Tredimin

Package leaflet: Information for the patient

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

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

1. What TREDIMIN is and what it is used for

TREDIMIN contains the active substance colecalciferol (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.
TREDIMIN is used to prevent and treat vitamin D deficiency.

2. What you need to know before taking TREDIMIN

Do not take TREDIMIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood and urine;
• if you suffer from kidney stones;
• if you have renal failure.

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

• in newborns (especially if premature) and infants;
• during the last trimester of pregnancy;
• in breastfeeding women at the end of winter and in spring;
• in the elderly;
• in children and adolescents with insufficient sun exposure;
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet);
• in case of extensive dermatological diseases, digestive disorders, or hepatic insufficiency;
• in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory drugs.

Inform your doctor if you are already taking other products containing vitamin D, or foods or milk fortified with vitamin D,
as 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 will monitor you and may request blood and/or urine tests if you:

• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly person being treated with cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases.

Other medicines and TREDIMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of TREDIMIN may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medicines used to treat epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis (used to treat heart problems);
• aluminium- or magnesium-containing antacids;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (used for the treatment of obesity).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if strictly necessary due to possible teratogenic effects (fetal malformations).
Breastfeeding
Your doctor may prescribe this medicine when necessary during breastfeeding. This supplementation does not replace vitamin D administration in the newborn.
Driving and using machines
There are no data available on the effects of this product on the ability to drive.

3. How to take TREDIMIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is recommended to take TREDIMIN during meals.

The recommended dose is:

Paediatric population (< 18 years)
Neonates (0–1 year)
Prevention: 1–2 drops (equivalent to 250–500 IU vitamin D) daily.
Treatment: Your 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 vitamin D).

Children (1–11 years)
Prevention: 1–2 drops (equivalent to 250–500 IU 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 vitamin D).
Treatment: Your 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 vitamin D).

Adolescents (12–17 years)
Prevention: 2–4 drops daily (equivalent to 500–1,000 IU vitamin D).
Treatment: 4–16 drops daily (equivalent to 1,000–4,000 IU vitamin D). Your 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 vitamin D).

Pregnant women
The recommended dose is 3–4 drops daily (equivalent to 750–1,000 IU 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 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 vitamin D).
Treatment: 4 drops (equivalent to 1,000 IU vitamin D) daily. Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. Higher doses should 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 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 cap of the dropper;
4. Screw the dropper onto the bottle and draw the content;
5. Remove the dropper and place it back into the protective cap;
6. Screw the bottle cap back on to close the bottle.

If you take more TREDIMIN than you should
If you accidentally take an excessive dose of TREDIMIN, 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, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a correlation between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Elevated calcium levels in the maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.

If you forget to take TREDIMIN
Do not take a double dose to make up for the missed dose. Skip the missed dose and continue your treatment as usual.

If you stop taking TREDIMIN
Do not stop taking TREDIMIN on your own initiative. 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 will experience them.
The following are side effects that have been reported; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, intestinal gas, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, hives;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in the blood and in the urine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: 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 TREDIMIN

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.
After 5 months from first opening, the medicine must be discarded, even if not completely used.
Store this medicine in the original packaging to protect it from light.
Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TREDIMIN contains

• The active substance is colecalciferol (Vitamin D3). 10 ml of solution contain: 2.5 mg (equivalent to 100,000 IU) of colecalciferol. 1 drop contains: 250 IU of colecalciferol.
• Excipients: refined olive oil

Description of the appearance of TREDIMIN and contents of the pack
Clear, light yellow, odourless solution.
TREDIMIN is available in packs of 1 or 10 amber glass bottles containing 10 ml of solution, closed with a child-resistant cap made of polypropylene and supplied with 1 or 10 droppers.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SPA Società Prodotti Antibiotici S.p.A., Via Biella 8, 20143 Milano

Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta, 12 - 20141 Milano
Lachifarma S.p.A. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE)

Patient information leaflet

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

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

Contents of this leaflet:

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

1. What TREDIMIN is and what it is used for

TREDIMIN contains the active substance colecalciferol (vitamin D). The main function of vitamin D
is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
TREDIMIN is used to prevent and treat vitamin D deficiency.

