Colecalciferol EG Stada Italia

Package leaflet: Information for the patient

COLECALCIFEROLO EG STADA ITALIA 10,000 IU, soft capsules, 25,000 IU, soft capsules

Colecalciferol (vitamin D3)
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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

COLECALCIFEROLO EG STADA ITALIA contains the active substance colecalciferol, better known as Vitamin D3.
COLECALCIFEROLO EG STADA ITALIA is indicated for:
Prevention and treatment of vitamin D deficiency in adults.
For the prevention of vitamin D deficiency, COLECALCIFEROLO EG STADA ITALIA 25,000 IU is used in adults only when therapeutic adherence cannot be achieved with daily administration of low doses of colecalciferol.
COLECALCIFEROLO EG STADA 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 EG STADA ITALIA

Do not take COLECALCIFEROLO EG STADA 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 have kidney disease (severe renal impairment) (see section “Warnings and precautions”).

COLECALCIFEROLO EG STADA ITALIA must not be given to newborns and children under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking COLECALCIFEROLO EG STADA ITALIA, particularly:
if you need to take COLECALCIFEROLO EG STADA 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, your blood and urine calcium levels should be checked.
If you are already taking medicines containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk.
If you have a chronic inflammatory disease affecting multiple organs called sarcoidosis.
If you have impaired kidney function, as vitamin D levels in your body may be altered.
If you are prone to developing calcium-containing kidney stones.
If you have severe renal insufficiency: in this case, other forms of vitamin D should be used.
If you are taking this medicine long-term, especially if you are elderly. In such cases, your doctor will monitor urinary calcium excretion and kidney function. If necessary, your doctor will 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 dose adjustment may be required as indicated in section 3 “How to take COLECALCIFEROLO EG STADA ITALIA”:
If you are being treated with antiepileptic drugs (anticonvulsants or barbiturates).
If you are being treated with anti-inflammatory drugs (corticosteroids).
If you are being treated with lipid-lowering drugs (colestipol, cholestyramine, orlistat) or laxatives (such as paraffin oil).
If you are being treated with drugs used to treat excessive stomach acid production (aluminum-containing antacids).
If you are obese.
If you have digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis).
If you have liver disease (hepatic insufficiency).
Children
COLECALCIFEROLO EG STADA ITALIA must not be given to newborns or children under 18 years of age.
Other medicines and COLECALCIFEROLO EG STADA 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 EG STADA ITALIA:
other medicines containing vitamin D.
medicines used to treat epilepsy (anticonvulsants or barbiturates), such as phenytoin, phenobarbital, primidone, etc.
medicines to lower blood fats such as colestipol, cholestyramine, orlistat, and laxatives (e.g. paraffin oil).
aluminum-containing antacids, medicines used to treat excess stomach acid that may rise into the esophagus.
thiazide diuretics, medicines used to treat high blood pressure that increase urine production.
digitalis, a medicine used to treat certain heart disorders.
medicines used to treat tuberculosis, such as rifampicin or isoniazid.
antifungal agents such as imidazoles (e.g. ketoconazole), medicines used to inhibit fungal growth.
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 EG STADA ITALIA with food, drinks and alcohol
Inform your doctor if you are taking other vitamin D-containing products, vitamin D-fortified foods, or using vitamin D-enriched milk, so that the total vitamin D intake can be taken into account to avoid excessive doses.
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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
COLECALCIFEROLO EG STADA 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 EG STADA 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 needed, your doctor may prescribe low-dose vitamin D during breastfeeding. This does not replace the need to administer vitamin D to the newborn.
Driving and using machines
COLECALCIFEROLO EG STADA ITALIA does not affect or has negligible effect on the ability to drive vehicles and use machinery.

3. How to take COLECALCIFEROLO EG STADA ITALIA

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment should 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 EG STADA ITALIA with meals.

COLECALCIFEROLO EG STADA 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).
If you are at high risk of vitamin D deficiency, your doctor will evaluate whether the dosage 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 suitable dose for
you based on your response to therapy. Higher doses should be adjusted according to the desired serum
levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the response to
treatment.
Long-term treatment:
In case of long-term treatment, particularly in elderly patients, your doctor will monitor urinary calcium
excretion and renal function. If necessary, your doctor may reduce the dose.

COLECALCIFEROLO EG STADA 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.
If you are at high risk of vitamin D deficiency, your doctor will evaluate whether the dosage 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 per week) 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. It is recommended to reduce or discontinue treatment 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 suitable dose for
you based on your response to therapy.
Higher doses should be adjusted according to the desired serum levels of 25-hydroxycholecalciferol
(25(OH)D), the severity of the disease, and the response to treatment.

If you take more COLECALCIFEROLO EG STADA ITALIA than you should
In case of accidental ingestion/overdose of COLECALCIFEROLO EG STADA ITALIA, inform 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 urine production (polyuria), constipation, and dehydration.
Other symptoms of overdose include:
Diarrhea, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, kidney stones,
nephrocalcinosis, and renal failure.
Excessive chronic overdoses may lead to calcium salt deposits in blood vessels and organs. The use of
excessive doses of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus
and newborn.

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

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

COLECALCIFEROLO EG STADA 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 everyone gets them.
The side effects reported with vitamin D use are as follows:
Uncommon side effects which may affect up to 1 in 100 people:
Allergic reactions, weakness, loss of appetite (anoresia), increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).
Rare side effects which may affect up to 1 in 1,000 people:
Drowsiness, confusion, constipation, gas from the intestine (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 deposits 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 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 COLECALCIFEROLO EG STADA 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 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 25 °C.
Keep in the original packaging to protect the medicine from light.
Do not freeze.

6. Package contents and other information

What COLECALCIFEROLO EG STADA ITALIA contains
COLECALCIFEROLO EG STADA 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 AC (E129).

COLECALCIFEROLO EG STADA 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 AC (E129).

Description of the appearance of COLECALCIFEROLO EG STADA ITALIA and contents of the pack
COLECALCIFEROLO EG STADA ITALIA 10,000 IU soft capsules
The pack contains 2, 4, 8, or 10 capsules in a thermoformed PVC/PVDC and aluminium blister.
COLECALCIFEROLO EG STADA ITALIA 25,000 IU soft capsules
The pack contains 1, 2, 4 capsules in a thermoformed PVC/PVDC and aluminium blister, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy
Manufacturer
DOPPEL FARMACEUTICI S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
MT: DIBECON, soft capsules
IT: COLECALCIFEROLO EG STADA ITALIA