Vibon

Patient Information Leaflet

VIBON 10,000 IU, Soft Capsules

Colecalciferol (vitamin D3)
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What VIBON is and what it is used for

VIBON contains the active substance colecalcifer0l, better known as Vitamin D3.
VIBON is indicated for:
Prevention and treatment of vitamin D deficiency.
VIBON is indicated in adults.
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking VIBON

Do not take VIBON
If you are allergic to cholecalciferol (vitamin D3) or to any of the other ingredients of this
medicinal product (listed in section 6).

• If you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria)
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis)
• if you have high levels of vitamin D in the body (hypervitaminosis D)
• if you suffer from kidney disease (severe renal impairment) (see section “Warnings and precautions”).

VIBON must not be given to neonates and children under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking VIBON, especially:
if you need to take VIBON for a long period and at high doses.
If you are elderly and are already taking medicines to treat heart conditions (cardiac glycosides or
diuretics). In this case, you must check calcium levels in blood and urine.
If you are already taking medicines containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk.
If you suffer from a chronic inflammatory disease that can affect all organs, called
sarcoidosis.
If you have impaired kidney function, as vitamin D levels in the body may be altered.
If you are prone to calcium-containing kidney stones.
If you have severe renal insufficiency: in this case, other forms of vitamin D should be used.
If you take this medicine for long-term treatment, especially if you are elderly. In
this case, your doctor will monitor urinary calcium excretion and kidney function. If necessary, your
doctor will reduce the dose.
If you have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism).
Inform your doctor if you have any of the following conditions, as a dosage increase may be required as indicated in section 3 “How to take VIBON.”:
If you are being treated with medicines for epilepsy (anticonvulsants or barbiturates).
If you are being treated with medicines for inflammation (corticosteroids).
If you are being treated with medicines that reduce blood fat levels (colestipol,
cholestyramine, orlistat, and laxatives (such as paraffin oil).
If you are being treated with medicines used to treat excessive stomach acid production (antacids containing aluminum).
If you are obese.
If you suffer from digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis).
If you suffer from liver disease (hepatic insufficiency).
Children
VIBON must not be given to neonates or children under 18 years of age.
Other medicines and VIBON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
In particular, inform your doctor if you are taking the following medicines, as they may reduce or
increase the effect of VIBON:
other medicines containing vitamin D.
medicines used to treat epilepsy (anticonvulsants or barbiturates), such as
phenytoin, phenobarbital, primidone, etc.
medicines to reduce blood fats such as colestipol, cholestyramine, orlistat, and laxatives
(e.g. paraffin oil)
antacids containing aluminum, medicines used to treat excess stomach acid that may
reflux into the esophagus
thiazide diuretics, medicines used to treat high blood pressure, which
increase urine production
digitalis, a medicine used to treat certain heart disorders
medicines used to treat tuberculosis, such as rifampicin and isoniazid
antifungal agents such as imidazoles (e.g. ketoconazole), medicines used to inhibit
the growth of fungal organisms
warfarin, a medicine used to thin the blood
heart medicines (cardiac glycosides), because you will need to be monitored by a doctor, possibly undergo an ECG, and have calcium levels checked.
VIBON with food, drinks and alcohol
Inform your doctor if you consume other products containing vitamin D, vitamin D-fortified foods,
or if you use vitamin D-enriched milk, so that your total vitamin D intake can be assessed and excessive doses avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
VIBON must not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical condition requires treatment with cholecalciferol at lower dosages.
Pregnancy
Your doctor will prescribe vitamin D during the first 6 months of pregnancy only if strictly
necessary, due to the risk of harmful effects on the fetus (see section 3: “If you take more VIBON”).
However, since vitamin D deficiency is harmful to both the fetus and the mother, if necessary, your
doctor may prescribe low-dose vitamin D during pregnancy.
Breastfeeding
If necessary, your doctor may prescribe low-dose vitamin D during breastfeeding. This does not replace the need for vitamin D supplementation in the newborn.
Driving and using machines
VIBON does not affect or affects negligibly the ability to drive vehicles and use machinery.

3. How to take VIBON

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The dose and duration of treatment should be determined by your doctor according to your health condition.
Do not exceed the doses indicated by your doctor.
Take the dose orally.
Take VIBON with meals.

Adults and elderly patients
Prevention:
The recommended dose is 1 capsule every 2 weeks (equivalent to 20,000 IU of vitamin D3 per month).
If there is a high risk of vitamin D deficiency, your doctor will assess whether the dose should be increased up to 1 capsule per week (equivalent to 10,000 IU of vitamin D3).

Treatment:
The recommended dose is 2 capsules per week (equivalent to 20,000 IU of vitamin D3 weekly) for 1–3 months. Your doctor will determine the most appropriate dose for you and may subsequently prescribe lower maintenance doses.
In cases of severe vitamin D deficiency in adults and elderly patients, the required amount will depend on vitamin D levels and response to treatment. Your doctor will determine the most suitable dose based on your response to therapy. Higher doses must be adjusted according to desired serum levels of 25-hydroxycholecalciferol (25(OH)D), severity of the condition, and response to treatment.

Long-term treatment:
If long-term treatment is required, particularly in elderly patients, your doctor will monitor urinary calcium excretion and renal function. If necessary, your doctor may reduce the dose.

If you take more VIBON than you should
In case of accidental ingestion/overdose of VIBON, inform your doctor immediately or go to the nearest hospital. Overdose may lead to increased levels of calcium in the blood and urine (hypercalcaemia and hypercalciuria), with symptoms including: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine production (polyuria), constipation, and dehydration.

Other symptoms of overdose include:
Diarrhoea, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and renal failure.
Chronic excessive overdosage may lead to calcium salt deposits in blood vessels and organs.
Excessive vitamin D intake during the first 6 months of pregnancy may cause severe harm to the fetus and newborn.

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

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

VIBON contains glycerol
It may cause headache, stomach upset, and diarrhoea.

VIBON contains Allura Red AC (E129)
It may cause allergic reactions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with vitamin D use are as follows:

Uncommon side effects (may affect up to 1 in 100 people):
Allergic reactions, weakness, loss of appetite (anorexia), increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Rare side effects (may affect up to 1 in 1,000 people):
Drowsiness, confusion, constipation, intestinal gas (flatulence), stomach ache, nausea, vomiting, diarrhoea, metallic taste, dry mouth, skin rash, itching, urticaria.

Frequency not known (frequency cannot be estimated from the available data):
Headache, excessive calcium accumulation in the kidneys (nephrocalcinosis), increased urine production (polyuria), intense thirst (polydipsia), kidney disease (renal failure).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VIBON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the pack after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 25  C.
Keep in the original packaging to protect the medicine from light.
Do not freeze.

6. Package contents and other information

What VIBON contains

• The active substance is colecalciferol (vitamin D). Each soft capsule contains: 0.250 mg colecalciferol (vitamin D) equivalent to 10,000 IU.
• The other components are:
• Capsule contents: refined olive oil, butyl hydroxytoluene (E321).
  Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin, succinic acid and Allura Red 40 (E129).

Description of the appearance of VIBON and contents of the pack
The pack contains 2, 4, 8 or 10 capsules in a thermo-sealed PVC/PVDC and aluminium blister,
housed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy

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

This medicinal product is authorized in the European Economic Area countries under the
following names:
MT: VIBON, 10,000 I.U. soft capsules
IT: VIBON

Patient information leaflet

VIBON 25,000 UI, soft capsules

Colecalciferol (vitamin D3)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of this leaflet:

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

1. What VIBON is and what it is used for

VIBON contains the active substance colecalciferol, better known as Vitamin D3.
VIBON is indicated for:
Prevention of vitamin D deficiency, but only in cases where therapeutic adherence
cannot be achieved with daily administration of low doses of colecalciferol.
Treatment of vitamin D deficiency.
VIBON is indicated in adults.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking VIBON

Do not take VIBON

• if you are allergic to colecalciferol (vitamin D3) or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria)
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis)
• if you have high levels of vitamin D in your body (hypervitaminosis D)
• if you suffer from kidney disease (severe renal impairment) (see section “Warnings and precautions”).

VIBON must not be given to neonates and children under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking VIBON, particularly:

• if you need to take VIBON for a long time and at high doses.
• if you are elderly and are already taking medicines to treat heart conditions (cardiac glycosides or diuretics). In this case, you must check calcium levels in blood and urine.
• if you are already taking medicines containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk.
• if you suffer from a chronic inflammatory disease that can affect all organs called sarcoidosis.
• if you have impaired kidney function, as vitamin D levels in the body may be altered.
• if you are prone to developing calcium-containing kidney stones.
• if you have severe renal failure: in this case, other forms of vitamin D should be used.
• if you take this medicine for long-term treatment, especially if you are elderly. In this case, your doctor will monitor urinary calcium excretion and kidney function. If necessary, your doctor will reduce the dose.
• if you have a disorder of parathyroid hormone levels (pseudohypoparathyroidism).

Inform your doctor if you have any of the following conditions, as a dosage increase may be required as indicated in section 3 “How to take VIBON”:

• if you are being treated with medicines for epilepsy (anticonvulsants or barbiturates).
• if you are being treated with anti-inflammatory medicines (corticosteroids).
• if you are being treated with medicines that reduce blood fat levels (cholestyramine, colestipol, orlistat) or laxatives (such as paraffin oil).
• if you are being treated with medicines used to treat excessive stomach acid production (aluminum-containing antacids).
• if you are obese.
• if you suffer from digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis).
• if you suffer from liver disease (hepatic insufficiency).

