Patient Information Leaflet

Colcad 10,000 IU/ml oral drops, solution

colecalciferol (vitamin D)
Generic medicine
Please read all of this leaflet carefully before you take this medicine, as 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 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:

What Colcad is and what it is used for
What you need to know before taking Colcad
How to take Colcad
Possible side effects
How to store Colcad
Contents of the pack and other information

1. What Colcad is and what it is used for

Colcad contains colecalciferol, better known as vitamin D. The main function of vitamin D is to ensure adequate calcium absorption in the intestine and to promote proper bone mineralization.
Colcad 10,000 IU/ml oral drops, solution is indicated for the prevention and treatment of vitamin D deficiency.

2. What you need to know before taking Colcad

Do not take Colcad

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Colcad.
Your doctor may recommend taking Colcad 10,000 IU/ml oral drops, solution as prevention of vitamin D deficiency:

in newborns (especially if premature) and infants;
during the last trimester of pregnancy;
during breastfeeding;
in the elderly;
in case of insufficient or ineffective sun exposure, particularly in children and adolescents;
in case of special diets or eating patterns (e.g. low in calcium, vegetarian, etc.);
in case of deeply pigmented skin;
in case of extensive skin diseases or infectious diseases (such as tuberculosis, leprosy);
in case of liver diseases (hepatic insufficiency);
in case of gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis, celiac disease);
in patients being treated with antiepileptic drugs or long-term therapy with certain anti-inflammatory agents.

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

if you need to take Colcad for a long time and at high doses;
if you are elderly and already receiving treatment 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, or other granulomatous diseases;
if you suffer from primary hyperparathyroidism, a disease caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are elevated, your doctor will reduce the dose or discontinue treatment with Colcad.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “Colcad with food, drinks and alcohol”).
You must not take Colcad if you have significantly reduced kidney function (see section “Do not take Colcad”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if your doctor considers treatment with Colcad absolutely necessary, periodic blood tests to monitor calcium and phosphate levels must be performed. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Colcad.
Inform your doctor in the following cases, as dosage adjustments may be needed compared to those indicated in section 3 “How to take Colcad”:

if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), medicines used to lower blood lipids (such as colestipol, cholestyramine), orlistat (used to treat obesity) (see section “Other medicines and Colcad”);
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 Colcad”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and Colcad”);
if you are obese;
if you suffer from intestinal malabsorption (e.g., Crohn’s disease, chronic inflammatory bowel disease, celiac disease, mucoviscidosis or cystic fibrosis) or have undergone bariatric surgery;
if you suffer from liver disease (hepatic insufficiency).

Other medicines and Colcad
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking the following medicines, inform your doctor, who will keep you under close monitoring and carefully evaluate whether additional tests are needed:

digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
warfarin, a medicine used to prolong blood clotting time, reducing the risk of blood clots;
magnesium-containing preparations;
thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Moreover, inform your doctor if you are taking the following medicines, as they may reduce the effect of Colcad:

antiepileptics, for example barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
corticosteroids, medicines used to treat inflammation;
certain antibiotics such as rifampicin and isoniazid, used to treat infections;
aluminum-containing antacids, medicines used to treat excessive stomach acid; the combination with vitamin D may increase the risk of aluminum toxicity and should therefore be avoided;
lipid-lowering medicines (hypolipidemics) such as colestipol and cholestyramine;
medicines used to treat obesity such as orlistat;
laxatives such as paraffin oil;
actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various types of Streptomyces bacteria;
antifungal imidazole agents, capable of inhibiting fungal growth (e.g. ketoconazole).

Colcad with food, drinks and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or using vitamin D-enriched milk, so that the total intake of vitamin D 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, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If necessary, your doctor will prescribe vitamin D at low doses during the last trimester of pregnancy.
Colcad 10,000 IU/ml oral drops, solution may be taken during the last trimester of pregnancy (see section 3 “How to take Colcad”).

Breastfeeding
If necessary, your doctor may prescribe this medicine during breastfeeding. This does not replace vitamin D supplementation in the newborn. Vitamin D and its metabolites are present in breast milk. Your doctor will take this into account when prescribing vitamin D to a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of Colcad on the ability to drive vehicles or operate machinery. However, you should be aware that drowsiness may occur as a side effect of treatment with Colcad, although this is rare.

3. How to take Colcad

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

Use in children and adolescents
Newborns (0-1 year)
Prevention: 1-2 drops (equivalent to 250-500 IU of vitamin D) per day.
Treatment: The doctor will determine the appropriate dose and may subsequently prescribe a lower dose.
The daily dose must not exceed 4 drops per day (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: The 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). The 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 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 third trimester.
However, in women considered deficient in vitamin D, a higher dose may be necessary (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. The 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), 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 of vitamin D).

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

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

If you take more Colcad than you should
In case of accidental ingestion/overdose of Colcad, 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, excessive thirst (polydipsia), increased urine production (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 (see section “Pregnancy, breastfeeding and fertility”).

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below, classified by frequency:
Uncommon (may affect up to 1 in 100 people)

increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria)
headache (cephalalgia)
stomach ache (abdominal pain)
nausea
diarrhoea
vomiting
skin rash
itching (pruritus)

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

allergic reactions (hypersensitivity)
reduced appetite
excessive thirst (polydipsia)
drowsiness
confusion
constipation (stipsis)
passing gas (flatulence)
dry mouth
altered taste (dysgeusia)
urticaria
increased urine output (polyuria)
weakness (asthenia)
dizziness
cardiac arrhythmia

Very rare (may affect up to 1 in 10,000 people)

kidney disease (renal failure)

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

thirst
excessive deposition of calcium in the kidneys (nephrocalcinosis).

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

5. How to store Colcad

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
Store below 30°C.
Keep in the original packaging to protect the medicine from light.
The shelf life of the medicine after first opening of the bottle is 5 months (record the date of first opening
in the designated space on the carton).
After this period, any remaining medicine must be discarded.

6. Package contents and other information

What Colcad contains
The active substance is cholecalciferol (vitamin D).
2.5 mg (equivalent to 100,000 IU) of cholecalciferol are contained in 10 ml of solution.
1 drop contains: 250 IU of vitamin D3.
The other component is refined olive oil.

Description of the appearance of Colcad and contents of the pack
Colcad is a clear, colourless or yellowish-green transparent solution contained in an amber glass bottle closed with a child-resistant cap made of polypropylene with an inner seal of polyethylene.
It is available in packs containing 1 bottle of 10 ml and 1 glass dropper.

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

Manufacturer

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

Package leaflet: Information for the patient

Colcad 25,000 IU/2.5 ml oral solution in single-dose container

colecalciferol (vitamin D )
Equivalent medicine
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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Colcad is and what it is used for
What you need to know before taking Colcad
How to take Colcad
Possible side effects
How to store Colcad
Contents of the pack and other information

1. What Colcad is and what it is used for

Colcad contains colecalciferol, better known as vitamin D. The main function of vitamin
D is to ensure adequate absorption of calcium in the intestine and to support proper mineralization of
bones.
Colcad 25,000 IU/2.5 ml oral solution in single-dose container 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 (over 18 years of age).

2. What you need to know before taking Colcad

Do not take Colcad

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Colcad.
Your doctor may recommend taking Colcad 25,000 IU/2.5 ml oral solution in single-dose container
as prevention of vitamin D deficiency:

in elderly patients;
in case of insufficient or ineffective sun exposure;
in case of special diets or eating regimens (e.g. low-calcium diet, vegetarian diet, etc.);
in case of dark skin pigmentation;
in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy);
in case of liver diseases (hepatic insufficiency);
in case of gastrointestinal diseases (intestinal malabsorption, cystic fibrosis, celiac disease);
in patients receiving antiepileptic drugs or long-term treatment with certain anti-inflammatory medicines.

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

if you need to take Colcad for a long time and at high doses;
if you are elderly and already taking medicines for certain heart conditions (cardiac glycosides) or medicines that reduce blood pressure by increasing urine production (diuretics);
if you have sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation, or other granulomatous diseases;
if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
if you have kidney problems.

If your vitamin D, calcium, or phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Colcad.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “Colcad with food, drinks, and alcohol”).
You must not take Colcad if you have significantly reduced kidney function (see section “Do not take Colcad”). If you have mild to moderate reduction in kidney function (mild or moderate renal insufficiency), and your doctor considers treatment with Colcad absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Colcad.
Inform your doctor in the following cases, as dose adjustments from those indicated in section 3 “How to take Colcad” may be necessary:

if you are on long-term therapy with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents (such as colestipol, cholestyramine), orlistat (used to treat obesity) (see section “Other medicines and Colcad”);
if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may also rise into the oesophagus (see section “Other medicines and Colcad”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and Colcad”);
if you are obese;
if you suffer from intestinal malabsorption (e.g. Crohn’s disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis) or have undergone bariatric surgery;
if you have liver disease (hepatic insufficiency).

