Apod3 med

Package leaflet: Information for the user

APOD3 Med, 4000 IU, soft capsules
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as
instructed by your doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse, you should contact your doctor.

Contents of the leaflet:

1. What APOD3 Med is and what it is used for
2. Important information before taking APOD3 Med
3. How to take APOD3 Med
4. Possible side effects
5. How to store APOD3 Med
6. Contents of the pack and other information

1. What APOD3 Med is and what it is used for

APOD3 Med 4000 IU (international units) contains cholecalciferol as the active substance, which is identical to the vitamin D produced in the human body.
Vitamin D is found in certain foods and is also produced in the body when the skin is exposed to sunlight.
Vitamin D increases calcium absorption from the intestines and reduces its excretion by the kidneys, thus supporting bone formation.
Vitamin D deficiency causes rickets (impaired bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).
APOD3 Med is used:

• for the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity [body mass index (BMI) ≥ 30].

Prophylactic intake of vitamin D is recommended during months with insufficient sunlight exposure (from October to April).
During periods of high sunlight exposure in summer months (from May to September), periodic interruption of vitamin D intake is advised.

2. Important information before using APOD3 Med

When not to use APOD3 Med:

• if the patient is allergic to cholecalciferol (vitamin D) 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 vitamin D levels in the blood (hypervitaminosis D);
• in cases of pseudohypoparathyroidism;
• in children and adolescents under 18 years of age;
• if the patient is pregnant;
• during breastfeeding.

Warnings and precautions
Before starting treatment with APOD3 Med, 4000 IU, discuss the following with your doctor or pharmacist:

• if the patient is taking certain medications used for heart conditions (e.g. cardiac glycosides such as digoxin);
• if the patient has sarcoidosis (an immune system disorder that may increase vitamin D levels in the body);
• if the patient is also taking other medicines and/or dietary supplements or consuming foods rich in vitamin D, because additional doses of vitamin D should only be taken under medical supervision;
• if the patient is taking additional calcium supplements;
• if the patient is likely to be exposed to significant sunlight during treatment with APOD3 Med;
• if the patient has impaired kidney function;
• if vitamin D treatment is long-term, in which case the doctor should monitor serum and urinary calcium levels and assess kidney function by measuring blood creatinine levels.

APOD3 Med and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 (e.g. bendroflumethiazide). Concomitant use with vitamin D may lead to a significant increase in blood and urinary calcium levels;
• medicines containing vitamin D, calcitriol, or other vitamin D metabolites and analogues, as well as foods rich in vitamin D;
• actinomycin (a medicine used in the treatment of certain cancers) and imidazole antifungal agents (e.g. clotrimazole and ketoconazole, used to treat fungal infections);
• anticonvulsant (antiepileptic) medicines;
• barbiturates (sleeping or anticonvulsant medicines);
• glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone);
• cholesterol-lowering medicines (such as cholestyramine or colestipol);
• certain medicines used to treat obesity that reduce fat absorption (e.g. orlistat);
• certain laxatives (such as liquid paraffin);
• medicines used in hypercalcaemia (elevated blood calcium levels), such as calcitonin, etidronate, pamidronate;
• antacids containing magnesium or aluminium (used for heartburn and indigestion);
• medicines used in the treatment of tuberculosis (e.g. rifampicin, isoniazid).

APOD3 Med 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 have a child, she should consult her doctor or pharmacist before using this medicine.
APOD3 Med, 4000 IU is contraindicated in women during pregnancy.
APOD3 Med, 4000 IU is contraindicated in breastfeeding women.
Driving and operating machinery
APOD3 Med, 4000 IU does not affect the ability to drive or operate machinery.

3. How to use APOD3 Med

This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Prophylaxis of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults
with obesity
The usual recommended dose is 4000 IU (1 capsule) daily, from October to April, or throughout the
year if effective cutaneous synthesis of vitamin D is not ensured during summer months.
Do not use other medicines, dietary supplements, or food products containing vitamin D
(cholecalciferol), calcitriol, or other metabolites and analogues of vitamin D without medical
supervision.
Do not use APOD3 Med for longer than recommended or in doses higher than recommended without
medical supervision.
Patients with renal impairment
APOD3 Med should not be used in patients with severe renal impairment.
This medicine should not be used in patients with impaired kidney function without medical supervision.
Patients with hepatic impairment
No special dosage recommendations are required.
Children and adolescents
APOD3 Med is contraindicated in children and adolescents under 18 years of age.
Method of administration
The capsules should be swallowed whole with water, preferably during a main meal.
Taking more APOD3 Med than recommended
If a patient accidentally takes one extra capsule, symptoms of overdose are unlikely.
In case of overdose, contact your doctor or pharmacist, or go to the nearest hospital emergency
department for further advice. If possible, bring the medicine packaging and this leaflet to show the
doctor.
Missing a dose of APOD3 Med
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. However, if it is almost time for the next dose, the missed dose should not
be taken; only the next scheduled dose should be taken at the usual time. Do not take a double dose
to make up for a missed dose.
If you have any further doubts concerning 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 everybody gets them.
Some adverse reactions may be serious and may require immediate medical attention.
You should contact your doctor immediately if symptoms of angioedema occur, such as:

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

Other adverse reactions associated with the use of APOD3 Med, 4000 IU include:
Not common (occur in less than 1 in 100 patients)

• elevated calcium levels in the blood (hypercalcaemia)
• elevated calcium levels in the urine (hypercalciuria)

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

• rash
• itching
• urticaria

Frequency not known (cannot be estimated from the available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store APOD3 Med

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
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.
Medicines must 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 APOD3 Med, 4000 IU contains

• The active substance is cholecalciferol. Each capsule contains 100 micrograms of cholecalciferol, equivalent to 4000 IU of vitamin D.
• Other components are: Capsule contents: medium-chain triglycerides, all-rac-α-tocopheryl acetate. Capsule shell composition: gelatin, glycerol, purified water.

What APOD3 Med looks like and contents of the pack
APOD3 Med is in the form of light yellowish, oval-shaped soft capsules filled with a colorless to light yellow oily liquid.
The pack contains 30, 60 or 90 capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer:
Curtis Health Caps S.A.
Wysogotowo, Batorowska 52
62-081 Przeźmierowo
Poland