Prednisolone 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone

Available from:

Strides Pharma UK Ltd

ATC code:

H02AB06

INN (International Name):

Prednisolone

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5031676002666

Patient Information leaflet

Front & Back side printing, to be supplied in the Unfolded size.
Record No.: 333151 & 360652
Black
1047129
1046114
1
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9.0
Pack Insert
190 x 310 mm
Strides Pharma UK Ltd.
PREDNISOLONE TABLETS 1MG & 5MG
60 GSM Paper.
PRINTING CLARITY TO BE CLEAR AND SHARP.
190 x 310 mm
FRONT PAGE
9933
9933
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PREDNISOLONE TABLETS BP
1 MG AND 5 MG
prednisolone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
IMPORTANT THINGS YOU NEED TO KNOW ABOUT PREDNISOLONE TABLETS
•
Prednisolone is a steroid medicine, prescribed for many different
conditions, including serious illnesses.
•
You need to take it regularly to get the maximum benefit.
•
Do not 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 (see section 4).
Some side effects 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 round face (see section 4).
•
If you take this medicine for more than 3 weeks, you will be given 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 come into
contact with c

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone Tablets BP 1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains prednisolone 1mg
Excipient(s) with known effect
Lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, circular normal convex tablets
4.1 THERAPEUTIC INDICATIONS
Prednisolone is indicated in the management of all conditions deemed
likely to benefit from
short- or long-term glucocorticoid therapy. These include:
Allergic states
Severe, incapacitating allergies unresponsive to conventional
treatment; asthma serum
sickness; drug hypersensitivity reactions.
Collagen disorders
Eg systemic lupus erythematosus, polymyositis, polymyalgia rheumatica
and temporal (giant
cell) arteritis, mixed connective tissue disease syndrome, acute
rheumatic carditis.
Rheumatic disorders
Usually given as an adjunctive therapy for short term administration
during an acute episode
or exacerbation of rheumatoid arthritis, psoriatic arthritis.
Skin conditions
Life-threatening or incapacitating skin conditions such as pemphigus
and exfoliative
dermatitis.
Neoplastic disease
Leukaemias and lymphomas in adults, acute leukaemia of childhood.
Gastro-Intestinal disease
During acute exacerbation in ulcerative colitis and regional ileitis
(Crohn's Disease).
Respiratory disease
Sarcoidosis (especially with hypercalcaemia), fulminating or
disseminated pulmonary
tuberculosis when used concurrently with appropriate antituberculosis
chemotherapy.
Haematological disorders
Various blood dyscrasias eg selected cases of haemolytic anaemia,
thrombocytopenic
purpura.
Miscellaneous
Nephrotic syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
In adults and the elderly:
The lowest effective dose should be used for the minimum period in
order to minimise side
effects.
Paediatric population:
Prednisolone should be used only when specifically indicated, in a
minimum dosage and for
the shortest possible time.
The initial dosage of Prednisolone Tablets may vary