to know before you take Eurocal D3
• 3. How to take Eurocal D3
• 4. Possible side effects
• 5. How to store Eurocal D3
• 6. Contents of the pack and other information

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

Eurocal D3 contains the active ingredients calcium carbonate (a mineral salt) and cholecalciferol (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 that causes thinning of the bones
leading to fractures) in patients at risk of concomitant vitamin D and calcium deficiency.
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, cholecalciferol or any of the other ingredients of this medicine (listed in section 6).
• If you are immobilised for a long time, in association with a high concentration of calcium in the urine or blood.
• If you suffer from kidney stones.
• If blood tests have identified high levels of calcium in your blood.
• If urine tests have identified 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.

• In case of prolonged treatment, it is advisable to monitor the level of calcium in the serum and urine and kidney function. It is advisable to reduce or temporarily interrupt treatment if the calcium level in the urine exceeds 7.5 mmol in 24 hours (300 mg in 24 hours).
• In case of concomitant treatment with digitalis, bisphosphonates, sodium fluoride, thiazide diuretics, tetracyclines: see section "Other medicines and Eurocal D3".
• Consider the dose of vitamin D per dosage unit (440 IU) and any other prescription of vitamin D.
• Additional administrations of vitamin D or calcium must be carried out under strict medical supervision. In these cases, it is absolutely necessary to monitor serum and urinary calcium levels weekly.
• The medicine should be prescribed with caution if you suffer from sarcoidosis (a chronic inflammatory disease that affects several organs), due to the possible increase in vitamin D concentration. If you belong to this category of patients, you should monitor the level of calcium in the blood and urine.
• The medicine should be used with caution if you suffer from renal insufficiency and it is necessary to monitor the effects on calcium and phosphate concentrations.

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

• Medicines for the heart 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 the treatment of bone diseases such as bisphosphonates and sodium fluoride.
• Medicines for the treatment of epilepsy, such as phenytoin and barbiturates.
• Medicines to treat 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 that contain 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),
as these foods can reduce calcium absorption. Do not take Eurocal D3 within two hours
after consuming foods rich in oxalic acid and phytic acid.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Women who are pregnant or breastfeeding can 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 and operate machinery.

EUROCAL D3 contains:

• SorbitolIf your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
• Sucrose.If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
• Potassium.Contains 81.5 mg of potassium per dose. To be taken into consideration in people with reduced kidney function or who are following a low-potassium diet.
• Vegetable oils.Do not use this medicine if you are allergic to peanuts or soya.
• 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 following exactly the instructions of your doctor or pharmacist. If you have 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 in a day.
Pour the contents of the sachet into a glass, add a large amount of water, mix and drink
immediately 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, proceed with rehydration, immediately inform your doctor or go to the nearest emergency room
(if possible bring the package with you).
Symptoms of overdose may include nausea, vomiting, thirst, polydipsia (excessive thirst), polyuria (frequent
urination), constipation.
You may also experience milk-alkali syndrome (characterized by the presence of high concentrations of calcium
in the blood). This is a condition that can occur if you take too much medicine. Contact
your doctor immediately or proceed as described above, as your kidneys may no longer function
correctly. Symptoms are: frequent urge to urinate, persistent headache, permanent loss of
appetite, nausea or vomiting, unusual fatigue or weakness. Blood tests may show hypercalcemia
(high levels of calcium in the blood) and alkalosis (the pH of the blood is 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 to take the medicine as
before. 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.
For all the side effects listed below, the frequency cannot be defined based on the available data:

• Sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body) must be reported to your doctor immediately.
• Dental lesions
• Constipation
• Flatulence (passage of gas from the intestines)
• 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, permanent loss of appetite, nausea or vomiting, unusual fatigue or weakness, usually observed in overdose) Some further side effects can only be detected by the doctor, these include:
• Excessive urinary excretion of calcium after a urine test
• Exceptionally high calcium levels, after a blood test
• Exceptionally high potassium levels, after a blood test

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor,
pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side
effects you can help to provide more information on the safety of this medicine.

5. How to store Eurocal D3

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 Eurocal D3 contains

• The active ingredients are calcium carbonate and cholecalciferol. One 4 g sachet contains 1250 mg of calcium carbonate (corresponding to 500 mg of calcium or 12.5 mmol of calcium) and 440 I.U. of cholecalciferol (corresponding to 11 µg of Vitamin D3). The amount of sodium per sachet is 5 mg or 0.22 mmol
• The other ingredients 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, corn starch.

