DIBASE <10.000 U.I./ml Roztwór doustny

Treść ulotki

1. DIBASE 100.000 U.I./ml injectable solution, 300.000 U.I./ml injectable solution
   1. What is DIBASE and what is it used for
   2. What you need to know before you take DIBASE
   3. How to take DIBASE
   4. Possible side effects
   5. How to store DIBASE
   6. Contents of the pack and other information
2. DIBASE 50.000 U.I./2,5 ml oral solution in single-dose container
   1. What is DIBASE and what is it used for
   2. What you need to know before you take DIBASE
   3. How to take DIBASE
   4. Possible side effects
   5. How to store DIBASE
   6. Contents of the pack and other information
3. DIBASE 25.000 U.I./2,5 ml oral solution in single-dose container
   1. What is DIBASE and what is it used for
   2. What you need to know before taking DIBASE
   3. How to take DIBASE
   4. Possible side effects
   5. How to store DIBASE
   6. Contents of the pack and other information
4. DIBASE 10.000 U.I./ml oral drops, solution
   1. What is DIBASE and what is it used for
   2. What you need to know before you take DIBASE
   3. How to take DIBASE
   4. Possible side effects
   5. How to store DIBASE
   6. Contents of the pack and other information
5. DIBASE 100,000 I.U. oral solution in single-dose container
   1. What is DIBASE and what is it used for
   2. What you need to know before you take DIBASE
   3. How to take DIBASE
   4. Possible side effects
   5. How to store DIBASE
   6. Contents of the pack and other information
6. DIBASE 25.000 U.I. hard capsules
   1. What is Dibase and what is it used for
   2. What you need to know before you take Dibase
   3. How to take Dibase
   4. Possible side effects
   5. How to store Dibase
   6. Contents of the pack and other information
7. DIBASE 50.000 U.I. hard capsules, 100.000 U.I. hard capsules
   1. What is Dibase and what is it used for
   2. What you need to know before you take Dibase
   3. How to take Dibase
   4. Possible side effects
   5. How to store Dibase
   6. Contents of the pack and other information
8. DIBASE 2.000 U.I. hard capsules, 6.000 U.I. hard capsules
   1. What is DIBASE and what is it used for
   2. What you need to know before you take DIBASE
   3. How to take DIBASE
   4. Possible side effects
   5. How to store DIBASE
   6. Contents of the pack and other information
9. DIBASE 1.000 U.I. hard capsules
   1. What is DIBASE and what is it used for
   2. What you need to know before you take DIBASE
   3. How to take DIBASE
   4. Possible side effects
   5. How to store DIBASE
   6. Contents of the pack and other information

DIBASE 100.000 U.I./ml injectable solution, 300.000 U.I./ml injectable solution

colecalciferol (vitamin D)

Read this leaflet carefully before you start to take 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 DIBASE is and what it is used for
• 2. What you need to know before you take DIBASE
• 3. How to take DIBASE
• 4. Possible side effects
• 5. How to store DIBASE
• 6. Contents of the pack and other information

1. What is DIBASE and what is it used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 100,000 I.U. and 300,000 I.U. is indicated for the treatment of vitamin D deficiency in adults
(age over 18 years).

2. What you need to know before you take DIBASE

Do not take DIBASE

• 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 (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have a severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or of
calcium in the blood and urine in the following cases:

• if you need to follow treatment with DIBASE for a long period and with high doses;
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or 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;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.

In the event that your levels of vitamin D or calcium and phosphate are high, your doctor will reduce
the dose or stop treatment with DIBASE.
Tell your doctor if you are taking vitamin D from other sources, both medicines and foods (see
section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you suffer from a significant reduction in kidney function (see
“Do not take DIBASE”). In case of mild to moderate reduction in kidney function
(mild or moderate renal insufficiency), if the doctor believes that treatment with DIBASE is
absolutely necessary, he/she will have to perform periodic tests to check the levels of calcium
and phosphate in the blood. If your levels of calcium and phosphate are high, your doctor
will reduce the dose or stop treatment with DIBASE.
Tell your doctor in the following cases, as dosage adjustments may be necessary
compared to those indicated in section 3. “How to take DIBASE”:
if you are undergoing long-term therapy with medicines such as, for example, antiepileptics (used to treat
epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fats in the
blood, orlistat (used for the treatment of obesity) (see section “Other medicines and
DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive stomach acid
that can also rise into the esophagus (see section “Other medicines and
DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Children and adolescents
At these dosages, DIBASE is not recommended in children and adolescents between 0 and
18 years of age.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, 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:

• digitalisand other cardiac glycosides, medicine for treating some heart disorders;
• warfarin, medicine used to prolong blood clotting time with a reduction in the risk of blood clot formation;
• magnesium-containing preparations;
• thiazide diuretics, medicines for treating high blood pressure by increasing urine production.

Also, tell your doctor if you are taking the following drugs, as they may reduce the effect of
DIBASE:

• antiepileptics, for example barbiturates, carbamazepine, phenytoin, medicines used for the treatment of epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some antibiotics such as rifampicinand isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive stomach acid; the combination with vitamin D may increase the risk of aluminum toxicity and should therefore be avoided;
• medicines to reduce blood fats (hypolipidemic agents) such as cholestyramineand colestipol;
• medicines for treating obesity such as, for example, orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various species of Streptomyces bacteria;
• imidazole antifungal agents, capable of preventing the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drinks and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods supplemented with vitamin
D or if you are using vitamin D-enriched milk, 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 vitamin D reserves
in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
DIBASE 100,000 I.U. and DIBASE 300,000 I.U. are not recommended during pregnancy. However, since
vitamin D deficiency is harmful to both mother and fetus, when necessary your doctor will
prescribe vitamin D during pregnancy at lower doses.
Breastfeeding
DIBASE 100,000 I.U. and DIBASE 300,000 I.U.) are 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 found in breast milk: your doctor will take this into account when prescribing vitamin D to the baby
breastfed with breast milk.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, as an undesirable effect of treatment with DIBASE, drowsiness may occur, although rarely.

3. How to take DIBASE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask 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.
This medicine must be administered by injection into a muscle (intramuscular use).
Intramuscular therapy is indicated in malabsorption syndromes.

Adults and Elderly
Treatment:

DIBASE 100.000 U.I.
1 vial (equivalent to 100,000 U.I. of vitamin D) per month for 3 months. The doctor will establish the appropriate dose for you and may subsequently prescribe a lower dose.

DIBASE 300.000 U.I.
1 vial (equivalent to 300,000 U.I. of vitamin D). The doctor will establish the appropriate dose for you and may subsequently prescribe a lower dose.

Use in children and adolescentsThe use of DIBASE at these dosages is not recommended in newborns, children and adolescents under the age of 18 years.

Pregnant women
The use of DIBASE at these dosages is not recommended during pregnancy.

Instructions for use
The vials contained in the package are equipped with a break-ring. Follow the instructions below for use.
BEFORE OPENING: it is recommended to use devices for protecting the fingers (e.g. a clean cloth, a cotton ball).
INSTRUCTIONS FOR OPENING

• a. hold the lower part of the vial with one hand;
• b. place the other hand on the upper part of the vial, positioning the thumb above the white ring;
• c. keeping the lower body of the vial firm with one hand, apply pressure with the other hand bending downwards and simultaneously imprint a rotation on the upper part of the vial. AFTER OPENING: to avoid the risk of cuts, do not touch the sharp edges or any points generated by the breakage .

If you take more DIBASE than you should
In case of ingestion/accidental intake of an excessive dose of DIBASE, 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 urine output (polyuria), constipation and dehydration.
Chronic excessive dosages can lead to calcium salt deposits in blood vessels and organs.

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

If you stop taking DIBASE
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 everyone gets them.
The possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• emission of gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• cardiac arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DIBASE

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 waste water 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. Do not freeze.
Store in the original packaging to protect the medicine from light.

6. Contents of the pack and other information

What DIBASE contains

DIBASE 100,000 I.U./ml injectable solution

• The active ingredient is cholecalciferol (vitamin D) (one vial contains 2.5 mg equivalent to 100,000 I.U.)
• The other component is refined olive oil for injectable use.

DIBASE 300,000 I.U./ml injectable solution

• The active ingredient is cholecalciferol (vitamin D) (one vial contains 7.5 mg equivalent to 300,000 I.U.)
• The other component is refined olive oil for injectable use.

Description of the appearance of DIBASE and contents of the pack
DIBASE 100,000 I.U./ml and 300,000 I.U./ml injectable solution appears as a solution
contained in amber glass vials, equipped with a pre-break ring.

DIBASE 100,000 I.U./ml injectable solution
It is available in packs of 1 vial, 3 vials or 6 vials of 100,000 I.U./ml.

DIBASE 300,000 I.U./ml injectable solution
It is available in packs of 1 vial or 2 vials of 300,000 I.U./ml.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

DIBASE 50.000 U.I./2,5 ml oral solution in single-dose container

colecalciferol (vitamin D)

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

Contents of this leaflet:

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

1. What is DIBASE and what is it used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 50,000 I.U./2.5 ml oral solution in a single-dose container is indicated for the treatment of
vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before you take DIBASE

Do not take DIBASE

• 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 (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have a severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or of
calcium in the blood and urine in the following cases:

• if you need to follow treatment with DIBASE for a long period and with high doses;
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or 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;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D or calcium and phosphate are high, your doctor will reduce
the dose or stop treatment with DIBASE.
Tell your doctor if you are taking vitamin D from other sources, both medicines and foods (see
section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you suffer from a significant reduction in kidney function (see
“Do not take DIBASE”). In case of mild to moderate reduction in kidney function
(mild or moderate renal insufficiency), if the doctor considers that treatment with DIBASE is
absolutely necessary, he/she will need to perform periodic tests to check the levels of calcium
and phosphate in the blood. If your levels of calcium and phosphate are high, your doctor
will reduce the dose or stop treatment with DIBASE.
Tell your doctor in the following cases, as dosage adjustments may be necessary
compared to those indicated in section 3. “How to take DIBASE”:
if you are undergoing long-term therapy with medicines such as, for example, antiepileptics (used to treat
epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fats in the
blood, orlistat (used to treat obesity) (see section “Other medicines and
DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive acid in the stomach that can also rise into the esophagus (see section “Other medicines and
DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as, for example, Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis or cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Children and adolescents
DIBASE is not recommended in children and adolescents aged between 0
and 18 years at this dosage.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, 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:

• digitalisand other cardiac glycosides, medicine for treating certain heart disorders;
• warfarin, medicine used to prolong blood clotting time with a reduced risk of blood clot formation;
• magnesium-containing preparations;
• thiazide diuretics, medicines for treating high blood pressure by increasing urine production.

Also, tell your doctor if you are taking the following drugs, as they may reduce the effect of
DIBASE:

• antiepileptics, for example barbiturates, carbamazepine, phenytoin, medicines used for the treatment of epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some antibiotics such as rifampicinand isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive acid in the stomach; the combination with vitamin D may increase the risk of aluminum toxicity and should therefore be avoided;
• medicines to reduce fats in the blood (hypolipidemic agents) such as cholestyramineand colestipol;
• medicines to treat obesity such as, for example, orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various types of Streptomyces bacteria;
• imidazole antifungal agents, capable of preventing the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drinks and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods supplemented 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 large 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
DIBASE 50,000 I.U./2.5 ml oral solution in a single-dose container is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, when necessary the
doctor will prescribe you vitamin D during pregnancy at lower doses.
Breastfeeding
DIBASE 50,000 I.U./2.5 ml oral solution in a single-dose container is not recommended during
breastfeeding.
When necessary, the doctor will prescribe you 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: the doctor will take this into account when
prescribing vitamin D to the breastfed baby.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, drowsiness may occur as an undesirable effect of treatment with DIBASE, although rarely.

3. How to take DIBASE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask 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 DIBASE during meals.

Adults and Elderly
Treatment:
1 single-dose container (equivalent to 50,000 I.U. 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.

Use in children and adolescents
The use of DIBASE 50,000 I.U./2.5 ml oral solution in a single-dose container is not recommended in
newborns, children and adolescents under the age of 18 years.

Pregnant women
The use of DIBASE 50,000 I.U./2.5 ml oral solution in a single-dose container is not recommended in
pregnancy.

If you take more DIBASE than you should
In case of accidental ingestion/intake of an excessive dose of DIBASE, 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, with
the following symptoms: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine output
(polyuria), constipation and dehydration.
Chronic excessive dosages can lead to calcium salt deposits in blood vessels and organs.

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

If you stop taking DIBASE
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• heart arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

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

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DIBASE

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 waste water 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 not exceeding 25°C. Do not freeze.
Store in the original packaging to keep the medicine protected from light.

6. Contents of the pack and other information

What DIBASE contains
In a single-dose container:

• The active ingredient is colecalciferol (vitamin D) 1.25 mg equivalent to 50,000 I.U.
• The other component is refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 50,000 I.U./2.5 ml oral solution in a single-dose container appears as a solution
contained in an amber glass container, sealed 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 and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

DIBASE 25.000 U.I./2,5 ml oral solution in single-dose container

colecalciferol (vitamin D)

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it 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 DIBASE is and what it is used for
• 2. What you need to know before you take DIBASE
• 3. How to take DIBASE
• 4. Possible side effects
• 5. How to store DIBASE
• 6. Contents of the pack and other information

1. What is DIBASE and what is it used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 25,000 U.I./2.5 ml oral solution in a single-dose container 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 cholecalciferol;
• the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking DIBASE

Do not take DIBASE

• 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 (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have a severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
The doctor may advise taking DIBASE 25,000 I.U./2.5 ml oral solution in a single-dose container
as a prevention of vitamin D deficiency in case of:

• elderly people,
• insufficient sun exposure
• special diets or dietary regimes (e.g. low in calcium, vegetarian, etc.),
• intense skin pigmentation,
• extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• liver diseases (hepatic insufficiency),
• diseases of the digestive system (intestinal malabsorption, cystic fibrosis)
• treatment with antiepileptic drugs or long-term therapy with some anti-inflammatory drugs.

The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or of
calcium in the blood and urine in the following cases:

• if you need to follow the treatment with DIBASE for a long period and with high dosages;
• if you are elderly and are already being treated with medicines to treat some heart diseases (cardiac glycosides) or 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;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D or calcium and phosphate are high, your doctor will reduce
the dose or stop the treatment with DIBASE.
Tell your doctor if you are taking vitamin D from other sources, both medicines and foods (see
section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you suffer from a significant reduction in kidney function (see
“Do not take DIBASE”). In case of mild to moderate reduction in kidney function
(mild or moderate renal insufficiency), if the doctor considers that treatment with DIBASE is
absolutely necessary, he/she will have to perform periodic tests to check the levels of calcium
and phosphate in the blood. If your levels of calcium and phosphate are high, your doctor
will reduce the dose or stop the treatment with DIBASE.
Tell your doctor in the following cases, as dosage adjustments may be necessary
compared to those indicated in section 3. “How to take DIBASE”:
if you are undergoing long-term therapy with medicines such as, for example, antiepileptics (used to treat
epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fats in
the blood, orlistat (used for the treatment of obesity) (see section “Other medicines and
DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive presence
of acid in the stomach that can also reflux into the esophagus (see section “Other medicines and
DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Children and adolescents
DIBASE 25,000 I.U./2.5 ml oral solution in a single-dose container is not recommended in children
and adolescents aged between 0 and 18 years.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, 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:

• digitoxinand other cardiac glycosides, medicine for treating some heart disorders;
• warfarin, medicine used to prolong blood clotting time with a reduction in the risk of blood clot formation;
• magnesium-containing preparations;
• thiazide diuretics, medicines for treating high blood pressure, increasing urine production.

Also, tell your doctor if you are taking the following drugs, as they may reduce the effect of
DIBASE:

• antiepileptics, for example barbiturates, carbamazepine, phenytoin, medicines used for the treatment of epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some antibiotics such as rifampicinand isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive acid in the stomach; the combination with vitamin D may increase the risk of aluminum toxicity and should therefore be avoided;
• medicines for reducing fats in the blood (hypolipidemic drugs) such as cholestyramineand colestipol;
• medicines for treating obesity such as, for example, orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various species of the Streptomyces genus;
• imidazole antifungal agents, capable of preventing the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drinks and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods supplemented with vitamin
D or if you are using milk fortified with vitamin D, so that he/she 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 vitamin D reserves
in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
DIBASE 25,000 I.U./2.5 ml oral solution in a single-dose container is not recommended during pregnancy.
However, as vitamin D deficiency is harmful to both mother and fetus, when necessary, your doctor will prescribe
vitamin D during pregnancy at lower dosages.
Breastfeeding
DIBASE 25,000 I.U./2.5 ml oral solution in a single-dose container is not recommended during
breastfeeding.
When necessary, your doctor will prescribe vitamin D during breastfeeding at lower dosages.
This does not replace the administration of vitamin D to the newborn.
Vitamin D and its metabolites are found in breast milk: your doctor will take this into account when
prescribing vitamin D to the breastfed baby.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as an undesirable effect of treatment with DIBASE, although rarely.

3. How to take DIBASE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any 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 DIBASE during meals.

Adults and Elderly

Prevention:1 single-dose container (equivalent to 25,000 I.U. of vitamin D) once a month.

Treatment:1 single-dose container (equivalent to 25,000 I.U. 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.

Use in children and adolescents
The use of DIBASE 25,000 I.U./2.5 ml oral solution in a single-dose container is not recommended in
newborns, children and adolescents under the age of 18 years.

Pregnant women
The use of DIBASE 25,000 I.U./2.5 ml oral solution in a single-dose container is not recommended in
pregnancy.

If you take more DIBASE than you should
In case of accidental ingestion/intake of an excessive dose of DIBASE, 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 urine output
(polyuria), constipation and dehydration.
Chronic excessive dosages can lead to calcium salt deposits in blood vessels and organs.

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

If you stop taking DIBASE
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 possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• emission of gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• heart arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

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

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DIBASE

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 waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.
Store at a temperature not exceeding 25°C. Do not freeze.
Store in the original package to keep the medicine protected from light.

6. Contents of the pack and other information

What DIBASE contains
In a single-dose container:

• The active ingredient is cholecalciferol (vitamin D) 0.625 mg equivalent to 25,000 I.U.
• The other component is refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 25,000 I.U./2.5 ml oral solution in a single-dose container appears as a 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 and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

DIBASE 10.000 U.I./ml oral drops, solution

cholecalciferol (vitamin D)

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If 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 DIBASE is and what it is used for
• 2. What you need to know before you take DIBASE
• 3. How to take DIBASE
• 4. Possible side effects
• 5. How to store DIBASE
• 6. Contents of the pack and other information

1. What is DIBASE and what is it used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 10,000 I.U./ml oral drops, solution is indicated for the prevention and treatment of
vitamin D deficiency.

2. What you need to know before you take DIBASE

Do not take DIBASE

• 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 (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have a severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).
• Warnings and precautionsTalk to your doctor or pharmacist before taking DIBASE. The doctor may recommend taking DIBASE as prevention of vitamin D deficiency:
• in newborns (especially if premature) and infants,
• during the last trimester of pregnancy,
• in women who are breastfeeding at the end of winter and in spring,
• in the elderly,
• in case of insufficient sun exposure, especially in children and adolescents,
• in case of special diets or dietary regimes (e.g. low in calcium, vegetarian, etc.),
• in case of intense skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• in case of liver diseases (hepatic insufficiency),
• in case of diseases of the digestive system (intestinal malabsorption, cystic fibrosis),
• in patients treated with antiepileptic drugs or long-term therapy with some anti-inflammatory drugs.

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 the treatment with DIBASE for a long period and with high doses;
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or 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;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D or calcium and phosphate are high, your doctor will reduce the dose or stop treatment with DIBASE.
Tell your doctor if you are taking vitamin D from other sources, both medicines and foods (see section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you suffer from a significant reduction in kidney function (see “Do not take DIBASE”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if the doctor considers that treatment with DIBASE is absolutely necessary, he/she will have to perform periodic tests to check the levels of calcium and phosphate in the blood. If your levels of calcium and phosphate are high, your doctor will reduce the dose or stop treatment with DIBASE.
Tell your doctor in the following cases, as dosage adjustments may be necessary compared to those indicated in section 3. “How to take DIBASE”:
if you are on long-term therapy with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fats in the blood, orlistat (used for the treatment of obesity) (see section “Other medicines and DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive acid in the stomach that can also rise into the esophagus (see section “Other medicines and DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, if you are taking the following medicines, tell your doctor, who will keep you under close control and carefully assess whether further tests are needed:

• digitalisand other cardiac glycosides, medicine for treating some heart disorders;
• warfarin, medicine used to prolong blood clotting time with a reduction in the risk of blood clot formation;
• magnesium-containing preparations;
• thiazide diuretics, medicines for treating high blood pressure by increasing urine production.

Also, tell your doctor if you are taking the following drugs, as they may reduce the effect of DIBASE:

• antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some antibiotics such as rifampicinand isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive acid in the stomach; the combination with vitamin D may increase the risk of aluminum toxicity and should therefore be avoided;
• medicines to reduce fats in the blood (hypolipidemic agents) such as cholestyramineand colestipol;
• medicines to treat obesity such as, for example, orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various types of Streptomyces bacteria;
• imidazole antifungal agents, capable of preventing the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drinks 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 he/she can take into account the total dose of vitamin D you are taking and avoid an excessive dose.
Consumption of large amounts of alcohol for a long time (chronic alcoholism) decreases vitamin D stores 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, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
When necessary, the doctor will prescribe you vitamin D at low doses during the last trimester of pregnancy.
DIBASE 10,000 I.U./ml oral drops, solution can be taken during the last trimester of pregnancy (see section 3 “How to take DIBASE”).
Breastfeeding
When necessary, the doctor will prescribe this medicine during breastfeeding. This does not replace the administration of vitamin D in the newborn.
Vitamin D and its metabolites are found in breast milk: the doctor will take this into account when prescribing vitamin D to the breastfed baby.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, drowsiness may occur as an undesirable effect of treatment with DIBASE, although rarely.

