Prednisolone 5 mg soluble tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Prednisolone

Tersedia dari:

Focus Pharmaceuticals Ltd

Kode ATC:

H02AB; H02AB06

INN (Nama Internasional):

Prednisolone

Dosis:

5 milligram(s)

Bentuk farmasi:

Soluble tablet

Jenis Resep:

Product subject to prescription which may not be renewed (A)

Area terapi:

Glucocorticoids; prednisolone

Status otorisasi:

Marketed

Tanggal Otorisasi:

2014-11-14

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 5MG SOLUBLE TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD, 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 or your child, 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 or your child, get any side effects, talk to your doctor,
pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Prednisolone Soluble Tablets are and what they are used for
2.
What you need to know before you take Prednisolone Soluble Tablets
3.
How to take Prednisolone Soluble Tablets
4.
Possible side effects
5.
How to store Prednisolone Soluble Tablets
6.
Contents of the pack and other information
1.
WHAT PREDNISOLONE SOLUBLE TABLETS ARE AND WHAT THEY ARE USED FOR
Your doctor has decided that you or your child, need this medicine to
help treat your or their,
condition.
Prednisolone 5mg Soluble Tablets (called Prednisolone Soluble Tablets
throughout the rest of
this leaflet) contain the active ingredient prednisolone. Prednisolone
belongs to a group of
medicines called steroids (the full name is corticosteroids).
Corticosteroids
occur
naturally
in
the
body
and
help
to
maintain
health
and
wellbeing.
Boosting your body with extra corticosteroid (such as prednisolone) is
an effective way to treat
various illnesses involving inflammation in the body.
Prednisolone Soluble Tablets reduce this inflammation, which could
otherwise go on making
your condition worse. You must take this medicine regularly to get the
maximum benefit from
it.
PREDNISOLONE SOLUBLE
TABLETS CAN BE USED:

to treat breathing difficulties associated with asthma;

to treat severe allergic reactions;

to treat illnesses which cause inflammation of

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prednisolone 5mg Soluble Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg prednisolone as the sodium phosphate ester.
Excipient with known effect
Each tablet contains 1.2mmol (28.2mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soluble Tablet
Pink flat, round soluble tablets engraved with
5 and break marked on the same side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prednisolone 5mg Soluble Tablets are indicated in adults and children.
A wide variety of diseases may sometimes require corticosteroid
therapy. Some of the principal indications are:
• bronchial asthma, severe hypersensitivity reactions, anaphylaxis;
• rheumatoid arthritis, systemic lupus erythematosus,
dermatomyositis, mixed connective tissue disease (excluding
systemic sclerosis), polyarteritis nodosa;
• inflammatory skin disorders, including pemphigus vulgaris, bullous
pemphigoid and pyoderma gangrenosum;
• minimal change nephrotic syndrome, acute interstitial nephritis;
• ulcerative colitis, Crohn's disease; sarcoidosis;
• rheumatic carditis;
• haemolytic anaemia (autoimmune), acute lymphoblastic and chronic
lymphocytic leukaemia, malignant lymphoma,
multiple myeloma, idiopathic thrombocytopenic purpura;
• immunosuppression in transplantation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest dosage that will produce an acceptable result should be
used (see section 4.4); when it is possible to reduce
the dosage, this must be accomplished by stages. During prolonged
therapy any intercurrent illness, trauma or surgical
procedure will require a temporary increase in dosage; if
corticosteroids have been stopped following prolonged
therapy they may need to be temporarily re-introduced.
ADULTS: The dose used will depend upon the disease, its severity and
the clinical response obtained. The following
regimens are for guidance only. Divided dosage