Prednisolone 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone

Available from:

Accord-UK Ltd

ATC code:

H02AB06

INN (International Name):

Prednisolone

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5012617004093

Patient Information leaflet

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Prednisolone Tablets
1mg x 28 (UK)
296x210 (Reel Fed)
51009531
Leaflet for Blisters
4397
T. Hull
08/12/21
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
[e-mail]
PREDNISOLONE 1MG AND 5MG TABLETS, PIL UNITED KINGDOM
Black
Profile
BBBB3581
R.Paul
23.12.2021
17.02.2022
R.Paul
296x210
8pts
Accord Barnstaple
NA
5
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
page 4
page 1
51009531 BBBB3581
•
PREDNISOLONE IS A STEROID MEDICINE,
prescribed for many different conditions,
including serious illnesses.
•
YOU NEED TO TAKE IT REGULARLY to get the
maximum benefit.
•
DO NOT 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 for more
information). Some side effects 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
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 affe

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
PREDNISOLONE 1mg TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg of Prednisolone.
Excipient with known effect
Each 1mg tablet contains 50.00mg of Lactose Monohydrate PhEur.
For the full list of excipients, see section 6.1.
_3 _
_PHARMACEUTICAL FORM _
White, circular, flat bevelled edge tablets, 5.56mm in diameter,
embossed ‘C’ on one side and
the identifying letters ‘PJ on the reverse.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Prednisolone is indicated in the management of all conditions deemed
likely to benefit from
short or long term glucocorticoid therapy. These include:
_ALLERGIC STATES _
Severe, incapacitating allergies unresponsive to conventional
treatment; asthma serum
sickness; drug hypersensitivity reactions.
_COLLAGEN DISORDERS _
Eg systemic lupus erythematosus, polymyositis, polymyalgia rheumatica
and temporal (giant
cell) arteritis, mixed connective tissue disease syndrome, acute
rheumatic carditis.
_RHEUMATIC DISORDERS _
Usually given as an adjunctive therapy for short term administration
during an acute episode
or exacerbation of rheumatoid arthritis, psoriatic arthritis.
_SKIN CONDITIONS _
Life-threatening or incapacitating skin conditions such as pemphigus
and exfoliative
dermatitis.
_NEOPLASTIC DISEASE _
Leukaemias and lymphomas in adults, acute leukaemia of childhood.
_GASTRO-INTESTINAL DISEASE _
During acute exacerbation in ulcerative colitis and regional ileitis
(Crohn's Disease).
_RESPIRATORY DISEASE _
Sarcoidosis (especially with hypercalcaemia), fulminating or
disseminated pulmonary
tuberculosis when used concurrently with appropriate antituberculosis
chemotherapy.
_HAEMATOLOGICAL DISORDERS _
Various blood dyscrasias eg selected cases of haemolytic anaemia,
thrombocytopenic
purpura.
_MISCELLANEOUS _
Nephrotic syndrome.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
In adults and the elderly:
The lowest effective dose should be used for the minimum period in
order to minimise side
effects.
Paediatric populat