3. How to take DIBASE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask 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 DIBASE during meals.

Use in children and adolescents
Infants (0-1 year)

Prevention:1-2 drops (equivalent 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 (equivalent to 1,000 IU of vitamin D).

Children (1-11 years)

Prevention:1-2 drops (equivalent 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 according to the doctor's judgment, the dosage may be increased up to 3 drops per day (equivalent to 750 IU of vitamin D).

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 (equivalent to 2,000 IU of vitamin D).

Adolescents (12-17 years)

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

Treatment:4-16 drops per day (equivalent 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 (equivalent to 4,000 IU of vitamin D).

Pregnant women
The recommended dose is 3-4 drops per day (equivalent 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).

Adults and Elderly

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

Treatment:4 drops (equivalent to 1000 IU of vitamin D) per day. The doctor will establish the appropriate dose and may subsequently prescribe a lower dose. Higher doses must be adjusted according to serum levels of 25-hydroxycholecalciferol (25 (OH) D) that you want to achieve, the severity of the disease and the patient's response to treatment. The daily dose should not exceed 16 drops per day (equivalent to 4000 IU of vitamin D).

Instructions for use of the bottle with separate dropper
The package contains 1 bottle and 1 dropper. The bottle is equipped with a child-resistant cap. The dropper is equipped with a plastic cover. For use, follow the instructions below:

• a. open the bottle by removing the cap as follows: press and simultaneously unscrew (see Figure 1);
• b. unscrew the plastic cover that wraps around the tip of the dropper (see Figure 2);
• c. insert the dropper into the bottle to draw up the contents. Dose in a teaspoon the number of drops prescribed by the doctor and take them;
• d. close the bottle with its cap (see Figure 3).
• e. Re-screw the plastic cover onto the tip of the dropper;
• f. put the bottle and the dropper back in the package.

Instructions for use of the dropper bottle
The package contains 1 dropper bottle, closed with a child-resistant cap. For use, follow the instructions below:

• a. open the dropper bottle by removing the cap as follows: press and simultaneously unscrew;
• b. turn the dropper bottle upside down and, keeping it in a vertical position, dose in a spoon the number of drops prescribed by the doctor and take them;
• c. close the dropper bottle;
• d. put the dropper bottle back in the package.

If you take more DIBASE than you should
In case of accidental ingestion/intake of an excessive dose of DIBASE, immediately notify 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 urine output (polyuria), constipation and dehydration.
Chronic excessive dosages can lead to deposits of calcium salts in blood vessels and 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 (see section “Pregnancy, breastfeeding and fertility”).

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

If you stop taking DIBASE
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 possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• heart arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

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

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DIBASE

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 waste water 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 not exceeding 25°C. Do not freeze.
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 (record the date of first
opening in the designated space on the packaging).
After this period, any remaining medicine must be disposed of.

6. Contents of the pack and other information

What DIBASE contains
The active ingredient is cholecalciferol (vitamin D) 2.5 mg equivalent to 100,000 U.I.
1 drop contains: 250 U.I. of vitamin D.
The other component is refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 10,000 IU/ml oral drops, solution appears as a solution contained in an amber glass bottle containing 10 ml of solution.
It is available in a pack with 1 bottle closed with a child-resistant cap and 1 separate dropper, or 1 dropper bottle closed with a child-resistant cap.

Marketing authorisation holder and manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

DIBASE 100,000 I.U. oral solution in single-dose container

colecalciferol (vitamin D)

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

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

Contents of this leaflet:

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

1. What is DIBASE and what is it used for

DIBASE 100,000 I.U. oral solution in a single-dose container contains cholecalciferol, better
known as vitamin D.
DIBASE 100,000 I.U. oral solution in a single-dose container is indicated for the treatment of
vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before you take DIBASE

Do not take DIBASE

• 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 (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have a severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Consult your doctor or pharmacist before taking DIBASE 100,000 I.U. oral solution in
single-dose container.
The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or of
calcium in the blood and urine in the following cases:

• if you need to follow treatment with DIBASE for a long period and with high doses;
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
• if you suffer from sarcoidosis, an inflammatory disease that can involve the whole body and leads to the formation of nodules;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.
• If your levels of vitamin D or calcium and phosphate are high, your doctor will reduce the dose or stop treatment with DIBASE.

Inform your doctor if you are taking vitamin D from other sources, both medicines and foods (see
section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you suffer from a significant reduction in kidney function (see
“Do not take DIBASE”). In case of mild to moderate reduction in kidney function
(mild or moderate renal insufficiency), if the doctor believes that treatment with DIBASE is
absolutely necessary, he/she will need to perform periodic tests to check the levels of calcium
and phosphate in the blood. If your levels of calcium and phosphate are high, your doctor
will reduce the dose or stop treatment with DIBASE.
Inform your doctor in the following cases, as dosage adjustments may be necessary
compared to those indicated in section 3. “How to take DIBASE”:
if you are undergoing long-term therapy with medicines such as, for example, antiepileptics (used to treat
epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fats in the
blood, orlistat (used for the treatment of obesity) (see section “Other medicines and
DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive acid in the stomach that can also rise into the esophagus (see section “Other medicines and
DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as, for example, Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Children and adolescents
DIBASE 100,000 I.U. oral solution in a single-dose container is not recommended in children and
adolescents between 0 and 18 years of age.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, 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:

• digoxinand other cardiac glycosides, medicine for treating some heart disorders;
• warfarin, medicine used to prolong blood clotting time with a reduction in the risk of blood clot formation;
• magnesium-containing preparations;
• thiazide diuretics, medicines for treating high blood pressure, increasing urine production.

Also, tell your doctor if you are taking the following drugs, as they may reduce the effect of
DIBASE:

• antiepileptics, for example barbiturates, carbamazepine, phenytoin, medicines used for the treatment of epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some antibiotics such as rifampicinand isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive acid in the stomach; the association with vitamin D may increase the risk of aluminum toxicity and therefore should be avoided;
• medicines for reducing fats in the blood (hypolipidemic agents) such as cholestyramineand colestipol;
• medicines for treating obesity such as, for example, orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various types of Streptomyces bacteria;
• imidazole antifungal agents, capable of preventing the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drinks and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods supplemented with vitamin
D or if you are using milk enriched with vitamin D, so that he/she can take into account the total dose
of vitamin D you are taking and avoid an excessive dose.
Drinking large amounts of alcohol for a long time (chronic alcoholism) decreases vitamin D reserves 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
DIBASE 100,000 I.U. oral solution in a single-dose container is not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, when necessary the
doctor will prescribe vitamin D during pregnancy at lower doses.
Breastfeeding
DIBASE 100,000 I.U. oral solution in a single-dose container 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: the doctor will take this into account when
prescribing vitamin D to a breastfed baby.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as an undesirable effect of treatment with DIBASE, although rarely.

3. How to take DIBASE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any 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 DIBASE during meals. The
single-dose container must be used in a single administration, making sure to take
the entire dose.
Adults

Treatment: the recommended dose is 1 single-dose container (equivalent to 100,000 I.U. of vitamin D) every
2 weeks for 6 weeks (for a maximum of three administrations). The doctor will establish the dose
appropriate for you and may subsequently prescribe a lower dose.

Use in children and adolescents
DIBASE 100,000 I.U. oral solution in a single-dose container is not recommended for newborns,
children and adolescents (˂ 18 years).

Pregnant women
The use of DIBASE 100,000 I.U. oral solution in a single-dose container is not recommended during
pregnancy.

If you take more DIBASE than you should
In case of accidental ingestion/intake of an excessive dose of DIBASE, 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, whose
symptoms are as follows: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine output
(polyuria), constipation and dehydration.
Chronic excessive dosages can lead to calcium salt deposits in blood vessels and organs.

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

If you stop taking DIBASE
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 possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• emission of gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• heart arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DIBASE

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 waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.
Store at a temperature not exceeding 25°C. Do not freeze.
Store in the original package to keep the medicine protected from light.

6. Contents of the pack and other information

What DIBASE contains
In a single-dose container:

• The active ingredient is cholecalciferol (vitamin D): a 2.5 ml single-dose container of solution contains 2.5 mg (equivalent to 100,000 I.U.) of cholecalciferol.
• The other component is refined olive oil.

Description of the appearance of DIBASE and contents of the pack
DIBASE 100,000 I.U. oral solution in a single-dose container appears as a
transparent, clear colorless or yellowish-green solution contained in an amber glass container,
closed with a polypropylene cap.
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 and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

DIBASE 25.000 U.I. hard capsules

colecalciferol (vitamin D)

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

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

Contents of this leaflet:

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

1. What is Dibase and what is it used for

Dibase contains cholecalciferol, better known as vitamin D.
Dibase 25,000 IU hard capsules is indicated for:

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

2. What you need to know before you take Dibase

Do not take Dibase

• 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 (hypercalciuria);
• if you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• if you have a severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dibase.
The doctor may advise you to take Dibase 25,000 IU hard capsules as a prevention of
vitamin D deficiencyin the case of:

• elderly people,
• insufficient sun exposure
• special diets or dietary regimes (e.g. low in calcium, vegetarian, etc.),
• intense skin pigmentation,
• extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• liver diseases (hepatic insufficiency),
• diseases of the digestive system (intestinal malabsorption, cystic fibrosis),
• treatment with antiepileptic drugs or long-term therapy with some anti-inflammatory drugs.

The doctor may prescribe you periodic tests to check your vitamin D levels in the blood or
calcium in the blood and urine in the following cases:

• if you need to follow treatment with DIBASE for a long period and at high doses;
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or 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;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.
• If your vitamin D or calcium and phosphate levels are high, your doctor will reduce the dose or stop treatment with DIBASE.

Tell your doctor if you are taking vitamin D from other sources, both medicines and foods (see
section “DIBASE with food, drinks and alcohol”).
Do not take DIBASE if you suffer from a significant reduction in kidney function (see
“Do not take DIBASE”). In case of mild to moderate reduction in kidney function
(mild or moderate renal insufficiency), if the doctor considers that treatment with DIBASE is
absolutely necessary, he/she will need to perform periodic tests to check calcium
and phosphate levels in the blood. If your calcium and phosphate levels are high, your doctor
will reduce the dose or stop treatment with DIBASE.
Tell your doctor in the following cases, as dosage adjustments may be necessary
compared to those indicated in section 3. “How to take DIBASE”:
if you are undergoing long-term therapy with medicines such as antiepileptics (used to treat
epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fats in the
blood, orlistat (used to treat obesity) (see section “Other medicines and
DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive acid in the stomach that can also rise into the esophagus (see section “Other medicines and
DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Children and adolescents
Dibase 25,000 IU hard capsules are not recommended in children and adolescents aged
between 0 and 18 years.

Dibase with food, drinks 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 he/she can take into account the total dose
of vitamin D you are taking and avoid an excessive dose.
Consuming high amounts of alcohol for a long time (chronic alcoholism) decreases vitamin D stores 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
Dibase 25,000 IU hard capsules are not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, when necessary, the
doctor will prescribe vitamin D during pregnancy at lower doses.
Breastfeeding
Dibase 25,000 IU hard capsules are 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: the doctor will take this into account when
prescribing vitamin D to the breastfed baby.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as an undesirable effect of treatment with DIBASE, although rarely.

3. How to take Dibase

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doses and duration of treatment will be evaluated by the doctor based on your state of health. If you suffer
from a kidney disease, liver disease, skin diseases, gastrointestinal diseases, and in other cases,
at the doctor's discretion, a dosage adjustment may be necessary compared to those indicated
below.
The recommended dose is:

Adults and Elderly

Prevention:1 capsule (equivalent to 25,000 IU of vitamin D3) once a month.

Treatment:1 capsule (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 you a lower dose.

Pregnancy and breastfeeding
The use of Dibase 25,000 IU hard capsules is not recommended during pregnancy and breastfeeding
with breast milk.

Use in children and adolescents
The use of Dibase 25,000 IU hard capsules is not recommended in newborns, children and adolescents under the age of
18 years.

Instructions for use
The Dibase hard capsules are for oral use.
Take Dibase during meals.
Swallow the capsule whole, do not chew and do not open it.

If you take more Dibase than you should
In case of accidental ingestion/intake of an excessive dose of Dibase, 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, whose
symptoms are as follows: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine output
(polyuria), constipation and dehydration.
Chronic excessive dosages can lead to calcium salt deposits in blood vessels and organs.

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

If you stop taking Dibase
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 possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• emission of gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• heart arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

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

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Dibase

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 waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store in the original packaging to protect the medicine from light.
Store at a temperature below 25°C. Do not freeze.

6. Contents of the pack and other information

What Dibase contains
The active ingredient is cholecalciferol (vitamin D) 0.625 mg equivalent to 25,000 I.U.
The other ingredients are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), refined olive oil.

Description of the appearance of Dibase and contents of the pack
Dibase 25,000 I.U. hard capsules are presented as hard capsules with a transparent body and a white cap,
with a green sealing band.
It is available in packs of 1 capsule, 2 capsules, 4 capsules, 8 capsules or 12 capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

DIBASE 50.000 U.I. hard capsules, 100.000 U.I. hard capsules

colecalciferol (vitamin D)

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If 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 Dibase is and what it is used for
• 2. What you need to know before you take Dibase
• 3. How to take Dibase
• 4. Possible side effects
• 5. How to store Dibase
• 6. Contents of the pack and other information

1. What is Dibase and what is it used for

Dibase contains cholecalciferol, better known as vitamin D.
Dibase 50,000 IU hard capsules and 100,000 IU hard capsules is indicated for the treatment of
vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before you take Dibase

Do not take Dibase

• 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 (hypercalciuria);
• if you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• if you have a severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dibase.
The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or of
calcium in the blood and urine in the following cases:

• if you need to follow treatment with DIBASE for a long period and with high doses;
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or 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;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D or calcium and phosphate are high, your doctor will reduce
the dose or stop treatment with DIBASE.
Tell your doctor if you are taking vitamin D from other sources, both medicines and foods (see
section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you suffer from a significant reduction in kidney function (see
“Do not take DIBASE”). In case of mild to moderate reduction in kidney function
(mild or moderate renal insufficiency), if the doctor considers that treatment with DIBASE is
absolutely necessary, he/she will need to perform periodic tests to check the levels of calcium
and phosphate in the blood. If your levels of calcium and phosphate are high, your doctor
will reduce the dose or stop treatment with DIBASE.
Tell your doctor in the following cases, as dosage adjustments may be necessary
compared to those indicated in section 3. “How to take DIBASE”:
if you are on long-term therapy with medicines such as, for example, antiepileptics (used to treat
epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fat in the
blood, orlistat (used for the treatment of obesity) (see section “Other medicines and
DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive acid in the stomach that can also rise into the esophagus (see section “Other medicines and
DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Children and adolescents
At these dosages, Dibase is not recommended in children and adolescents between 0 and
18 years of age.

