Tomaino

Package leaflet: Information for the patient

TOMAINO 10,000 U.I./ml oral drops, solution

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

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

Contents of this leaflet:

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

1. What TOMAINO is and what it is used for

TOMAINO contains colecalciferol, better known as vitamin D. The main function
of vitamin D is to ensure adequate absorption of calcium in the intestine and to promote proper
mineralization of bones.
TOMAINO is indicated for the prevention and treatment of vitamin D deficiency.

2. What you should know before taking TOMAINO

Do not take TOMAINO

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

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

• in newborns (especially premature infants) and infants,
• during the last trimester of pregnancy,
• in breastfeeding women at the end of winter and in spring,
• in the elderly,
• in case of inadequate sun exposure, particularly in children and adolescents,
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet),
• in case of dark skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• gastrointestinal disorders or liver disease (hepatic insufficiency),
• in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines. Inform your doctor if you are already taking other products containing vitamin D, foods or milk fortified with vitamin D, because vitamin D accumulates in the body and excessive doses may cause toxic effects. For this reason, it is important not to exceed the recommended dose.

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

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

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

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

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

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

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

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

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, 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 TOMAINO than you should”).
Breastfeeding
If necessary, your doctor may prescribe this medicine during breastfeeding. However, this does not replace the need for vitamin D supplementation in the newborn.

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

3. How to take TOMAINO

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

Paediatric population (<18 years)
Neonates (0–1 year)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D) daily.
Treatment: The doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 4 drops (equivalent to 1,000 IU of vitamin D).

Children (1–11 years)
Prevention: 1–2 drops (equivalent to 250–500 IU of vitamin D) daily. From the second year of life, in the presence of multiple risk factors for vitamin D deficiency and according to the doctor’s judgment, the dosage may be increased up to 3 drops daily (equivalent to 750 IU of vitamin D).
Treatment: The doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 8 drops (equivalent to 2,000 IU of vitamin D).

Adolescents (12–17 years)
Prevention: 2–4 drops daily (equivalent to 500–1,000 IU of vitamin D).
Treatment: 4–16 drops daily (equivalent to 1,000–4,000 IU of vitamin D). The doctor will determine the appropriate dose and may subsequently prescribe a lower dose.
The daily dose must not exceed 16 drops (equivalent to 4,000 IU of vitamin D).

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

Adults and elderly
Prevention: The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D). In the presence of multiple risk factors for vitamin D deficiency, according to the doctor’s judgment, the dosage may be increased up to 8 drops daily (equivalent to 2,000 IU of vitamin D).
Treatment: 4 drops (equivalent to 1,000 IU of vitamin D) daily. The doctor will determine the appropriate dose and may subsequently prescribe a lower dose. Higher doses must be adjusted according to the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the patient’s response to treatment. The daily dose must not exceed 16 drops (equivalent to 4,000 IU of vitamin D).

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

1. press and unscrew the bottle cap simultaneously;
2. remove the cap;
3. unscrew the protective cover of the dropper;
4. screw the dropper onto the bottle and draw up the contents;
5. remove the dropper and return it to the protective cover;
6. screw the cap back on to close the bottle.

If you take more TOMAINO than you should
In case of accidental ingestion/overdose of TOMAINO, inform your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include elevated levels of calcium in the blood and urine, with symptoms such as nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
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 TOMAINO
Do not take a double dose to make up for a forgotten dose.

If you stop taking TOMAINO
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 the following:

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

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

5. How to store TOMAINO

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 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.
Keep in the original packaging to protect the medicine from light.
The shelf life of the medicine after first opening the bottle is 5 months (record the date of first
opening in the designated space on the carton).
After this period, any remaining medicine must be discarded.

6. Package contents and other information

What TOMAINO contains

• The active substance is colecalciferol (vitamin D): 10 ml of solution contain 2.5 mg (equivalent to 100,000 IU) of colecalciferol. One drop contains: 250 IU of vitamin D.
• The other component is refined olive oil.

