Colecalciferol Pensapreparations

Package leaflet: Information for the patient

Colecalciferolo Pensa 50,000 IU/2.5 ml oral solution

colecalciferol (vitamin D )
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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Colecalciferolo Pensa contains colecalciferol, better known as 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 Pensa 50,000 IU/2.5 ml oral solution is indicated for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking Colecalciferol Pensa

Do not take Colecalciferol Pensa

• if you are allergic to colecalciferol (vitamin D) 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 have high levels of vitamin D in your blood (hypervitaminosis D);
• if you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you have severe kidney disease (renal failure) (see section "Warnings and precautions");

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferol Pensa.
Inform your doctor if you are already taking other products containing vitamin D, or if you consume many foods known to be sources of vitamin D (such as fish liver oil, fish, and eggs), 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 may prescribe periodic blood tests to monitor your vitamin D levels or calcium levels in blood and urine in the following cases:

• if you need to take Colecalciferol Pensa for a long time and at high doses;
• if you have or have had kidney stones;
• if you have kidney problems;
• if you have heart problems;
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that can affect the whole 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 stop treatment with Colecalciferol Pensa.

In general, you should not take Colecalciferol Pensa if you have impaired kidney function (see section "Do not take Colecalciferol Pensa"); however, if your doctor considers treatment with Colecalciferol Pensa to be absolutely necessary, periodic blood tests will be required to monitor calcium and phosphate levels. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Colecalciferol Pensa.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 "How to take Colecalciferol Pensa" may be required:

• if you are taking medicines used to treat epilepsy (anticonvulsants) (see section "Other medicines and Colecalciferol Pensa") or barbiturates (used in anaesthesia);
• if you are taking corticosteroids, medicines used to treat inflammation (see section "Other medicines and Colecalciferol Pensa");
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section "Other medicines and Colecalciferol Pensa");
• if you are taking medicines for obesity such as orlistat (see section "Other medicines and Colecalciferol Pensa");
• 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 Colecalciferol Pensa");
• if you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
• if you have liver problems (hepatic insufficiency);
• if you are obese.

Children and adolescents
Colecalciferol Pensa 50,000 IU oral solution is not recommended in children and adolescents aged 0 to 18 years.

Other medicines and Colecalciferol Pensa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines, as they may reduce the effect of Colecalciferol Pensa:

• medicines used to treat epilepsy (anticonvulsants such as, for example, phenytoin) or barbiturates, medicines used in anaesthesia;
• rifampicin (an antibiotic);
• medicines used to lower blood lipids such as colestipol, cholestyramine;
• medicines used to treat obesity (orlistat);
• certain laxatives (such as liquid paraffin);
• antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus;
• corticosteroids, medicines used to treat inflammation;
• actinomycin (a medicine used to treat certain forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole), medicines used to treat fungal diseases.

Moreover, if you are taking the following medicines, inform your doctor, who will keep you under close monitoring and carefully evaluate whether additional tests are needed:

• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
• calcium-containing preparations;
• digitalis and other cardiac glycosides, medicines used to treat certain heart disorders;
• magnesium-containing preparations;
• warfarin, a medicine used to make blood less prone to clotting.

Colecalciferol Pensa with food, drinks and alcohol
Inform your doctor if you are taking other products already containing vitamin D, foods fortified with vitamin D, or if you are using vitamin D-enriched milk, so that your total vitamin D intake can be taken into account and excessive dosing avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice 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 foetus (see section 3 "If you take more Colecalciferol Pensa than you should").
Colecalciferol Pensa 50,000 IU oral solution is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
Colecalciferol Pensa 50,000 IU oral solution is not recommended during breastfeeding.
When necessary, your doctor will 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 excreted in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Fertility
The effect of high doses of vitamin D on fertility is unknown.

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

3. How to take Colecalciferolo Pensa

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor based on your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Colecalciferolo Pensa during meals. The single-dose container must be used for a single administration, making sure to take the entire dose.

Recommended dose:
Adults and elderly
1 single-dose container (equivalent to 50,000 IU of 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.

Paediatric population
The use of Colecalciferolo Pensa 50,000 IU oral solution is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of Colecalciferolo Pensa 50,000 IU oral solution is not recommended during pregnancy.

If you take more Colecalciferolo Pensa than you should
In case of accidental ingestion/overdose of Colecalciferolo Pensa, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Excessive intake of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.