Children and adolescents
Colcad 25,000 IU/2.5 ml oral solution in single-dose container is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and Colcad
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, inform your doctor, who will keep you under close monitoring and carefully evaluate whether additional tests are needed:

digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
warfarin, a medicine used to prolong blood clotting time and reduce the risk of blood clots;
magnesium-containing preparations;
thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Additionally, inform your doctor if you are taking any of the following medicines, as they may reduce the effect of Colcad:

antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
corticosteroids, medicines used to treat inflammation;
certain antibiotics such as rifampicin and isoniazid, used to treat infections;
antacids containing aluminium, medicines used to treat excessive stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
medicines used to treat obesity such as orlistat;
laxatives such as paraffin oil;
actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various types of Streptomyces bacteria;
antifungal imidazole agents, capable of inhibiting fungal growth (e.g. ketoconazole).

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

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

Pregnancy
Colcad 25,000 IU/2.5 ml oral solution in single-dose container 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
Colcad 25,000 IU/2.5 ml oral solution in single-dose container is not recommended during breastfeeding.
When necessary, your doctor may prescribe vitamin D at lower doses during breastfeeding. This does not replace vitamin D supplementation in the newborn. Vitamin D and its metabolites are excreted in breast milk; your doctor will take this into account when prescribing vitamin D for a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of Colcad on the ability to drive or operate machinery. However, drowsiness may occur as a rare side effect of Colcad treatment, and this should be taken into account.

3. How to take Colcad

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor according to your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Colcad during meals. The single-dose container
must be used for a single administration, ensuring that the entire dose is taken.

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 and may subsequently prescribe a lower dose.

Use in children and adolescents
The use of Colcad 25,000 IU/2.5 ml oral solution in single-dose containers is not recommended in neonates,
children, and adolescents under 18 years of age.

Pregnant women
The use of Colcad 25,000 IU/2.5 ml oral solution in single-dose containers is not recommended during
pregnancy.

If you take more Colcad than you should
In case of accidental ingestion/overdose of Colcad, 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 urination (polyuria), constipation, and
dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Excessive vitamin D intake during the first 6 months of pregnancy may cause serious harm to the fetus and
newborn (see section “Pregnancy, breastfeeding and fertility”).

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

If you stop taking Colcad
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 possible side effects are listed below, by frequency:
Uncommon (may affect up to 1 in 100 people)

increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria)
headache (cephalalgia)
stomach ache (abdominal pain)
nausea
diarrhoea
vomiting
skin rash
itching (pruritus)

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

allergic reactions (hypersensitivity)
decreased appetite
excessive thirst (polydipsia)
drowsiness
confusion
constipation (stipsis)
passing gas (flatulence)
dry mouth
altered taste (dysgeusia)
hives (urticaria)
increased urine production (polyuria)
weakness (asthenia)
dizziness
cardiac arrhythmia

Very rare (may affect up to 1 in 10,000 people)

kidney disease (renal failure)

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

thirst
excessive deposition of calcium in the kidneys (nephrocalcinosis).

Reporting of side effects
If you get 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 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 Colcad

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

6. Package contents and other information

What Colcad contains
The active substance is colecalciferol (vitamin D).
Each single-dose container with 2.5 ml of solution contains 0.625 mg (equivalent to 25,000 IU) of colecalciferol.
The other ingredient is refined olive oil.

Description of the appearance of Colcad and contents of the package
Colcad 25,000 IU/2.5 ml oral solution in single-dose container is a clear, colourless or yellowish-green transparent solution, contained in an amber glass container closed with a polypylene cap with an inner polyethylene lining.
It is available in packages containing 1, 2 or 4 single-dose containers of 2.5 ml.
Not all pack sizes may be marketed.

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

Manufacturer

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

Patient Information Leaflet

Colcad 50,000 IU/2.5 ml oral solution in single-dose container

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

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

Contents of this leaflet:

What Colcad is and what it is used for
What you need to know before taking Colcad
How to take Colcad
Possible side effects
How to store Colcad
Contents of the pack and other information

1. What Colcad is and what it is used for

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

2. What you need to know before taking Colcad

Do not take Colcad

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

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

if you need to take Colcad for a long time and at high doses;
if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics);
if you have sarcoidosis, an inflammatory disease that can affect the whole body and leads to nodule formation, or other granulomatous diseases;
if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are elevated, your doctor will reduce the dose or stop treatment with Colcad.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “Colcad with food, drinks, and alcohol”).
You must not take Colcad if you have significantly reduced kidney function (see section “Do not take Colcad”). If you have mild to moderate reduction in kidney function (mild or moderate renal insufficiency), and your doctor considers treatment with Colcad absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Colcad.
Inform your doctor in the following cases, as dose adjustments may be needed compared to those indicated in section 3 “How to take Colcad”:

if you are on long-term treatment with medicines such as antiepileptics (used to treat epilepsy), corticosteroids (used to treat inflammation), lipid-lowering agents (such as colestipol, cholestyramine), or orlistat (used to treat obesity) (see section “Other medicines and Colcad”);
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 Colcad”);
if you are taking laxatives (such as paraffin oil) (see section “Other medicines and Colcad”);
if you are obese;
if you have intestinal malabsorption (e.g., Crohn’s disease, chronic inflammatory bowel disease, coeliac disease, mucoviscidosis or cystic fibrosis) or have undergone bariatric surgery;
if you have liver disease (hepatic insufficiency).