2. What you need to know before taking TREDIMIN

Do not take TREDIMIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood or urine;
• if you suffer from kidney stones;
• if you have renal failure.

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

• in newborns (especially if premature) and infants;
• during the last trimester of pregnancy;
• in breastfeeding women at the end of winter and in spring;
• in elderly people;
• in children and adolescents with insufficient sun exposure;
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet);
• in case of extensive dermatological diseases, digestive disorders, or hepatic insufficiency;
• in patients being treated with antiepileptic drugs or undergoing long-term treatment with certain anti-inflammatory agents.

Inform your doctor if you are already taking other products containing vitamin D, or foods or milk fortified with vitamin D,
as 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 will monitor you and may request blood and/or urine tests if you:

• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly person being treated with cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases.

Other medicines and TREDIMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of TREDIMIN may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medicines for the treatment of epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (used for the treatment of obesity).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, 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 possible teratogenic effects (fetal malformations).
Breastfeeding
Your doctor may prescribe this medicine when necessary during breastfeeding. This supplementation does not replace vitamin D administration in the newborn.
Driving and using machines
There are no data available on the effects of this product on the ability to drive.

3. How to take TREDIMIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
It is recommended to take TREDIMIN during meals.
The recommended dose is:
Paediatric population (< 18 years)
Neonates (0–1 year)
Prevention: 1–2 drops (equivalent to 250–500 IU vitamin D) per day.
Treatment: Your 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 vitamin D).
Children (1–11 years)
Prevention: 1–2 drops (equivalent to 250–500 IU vitamin D) per day. 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 per day (equivalent to 750 IU vitamin D).
Treatment: Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose.
The daily dose must not exceed 8 drops per day (equivalent to 2,000 IU vitamin D).
Adolescents (12–17 years)
Prevention: 2–4 drops per day (equivalent to 500–1,000 IU vitamin D).
Treatment: 4–16 drops per day (equivalent to 1,000–4,000 IU vitamin D). Your doctor will determine the
appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 16 drops per
day (equivalent to 4,000 IU vitamin D).
Pregnant women
The recommended dose is 3–4 drops per day (equivalent to 750–1,000 IU vitamin D) during the last
trimester. However, in women considered deficient in vitamin D, a higher dose may be required (up to 2,000
IU per day – 8 drops).
Adults and elderly
Prevention: The recommended dose is 3–4 drops per day (equivalent to 750–1,000 IU 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 per day (equivalent to 2,000 IU vitamin D).
Treatment: 4 drops per day (equivalent to 1,000 IU vitamin D). Your doctor will determine the appropriate
dose and may subsequently prescribe a lower dose. Higher doses should 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 per day (equivalent to 4,000 IU vitamin D).
If you take more TREDIMIN than you should
If you accidentally take an excessive dose of TREDIMIN, 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, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a known
correlation between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed
physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Increased calcium
levels in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced
blood calcium levels, muscle cramps and spasms (tetany), and seizures.
If you forget to take TREDIMIN
Do not take a double dose to make up for a forgotten dose. Skip the missed dose and continue your treatment as
usual.
If you stop taking TREDIMIN
Do not stop taking TREDIMIN on your own initiative. 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 listed below have been reported; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, intestinal gas, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, hives;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in blood and urine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact 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 TREDIMIN

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.
After 5 months from first opening, the medicine must be discarded, even if not completely used.
Store this medicine in the original packaging to protect it from light.
Do not freeze.
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.

6. Package contents and other information

What TREDIMIN contains

• The active substance is colecalciferol (Vitamin D3). 10 ml of solution contain: 2.5 mg (equivalent to 100,000 IU) of colecalciferol. 1 drop contains: 250 IU of colecalciferol.
• Excipients: refined olive oil

Description of the appearance of TREDIMIN and package contents
Clear, pale yellow, odourless solution.
TREDIMIN is available in packages containing 1 or 10 amber glass bottles with a dropper insert, each containing 10 ml of solution, closed with a child-resistant cap made of polypropylene.
Marketing Authorization Holder
SPA Società Prodotti Antibiotici S.p.A., Via Biella 8, 20143 Milan
Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta, 12 - 20141 Milan

Patient Information Leaflet

TREDIMIN 25,000 IU/2.5 ml oral solution

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

1. What TREDIMIN is and what it is used for

TREDIMIN contains the active substance colecalciferol (vitamin D ). The main function of vitamin D
is to ensure adequate absorption of calcium in the intestine and to support proper bone mineralization.
TREDIMIN 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 adults (age over 18 years).

2. What you need to know before taking TREDIMIN

Do not take TREDIMIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood and urine;
• if you suffer from kidney stones;
• if you have renal failure.

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

• in elderly patients;
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet);
• in case of extensive dermatological conditions, digestive disorders, or liver insufficiency;
• in patients being treated with antiepileptic drugs or undergoing long-term therapy with certain anti-inflammatory agents.

Inform your doctor if you are already taking other products containing vitamin D, or foods or milk fortified with vitamin D,
since 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 will monitor you and may request blood and/or urine tests if you

• have or have had kidney stones;
• have kidney problems;
• are an elderly patient being treated with cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases.

Children and adolescents
TREDIMIN 25,000 IU oral solution is not recommended for children and adolescents aged between 0 and 18 years.

Other medicines and TREDIMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of TREDIMIN may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medicines used to treat epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce blood cholesterol levels);
• orlistat (used to treat obesity).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, 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 TREDIMIN than you should").
TREDIMIN 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
TREDIMIN 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 product on the ability to drive.

3. How to take TREDIMIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is recommended to take TREDIMIN 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 maintenance dose.

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

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

If you take more TREDIMIN than you should
If you accidentally take an excessive dose of TREDIMIN, contact your doctor immediately or go to the nearest hospital.
In case of overdose, elevated levels of calcium in the blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a correlation between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Increased calcium levels in maternal blood may also lead to suppression of fetal parathyroid function, resulting in reduced calcium levels in newborns, with muscle cramps and spasms (tetany), and seizures.

If you forget to take TREDIMIN
Do not take a double dose to make up for a forgotten dose. Skip the missed dose and continue with your regular dosing schedule.

If you stop taking TREDIMIN
Do not stop taking TREDIMIN on your own initiative. 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 are listed below; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in the blood and in the urine.

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 the website http://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 TREDIMIN

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.
Store this medicine in the original packaging to protect it from light.
Do not freeze.
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.

6. Contents of the pack and other information

What TREDIMIN contains
TREDIMIN 25,000 IU/2.5 ml oral solution
In a single-dose container:

• The active substance is colecalciferol (vitamin D_) 0.625 mg, equivalent to 25,000 IU.
• Excipients: refined olive oil.

Description of the appearance of TREDIMIN and contents of the pack
Clear, light yellow, odourless solution.
TREDIMIN 25,000 IU/2.5 ml oral solution is available in packs containing 1, 2, 4 or 10 single-dose containers made of amber glass, each containing 2.5 ml of solution, closed with a polypropylene cap.

Marketing Authorization Holder
SPA Società Prodotti Antibiotici S.p.A., Via Biella 8, 20143 Milan

Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta 12 - 20141 Milan
Lachifarma S.p.A. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE)

Patient information leaflet

TREDIMIN 50,000 IU/2.5 ml oral solution

Colecalciferol
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 other people, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TREDIMIN is and what it is used for

TREDIMIN contains the active substance colecalciferol (vitamin D). The main function of vitamin D
is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
TREDIMIN is indicated for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking TREDIMIN

Do not take TREDIMIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood and urine;
• if you suffer from kidney stones;
• if you have renal failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking TREDIMIN.
Inform your doctor if you are already taking other products containing vitamin D, or foods or milk fortified with vitamin D,
as 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 will monitor you and may request blood and/or urine tests if you

• have had or currently have kidney stones;
• have kidney problems;
• are an elderly person being treated with cardiac glycosides or diuretics;
• have sarcoidosis or other granulomatous diseases.