Children
VIBON must not be given to neonates or children under 18 years of age.

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

• other medicines containing vitamin D.
• medicines used to treat epilepsy (anticonvulsants or barbiturates), such as phenytoin, phenobarbital, primidone, etc.
• medicines to reduce blood fats such as colestipol, cholestyramine, orlistat, and laxatives (e.g. paraffin oil).
• aluminum-containing antacids, medicines used to treat excess stomach acid that may reflux into the esophagus.
• thiazide diuretics, medicines used to treat high blood pressure that increase urine production.
• digitalis, a medicine used to treat certain heart conditions.
• medicines used to treat tuberculosis, such as rifampicin and isoniazid.
• antifungal agents such as imidazoles (e.g. ketoconazole), medicines used to inhibit the growth of fungal organisms.
• warfarin, a medicine used to thin the blood.
• heart medicines (cardiac glycosides), because you will need to be monitored by a doctor, possibly undergo an ECG, and have your calcium levels checked.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
VIBON must not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical condition requires treatment with colecalciferol at lower doses.

Pregnancy
Your doctor will prescribe vitamin D during the first 6 months of pregnancy only if strictly necessary, due to the risk of harmful effects on the fetus (see section 3: “If you take more VIBON”).
However, since vitamin D deficiency is harmful to both the fetus and the mother, if necessary, your doctor will prescribe low-dose vitamin D during pregnancy.

Breastfeeding
If necessary, your doctor will prescribe low-dose vitamin D during breastfeeding. This does not replace the administration of vitamin D to the newborn.

Driving and using machines
VIBON does not affect or has negligible effect on the ability to drive and use machines.

3. How to take VIBON

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose and duration of treatment should be determined by your doctor according to your
health condition.
Do not exceed the doses indicated by your doctor.
Take the dose orally.
Take VIBON with meals.

Adults and elderly
Prevention:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3) once a month.
Your doctor will determine the dose most suitable for you and may subsequently prescribe lower doses.

Treatment:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3) once a week for 4–12
weeks. Your doctor will determine the dose most suitable for you and may subsequently prescribe lower
doses.

During long-term treatment with high doses, urinary calcium excretion and renal function should be monitored, especially in elderly patients. Dose reduction or discontinuation of treatment is recommended if urinary calcium exceeds 7.5 mmol/24 hours (300 mg/24 hours).

In cases of severe vitamin D deficiency in adults and elderly, the required amount will depend on vitamin D levels and response to treatment. Your doctor will determine the most appropriate dose based on your response to therapy. Higher doses should be adjusted according to desired serum levels of 25-hydroxycholecalciferol (25(OH)D), disease severity, and response to treatment.

If you take more VIBON than you should
In case of accidental ingestion/overdose of VIBON, inform your doctor immediately or go to the nearest hospital. Overdose may lead to increased levels of calcium in the blood and urine, with symptoms including: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine production (polyuria), constipation, and dehydration.

Other symptoms of overdose include:
Diarrhoea, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and renal failure.

Excessive chronic overdosage may lead to deposition of calcium salts in blood vessels and organs. Excessive vitamin D intake during the first 6 months of pregnancy may cause severe harm to the fetus and newborn.

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

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

VIBON contains glycerol
It may cause headache, stomach upset, and diarrhoea.

VIBON contains Allura Red AC (E129)
It may cause allergic reactions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects reported with vitamin D use are as follows:

Uncommon side effects (may affect up to 1 in 100 people):
Allergic reactions, weakness, loss of appetite (anorexia), increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Rare side effects (may affect up to 1 in 1,000 people):
Drowsiness, confusion, constipation, gas from the intestine (flatulence), stomach ache, nausea, vomiting, diarrhoea, metallic taste, dry mouth, skin rash, itching, urticaria.

Frequency not known (frequency cannot be estimated from the available data):
Headache, excessive calcium accumulation in the kidneys (nephrocalcinosis), increased urine production (polyuria), intense thirst (polydipsia), kidney disease (renal failure).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VIBON

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 label of the pack after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 25 °C.
Keep in the original packaging to protect the medicine from light.
Do not freeze.

6. Package contents and other information

What VIBON contains

• The active substance is colecalciferol (vitamin D). Each soft capsule contains: 0.625 mg of colecalciferol (vitamin D) equivalent to 25,000 IU.
• The other components are:
• Capsule contents: refined olive oil, butyl hydroxytoluene (E321).
  Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin, succinic acid, and Allura Red AC 40 (E129).

Description of the appearance of VIBON and contents of the pack
The pack contains 1, 2, 4 capsules in a thermo-sealed PVC/PVDC and aluminum blister, inserted into a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy

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

This medicinal product is authorized in the European Economic Area countries under the following names:
MT: VIBON, 25,000 IU, soft capsules
IT: VIBON