Package leaflet: Information for the patient

Vitaminum D3 MAX APTEO MED, 4000 IU, soft capsules
Cholecalciferolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, so you can read it again if necessary.
If you need advice or additional information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents

What Vitaminum D3 MAX APTEO MED is and what it is used for
Important information before taking Vitaminum D3 MAX APTEO MED
How to use Vitaminum D3 MAX APTEO MED
Possible side effects
How to store Vitaminum D3 MAX APTEO MED
Contents of the pack and other information

1. What Vitaminum D3 MAX APTEO MED is and what it is used for

Vitaminum D3 MAX APTEO MED contains cholecalciferol as the active substance, which is identical to the vitamin D produced in the human body. Vitamin D plays an important role in bone formation.
Vitamin D is found in certain foods and is also produced in the body when the skin is exposed to sunlight.
Vitamin D enhances 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).
Vitaminum D3 MAX APTEO MED is indicated:

for the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity [body mass index (BMI) ≥ 30 kg/m²].

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

2. Important information before using Vitaminum D3 MAX APTEO MED

When not to use Vitaminum D3 MAX APTEO MED:

if the patient is allergic to cholecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6);
if the patient has elevated calcium levels in the blood (hypercalcemia) or excessive calcium excretion 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.

Warnings and precautions
Before starting treatment with Vitaminum D3 MAX APTEO MED, consult a doctor or pharmacist if:

the patient is taking certain medications used for heart conditions (e.g. cardiac glycosides such as digoxin);
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 high levels of sunlight during treatment with Vitaminum D3 MAX APTEO MED;
if the patient has impaired kidney function;
if vitamin D treatment is long-term (longer than 3 months), as in such cases the doctor should monitor serum and urinary calcium levels and assess kidney function by measuring blood creatinine levels.

Vitaminum D3 MAX APTEO MED 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 using:

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 cause a significant increase in blood and urinary calcium levels;
medicines containing vitamin D, calcitriol, or other vitamin D metabolites and analogs, as well as foods rich in vitamin D;
actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungal agents (e.g. clotrimazole and ketoconazole, used to treat fungal infections);
antiepileptic (anticonvulsant) medicines;
barbiturates (sedatives, anticonvulsants);
glucocorticoids (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 (e.g. liquid paraffin);
medicines used in hypercalcemia (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).

Vitaminum D3 MAX APTEO 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 a doctor or pharmacist before using this medicine.
Vitaminum D3 MAX APTEO MED is contraindicated in pregnant women due to the excessively high dose of the medicine.
Vitaminum D3 MAX APTEO MED is contraindicated in breastfeeding women due to the excessively high dose of the medicine.

Driving and operating machinery
Vitaminum D3 MAX APTEO MED has no effect on the ability to drive or operate machinery.

3. How to use Vitaminum D3 MAX APTEO MED

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Prevention 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 Vitaminum D3 MAX APTEO MED for longer than recommended (i.e. longer than 3 months) or in doses higher than recommended without medical supervision.
Without medical supervision, do not use other medicines, dietary supplements, or other types of food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs simultaneously.
Patients with renal impairment
Vitaminum D3 MAX APTEO MED must not be used in patients with severe renal impairment. The medicine must not be used in patients with renal function disorders without physician monitoring.
Patients with hepatic impairment
No special dosage recommendations.
Children and adolescents under 18 years of age
Vitaminum D3 MAX APTEO 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.
Use of a higher than recommended dose of Vitaminum D3 MAX APTEO MED
If a patient accidentally takes one extra capsule, the occurrence of overdose symptoms is unlikely.
In case of overdose, inform a physician or pharmacist or contact the nearest hospital emergency department for further advice. If possible, bring the medicine packaging and this leaflet to show the physician.
Missed dose of Vitaminum D3 MAX APTEO 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 dose at the usual time should be taken.
Do not take a double dose to make up for a missed dose.
Discontinuation of Vitaminum D3 MAX APTEO MED
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Some adverse reactions may be serious and may require immediate medical attention.
Seek immediate medical advice 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 Vitaminum D3 MAX APTEO MED include:
Not common (occur in less than 1 in 100 patients):

increased calcium levels in blood (hypercalcaemia);
increased calcium levels in urine (hypercalciuria).

Rare (occur in less than 1 in 1000 patients):

rash;
itching;
urticaria.

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

constipation;
gas (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 of Adverse Drug Reactions, 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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vitaminum D3 MAX APTEO 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 after "Expiry date (EXP)" and on the 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 Vitaminum D3 MAX APTEO MED contains

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

What Vitaminum D3 MAX APTEO MED looks like and contents of the pack
Vitaminum D3 MAX APTEO MED is pale yellow, oval, soft gelatin capsules,
size 2 (approximately 8 mm in length and 5.7 mm in diameter), filled with an oily liquid, colourless to pale yellow.
The capsules are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box.
The pack contains 60 or 120 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Tel: +48 22 32 16 240

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