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

Other medicines and TREDIMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of TREDIMIN may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medicines for epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity).

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, are planning a pregnancy, or are 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 TREDIMIN than you should").
TREDIMIN 50,000 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
TREDIMIN 50,000 IU oral solution is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D during breastfeeding at lower doses.
This does not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are excreted in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Driving and use of machines
There are no data available on the effects of this product on the ability to drive.

3. How to take TREDIMIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is recommended to take TREDIMIN during meals.

Adults and elderly
Treatment: 1 single-dose container (equivalent 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 TREDIMIN 50,000 IU oral solution is not recommended in neonates, children, and adolescents under 18 years of age.

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

If you take more TREDIMIN than you should
If you accidentally take an excessive dose of TREDIMIN, 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, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a correlation between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development of the child, supravalvular aortic stenosis, and retinopathy. Elevated calcium levels in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced calcium levels in the blood, muscle cramps and spasms (tetany), and seizures.

If you forget to take TREDIMIN
Do not take a double dose to make up for the missed dose. Skip the forgotten dose and continue your treatment as usual.

If you stop taking TREDIMIN
Do not stop taking TREDIMIN on your own initiative. 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 are listed below; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, intestinal gas, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, urticaria;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in blood and urine.

Reporting of side effects
If you experience any side effects, 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 http://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 TREDIMIN

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.
Store this medicine in its original packaging to protect it from light.
Do not freeze.
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.

6. Package contents and other information

What TREDIMIN contains
TREDIMIN 50,000 IU/2.5 ml oral solution
In a single-dose container:

• The active substance is colecalciferol (vitamin D) 1.25 mg equivalent to 50,000 IU.
• Excipients: refined olive oil

Description of the appearance of TREDIMIN and contents of the pack
Clear, light yellow, odourless solution.
TREDIMIN 50,000 IU/2.5 ml oral solution is available in packs of 1, 2, 4 or 10 single-dose containers made of amber glass containing 2.5 ml of solution, closed with a polypropylene cap.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SPA Società Prodotti Antibiotici S.p.A., Via Biella 8, 20143 Milano

Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta 12 - 20141 Milano
Lachifarma S.p.A. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE)

Package leaflet: Information for the patient

TREDIMIN 10,000 IU soft capsules

Colecalciferol
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 they have the same symptoms as you, because it could 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 TREDIMIN is and what it is used for
2. What you need to know before taking TREDIMIN
3. How to take TREDIMIN
4. Possible side effects
5. How to store TREDIMIN
6. Contents of the pack and other information

1. What TREDIMIN is and what it is used for

TREDIMIN contains the active substance colecalciferol (vitamin D). The main function of vitamin D
is to ensure adequate calcium absorption in the intestine and to promote proper bone mineralization.
TREDIMIN is indicated for the prevention and treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking TREDIMIN

Do not take TREDIMIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood and urine;
• if you suffer from kidney stones;
• if you have severe renal insufficiency;
• if you have high levels of vitamin D in the blood.

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

• in elderly patients;
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet);
• in case of extensive dermatological, digestive diseases, or liver insufficiency;
• in patients treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory agents.

Inform your doctor if you are already taking other products containing vitamin D, or foods or milk fortified with vitamin D,
as 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 will monitor you and may request blood and/or urine tests if you:

• have or have had kidney stones;
• have kidney problems;
• are an elderly patient taking cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases;
• have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism).

Children and adolescents
TREDIMIN 10,000 IU soft capsules are not recommended for children and adolescents aged between 0 and 18 years.
Other medicines and TREDIMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of TREDIMIN may be affected by other medicines; therefore, inform your doctor if you are taking:

• medicines used to treat epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin and isoniazid (antibiotics);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis and other cardiac glycosides (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity);
• actinomycin (an antibiotic);
• antifungal imidazole agents (such as ketoconazole), capable of inhibiting the growth of fungal organisms.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, 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 vitamin D only if strictly necessary due to the risk of harmful effects on the fetus (see section 3. “If you take more TREDIMIN than you should”).
TREDIMIN 10,000 IU soft capsules are 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
TREDIMIN 10,000 IU soft capsules are not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D during breastfeeding at lower doses. This does not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are present in breast milk. This should be taken into account when additional vitamin D is administered to the infant.
Driving and using machines
There are no data available on the effects of this product on the ability to drive.
TREDIMIN 10,000 IU soft capsules contain Allura Red AC (E 129).
This medicine contains Allura Red AC (E 129), which may cause allergic reactions.

3. How to take TREDIMIN

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
It is recommended to take TREDIMIN during meals.

Adults and elderly
Prevention: 1 capsule (equivalent to 10,000 IU of vitamin D) every 2 weeks.
In the presence of multiple risk factors for vitamin D deficiency, according to the physician's judgment, the dose may
be increased up to 1 capsule (equivalent to 10,000 IU of vitamin D) once a week.
Treatment: 2 capsules (equivalent to 20,000 IU of vitamin D) once a week for 8–12 weeks, and in any case
up to a maximum of 15 weeks. Your doctor will determine the appropriate dose for you and may subsequently
prescribe a lower maintenance dose.

Paediatric population
The use of TREDIMIN 10,000 IU soft capsules is not recommended in neonates, children, and adolescents under
18 years of age.

Pregnant women
The use of TREDIMIN 10,000 IU soft capsules is not recommended during pregnancy.

If you take more TREDIMIN than you should
If you accidentally take an excessive dose of TREDIMIN, contact your doctor immediately or go to the
nearest hospital.
In case of overdose, elevated levels of calcium in blood and urine may occur, with the following symptoms:
nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a correlation
between excessive vitamin D intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed
physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Elevated
maternal blood calcium levels may also lead to suppression of neonatal parathyroid function, resulting in
reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.

If you forget to take TREDIMIN
Do not take a double dose to make up for the missed dose. Skip the forgotten dose and continue your treatment as usual.

If you stop taking TREDIMIN
Do not stop taking TREDIMIN on your own initiative. 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 everyone gets them.
The side effects reported are listed below; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, urticaria;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in blood and urine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may 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 TREDIMIN

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 store above 30°C.
Keep this medicine in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TREDIMIN contains
TREDIMIN 10,000 IU soft capsules

• The active substance is colecalciferol (vitamin D) 0.25 mg, equivalent to 10,000 IU.
• Excipients: refined olive oil, gelatin succinate, glycerol, titanium dioxide (E 171), Allura Red No. 40 (E 129), butylated hydroxytoluene.

Description of the appearance of TREDIMIN and contents of the pack
Oblong soft capsules, dark red in colour, diameter 5.10 mm ± 10%, containing a colourless or yellow-green transparent solution.
TREDIMIN 10,000 IU soft capsules is available in packs of 4 or 8 capsules, packed in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SPA Società Prodotti Antibiotici S.p.A., Via Biella 8, 20143 Milano

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

Package leaflet: Information for the patient

TREDIMIN 25,000 IU soft capsules

Colecalciferol
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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TREDIMIN is and what it is used for

TREDIMIN contains the active substance colecalciferol (vitamin D). The main function of vitamin D
is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
TREDIMIN 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 TREDIMIN

Do not take TREDIMIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood or urine;
• if you suffer from kidney stones;
• if you have severe renal insufficiency;
• if you have high levels of vitamin D in the blood.

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

• in elderly patients;
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet);
• in case of extensive skin disorders, digestive diseases, or liver insufficiency;
• in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory agents.

Inform your doctor if you are already taking other products containing vitamin D, or vitamin D-fortified foods or milk,
as 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 will monitor you and may request blood and/or urine tests if you:

• have or have had kidney stones;
• suffer from kidney problems;
• are an elderly patient taking cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases;
• have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism).

Children and adolescents
TREDIMIN 25,000 IU soft capsules are not recommended for children and adolescents aged
0 to 18 years.

Other medicines and TREDIMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
The effect of TREDIMIN may be affected by other medicines; therefore, inform your doctor if you are taking:

• medicines used to treat epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin and isoniazid (antibiotics);
• thiazide diuretics (medicines that increase urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis and other cardiac glycosides (used to treat heart conditions);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity);
• actinomycin (an antibiotic);
• antifungal imidazole agents (such as ketoconazole), capable of inhibiting the growth of fungal organisms.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, 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 TREDIMIN than you should").
TREDIMIN 25,000 IU soft capsules are 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
TREDIMIN 25,000 IU soft capsules are not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D at lower doses 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.

Driving and using machines
There are no data available on the effects of this product on the ability to drive.
TREDIMIN 25,000 IU soft capsules contain Allura Red AC (E 129).
This medicine contains Allura Red AC (E 129), which may cause allergic reactions.

3. How to take TREDIMIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
It is recommended to take TREDIMIN during meals.

Adults and elderly
Prevention: 1 capsule (equivalent to 25,000 IU of vitamin D) once a month.
Treatment: 1 capsule (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 TREDIMIN 25,000 IU soft capsules is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of TREDIMIN 25,000 IU soft capsules is not recommended during pregnancy.

If you take more TREDIMIN than you should
If you accidentally take an excessive dose of TREDIMIN, contact your doctor immediately or go to the nearest hospital.
In case of overdose, elevated levels of calcium in the blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a correlation between excessive intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Increased calcium levels in maternal blood may also lead to suppression of neonatal parathyroid function, resulting in reduced calcium levels in the newborn, muscle cramps and spasms (tetany), and seizures.

If you forget to take TREDIMIN
Do not take a double dose to make up for a missed dose. Skip the missed dose and continue your treatment as usual.

If you stop taking TREDIMIN
Do not stop taking TREDIMIN on your own initiative. 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 will experience them.
The side effects reported are listed below; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, urticaria;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in blood and urine.

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 TREDIMIN

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 store above 30°C.
Keep this medicine in the original packaging in order to protect it from light.
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.

6. Package contents and other information

What TREDIMIN contains
TREDIMIN 25,000 IU soft capsules

• The active substance is colecalciferol (vitamin D_), 0.625 mg equivalent to 25,000 IU.
• Excipients: refined olive oil, succinated gelatin, glycerol, titanium dioxide (E 171), Allura Red No. 40 (E 129), butylated hydroxytoluene.

Description of the appearance of TREDIMIN and package contents
Oblong soft capsules, dark red in colour, diameter 6.50 mm ± 10%, containing a colourless or yellowish-green transparent solution.
TREDIMIN 25,000 IU soft capsules is available in packages containing 2 or 4 capsules, packed in blisters.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
SPA Società Prodotti Antibiotici S.p.A., Via Biella 8, 20143 Milan, Italy

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

Patient Information Leaflet

TREDIMIN 50,000 IU Soft Capsules

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

Contents of this leaflet:

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

1. What TREDIMIN is and what it is used for

TREDIMIN contains the active substance colecalciferol (vitamin D). The main function of vitamin D
is to ensure adequate absorption of calcium in the intestine and to promote proper bone mineralization.
TREDIMIN is indicated for the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking TREDIMIN

Do not take TREDIMIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood or urine;
• if you suffer from kidney stones;
• if you have severe renal insufficiency;
• if you have high levels of vitamin D in the blood.

