Dincrel

Patient Information Leaflet

DINCREL 600 mg/1000 IU orodispersible tablets

calcium / colecalciferol
Please read all of this leaflet carefully before you start 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DINCREL is and what it is used for

DINCREL is used for the prevention and treatment of calcium and vitamin D deficiency in the elderly and as an additional treatment in the management of osteoporosis in patients at risk of calcium and vitamin D deficiency, when dietary supplementation with 600 mg/day of calcium and 1000 IU/day of vitamin D is considered appropriate.
DINCREL contains calcium and vitamin D, both of which are important components for bone formation. Vitamin D regulates the absorption and metabolism of calcium as well as the deposition of calcium in bone tissue.
Consult your doctor or pharmacist if you have any further questions and always follow their instructions.
Contact your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking DINCREL

Do not take DINCREL

• if you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6);
• if you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine);
• if you have hypervitaminosis D (high levels of vitamin D in the blood);
• if you have kidney stones;
• if you suffer from renal insufficiency;
• if you are allergic to peanuts or soy;

Warnings and precautions
Talk to your doctor or pharmacist before taking DINCREL

• if you suffer from sarcoidosis (a specific connective tissue disorder affecting the lungs, skin, and joints);
• if you are taking other medicines containing vitamin D or calcium;
• if you have reduced kidney function or a high tendency to form kidney stones;
• if you are bedridden due to osteoporosis;

Other medicines and DINCREL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of this treatment may be influenced if this medicine is taken simultaneously with certain drugs used for:

• hypertension (thiazide diuretics);
• heart conditions (cardiac glycosides such as digoxin);
• hypercholesterolemia (cholestyramine);
• constipation (laxatives such as mineral oil);
• epilepsy (phenytoin or barbiturates);
• inflammatory conditions/immune system suppression (corticosteroids);
• obesity (orlistat);

Make sure your doctor is aware if you are taking any of the medicines listed above. A dose adjustment may be necessary.
If you are taking a medicine for:

• osteoporosis (bisphosphonates), you must take this medicine at least one hour before taking DINCREL

If you are taking medicines for:

• infections (quinolones), you must take these medicines two hours before or six hours after taking DINCREL

If you are taking a medicine for:

• infections (tetracyclines), you must take these medicines two hours before or four to six hours after taking DINCREL

If you are taking a medicine for:

• dental caries (sodium fluoride)
• anemia (iron), you must take these medicines at least three hours before taking DINCREL

If you are taking medicines for:

• hypothyroidism (levothyroxine), you must take these medicines at least four hours apart from the administration of DINCREL

DINCREL with food, drinks and alcohol
Calcium absorption may be inhibited by foods containing oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains).
You should wait at least two hours before taking DINCREL if you have consumed foods high in oxalic acid or phytic acid.
Pregnancy, breastfeeding and fertility
During pregnancy, daily intake of calcium and vitamin D should not exceed 1500 mg of calcium and 600 IU of vitamin D, respectively.
Therefore, DINCREL is not recommended during pregnancy.
DINCREL may be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account if additional vitamin D is administered to the infant.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No known effects on the ability to drive or operate machinery.
DINCREL contains aspartame.
Aspartame is a source of phenylalanine. Phenylalanine may be harmful to patients with phenylketonuria.
DINCREL contains lactose and sucrose.
If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.
DINCREL contains soya oil.
If you are allergic to peanuts or soya, do not take this medicine.

3. How to take DINCREL

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, you must consult your doctor or pharmacist.
The dosage will be individually determined for you by your doctor.
The recommended dose is one tablet per day.
The tablets are to be sucked and must not be swallowed whole.
The tablets should preferably be taken after meals.
The amount of calcium in DINCREL is lower than the recommended daily intake.
Therefore, DINCREL should primarily be used in patients who require vitamin D supplementation but whose dietary calcium intake ranges between 500 mg and 1000 mg per day.
The amount of calcium taken through diet should be assessed by the doctor.
Use in children and adolescents
DINCREL is not indicated in children and adolescents.
If you take more DINCREL than you should
If you take more DINCREL than prescribed, contact your doctor or pharmacist immediately.
Some symptoms of DINCREL overdose include: loss of appetite, thirst, abnormally increased urinary excretion, nausea, vomiting, and constipation.
If you forget to take DINCREL
Take the tablet as soon as possible. Afterwards, take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose and continue as usual.
Never take two doses at the same time.
If you have further 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 will experience them.
You must stop taking DINCREL and contact your doctor immediately if you experience symptoms of a severe allergic reaction such as:

• swelling of the face, lips, tongue or throat
• difficulty swallowing
• hives and breathing difficulties

Uncommon (may affect up to 1 in 100 people): hypercalcaemia (high levels of calcium in the blood) and/or hypercalciuria (high levels of calcium in the urine).
Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, itching, rash, urticaria.
Not known (frequency cannot be estimated from the available data): severe allergic reactions.

Special populations
Patients with renal impairment: there is a potential risk of hyperphosphataemia, 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 national reporting system at http://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 DINCREL

• Keep this medicine out of the sight and reach of children.
• Keep the container closed. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
• Store in the original packaging to protect from light.
• Keep the container tightly closed to protect the product from moisture.
• The shelf life of the product after first opening the bottle is 60 days.
• Do not use this medicine if you notice any visible signs of deterioration.
• 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 DINCREL contains

• The active substances are: calcium carbonate 1500 mg, equivalent to 600 mg of calcium, and colecalciferol (vitamin D3) 1000 IU, equivalent to 0.025 mg.
• The other excipients are: maltodextrins, aspartame (E 951), low-substituted hydroxypropylcellulose (E 463), monohydrate lactose, anhydrous citric acid (E 330), orange flavour, stearic acid, DL--tocopherol (E 307), partially hydrogenated soybean oil, gelatin, sucrose, corn starch.

Description of the appearance of DINCREL and contents of the pack

DINCREL orodispersible tablets are round, white or almost white, with bevelled edges.
The tablet container contains 30 or 60 tablets.
The multiple pack contains 60 orodispersible tablets (2 packs of 30).
Not all pack sizes may be marketed.

Marketing Authorization Holder
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milan, Italy.
Tel. +39 02 64431
Fax. +39 02 644346
e-mail: [email protected]

Manufacturer responsible for batch release
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milan, Italy.

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Dincrel 600mg/1.000UI orodispersible tablets
Spain: Demilos 600 mg/1,000 IU bucodispersable tablets
France: Demilos 600 mg/1.000 UI comprimés orodispersibles
Portugal: Demilos 600 mg + 1000 UI comprimidos orodispersíveis
Ireland: Cadelius 600 mg/1,000 IU orodispersible tablets

This leaflet was last approved on:

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

DINCREL 600 mg / 2.000 IU orodispersible tablets

calcium / colecalciferol
Please read this entire leaflet carefully before using 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, pharmacist, or nurse.
• 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What DINCREL is and what it is used for

DINCREL is used to treat calcium and vitamin D deficiency in adults.
DINCREL contains calcium and vitamin D3, both of which are important components for bone formation.
Vitamin D3 regulates the absorption and metabolism of calcium and the incorporation of calcium into bone tissue.
If you have any further questions, consult your doctor or pharmacist and always follow their instructions.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking DINCREL

Do not take DINCREL

• if you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6)
• if you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine)
• if you have hypervitaminosis D (excess levels of vitamin D in the blood)
• if you have kidney stones
• if you suffer from renal failure
• if you are pregnant
• if you are allergic to soy or peanuts

Warnings and precautions
Talk to your doctor or pharmacist before taking DINCREL

• if you suffer from sarcoidosis (a specific connective tissue disorder affecting the lungs, skin, and joints)
• if you are taking other medicines containing vitamin D or calcium
• if you have reduced kidney function or a high tendency to form kidney stones
• if you are immobilized with osteoporosis

Children and adolescents
DINCREL orodispersible tablets are not intended for use in children and adolescents.
Other medicines and DINCREL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be influenced if this medicine is taken at the same time as certain other medicines used for:

• hypertension (thiazide diuretics)
• heart disorders (cardiac glycosides such as digoxin)
• high cholesterol (cholestyramine)
• constipation (laxatives such as paraffin oil)
• epilepsy (phenytoin or barbiturates)
• inflammatory conditions/immunosuppression (corticosteroids)
• obesity (orlistat)

Make sure your doctor knows if you are taking any of the medicines listed above. A dose adjustment may be necessary.
If you are taking a medicine for:

• osteoporosis (bisphosphonates), you must take it at least three hours before taking DINCREL

If you are taking certain medicines for:

• infection (quinolones), you must take these medicines at least two hours before or six hours after taking DINCREL

If you are taking certain medicines for:

• infection (tetracyclines), you must take these medicines at least two hours before or four to six hours after taking DINCREL

If you are taking certain medicines for:

• dental caries (sodium fluoride)
• anaemia (iron), you must take these medicines at least three hours before taking DINCREL

If you are taking medicines for:

• hypothyroidism (levotiroxine), you must take these medicines at least four hours apart from taking DINCREL

DINCREL with food, drinks and alcohol
Calcium absorption may be inhibited by foods containing oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains). You should wait at least two hours after consuming foods high in oxalic or phytic acid before taking DINCREL.

Pregnancy, breastfeeding and fertility
DINCREL must not be used during pregnancy.
DINCREL may be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when additional vitamin D is given to the infant. Such supplementation does not replace the administration of vitamin D to newborns.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
DINCREL has no known effect on the ability to drive vehicles or operate machinery.

DINCREL contains aspartame
This medicine contains 8.67 mg of aspartame per orodispersible tablet.
Aspartame is a source of phenylalanine. Phenylalanine may be harmful to people with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.

DINCREL contains lactose and sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

DINCREL contains soybean oil.
If you are allergic to peanuts or soy, do not take this medicine.

3. How to take DINCREL

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, you must consult your doctor or pharmacist.
The dosage will be individually determined for you by your doctor.
The recommended dose is one tablet per day.
The tablets may be sucked and must not be swallowed whole.
The tablets should preferably be taken after meals.
The amount of calcium in DINCREL is lower than the recommended daily intake.
Therefore, DINCREL should primarily be used in patients who require vitamin D supplementation but whose dietary calcium intake ranges between 500 mg and 1000 mg per day.
The amount of calcium consumed through the diet must be assessed by the doctor.
Use in children and adolescents
DINCREL is not indicated in children and adolescents.
If you take more DINCREL than you should
If you take more DINCREL than you should, contact your doctor or pharmacist immediately.
Some symptoms of DINCREL overdose include: loss of appetite, thirst, abnormally increased urinary
secretion, nausea, vomiting, and constipation.
If you forget to take DINCREL
Take the tablet as soon as possible. Afterwards, take the next dose at the usual time. However, if it is
almost time for the next dose, do not take the missed dose and continue as usual.
Never take two doses at the same time.
If you have further questions 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 everyone experiences them.
You must stop taking DINCREL and contact your doctor immediately if you experience symptoms of a severe allergic reaction, such as:

• swelling of the face, lips, tongue or throat
• difficulty swallowing
• hives and difficulty breathing

Uncommon (may affect up to 1 in 100 people): hypercalcemia (elevated serum calcium levels) and/or hypercalciuria (elevated calcium levels in urine).
Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, diarrhoea, abdominal distension, pruritus, rash and urticaria.
Not known (frequency cannot be estimated from the available data): severe allergic reactions.

Other special population
Patients with renal impairment may have a potential risk of hyperphosphatemia, 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 national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DINCREL

• Keep this medicine out of the sight and reach of children.
• Keep the container tightly closed. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
• Store in the original packaging to protect from light.
• Keep the container tightly closed to protect the product from moisture.
• The product is stable for 30 days after first opening of the bottle.
• Do not use this medicine if you notice any visible signs of deterioration.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DINCREL contains

• The active substances are: calcium carbonate 1500 mg, equivalent to 600 mg of calcium, and colecalciferol (vitamin D3) 2,000 I.U., equivalent to 0.050 mg.

• The other components are: maltodextrins, aspartame (E 951), low-substituted hydroxypropylcellulose (E 463), lactose monohydrate, anhydrous citric acid (E 330), orange flavour (containing flavouring preparations, natural flavouring substances, maltodextrin and dextrin), stearic acid, DL-α-tocopherol (E 307), partially hydrogenated soybean oil, gelatin, sucrose, corn starch.

Description of the appearance of DINCREL and pack contents
DINCREL is an orodispersible tablet, white to almost white, rounded in shape, with bevelled edges, 30 tablets per bottle.
Multipacks contain 60 tablets (2 packs of 30) orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milan, Italy.
Tel. +39 02 64431
Fax. +39 02 644346
e-mail: [email protected]
Manufacturer
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milan, Italy.
This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Dincrel 600mg/2.000UI orodispersible tablets
Spain: Demilos 600 mg/2.000 IU bucodispersable tablets
France: Demilos 600 mg/2.000 UI comprimés orodispersibles
Portugal: Demilos 600 mg + 2000 UI comprimidos orodispersíveis
Ireland: Cadelius 600 mg/2.000 IU orodispersible tablets
This leaflet was last approved on: