Colecalciferol polpharma

Package leaflet: Information for the patient

Colecalciferol Polpharma, 10,000 IU, soft capsules
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Colecalciferol Polpharma is and what it is used for

Colecalciferol Polpharma contains cholecalciferol as the active substance, which is identical to vitamin D produced in the human body.
Colecalciferol Polpharma is used:

• for the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency (e.g. osteomalacia) in adults
• for the treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults.

Vitamin D deficiency is defined as a serum concentration of 25-hydroxycholecalciferol
(25(OH)D) < 20 ng/ml (< 50 nmol/l); the target concentration for optimal vitamin D activity is considered to be 30 to 50 ng/ml (75 to 125 nmol/l).
Vitamin D deficiency may occur in individuals living at high geographical latitudes
(> 35°), or in those whose diet or lifestyle does not provide sufficient vitamin D
(individuals spending most of their time indoors, or working at night), or when vitamin D requirements are increased (pregnant women, individuals with overweight).

2. Important information before using Colecalciferol Polpharma

When not to use Colecalciferol Polpharma:

• if the patient is allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has elevated calcium levels in the blood (hypercalcaemia) or in the urine (hypercalciuria);
• if the patient has severe kidney failure, kidney stones (nephrolithiasis), or a tendency to develop kidney stones;
• if the patient has elevated levels of vitamin D in the blood (hypervitaminosis D);
• in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Colecalciferol Polpharma, discuss the following with your doctor or
pharmacist:

• if the patient is taking certain medicines used for heart conditions (e.g. cardiac glycosides such as digoxin);
• if the patient has sarcoidosis (an immune system disorder which may cause increased levels of vitamin D in the body);
• if the patient is taking other medicines, including calcitriol or other metabolites or analogues of vitamin D, and/or dietary supplements containing vitamin D and calcium, or consuming foods fortified with vitamin D;
• if the patient is likely to be exposed to high levels of sunlight during treatment with Colecalciferol Polpharma;
• if the patient is taking additional calcium supplements. During treatment with Colecalciferol Polpharma, the doctor will monitor blood calcium levels to ensure they are not too high;
• if the patient has impaired or diseased kidneys. In such cases, the doctor may recommend testing calcium levels in blood or urine. Colecalciferol Polpharma is contraindicated in patients with severe renal failure.

If the patient is taking this medicine for a prolonged period, regular visits to the doctor are recommended to monitor calcium levels in blood and urine.
Children and adolescents
Colecalciferol Polpharma is not recommended for children and adolescents under 18 years of age.
Colecalciferol Polpharma and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
This is particularly important if the patient is taking:

• medicines affecting the heart or kidneys, such as cardiac glycosides (e.g. digoxin) or thiazide diuretics. When used concomitantly with vitamin D, these medicines may cause a significant increase in blood and urine calcium levels;
• medicines containing vitamin D, calcitriol, or other vitamin D analogues and metabolites, as well as foods rich in vitamin D;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal agents (e.g. clotrimazole and ketoconazole, used to treat fungal infections), as they may affect vitamin D metabolism;
• the following medicines, as they may affect the action or absorption of vitamin D:
• antiepileptic (anticonvulsant) medicines, barbiturates;
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These may reduce the effectiveness of vitamin D;
• medicines that lower blood cholesterol levels (such as cholestyramine or colestipol);
• certain medicines used to treat obesity that reduce fat absorption (e.g. orlistat);
• certain laxatives (e.g. liquid paraffin);
• antacids containing magnesium or aluminium (used for heartburn or indigestion);
• medicines used to treat tuberculosis (e.g. rifampicin, isoniazid).

Colecalciferol Polpharma with food and drink
This medicine should be taken with a main meal to facilitate absorption of vitamin D.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Colecalciferol Polpharma should be used during pregnancy and/or breastfeeding only if recommended by a doctor.
Pregnancy
Excessive intake of vitamin D during pregnancy should be avoided, as prolonged hypercalcaemia (elevated calcium levels in blood) may lead to delayed physical and mental development, congenital heart defects, and eye abnormalities in the child.
Breastfeeding
Vitamin D and its metabolites pass into breast milk.
No cases of overdose have been observed in breastfed infants. Breastfeeding women should not take high doses of vitamin D to supplement their infant.
Driving and operating machinery
Colecalciferol Polpharma is unlikely to affect the ability to drive or operate machinery.

3. How to use Colecalciferol Polpharma

This medicine should always be taken exactly as directed by the physician or pharmacist. In case of
doubt, consult your doctor or pharmacist.
The dosing regimen and treatment approach should take into account the individual patient's clinical condition.
Patients with obesity (adults - BMI ≥ 30) require twice the recommended dose of vitamin D compared to
peers with normal body weight.
Adults
Prophylaxis of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults
The usual recommended dose is 10,000 IU once weekly, from October to April, or throughout the year if effective cutaneous synthesis of vitamin D is not ensured during summer months.
Treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults
10,000 IU (1 capsule) daily for 1 to 3 months, followed by 2,000 IU daily or 10,000 IU weekly, depending on age and body weight, under medical supervision.
Do not use other medications, including calcitriol or other metabolites and analogs of vitamin D,
dietary supplements, or foods containing vitamin D (cholecalciferol), without medical supervision.
Patients should receive calcium supplementation if dietary calcium intake is insufficient.
Method of administration
The capsules should be swallowed whole with water, preferably during a main meal.
Taking more Colecalciferol Polpharma than recommended
If more capsules than prescribed have been accidentally taken, contact a doctor immediately or seek other medical help. If possible, bring the package and this leaflet with you to show the doctor.
The most common symptoms of overdose include nausea, vomiting, diarrhoea – often occurring in the initial phase, followed by constipation, loss of appetite, fatigue, headache, muscle and joint pain, muscle weakness, drowsiness, excessive thirst, frequent urination lasting more than 24 hours, dehydration, and laboratory-confirmed elevated calcium levels in blood and urine.
High calcium levels in blood may cause cardiac arrhythmias, kidney failure, pancreatitis, and even lead to death.
Missing a dose of Colecalciferol Polpharma
If a patient forgets to take the medicine, it should be taken as soon as possible. The next dose should be taken at the usual time. If the time for the next dose is approaching, do not take the missed dose; only take the next scheduled dose at the regular time.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and may require immediate medical attention.
You should immediately contact a doctor if symptoms of angioedema occur, such as:

• swelling of the face, tongue or throat (larynx)
• difficulty swallowing
• hives and breathing difficulties

Other adverse reactions associated with the use of Colecalciferol Polpharma include:
Not very common (occurring in less than 1 in 100 patients)

• increased calcium levels in blood (hypercalcaemia)
• increased calcium levels in urine (hypercalciuria)

Rare (occurring in less than 1 in 1,000 patients)

• rash
• itching
• urticaria

Frequency not known (cannot be estimated based on available data)

• constipation
• flatulence (bloating)
• nausea
• abdominal pain
• diarrhoea

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Colecalciferol Polpharma

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Colecalciferol Polpharma contains

• The active substance is cholecalciferol. Each capsule contains 250 micrograms of cholecalciferol, equivalent to 10,000 IU of vitamin D.
• The other ingredients are: capsule contents: purified croton oil (type I); capsule shell composition: gelatin, glycerol, purified water, medium-chain triglycerides.

What Colecalciferol Polpharma looks like and contents of the pack
Colecalciferol Polpharma is in the form of light yellow, oval, soft capsules (shorter diameter approximately 9 mm) with a central seam, filled with a light yellow oily liquid.
The pack contains 4, 30 or 60 capsules in blisters made of PVC/PVDC/Aluminium foil, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz