Balavita

Patient Information Leaflet

Balavita 50,000 IU/ml oral solution in single-dose container

Colecalciferol (Vitamin D3)
Please read all of 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 effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Balavita is and what it is used for

Balavita contains colecalciferol, better known as vitamin D3.
Balavita is indicated for the treatment of vitamin D deficiency in adult patients.

2. What you need to know before taking Balavita

Do not take Balavita

• if you are allergic to cholecalciferol (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 blood.
• if you suffer from severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Balavita.
Your doctor may prescribe periodic blood and urine tests to monitor vitamin D and calcium levels in the following cases:

• if you need to take Balavita for a long time and at high doses,
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics),
• if you have sarcoidosis, an inflammatory disease that may affect the whole body and leads to nodule formation.

If your vitamin D or calcium levels are found to be high, your doctor will reduce the dose or stop treatment with Balavita.
In general, you should not take Balavita if you have impaired kidney function (see section “Do not take Balavita”). You will need periodic blood tests to monitor calcium and phosphate levels. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Balavita.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Balavita” may be required:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Balavita”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Balavita”);
• if you are taking medicines to lower blood fats such as colestipol, cholestyramine (see section “Other medicines and Balavita”);
• if you are taking medicines that reduce fat absorption (Orlistat);
• if you are taking aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus (see section “Other medicines and Balavita”);
• if you are obese;
• if you suffer from digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
• if you have liver disease (hepatic insufficiency).

Children and adolescents
The use of Balavita 25,000 IU/2.5 ml oral solution and Balavita 50,000 IU/2.5 ml oral solution is not recommended in children and adolescents.

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

• medicines used to treat epilepsy (anticonvulsants or barbiturates);
• medicines to lower blood fats such as colestipol, cholestyramine;
• medicines that reduce fat absorption (Orlistat);
• aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus;
• corticosteroids, medicines used to treat inflammation.

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

• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
• digitalis, medicines used to treat certain heart conditions;
• magnesium-containing preparations;
• warfarin, a medicine used to thin the blood;
• actinomycin;
• antifungals;
• ketoconazole.

Balavita 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 milk fortified with vitamin D, so that the total intake of vitamin D can be considered to avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

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

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

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

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

Driving and using machines
It is unlikely that Balavita will affect your ability to drive.

3. How to take Balavita

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The doses and duration of treatment will be determined by your doctor according to your health condition. Do not
exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Balavita during meals.
Adults and Elderly
Treatment: 1 single-dose container once a week for up to 6 weeks.
Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.
If you take more Balavita than you should
In case of accidental ingestion/overdose of Balavita, inform your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine output (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Excessive intake of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.
If you forget to take Balavita
Do not take a double dose to make up for the missed dose.
If you stop treatment with Balavita
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with vitamin D use are listed below, classified according to the following frequency: common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (< 1/10,000); not known (frequency cannot be estimated from the available data).

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

5. How to store Balavita

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Store below 30°C. Do not freeze.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What Balavita contains
In a single-dose container:

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

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Medinitaly Pharma Progress S.r.l.
Via di Villa Massimo, 37
00161 Rome, Italy

Manufacturer:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy

Patient information leaflet

Balavita 10,000 IU/mL oral drops, solution

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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Balavita is and what it is used for

Balavita contains colecalciferol, better known as vitamin D3.
Balavita is indicated for the prevention and treatment of vitamin D deficiency.

2. What you need to know before taking Balavita

Do not take Balavita

• if you are allergic to cholecalciferol (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 blood.
• if you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Balavita.
Your doctor may recommend taking Balavita to prevent vitamin D deficiency:

• in newborns (especially premature infants) and infants,
• during the last trimester of pregnancy,
• in breastfeeding women,
• in the elderly,
• in case of insufficient sun exposure,
• in case of special diets (e.g. low in calcium, vegetarian diet),
• in case of dark skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), gastrointestinal disorders or liver diseases (hepatic insufficiency),
• in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory drugs.

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

• if you are to take Balavita for a long period and at high doses,
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that reduce blood pressure by increasing urine production (diuretics),
• if you suffer from sarcoidosis, an inflammatory disease that may affect the whole body and leads to nodule formation.

