Trevid

Patient Information Leaflet

Trevid 10,000 IU/mL oral drops, solution

colecalciferol (vitamin D )
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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Trevid is and what it is used for

Trevid contains colecalciferol, better known as vitamin D.
Trevid 10,000 IU/ml oral drops is indicated for the prevention and treatment of vitamin D deficiency.

2. What you need to know before taking Trevid

Do not take Trevid

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

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

• in newborns (especially if premature) and infants,
• during the last trimester of pregnancy,
• during breastfeeding,
• in elderly people,
• if you have insufficient or ineffective exposure to sunlight,
• if you have dark skin pigmentation,
• if you follow a special diet (e.g. low in calcium, vegetarian diet),
• if you have extensive skin diseases or infectious diseases (such as tuberculosis, leprosy),
• if you have liver diseases (hepatic insufficiency),
• if you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines,
• if you suffer from gastrointestinal disorders (e.g. intestinal malabsorption, mucoviscidosis or cystic fibrosis, celiac disease).

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

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

If your vitamin D or calcium levels are high, your doctor will reduce the dose or stop treatment with Trevid.
In general, if you have impaired kidney function, you should undergo periodic tests to monitor calcium and phosphate levels in your blood. If your calcium and phosphate levels are high, your doctor will reduce the dose or stop treatment with Trevid.

Inform your doctor in the following cases, as higher doses than those indicated in section “How to take Trevid” may be necessary:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Trevid”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Trevid”);
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and Trevid”);
• if you are taking a medicine used to treat obesity called orlistat (see section “Other medicines and Trevid”);
• 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 Trevid”);
• if you are obese;
• if you suffer from gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
• if you suffer from extensive skin diseases;
• if you suffer from liver disease (hepatic insufficiency).

Other medicines and Trevid
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 Trevid:

• medicines used to treat epilepsy (anticonvulsants or barbiturates);
• medicines to lower blood lipids such as colestipol, cholestyramine, and orlistat, a medicine used to treat obesity;
• antacids containing aluminum, medicines used to treat excessive stomach acid that may rise into the esophagus;
• corticosteroids, medicines used to treat inflammation;
• actinomycin, an agent belonging to the actinomycin group, antibiotics produced by various types of bacteria of the species Streptomyces;
• antifungal imidazole agents, capable of inhibiting the growth of fungal organisms.

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

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

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect 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 colecalciferol only if strictly necessary due to the risk of harmful effects on the fetus. (See section 3 “If you take more Trevid than you should”).

Breastfeeding
When necessary, your doctor will prescribe vitamin D 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 giving additional vitamin D to the infant.

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

Driving and using machines
It is unlikely that Trevid will affect your ability to drive or operate machinery.

3. How to take Trevid

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.
Paediatric population (< 18 years)
Newborns (0-1 year)
Prevention: 1-2 drops (equivalent to 250-500 IU of 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 of vitamin D).
Children (1-11 years)
Prevention: 1-2 drops (equivalent to 250-500 IU of vitamin D) per day. From the second year of life, in
the presence of 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 of 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 of vitamin D).
Adolescents (12-17 years)
Prevention: 2-4 drops per day (equivalent to 500-1,000 IU of vitamin D).
Treatment: 4-16 drops per day (equivalent to 1,000-4,000 IU of vitamin D). 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 of vitamin D).
Pregnant women
The recommended dose is 3-4 drops per day (equivalent to 750-1,000 IU of 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 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 per day (equivalent to 2,000 IU of vitamin D).
Treatment: 4 drops (equivalent to 1,000 IU of vitamin D) per day. Your doctor will determine the
appropriate dose and may subsequently prescribe a lower dose. Higher doses should be adjusted according
to serum levels of 25-hydroxycholecalciferol (25(OH)D) to be achieved, 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 of
vitamin D).
Instructions for use
Take the doses orally.
It is recommended to take Trevid during meals.
The package contains 1 bottle and a dropper. The bottle is equipped with a child-resistant cap. The dropper
comes with a protective cap. For use, follow the instructions below:
a. open the bottle by removing the cap as follows: press down and simultaneously unscrew (see Figure 1);
b. unscrew the plastic protective cap covering the tip of the dropper (see Figure 2);
c. insert the dropper into the bottle to draw up the contents. Measure the drops into a spoon and administer
(see "Dosage and method of administration");
d. close the bottle (see Figure 3). Replace the protective cap on the tip of the dropper;
e. store the bottle and dropper in the original packaging.

If you take more Trevid than you should
In case of accidental ingestion or overdose of Trevid, 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, 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 Trevid
Do not take a double dose to make up for the missed dose.
If you stop taking Trevid
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 the use of vitamin D are as follows:
Uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• weakness (asthenia)

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

• allergic reactions
• reduced appetite, thirst
• drowsiness, confusion
• constipation (stipsis), gas (flatulence), stomach pain, nausea, diarrhoea
• skin rash, itching, hives (urticaria)

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

• headache (cephalalgia)
• vomiting, metallic taste (dysgeusia), dry mouth
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased volume 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 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 Trevid

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.
Store in the original packaging to protect the medicine from light and heat sources.
Do not refrigerate.
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 disposed of.
Do not dispose of medicines 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 Trevid contains

• The active substance is colecalciferol (vitamin D): 10 ml of solution contain 2,5 mg, equivalent to 100,000 IU; 1 drop contains 250 IU of vitamin D.
• The other component is refined olive oil.

Description of the appearance of Trevid and contents of the pack
Trevid 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.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LANOVA FARMACEUTICI S.r.l. – Via Conca D’Oro, 212 – 00141 Rome
Manufacturer
LACHIFARMA SPA - Laboratorio Chimico Farmaceutico Salentino
S.S.16 – Zona Industriale
73010 - Zollino (LE)
Italy

Patient Information Leaflet

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

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

Contents of this leaflet:

1. What Trevid is and what it is used for
2. What you need to know before taking Trevid
3. How to take Trevid
4. Possible side effects
5. How to store Trevid
6. Package contents and other information

1. What Trevid is and what it is used for

Trevid contains colecalciferol, better known as vitamin D.
Trevid 25,000 IU oral solution in single-dose container is indicated for:

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

2. What you need to know before taking Trevid

Do not take Trevid

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

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

• in elderly people,
• if you have insufficient or ineffective exposure to sunlight,
• if you have dark skin pigmentation,
• if you follow a special diet (e.g. low in calcium, vegetarian diet),
• if you have extensive skin diseases or infectious diseases (such as tuberculosis, leprosy),
• if you have liver diseases (hepatic insufficiency),
• if you are being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory medicines,
• if you suffer from gastrointestinal disorders (e.g. intestinal malabsorption, mucoviscidosis or cystic fibrosis, coeliac disease).

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

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

If your vitamin D or calcium levels are high, your doctor will reduce the dose or stop treatment with Trevid.
In general, if you have impaired kidney function, you should undergo periodic tests to monitor calcium and phosphate levels in the blood. If your calcium and phosphate levels are high, your doctor will reduce the dose or discontinue treatment with Trevid.

Inform your doctor in the following cases, as an increase in dosage above that indicated in section "How to take Trevid" may be necessary:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section "Other medicines and Trevid");
• if you are taking corticosteroids, medicines used to treat inflammation (see section "Other medicines and Trevid");
• if you are taking lipid-lowering medicines such as colestipol, cholestyramine (see section "Other medicines and Trevid");
• if you are taking a medicine used to treat obesity called orlistat (see section "Other medicines and Trevid");
• 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 Trevid");
• if you are obese;
• if you suffer from gastrointestinal disorders (e.g. intestinal malabsorption, mucoviscidosis or cystic fibrosis);
• if you suffer from extensive skin diseases;
• if you have a liver disease (hepatic insufficiency).

Children and adolescents
Trevid 25,000 IU oral solution in single-dose container is not recommended for children and adolescents aged between 0 and 18 years.

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

• medicines used to treat epilepsy (anticonvulsants or barbiturates);
• lipid-lowering medicines such as colestipol, cholestyramine, and orlistat, a medicine used to treat obesity;
• aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus;
• corticosteroids, medicines used to treat inflammation;
• actinomycin, an agent belonging to the group of actinomycins, antibiotics produced by various types of bacteria of the species Streptomyces;
• antifungal imidazole agents, capable of inhibiting the growth of fungal organisms.

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 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.

Trevid with food and drink 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 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, breastfeeding and fertility
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 foetus (see section 3. "If you take more Trevid than you should"). Trevid 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
Trevid 25,000 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 present in breast milk. This should be taken into account when administering additional vitamin D to the infant.

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

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

3. How to take Trevid

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor based on your health status.
Do not exceed the doses indicated by your doctor.
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.
Use in children and adolescents
Trevid 25,000 IU is not recommended for neonates, children, and adolescents under 18 years of age.
Pregnant women
Trevid 25,000 IU is not recommended during pregnancy and breastfeeding.
Instructions for use
Take the dose orally.
It is recommended to take Trevid during meals.
If you take more Trevid than you should
If you accidentally ingest or take an excessive dose of Trevid, 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 symptoms including: 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 Trevid
Do not take a double dose to make up for the missed dose.
If you stop taking Trevid
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 the use of vitamin D are as follows:
Uncommon (may affect up to 1 in 100 people)

• Increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• Weakness (asthenia)

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

• Allergic reactions
• Reduced appetite, thirst
• Drowsiness, confusion
• Constipation (stipsis), flatulence, stomach pain, nausea, diarrhea
• Skin rash, itching, urticaria

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

• Headache (cephalalgia)
• Vomiting, metallic taste (dysgeusia), dry mouth
• Excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output (polyuria), excessive thirst (polydipsia), kidney disease (renal failure)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Trevid

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.
Store in the original packaging to protect the medicine from light and heat sources.
Do not refrigerate.

