Prednisolone 1 mg Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Prednisolone

Tilgjengelig fra:

Clonmel Healthcare Ltd

ATC-kode:

H02AB; H02AB06

INN (International Name):

Prednisolone

Dosering :

1 milligram(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Glucocorticoids; prednisolone

Autorisasjon status:

Marketed

Autorisasjon dato:

1988-05-11

Informasjon til brukeren

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 1MG TABLETS
PREDNISOLONE

PREDNISOLONE IS A STEROID MEDICINE,
prescribed for many different conditions, including
serious illness.

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 ‘Possible side effects’
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 ‘STEROID
TREATMENT 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
chickenpox 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.
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 further questions, please 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Prednisolone is and what it is used for
2. What you need to know b

Preparatomtale

Health Products Regulatory Authority
28 June 2021
CRN00CDXN
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prednisolone 1 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg Prednisolone.
Excipient(s) with known effects:
Lactose monohydrate 36 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Circular, white, biconvex tablet engraved 1.
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), autoimmune 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 and
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 glomerulonephritis.
RESPIRATORY DISEASE: Allergic pneum