Colecalciferol Eg

Package leaflet: information for the patient

COLECALCIFEROLO EG 10,000 IU/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 they have the same symptoms as yours, 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 COLECALCIFEROLO EG is and what it is used for
2. What you need to know before taking COLECALCIFEROLO EG
3. How to take COLECALCIFEROLO EG
4. Possible side effects
5. How to store COLECALCIFEROLO EG
6. Contents of the pack and other information

1. What COLECALCIFEROLO EG is and what it is used for

COLECALCIFEROLO EG 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.
COLECALCIFEROLO EG is used to prevent and treat vitamin D deficiency.

2. What you need to know before taking COLECALCIFEROLO EG

Do not take COLECALCIFEROLO EG

• 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 COLECALCIFEROLO EG.
Your doctor may recommend taking COLECALCIFEROLO EG as prevention of vitamin D deficiency:

• in newborns (especially premature infants) and infants;
• during the last trimester of pregnancy;
• in breastfeeding women at the end of winter and in spring;
• in the elderly;
• in children and adolescents with insufficient sun exposure;
• in case of unbalanced diet (e.g. low in calcium, vegetarian diet);
• in case of extensive dermatological conditions, digestive disorders, or hepatic insufficiency;
• in patients 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, as vitamin D accumulates in the body and excessive doses may cause toxic effects. For this reason, it is important not to exceed the recommended dose. Your doctor will monitor you and may request blood and/or urine tests if you:

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

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

• medicines used to treat epilepsy;
• barbiturates (used in anesthesia);
• 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, 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
If necessary, your doctor may prescribe this medicine during breastfeeding. This supplementation does not replace vitamin D administration in the newborn.
Driving and using machines
No data are available regarding the effects of this product on the ability to drive.

3. How to take COLECALCIFEROLO EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
COLECALCIFEROLO EG may be administered on a daily or weekly basis.
It is recommended to take COLECALCIFEROLO EG with meals.
The recommended dose is:
The daily doses indicated below may also be taken once weekly by multiplying
the daily dose indicated by seven.

Infants, children and adolescents (<18 years)
Prevention: 2–4 drops daily (equivalent to 500–1,000 IU of vitamin D).
Treatment: 8–16 drops daily (equivalent to 2,000–4,000 IU of vitamin D) for 4–5 months.

Pregnant women
3–4 drops daily (equivalent to 750–1,000 IU of vitamin D) during the last trimester.

Adults and elderly
Prevention: 3–4 drops daily (equivalent to 750–1,000 IU of vitamin D). In subjects at high risk of deficiency,
the dosage may need to be increased up to 8 drops daily (equivalent to 2,000 IU of vitamin D).
Treatment: 20–40 drops daily (equivalent to 5,000–10,000 IU of vitamin D) for 1–2 months.

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

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

If you take more COLECALCIFEROLO EG than you should
If you accidentally take an excessive dose of COLECALCIFEROLO EG, contact your
doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in blood and urine may occur, with the following
symptoms: nausea, vomiting, thirst, 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.
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 COLECALCIFEROLO EG
Do not take a double dose to make up for the missed dose. Skip the forgotten dose and
continue treatment as usual.

If you stop taking COLECALCIFEROLO EG
Do not stop taking COLECALCIFEROLO EG 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 experiences them.
The following side effects 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;
• excessive deposition of calcium 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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store COLECALCIFEROLO EG

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.
After 5 months from first opening, the medicine must be discarded, even if not completely used.
Keep 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 COLECALCIFEROLO EG 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 COLECALCIFEROLO EG and package contents
Clear, light yellow, odourless solution.
COLECALCIFEROLO EG is available in packs containing 1 amber glass bottle with 10 ml of solution, closed with a child-resistant cap made of polypropylene and supplied with 1 dropper.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 MILAN
Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta, 12, 20141 MILAN

Patient Information Leaflet

COLECALCIFEROLO EG 25,000 IU/2.5 ml oral solution, 50,000 IU/2.5 ml oral solution

Colecalciferol
Please read this leaflet carefully before taking this medicine, as 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 side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLECALCIFEROLO EG is and what it is used for

COLECALCIFEROLO EG 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.
COLECALCIFEROLO EG is used to prevent and treat vitamin D deficiency.

