Fultium 3200 IE Kapsel, mjuk

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Bipacksedel Bipacksedel (PIL)

01-03-2019

Produktens egenskaper Produktens egenskaper (SPC)

01-03-2019

Aktiva substanser:
kolekalciferol
Tillgänglig från:
STADA Arzneimittel AG
ATC-kod:
A11CC05
INN (International namn):
cholecalciferol
Dos:
3200 IE
Läkemedelsform:
Kapsel, mjuk
Sammansättning:
glycerol Hjälpämne; butylhydroxitoluen Hjälpämne; kolekalciferol 80 mikrog Aktiv substans
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Blister, 7 kapslar; Blister, 14 kapslar; Blister, 28 kapslar; Blister, 30 kapslar; Blister, 35 kapslar; Blister, 37 kapslar
Bemyndigande status:
Godkänd
Godkännandenummer:
54663
Tillstånd datum:
2017-05-22

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

09-07-2021

Produktens egenskaper Produktens egenskaper - engelska

01-03-2019

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

22-05-2017

Läs hela dokumentet

Package leaflet: Information for the patient

Fultium 3 200 IU Capsules

cholecalciferol (vitamin D

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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 signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Fultium is and what it is used for

What you need to know before you take Fultium

How to take Fultium

Possible side effects

How to store Fultium

Contents of the pack and other information

1.

What Fultium is and what it is used for

Fultium contains the active ingredient cholecalciferol (vitamin D

Vitamin D

regulates the uptake and metabolism of calcium as well as the incorporation of calcium in

bone tissue.

Fultium

is used for initial treatment of symptomatic vitamin D deficiency in adults.

2.

What you need to know before you take Fultium

Do not take Fultium

if you are allergic to vitamin D or any of the other ingredients of this medicine (listed in section

if you have high levels of vitamin D in your blood (hypervitaminosis D)

if you have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium

(hypercalciuria)

if you have kidney stones or serious kidney problems

.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fultium

if you have kidney damage or disease. Your doctor will need to measure the levels of calcium

in your blood or urine

if you are being treated for heart disease

if you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or

lymph nodes)

if you are already taking additional doses of calcium or vitamin D.

While you are taking

Fultium your doctor will monitor your blood levels of calcium to make sure they are not too

high.

Other medicines and Fultium

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

In particular the following medicines may interact with Fultium

Heart medicines (cardiac glycosides such as digoxin). Your doctor may monitor your heart with

an electrocardiogram (ECG) and measure the levels of calcium in your blood.

Medicines to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates

such as phenobarbitone) as these medicines can decrease the effect of vitamin D.

Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease

the effect of vitamin D.

Laxatives (such as paraffin oil) or a cholesterol lowering drug called colestyramine may reduce

the absorption of vitamin D.

Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals

(medicines such as clotrimazole and ketoconazole used to treat fungal diseases) as they may

interfere with the metabolism of vitamin D.

Children and adolescents

Fultium 3 200 IU Capsules are not recommended in children and adolescents under 18 years of age

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

You should not take this medicine during pregnancy without a confirmed vitamin D deficiency and

your doctor finds it absolutely necessary for you.

Fultium is not recommended during breast-feeding.

Driving and using machines

Fultium

has no known effects on ability to drive or use machines.

3.

How to take Fultium

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not

sure.

The recommended dose is 1 capsule per day during the first month, your doctor will adjust the dose

for you.

The capsules should be swallowed whole with water, preferably with food.

Use in children

Fultium 3 200 IU Capsules are not recommended in children and adolescents under 18 years of age.

If you take more Fultium than you should

If you accidentally take one capsule too many, nothing is likely to happen. If you accidentally take

several capsules too many tell your doctor or get other medical advice immediately. If possible, take

the capsules, the box and this leaflet with you to show the doctor. If you take too many capsules you

may feel or be sick, become constipated or have stomach pains, weak muscles, tiredness, lack of

appetite, kidney problems and in severe cases irregular heartbeats.

If you forget to take Fultium

If you forget to take your capsules, take them as soon as you can. Do not take a double dose to make

up for a forgotten dose. After that, take the next capsule in accordance with the instructions given to

you by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects with Fultium may include:

Uncommon side effects

(affecting less than 1 in 100 people)

too much calcium in your blood (hypercalcaemia). You may feel or be sick, lose your appetite,

have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness or

confusion

too much calcium in your urine (hypercalciuria).

