Prednisolone 5mg soluble tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone sodium phosphate

Available from:

Alliance Healthcare (Distribution) 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

Patient Information leaflet

PREDNESOL
® 5MG TABLETS
(prednisolone sodium phosphate)
Your medicine is known by the above name, but will be referred to as
Prednesol Tablets throughout this:
PATIENT INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET:
1) What Prednesol Tablets are and what they are used for
2) What you need to know before you take Prednesol Tablets
3) How to take Prednesol Tablets
4) Possible side effects
5) How to store Prednesol Tablets
6) Contents of the pack and other information
1) WHAT PREDNESOL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Prednesol Tablets. This medicine contains
the
active ingredient prednisolone which belongs to a group of medicines
called
corticosteroids or “steroids”.
These corticosteroids occur naturally in the body, and help to
maintain health
and
well-being.
Boosting
your
body
with
extra
corticosteroid
(such
as
Prednisolone)
is
an
effective
way
to
treat
various
illnesses
involving
inflammation in the body. You must take this medicine regularly to get
maximum benefit from it.
Steroids work by reducing inflammation and lowering the body’s
immune
response.
Prednesol Tablets are used to treat a variety of inflammatory diseases
including
severe
asthma,
rheumatoid
arthritis,
allergic
reactions,
bowel
diseases, severe skin conditions, kidney disorders and some blood
disorders.
2)
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREDNESOL TABLETS
DO NOT TAKE PREDNESOL TABLETS:
−
if you are ALLERGIC to prednisolone or any of the other ingredients of
this
medicine (listed in section 6). (allergic reactions include mild
symptoms
such as itching and/or rash. More severe symptoms include swelling of
the
face,
lips,
tongue
and/or
throat
with
difficulty
in
swallowing
or
breathing);
−
if you have recently had a VACCINATION or have a vaccination planned;
−
if you have a viral INFECTION such as MEASLES, CHICKENPOX OR SHINGLES,
or any other infection. Tell your doctor IMMEDIATELY if you have come
into
contact with anyone suffering with measles, chickenpox or shingles in
the
last three months.
WARNI

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 5 mg prednisolone as prednisolone sodium
phosphate
Excipient with known effect
Each tablet contains 1.18 mmol (27.22 mg) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Soluble Tablet
White, 7mm, round, with a score line on one side, imprinted with
“A” and “615”
respectively on each side of the score.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
precautions section); 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.
_Adult _
The dose used will depend upon the disease, its severity, and the
clinical response
obtained. The following regimens are for guidance only. Divided dosage
is usually
employed.
_Short-term treatment