Divisun 800 IE Tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)

30-08-2019

Produktens egenskaper Produktens egenskaper (SPC)

30-06-2016

Aktiva substanser:
kolekalciferol
Tillgänglig från:
Abacus Medicine A/S
ATC-kod:
A11CC05
INN (International namn):
cholecalciferol
Dos:
800 IE
Läkemedelsform:
Tablett
Sammansättning:
sackaros Hjälpämne; kolekalciferol 20 mikrog Aktiv substans; isomalt Hjälpämne
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Burk, 250 tabletter; Blister, 90 tabletter
Bemyndigande status:
Godkänd
Godkännandenummer:
58319
Tillstånd datum:
2019-03-06

Dokument på andra språk

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20-06-2018

Produktens egenskaper Produktens egenskaper - engelska

25-01-2021

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

28-01-2013

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Package leaflet: Information for the user

Divisun 800 IU tablets

Colecalciferol (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 Divisun is and what it is used for

What you need to know before you take Divisun

How to take Divisun

Possible side effects

How to store Divisun

Contents of the pack and other information

1.

What Divisun is and what it is used for

Divisun contains vitamin D

which regulates the uptake and metabolism of calcium as well as the

incorporation of calcium in bone tissue.

Divisun is used to prevent and treat vitamin D

deficiency in adults and adolescents.

Your doctor may prescribe Divisun as an adjunct to specific bone loss medication.

2.

What you need to know before you take Divisun

Do not take Divisun

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

section 6).

if you have hypercalcaemia (increased levels of calcium in the blood) or hypercalciuria

(increased levels of calcium in the urine).

if you have hypervitaminosis D (increased levels of vitamin D in the blood).

if you have kidney stones.

If any of the above applies to you, talk to your doctor or pharmacist before taking Divisun.

Warnings and precautions

Talk to your doctor or pharmacist before using Divisun

if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs,

skin and joints).

when using other drugs containing vitamin D.

if you have kidney problems or have had kidney stones.

Other medicines and Divisun

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

Cholestyramine (used to treat high cholesterol).

Phenytoin or barbiturates (used to treat epilepsy).

Laxatives which contain paraffin oil.

Thiazide diuretics (to treat high blood pressure).

Glucocorticoids (to treat inflammation).

Cardiac glycosides (to treat heart conditions), e.g. digoxin.

Divisun with food and drink

Divisun can be taken with food.

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.

During pregnancy the daily intake should not exceed 600 IU vitamin D.

Divisun should only be used during pregnancy if vitamin D deficiency has been clinically established.

Divisun can be used during breast-feeding. Vitamin D

passes over into breast milk. This should be

considered when giving additional vitamin D to the breast-fed child.

Driving and using machines

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

Divisun contains sucrose and isomalt

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor

before taking Divisun.

3.

How to take Divisun

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

The recommended dose is 1 tablet every day.

The daily dose shall not exceed 4000 IU (five tablets).

The tablets can be swallowed whole or crushed.

Use in children

Divisun is not intended for use in children under 12 years due to lack of study data.

If you take more Divisun than you should

If you have taken more of this medicine than directed, or if a child accidentally has taken this

medicine, please contact your doctor or emergency unit for judgement of the risk and advice.

If you forget to take Divisun

Do not take a double dose to make up for a forgotten dose.

If you stop taking Divisun

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.

Stop taking Divisun and seek immediate medicinal help if you experience symptoms of serious

allergic reactions, such as:

swollen face, lips, tongue or throat

difficult to swallow

hives and difficulty breathing

Uncommon (occurs in less than 1 out of 100 patients)

: Hypercalcaemia (increased levels of serum

calcium)

and hypercalciuria (increased levels of urine calcium).

Rare (occurs in less than 1 out of 1 000 patients)

: Pruritus, rash and urticaria.

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 Divisun

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 and the blister or the bottle

after EXP. The expiry date refers to the last day of the month.

Do not store above 30

C. Store the tablets in the original container, in order to protect from light. Keep

the container tightly closed in order to protect from moisture.