Warnings and precautions
Talk to your doctor or pharmacist before taking TREDIMIN.
Inform your doctor if you are already taking other products containing vitamin D, 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 will monitor you and may request blood and/or urine tests if you

• suffer or have suffered from kidney stones;
• have kidney problems;
• are an elderly person being treated with cardiac glycosides or diuretics;
• suffer from sarcoidosis or other granulomatous diseases;
• have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism).

Children and adolescents
TREDIMIN 50,000 IU soft capsules is not recommended for children and adolescents aged
0 to 18 years.
Other medicines and TREDIMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
The effect of TREDIMIN may be influenced by other medicines; therefore, inform your doctor if you are taking:

• medicines for the treatment of epilepsy;
• barbiturates (used in anaesthesia);
• rifampicin and isoniazid (antibiotics);
• thiazide diuretics (medicines that promote urinary excretion);
• glucocorticosteroids (used to treat inflammation);
• medicines containing digitalis and other cardiac glycosides (used to treat heart problems);
• antacids containing aluminium or magnesium;
• warfarin (a medicine used to thin the blood);
• cholestyramine and colestipol (used to reduce cholesterol levels in the blood);
• orlistat (for the treatment of obesity);
• actinomycin (an antibiotic);
• antifungal imidazole agents (such as ketoconazole), capable of inhibiting the growth of fungal organisms.

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.
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 TREDIMIN than you should").
TREDIMIN 50,000 IU soft capsules 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
TREDIMIN 50,000 IU soft capsules 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 excreted in breast milk. This should be taken into account when
administering additional vitamin D to the infant.

Driving and using machines
No data are available on the effects of this product on the ability to drive.
TREDIMIN 50,000 IU soft capsules contains Allura Red AC (E 129).
This medicine contains Allura Red AC (E 129), which may cause allergic reactions.

3. How to take TREDIMIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is recommended to take TREDIMIN with meals.

Adults and elderly
Treatment: 1 capsule (equivalent to 50,000 IU of vitamin D) once weekly for up to 6 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.

Paediatric population
The use of TREDIMIN 50,000 IU soft capsules is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of TREDIMIN 50,000 IU soft capsules is not recommended during pregnancy.

If you take more TREDIMIN than you should
If you accidentally take an excessive dose of TREDIMIN, contact your doctor immediately or go to the nearest hospital.
In case of overdose, elevated levels of calcium in blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.
Overdose during the first 6 months of pregnancy may have toxic effects on the fetus: there is a known association between excessive vitamin D intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Increased calcium levels in maternal blood may also lead to suppression of parathyroid function in newborns, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.

If you forget to take TREDIMIN
Do not take a double dose to make up for the missed dose. Skip the missed dose and continue your treatment as usual.

If you stop taking TREDIMIN
Do not stop taking TREDIMIN on your own initiative. If you have any questions 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 will experience them.
The side effects reported are listed below; their frequency is unknown:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, intestinal gas, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
• skin rash, itching, urticaria;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
• high levels of calcium in the blood and urine.

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 TREDIMIN

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 store above 30°C.
Keep this medicine in the original packaging to protect it from light.
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.

6. Package contents and other information

What TREDIMIN contains
TREDIMIN 50,000 U.I. soft capsules

• The active substance is colecalciferol (vitamin D) 1.25 mg, equivalent to 50,000 U.I.
• Excipients: refined olive oil, gelatin succinate, glycerol, titanium dioxide (E 171), Allura red No. 40 (E 129), butylated hydroxytoluene.

Description of the appearance of TREDIMIN and package contents
Oval soft capsules, dark red in colour, diameter 9.10 mm ± 10%, containing a colourless or yellowish-green transparent solution.
TREDIMIN 50,000 U.I. soft capsules is available in packs of 2 or 4 capsules, packaged in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SPA Società Prodotti Antibiotici S.p.A., Via Biella 8, 20143 Milan, Italy

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