Deflacortin tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

deflazacort

Available from:

LACER

ATC code:

H02AB13

INN (International Name):

deflazacort

Dosage:

30mg

Pharmaceutical form:

tablets

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-01-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEFLACORTIN
®
DEFLAZACORT 6 MG TABLETS
DEFLAZACORT 30 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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 any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
________________________________________________________________________
IN THIS LEAFLET:
1.
What Deflacortin
®
is and what it is used for
2.
Before you take Deflacortin
®
3.
How to take Deflacortin
®
4.
Possible side effects
5.
How to store Deflacortin
®
6.
Further information
1.
WHAT DEFLACORTIN
® IS AND WHAT IT IS USED FOR?
Deflacortin
®
contains deflazacort as the active ingredient which is a
corticosteroid.
How Deflacortin
®
works:

These corticosteroids occur naturally in the body, and help to
maintain health and
wellbeing.

Boosting your body with extra corticosteroid (such as Deflacortin
®
) is an effective
way to treat various illnesses involving inflammation in the body.

Deflacortin
®
works by reducing this inflammation, which could otherwise go on
making your condition worse.

Deflacortin
®
also works by stopping reactions known as autoimmune reactions. These
reactions happen when your body’s immune system attacks the body
itself and causes
damage.

You must take this medicine regularly to get maximum benefit from it.
Deflacortin
®
can be used to:

Treat inflammation including asthma, arthritis and allergies.

Treat problems with your skin, kidney, heart, digestive system, eyes
or blood.

Treat problems where your body has growths (tumours).

Suppress the immune system in transplant operations.
2
2.
BEFORE YOU TAKE / USE DEFLACORTIN
®
DO NOT TAKE DEFLACORTIN
® IF

You are allergic (

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.-
NAME OF THE MEDICINAL PRODUCT
Deflacortin 6 mg tablets Deflacortin 30 mg tablets
2.-
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Deflacortin 6 mg tablet contains:
Deflazacort, 6 mg.
Each Deflacortin 30 mg tablet contains:
Deflazacort, 30 mg.
For a full list of excipients, see section 6.1
3.-
PHARMACEUTICAL FORM
Tablets.
Deflacortin 6 mg tablets are ivory white round tablets without
irregularities.
Deflacortin 30 mg tablets are round, marked with a cross and white
ivory color.
The score line serves only to divide and facilitate swallowing but not
to divide
into equal doses.
4.-
CLINICAL PARTICULARS
4.1.-
THERAPEUTIC INDICATIONS
A wide range of conditions may sometimes need treatment with
glucocorticoids.
The indications include:

Anaphylaxis, asthma, severe hypersensitivity reactions

Rheumatoid arthritis, juvenile chronic arthritis, polymyalgia
rheumatic

Systemic
lupus
erythematosus,
dermatomyositis,
mixed
connective
tissue
disease (other than systemic sclerosis), polyarteritis nodosa,
sarcoidosis

Pemphigus, bullous pemphigoid, pyoderma gangrenosum

Minimal change nephrotic syndrome, acute interstitial nephritis

Rheumatic carditis

Ulcerative colitis, Crohn's disease

Uveitis, optic neuritis

Autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura

Acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma

Immune suppression in transplantation
4.2.-
POSOLOGY AND METHOD OF ADMINISTRATION
Deflazacort is a glucocorticoid derived from prednisolone and 6mg of
deflazacort
has approximately the same anti-inflammatory potency as 5mg
prednisolone or
prednisone.
Doses vary widely in different diseases and different patients. In
more serious and
life-threatening conditions, high doses of deflazacort may need to be
given. When
deflazacort
is
used
long
term
in
relatively
benign
chronic
diseases,
the
maintenance dose should be kept as low as possible. Dosage may need to
be
increased during periods of stress or in exacerbation of i