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

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

Manufacturer

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

Package leaflet: Information for the patient

TOMAINO 25,000 IU/2.5 ml oral solution

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TOMAINO is and what it is used for

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

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

2. What you should know before taking TOMAINO

Do not take TOMAINO

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

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

• in elderly patients,
• in case of insufficient sun exposure,
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet),
• in case of dark skin pigmentation,
• in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy),
• gastrointestinal disorders or liver disease (hepatic insufficiency),
• in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines. Inform your doctor if you are already taking other products containing vitamin D, foods or milk fortified with vitamin D, because vitamin D accumulates in the body and excessive doses may cause toxic effects. For this reason, it is important that you do not exceed the recommended dose.

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

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

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

Inform your doctor in the following cases, as an increase in dosage compared to those indicated in section 3 “How to take TOMAINO” may be necessary:

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

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

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

• antiepileptic medicines (anticonvulsants) or barbiturates, medicines used in anaesthesia,
• rifampicin (an antibiotic),
• medicines to lower blood lipids such as colestipol, cholestyramine,
• medicines used for obesity treatment (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, medicines used to treat certain heart disorders,
• magnesium-containing preparations,
• warfarin, a medicine used to make blood less prone to clotting.

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

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

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

Breastfeeding
TOMAINO 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.

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

3. How to take TOMAINO

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor 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 TOMAINO during meals.

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

Paediatric population
The use of Tomaino 25,000 IU oral solution is not recommended in neonates, children, and adolescents under 18 years of age.

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

If you take more TOMAINO than you should
In case of accidental ingestion/overdose of TOMAINO, contact your doctor immediately 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, 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 TOMAINO
Do not take a double dose to make up for the missed dose.

If you stop treatment with TOMAINO
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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

5. How to store TOMAINO

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

6. Package contents and other information

What TOMAINO contains

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

Description of the appearance of TOMAINO and contents of the pack
TOMAINO is a solution contained in an amber glass container closed with a polypropylene cap.
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
Epifarma S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer

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

Patient information leaflet

Tomaino 50,000 IU/2.5 ml oral solution

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

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

Contents of this leaflet:

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

1. What Tomaino is and what it is used for

Tomaino contains colecalciferol, better known as vitamin D. The main function of vitamin D is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
Tomaino 50,000 IU/2.5 ml oral solution is indicated for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you should know before taking Tomaino

Do not take Tomaino

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Tomaino.
Inform your doctor if you are already taking other products containing vitamin D, or if you consume many foods known to be sources of vitamin D (such as fish liver oil, fish, and eggs), or vitamin D-fortified foods or milk, because vitamin D accumulates in the body and excessive doses may cause toxic effects. For this reason, it is important that you do not exceed the recommended dose.
Your doctor may prescribe periodic blood or urine tests to monitor your vitamin D levels, or calcium levels in your blood and urine in the following cases:

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

In general, you should not take Tomaino if you have poor kidney function (see section “Do not take Tomaino”); however, if your doctor considers treatment with Tomaino to be absolutely necessary, periodic blood tests will be required to monitor calcium and phosphate levels. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Tomaino.
Inform your doctor in the following cases, as an increase in dosage above that indicated in section 3 “How to take Tomaino” may be necessary:

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

Children and adolescents
Tomaino 50,000 IU oral solution is not recommended for children and adolescents aged 0 to 18 years.

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

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

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

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

Tomaino with food and drink 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 taken into account to avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, 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 Tomaino than you should”).
Tomaino 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
Tomaino 50,000 IU oral solution is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D at lower doses during breastfeeding. This does not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are present in breast milk. This should be taken into account when additional vitamin D is given to the infant.

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

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

3. How to take Tomaino

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor 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 Tomaino during meals. The single-dose container must be used for a single administration, ensuring that the entire dose is taken.

Recommended dose:
Adults and elderly
1 single-dose container (equal to 50,000 IU of vitamin D) once a week for up to 6 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.

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

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

If you take more Tomaino than you should
In case of accidental ingestion/overdose of Tomaino, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, 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 vitamin D intake during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.

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

If you stop taking Tomaino
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with vitamin D use are as follows:
Uncommon (may affect up to 1 in 100 people)

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

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

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

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

• headache
• vomiting, metallic taste (dysgeusia), dry mouth
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased amount of urine excreted (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 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 Tomaino

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

6. Package contents and other information

What Tomaino contains

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

Description of the appearance of Tomaino and contents of the pack
Tomaino is a clear, colourless or yellowish-green transparent solution contained in an amber glass container closed with a polipropylene cap with an inner polyethylene lining.
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
Epifarma S.r.l. – Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer

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