Colecalciferol Doc

Patient Information Leaflet

COLECALCIFEROLO DOC 10,000 IU Soft Capsules

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, ask 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 you, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLECALCIFEROLO DOC is and what it is used for

COLECALCIFEROLO DOC contains the active substance colecalciferol (vitamin D).
The main function of vitamin D is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
COLECALCIFEROLO DOC is used for the prevention and treatment of vitamin D deficiency in adults.

2. What you should know before taking COLECALCIFEROLO DOC

Do not take COLECALCIFEROLO DOC

• if you are allergic to colecalciferol or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you have severe renal insufficiency (see section “Warnings and precautions”);
• if you have high levels of vitamin D in your blood (hypervitaminosis D). In case of deeply pigmented skin, extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), if you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory drugs, or if you suffer from intestinal malabsorption, cystic fibrosis (mucoviscidosis), or celiac disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO DOC.
Your doctor may recommend taking COLECALCIFEROLO DOC for prevention of vitamin D deficiency:

• in elderly patients,
• in cases of insufficient or ineffective sun exposure,
• special diets (e.g. low-calcium diet, vegetarian diet),
• in case of deeply pigmented skin,
• in case of extensive dermatological conditions, infectious diseases (such as tuberculosis, leprosy), gastrointestinal disorders or liver diseases (hepatic insufficiency),
• if you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory drugs.

Inform your doctor if you are already taking other products containing vitamin D, fortified foods or vitamin D-enriched milk, as vitamin D accumulates in the body and excessive doses may cause toxic effects.
For this reason, it is important that you do not exceed the recommended dose.
Your doctor will monitor you and may request blood and/or urine tests if you:

• need to take COLECALCIFEROLO DOC for a prolonged period and at high doses;
• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly patient taking medications for certain heart conditions (cardiac glycosides) or medications that lower blood pressure by increasing urine production (diuretics);
• suffer from sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation, or other granulomatous diseases.

If your vitamin D or calcium levels are elevated, your doctor will reduce the dose or discontinue treatment with COLECALCIFEROLO DOC.
Generally, if you have impaired kidney function, you should undergo periodic tests to monitor calcium and phosphate levels in the blood. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or stop treatment with COLECALCIFEROLO DOC.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take COLECALCIFEROLO DOC” may be required:

• if you are taking medications used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking corticosteroids, medications used to treat inflammation (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking medications to reduce blood lipids such as colestipol, cholestyramine (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking a medicine for obesity called orlistat (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking antacids containing aluminum, medications used to treat excessive stomach acid that may rise into the esophagus (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are obese;
• if you suffer from gastrointestinal diseases (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
• if you suffer from extensive skin diseases;
• if you suffer from liver disease (hepatic insufficiency).

Children and adolescents
COLECALCIFEROLO DOC 10,000 IU capsules are not suitable for children and adolescents aged 0 to 18 years.
Other medicines and COLECALCIFEROLO DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of COLECALCIFEROLO DOC may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medications for the treatment of epilepsy;
• barbiturates (used in anesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medications that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• imidazole antifungals (medications such as clotrimazole and ketoconazole used to treat fungal infections), actinomycin (an antibiotic);
• medications containing digitalis and other cardiac glycosides (used to treat heart conditions);
• antacids containing aluminum or magnesium;
• warfarin (a medication used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if strictly necessary due to possible teratogenic effects (fetal malformations).
COLECALCIFEROLO DOC 10,000 IU capsules are not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.
Breastfeeding
COLECALCIFEROLO DOC 10,000 IU capsules are not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D during breastfeeding at lower doses. This supplementation does not replace the administration of vitamin D to the newborn.
Vitamin D and its metabolites are present in breast milk. This should be taken into account when administering additional vitamin D to the infant.
Fertility
There are no data on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported for vitamin D levels within the normal range.
Driving and using machines
There are no data available on the effects of this product on the ability to drive.
COLECALCIFEROLO DOC contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per soft capsule, i.e. it is essentially “sodium-free”.

3. How to take COLECALCIFEROLO DOC
   Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The dosage and duration of treatment will be determined by your doctor based on your health status.
Do not exceed the doses indicated by your doctor.
It is recommended to take COLECALCIFEROLO DOC orally during meals.
Adults and elderly
Prevention: 1 capsule (equivalent to 10,000 IU of vitamin D3) every two weeks. In case of multiple risk factors, according to the doctor's judgment, the dosage may be increased up to 1 capsule (equivalent to 10,000 IU of vitamin D) once a week.
Treatment: 1 capsule (equivalent to 10,000 IU of vitamin D) once a week for 1–3 months. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.
Paediatric population
The use of COLECALCIFEROLO DOC 10,000 IU capsules is not suitable for neonates, children, or adolescents under 18 years of age.
Pregnant women
The use of COLECALCIFEROLO DOC 10,000 IU capsules is not recommended during pregnancy.
If you take more COLECALCIFEROLO DOC than you should
If you accidentally take an excessive dose of COLECALCIFEROLO DOC, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include elevated calcium levels in blood and urine, with symptoms such as: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a known association between excessive maternal intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Increased calcium levels in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in low blood calcium levels, muscle cramps and spasms (tetany), and seizures.
If you forget to take COLECALCIFEROLO DOC
Do not take a double dose to make up for the forgotten dose. Skip the missed dose and continue your treatment as usual.
If you stop taking COLECALCIFEROLO DOC
Do not stop taking COLECALCIFEROLO DOC on your own initiative. If you have any doubts about using 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.
The side effects reported are listed below; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in the blood and urine.

Reporting of side effects
If you experience any side effects, 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.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 COLECALCIFEROLO DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store this medicine 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 COLECALCIFEROLO DOC contains
The active substance is colecalciferol (vitamin D).
Each soft capsule contains 0.25 mg colecalciferol (vitamin D3), equivalent to 10,000 IU.
The other components are: refined olive oil, gelatin, glycerol, titanium dioxide, Allura Red
n.40, butylated hydroxytoluene.
Description of the appearance of COLECALCIFEROLO DOC and package contents
Soft, oblong capsules, size 5.25 mm ±10% x 10.526 mm ± 0.2259, dark red in colour, containing a yellow-green transparent solution.
Each pack contains 4, 8 or 10 capsules in white opaque PVC/PVDC/Al blisters.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan, Italy
Manufacturer
DOPPEL Farmaceutici S.r.l.
Via Martiri delle Foibe 1
29016 Cortemaggiore (PC)
Italy

Patient information leaflet

COLECALCIFEROLO DOC 25,000 IU Soft Capsules

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, 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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What COLECALCIFEROLO DOC is and what it is used for
2. What you need to know before taking COLECALCIFEROLO DOC
3. How to take COLECALCIFEROLO DOC
4. Possible side effects
5. How to store COLECALCIFEROLO DOC
6. Package contents and other information

1. What Colecalciferolo DOC is and what it is used for

COLECALCIFEROLO DOC contains the active substance colecalciferol (vitamin D).
The main function of vitamin D is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
COLECALCIFEROLO DOC 25,000 IU capsules are used for:

• prevention of vitamin D deficiency in adults, only in cases where therapeutic adherence cannot be achieved with daily administration of low doses of colecalciferol;
• treatment of vitamin D deficiency in adults (age over 18 years).

2. What you should know before taking COLECALCIFEROLO DOC

Do not take COLECALCIFEROLO DOC

• if you are allergic to colecalciferol or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium (hypercalcemia) in your blood or urine (hypercalciuria);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you have severe renal insufficiency (see section “Warnings and precautions”);
• if you have high levels of vitamin D in your blood (hypervitaminosis D);
• in case of intense skin pigmentation;
• in case of extensive skin diseases or infectious diseases (such as tuberculosis, leprosy);
• if you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines;
• if you suffer from intestinal malabsorption, cystic fibrosis or mucoviscidosis, celiac disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO DOC.
Your doctor may recommend taking COLECALCIFEROLO DOC 25,000 IU capsules as
prevention of vitamin D deficiency

• in elderly patients,
• in cases of insufficient or ineffective sun exposure,
• special diets (e.g. low-calcium diet, vegetarian diet),
• in case of intense skin pigmentation,
• in case of extensive dermatological conditions, infectious diseases (such as tuberculosis, leprosy), gastrointestinal disorders or liver diseases (hepatic insufficiency),
• if you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines.

Inform your doctor if you are already taking other products containing vitamin D, or foods or milk fortified with vitamin D, because vitamin D accumulates in the body and excessive doses may cause toxic effects.
For this reason, it is important that you do not exceed the recommended dose.
Your doctor will monitor you and may request blood and/or urine tests if you

• need to take COLECALCIFEROLO DOC for a long time and at high doses;
• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly person taking medicines to treat certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• suffer from sarcoidosis, an inflammatory disease that can affect the entire body and leads to nodule formation, or other granulomatous diseases. If your vitamin D or calcium levels are elevated, your doctor will reduce the dose or discontinue treatment with COLECALCIFEROLO DOC.

In general, if you have impaired kidney function, you should undergo periodic tests to monitor calcium and phosphate levels in the blood. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or stop treatment with COLECALCIFEROLO DOC.
Inform your doctor in the following cases, as an increase in dosage compared to those indicated in section 3 “How to take COLECALCIFEROLO DOC” may be necessary:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking a medicine used to treat obesity called orlistat (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are obese;
• if you suffer from gastrointestinal diseases (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
• if you suffer from extensive skin diseases;
• if you suffer from liver disease (hepatic insufficiency).

Children and adolescents

• COLECALCIFEROLO DOC 25,000 IU capsules are not suitable for children and adolescents aged between 0 and 18 years.