Other medicines and Dibase
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, 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:

• digitoxinand other cardiac glycosides, medicine for treating some heart disorders;
• warfarin, medicine used to prolong blood clotting time with a reduced risk of blood clot formation;
• magnesium-containing preparations;
• thiazide diuretics, medicines for treating high blood pressure by increasing urine production.

Also, tell your doctor if you are taking the following drugs, as they may reduce the effect of
DIBASE:

• antiepileptics, for example barbiturates, carbamazepine, phenytoin, medicines used for the treatment of epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some antibiotics such as rifampicinand isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive acid in the stomach; the association with vitamin D may increase the risk of aluminum toxicity and should therefore be avoided;
• medicines to reduce blood fats (hypolipidemic agents) such as cholestyramineand colestipol;
• medicines for treating obesity such as, for example, orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various types of Streptomyces bacteria;
• imidazole antifungal agents, capable of preventing the growth of fungal organisms (e.g. ketoconazole).

Dibase with food, drinks and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods supplemented with vitamin
D or if you are using vitamin D-enriched milk, so that he/she can take into account the total dose of vitamin D you are taking and avoid an excessive dose.
Drinking large amounts of alcohol for a long time (chronic alcoholism) decreases vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Dibase 50,000 IU hard capsules and 100,000 IU hard capsules are not recommended during pregnancy.
However, since vitamin D deficiency is harmful to both mother and fetus, if necessary your doctor will prescribe vitamin D during pregnancy at lower doses.
Breastfeeding
Dibase 50,000 IU hard capsules and 100,000 IU hard capsules are not recommended during
breastfeeding.
If 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 found in breast milk: your doctor will take this into account when prescribing vitamin D to the breastfed baby.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, as an undesirable effect of treatment with DIBASE, drowsiness may occur, although rarely.

3. How to take Dibase

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doses and duration of treatment will be evaluated by the doctor based on your state of health. If you suffer
from a kidney disease, liver disease, skin diseases, gastrointestinal diseases, and in other cases,
at the doctor's discretion, a dosage adjustment may be necessary compared to those indicated
below.
The recommended dose is:

Adults and Elderly
Dibase 50,000 I.U. hard capsules
1 capsule (equivalent to 50,000 I.U. 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 you a lower dose.

Dibase 100,000 I.U. hard capsules
1 capsule (equivalent to 100,000 I.U. of vitamin D) per month for a maximum of 3 months. The doctor will establish the
appropriate dose for you and may subsequently prescribe you a lower dose.

Pregnancy and breastfeeding
The use of Dibase at these dosages is not recommended during pregnancy and while breastfeeding.
materno.

Use in children and adolescents
The use of Dibase at these dosages is not recommended in infants, children and adolescents under the age of
18 years.

Instructions for use
The Dibase hard capsules are for oral use.
Take Dibase during meals.
Swallow the capsule whole, do not chew it and do not open it.

If you take more Dibase than you should
In case of accidental ingestion/intake of an excessive dose of Dibase, 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, whose
symptoms are as follows: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine output
(polyuria), constipation and dehydration.
Chronic excessive dosages can lead to calcium salt deposits in blood vessels and organs.

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

If you stop taking Dibase
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 possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• emission of gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• heart arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Dibase

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 waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store in the original packaging to protect the medicine from light.
Store at a temperature below 25°C. Do not freeze.

6. Contents of the pack and other information

What Dibase contains

Dibase 50,000 I.U. hard capsules

• The active ingredient is cholecalciferol (vitamin D) 1.25 mg equivalent to 50,000 I.U.
• The other ingredients are: gelatin, titanium dioxide (E171), red iron oxide (E 172), refined olive oil. Dibase 100,000 U.I. hard capsules
• The active ingredient is cholecalciferol (vitamin D) 2.5 mg equivalent to 100,000 I.U.
• The other ingredients are: gelatin, titanium dioxide (E171), red iron oxide (E 172), black iron oxide (E172), refined olive oil.

Description of the appearance of Dibase and contents of the pack

Dibase 50,000 U.I. hard capsules
Dibase is presented as hard capsules with a transparent body and white cap, with a red sealing band.
It is available in packs of 1 capsule, 2 capsules, 4 capsules or 6 capsules in blisters.

Dibase 100,000 U.I. hard capsules
Dibase is presented as hard capsules with a transparent body and white cap, with a brown sealing band.
It is available in packs of 1 capsule, 2 capsules or 3 capsules in blisters.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

DIBASE 2.000 U.I. hard capsules, 6.000 U.I. hard capsules

Cholecalciferol (vitamin D)

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

1. What is DIBASE and what is it used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 2,000 I.U. hard capsules and 6,000 I.U. hard capsules is indicated for the prevention and
treatment of vitamin D deficiency in adults and adolescents over 12 years of age.

2. What you need to know before you take DIBASE

Do not take DIBASE

• 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 (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have a severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIBASE.
The doctor may advise you to take DIBASE as a prevention of vitamin D deficiency:

• during the last trimester of pregnancy,
• during breastfeeding,
• if you are elderly,
• in case of insufficient or ineffective sun exposure,
• in case of special diets or dietary regimes (e.g. low in calcium, vegetarian etc.),
• in case of intense skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• in case of digestive diseases or 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).

The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or of
calcium in the blood and urine in the following cases:

• if you have to follow the treatment with DIBASE for a long period and with high doses;
• if you are elderly and are already being treated with medicines to treat some heart diseases (cardiac glycosides) or 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;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D or calcium and phosphate are high, your doctor will reduce
the dose or stop the treatment with DIBASE.
Tell your doctor if you are taking vitamin D from other sources, both medicines and foods (see
section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you suffer from a significant reduction in kidney function (see
“Do not take DIBASE”). In case of mild to moderate reduction in kidney function
(mild or moderate renal insufficiency), if the doctor considers that treatment with DIBASE is
absolutely necessary, he/she will have to perform periodic tests to check the levels of calcium
and phosphate in the blood. If your levels of calcium and phosphate are high, your doctor
will reduce the dose or stop the treatment with DIBASE.
Tell your doctor in the following cases, as dosage adjustments may be necessary
compared to those indicated in section 3. “How to take DIBASE”:
if you are undergoing long-term therapy with medicines such as, for example, antiepileptics (used to treat
epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fats in
the blood, orlistat (used for the treatment of obesity) (see section “Other medicines and
DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive acid in the stomach
that can also reflux into the esophagus (see section “Other medicines and
DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Children
DIBASE hard capsules are not recommended in children aged between 0 and 12 years due to
the pharmaceutical form in which it is presented, for the difficulty of swallowing.
In children aged between 0 and 12 years, it is advisable to use other formulations of DIBASE.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, 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:

• digitalisand other cardiac glycosides, medicine for treating some heart disorders;
• warfarin, medicine used to prolong blood clotting time with a reduction in the risk of blood clot formation;
• magnesium-containing preparations;
• thiazide diuretics, medicines for treating high blood pressure, increasing urine production.