If you forget to take Colecalciferolo Pensa
Do not take a double dose to make up for the missed dose.

If you stop taking Colecalciferolo Pensa
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 side effects reported with vitamin D use are as follows:

Uncommon (may affect up to 1 in 100 people)

• high levels of calcium in the blood (hypercalcemia, which may occur only in case of overdose or prolonged, uncontrolled use leading to excessive accumulation of vitamin) and in the urine (hypercalciuria)

Rare (may affect up to 1 in 1,000 people)

• allergic reactions
• weakness (asthenia), loss of appetite (anorexia), thirst
• drowsiness, confusion
• constipation, gas (flatulence), stomach pain, nausea, diarrhoea
• skin rash, itching, hives (urticaria)

Not known (frequency cannot be estimated from the available data)

• headache
• vomiting, metallic taste (dysgeusia), dry mouth
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output (polyuria), intense thirst (polydipsia), kidney disease (renal failure)

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

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.
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.
Store below 30°C.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What Colecalciferolo Pensa contains

• The active substance is colecalciferol (vitamin D): one single-dose container with 2.5 ml of solution contains 1.25 mg (corresponding to 50,000 IU) of colecalciferol.
• The other component is refined olive oil.

Description of the appearance of Colecalciferolo Pensa and contents of the pack
Colecalciferolo Pensa is a clear, colourless or slightly yellowish-green transparent solution, contained in an amber glass container closed with a cap made of polypropylene and an inner seal made of polyethylene.
It is available in packs containing 1, 2 or 4 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder
FG S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ)
Manufacturer

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy.
• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (Milan) - Italy
• Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy

Patient information leaflet

COLECALCIFEROLO PENSA 25,000 IU/2.5 ml oral solution

colecalciferol (vitamin D)
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, 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 PENSA is and what it is used for
2. What you need to know before taking COLECALCIFEROLO PENSA
3. How to take COLECALCIFEROLO PENSA
4. Possible side effects
5. How to store COLECALCIFEROLO PENSA
6. Contents of the pack and other information

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

COLECALCIFEROLO PENSA contains colecalciferol, better known as vitamin D.
The main function of vitamin D is to ensure proper calcium absorption in the intestine and to promote correct bone mineralization.
COLECALCIFEROLO PENSA is indicated for:

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

2. What you need to know before taking COLECALCIFEROLO PENSA

Do not take COLECALCIFEROLO PENSA

• if you are allergic to colecalciferol (vitamin D) 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 kidney disease (renal failure) (see section "Warnings and precautions").

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

• in the elderly,
• in case of insufficient sun exposure,
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet),
• in case of dark skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• digestive disorders or liver diseases (hepatic insufficiency),
• in patients 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, vitamin D-fortified foods or milk, 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 may prescribe periodic blood or urine tests to monitor vitamin D levels or calcium levels in the following cases:

• if you need to take COLECALCIFEROLO PENSA for a long time and at high doses,
• if you have or have had kidney stones,
• if you have kidney problems,
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics),
• if you have sarcoidosis, an inflammatory disease that can affect the whole body and leads to nodule formation, or other granulomatous diseases. If your vitamin D or calcium levels are high, your doctor will reduce the dose or stop treatment with COLECALCIFEROLO PENSA.

In general, you should not take COLECALCIFEROLO PENSA if you have impaired kidney function (see section "Do not take COLECALCIFEROLO PENSA"); however, if your doctor considers treatment with COLECALCIFEROLO PENSA absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are high, your doctor will reduce the dose or discontinue treatment with COLECALCIFEROLO PENSA.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 "How to take COLECALCIFEROLO PENSA" may be needed:

• if you are taking medicines used to treat epilepsy (anticonvulsants) (see section "Other medicines and COLECALCIFEROLO PENSA") or barbiturates (used in anesthesia);
• if you are taking corticosteroids, medicines used to treat inflammation (see section "Other medicines and COLECALCIFEROLO PENSA");
• if you are taking medicines to lower blood fats such as colestipol, cholestyramine (see section "Other medicines and COLECALCIFEROLO PENSA");
• if you are taking medicines for obesity such as orlistat (see section "Other medicines and COLECALCIFEROLO PENSA");
• 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 PENSA");
• if you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis);
• if you have liver disease (hepatic insufficiency).

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

Other medicines and COLECALCIFEROLO PENSA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines, as they may reduce the effect of COLECALCIFEROLO PENSA:

• medicines used to treat epilepsy (anticonvulsants) or barbiturates, medicines used in anesthesia,
• rifampicin (an antibiotic),
• medicines to lower blood fats such as colestipol, cholestyramine,
• medicines used to treat obesity (orlistat),
• antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus,
• corticosteroids, medicines used to treat inflammation.

Additionally, if you are taking any of the following medicines, inform your doctor, who will keep you under close monitoring and carefully evaluate whether further tests are needed:

• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production,
• digitalis, a medicine used to treat certain heart conditions,
• magnesium-containing preparations,
• warfarin, a medicine used to make blood less likely to clot.

COLECALCIFEROLO PENSA with food, drink and alcohol
Inform your doctor if you are taking other products already containing vitamin D, vitamin D-fortified foods, or if you are consuming vitamin D-enriched milk, so that the total daily intake of vitamin D can be taken into account and excessive dosing avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, 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 foetus (see section 3 "If you take more COLECALCIFEROLO PENSA than you should").
COLECALCIFEROLO PENSA 25,000 IU oral solution is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and foetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
COLECALCIFEROLO PENSA 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 vitamin D supplementation in 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.

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

3. How to take COLECALCIFEROLO PENSA

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor based on your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take COLECALCIFEROLO PENSA during meals.

Adults and elderly
Prevention: 1 single-dose container (equivalent to 25,000 IU of vitamin D) once a month.
Treatment: 1 single-dose container (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 PENSA 25,000 IU oral solution is not recommended in neonates, children, and adolescents under 18 years of age.

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

If you take more COLECALCIFEROLO PENSA than you should
In case of accidental ingestion or overdose of COLECALCIFEROLO PENSA, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include increased levels of calcium in the blood and urine, with symptoms such as nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Taking an excessive dose of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.

If you forget to take COLECALCIFEROLO PENSA
Do not take a double dose to make up for the missed dose.

If you stop taking COLECALCIFEROLO PENSA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The adverse reactions reported with vitamin D use are as follows:

• allergic reactions
• weakness, loss of appetite (anorexia), thirst
• drowsiness, confusion
• headache
• constipation, gas (flatulence), stomach pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth
• skin rash, itching, urticaria
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output (polyuria), intense thirst (polydipsia), kidney disease (renal failure)
• high levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store COLECALCIFEROL PENSA

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.
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.
Store below 30°C.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What COLECALCIFEROLO PENSA contains

• The active substance is colecalciferol (vitamin D): one single-dose container of 2.5 ml of solution contains 0.625 mg (equivalent to 25,000 IU) of colecalciferol.
• The other component is refined olive oil.

Description of the appearance of COLECALCIFEROLO PENSA and contents of the pack
COLECALCIFEROLO PENSA is a solution contained in an amber glass container, closed with a cap made of polypropylene.
It is available in packs containing 1, 2 or 4 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder
FG S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy.
• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (Milan) - Italy
• Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy

Patient information leaflet

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

colecalciferol (vitamin D)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

COLECALCIFEROLO PENSA contains colecalciferol, better known as 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 PENSA is indicated for the prevention and treatment of
vitamin D deficiency.

2. What you need to know before taking COLECALCIFEROLO PENSA

Do not take COLECALCIFEROLO PENSA

• if you are allergic to colecalciferol (vitamin D) 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 kidney disease (renal failure) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO PENSA.
Your doctor may recommend taking COLECALCIFEROLO PENSA 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 case of insufficient sun exposure, particularly in children and adolescents,
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet),
• in case of dark skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• gastrointestinal disorders or liver disease (hepatic insufficiency),
• in patients 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, vitamin D-fortified foods or milk, 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 may prescribe periodic blood or urine tests to monitor your vitamin D levels or calcium levels in the following cases:

• if you need to take COLECALCIFEROLO PENSA for a long time and at high doses,
• if you have or have had kidney stones,
• if you have kidney problems,
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics),
• if you have 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 PENSA.

In general, you should not take COLECALCIFEROLO PENSA if you have impaired kidney function (see section “Do not take COLECALCIFEROLO PENSA”); however, if your doctor considers treatment with COLECALCIFEROLO PENSA absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or stop treatment with COLECALCIFEROLO PENSA.