Rare side effects

(affecting less than 1 in 1000 people)

skin rash

itching

hives

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V.* By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store Fultium

This medicinal product does not require any special temperature storage conditions.

Store blister in the original carton in order to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry

date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Fultium 3 200 IU Capsules contain

The active substance is cholecalciferol

vitamin D

1 capsule contains

3 200 IU cholecalciferol

corresponding to 80 microgram vitamin D

The other ingredients are:

Capsule Content:

Maize oil, refined

Butylated hydroxytoluene (BHT) (E321)

Capsule Shell:

Gelatin (E441)

Glycerol

Chlorophyllin copper complex sodium (E141)

Purified Water

What Fultium looks like and contents of the pack

Fultium 3 200 IU Capsules are small (10.6 mm x 6.2 mm) translucent green capsules which have no

markings.

It is available in blister packs containing 7, 14, 28, 30, 35, 37 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

<To be completed nationally>

The Manufacturer is:

Capsugel Ploërmel

Z.I. de Camagnon

56 800 Ploërmel

France

Swiss Caps GmbH

Grassingerstrasse No.9

83043 Bad Aibling,

Germany

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicinal product is authorised in the Member States of the EEA under the following

names:

Denmark:

Fultium

Finland:

Fultium 3200 IU pehmeät kapselit

Germany:

Vitamin D3 AL 3.200 I.E. Weichkapseln

Ireland:

Fultium-D

3200 IU Capsules

Netherlands:

Vitamine D

STADA 3.200 IE zachte capsules

Norway:

Fultium 3200 IU myke kapsler

Sweden:

Fultium 3200 IE mjuka kapslar

This leaflet was last revised in June 2021

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SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

Fultium 3 200 IU Capsule

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

3 200 IU Cholecalciferol (equivalent to 80 micrograms vitamin D

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Capsule, soft

Green coloured translucent soft gelatin capsule, 10.6 mm x 6.2 mm

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Initial treatment of symptomatic vitamin D deficiency in adults.

4.2

Posology and method of administration

Posology

Recommended dose: One capsule per day.

After first month, lower doses may be considered, dependent upon desirable serum levels of 25-

hydroxyFultium (25(OH)D), the severity of the disease and the patient´s response to treatment.

Alternatively, national posology recommendations in treatment of vitamin D deficiency can be

followed.

Dosage in hepatic impairment

No dose adjustment is required.

Dosage in renal impairment

Fultium should not be used in patients with severe renal impairment (see section 4.3).

Paediatric population

Fultium is not recommended in children and adolescents under 18 years of age.

Method of administration

This medicine is taken orally.

The capsule should be swallowed whole with water, preferably with the main meal of the day.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypervitaminosis D

Nephrolithiasis

Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria

Severe renal impairment

4.4

Special warnings and precautions for use

Vitamin D should be used with caution in patients with impairment of renal function and the effect on

calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be

taken into account. In patients with severe renal insufficiency, vitamin D in the form of

cholecalciferol is not metabolised normally and other forms of vitamin D should be used (see section

4.3).

Caution is required in patients receiving treatment for cardiovascular disease (see section 4.5 –

cardiac glycosides including digitalis).

Vitamin D

should be prescribed with caution to patients suffering from sarcoidosis because of the

risk of increased metabolism of vitamin D to its active form. These patients should be monitored with

regard to the calcium content in serum and urine.

During long-term treatment with an equivalent daily dose exceeding 1,000 IU vitamin D the serum

calcium values and renal function must be monitored, especially in elderly patients. In case of

hypercalciuria (exceeding 300 mg (7.5 mmol)/24 hours) or signs of impaired renal function, the dose

should be reduced or the treatment discontinued.

The content of vitamin D in Fultium should be considered when prescribing other medicinal

products containing vitamin D. Additional doses of vitamin D should be taken under close medical

supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium

excretion frequently.

Paediatric population

Fultium is not recommended in children and adolescents under 18 years of age. Capsules are not a

suitable dose form for children under 12 years, due to the risk of choking.

4.5

Interaction with other medicinal products and other forms of interaction

Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of

metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration

of calcium combined with vitamin D. Strict medical supervision is needed and, if necessary

monitoring of ECG and calcium.

Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin

oil may reduce the gastrointestinal absorption of vitamin D.

The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by

inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme,

25-hydroxyvitamin D-1-hydroxylase.

Ketoconazole may inhibit both synthetic and catabolic enzymes of vitamin D. Reductions in serum

endogenous vitamin D concentrations have been observed following the administration of 300 mg/day

to 1,200 mg/day ketoconazole for a week to healthy men. However, in vivo drug interaction studies of

ketoconazole with vitamin D have not been investigated.

4.6

Fertility, pregnancy and lactation

Pregnancy

Vitamin D deficiency is harmful for mother and child. There are no signals that recommended doses

of vitamin D

are harmful for the embryo/fetus. High doses of vitamin D have been shown to have

teratogenic effects in animal experiments (see section 5.3). Overdose of vitamin D must be avoided

during pregnancy, as prolonged hypercalcaemia can lead to physical and mental retardation,

supravalvular aortic stenosis and retinopathy of the child.

Fultium is not recommended during pregnancy in patients without a vitamin D deficiency. During

pregnancy, Fultium Jenson should be taken only when strictly indicated and dosed only as it is

absolutely necessary to correct vitamin D deficiency. Where there is a vitamin D deficiency the

recommended dose is dependent on national guidelines, however, the maximum dose should not

exceed 4,000 IU/day.

Breast-feeding

Vitamin D

and metabolites pass into the breast-milk. This should, however, be borne in mind when

administering additional vitamin D to the child. Treatment with high-dose vitamin D in breast-feeding

women is not recommended.

Fertility

Normal endogenous levels of vitamin D are not expected to have any adverse effects on fertility.

4.7

Effects on ability to drive and use machines

There are no data about the effect of this product on driving capacity. An effect is, however,

unlikely.

4.8

Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as:

uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system

listed in Appendix V.

4.9

Overdose

The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D

toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and

constipation. Chronic overdoses can lead to vascular and organ calcification as a result of

hypercalcaemia.

Treatment should consist of stopping all intake of vitamin D and rehydration.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Vitamin D and analogues, ATC code: A11CC05

In its biologically active form, vitamin D

stimulates intestinal calcium absorption, incorporation of

calcium into the osteoid, and release of calcium from bone tissue.

In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport

of phosphate is also stimulated.

In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The

production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically

active form of vitamin D

. PTH secretion is inhibited additionally by the increased calcium uptake in

the small intestine under the influence of biologically active vitamin D

5.2

Pharmacokinetic properties

Absorption

Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile, so the

administration with food might therefore facilitate the absorption of vitamin D

Distribution and Biotransformation

Fultium and its metabolites circulate in the blood bound to a specific globulin. It is hydroxylated in

the liver to form 25-hydroxyFultium and then undergoes further hydroxylation in the kidney to form

the active metabolite 1, 25 dihydroxyFultium (calcitriol). , responsible for increasing calcium

absorption. Vitamin D, which is not metabolised, is stored in adipose and muscle tissues.

After a single oral dose of Fultium, the maximum serum concentrations of the primary storage form

are reached after approximately 7 days. 25-hydroxyFultium is then slowly eliminated with an apparent

half-life in serum of about 50 days.

Elimination

Vitamin D

and its metabolites are excreted mainly in the bile and faeces with a small percentage

found in urine.

Special population

A defect in the metabolism and excretion of vitamin D has been described in patients with chronic

renal failure.

5.3

Preclinical safety data

Cholecalciferol has been shown to be teratogenic in high doses in animals (4-15 times the human

dose). Offspring from pregnant rabbits treated with high doses of vitamin D had lesions anatomically

similar to those of supravalvular aortic stenosis and offspring not showing such changes show

vasculotoxicity similar to that of adults following acute vitamin D toxicity.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Capsule content:

Maize oil, refined

Butylated hydroxytoluene (BHT) (E321)

Capsule shell:

Glycerol (E422)

Purified Water

Chlorophyllin copper complex sodium (E141)

Gelatin (E441)

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

2 years

6.4

Special precautions for storage

This medicinal product does not require any special temperature storage conditions.

Store blister foil in original container in order to protect from light.

6.5

Nature and contents of container

Opaque, white PVC/PVdC blister tray with aluminium foil, containing 7, 10 or 15 capsules.

Pack sizes: 7, 14, 28, 30, 35, 37

capsules.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

8.

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD month YYYY}

[To be completed nationally]

10.

DATE OF REVISION OF THE TEXT

2019-03-01

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