Also, tell your doctor if you are taking the following drugs, as they may reduce the effect of
DIBASE:

• antiepileptics, for example barbiturates, carbamazepine, phenytoin, medicines used for the treatment of epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some antibiotics such as rifampicinand isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive acid in the stomach; the association with vitamin D may increase the risk of aluminum toxicity and therefore should be avoided;
• medicines to reduce blood fats (hypolipidemic agents) such as cholestyramineand colestipol;
• medicines for treating obesity such as, for example, orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various species of the Streptomyces bacterium;
• imidazole antifungal agents, capable of preventing the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drinks and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods supplemented with vitamin
D or if you are using milk enriched with vitamin D, so that he/she 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 vitamin D stores
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
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
When necessary, the doctor will prescribe vitamin D at low doses during the last trimester of
pregnancy.
DIBASE 2,000 I.U. hard capsules and DIBASE 6,000 I.U. hard capsules can be taken during
the last trimester of pregnancy (see section 3 “How to take DIBASE”).
Breastfeeding
When necessary, you can take vitamin D during breastfeeding. This does not replace
the administration of vitamin D to the newborn.
Vitamin D and its metabolites are found in breast milk: the doctor will take this into account when
prescribing vitamin D to the breastfed baby.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as an undesirable effect of treatment with DIBASE, although rarely.

3. How to take DIBASE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. The doses and duration of treatment will be evaluated by the doctor based on your state of health. If you suffer
from a kidney disease, liver disease, skin diseases, diseases of the digestive system, and in other cases,
at the doctor's discretion, an adjustment of the dosage may be necessary compared to those indicated
below.

Adults

Prevention:
The recommended dose is as follows:

• Hard capsules of 2,000 I.U.: 1 capsule every other day.
• Hard capsules of 6,000 I.U.: 1 capsule every 6-8 days.

In the presence of many risk factors for vitamin D deficiency, at the doctor's discretion, the
dosage may be increased up to:

• Hard capsules of 2,000 I.U.: 1 capsule daily.
• Hard capsules of 6,000 I.U.: 1 capsule every 3 days.

Treatment:
The recommended daily doses are between 1,000 and 4,000 I.U. These doses must be
adjusted according to the serum levels of 25-hydroxycholecalciferol (25 (OH) D) to be achieved,
the severity of the disease and the patient's response to treatment. The doctor will establish the appropriate dose
and may subsequently prescribe a lower dose.
The recommended dosage is as follows:

• Hard capsules of 2,000 I.U.: from 1 capsule every other day to a maximum of 2 capsules daily.
• Hard capsules of 6,000 I.U.: from 1 capsule every 6 days to a maximum of 2 capsules every 3 days.

Pregnant women (last trimester)
The recommended dosage is as follows, to be adjusted at the doctor's discretion:

• Hard capsules of 2,000 I.U.: 1 capsule every other day. However, in women considered deficient in vitamin D, a higher dose may be necessary (up to 1 capsule daily)
• Hard capsules of 6,000 I.U.: 1 capsule every 6-8 days. However, in women considered deficient in vitamin D, a higher dose may be necessary (up to 1 capsule every 3 days).

Use in children and adolescents

Children (0-12 years)
In children between 0 and 12 years of age, it is advisable to use other formulations of DIBASE.

Adolescents (>12 years)

Prevention:
The recommended dosage is as follows:

• Hard capsules of 2,000 I.U.: from 1 capsule every 4 days to 1 capsule every 2 days.
• Hard capsules of 6,000 I.U.: from 1 capsule every 12 days to 1 capsule every 6 days.

Treatment:
The recommended daily doses are between 1,000 and 4,000 I.U. These doses must be
adjusted according to the serum levels of 25-hydroxycholecalciferol (25 (OH) D) to be achieved,
the severity of the disease and the patient's response to treatment. The doctor will establish the appropriate dose
and may subsequently prescribe a lower dose.
The recommended dosage is as follows:

• Hard capsules of 2,000 I.U.: from 1 capsule every other day to a maximum of 2 capsules daily.
• Hard capsules of 6,000 I.U.: from 1 capsule every 6 days to a maximum of 2 capsules every 3 days.

Instructions for use
The hard capsules of DIBASE are for oral use.
Take DIBASE during meals.
Swallow the capsule whole, do not chew and do not open it.

If you take more DIBASE than you should
In case of accidental ingestion/intake of an excessive dose of DIBASE, 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, whose
symptoms are as follows: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine output
(polyuria), constipation and dehydration.
Chronic excessive dosages can lead to deposits of calcium salts in blood vessels and organs.
If you are pregnant, the use of an excessive dose of vitamin D can cause serious damage to
the newborn (see paragraph “Pregnancy, breastfeeding and fertility”).

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

If you stop taking DIBASE
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• heart arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store DIBASE

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.

DIBASE 2,000 I.U. hard capsules
Store at a temperature below 25°C.
Do not freeze.
Store in the original package to protect the medicine from light.

DIBASE 6,000 I.U. hard capsules
Store at a temperature below 25°C.
Do not freeze.
Store in the original package to protect the medicine from light.

6. Contents of the pack and other information

What DIBASE contains

DIBASE 2,000 I.U. hard capsules

• The active ingredient is cholecalciferol (vitamin D) 0.050 mg equivalent to 2,000 I.U.
• The other ingredients are: gelatin, titanium dioxide (E171), refined olive oil. DIBASE 6,000 I.U. hard capsules
• The active ingredient is cholecalciferol (vitamin D) 0.150 mg equivalent to 6,000 I.U.
• The other ingredients are: gelatin, titanium dioxide (E171), yellow iron oxide (E 172), refined olive oil.

Description of the appearance of DIBASE and contents of the pack

DIBASE 2,000 I.U. hard capsules:
It appears as hard capsules with a transparent body and a white cap, with a white sealing band.
It is available in packs of 30 capsules (3 opaque white blisters of 10 capsules each).

DIBASE 6,000 I.U. hard capsules:
It appears as hard capsules with a transparent body and a white cap, with a yellow sealing band.
It is available in packs of 4 capsules (1 opaque white blister of 4 capsules) or 12 capsules (3
opaque white blisters of 4 capsules each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy

DIBASE 1.000 U.I. hard capsules

Cholecalciferol (vitamin D)

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If 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 DIBASE is and what it is used for
• 2. What you need to know before you take DIBASE
• 3. How to take DIBASE
• 4. Possible side effects
• 5. How to store DIBASE
• 6. Contents of the pack and other information

1. What is DIBASE and what is it used for

DIBASE contains cholecalciferol, better known as vitamin D.
DIBASE 1,000 I.U. hard capsules is indicated for the prevention and treatment of vitamin
D deficiency in adults and adolescents over 12 years of age.

2. What you need to know before you take DIBASE

Do not take DIBASE

• 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 (hypercalciuria).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have a severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).
• If you have high levels of vitamin D (hypervitaminosis D).

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

• during the last trimester of pregnancy,
• during breastfeeding,
• if you are elderly,
• in case of insufficient or ineffective sun exposure,
• in case of special diets or dietary regimes (e.g. low in calcium, vegetarian, etc.),
• in case of intense skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy, for example),
• in case of digestive diseases or 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).