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 Divisun contains

The active substance is colecalciferol 20 microgram corresponding to 800 IU Vitamin D

The other ingredients are pregelatinized maize starch, isomalt (E 953), magnesium stearate

sucrose, sodium ascorbate, medium chain triglycerides, silica colloidal anhydrous, modified food

(maize) starch and all-rac-alpha-tocopherol.

What Divisun looks like and contents of the pack

Divisun is a white to light yellow, biconvex, tablet, 7 mm in diameter.

30, 60 or 90 tablets in blisters.

250 tablets in plastic bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

“To be completed nationally”

Manufacturer

Rottapharm Ltd

Damastown Industrial Park

Mulhuddart

Dublin 15

Ireland

Vemedia Manufacturing B.V.

NL-1112 AX Diemen

Netherlands

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

names:

Desunin: Ireland and United Kingdom

Divisun: Austria, Denmark, Finland, the Netherlands, Norway, Spain and Sweden

This leaflet was last revised in

2018-06-20

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SUMMARY

OF

PRODUCT

CHARACTERISTICS

1

NAME

OF

THE

MEDICINAL

PRODUCT

Divisun 800 IU tablet

2

QUALITATIVE

AND

QUANTITATIVE

COMPOSITION

Each tablet contains colecalciferol (vitamin D

) 800 IU (equivalent to 20 microgram vitamin D

Excipients with known effect:

Each tablet contains isomalt 91.0 mg and sucrose 1.68 mg.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL

FORM

Tablet

White to light yellow, biconvex, 7 mm in diameter.

4

CLINICAL

PARTICULARS

4.1

Therapeutic indications

Prevention and treatment of vitamin D deficiency in adults and adolescents. Vitamin D deficiency is

defined as serum levels of 25-hydroxycolecalciferol (25(OH)D) < 25 nmol/l.

In addition to specific osteoporosis treatment of patients who are at risk of vitamin D deficiency,

preferably in combination with calcium.

4.2

Posology and method of administration

Posology

Recommended dose: One tablet per day.

Higher doses can be necessary in treatment of vitamin D deficiency, where the dose should be

adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity

of the disease and the patient´s response to treatment.

The daily dose should not exceed 4000 IU (five tablets per day).

Pediatric population

The safety and efficacy of Divisun in children under 12 years have not been established.

Dosage in hepatic impairment

No dose adjustment is required.

Dosage in renal impairment

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

Method of administration

The tablets can be swallowed whole or crushed. The tablets can be taken with food.

4.3

Contraindications

Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria.

Nephrolithiasis.

Nephrocalcinosis

Hypervitaminosis D.

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

4.4

Special warnings and precautions for use

Divisun should be prescribed with caution to patients suffering from sarcoidosis due to risk of

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

regard to the calcium content in serum and urine.

During long-term treatment, serum calcium levels should be followed and renal function should be

monitored through measurements of serum creatinine. Monitoring is especially important in elderly

patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients

with a high tendency to calculus formation. 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.

Divisun 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 colecalciferol

is not metabolised normally and other forms of vitamin D should be used.

The content of vitamin D (800 IU) in Divisun 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.

Divisun contains sucrose, isomalt and sodium.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or

sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially

‘sodium-free’.

4.5

Interaction with other medicinal products and other forms of interaction

Thiazide diuretics reduce the urinary excretion of calcium. Due to the increased risk of

hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide

diuretics.

Concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D since the

metabolism increases.

Excessive dosing of vitamin D can induce hypercalcaemia, which may increase the risk of digitalis

toxicity and serious arrhythmias due to the additive inotropic effects. The electrocardiogram (ECG)

and serum calcium levels of patients should be closely monitored.

Glucocorticoid steroids may increase vitamin D metabolism and elimination. During concomitant use,

it may be necessary to increase the dose of Divisun tablets.

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

oil may reduce the gastrointestinal absorption of vitamin D.

4.6

Fertility, pregnancy and lactation

Fertility

There are no data on the effect of Divisun on fertility. However, normal endogenous levels of vitamin

D are not expected to have any adverse effects on fertility.