Children and adolescents
Colcad 50,000 IU/2.5 ml oral solution is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and Colcad
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. Your doctor will closely monitor you and may decide to carry out additional tests:

digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
warfarin, a medicine used to prolong blood clotting time and reduce the risk of blood clots;
magnesium-containing preparations; thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Additionally, inform your doctor if you are taking any of the following medicines, as they may reduce the effectiveness of Colcad:

antiepileptics, such as barbiturates, carbamazepine, phenytoin, medicines used to treat epilepsy;
corticosteroids, medicines used to treat inflammation;
some antibiotics such as rifampicin and isoniazid, used to treat infections;
antacids containing aluminium, medicines used to treat excessive stomach acid; concomitant use with vitamin D may increase the risk of aluminium toxicity and should therefore be avoided;
lipid-lowering medicines (hypolipidemics) such as colestipol and cholestyramine;
medicines used to treat obesity, such as orlistat;
laxatives such as paraffin oil;
actinomycin, a cytotoxic agent belonging to the group of actinomycins, antibiotics produced by various types of Streptomyces bacteria;
antifungal imidazole agents, which inhibit the growth of fungal organisms (e.g. ketoconazole).

Colcad with food, drinks, and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk, so that your total vitamin D intake can be monitored 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, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Colcad 50,000 IU/2.5 ml single-dose 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
Colcad 50,000 IU/2.5 ml single-dose oral solution is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D at lower doses during breastfeeding.
This does not replace the need for vitamin D supplementation in the newborn. Vitamin D and its metabolites are excreted in breast milk; your doctor will take this into account when prescribing vitamin D to a breastfed infant.

Fertility
There are no data on the effects of vitamin D on fertility.

Driving and using machines
There are no data on the effects of Colcad on the ability to drive or operate machinery. However, drowsiness may occur as a rare side effect of treatment with Colcad, and this should be taken into account.

3. How to take Colcad

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor according to your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Colcad during meals. The single-dose container
must be used for a single administration, making sure to take the entire dose.

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

Use in children and adolescents
The use of Colcad 50,000 IU/2.5 ml oral solution in single-dose containers is not recommended in neonates,
children, and adolescents under 18 years of age.

Pregnant women
The use of Colcad 50,000 IU/2.5 ml oral solution in single-dose containers is not recommended during
pregnancy.

If you take more Colcad than you should
In case of accidental ingestion/overdose of Colcad, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood and urine may occur, with the following symptoms:
nausea, vomiting, thirst, excessive thirst (polydipsia), increased urination (polyuria),
constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Excessive vitamin D intake during the first 6 months of pregnancy may cause serious harm to the fetus
and newborn (see section “Pregnancy, breastfeeding and fertility”).

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

If you stop taking Colcad
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 will experience them.
The possible side effects are listed below, by frequency:
Uncommon (may affect up to 1 in 100 people)

increased levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria)
headache (cephalalgia)
stomach ache (abdominal pain)
nausea
diarrhoea
vomiting
skin rash
itching (pruritus)

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

allergic reactions (hypersensitivity)
reduced appetite
excessive thirst (polydipsia)
drowsiness
confusion
constipation (stipsis)
passing gas (flatulence)
dry mouth
altered taste (dysgeusia)
hives (urticaria)
increased urine production (polyuria)
weakness (asthenia)
dizziness
cardiac arrhythmia

Very rare (may affect up to 1 in 10,000 people)

kidney disease (renal failure)

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

thirst
excessive deposition of calcium in the kidneys (nephrocalcinosis).

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 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 Colcad

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

6. Package contents and other information

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

Description of the appearance of Colcad and contents of the pack
Colcad 50,000 IU/2.5 ml oral solution in single-dose container is a clear, colourless or yellowish-green transparent solution, contained in an amber glass container closed with a cap made of polypropylene and an inner seal made of polyethylene.
It is available in packs containing 1, 2 or 4 single-dose containers of 2.5 ml.
It is possible that not all pack sizes are marketed.

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

Manufacturer

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