The doctor may prescribe you periodic tests to check the levels of vitamin D in the blood or of
calcium in the blood and urine in the following cases:

• if you have to follow the treatment with DIBASE for a long period and with high doses;
• if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or 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;
• if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone by one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D or calcium and phosphate are high, your doctor will reduce
the dose or stop treatment with DIBASE.
Tell your doctor if you are taking vitamin D from other sources, both medicines and foods (see
section “DIBASE with food, drinks and alcohol”).
You must not take DIBASE if you suffer from a significant reduction in kidney function (see
“Do not take DIBASE”). In case of mild to moderate reduction in kidney function
(mild or moderate renal insufficiency), if the doctor believes that treatment with DIBASE is
absolutely necessary, he/she will have to perform periodic tests to check the levels of calcium
and phosphate in the blood. If your levels of calcium and phosphate are high, your doctor
will reduce the dose or stop treatment with DIBASE.
Tell your doctor in the following cases, as dosage adjustments may be necessary
compared to those indicated in paragraph 3. “How to take DIBASE”:
if you are undergoing long-term therapy with medicines such as, for example, antiepileptics (used to treat
epilepsy), corticosteroids (used to treat inflammation), medicines used to reduce fats in
the blood, orlistat (used for the treatment of obesity) (see section “Other medicines and
DIBASE”);
if you are taking antacids containing aluminum, medicines to treat excessive presence
of acid in the stomach that can also reflux into the esophagus (see section “Other medicines and
DIBASE”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and DIBASE”);
if you are obese;
if you suffer from intestinal malabsorption (such as Crohn's disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or if you have undergone bariatric surgery;
if you suffer from a liver disease (hepatic insufficiency).

Children
DIBASE hard capsules are not recommended in children aged 0 to 12 years due to
the pharmaceutical form in which it is presented, for the difficulty of swallowing.
In children between 0 and 12 years of age, it is advisable to use other formulations of DIBASE.

Other medicines and DIBASE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, 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:

• digitalisand other cardiac glycosides, medicine for treating some heart disorders;
• warfarin, medicine used to prolong blood clotting time with a reduction in the risk of blood clot formation;
• magnesium-containing preparations;
• thiazide diuretics, medicines for treating high blood pressure by increasing urine production.

Also, tell your doctor if you are taking the following drugs, as they may reduce the effect of
DIBASE:

• antiepileptics, for example barbiturates, carbamazepine, phenytoin, medicines used for the treatment of epilepsy;
• corticosteroids, medicines used to treat inflammation;
• some antibiotics such as rifampicinand isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive acid in the stomach; the association with vitamin D may increase the risk of aluminum toxicity and should therefore be avoided;
• medicines to reduce fats in the blood (hypolipidemic agents) such as cholestyramineand colestipol;
• medicines for treating obesity such as, for example, orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various species of Streptomyces bacteria;
• imidazole antifungal agents, capable of preventing the growth of fungal organisms (e.g. ketoconazole).

DIBASE with food, drinks and alcohol
Tell your doctor if you are taking other products that already contain vitamin D, foods supplemented with vitamin
D or if you are using milk fortified with vitamin D, so that he/she 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 vitamin D reserves
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
When necessary, the doctor will prescribe vitamin D at low doses during the last trimester of
pregnancy.
DIBASE 1,000 I.U. hard capsules can be taken during the last trimester of pregnancy (see
section 3 “How to take DIBASE”).
Breastfeeding
When necessary, you may take vitamin D during breastfeeding. This does not replace
the administration of vitamin D to the newborn.
Vitamin D and its metabolites are found in breast milk: the doctor will take this into account when
prescribing vitamin D to the breastfed baby.
Fertility
There are no data on the effects of vitamin D on fertility.

Driving and operating machinery
There are no data on the effects of DIBASE on the ability to drive.
However, it should be noted that drowsiness may occur as an undesirable effect of treatment with DIBASE, although rarely.

3. How to take DIBASE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The doses and duration of treatment will be evaluated by the doctor based on your state of health. If you suffer
from a kidney disease, liver disease, skin diseases, diseases of the digestive system, and in other cases,
at the doctor's discretion, an adjustment of the dosage may be necessary compared to those indicated
below.

Adults

Prevention:
The recommended dose is as follows:

• 1 hard capsule per day (equivalent to 1,000 I.U.).

In the presence of many risk factors for vitamin D deficiency, at the doctor's discretion, the
dosage may be increased up to:

• 2 hard capsules per day (equivalent to 2,000 I.U.).

Treatment:
The recommended daily doses are between 1,000 and 4,000 I.U.. These doses must be
adjusted according to the 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 doctor will establish the dose
appropriate and may subsequently prescribe a lower dose.
The recommended dosage is as follows:

• from 1 hard capsule (equivalent to 1,000 I.U.) to a maximum of 4 hard capsules per day (equivalent to
• 4,000 I.U.).

Pregnant women (last trimester)
The recommended dosage is as follows, to be adjusted at the doctor's discretion:

• 1 hard capsule per day (equivalent to 1,000 I.U.). However, in women considered deficient in vitamin D, a higher dose may be necessary (up to 2 hard capsules per day, equivalent to 2,000 I.U.)

Use in children and adolescents

Children (0-12 years)
In children between 0 and 12 years of age, it is advisable to use other formulations of DIBASE.

Adolescents (>12 years)

Prevention:
The recommended dosage is as follows:

• from 1 hard capsule (equivalent to 1,000 I.U.) every other day to 1 capsule per day. Treatment:The recommended daily doses are between 1,000 and 4,000 I.U.. These doses must be adjusted according to the 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 doctor will establish the appropriate dose and may subsequently prescribe a lower dose. The recommended dosage is as follows:
• from 1 hard capsule (equivalent to 1,000 I.U.) to a maximum of 4 hard capsules per day (equivalent to
• 4,000 I.U.).

Instructions for use
The hard capsules of DIBASE are for oral use.
Take DIBASE during meals.
Swallow the capsule whole, do not chew it and do not open it.

If you take more DIBASE than you should
In case of accidental ingestion/intake of an excessive dose of DIBASE, 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 urine output
(polyuria), constipation and dehydration.
Chronic excessive dosages can lead to deposits of calcium salts in blood vessels and organs.
If you are pregnant, the use of an excessive dose of vitamin D can cause serious harm to the newborn
(see section “Pregnancy, breastfeeding and fertility”).

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

If you stop taking DIBASE
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, according to their frequency:

uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• headache
• stomach pain (abdominal pain)
• nausea
• diarrhoea
• vomiting
• skin rash
• itching

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

• allergic reactions (hypersensitivity)
• loss of appetite
• intense thirst (polydipsia)
• drowsiness
• confusional state
• constipation
• passing gas (flatulence)
• dry mouth
• altered taste (dysgeusia)
• urticaria
• increased urine output (polyuria)
• weakness (asthenia)
• dizziness
• heart arrhythmia

very rare (may affect up to 1 in 10,000 people)

• kidney disease (renal failure)

not known (frequency cannot be estimated from available data)

• thirst
• excessive calcium deposition in the kidneys (nephrocalcinosis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store DIBASE

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 waste water 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 25°C. Do not freeze.
Store in the original packaging to protect the medicine from light.

6. Contents of the pack and other information

What DIBASE contains

• The active ingredient is cholecalciferol (vitamin D) 0.025 mg equivalent to 1,000 I.U.
• The other ingredients are: gelatin, titanium dioxide (E171), red iron oxide (E 172), refined olive oil.

Description of the appearance of DIBASE and contents of the pack
It is presented as hard capsules with a transparent body and white cap, with a pink sealing band.
It is available in packs of 30 capsules (3 white opaque blisters of 10 capsules each).

Marketing Authorisation Holder and Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy