Colecalciferol Zentiva Italia

Patient Information Leaflet

COLECALCIFEROLO ZENTIVA ITALIA 10,000 IU, soft capsules, 25,000 IU, soft capsules

Colecalciferol (vitamin D3)
Please read this entire 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLECALCIFEROLO ZENTIVA ITALIA is and what it is used for

COLECALCIFEROLO ZENTIVA ITALIA contains the active substance colecalciferol, better known as Vitamin D3.
COLECALCIFEROLO ZENTIVA ITALIA is indicated for:
Prevention and treatment of vitamin D deficiency in adults.
For the prevention of vitamin D deficiency, COLECALCIFEROLO ZENTIVA ITALIA 25,000 IU is used in adults only when therapeutic adherence cannot be achieved with daily administration of low-dose colecalciferol.
COLECALCIFEROLO ZENTIVA ITALIA is indicated in adults.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking COLECALCIFEROLO ZENTIVA ITALIA

Do not take COLECALCIFEROLO ZENTIVA ITALIA

• if you are allergic to colecalciferol (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 high levels of vitamin D in your body (hypervitaminosis D)
• if you suffer from kidney disease (severe renal impairment) (see section “Warnings and precautions”). COLECALCIFEROLO ZENTIVA ITALIA must not be given to neonates and children under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO ZENTIVA ITALIA, especially:

• if you need to take COLECALCIFEROLO ZENTIVA ITALIA for a long period and at high doses.
• if you are elderly and are already taking medicines to treat heart conditions (cardiac glycosides or diuretics). In this case, you must check your calcium levels in blood and urine.
• if you are already taking medicines containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk.
• if you suffer from a chronic inflammatory disease that can affect all organs, called sarcoidosis.
• if you have impaired kidney function, as vitamin D levels in the body may be altered.
• if you are prone to calcium-containing kidney stones.
• if you have severe renal failure: in this case, other forms of vitamin D should be used.
• if you take this medicine for long-term treatment, especially if you are elderly. In this case, your doctor will monitor urinary calcium excretion and kidney function. If necessary, your doctor may reduce the dose.
• if you have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism).

Inform your doctor if you have any of the following conditions, as a dosage increase may be required as indicated in section 3 “How to take COLECALCIFEROLO ZENTIVA ITALIA”:

• if you are being treated with antiepileptic drugs (anticonvulsants or barbiturates).
• if you are being treated with anti-inflammatory medicines (corticosteroids).
• if you are being treated with medicines that reduce blood fat levels (cholestyramine, colestipol, orlistat) or laxatives (such as mineral oil).
• if you are being treated with medicines used to treat excessive stomach acid production (antacids containing aluminium).
• if you are obese.
• if you suffer from digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis).
• if you suffer from liver disease (hepatic insufficiency).

Children
COLECALCIFEROLO ZENTIVA ITALIA must not be given to neonates or children under 18 years of age.

Other medicines and COLECALCIFEROLO ZENTIVA ITALIA
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 or increase the effect of COLECALCIFEROLO ZENTIVA ITALIA:

• other medicines containing vitamin D.
• medicines used to treat epilepsy (anticonvulsants or barbiturates), such as phenytoin, phenobarbital, primidone, etc.
• medicines to reduce blood fats such as colestipol, cholestyramine, orlistat, and laxatives (e.g. mineral oil).
• antacids containing aluminium, medicines used to treat excess stomach acid that may rise into the oesophagus.
• thiazide diuretics, medicines used to treat high blood pressure, which increase urine production.
• digitalis, a medicine used to treat certain heart conditions.
• medicines used to treat tuberculosis, such as rifampicin or isoniazid.
• antifungal agents such as imidazoles (e.g. ketoconazole), medicines used to inhibit the growth of fungal organisms.
• warfarin, a medicine used to thin the blood.
• heart medicines (cardiac glycosides), because you will need to be monitored by a doctor, possibly undergo an ECG, and have your calcium levels checked.

COLECALCIFEROLO ZENTIVA ITALIA with food, drinks and alcohol
Inform your doctor if you take other products containing vitamin D, vitamin D-fortified foods, or if you consume vitamin D-enriched milk, so that the total intake of vitamin D can be taken into account and excessive doses avoided.

Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

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

COLECALCIFEROLO ZENTIVA ITALIA must not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical condition requires treatment with colecalciferol at lower doses.

Pregnancy
Your doctor will prescribe vitamin D during the first 6 months of pregnancy only if strictly necessary, due to the risk of harmful effects on the fetus (see section 3: “If you take more COLECALCIFEROLO ZENTIVA ITALIA”).

However, since vitamin D deficiency is harmful to both the fetus and the mother, if necessary, your doctor may prescribe low-dose vitamin D during pregnancy.

Breastfeeding
If necessary, your doctor may prescribe low-dose vitamin D during breastfeeding. This does not replace the administration of vitamin D to the newborn.

Driving and using machines
COLECALCIFEROLO ZENTIVA ITALIA does not affect or has negligible effect on the ability to drive and use machines.

3. How to take COLECALCIFEROLO ZENTIVA ITALIA

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The dose and duration of treatment must be determined by your doctor according to your health condition.
Do not exceed the doses indicated by your doctor.
Take the dose orally.
Take COLECALCIFEROLO ZENTIVA ITALIA with food.

