Prednisolone 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone

Available from:

Teva 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: 5017007240143

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 1 MG AND 5 MG TABLETS
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.

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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
PREDNISOLONE TABLETS LEAFLET - HEADLINES

PREDNISOLONE TABLETS ARE 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 TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (see
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 (see 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 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.
WHAT IS IN THIS LEAFLET
1.
What Prednisolone tablets are and what they are used for
2.
What you need

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 1 mg of the active ingredient prednisolone.
Excipient with known effect
Each tablet contains 47.4 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White biconvex tablets. Engraved: ‘APS’ over ‘2401’ on one
side and plain 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, millary 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 nephritis, acute interstitial nephritis,
minimal change
glomeru