DIVOD 10.000 IU/ML Oral drops, solution

Содержание инструкции

1. What is Colecalciferol Epifarma and what is it used for
2. What you need to know before you take Colecalciferol Epifarma
3. How to take Colecalciferolo Epifarma
4. Possible side effects
5. How to store Colecalciferolo Epifarma
6. Package Contents and Other Information
7. What is Colecalciferolo Epifarma and what is it used for
8. What you need to know before taking Colecalciferol Epifarma
9. How to take Colecalciferolo Epifarma
10. Possible side effects
11. How to store Colecalciferolo Epifarma
12. Package Contents and Other Information
13. What is Colecalciferol Epifarma and what is it used for
14. What you need to know before you take Colecalciferol Epifarma
15. How to take Colecalciferolo Epifarma
16. Possible side effects
17. How to store Colecalciferolo Epifarma
18. Contents of the pack and other information

Colecalciferol Epifarma 10,000 U.I./ml oral drops, solution
colecalciferol (vitamin D)
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Colecalciferol Epifarma and what is it used for

Colecalciferol Epifarma contains cholecalciferol, better known as vitamin D. The
main function of vitamin D is to ensure good absorption of calcium in the intestine and
promote correct mineralization of the bones.
Colecalciferol Epifarma is indicated for the prevention and treatment of vitamin D deficiency.

2. What you need to know before you take Colecalciferol Epifarma

Do not take Colecalciferol Epifarma

• if you are allergic to cholecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalcinuria);
• if you have high levels of vitamin D in the blood (hypervitaminosis D);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you suffer from a severe kidney disease (renal insufficiency) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferol Epifarma.
The doctor may advise taking Colecalciferol Epifarma as prevention of
vitamin D deficiency:

• in newborns (especially if premature) and infants,
• during the last trimester of pregnancy,
• during breastfeeding,
• in the elderly,
• in case of insufficient or ineffective sun exposure,
• in case of a special diet (e.g. low in calcium, vegetarian diet),
• in case of intense skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• liver disease (hepatic insufficiency),
• if you are being treated with antiepileptic drugs or long-term therapy with some anti-inflammatory drugs,
• if you suffer from diseases of the digestive system (intestinal malabsorption, cystic fibrosis, celiac disease).

Tell your doctor if you are already taking other products containing vitamin D, if you consume many foods known
to be a source of vitamin D (such as cod liver oil, fish and eggs), foods or milk
fortified with vitamin D because vitamin D accumulates in the body and an excessive dose can
cause toxic effects. For this reason, it is important that you do not exceed the recommended dose.
The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or
calcium in the blood and urine in the following cases:

• if you need to follow treatment with Colecalciferol Epifarma for a long period and at high doses
• if you suffer or have suffered from kidney stones
• if you suffer from kidney problems
• if you suffer from heart problems
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or with medicines that reduce blood pressure by increasing urine production (diuretics)
• if you suffer from sarcoidosis, an inflammatory disease that can affect the whole body and leads to the formation of nodules, or other granulomatous diseases. If your levels of vitamin D or calcium are high, your doctor will reduce the dose or stop treatment with Colecalciferol Epifarma.

In general, if you suffer from poor kidney function, you should undergo periodic tests to
check the levels of calcium and phosphate in the blood. If your levels of calcium and phosphate
are high, the doctor will reduce the dose or stop treatment with Colecalciferol
Epifarma.
Tell your doctor in the following cases, as an increase in dosages compared to
those indicated in section 3. “How to take Colecalciferol Epifarma” may be necessary:
if you are taking medicines used for the treatment of epilepsy (anticonvulsants) (see
section “Other medicines and Colecalciferol Epifarma”) or barbiturates (used in anesthesia);
if you are taking corticosteroids, medicines for treating inflammation (see section “Other
medicines and Colecalciferol Epifarma”);
if you are taking medicines to reduce blood fats such as colestipol, colestyramine (see section “Other medicines and Colecalciferol Epifarma”);
if you are taking medicines for the treatment of obesity such as orlistat (see section “Other
medicines and Colecalciferol Epifarma”);
if you are taking antacids containing aluminum, medicines for treating excessive acidity
in the stomach that can also rise into the esophagus (see section “Other medicines and
Colecalciferol Epifarma”);
if you suffer from diseases of the digestive system (intestinal malabsorption, cystic fibrosis or
cystic fibrosis);
if you suffer from extensive skin diseases;
if you suffer from a liver disease (hepatic insufficiency).

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

• medicines used for the treatment of epilepsy (anticonvulsants such as phenytoin) or barbiturates, medicines used in anesthesia;
• rifampicin (an antibiotic);
• medicines to reduce blood fats such as colestipol, colestyramine;
• medicines used for the treatment of obesity (orlistat);
• some laxatives (such as liquid paraffin);
• antacids containing aluminum, medicines for treating excessive acidity in the stomach that can also rise into the esophagus;
• corticosteroids, medicines for treating inflammation;
• actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole) medicines used for the treatment of fungal diseases.

Furthermore, if you are taking the following medicines, inform your doctor, who will keep you under strict control
and carefully assess whether further tests are necessary:

• thiazide diuretics, medicines for treating high blood pressure, increasing urine production;
• preparations containing high amounts of calcium;
• digitalis and other cardiac glycosides, medicines for treating some heart disorders;
• preparations containing magnesium;
• warfarin, a medicine to make the blood more fluid.

Colecalciferol Epifarma with food and drink and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods fortified with
vitamin D or if you use milk enriched with vitamin D, so that they can take into account
the total dose of vitamin D you are taking and avoid an excessive dose.
The consumption of high amounts of alcohol for a long time (chronic alcoholism) decreases the reserves
of vitamin D in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if deemed
strictly necessary, due to the risk of harmful effects to the fetus (see section 3. “If you take more
Colecalciferol Epifarma than you should”).
Breastfeeding
When necessary, your doctor will prescribe this medicine during breastfeeding. This does
not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are
found in breast milk. This aspect must be taken into consideration when
administering further vitamin D to the child.
Fertility
There are no data on the effects of vitamin D on fertility. No adverse effects on fertility have been reported
however, for blood levels of vitamin D within the normal range.

Driving and operating machinery
There are no data on the effects of the product on the ability to drive vehicles or operate
machinery.

3. How to take Colecalciferolo Epifarma

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The doses and duration of treatment will be evaluated by the doctor based on your health condition.
Do not exceed the doses indicated by the doctor.
The doses must be taken orally. It is recommended to take Colecalciferolo Epifarma
during meals.

Adults and the elderly

Prevention:the recommended dose is 3-4 drops per day (equal to 750-1,000 IU of vitamin D). In
the presence of many risk factors for vitamin D deficiency, at the doctor's discretion, the
dosage may be increased up to 8 drops per day (equal to 2,000 IU of vitamin D).

Treatment:4 drops (equal to 1,000 IU of vitamin D) per day. The doctor will establish the appropriate dose
for you and may subsequently prescribe a lower dose. Higher doses must be
adjusted according to serum levels of 25-hydroxycholecalciferol (25 (OH) D) that you wish to
achieve, the severity of the disease and the patient's response to treatment. The daily dose
should not exceed 16 drops per day (equal to 4,000 IU of vitamin D).

Paediatric population (< 18 years)
Infants (0-1 year)

Prevention:1-2 drops (equal to 250-500 IU of vitamin D) per day.

Treatment:The doctor will establish the appropriate dose and may subsequently prescribe a lower dose.
The daily dose should not exceed 4 drops per day (1,000 IU of vitamin D).

Children (1-11 years)

Prevention:1-2 drops (equal to 250-500 IU of vitamin D) per day. From the second year of life, in
the presence of many risk factors for vitamin D deficiency and at the doctor's discretion, the
dosage may be increased up to 3 drops per day (equal to 750 IU of vitamin D3).

Treatment:The doctor will establish the appropriate dose and may subsequently prescribe a lower dose.
The daily dose should not exceed 8 drops per day (equal to 2,000 IU of vitamin D).

Adolescents (12-17 years)

Prevention:2-4 drops per day (equal to 500-1,000 IU of vitamin D).

Treatment:4-16 drops per day (equal to 1,000-4,000 IU of vitamin D). The doctor will establish the
appropriate dose and may subsequently prescribe a lower dose. The daily dose should not
exceed 16 drops per day (equal to 4,000 IU of vitamin D).