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

• if you are taking antiepileptic medicines (anticonvulsants) (see section “Other medicines and COLECALCIFEROLO PENSA”) or barbiturates (used in anesthesia);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and COLECALCIFEROLO PENSA”);
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and COLECALCIFEROLO PENSA”);
• if you are taking medicines for obesity such as orlistat (see section “Other medicines and COLECALCIFEROLO PENSA”);
• if you are taking aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus (see section “Other medicines and COLECALCIFEROLO PENSA”);
• if you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis);
• if you have liver disease (hepatic insufficiency).

Other medicines and COLECALCIFEROLO PENSA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor if you are taking the following medicines, as they may reduce the effect of COLECALCIFEROLO PENSA:

• medicines used to treat epilepsy (anticonvulsants) or barbiturates, medicines used in anesthesia,
• rifampicin (an antibiotic),
• medicines to lower blood fats such as colestipol, cholestyramine,
• medicines used to treat obesity (orlistat),
• aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus,
• corticosteroids, medicines used to treat inflammation.

Additionally, if you are taking any of the following medicines, inform your doctor, who will monitor you closely and carefully evaluate whether further tests are needed:

• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production,
• digitalis, medicines used to treat certain heart conditions,
• magnesium-containing preparations,
• warfarin, a medicine used to make blood less likely to clot.

COLECALCIFEROLO PENSA with food, drinks and alcohol
Inform your doctor if you are taking other products already containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk, so that the total intake of vitamin D can be taken into account to avoid excessive dosing.

Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan 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 the risk of harmful effects on the fetus (see section 3. “If you take more COLECALCIFEROLO PENSA than you should”).

Breastfeeding
If necessary, your doctor may prescribe this medicine during breastfeeding. However, this does not replace the need for vitamin D supplementation in the newborn.

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

3. How to take COLECALCIFEROLO PENSA

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by the doctor according to your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take COLECALCIFEROLO PENSA during meals.

Paediatric population (<18 years)

Newborns (0-1 year)
Prevention: 1-2 drops (equivalent to 250-500 IU of vitamin D) daily.
Treatment: The 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 D).

Children (1-11 years)
Prevention: 1-2 drops (equivalent to 250-500 IU of vitamin D) 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 D).
Treatment: The 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 D).

Adolescents (12-17 years)
Prevention: 2-4 drops daily (equivalent to 500-1,000 IU of vitamin D).
Treatment: 4-16 drops daily (equivalent to 1,000-4,000 IU of vitamin D). The 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 D).

Pregnant women
The recommended dose is 3-4 drops daily (equivalent to 750-1,000 IU of vitamin D) during the third trimester. However, in women considered 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 D). 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 D).
Treatment: 4 drops (equivalent to 1,000 IU of vitamin D) daily. The doctor will determine the appropriate dose and may subsequently prescribe a lower dose. Higher doses must 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 D).

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

1. press and unscrew the cap simultaneously;
2. remove the cap;
3. unscrew the protective cover of the dropper;
4. screw the dropper onto the bottle and draw up the content;
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 PENSA than you should
In case of accidental ingestion or overdose of COLECALCIFEROLO PENSA, 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 including: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation, and dehydration.
Chronic excessive dosing may result in calcium salt deposits in blood vessels and organs.
Excessive intake of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.

If you forget to take COLECALCIFEROLO PENSA
Do not take a double dose to make up for the missed dose.

If you stop taking COLECALCIFEROLO PENSA
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 may cause side effects, although not everybody gets them.
The side effects reported with vitamin D use are the following:

• allergic reactions
• weakness, loss of appetite (anorexia), thirst
• drowsiness, confusion
• headache
• constipation, gas (flatulence), stomach pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth
• skin rash, itching, hives
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased amount of urine excreted (polyuria), intense thirst (polydipsia), kidney disease (renal failure)
• high levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 COLECALCIFEROL PENSA

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 dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.
Store below 30°C.
Keep in the original packaging to protect the medicine from light.
The shelf life of the medicine after first opening the bottle is 5 months (record the date of first
opening in the designated space on the carton).
After this period, any remaining medicine must be discarded.

6. Package contents and other information

What COLECALCIFEROLO PENSA 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 vitamin D.
• The other component is refined olive oil.

Description of the appearance of COLECALCIFEROLO PENSA and contents of the pack
COLECALCIFEROLO PENSA is a solution contained in an amber glass bottle, closed with a child-resistant cap made of polypropylene.
It is available in a pack containing 1 bottle of 10 ml and 1 dropper.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
FG S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy.
• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (Milan) - Italy
• Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO) - Italy