Colecalciferol Polpharma

Leaflet attached to the packaging: patient information

Colecalciferol Polpharma, 10,000 IU, soft capsules

Cholecalciferol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Colecalciferol Polpharma contains the active substance cholecalciferol, 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 25-hydroxycholecalciferol (25(OH)D) concentration <20 ng ml (< 50 nmol l); the target concentration for optimal vitamin d activity is 30 to (75 125 l).
Vitamin D deficiency may occur in people living at high geographic latitudes (> 35°), or in those whose diet or lifestyle does not provide sufficient vitamin D (people spending most of their time indoors, working at night), or when the demand for vitamin D is increased (pregnant women, overweight people).

2. Important information before taking Colecalciferol Polpharma

When not to take Colecalciferol Polpharma:

• if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if you have high blood calcium levels (hypercalcemia) or high urine calcium levels (hypercalciuria);
• if you have severe kidney failure, kidney stones (nephrolithiasis) or a tendency to form kidney stones;
• if you have high blood vitamin D levels (hypervitaminosis D);
• in children and adolescents under 18 years of age.

Warnings and precautions

Before taking Colecalciferol Polpharma, discuss it with your doctor or pharmacist:

• if you are taking certain heart medicines (e.g. cardiac glycosides, such as digoxin);
• if you have sarcoidosis (an immune system disease that can cause increased vitamin D levels in the body);
• if you are taking other medicines, including calcitriol or other vitamin D metabolites and analogues, and/or dietary supplements containing vitamin D and calcium, or foods enriched with vitamin D;
• if there is a risk that you will be exposed to large amounts of sunlight during treatment with Colecalciferol Polpharma;
• if you are taking additional calcium doses. During treatment with Colecalciferol Polpharma, your doctor will monitor your blood calcium levels to ensure they are not too high;
• if you have damaged or diseased kidneys. In this case, your doctor may recommend testing your blood or urine calcium levels. In patients with severe kidney failure, the medicine is contraindicated.

If you are taking this medicine for a long time, you should see your doctor for a check-up of your blood and urine calcium levels.

Children and adolescents

Colecalciferol Polpharma is not recommended for children and adolescents under 18 years of age.

Colecalciferol Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
This is especially important if you are taking:

• heart or kidney medicines, such as cardiac glycosides (e.g. digoxin) or thiazide diuretics. These medicines may cause a significant increase in blood and urine calcium levels when taken with vitamin D;
• medicines containing vitamin D, calcitriol or other vitamin D metabolites and analogues, as well as foods rich in vitamin D;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal medicines (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 medicines (anticonvulsants), barbiturates;
• glucocorticoids (steroid hormones, such as hydrocortisone or prednisolone). They may weaken the effect of vitamin D;
• medicines that lower blood cholesterol levels (such as cholestyramine or colestipol);
• certain medicines used to treat obesity, which reduce fat absorption (e.g. orlistat);
• certain laxatives (e.g. paraffin oil);
• antacids containing magnesium or aluminum (used for heartburn or indigestion);
• medicines used to treat tuberculosis (e.g. rifampicin, isoniazid).

Colecalciferol Polpharma with food and drink

This medicine is best taken with the main meal to facilitate vitamin D absorption.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Colecalciferol Polpharma should be taken during pregnancy and/or breastfeeding only if recommended by a doctor.
Pregnancy
During pregnancy, it is essential to avoid vitamin D overdose, as prolonged hypercalcemia (elevated blood calcium levels) may lead to physical and mental development delays, as well as congenital heart and eye defects in the child.
Breastfeeding
Vitamin D and its metabolites pass into breast milk.
No overdose has been observed in breastfed infants. Breastfeeding women should not take high doses of vitamin D to supplement their child.

Driving and using machines

Colecalciferol Polpharma is unlikely to affect your ability to drive or use machines.

3. How to take Colecalciferol Polpharma

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The dosing schedule and treatment should take into account the patient's clinical condition.
Patients with obesity (adults - BMI ≥ 30) require twice the dose of vitamin D recommended for their peers with normal body weight.

Adults

Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults
The recommended dose is 10,000 IU once a week, from October to April or throughout the year, if effective skin synthesis of vitamin D is not ensured during the summer months.
Treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults
10,000 IU (1 capsule) per day for 1 to 3 months, then 2,000 IU per day or 10,000 IU per week, depending on age and body weight, under medical supervision.

Do not take other medicines, including calcitriol or other vitamin D metabolites and analogues, dietary supplements, or foods containing vitamin D (cholecalciferol) without medical supervision.

Patients should receive calcium supplements if their dietary calcium intake is insufficient.

Method of administration

The capsules should be swallowed whole, with water, preferably during the main meal.

Overdose of Colecalciferol Polpharma

If you have taken more capsules than prescribed, contact your doctor or seek medical attention immediately.
If possible, take the package and this leaflet with you to show the doctor.
The most common symptoms of overdose are nausea, vomiting, diarrhea - often occurring in the initial stage, 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 elevated blood and urine calcium levels found in laboratory tests.
High blood calcium levels can cause heart rhythm disturbances, kidney failure, pancreatitis, and even death.

Missed dose of Colecalciferol Polpharma

If you have missed a dose, take it as soon as possible. Take the next dose at the usual time. If it is almost time for the next dose, do not take the missed dose, just take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Colecalciferol Polpharma can cause side effects, although not everybody gets them.

Some side effects may be serious and may require immediate medical attention

Seek medical attention immediatelyif you experience symptoms of angioedema, such as:

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

Other side effects associated with Colecalciferol Polpharma include:

Uncommon(occurring in less than 1 in 100 patients)

• high blood calcium levels (hypercalcemia)
• high urine calcium levels (hypercalciuria)

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

• rash
• itching
• hives

Frequency not known(cannot be estimated from available data)

• constipation
• gas (bloating)
• nausea
• abdominal pain
• diarrhea.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 package 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 month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 content: purified peanut oil (type I), capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides.

What Colecalciferol Polpharma looks like and contents of the pack

Colecalciferol Polpharma is a light yellow, oval, soft capsule (shorter diameter approximately 9 mm) with a seam in the middle, filled with a light yellow, oily liquid.
The pack contains 4, 30, or 60 capsules in PVC/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

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

Date of last revision of the leaflet: