Methylprednisolon Eurogenerics 16 mg tabletten

Land: Nederländerna

Språk: nederländska

Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiva substanser:

METHYLPREDNISOLON 16 mg/stuk

Tillgänglig från:

Eurogenerics N.V. Heizel Esplanade b22 1020 BRUSSEL (BELGIË)

ATC-kod:

H02AB04

INN (International namn):

METHYLPREDNISOLON 16 mg/stuk

Läkemedelsform:

Tablet

Sammansättning:

LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SACCHAROSE ; SILICIUMDIOXIDE (E 551), LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551),

Administreringssätt:

Oraal gebruik

Terapiområde:

Methylprednisolone

Produktsammanfattning:

Hulpstoffen: LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SACCHAROSE; SILICIUMDIOXIDE (E 551);

Tillstånd datum:

1900-01-01

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHYLPREDNISOLON EUROGENERICS 4 MG TABLETTEN
METHYLPREDNISOLON EUROGENERICS 16 MG TABLETTEN
Methylprednisolone
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 Methylprednisolon Eurogenerics is and what it is used for
2.
What you need to know before you take Methylprednisolon Eurogenerics
3.
How to take Methylprednisolon Eurogenerics
4.
Possible side effects
5.
How to store Methylprednisolon Eurogenerics
6.
Contents of the pack and other information
1.
WHAT METHYLPREDNISOLON EUROGENERICS IS AND WHAT IT IS USED FOR
Methylprednisolon Eurogenerics contains methylprednisolone.
Methylprednisolone belongs to a group of
medicines called corticosteroids.
Methylprednisolone inhibits local signs of inflammation (fever,
swelling, pain, redness) and hypersensitivity
reactions. It also acts on several organs and metabolic processes.
Therefore, it is used to treat a wide range of conditions, including:
-
rheumatic conditions of a variety of origins;
-
allergic conditions: including hay fever, asthma, drug allergies;
-
skin conditions;
-
eye conditions of allergic or inflammatory origin;
-
certain types of inflammation of the digestive tract;
-
certain disorders of the airways;
-
certain severe blood diseases;
-
abnormal adrenal function;
-
organ transplantation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHYLPREDNISOLON EUROGENERICS
DO NOT TAKE METHYLPREDNISOLON EUROGENERICS:
-
if you are allergic to methylprednisolone or any of the other
ingredients of this medicin

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Methylprednisolon Eurogenerics 4 mg tabletten
Methylprednisolon Eurogenerics 16 mg tabletten
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Methylprednisolon Eurogenerics 4 mg tablets: Each tablet contains 4 mg
methylprednisolone
Methylprednisolon Eurogenerics 16 mg tablets: Each tablet contains 16
mg methylprednisolone
Excipients with known effect:
Methylprednisolon Eurogenerics 4 mg tablets: Each tablet contains
36.625 mg of lactose monohydrate and
5.625 mg of sucrose.
Methylprednisolon Eurogenerics 16 mg tablets: Each tablet contains
146.5 mg of lactose monohydrate and
22.5 mg of sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Methylprednisolon Eurogenerics 4 mg tablets:
White to off white, round, 4 mm in diameter, biconvex tablets, plain
on both sides.
Methylprednisolon Eurogenerics 16 mg tablets:
White to off white, oval, with a length of 10,10 mm and a height of
7,30 mm, biconvex tablets, breakline on
one side and embossed ‘16’ on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glucocorticoids should be considered as a purely symptomatic
treatment, unless in case of certain endocrine
disorders, where they are applied as substitution treatment.
Methylprednisolon Eurogenerics is indicated in the following cases:
NONENDOCRINE DISORDERS
1. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or
exacerbation) in:
-
Psoriatic arthritis
-
Rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require low-dose
maintenance therapy)
-
Ankylosing spondylitis
-
Abarticular inflammations (such as acute and subacute bursitis, acute
nonspecific tenosynovitis and
epicondylitis)
-
Acute arthritis (gouty, post-traumatic)
2/18
-
Synovitis of osteoarthritis
2. COLLAGEN DISEASES
During an exacerbation or as maintenance therapy in selected cases of:
-
S