Prednisolone 10mg 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:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5012617026262

Patient Information leaflet

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, 28s, 56s - UK
296x210 (Reel Fed)
50999609
Leaflet for Blisters
3695
RH
24-03-21
* 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
[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
BBBB1052
C.Grant
29/03/2021
30/03/2021
C.Grant
296x210
8.5pt
Accord Barnstaple
n/a
n/a
02
Version 2
01.11.2017
page 4
page 1
BBBB1052 50999609
RARE (may affect up to 1 in 1,000 people):
•
Depression
•
Mania in patients without a history of psychiatric
illness
•
Benign pressure increase in the skull
•
Breakdown of bone tissue, tendon rupture.
NOT KNOWN (frequency cannot be estimated from the
available data):
•
Increased number of white blood cells
(leukocytosis)
•
Withdrawal syndrome when reducing the dose
(see section 3)
•
Lowered blood pH, decreased blood potassium,
elevated blood fats, impaired sugar tolerance,
accumulation of fatty tissue at secluded places in
the body, increased appetite (which can lead to
weight gain)
•
Emotional symptoms (such as elation,
emotional instability, drug dependence), mental
disorder (such as delusions, hallucinations and
schizophrenia), personality change, confusion,
anxiety, mood swings, abnormal behaviour, sleep
problems, irritability
•
Seizures, problems with memory, intellectual
disturbance, dizziness, headache, increased
amount of fat around the spinal cord
•
Acid reduction (central ser

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg prednisolone.
Excipient with known affect
Each 10mg tablet contains 81.7mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
10mg tablet
Red, 7mm, round, flat, tablet, with a score line on one side,
imprinted with “A630” on
one side and “10” 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