Prednisolone 5mg soluble tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Prednisolone sodium phosphate

MAH:

Pilsco Ltd

ATC_code:

H02AB06

INN:

Prednisolone sodium phosphate

dosage:

5mg

pharmaceutical_form:

Soluble tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 06030200; GTIN: 05060669871101

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 5 MG SOLUBLE TABLETS
(Prednisolone sodium phosphate)
•
PREDNISOLONE IS A STEROID MEDICINE, prescribed for many
different conditions, including serious illnesses.
•
YOU NEED TO TAKE IT REGULARLY to get the maximum benefit.
•
DON’T STOP TAKING THIS MEDICINE without talking to your doctor
•
you may need to reduce the dose gradually.
•
PREDNISOLONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read
section 4 below). Some problems such as mood changes (feeling
depressed or ‘high’) or stomach problems can happen straight
away. If you feel unwell in any way, keep taking your tablets, but
SEE YOUR DOCTOR STRAIGHT AWAY.
•
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These
include weakness of arms and legs or developing a rounder face
(read section 4 for more information).
•
IF YOU TAKE THIS MEDICINE FOR MORE THAN THREE WEEKS, YOU WILL
GET A BLUE ‘STEROID CARD’: always keep it with you and show it to
any doctor or nurse treating you.
•
KEEP AWAY FROM PEOPLE WHO HAVE CHICKENPOX OR SHINGLES, if
you have never had them. They could affect you severely. If you
do come into contact with chickenpox or shingles, SEE YOUR
DOCTOR STRAIGHT AWAY.
Read all of this leaflet carefully before you start using 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 Prednisolo

SPC

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