If your vitamin D or calcium levels are found to be high, your doctor will reduce the dose or
discontinue treatment with Balavita.
In general, if you suffer from impaired kidney function (see section “Do not take Balavita”),
you should undergo periodic tests to monitor calcium and phosphate levels in your blood. If your
calcium and phosphate levels are high, your doctor will reduce the dose or discontinue
treatment with Balavita.
Inform your doctor in the following cases, as higher doses than those indicated in
section 3 “How to take Balavita” may be necessary:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Balavita”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Balavita”);
• if you are taking medicines to lower blood fats such as colestipol, cholestyramine (see section “Other medicines and Balavita”);
• if you are taking medicines that reduce fat absorption (Orlistat);
• if you are taking aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and Balavita”);
• if you are obese;
• if you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
• if you suffer from liver disease (hepatic insufficiency).

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

• medicines used to treat epilepsy (anticonvulsants or barbiturates);
• medicines to lower blood fats such as colestipol, cholestyramine;
• medicines that reduce fat absorption (Orlistat);
• aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus;
• corticosteroids, medicines used to treat inflammation.

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

• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
• digitalis, a medicine used to treat certain heart disorders;
• magnesium-containing preparations;
• warfarin, a medicine used to make the blood less prone to clotting;
• actinomycin;
• antifungals;
• ketoconazole.

Balavita with food, drinks and alcohol
Inform your doctor if you are taking other products that already contain vitamin D, vitamin D-fortified foods, or if you are using vitamin D-enriched milk, so that your doctor can consider your total vitamin D intake and avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, please consult your doctor or pharmacist before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if strictly necessary, due to the risk of harmful effects on the fetus (see section 3 “If you take more Balavita than you should”).
Breastfeeding
Your doctor may prescribe this medicine when necessary during breastfeeding. This does not replace the need for vitamin D supplementation in the newborn. Vitamin D and its metabolites are present in breast milk. This should be taken into account when administering additional vitamin D to the infant.
Fertility
There are no data available on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported with vitamin D blood levels within the normal range.
Driving and using machines
It is unlikely that Balavita will affect your ability to drive.

3. How to take Balavita

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

Adults and elderly
Prevention: The recommended dose is 3–5 drops (equivalent to 600–1,000 IU of vitamin D3 daily). In the
presence of multiple risk factors for vitamin D deficiency, the dosage may be increased up to 10 drops
daily (equivalent to 2,000 IU of vitamin D3), according to the doctor's judgment.
Treatment: 5 drops (equivalent to 1,000 IU of vitamin D3 daily). Your doctor will determine the appropriate
dose and may subsequently prescribe a lower dose. Higher doses must be adjusted according to the
target serum levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the
patient’s response to treatment. The daily dose must not exceed 20 drops (equivalent to 4,000 IU of
vitamin D3).

Use in children and adolescents
Newborns (up to 1 year of age)
Prevention: The recommended daily dose is 2 drops (equivalent to 400 IU of vitamin D3 daily).
Treatment: The daily dose must not exceed 5 drops (equivalent to 1,000 IU of vitamin D3 daily). Your
doctor will determine the appropriate dose and may subsequently prescribe a lower dose. Higher
doses must be adjusted according to the target serum levels of 25-hydroxycholecalciferol (25(OH)D),
the severity of the disease, and the patient’s response to treatment.

Children (1–11 years)
Prevention: 2 drops (equivalent to 400 IU of vitamin D3) daily. From the second year of life, in the
presence of multiple risk factors for vitamin D deficiency and according to the doctor's judgment, the
dosage may be increased up to 4 drops daily (equivalent to 800 IU of vitamin D3).
Treatment: The daily dose must not exceed 10 drops (equivalent to 2,000 IU of vitamin D3 daily). Your
doctor will determine the appropriate dose and may subsequently prescribe a lower dose. Higher
doses must be adjusted according to the target serum levels of 25-hydroxycholecalciferol (25(OH)D),
the severity of the disease, and the patient’s response to treatment.

Adolescents (12–17 years of age)
Prevention: The recommended daily dose is 3–5 drops (equivalent to 600–1,000 IU of vitamin D3
daily).
Treatment: The daily dose must not exceed 20 drops (equivalent to 4,000 IU of vitamin D3 daily). Your
doctor will determine the appropriate dose and may subsequently prescribe a lower dose. Higher
doses must be adjusted according to the target serum levels of 25-hydroxycholecalciferol (25(OH)D),
the severity of the disease, and the patient’s response to treatment.

Pregnancy
For pregnant women, the recommended daily dose is 3–5 drops (equivalent to 600–1,000
IU/day of vitamin D3). However, in women considered deficient in vitamin D, a higher dose may be
necessary (up to 2,000 IU daily – 10 drops).