6. Package contents and other information

What Trevid contains

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

Description of the appearance of Trevid and contents of the pack
Trevid is a solution contained in an amber glass container, closed with a cap made of polypropylene.
It is available in packs containing 1 or 2 single-dose containers of 2.5 ml each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LANOVA FARMACEUTICI S.r.l. - Via Conca D’Oro, 212 – 00141 Rome, Italy
Manufacturer
LACHIFARMA SPA - Laboratorio Chimico Farmaceutico Salentino
S.S.16 – Zona Industriale
73010 - Zollino (LE)
Italy

Package leaflet: Information for the patient

Trevid 50,000 IU oral solution in single-dose container

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

Contents of this leaflet:

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

1. What Trevid is and what it is used for

Trevid contains colecalciferol, better known as vitamin D.
Trevid 50,000 IU oral solution in single-dose container is used to treat vitamin D deficiency in adults (aged over 18 years).

2. What you need to know before taking Trevid

Do not take Trevid

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Trevid.

• Your doctor may prescribe periodic blood tests to monitor vitamin D levels or calcium levels in your blood and urine in the following cases: if you need to take Trevid for a long time and at high doses,
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics),
• if you suffer from sarcoidosis, an inflammatory disease that can affect the entire body and leads to the formation of nodules.

If your vitamin D or calcium levels are elevated, your doctor will reduce the dose or
discontinue treatment with Trevid.
In general, if you have impaired kidney function, you should undergo periodic tests to
monitor calcium and phosphate levels in your blood. If your calcium and phosphate levels are
elevated, your doctor will reduce the dose or discontinue treatment with Trevid.
Inform your doctor in the following cases, as an increase in dosage compared to those
indicated in section “How to take Trevid” may be necessary:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Trevid”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Trevid”);
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and Trevid”);
• if you are taking a medicine for obesity called orlistat (see section “Other medicines and Trevid”);
• if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and Trevid”);
• if you are obese;
• if you suffer from gastrointestinal diseases (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
• if you suffer from extensive skin diseases;
• if you suffer from liver disease (hepatic insufficiency).

Children and adolescents
Trevid 50,000 IU oral solution in single-dose container is not recommended for children and
adolescents aged 0 to 18 years.
Other medicines and Trevid
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
Trevid:

• medicines used to treat epilepsy (anticonvulsants or barbiturates);
• medicines to lower blood lipids such as colestipol, cholestyramine, and orlistat, a medicine used to treat obesity;
• antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus;
• corticosteroids, medicines used to treat inflammation;
• actinomycin, an agent belonging to the group of actinomycins, antibiotics produced by various types of bacteria of the species Streptomyces;
• antifungal imidazole agents, capable of inhibiting the growth of fungal organisms.

In addition, if you are taking the following medicines, inform your doctor, who will monitor you closely and
carefully evaluate whether further tests are needed:

• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
• 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.

Trevid with food and drink and alcohol
Inform your doctor if you are taking other products that already contain vitamin D, foods fortified with vitamin D, or if you are using vitamin D-enriched milk, so that your doctor can consider the total dose of vitamin D you are taking and avoid excessive intake.
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,
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 Trevid than you should”). Trevid 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 dosages when necessary.
Breastfeeding
Trevid 50,000 IU in single-dose container is not recommended during breastfeeding. When necessary,
your doctor will prescribe vitamin D during breastfeeding at lower dosages. This does not replace
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.
Fertility
There are no data available on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported with vitamin D blood levels within the normal range.
Driving and using machines
It is unlikely that Trevid will affect your ability to drive vehicles.

3. How to take Trevid

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.
Adults and Elderly
Treatment: 1 single-dose container (equivalent to 50,000 IU of vitamin D) once weekly for up to
a maximum of 6 weeks.
Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.
Use in children and adolescents
Trevid 50,000 IU is not recommended in neonates, children, and adolescents under 18 years of age.
Pregnant women
Trevid 50,000 IU is not recommended during pregnancy and breastfeeding.
Instructions for use
Take the dose orally.
It is recommended to take Trevid during meals.
If you take more Trevid than you should
In case of accidental ingestion/overdose of Trevid, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include elevated levels of calcium in the blood and urine, 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 Trevid
Do not take a double dose to make up for the missed dose.
If you stop treatment with Trevid
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 experiences them.
The side effects reported with the use of vitamin D are as follows:
Uncommon (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• weakness (asthenia)

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

• allergic reactions
• reduced appetite, thirst
• drowsiness, confusion
• constipation (stipsis), flatulence, abdominal pain, nausea, diarrhea
• skin rash, itching, urticaria

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

• headache (cephalalgia)
• vomiting, metallic taste (dysgeusia), dry mouth
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output (polyuria), excessive thirst (polydipsia), kidney disease (renal failure)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Trevid

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.
Store in the original packaging to protect the medicine from light and heat sources.
Do not refrigerate.

6. Pack contents and other information

What Trevid contains
In a single-dose container:

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

Description of the appearance of Trevid and pack contents
Trevid is a solution contained in an amber glass container, closed with a cap made of polypropylene.
It is available in packs of 1 and 2 single-dose containers of 2.5 ml each.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LANOVA FARMACEUTICI S.r.l. – Via Conca D’Oro, 212 – 00141 Rome, Italy
Manufacturer
LACHIFARMA SPA - Laboratorio Chimico Farmaceutico Salentino
S.S.16 – Zona Industriale
73010 - Zollino (LE)
Italy