Prednesol 5mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-08-2022
Summary of Product characteristics
(SPC)
09-07-2021
Active ingredient:
Prednisolone
Available from:
Phoenix Labs
ATC code:
H02AB; H02AB06
INN (International Name):
Prednisolone
Dosage:
5 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Glucocorticoids; prednisolone
Authorization status:
Marketed
Authorization date:
1978-10-27
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNESOL
5MG TABLETS
Active Ingredient: Prednisolone sodium phosphate
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.
PREDNESOL TABLETS 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.
PREDNESOL TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section 4 “Possible side
effects” 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
“Possible
side
effects”
for
more
information).
IF YOU TAKE IT FOR MORE THAN 3 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.
NOW READ THE REST OF THIS LEAFLET.
It includes other important information on the safe and effective
use of this medicine that might be especially important for you.
IN THIS LEAFLET
:
1.
WHAT PREDNESOL 5MG TABLETS A
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
08 July 2021
CRN00CCSK
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prednesol 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of prednisolone as Prednisolone Sodium
Phosphate.
Excipients: - Contains Sodium Benzoate (E211) 7.5mg, Sodium Acid
Citrate 99.17mg, Sodium Bicarbonate 31.7mg and Saccarin
Sodium 0.5mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Pink, circular, flat, bevel-edged tablets engraved ‘PRED 5’ on one
face and a breakline on the other.
The scoreline allows the tablet to be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A wide variety of diseases may sometimes require corticosteroid
therapy.
Prednisolone is used principally for its anti-inflammatory and
immunosuppressant action or anti-neoplastic properties.
Prednisolone may also be used as a replacement therapy but cortisone
is usually preferred.
The major indications are listed below. This list of indications is
not exhaustive but represents the major established disease
states with evidence of an established and current role in their
management. Prednisolone may be used in a wide variety of
other inflammatory and immune disorders according to local guidelines
and according to the assessment of the benefit risk in
individual patients.
Inflammatory and immunological disorders
Pemphigus
Asthma
Sarcoid disease
Rheumatoid arthritis, polymyalgia rheumatica and giant cell (temporal)
arteritis and polyarteritis nodosa
Systemic lupus erythematosus,
Polymyositis
Inflammatory bowel disease: ulcerative colitis and Crohn's disease
Renal disease: minimal change nephrotic syndrome, acute interstitial
nephritis; renal lupus
Autoimmune hepatitis,
Thrombocytopenic purpura and acquired haemolytic anaemia
Immunosuppression – in organ transplantation
Health Products Regulatory Authority
08 July 2021
CRN00CCSK
Page 2 of 12
Neoplasms Treated with Cortic
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