Pregnant women
The recommended dose is 3-4 drops per day (equal to 750-1,000 IU of vitamin D) in the
last trimester. However, in women considered deficient in vitamin D, a higher dose may be necessary
(up to 2,000 IU per day – 8 drops).

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

• 1. press and unscrew the bottle cap simultaneously;
• 2. remove the cap;
• 3. unscrew the protective cap of the dropper;
• 4. screw the dropper onto the bottle and take the contents;
• 5. remove the dropper and put it back in the protective cap;
• 6. screw the cap back on to close the bottle

If you take more Colecalciferolo Epifarma than you should
In case of accidental ingestion/intake of an excessive dose of Colecalciferolo Epifarma
immediately inform your doctor or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood and urine may occur, the
symptoms of which are as follows: nausea, vomiting, thirst, intense thirst (polydipsia), increased amount of
urine excreted (polyuria), constipation and dehydration.
Chronic excessive dosages can lead to calcium salt deposits in blood vessels and
organs.
The use of an excessive dose of vitamin D in the first 6 months of pregnancy can cause serious
damage to the fetus and newborn.

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

If you stop taking Colecalciferolo Epifarma
If you have any doubts 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 the use of vitamin D are the following:

Uncommon(may affect up to 1 in 100 people)

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

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

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

Not known(frequency cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-
reazioni.By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Colecalciferolo Epifarma

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 pack after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store at a temperature below 30°C.
Store in the original packaging to protect the medicine from light.
The validity of the medicine after first opening of the bottle is 5 months (write the date of first
opening in the designated space on the package).
After this period, any remaining medicine must be disposed of.

6. Package Contents and Other Information

What Colecalciferolo Epifarma Contains

• The active ingredient is colecalciferol (vitamin D): 10 ml of solution contains 2.5 mg (equivalent to
• 100,000 I.U.) of colecalciferol. 1 drop contains: 250 I.U. of vitamin D.
• The other component is refined olive oil.

Description of the Appearance of Colecalciferolo Epifarma and Package Contents
Colecalciferolo Epifarma appears as a transparent, clear colorless or yellowish-
greenish solution, contained in an amber glass bottle, closed with a child-resistant polypropylene cap.
It is available in packs of 1 bottle of 10 ml and 1 glass dropper.

Marketing Authorisation Holder
Epifarma S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ), Italy

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

ColecalciferoloEpifarma 25,000 I.U. oral solution in single-dose container
colecalciferol (vitamin D)
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• the prevention of vitamin D deficiency in adults only in cases where therapeutic adherence is not achieved with the 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 Colecalciferol Epifarma

Do not take Colecalciferol Epifarma

• if you are allergic to cholecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalcinuria);
• if you have high levels of vitamin D in the blood (hypervitaminosis D);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you suffer from a severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferol Epifarma.
The doctor may recommend taking Colecalciferol Epifarma as prevention of
vitamin D deficiency:

• in the elderly,
• in case of insufficient or ineffective sun exposure,
• in case of a special diet (e.g. low in calcium, vegetarian diet),
• in case of intense skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), liver diseases (hepatic insufficiency),
• if you are being treated with antiepileptic drugs or long-term therapy with some anti-inflammatory drugs,
• if you suffer from diseases of the digestive system (intestinal malabsorption, cystic fibrosis, celiac disease).

Tell your doctor if you are already taking other products containing vitamin D, if you consume many foods known
to be a source of vitamin D (such as cod liver oil, fish and eggs), foods or milk
fortified with vitamin D because vitamin D accumulates in the body and an excessive dose can
cause toxic effects. For this reason, it is important that you do not exceed the recommended dose.
The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or
calcium in the blood and urine in the following cases:

• if you have to follow treatment with Colecalciferol Epifarma for a long period and at high doses
• if you suffer or have suffered from kidney stones
• if you suffer from kidney problems
• if you suffer from heart problems
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics)
• if you suffer from sarcoidosis, an inflammatory disease that can affect the whole body and leads to the formation of nodules, or other granulomatous diseases. If your levels of vitamin D or calcium are high, your doctor will reduce the dose or stop treatment with Colecalciferol Epifarma.

In general, if you suffer from poor kidney function, you will need to undergo periodic tests to
check the levels of calcium and phosphate in the blood. If your levels of calcium and phosphate
are high, the doctor will reduce the dose or stop treatment with Colecalciferol
Epifarma.
Tell your doctor in the following cases, as a dose increase compared to
those indicated in section 3. “How to take Colecalciferol Epifarma” may be necessary:
if you are taking medicines used for the treatment of epilepsy (anticonvulsants)
(see section “Other medicines and Colecalciferol Epifarma”) or barbiturates (used in
anesthesia);
if you are taking corticosteroids, medicines to treat inflammation (see section “Other
medicines and ColecalciferolEpifarma”);
if you are taking medicines to reduce blood fats such as colestipol,
cholestyramine (see section “Other medicines and Colecalciferol Epifarma”);
if you are taking medicines for the treatment of obesity such as orlistat (see section
“Other medicines and Colecalciferol Epifarma”);
if you are taking antacids containing aluminum, medicines to treat an excessive presence
of acid in the stomach that can also rise into the esophagus (see section “Other medicines and
Colecalciferol Epifarma”);
if you suffer from diseases of the digestive system (intestinal malabsorption, cystic fibrosis or
fibrotic cystis);
if you suffer from extensive skin diseases;
if you suffer from a liver disease (hepatic insufficiency).
Children and adolescents
Colecalciferol Epifarma 25,000 I.U. oral solution is not recommended in children and
adolescents between 0 and 18 years of age.

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

• medicines used for the treatment of epilepsy (anticonvulsants such as phenytoin) or barbiturates, medicines used in anesthesia;
• rifampicin (an antibiotic);
• medicines to reduce blood fats such as colestipol, cholestyramine;
• medicines used for the treatment of obesity (orlistat);
• some laxatives (such as liquid paraffin);
• antacids containing aluminum, medicines to treat an excessive presence of acid in the stomach that can also rise into the esophagus;
• corticosteroids, medicines to treat inflammation;
• actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole) medicines used for the treatment of fungal diseases.

Also, if you are taking the following medicines, tell your doctor, who will keep you under close control
and carefully assess whether further tests are necessary:

• thiazide diuretics, medicines to treat high blood pressure, increasing urine production;
• preparations containing high amounts of calcium;
• digitalis and other cardiac glycosides, medicines to treat some heart disorders;
• preparations containing magnesium;
• warfarin, medicine to make the blood more fluid.

Colecalciferol Epifarma with food and drink and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods fortified with
vitamin D or if you are using milk enriched with vitamin D, so that they can take into account
the total dose of vitamin D you are taking and avoid an excessive dose.
The consumption of high amounts of alcohol for a long time (chronic alcoholism) decreases the reserves
of vitamin D in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, the doctor will prescribe vitamin D only if strictly necessary, due to the risk of harmful effects to the fetus (see section 3. “If you take more
Colecalciferol Epifarma than you should”).
Colecalciferol Epifarma 25,000 I.U. oral solution is not recommended during pregnancy.
However, vitamin D deficiency is harmful to both mother and fetus, so when necessary
the doctor will prescribe vitamin D during pregnancy at lower doses.
Breastfeeding
Colecalciferol Epifarma 25,000 I.U. oral solution is not recommended during breastfeeding.
When necessary, the 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 found in breast milk. This aspect must be taken into consideration when
administering further vitamin D to the baby.
Fertility
There are no data on the effects of vitamin D on fertility. No adverse effects on fertility have been reported
however, for blood levels of vitamin D within the normal range.

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

3. How to take Colecalciferolo Epifarma

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The doses and duration of treatment will be evaluated by the doctor based on your state of health.
Do not exceed the doses indicated by the doctor.
The doses must be taken orally. It is recommended to take Colecalciferolo Epifarma
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. The doctor will establish the appropriate dose for you and may subsequently prescribe a
lower dose.

Paediatric population
The use of Colecalciferolo Epifarma 25,000 IU oral solution is not recommended in infants,
children and adolescents under the age of 18 years.

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

If you take more Colecalciferolo Epifarma than you should
In case of accidental ingestion/intake of an excessive dose of Colecalciferolo Epifarma
immediately inform your doctor or go to the nearest hospital.
In case of overdose, an increase in calcium levels in the blood and urine may occur, the
symptoms of which are as follows: nausea, vomiting, thirst, intense thirst (polydipsia), increased amount of
urine excreted (polyuria), constipation and dehydration.
Chronic excessive dosages can lead to deposits of calcium salts in blood vessels and in
organs.
The use of an excessive dose of vitamin D during the first 6 months of pregnancy can cause serious
damage to the fetus and newborn.

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

If you stop taking Colecalciferolo Epifarma
If you have any doubts 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 the use of vitamin D are as follows:

Uncommon(may affect up to 1 in 100 people)

• high levels of calcium in the blood (hypercalcemia, which can only occur in case of overdose or following prolonged and uncontrolled use leading to excessive vitamin accumulation) 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, confused state
• constipation, gas emission (flatulence), stomach pain, nausea, diarrhea
• skin rash, itching, hives.

Not known(frequency cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 Epifarma

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 pack after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
Store at a temperature below 30°C.
Store in the original package to keep the medicine protected from light.

6. Package Contents and Other Information

What Colecalciferolo Epifarma contains

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

Description of the appearance of Colecalciferolo Epifarma and contents of the pack
Colecalciferolo Epifarma presents as a transparent, clear colorless or yellowish-
greenish solution, contained in an amber glass container, closed with a polypropylene capsule.
It is available in packs of 1, 2 or 4 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Epifarma S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ), Italy

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 (Milano)- Italy

Colecalciferolo Epifarma 50,000 I.U. oral solution in single-dose container
colecalciferol (vitamin D)
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Colecalciferol Epifarma and what is it used for

Colecalciferol Epifarma contains cholecalciferol, better known as vitamin D. The
main function of vitamin D is to ensure good absorption of calcium in the intestine and
promote correct mineralisation of the bones.
Colecalciferol Epifarma is indicated for the treatment of vitamin D deficiency in adults (age
over 18 years).

2. What you need to know before you take Colecalciferol Epifarma

Do not take Colecalciferol Epifarma

• if you are allergic to cholecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalcinuria);
• if you have high levels of vitamin D in the blood (hypervitaminosis D);
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis);
• if you suffer from a severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).

Warnings and precautions
Consult your doctor or pharmacist before taking Colecalciferol Epifarma.
Tell your doctor if you are already taking other products containing vitamin D, if you consume many foods known
to be a source of vitamin D (such as cod liver oil, fish and eggs), foods or milk
fortified with vitamin D because vitamin D accumulates in the body and an excessive dose can
cause toxic effects. For this reason, it is important that you do not exceed the recommended dose.
Your doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or
calcium in the blood and urine in the following cases:

• if you need to follow treatment with Colecalciferol Epifarma for a long period and with high doses
• if you suffer or have suffered from kidney stones
• if you suffer from kidney problems
• if you suffer from heart problems
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or with medicines that reduce blood pressure by increasing urine production (diuretics)
• if you suffer from sarcoidosis, an inflammatory disease that can affect the whole body and leads to the formation of nodules, or other granulomatous diseases. If your levels of vitamin D and calcium are high, your doctor will reduce the dose or stop treatment with Colecalciferol Epifarma.

In general, if you suffer from poor kidney function, you should undergo periodic tests to
check the levels of calcium and phosphate in the blood. If your levels of calcium and phosphate
are high, the doctor will reduce the dose or stop treatment with Colecalciferol
Epifarma.
Tell your doctor in the following cases, as it may be necessary to increase the dosages compared to
those indicated in section 3. “How to take Colecalciferol Epifarma”:
if you are taking medicines used for the treatment of epilepsy (anticonvulsants) (see
section “Other medicines and Colecalciferol Epifarma”) or barbiturates (used in anesthesia);
if you are taking corticosteroids, medicines to treat inflammation (see section “Other
medicines and Colecalciferol Epifarma”);
if you are taking medicines to reduce blood fats such as colestipol,
cholestyramine (see section “Other medicines and Colecalciferol Epifarma”);
if you are taking medicines for the treatment of obesity such as orlistat (see section “Other
medicines and Colecalciferol Epifarma”);
if you are taking antacids containing aluminum, medicines to treat an excessive presence
in the stomach of acid that can also rise into the esophagus (see section “Other medicines and
Colecalciferol Epifarma”);
if you suffer from diseases of the digestive system (intestinal malabsorption, cystic fibrosis or
cystic fibrosis);
if you suffer from extensive skin diseases;
if you suffer from a liver disease (hepatic insufficiency).

