Prednisolone 5mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Prednisolone

Tersedia dari:

Accord-UK Ltd

Kode ATC:

H02AB06

INN (Nama Internasional):

Prednisolone

Dosis:

5mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 06030200; GTIN: 5012617040091

Selebaran informasi

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 (UK)
296x210 (Reel Fed)
51009793
Leaflet for Blisters
4464
T. Hull
22/12/21
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 ALL STRENGTHS TABLETS, PIL (REEL FED) - UNITED KINGDOM
Black
Profile
BBBB3695
R.Paul
11.01.2022
296x210 (Reel fed)
8.5pt
Accord Barnstaple
n/a
n/a
1
Version 2
01.11.2017
51009793 BBBB3695
•
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 WHO HAVE CHICKENPOX
OR SHINGLES, if you have never had them. They
could affect you severely. If you do

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg prednisolone.
Excipient with known effect
Each tablet contains 87.2mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
5mg tablet
White, 7mm, round, flat, tablet, with a score line on one side,
imprinted with “A620”
on one side and “5” 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.
RENAL DISORDERS: lupus neph