Plenadren

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

hydrocortisone

Beschikbaar vanaf:

Takeda Pharmaceuticals International AG Ireland Branch

ATC-code:

H02AB09

INN (Algemene Internationale Benaming):

hydrocortisone

Therapeutische categorie:

Corticosteroids for systemic use

Therapeutisch gebied:

Adrenal Insufficiency

therapeutische indicaties:

Treatment of adrenal insufficiency in adults.

Product samenvatting:

Revision: 14

Autorisatie-status:

Authorised

Autorisatie datum:

2011-11-03

Bijsluiter

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PLENADREN 5 MG MODIFIED-RELEASE TABLETS
PLENADREN 20 MG MODIFIED-RELEASE TABLETS
hydrocortisone
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
1.
What Plenadren is and what it is used for
2.
What you need to know before you take Plenadren
3.
How to take Plenadren
4.
Possible side effects
5.
How to store Plenadren
6.
Contents of the pack and other information
1.
WHAT PLENADREN IS AND WHAT IT IS USED FOR
Plenadren contains a substance called hydrocortisone (sometimes called
cortisol). Hydrocortisone is a
glucocorticoid. It belongs to a group of medicines called
corticosteroids. Glucocorticoids occur
naturally in the body, and help to maintain your general health and
well-being.
Plenadren is used in adults to treat a condition known as adrenal
insufficiency, or cortisol deficiency.
Adrenal insufficiency occurs when your adrenal glands (just above your
kidneys) do not produce
enough of the hormone cortisol. Patients suffering from long-term
(chronic) adrenal insufficiency need
a replacement therapy to survive.
Plenadren replaces the natural cortisol that is missing in adrenal
insufficiency. The medicine delivers
hydrocortisone to your body throughout the day. The cortisol levels in
your blood increase rapidly to a
maximum level, about 1 hour after taking the tablet in the morning,
and then gradually decrease over
the day with no or almost no cortisol level in the blood in the late
evening and night when the levels
should be low.
2.
WHAT

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Plenadren 5 mg modified-release tablets
Plenadren 20 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plenadren 5 mg modified-release tablets
Each modified-release tablet contains hydrocortisone 5 mg.
Plenadren 20 mg modified-release tablets
Each modified-release tablet contains hydrocortisone 20 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
Plenadren 5 mg modified-release tablets
The tablets are round (diameter 8 mm), convex and pink.
Plenadren 20 mg modified-release tablets
The tablets are round (diameter 8 mm), convex and white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adrenal insufficiency in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Plenadren is given as maintenance therapy. Oral replacement doses must
be individualised according
to the clinical response. A common maintenance dose is 20–30 mg per
day, given once daily in the
morning. In patients with some remaining endogenous cortisol
production a lower dose may be
sufficient. 40 mg is the highest maintenance dose studied. The lowest
possible maintenance dosage
should be used. In situations when the body is exposed to excessive
physical and/or mental stress,
patients may need additional substitution of immediate release
hydrocortisone tablets especially in the
afternoon/evening, see also section ‘Use in intercurrent illness’
where other ways of temporarily
increasing the dose of hydrocortisone is described.
_Changing from conventional oral glucocorticoid treatment to
Plenadren_
When changing patients from conventional oral hydrocortisone
replacement therapy given three times
daily to Plenadren, an identical total daily dose may be given. Due to
a lower bioavailability of the daily
dose of Plenadren compared to that of conventional hydrocortisone
tablets given three times daily (see
section 5.2) clinical response needs to be monitored and further dose
indiv