Description of the appearance of Eurocal D3 and contents of the pack
Sachets (paper/aluminium/polyethylene) of 4 g;
Eurocal D3 500 mg / 440 I.U., effervescent granules - 30 sachets
Eurocal D3 500 mg / 440 I.U., effervescent granules - 46 sachets

Marketing Authorisation Holder and Manufacturer
Amdipharm Ltd - 3 Burlington Road - Dublin 4 Temple Chambers- Ireland

Eurocal D3 1000 mg + 880 U.I. Granulato

effervescent
calcium carbonate + cholecalciferol

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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Eurocal D3 is and what it is used for
• 2. What you need to know before you take Eurocal D3
• 3. How to take Eurocal D3
• 4. Possible side effects
• 5. How to store Eurocal D3
• 6. Contents of the pack and other information

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

Eurocal D3 contains the active ingredients calcium carbonate (a mineral salt) and cholecalciferol (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 that causes thinning
of the bones with consequent fractures) in patients at risk of concomitant vitamin D and
calcium deficiency.
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, cholecalciferol or any of the other ingredients of this medicine (listed in section 6).
• If you remain immobilised for a long time, in association with a high concentration of calcium in the urine or blood.
• If you suffer from kidney stones.
• If blood tests have identified high levels of calcium in your blood.
• If urine tests have identified 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 you are undergoing prolonged treatment, it is recommended to monitor the calcium level in the serum and urine and kidney function. It is advisable to reduce or temporarily interrupt treatment if the calcium level in the urine exceeds 7.5 mmol in 24 hours (300 mg in 24 hours).
• If you are taking digoxin, bisphosphonates, sodium fluoride, thiazide diuretics, tetracyclines at the same time: see section "Other medicines and Eurocal D3".
• If you are taking vitamin D from other prescriptions, consider the dose of vitamin D per unit of dosage (880 IU).
• If you are taking additional vitamin D or calcium supplements, these must be carried out under strict medical supervision. In these cases, it is absolutely necessary to monitor serum and urinary calcium levels weekly.
• If you suffer from sarcoidosis (a chronic inflammatory disease that affects several organs), due to the possible increase in vitamin D concentration. If you belong to this category of patients, the level of calcium in the blood and urine must be monitored.
• If you suffer from renal insufficiency, it is necessary to monitor the effects on calcium and phosphate concentrations.

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

• Medicines for the heart such as digoxin or other cardiac glycosides.
• Tetracycline antibiotics such as doxycycline, demeclocycline etc.
• Thiazides, medicines used to increase urine output, also known as diuretics.
• Medicines for the treatment of bone diseases such as bisphosphonates and sodium fluoride.
• Medicines for the treatment of epilepsy, such as phenytoin and barbiturates.
• Medicines to treat 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. Do not take Eurocal D3 within two
hours of consuming foods rich in oxalic acid and phytic acid.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Due to the high dosage of vitamin D, the medicine is not indicated during pregnancy and
breastfeeding.

Driving and using machines
It is not expected that Eurocal D3 will affect your ability to drive and 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 before taking this medicine. It may be harmful to your teeth.
• Potassium.This medicine contains 4.18 mmol (or 163.15 mg) of potassium per sachet. This should be taken into consideration in people with reduced kidney function or who are following 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 following exactly the instructions of 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 in a day.
Pour the contents of the sachet into a glass, add a large amount of water, mix
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, immediately inform your doctor 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.
You may also experience milk-alkali syndrome (characterized by high concentrations
of calcium in the blood). This is a condition that can occur if you take too much medicine.
Contact your doctor immediately or proceed as described above, as your kidneys may not
function properly anymore. The symptoms are: frequent urge to urinate, persistent headache,
permanent loss of appetite, nausea or vomiting, unusual fatigue or weakness. Blood tests
may show hypercalcemia (high levels of calcium in the blood) and alkalosis (the pH of the blood is 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 to take
the medicine as before. 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.
Report to your doctor immediately if you experience sudden shortness of breath, difficulty breathing,
swelling of the eyelids, face or lips, rash or itching (especially if it affects
the whole body).
For all the side effects listed below, the frequency cannot be defined based on the
available data:

• Dental lesions
• Constipation
• Flatulence (passage of gas from the intestines)
• Nausea
• Stomach pain
• Diarrhea
• Itching, rash
• Kidney stones
• Formation of calcium deposits at the level of the kidneys
• Milk-alkali syndrome (characterized by frequent urge to urinate, persistent headache, permanent loss of appetite, nausea or vomiting, unusual fatigue or weakness, usually observed in overdose)

Some further side effects can only be detected by your doctor, these include:

• Excessive urinary excretion of calcium after a urine test
• Exceptionally high calcium levels, after a blood test
• Exceptionally high potassium levels, after a blood test

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
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 which is stated on the packaging. The expiry date
refers to the last day of that month.
Do not store at a temperature above 25°C.
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. Package contents and other

information
What Eurocal D3 contains

• The active ingredients are calcium carbonate and cholecalciferol. One 8 g sachet contains 2500 mg of calcium carbonate (corresponding to 1000 mg of calcium or 25 mmol of calcium) and 880 IU of cholecalciferol (corresponding to 22 |µg of Vitamin D3). The amount of sodium per sachet is 10 mg or 0.44 mmol.
• The other ingredients 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, vegetable
oils, gelatin, sucrose, corn starch.

Description of the appearance of Eurocal D3 and package contents
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