Fultium-d3

Package Leaflet: Information for the Patient

Fultium-D, 20,000 IU, Soft Capsules

Cholecalciferol (Vitamin D)

Read the Leaflet Carefully Before Taking the Medication, 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. 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 Fultium-D and what is it used for
• 2. Important information before taking Fultium-D
• 3. How to take Fultium-D
• 4. Possible side effects
• 5. How to store Fultium-D
• 6. Contents of the pack and other information

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

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

2. Important information before taking Fultium-D

When not to take Fultium-D:

Warnings and precautions

Before taking Fultium-D, discuss with your doctor or pharmacist:

Fultium-D and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.
In particular, the following medicines may interact with Fultium-D:

• cardiac glycosides (such as digoxin). Your doctor may monitor your heart activity using an electrocardiogram (ECG) and measure your blood calcium levels;
• diuretics (thiazide diuretics, used, for example, in the treatment of high blood pressure). When used together with Vitamin D, they can lead to high calcium levels in the blood (hypercalcemia) or high calcium levels in the urine (hypercalciuria);
• medicines used to treat epilepsy (such as phenytoin) or sleep-inducing medicines (barbiturates such as phenobarbital), as these medicines can weaken the effect of Vitamin D;
• glucocorticosteroids (steroid hormones, such as hydrocortisone or prednisolone). They can weaken the effect of Vitamin D;
• antibiotics used to treat bacterial infections such as tuberculosis (such as rifampicin and isoniazid), as they can weaken the effect of Vitamin D;
• laxatives (such as paraffin oil), a cholesterol-lowering medicine called cholestyramine, or a weight loss medicine called orlistat, as they can reduce the absorption of Vitamin D;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal medicines (such as clotrimazole and ketoconazole, used to treat fungal diseases), as they can affect Vitamin D metabolism.

Children and adolescents

Fultium-D, 20,000 IU, soft capsules, are not recommended for use in children and adolescents below 18 years of age.

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.
This form of the medicine containing a high dose is not recommended during pregnancy and in breastfeeding women.

Driving and using machines

Fultium-D does not affect the ability to drive and use machines.

3. How to take Fultium-D

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.
The recommended dose is 1 capsule per week for the first month; your doctor will adjust the dose for you.
The capsules should be swallowed whole with water, preferably during a meal.

Use in children

Fultium-D, 20,000 IU, soft capsules, are not recommended for use in children and adolescents below 18 years of age.

Overdose of Fultium-D

If you accidentally take too many capsules, tell your doctor or seek other medical advice immediately. If possible, take the capsules, the package, and this leaflet with you to show the doctor.
If you take too many capsules, you may experience nausea or vomiting, constipation or abdominal pain, muscle weakness, fatigue, loss of appetite, kidney problems, and in severe cases, irregular heartbeat.

Missed dose of Fultium-D

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.
Then, take the next capsule as your doctor has told you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fultium-D can cause side effects, although not everybody gets them.
The following are side effects of Fultium-D:

Uncommon side effects(may affect up to 1 in 100 people)

• high levels of calcium in the blood (hypercalcemia). You may experience nausea or vomiting, loss of appetite, constipation, abdominal pain, increased thirst, muscle weakness, dizziness, or confusion
• high levels of calcium in the urine (hypercalciuria)

Rare side effects(may affect up to 1 in 1,000 people)

• skin rash
• itching
• hives

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 Fultium-D

No special precautions for storage temperature.
Store the blister in the original package to protect from light.
Keep the medicine out of the 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 month.
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 Fultium-D, 20,000 IU, soft capsules contain

The active substance is cholecalciferol (Vitamin D).
1 capsule contains 500 micrograms of cholecalciferol (which corresponds to 20,000 IU (International Units) of Vitamin D).
The other ingredients are:

• purified corn oil
• butylhydroxytoluene (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 a small, transparent, yellow, unmarked capsule (10.6 mm x 6.2 mm).
Available in blisters of 4, 6, 15, or 50 capsules.
Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Denmark
Fultium
Finland
Fultium 20,000 IU soft capsules
Netherlands
Vitamine D STADA 20,000 IE soft capsules
Ireland
Fultium-D 20000 IU Capsules
Germany
Vitamin D3 AL 20,000 I.E. soft capsules
Norway
Fultium 20000 IU soft capsules
Poland
Fultium-D, 20,000 IU, soft capsules
Portugal
Fultium-D 20,000 UI capsules
Sweden
Fultium 20,000 IE soft capsules

Date of last revision of the leaflet: 03/2023