Prednisolone 20mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Prednisolone

Disponível em:

A A H Pharmaceuticals Ltd

Código ATC:

H02AB06

DCI (Denominação Comum Internacional):

Prednisolone

Dosagem:

20mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06030200

Folheto informativo - Bula

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Prednisolone Tablets 2.5,5,10,
20,25 & 30mg x 28 & 56’s (UK)
296x210 (Reel Fed)
50963374
Leaflet for Blisters
4123
R.Wrey
06/12/18
page 4
page 1
* 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
[e-mail]
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.
FMD info
NA (not a carton)

No

Yes

Details
PREDNISOLONE 2.5MG, 5MG, 10MG, 20MG, 25MG, 30MG TABLETS PIL - UK
Black
Profile
BBBA3552
T. Hull
11.12.2018
24/10/2019
G. Worth
296x210
8.5pt
Accord UK
n/a
n/a
7
Version 2
01.11.2017
50963374
BBBA3552
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 CARD’: always keep it with you and
show it to any doctor or nurse treating you.
•
KEEP AWAY FROM PEOPLE

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg prednisolone.
Excipient with known affect
Each 20mg tablet contains 163.4mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
20mg tablet
Red, 9mm, round, flat, tablet, with a score line on one side,
imprinted with “A640” on
one side and “20” 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.
RENA