Prednisolone 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

H02AB06

INN (International Name):

Prednisolone

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNESOL 5MG TABLETS
Prednisolone sodium phosphate
• PREDNISOLONE IS 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 CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read 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 (read section 4 for more
information)
• IF YOU TAKE THIS MEDICINE 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.
Read all of this leaflet carefully before you start using 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.
WHAT IS IN THIS LEAFLET
1. What Prednesol 5mg Tablets are and what they are used for
2. What you need to know before you take Prednesol 5mg Tablets
3. How to take Prednesol 5mg Tablets
4. Possible side effects
5. How to store Prednesol 5mg Tablets
6. Contents of the pack and

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg prednisolone.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
5mg tablet
White, 7mm, round, flat, tablet, with a score line on one side,
imprinted with “A620”
on one side and “5” 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 DISORDERS: lupus nephritis, acute interstitial nephritis,
minimal change
glomeruloneph