COLECALCIFEROLO ZENTIVA ITALIA 10,000 IU soft capsules
Adults and elderly

Prevention:
The recommended dose is 1 capsule every 2 weeks (equivalent to 20,000 IU of vitamin D3 per month).
In case of high risk of vitamin D deficiency, your doctor will assess whether the dose should be increased up to 1 capsule once a week (equivalent to 10,000 IU of vitamin D3).

Treatment:
The recommended dose is 2 capsules once a week (equivalent to 20,000 IU of vitamin D3 per week) for 1–3 months. Your doctor will determine the most appropriate dose for you and may subsequently prescribe lower doses.
In cases of severe vitamin D deficiency in adults and elderly patients, the required amount will depend on vitamin D levels and response to treatment. Your doctor will determine the most appropriate dose based on your response to therapy. Higher doses must be adjusted according to the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), disease severity, and response to treatment.

Long-term treatment:
In case of long-term treatment, especially in elderly patients, your doctor will monitor urinary calcium excretion and renal function. If necessary, your doctor may reduce the dose.

COLECALCIFEROLO ZENTIVA ITALIA 25,000 IU soft capsules
Adults and elderly

Prevention:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3) once a month.
In case of high risk of vitamin D deficiency, your doctor will assess whether the dose should be increased up to 2 capsules (equivalent to 50,000 IU of vitamin D3) once a month.
Your doctor will determine the most appropriate dose for you and may subsequently prescribe lower doses.

Treatment:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3 weekly) once a week for 4–12 weeks. Your doctor will determine the most appropriate dose for you and may subsequently prescribe lower doses.
During long-term treatment with high doses, urinary calcium excretion and renal function should be monitored, especially in elderly patients. Dose reduction or discontinuation of treatment is recommended if urinary calcium exceeds 7.5 mmol/24 hours (300 mg/24 hours).
In cases of severe vitamin D deficiency in adults and elderly patients, the required amount will depend on vitamin D levels and response to treatment. Your doctor will determine the most appropriate dose based on your response to therapy.
Higher doses must be adjusted according to the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), disease severity, and response to treatment.

If you take more COLECALCIFEROLO ZENTIVA ITALIA than you should
In case of accidental ingestion/overdose of COLECALCIFEROLO ZENTIVA ITALIA, inform your doctor immediately or go to the nearest hospital. Overdose may cause increased levels of calcium in the blood and urine, with symptoms including: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine production (polyuria), constipation, and dehydration.
Other symptoms of overdose include:
Diarrhea, loss of appetite (anoressia), fatigue, headache, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and renal failure.
Chronic excessive overdosing may lead to calcium salt deposits in blood vessels and organs. Excessive vitamin D intake during the first 6 months of pregnancy may cause severe harm to the fetus and newborn.

If you forget to take COLECALCIFEROLO ZENTIVA ITALIA
Do not take a double dose to make up for a missed dose.

If you stop taking COLECALCIFEROLO ZENTIVA ITALIA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

COLECALCIFEROLO ZENTIVA ITALIA contains glycerol.
It may cause headache, gastrointestinal disturbances, and diarrhea.
It may cause allergic reactions.

4. Possible side effects

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

Uncommon side effects (may affect up to 1 in 100 people):
Allergic reactions, weakness, loss of appetite (anorexia), increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Rare side effects (may affect up to 1 in 1,000 people):
Drowsiness, confusion, constipation, intestinal gas (flatulence), stomach ache, nausea, vomiting, diarrhoea, metallic taste, dry mouth, skin rash, itching, urticaria.

Frequency not known (frequency cannot be estimated from the available data):
Headache, excessive calcium accumulation in the kidneys (nephrocalcinosis), increased urine production (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 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 COLECALCIFEROLO ZENTIVA ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of 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 25 °C.
Keep in the original packaging to protect the medicine from light.
Do not freeze.

6. Package contents and other information

What COLECALCIFEROLO ZENTIVA ITALIA contains
COLECALCIFEROLO ZENTIVA ITALIA 10,000 IU soft capsules

• The active substance is colecalciferol (vitamin D). Each soft capsule contains: 0.250 mg of colecalciferol (vitamin D) equivalent to 10,000 IU.
• The other components are:
• Capsule contents: refined olive oil, butylhydroxytoluene (E321).
• Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin, and Allura red 40 (E129).

COLECALCIFEROLO ZENTIVA ITALIA 25,000 IU soft capsules

• The active substance is colecalciferol (vitamin D). Each soft capsule contains: 0.625 mg of colecalciferol (vitamin D) equivalent to 25,000 IU.
• The other components are:
• Capsule contents: refined olive oil, butylhydroxytoluene (E321).
• Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin, and Allura red 40 (E129).

Description of the appearance of COLECALCIFEROLO ZENTIVA ITALIA and contents of the
pack

COLECALCIFEROLO ZENTIVA ITALIA 10,000 IU soft capsules
The pack contains 2, 4, 8, or 10 capsules in a thermoformed blister made of PVC/PVDC and aluminum.

COLECALCIFEROLO ZENTIVA ITALIA 25,000 IU soft capsules
The pack contains 1, 2, 4 capsules in a thermoformed blister made of PVC/PVDC and aluminum, placed in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Zentiva Italia Srl
Via P. Paleocapa, 7
20121 Milan, Italy

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

This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
MT: COLECALCIFEROLO ZENTIVA, soft capsules
IT: COLECALCIFEROLO ZENTIVA ITALIA