Prednisolone 25mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Prednisolone

제공처:

A A H Pharmaceuticals Ltd

ATC 코드:

H02AB06

INN (국제 이름):

Prednisolone

복용량:

25mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 06030200; GTIN: 5025903019138

환자 정보 전단

Actavis BST - Packing Technical
[e-mail]
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)
* Please note that ONLY Artwork Studio is permitted to make changes to
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approved for print/date
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DATE RECEIVED:
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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

제품 특성 요약

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