Instructions for using the dropper bottle
The package contains 1 bottle with dropper and a child-resistant safety cap. Follow the instructions below for use:

1. Shake the bottle before use.
2. Unscrew the child-resistant safety cap by pressing downward and turning counterclockwise at the same time (see figure).
3. Count the drops into a spoon and administer directly into the mouth.
4. Close the bottle by screwing the cap back on tightly in a clockwise direction and store it in the
   original packaging.

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The adverse effects reported with vitamin D use are listed below, classified according to the following frequency categories: common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

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

5. How to store Balavita

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 30°C. Do not freeze.
Keep in the original packaging to protect from light.
The shelf life of the medicine after first opening the bottle is 6 months (record the date of first
opening in the designated space on the carton). After this period, any remaining medicine must be
discarded.

6. Package contents and other information

What Balavita contains

• The active substance is colecalciferol (vitamin D3) 2.5 mg, equivalent to 100,000 IU. Each drop contains: 200 IU of vitamin D3.
• The other component is refined olive oil.

Description of the appearance of Balavita and contents of the pack
Balavita is a solution contained in an amber glass bottle closed with a child-resistant cap made of polypropylene.
It is available in a pack containing 1 bottle with a 10 ml dropper.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Medinitaly Pharma Progress S.r.l.
Via di Villa Massimo, 37
00161 Rome, Italy

Manufacturer:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy

Patient Information Leaflet

Balavita 25,000 I.U. oral solution in single-dose container

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Balavita is and what it is used for

Balavita contains colecalciferol, better known as vitamin D3.
Balavita is indicated for:

• the prevention of vitamin D deficiency in adults, solely in cases where therapeutic adherence cannot be achieved with daily administration of low doses of colecalciferol.
• the treatment of vitamin D deficiency in adult patients.

2. What you should know before taking Balavita

Do not take Balavita

• if you are allergic to cholecalciferol (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 blood.
• if you have severe kidney disease (severe renal failure) (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Balavita if:

• you are elderly,
• you have limited sun exposure,
• you follow a special diet (e.g. low in calcium, vegetarian diet),
• you have deeply pigmented skin,
• you have extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), digestive disorders, or liver disease (hepatic insufficiency),
• you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines.

Your doctor may prescribe periodic tests to monitor vitamin D and calcium levels in your blood and urine in the following cases:

• if you need to take Balavita for a long time and at high doses,
• if you are elderly and already taking medicines to treat certain heart conditions (cardiac glycosides) or medicines that lower blood pressure by increasing urine production (diuretics),
• if you have sarcoidosis, an inflammatory disease that can affect the entire body and leads to the formation of nodules.

If your vitamin D or calcium levels are found to be high, your doctor will reduce the dose or stop treatment with Balavita.
In general, you should not take Balavita if you have impaired kidney function (see section “Do not take Balavita”). You will need periodic blood tests to monitor calcium and phosphate levels. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Balavita.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Balavita” may be required:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Balavita”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Balavita”);
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and Balavita”);
• if you are taking medicines that reduce fat absorption (Orlistat);
• if you are taking aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus (see section “Other medicines and Balavita”);
• if you are obese;
• if you have digestive disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
• if you have liver disease (hepatic insufficiency).

Children and adolescents
Balavita 25,000 IU oral solution is not recommended for children and adolescents.

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

• medicines used to treat epilepsy (anticonvulsants or barbiturates);
• medicines to lower blood lipids such as colestipol, cholestyramine;
• medicines that reduce fat absorption (Orlistat);
• aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus;
• corticosteroids, medicines used to treat inflammation.

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

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

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

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

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

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

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

Driving and using machines
It is unlikely that Balavita will affect your ability to drive.

3. How to take Balavita

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

Adults and Elderly

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

If you take more Balavita than you should

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

If you forget to take Balavita

Do not take a double dose to make up for the missed dose.

If you stop taking Balavita

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with vitamin D use are listed below, classified according to the following frequency categories: common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

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

5. How to store Balavita

Keep this medicine out of the sight and reach of children. Do not use this medicine
after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store below 30°C. Do not freeze.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What Balavita contains
In a single-dose container:

• The active substance is colecalciferol (vitamin D3) 0,625 mg, equivalent to 25,000 IU.
• The other component is refined olive oil.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Medinitaly Pharma Progress S.r.l.
Via di Villa Massimo, 37
00161 Rome, Italy

Manufacturer:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy