Package leaflet: Information for the user

Fultium-D, 20,000 IU, soft capsules
cholecalciferol (vitamin D )
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any unlisted side effects mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Fultium-D is and what it is used for
Important information before taking Fultium-D
How to take Fultium-D
Possible side effects
How to store Fultium-D
Contents of the pack and other information

1. What Fultium-D is and what it is used for

Fultium-D contains the active substance cholecalciferol (vitamin D ):
Vitamin D regulates calcium absorption and metabolism, and calcium deposition into bone tissue.
Fultium-D capsules are used for initial treatment of symptomatic vitamin D deficiency in adults.

2. Important information before taking Fultium-D

When not to use Fultium-D:

if the patient is allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6);
if the patient has high levels of vitamin D in the blood (vitamin D excess);
if the patient has high levels of calcium in the blood (hypercalcaemia) or high levels of calcium in the urine (hypercalciuria);
if the patient has kidney stones and/or nephrocalcinosis (calcification of the kidneys) or severe kidney function disorders.

Warnings and precautions
Before starting Fultium-D, discuss with a doctor or pharmacist:

if the patient has damaged or diseased kidneys. The doctor will arrange for blood and urine calcium tests;
if the patient is being treated for heart disease;
if the patient is prone to developing calcium-containing kidney stones;
if the patient's ability to move is severely limited, as in such cases there is a risk of high calcium levels in the blood (hypercalcaemia) or high calcium levels in the urine (hypercalciuria);
if the patient has sarcoidosis (an immune system disorder that may affect the liver, lungs, skin, or lymph nodes);
if the patient has pseudohypoparathyroidism (a disorder affecting the body's response to parathyroid hormone), as the requirement for vitamin D may be reduced. In such cases, there is a risk that the patient may receive too much vitamin D. Other vitamin D-containing medicines may be more suitable;
if the patient is already taking additional calcium and vitamin D supplements (e.g. medicines containing vitamin D), or if the patient consumes food or dietary supplements containing vitamin D. During treatment with Fultium-D, the doctor will monitor blood calcium levels to ensure they are not too high.

Fultium-D 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.
In particular, the following medicines may interact with Fultium-D:

heart medicines (cardiac glycosides such as digoxin). The doctor may monitor the patient's heart function using electrocardiography (ECG) and measure blood calcium levels;
diuretics (thiazide diuretics, used, for example, in the treatment of high blood pressure). When used together with vitamin D, they may lead to high calcium levels in the blood (hypercalcaemia) or high calcium levels in the urine (hypercalciuria);
antiepileptic drugs (such as phenytoin) or drugs used to aid sleep (barbiturates such as phenobarbital), as these drugs may reduce the effectiveness of vitamin D;
glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These may reduce the effectiveness of vitamin D;
antibiotics used to treat a bacterial infection called tuberculosis (such as rifampicin and isoniazid), as they may reduce the effectiveness of vitamin D;
laxatives (such as liquid paraffin), a cholesterol-lowering medicine called cholestyramine, or a weight-reducing medicine called orlistat, as they may reduce the absorption of vitamin D;
actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungal medicines (such as clotrimazole and ketoconazole, used in the treatment of fungal infections), as they may affect vitamin D metabolism.

Children and adolescents
Fultium-D 20,000 IU, capsules, is not recommended for use in children and adolescents under 18 years of age.

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.
This formulation, containing a high dose, is not recommended for use during pregnancy or in women who are breastfeeding.

Driving and operating machinery
Fultium-D has no influence on the ability to drive or operate machinery.

3. How to use Fultium-D

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor.

The recommended dose is 1 capsule per week during the first month; the doctor will adjust the dose appropriately for the patient.

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

Use in children
Fultium-D, 20,000 IU, capsules is not recommended for use in children and adolescents under 18 years of age.

Taking more than the recommended dose of Fultium-D
If too many capsules have been taken by accident, inform the doctor immediately or seek other medical advice. If possible, bring the capsules, the packaging, and this leaflet to show the doctor. If an excessive number of capsules has been taken, symptoms such as nausea or vomiting, constipation or abdominal pain, muscle weakness, fatigue, loss of appetite, kidney-related problems, and in severe cases even irregular heartbeat may occur.

Missing a dose of Fultium-D
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for a missed dose. Then continue taking the next capsule as instructed by the doctor.

If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions associated with Fultium-D may include:

Uncommon adverse reactions (may occur in not more than 1 in 100 people)

increased calcium levels in the blood (hypercalcaemia). Symptoms may include nausea or vomiting, loss of appetite, constipation, abdominal pain, increased thirst, muscle weakness, dizziness or confusion
increased calcium levels in the urine (hypercalciuria)

Rare adverse reactions (may occur in not more than 1 in 1000 people)

skin rash
itching
urticaria

Reporting of adverse reactions
If any adverse reactions occur in a patient, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.
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
Tel.: +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 Fultium-D

No special storage temperature precautions are required.
Store the blister pack in the original packaging to protect from light.
Keep the medicine out of sight and reach of children.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Fultium-D 20,000 IU capsules contain
The active substance is cholecalciferol (vitamin D).
Each capsule contains 500 micrograms of cholecalciferol (equivalent to 20,000 IU (so-called international units) of vitamin D).
The other ingredients are:
Capsule contents:

purified maize oil
butylated hydroxytoluene (E 321)

Capsule shell:

gelatin
glycerol
quinoline yellow (E 104)
purified water

What Fultium-D looks like and contents of the pack
Fultium-D 20,000 IU is available as small capsules (10.6 mm x 6.2 mm), transparent, yellow, unmarked.
It is available in blister packs of 4, 6, 15 or 50 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer:
Swiss Caps GmbH
Grassingerstrasse No.9
83043 Bad Aibling,
Germany
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
S.C. Swisscaps Romania S.R.L.
No. 20 Carol I Street, Cornu
Prahova 107180
Romania

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Denmark Fultium
Finland Fultium 20 000 IU pehmeät kapselit
Netherlands Vitamine D STADA 20.000 IE zachte capsules
Ireland Fultium-D 20000 IU Capsules
Germany Vitamin D3 AL 20.000 I.E. Weichkapseln
Norway Fultium 20000 IU myke kapsler
Poland Fultium-D 20 000 IU, capsules, soft
Portugal Fultium-D 20 000 UI Cápsulas
Sweden Fultium 20 000 IE mjuka kapslar