Prednisolon EQL Pharma 5 mg Tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

prednisolon

Tillgänglig från:

EQL Pharma AB

ATC-kod:

H02AB06

INN (International namn):

prednisolone

Dos:

5 mg

Läkemedelsform:

Tablett

Sammansättning:

laktosmonohydrat Hjälpämne; prednisolon 5 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Burk, 105 tabletter; Blister, 25 tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2018-04-06

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREDNISOLON EQL PHARMA 5 MG TABLETS
prednisolone
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, pharmacist or
nurse.
-
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 Prednisolon EQL Pharma is and what it is used for
2.
What you need to know before you take Prednisolon EQL Pharma
3.
How to take Prednisolon EQL Pharma
4.
Possible side effects
5.
How to store Prednisolon EQL Pharma
6.
Contents of the pack and other information
1.
WHAT PREDNISOLON EQL PHARMA IS AND WHAT IT IS USED FOR
Prednisolon EQL Pharma is a corticosteroid that prevents and
suppresses allergic disorders,
inflammation and rheumatic disorders.
The drug product is used in the states where one needs to suppress the
body's response such as
inflammatory response in rheumatoid arthritis (RA). Other examples
that can be mentioned is a
disease of the connective tissue (SLE), inflammation of the vessel
walls, connective tissue changes,
asthma, severe inflammation of the colon (ulcerative colitis), at
certain blood diseases, severe allergic
conditions and tumor treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREDNISOLON EQL PHARMA
DO NOT TAKE PREDNISOLON EQL PHARMA:
•
if you are allergic to prednisolone or any of the other ingredients of
this medicine (listed in
section 6).
•
if you have a fungal infection
You should not be vaccinated with live vaccine at the same time as you
take immunosuppressive
doses of cortisone drugs.
WARNINGS AND PRECAUTIONS
:
Talk to your doctor before taking Prednisolon EQL Pharma if you have:
- An infection or get an infe

Produktens egenskaper

1
1.
NAME OF THE MEDICINAL PRODUCT
Prednisolon EQL Pharma 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains prednisolone 5 mg.
Excipient(s) with known effect: lactose monohydrate 80 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, flat tablet with diameter of 7 mm.
The tablet has a score line on one side and can be divided into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-specific therapy in conditions where the anti-inflammatory and
immunosuppressive
effect of prednisolone is desired. Examples include rheumatoid
arthritis, SLE, certain
vasculitis as arteritis temporalis and periarteritis nodosa,
sarcoidosis, bronchial asthma,
ulcerative colitis, hemolytic anemia and granulocytopenia and severe
allergic conditions.
In tumor therapy, in some cases of acute leukemia, lymphomas, cancer
mammae and cancer
prostatae.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Individual. In general, 10-30 mg daily. In very severe emergency
cases, up to 50-60 mg or
more can be given over a few days. Once satisfactory response is
obtained the daily dose
should be reduced with 2,5-5 mg every other to every fifth day (faster
at the highest doses) to
the minimum maintenance dose. It is desirable that this does not
exceed 10 mg / day.
If the full maintenance dose is given in the morning (8 AM)
prednisolone is working as
adrenal cortex natural circadian and causes minimal suppression of the
adrenal cortex.
This dosing regimen can generally be considered in the first place.
However, in some cases,
e.g. for rheumatics with severe morning stiffness and for asthmatics
who need corticosteroid
protection during the night, a late evening dose or split dosing may
be preferred.
In some cases of asthma, allergic conditions, dermatoses, etc. may
advantageously provide
dual daily dose as a unitary dose every other day in the morning.
The dose should be gradually reduced to the lowest dose, especially in
high-dos treatment.
Treatment cessation should be success