Prednisolone 5mg soluble tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone sodium phosphate

Available from:

Focus Pharmaceuticals Ltd

ATC code:

H02AB06

INN (International Name):

Prednisolone sodium phosphate

Dosage:

5mg

Pharmaceutical form:

Soluble tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5060064792414

Patient Information leaflet

170 mm
10 mm
10 mm
375 mm
170 mm
375 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 5MG SOLUBLE 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,
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 inflamma

Summary of Product characteristics

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
λ
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 dosa