Other medicines and COLECALCIFEROLO DOC
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of COLECALCIFEROLO DOC may be affected by other medicines; therefore, inform your doctor if you are taking:

• medicines used to treat epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal infections);
• actinomycin (an antibiotic);
• medicines containing digitalis and other cardiac glycosides (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if strictly necessary due to possible teratogenic effects (fetal malformations).
COLECALCIFEROLO DOC 25,000 IU capsules are not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.
Breastfeeding
COLECALCIFEROLO DOC 25,000 IU capsules are not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D during breastfeeding at lower doses. This supplementation does not replace the administration of vitamin D to the newborn.
Vitamin D and its metabolites are excreted in breast milk. This should be taken into account when administering additional vitamin D to the infant.
Fertility
There are no data available on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported with vitamin D blood levels within the normal range.
Driving and using machines
No data are available on the effects of this product on the ability to drive.
COLECALCIFEROLO DOC contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per soft capsule, i.e. it is essentially “sodium-free”.

3. How to take COLECALCIFEROLO DOC

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
It is recommended to take COLECALCIFEROLO DOC during meals.

Adults and elderly
Prevention: 1 capsule (equivalent to 25,000 IU of vitamin D) once a month.
Treatment: 1 capsule (equivalent to 25,000 IU of vitamin D) once a week for 8–12 weeks.
Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.

Paediatric population
The use of COLECALCIFEROLO DOC 25,000 IU capsules is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of COLECALCIFEROLO DOC 25,000 IU capsules is not recommended during pregnancy.

If you take more COLECALCIFEROLO DOC than you should
If you accidentally take an excessive dose of COLECALCIFEROLO DOC, contact your doctor immediately or go to the nearest hospital.
In case of overdose, elevated levels of calcium in the blood and urine may occur, with symptoms including: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may cause toxic effects in the fetus: there is a known association between excessive vitamin D intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy.
Elevated calcium levels in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.

If you forget to take COLECALCIFEROLO DOC
Do not take a double dose to make up for the missed dose. Skip the forgotten dose and continue your treatment as usual.

If you stop taking COLECALCIFEROLO DOC
Do not stop taking COLECALCIFEROLO DOC on your own initiative. If you have any doubts about using 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.
The side effects reported are listed below; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, urticaria;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in blood and urine.

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.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 COLECALCIFEROLO DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not store this medicine 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 COLECALCIFEROLO DOC contains
The active substance is colecalciferol (vitamin D).
Each soft capsule contains 0.625 mg colecalciferol (vitamin D3), equivalent to 25,000 IU.
The other components are: refined olive oil, gelatin, glycerol, titanium dioxide, Allura Red AC No. 40, butylated hydroxytoluene.

Description of the appearance of COLECALCIFEROLO DOC and the contents of the pack
Oblong soft capsules, size 6.36 mm ±10% x 15.067 mm ± 0.3168, dark red in colour, containing a yellow-green transparent solution.
Each pack contains 2 or 4 capsules in white opaque PVC/PVDC/Al blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano, Italy

Manufacturer
DOPPEL Farmaceutici S.r.l.
Via Martiri delle Foibe 1
29016 Cortemaggiore (PC)
Italy

Patient Information Leaflet

COLECALCIFEROLO DOC 50,000 IU soft capsules, 100,000 IU soft capsules

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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLECALCIFEROLO DOC is and what it is used for

COLECALCIFEROLO DOC contains the active substance colecalciferol (vitamin D).
The main function of vitamin D is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
COLECALCIFEROLO DOC 50,000 and 100,000 IU capsules are used to treat vitamin D deficiency in adults.

2. What you need to know before taking COLECALCIFEROLO DOC

Do not take COLECALCIFEROLO DOC

• if you are allergic to cholecalciferol or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium (hypercalcemia) in the blood and in the urine (hypercalciuria);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis); if you have severe renal insufficiency (see section “Warnings and precautions”);
• if you have high levels of vitamin D in the blood (hypervitaminosis D). In case of intense skin pigmentation, extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), if you are being treated with antiepileptic drugs or long-term treatment with certain anti-inflammatory drugs, if you suffer from (intestinal malabsorption, cystic fibrosis or mucoviscidosis, celiac disease).

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO DOC.
Inform your doctor if you are already taking other products containing vitamin D, foods or milk fortified with vitamin D, as vitamin D accumulates in the body and excessive doses may cause toxic effects.
For this reason, it is important that you do not exceed the recommended dose.
Your doctor will monitor you and may request blood and/or urine tests if you

• need to take COLECALCIFEROLO DOC for a long time and at high doses;
• suffer or have suffered from kidney stones;
• suffer from kidney problems;
• are an elderly person being treated with medicines for certain heart diseases (cardiac glycosides) or with medicines that reduce blood pressure by increasing urine production (diuretics);
• suffer from sarcoidosis, an inflammatory disease that can affect the entire body and leads to nodule formation, or other granulomatous diseases.
  If your vitamin D or calcium levels are elevated, your doctor will reduce the dose or discontinue treatment with COLECALCIFEROLO DOC.
  In general, if you have impaired kidney function, you will need periodic tests to monitor calcium and phosphate levels in the blood. If your calcium and phosphate levels are high, your doctor will reduce the dose or discontinue treatment with COLECALCIFEROLO DOC.

Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take COLECALCIFEROLO DOC” may be necessary:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking a medicine for obesity called orlistat (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and COLECALCIFEROLO DOC”);
• if you are obese;
• if you suffer from gastrointestinal diseases (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
• if you suffer from extensive skin diseases;
• if you suffer from liver disease (hepatic insufficiency).

Children and adolescents
COLECALCIFEROLO DOC 50,000 - 100,000 IU capsules are not suitable for children and adolescents aged between 0 and 18 years.

Other medicines and COLECALCIFEROLO DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of COLECALCIFEROLO DOC may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medicines for the treatment of epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal infections);
• actinomycin (an antibiotic);
• medicines containing digitalis and other cardiac glycosides (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if strictly necessary due to possible teratogenic effects (fetal malformations).
COLECALCIFEROLO DOC 50,000 - 100,000 IU capsules are not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
COLECALCIFEROLO DOC 50,000 - 100,000 IU capsules are not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D during breastfeeding at lower doses. This supplementation does not replace the administration of vitamin D to the newborn.
Vitamin D and its metabolites are present in breast milk. This should be taken into account when additional vitamin D is administered to the infant.

Fertility
There are no data regarding the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported for vitamin D blood levels within the normal range.

Driving and using machines
No data are available on the effects of this product on the ability to drive.

COLECALCIFEROLO DOC contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per soft capsule, i.e. it is essentially “sodium-free”.

3. How to take COLECALCIFEROLO DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
COLECALCIFEROLO DOC may be taken on a weekly or monthly basis. Your doctor will determine the correct frequency of administration based on your condition.
It is recommended to take COLECALCIFEROLO DOC during meals.

COLECALCIFEROLO DOC 50,000 IU soft capsules
Adults and elderly
1 capsule (equivalent to 50,000 IU vitamin D) once a week for up to 6 weeks.
Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.

COLECALCIFEROLO DOC 100,000 IU soft capsules
Adults and elderly
1 capsule (equivalent to 100,000 IU vitamin D) once a month for up to 3 months.
Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.

Paediatric population
The use of COLECALCIFEROLO DOC 50,000 and 100,000 IU soft capsules is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of COLECALCIFEROLO DOC 50,000 and 100,000 IU soft capsules is not recommended during pregnancy.

If you take more COLECALCIFEROLO DOC than you should
If you accidentally take an excessive dose of COLECALCIFEROLO DOC, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood and urine may occur, with symptoms including: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a correlation between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Elevated calcium levels in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.

If you forget to take COLECALCIFEROLO DOC
Do not take a double dose to make up for the forgotten dose. Skip the missed dose and continue your treatment as usual.

If you stop taking COLECALCIFEROLO DOC
Do not stop taking COLECALCIFEROLO DOC on your own initiative. If you have any doubts about using 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.
The side effects reported are listed below; their frequency is not known:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, urticaria;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased volume of urine excreted, renal failure;
• high levels of calcium in the blood and in the urine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
http://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 COLECALCIFEROLO DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not store this medicine 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. Contents of the pack and other information

What COLECALCIFEROLO DOC contains
The active substance is cholecalciferol (vitamin D).
COLECALCIFEROLO DOC 50,000 IU soft capsules: each soft capsule contains
cholecalciferol (vitamin D3) 1.25 mg equivalent to 50,000 IU.
COLECALCIFEROLO DOC 100,000 IU soft capsules: each soft capsule contains
cholecalciferol (vitamin D3) 2.50 mg equivalent to 100,000 IU.
The other components are: refined olive oil, gelatin, glycerol, titanium dioxide, Allura Red
n.40, butylated hydroxytoluene.

Description of the appearance of COLECALCIFEROLO DOC and pack contents
COLECALCIFEROLO DOC 50,000 IU soft capsules: soft, oval capsules, 9.34 mm ±10% x 14.2060 mm ± 0.384, dark red in colour, containing a transparent yellow-green solution.
Each pack contains 2 or 4 capsules in white opaque PVC/PVDC/Al blisters.

COLECALCIFEROLO DOC 100,000 IU soft capsules: soft, oblong capsules, 9.21±10% x 24.020 mm ± 0.4119, dark red in colour, containing a transparent yellow-green solution.
Each pack contains 2 or 4 capsules in white opaque PVC/PVDC/Al blisters.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano, Italy

Manufacturer
DOPPEL Farmaceutici S.r.l.
Via Martiri delle Foibe 1
29016 Cortemaggiore (PC)
Italy

Patient information leaflet

COLECALCIFEROLO DOC 10,000 IU/ml oral drops, solution

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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLECALCIFEROLO DOC is and what it is used for

COLECALCIFEROLO DOC contains the active substance colecalciferol (vitamin D).
The main function of vitamin D is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
COLECALCIFEROLO DOC is used to prevent and treat vitamin D deficiency.

2. What you need to know before taking COLECALCIFEROLO DOC

Do not take COLECALCIFEROLO DOC

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood or urine;
• if you suffer from kidney stones;
• if you have renal failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO DOC.
Your doctor may recommend taking COLECALCIFEROLO DOC for prevention of vitamin D deficiency in the following cases:

• in newborns (especially premature infants) and infants;
• during the last trimester of pregnancy;
• in breastfeeding women at the end of winter and in spring;
• in elderly people;
• in children and adolescents with insufficient sun exposure;
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet);
• in case of extensive dermatological conditions, digestive disorders, or liver insufficiency;
• in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory agents.

Inform your doctor if you are already taking other products containing vitamin D, foods or milk fortified with vitamin D, as vitamin D accumulates in the body and excessive doses may cause toxic effects.
For this reason, it is important not to exceed the recommended dose.
Your doctor will monitor you and may request blood and/or urine tests if you:

• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly person taking cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases.

Other medicines and COLECALCIFEROLO DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of COLECALCIFEROLO DOC may be influenced by other medicines. Therefore, inform your doctor if you are taking:

• medicines used to treat epilepsy;
• barbiturates (used in anesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• colestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (used to treat obesity).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if strictly necessary, due to possible teratogenic effects (fetal malformations).
Breastfeeding
Your doctor may prescribe this medicine when necessary during breastfeeding. This supplementation does not replace vitamin D administration in the newborn.
Driving and use of machines
There are no data available on the effects of this product on the ability to drive.

3. How to take COLECALCIFEROLO DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
It is recommended to take COLECALCIFEROLO DOC during meals.

Recommended dosage:

Paediatric population (< 18 years)
Newborns (0–1 year)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D3) daily.
Treatment: Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 4 drops (equivalent to 1,000 IU of vitamin D3).

Children (1–11 years)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D3) daily. From the second year of life, in the presence of multiple risk factors for vitamin D deficiency and according to the physician’s judgment, the dosage may be increased up to 3 drops daily (equivalent to 750 IU of vitamin D3).
Treatment: Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 8 drops (equivalent to 2,000 IU of vitamin D3).

Adolescents (12–17 years)
Prevention: 2–4 drops daily (equivalent to 500–1,000 IU of vitamin D3).
Treatment: 4–16 drops daily (equivalent to 1,000–4,000 IU of vitamin D3). Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 16 drops (equivalent to 4,000 IU of vitamin D3).

Pregnant women
The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D3) during the third trimester. However, in women considered to be deficient in vitamin D, a higher dose may be required (up to 2,000 IU daily – 8 drops).

Adults and elderly
Prevention: The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D3). In the presence of multiple risk factors for vitamin D deficiency, according to the physician’s judgment, the dosage may be increased up to 8 drops daily (equivalent to 2,000 IU of vitamin D3).
Treatment: 4 drops (equivalent to 1,000 IU of vitamin D3) daily. Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. Higher doses should be adjusted according to the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the patient’s response to treatment. The daily dose must not exceed 16 drops (equivalent to 4,000 IU of vitamin D3).

Instructions for use
Follow these steps to open the bottle and use the dropper:

1. Press and unscrew the cap of the bottle simultaneously;
2. Remove the cap;
3. Unscrew the protective cover of the dropper;
4. Screw the dropper onto the bottle and draw up the solution;
5. Remove the dropper and place it back into the protective cover;
6. Screw the cap back on to close the bottle.

If you take more COLECALCIFEROLO DOC than you should
If you accidentally take too much COLECALCIFEROLO DOC, contact your doctor immediately or go to the nearest hospital.
Overdose may lead to increased levels of calcium in the blood and urine, with symptoms such as: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a correlation between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Elevated calcium levels in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.

If you forget to take COLECALCIFEROLO DOC
Do not take a double dose to make up for the missed dose. Skip the missed dose and continue your treatment as usual.

If you stop taking COLECALCIFEROLO DOC
Do not stop taking COLECALCIFEROLO DOC on your own. If you have any doubts about using 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.
The side effects reported are listed below; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, urticaria;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased volume of urine excreted, renal failure;
• high levels of calcium in blood and urine.