2. What you need to know before taking COLECALCIFEROLO EG

Do not take COLECALCIFEROLO EG

• 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 COLECALCIFEROLO EG.
Your doctor may recommend taking COLECALCIFEROLO EG as vitamin D deficiency prevention:

• 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 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 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 not to 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 COLECALCIFEROLO EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of COLECALCIFEROLO EG 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);
• colestyramine 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 might 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 this medicine only if strictly necessary, due to possible teratogenic effects (fetal malformations).
Breastfeeding
If necessary, your doctor will prescribe this medicine 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 COLECALCIFEROLO EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
COLECALCIFEROLO EG may be taken weekly or monthly. Your doctor will determine the appropriate
dosing frequency based on your condition.
It is recommended to take COLECALCIFEROLO EG during meals.
The recommended dose is:
COLECALCIFEROLO EG 25,000 IU/2.5 ml oral solution
Neonates, children and adolescents (<18 years)
Prevention: 1 single-dose container (25,000 IU) every 1-2 months.
Treatment: 1 single-dose container (25,000 IU) once a week for 16-24 weeks.
Pregnant women
1 single-dose container (25,000 IU) once a month during the last trimester.
Adults and elderly
Prevention: 1 single-dose container (25,000 IU) once a month. In subjects at high risk of deficiency,
the dose may need to be increased to 2 single-dose containers (equivalent to 50,000 IU of vitamin D)
once a month.
Treatment: 2 single-dose containers (equivalent to 50,000 IU of vitamin D) once a week for 8-12
weeks.
COLECALCIFEROLO EG 50,000 IU/2.5 ml oral solution
Neonates, children and adolescents (<18 years)
Prevention: 1 single-dose container (50,000 IU) every 2-4 months.
Treatment: 1 single-dose container (50,000 IU) once a week for 8-12 weeks.
Pregnant women
2 single-dose containers (equivalent to 100,000 IU of vitamin D) at the beginning of the last trimester.
Adults and elderly
Prevention: 1 single-dose container (50,000 IU) every 2 months. In case of high risk of deficiency, your doctor
will evaluate whether increasing the dose to 1 single-dose container (50,000 IU) once a month is necessary.
Treatment: 1 single-dose container (50,000 IU) once a week for 8-12 weeks.
If you take more COLECALCIFEROLO EG than you should
If you accidentally take an excessive dose of COLECALCIFEROLO EG, contact your doctor immediately or
go to the nearest hospital.
Symptoms of overdose may include elevated calcium levels in blood and urine, 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 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 COLECALCIFEROLO EG
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 COLECALCIFEROLO EG
Do not stop taking COLECALCIFEROLO EG 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;
• 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, contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following 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 COLECALCIFEROLO EG

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.
Keep 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 COLECALCIFEROLO EG contains
COLECALCIFEROLO EG 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.

COLECALCIFEROLO EG 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 COLECALCIFEROLO EG and contents of the package
Clear, light yellow, odorless solution.
COLECALCIFEROLO EG 25,000 IU/2.5 ml oral solution is available in packs of 1, 2 or 4 single-dose
amber glass containers containing 2.5 ml of solution, closed with a polypropylene cap.
COLECALCIFEROLO EG 50,000 IU/2.5 ml oral solution is available in packs of 1, 2 or 4 single-dose
amber glass containers containing 2.5 ml of solution, closed with a polypropylene cap.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano
Manufacturer
Mipharm S.p.A., Via Bernardo Quaranta 12 - 20141 Milano
Lachifarma S.r.l. Laboratorio Chimico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE) (only for 25,000
IU/2.5 ml oral solution)