Prednisolone 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone

Available from:

Wockhardt 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: 5012727901763

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Removed MT details to create UK specific artwork
• Changed text font size from 8pt. to 9pt.
• Updated dimensions from 148 x 420mm to
148 x 558mm to accommodate bigger font size text
• Changed folding size from 148x31mm to 148x35mm
PREDNISOLONE LEAFLET - HEADLINES
• 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 Tablets can cause side effects
in some people (read section 4. Possible side
effects for more information). Some
problems such as mood changes (feeling
depressed, or ‘high’), or stomach problems
may be experienced straight away. If you
feel unwell in any way, keep taking your
tablets, but see your doctor straight away
• Some side effects only occur after weeks or
months. These include weakness of arms
and legs, or developing a rounder face (read
section 4. Possible side effects for more
information)
• If you take it for more than three 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
chicken-pox or shingles, if you have never
had them. They could affect you severely. If
you do come into contact with chicken pox
or shingles, see your doctor straight away.
Now read the rest of this leaflet. It includes
other important information on the safe and
effective use of this medicine that might be
especially important for you.
You should keep this leaflet throughout your
course of treatment.
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 or
pharmacist or
n

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg of Prednisolone
Excipients with known effect
Each tablet contains 54.2 mg of lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White circular, flat faced tablets with break line and PL1 on one face
and CP on the
reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ALLERGY AND ANAPHYLAXIS_: bronchial asthma, drug hypersensitivity
reactions, serum
sickness, angioneurotic oedema, anaphylaxis.
_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_: 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 Grave’s disease.
_RENAL DISORDERS_: lupus nephritis, acute interstitial nephritis,
minimal change
glomerulonephritis.
_RESPIRATORY DISEASE_: all