Prednisolone 25mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
02-08-2019
Summary of Product characteristics
(SPC)
01-11-2019
Public Assessment Report
(PAR)
20-04-2020
Active ingredient:
Prednisolone
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
H02AB06
INN (International Name):
Prednisolone
Dosage:
25mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 06030200
Patient Information leaflet
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Prednisolone Tablets
all strengths x all sizes (UK)
296x210 (Reel Fed)
50919496
Leaflet for Blisters
4380
R.Wrey
27/01/17
296x210 Leaflet Reel Fed Bi Fold Profile (BST)
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DATE SENT:
DATE RECEIVED:
Item no:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
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PREDNISOLONE 2.5MG, 5MG, 10MG, 20MG, 25MG & 30MG TABLETS PIL - UK
Black
Profile
BBBA0491
S.Anson
01.02.17
22.11.17
S.Anson
296 x 210
8.5pts
Actavis UK
n/a
n/a
3
page 4
page 1
50919496 BBBA0491
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PREDNISOLONE 2.5MG, 5MG, 10MG,
20MG, 25MG AND 30MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
•
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 IT FOR MORE THAN 3
WEEKS, YOU WILL GET A BLUE ‘STEROID
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 25mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg prednisolone.
Excipient with known affect
Each 25mg tablet contains 159.4mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
25mg tablet
White, 9mm, round, flat, tablet, with a score line on one side,
imprinted with “A650”
on one side and “25” on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALLERGY AND ANAPHYLAXIS: bronchial asthma, drug hypersensitivity
reactions, serum
sickness, angioneurotic oedema, anaphylaxis, incapacitating allergies
unresponsive to
conventional treatment.
ARTERITIS/COLLAGENOSIS: giant cell arteritis/polymyalgia rheumatica,
mixed connective
tissue disease, polyarteritis nodosa, polymyositis.
BLOOD DISORDERS: haemolytic anaemia (auto-immune), leukaemia (acute
and chronic
lymphocytic), lymphoma, multiple myeloma, idiopathic thrombocytopenic
purpura.
CARDIOVASCULAR DISORDERS: post-myocardial infarction syndrome,
rheumatic fever
with severe carditis.
ENDOCRINE DISORDERS: primary and secondary adrenal insufficiency,
congenital
adrenal hyperplasia.
GASTRO-INTESTINAL DISORDERS: regional ileitis (Crohn's disease),
ulcerative colitis,
persistent coeliac syndrome (coeliac disease unresponsive to gluten
withdrawal),
auto-immune chronic active hepatitis, multisystem disease affecting
liver, biliary
peritonitis.
HYPERCALCAEMIA: sarcoidosis, vitamin D excess.
INFECTIONS (WITH APPROPRIATE CHEMOTHERAPY): helminthic infestations,
Herxheimer
reaction, infectious mononucleosis, miliary tuberculosis, mumps
orchitis (adult),
tuberculous meningitis, rickettsial disease.
MUSCULAR DISORDERS: polymyositis, dermatomyositis.
NEUROLOGICAL DISORDERS: infantile spasms, Shy-Drager syndrome,
sub-acute
demyelinating polyneuropathy.
OCULAR DISEASE: scleritis, posterior uveitis, retinal vasculitis,
pseudo-tumours of the
orbit, giant cell arteritis, malignant ophthalmic Graves disease.
RE
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