Pregnancy

Divisun should be used during pregnancy, only in the case of a vitamin D deficiency. Divisun is not

recommended during pregnancy in patients without a vitamin D deficiency as the daily intake should

not exceed 600 IU vitamin D. Studies in animals have shown reproductive toxicity of high doses of

vitamin D (see section 5.3). There are no indications that vitamin D at therapeutic doses is teratogenic

in humans.

Breast-feeding

Vitamin D can be used during breast-feeding. Vitamin D

passes into breast milk. This should be

considered when giving additional vitamin D to the child.

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 frequencies are defined as: uncommon (≥1/1,000, <1/100), rare (≥1/10,000,

<1/1,000) or not known (cannot be estimated from the available data).

Immune system disorders

Not known (cannot be estimated from the available data): Hypersensitivity reactions such as

angiooedema or laryngeal oedema.

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

Overdose can lead to hypervitaminosis D. An excess of vitamin D causes abnormally high levels of

calcium in the blood, which can eventually severely damage the soft tissues, and kidneys. Tolerable

Upper Intake Level for vitamin D

(colecalciferol) is set at 4000 IU (100 µg) per day. Vitamin D

should not be confused with its active metabolites.

Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal

pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain,

nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may

result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and

soft tissue calcification.

Treatment of hypercalcaemia: The treatment with vitamin D must be discontinued. Treatment with

thiazide diuretics, lithium, vitamin A, and cardiac glycosides must also be discontinued. Rehydration,

and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates,

calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis

must be monitored. In severe cases, ECG and CVP should be followed.

5

PHARMACOLOGICAL

PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Vitamin supplements

ATC-code: A11C C05

Vitamin D increases the intestinal absorption of calcium and phosphate.

Administration of vitamin D

counteracts development of rickets in children and osteomalacia in

adults. It also counteracts the increase of parathyroid hormone (PTH) which is caused by calcium

deficiency and which causes increased bone resorption.

In addition to bone and intestinal mucosa many other tissues have vitamin D receptors, to which the

active hormonal form of vitamin D, calcitriol, binds.

5.2

Pharmacokinetic properties

Vitamin D

Absorption

Vitamin D is easily absorbed in the small intestine.

Distribution and metabolism

Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is

converted in the liver by hydroxylation to 25-hydroxycolecalciferol. It is then further converted in the

kidneys to 1,25- dihydroxycolecalciferol. 1,25-dihydroxycolecalciferol is the active metabolite

responsible for increasing calcium absorption. Vitamin D, which is not metabolised, is stored in

adipose and muscle tissues.

Elimination

Vitamin D is excreted in faeces and urine.

5.3

Preclinical safety data

At doses far higher than the human therapeutic range teratogenicity has been observed in animal

studies. There is no further information of relevance to the safety assessment in addition to what is

stated in other parts of the SPC.

6

PHARMACEUTICAL

PARTICULARS

6.1

List of excipients

Pregelatinized maize starch

Isomalt (E 953)

Magnesium stearate

Sucrose

Sodium ascorbate

Triglycerides, medium chain

Silica, colloidal anhydrous

Modified food (maize) starch

All-rac-alpha-tocopherol

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

3 years.

6.4

Special precautions for storage

Do not store above 30

Store the tablets in the original container, in order to protect from light. Keep the container tightly

closed in order to protect from moisture.

6.5

Nature and contents of container

30, 60, 90 in white opaque PVC/PVDC/aluminium blister in outer paper carton.

250 tablets in plastic containers of HDPE with LDPE snap on cap.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements.

7

MARKETING

AUTHORISATION

HOLDER

<To be completed nationally>

8

MARKETING

AUTHORISATION

NUMBER

<To be completed nationally>

9

DATE

OF

FIRST

AUTHORISATION/

RENEWAL

OF

THE

AUTHORISATION

2012-04-18

10

DATE

OF

REVISION

OF

THE

TEXT

2021-01-25

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