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.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 COLECALCIFEROLO DOC

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.
After 5 months from first opening, the medicine must be discarded, even if not completely used.
Store this medicine in the original packaging to protect it from light.
Do not freeze.
Do not dispose of medicines 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 COLECALCIFEROLO DOC contains

• The active substance is colecalciferol (Vitamin D).
• 10 ml of solution contain: 2.5 mg (equivalent to 100,000 IU) of colecalciferol.
• 1 drop contains: 250 IU of colecalciferol.
• Excipients: refined olive oil

Description of the appearance of COLECALCIFEROLO DOC and package contents
Clear, pale yellow, odourless solution.
COLECALCIFEROLO DOC is available in packs containing 1 amber glass bottle with
10 ml of solution, closed with a child-resistant cap made of polypropylene and supplied with 1
dropper.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan
Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta 12, 20141 Milan
Vamfarma S.r.l. Via Kennedy, 5 , 26833 Comazzo (LO)
LACHIFARMA S.r.l. LABORATORIO CHIMICO FARMACEUTICO SALENTINO
S.S. 16 Zona Industriale 73010 Zollino Lecce

Package leaflet: information for the patient

COLECALCIFEROLO DOC 10,000 U.I./ml oral drops, solution

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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What COLECALCIFEROLO DOC is and what it is used for
2. What you need to know before taking COLECALCIFEROLO DOC
3. How to take COLECALCIFEROLO DOC
4. Possible side effects
5. How to store COLECALCIFEROLO DOC
6. Package contents and other information

1. What COLECALCIFEROLO DOC is and what it is used for

COLECALCIFEROLO DOC contains the active substance colecalciferol (vitamin D).
The main function of vitamin D is to ensure adequate absorption of calcium in the intestine and
to support proper mineralization of bones.
COLECALCIFEROLO DOC is used to prevent and treat vitamin D deficiency.

2. What you need to know before taking COLECALCIFEROLO DOC

Do not take COLECALCIFEROLO DOC

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood or urine;
• if you suffer from kidney stones;
• if you have renal failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO DOC.
Your doctor may recommend taking COLECALCIFEROLO DOC for prevention of vitamin D
deficiency:

• in newborns (especially if premature) and infants,
• during the last trimester of pregnancy,
• in breastfeeding women at the end of winter and in spring,
• in the elderly,
• in children and adolescents with insufficient sun exposure,
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet),
• in case of extensive dermatological conditions, digestive disorders, or liver insufficiency,
• in patients treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory agents.

Inform your doctor if you are already taking other products containing vitamin D, or foods or milk fortified with vitamin D, because vitamin D accumulates in the body and excessive doses may cause toxic effects.
For this reason, it is important not to exceed the recommended dose.
Your doctor will monitor you and may request blood and/or urine tests if you

• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly person being treated with cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases.

Other medicines and COLECALCIFEROLO DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of COLECALCIFEROLO DOC may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medicines for the treatment of epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if strictly necessary due to possible teratogenic effects (fetal malformations).
Breastfeeding
Your doctor may prescribe this medicine when necessary during breastfeeding. This supplementation does not replace vitamin D administration in the newborn.
Driving and using machines
There are no data available on the effects of this product on the ability to drive.

3. How to take COLECALCIFEROLO DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
It is recommended to take COLECALCIFEROLO DOC during meals.

Recommended dose:

Paediatric population (< 18 years)
Infants (0–1 year)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D3) daily.
Treatment: Your doctor will determine the appropriate dose and may later prescribe a lower dose. The daily dose must not exceed 4 drops (equivalent to 1,000 IU of vitamin D3).

Children (1–11 years)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D3) daily. From the second year of life, in the presence of multiple risk factors for vitamin D deficiency and according to the doctor’s judgment, the dosage may be increased up to 3 drops daily (equivalent to 750 IU of vitamin D3).
Treatment: Your doctor will determine the appropriate dose and may later prescribe a lower dose. The daily dose must not exceed 8 drops (equivalent to 2,000 IU of vitamin D3).

Adolescents (12–17 years)
Prevention: 2–4 drops daily (equivalent to 500–1,000 IU of vitamin D3).
Treatment: 4–16 drops daily (equivalent to 1,000–4,000 IU of vitamin D3). Your doctor will determine the appropriate dose and may later prescribe a lower dose. The daily dose must not exceed 16 drops (equivalent to 4,000 IU of vitamin D3).

Pregnant women
The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D3) during the third trimester. However, in women considered to be vitamin D deficient, a higher dose may be necessary (up to 2,000 IU daily – 8 drops).

Adults and elderly
Prevention: The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D3). In the presence of multiple risk factors for vitamin D deficiency, according to the doctor’s judgment, the dosage may be increased up to 8 drops daily (equivalent to 2,000 IU of vitamin D3).
Treatment: 4 drops (equivalent to 1,000 IU of vitamin D3) daily. Your doctor will determine the appropriate dose and may later prescribe a lower dose. Higher doses should be adjusted according to the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the patient’s response to treatment. The daily dose must not exceed 16 drops (equivalent to 4,000 IU of vitamin D3).

If you take more COLECALCIFEROLO DOC than you should
If you accidentally take an excessive dose of COLECALCIFEROLO DOC, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include elevated calcium levels in blood and urine, with symptoms such as nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the foetus: there is a known association between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Elevated maternal blood calcium levels may also lead to suppression of parathyroid function in newborns, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.

If you forget to take COLECALCIFEROLO DOC
Do not take a double dose to make up for the missed dose. Skip the forgotten dose and continue your treatment as usual.

If you stop taking COLECALCIFEROLO DOC
Do not stop taking COLECALCIFEROLO DOC on your own initiative. If you have any doubts about using 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.
The side effects reported are listed below; their frequency is not known:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, intestinal gas, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, hives;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in blood and urine.

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 through the national reporting system at
http://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 COLECALCIFEROLO DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of that month.
After 5 months from first opening, the medicine must be discarded, even if not completely used.
Store this medicine in the original packaging to protect it from light.
Do not freeze.
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 COLECALCIFEROLO DOC contains

• The active substance is colecalciferol (Vitamin D).
• 10 ml of solution contain: 2.5 mg (equivalent to 100,000 IU) of colecalciferol.
• 1 drop contains: 250 IU of colecalciferol.
• Excipients: refined olive oil

Description of the appearance of COLECALCIFEROLO DOC and package contents
Clear, pale yellow, odourless solution.
COLECALCIFEROLO DOC is available in packages containing:

• 1 amber glass bottle with 10 ml of solution, closed with a child-resistant cap made of polypropylene (with a dropper already inserted)

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano
Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta 12, 20141 Milano
Vamfarma S.r.l. Via Kennedy, 5 , 26833 Comazzo (LO)

Patient Information Leaflet

COLECALCIFEROLO DOC 25,000 IU/2.5 ml oral solution

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 their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLECALCIFEROLO DOC is and what it is used for

COLECALCIFEROLO DOC contains the active substance colecalciferol (vitamin D). The main function of vitamin D is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
COLECALCIFEROLO DOC is indicated:

• for the prevention of vitamin D deficiency in adults, but only in cases where therapeutic adherence cannot be achieved with daily administration of low doses of colecalciferol;
• for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking COLECALCIFEROLO DOC

Do not take COLECALCIFEROLO DOC

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood or urine;
• if you suffer from kidney stones;
• if you have renal failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO DOC.
Your doctor may recommend taking COLECALCIFEROLO DOC as prevention of vitamin D deficiency:

• in elderly people,
• in case of insufficient sun exposure,
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet),
• in case of extensive skin disorders, digestive diseases, or liver insufficiency,
• in patients being treated with antiepileptic drugs or undergoing long-term therapy with certain anti-inflammatory agents.

Inform your doctor if you are already taking other products containing vitamin D, or foods or milk fortified with vitamin D, since vitamin D accumulates in the body and excessive doses may cause toxic effects.
For this reason, it is important that you do not exceed the recommended dose.
Your doctor will monitor you and may request blood and/or urine tests if you

• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly person taking cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases.

Children and adolescents
COLECALCIFEROLO DOC 25,000 IU oral solution is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and COLECALCIFEROLO DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of COLECALCIFEROLO DOC may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medicines for the treatment of epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that increase urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity).

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.

Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe vitamin D only if strictly necessary due to the risk of harmful effects on the fetus (see section 3, "If you take more COLECALCIFEROLO DOC than you should").
COLECALCIFEROLO DOC 25,000 IU oral solution is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
COLECALCIFEROLO DOC 25,000 IU oral solution is not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D during breastfeeding at lower doses. This does not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are present in breast milk. This should be taken into account when giving additional vitamin D to the infant.

Driving and using machines
There are no data available on the effects of this product on the ability to drive.

3. How to take COLECALCIFEROLO DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the correct frequency of administration based on your condition.
It is recommended to take COLECALCIFEROLO DOC during meals.

Recommended dose:
Adults and elderly
Prevention: 1 single-dose container (equivalent to 25,000 IU of vitamin D3) once a month.
Treatment: 1 single-dose container (equivalent to 20,000 IU of vitamin D3) once a week for 8–12 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.

Paediatric population
The use of COLECALCIFEROLO DOC 25,000 IU oral solution is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of COLECALCIFEROLO DOC 25,000 IU oral solution is not recommended during pregnancy.

If you take more COLECALCIFEROLO DOC than you should
If you accidentally take an excessive dose of COLECALCIFEROLO DOC, contact your doctor immediately or go to the nearest hospital.
In case of overdose, elevated levels of calcium in the blood and urine may occur, with symptoms including: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may cause toxic effects in the fetus: there is a correlation between excessive maternal intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Elevated calcium levels in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.

If you forget to take COLECALCIFEROLO DOC
Do not take a double dose to make up for the missed dose. Skip the missed dose and continue your treatment as usual.

If you stop taking COLECALCIFEROLO DOC
Do not stop taking COLECALCIFEROLO DOC on your own initiative. If you have any questions about the use of 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.
The following side effects have been reported; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• excessive deposition of calcium in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in the blood and in the urine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website
http://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 COLECALCIFEROLO DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store this medicine in the original packaging to protect it from light.
Do not freeze.
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 COLECALCIFEROLO DOC contains
COLECALCIFEROLO DOC 25,000 IU/2.5 ml oral solution
In a single-dose container:

• The active substance is colecalciferol (vitamin D3) 0.625 mg, equivalent to 25,000 IU.
• Excipients: refined olive oil.

Description of the appearance of COLECALCIFEROLO DOC and contents of the pack
Clear, light yellow, odorless solution.
COLECALCIFEROLO DOC 25,000 IU/2.5 ml oral solution is available in packs containing 1, 2, or 4 single-dose amber glass containers, each containing 2.5 ml of solution, closed with a polypropylene cap.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan

Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta 12, 20141 Milan
Lachifarma S.r.l. Pharmaceutical and Chemical Laboratory Salentino - S.S. 16 Zona Industriale - 73010 Zollino (LE) – Italy
Vamfarma S.r.l. Via Kennedy, 5 26833 Comazzo (LO)

Patient information leaflet

COLECALCIFEROLO DOC 50,000 IU/2.5 ml oral solution

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 their symptoms appear to be the same as yours, as it could be harmful.
• If any adverse reaction occurs, including any not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLECALCIFEROLO DOC is and what it is used for

COLECALCIFEROLO DOC contains the active substance colecalciferol (vitamin D). The
main function of vitamin D is to ensure adequate calcium absorption in the intestine and
promote proper bone mineralization.
COLECALCIFEROLO DOC is indicated for the treatment of vitamin D deficiency in adults
(age over 18 years).

2. What you should know before taking COLECALCIFEROLO DOC

Do not take COLECALCIFEROLO DOC

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood or urine;
• if you suffer from kidney stones;
• if you have renal failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO DOC.
Inform your doctor if you are already taking other products containing vitamin D, foods or milk fortified with vitamin D, as vitamin D accumulates in the body and excessive doses may cause toxic effects.
For this reason, it is important that you do not exceed the recommended dose.
Your doctor will monitor you and may carry out blood and/or urine tests if you

• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly person being treated with cardiac glycosides or diuretics;
• have sarcoidosis or other granulomatous diseases.

Children and adolescents
COLECALCIFEROLO DOC 50,000 IU/2.5 ml oral solution is not recommended for children and adolescents aged between 0 and 18 years.

Pregnancy, breastfeeding and fertility
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe vitamin D only if strictly necessary due to the risk of harmful effects on the fetus (see section 3, “If you take more COLECALCIFEROLO DOC than you should”).
COLECALCIFEROLO DOC 50,000 IU oral solution is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
COLECALCIFEROLO DOC 50,000 IU oral solution is not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D during breastfeeding at lower doses. This does not replace vitamin D supplementation in the newborn. Vitamin D and its metabolites are present in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Other medicines and COLECALCIFEROLO DOC
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of COLECALCIFEROLO DOC may be affected by other medicines; therefore, inform your doctor if you are taking:

• medicines used to treat epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (used for the treatment of obesity).

Driving and use of machines
There are no data available on the effects of this product on the ability to drive.

3. How to take COLECALCIFEROLO DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
COLECALCIFEROLO DOC.
It is recommended to take COLECALCIFEROLO DOC during meals.
The recommended dose is:
Adults and Elderly
Treatment: 1 single-dose container (equivalent to 50,000 IU of vitamin D3) for up to 6 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.
Paediatric population
The use of COLECALCIFEROLO DOC 50,000 IU oral solution is not recommended in neonates, children, and adolescents under 18 years of age.
Pregnant women
The use of COLECALCIFEROLO DOC 50,000 IU oral solution is not recommended during pregnancy.
If you take more COLECALCIFEROLO DOC than you should
If you accidentally take an excessive dose of COLECALCIFEROLO DOC, contact your doctor immediately or go to the nearest hospital.
In case of overdose, elevated levels of calcium in the blood and urine may occur, with symptoms including: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a correlation between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Increased levels of calcium in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.
If you forget to take COLECALCIFEROLO DOC
Do not take a double dose to make up for the missed dose. Skip the forgotten dose and continue your treatment as usual.
If you stop taking COLECALCIFEROLO DOC
Do not stop taking COLECALCIFEROLO DOC on your own initiative. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects listed below have been reported; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in the blood and in the urine.

Reporting of side effects
If you experience any side effect, including any 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.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 COLECALCIFEROLO DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Store this medicine in the original packaging to protect it from light.
Do not freeze.
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 COLECALCIFEROLO DOC contains
COLECALCIFEROLO DOC 50,000 IU/2.5 ml oral solution
In a single-dose container:

• The active substance is colecalciferol (vitamin D3) 1.25 mg, equivalent to 50,000 IU.
• Excipients: refined olive oil.

Description of the appearance of COLECALCIFEROLO DOC and the contents of the pack
Clear, light yellow, odourless solution.
COLECALCIFEROLO DOC 50,000 IU/2.5 ml oral solution is available in packs containing 1, 2 or
4 single-dose amber glass containers, each containing 2.5 ml of solution, closed with a cap made of
polypropylene.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan
Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta 12, 20141 Milan
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010
Zollino (LE) – Italy
Vamfarma S.r.l., Via Kennedy, 5, 26833 Comazzo (LO)