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

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

• medicines used for the treatment of epilepsy (anticonvulsants such as phenytoin) or barbiturates, medicines used in anesthesia;
• rifampicin (an antibiotic);
• medicines to reduce blood fats such as colestipol, cholestyramine;
• medicines used for the treatment of obesity (orlistat);
• some laxatives (such as liquid paraffin);
• antacids containing aluminum, medicines to treat an excessive presence in the stomach of acid that can also rise into the esophagus;
• corticosteroids, medicines to treat inflammation;
• actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole) medicines used for the treatment of fungal diseases.

In addition, if you are taking the following medicines, inform your doctor, who will keep you under close control
and carefully assess whether further tests are necessary:

• thiazide diuretics, medicines to treat high blood pressure, increasing urine production;
• preparations containing high amounts of calcium;
• digitalis and other cardiac glycosides, medicines to treat some heart disorders;
• preparations containing magnesium;
• warfarin, a medicine to make the blood more fluid.

Colecalciferol Epifarma with food and drink and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods fortified with
vitamin D or if you are using milk enriched with vitamin D, so that they can take into account
the total dose of vitamin D you are taking and avoid an excessive dose.
Consumption of high amounts of alcohol for a long time (chronic alcoholism) decreases the reserves
of vitamin D in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, the doctor will prescribe vitamin D only if deemed
strictly necessary, due to the risk of harmful effects to the fetus (see section 3. “If you take
more Colecalciferol Epifarma than you should”).
Colecalciferol Epifarma 50,000 IU oral solution is not recommended during pregnancy.
However, vitamin D deficiency is harmful to both mother and fetus, so when necessary
your doctor will prescribe vitamin D during pregnancy at lower doses.
Breastfeeding
Colecalciferol Epifarma 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 in the newborn. Vitamin D and its
metabolites are found in breast milk. This aspect must be taken into consideration when
administering further vitamin D to the baby.
Fertility
There are no data on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported
for blood vitamin D levels within the normal range.

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

3. How to take Colecalciferolo Epifarma

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The doses and duration of treatment will be evaluated by the doctor based on your state of health.
Do not exceed the doses indicated by the doctor.
The doses must be taken orally. It is recommended to take Colecalciferolo Epifarma
during meals.

Adults and the elderly
1 single-dose container (equivalent to 50,000 IU of vitamin D) once a week for a maximum of
6 weeks. The doctor will establish the appropriate dose for you and may subsequently prescribe a
lower dose.

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

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

If you take more Colecalciferolo Epifarma than you should
In case of accidental ingestion/intake of an excessive dose of Colecalciferolo Epifarma
immediately inform your doctor or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood and urine may occur, the
symptoms of which are as follows: nausea, vomiting, thirst, intense thirst (polydipsia), increased amount of
urine excreted (polyuria), constipation and dehydration.
Chronic excessive dosages can lead to deposits of calcium salts in the blood vessels and in the
organs.
The use of an excessive dose of vitamin D during the first 6 months of pregnancy can cause serious
damage to the fetus and newborn.

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

If you stop taking Colecalciferolo Epifarma
If you have any doubts 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 the use of vitamin D are the following:

Uncommon(may affect up to 1 in 100 people)

• high levels of calcium in the blood (hypercalcemia, which can only occur in case of overdose or following prolonged and 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, confused state
• constipation, passing gas (flatulence), stomach pain, nausea, diarrhea
• skin rash, itching, hives.

Not known(frequency cannot be estimated based on available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through 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 Epifarma

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 pack after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store at a temperature below 30°C.
Store in the original package to keep the medicine protected from light.

6. Contents of the pack and other information

What Colecalciferolo Epifarma contains

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

Description of the appearance of Colecalciferolo Epifarma and contents of the pack
Colecalciferolo Epifarma presents as a transparent, clear colorless or yellowish-
greenish solution, contained in an amber glass container, closed with a polypropylene capsule.
It is available in packs of 1, 2 or 4 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Epifarma S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ), Italy

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 (Milano)- Italy