DILACORT
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
05-01-2018
Summary of Product characteristics
(SPC)
25-08-2018
Active ingredient:
PREDNISOLONE
Available from:
Crescent Pharma Limited
ATC code:
H02AB06
INN (International Name):
PREDNISOLONE
Dosage:
2.5 Milligram
Pharmaceutical form:
Tablets Gastro-Resistant
Administration route:
Oral use
Units in package:
Pack size of 28 tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic group:
Glucocorticoids
Therapeutic area:
prednisolone
Therapeutic indications:
It is indicated for: Allergy and anaphylaxis; Arteritis/collagenosis; Blood disorders; Cardiovascular disorders; Endocrine disorders; Gastro-intestinal disorders; Hypercalcaemia; Infections (with appropriate chemotherapy); Muscular disorders; Neurological disorders; Ocular disease; Renal disorders; Respiratory disease; Rheumatic disorders; Skin disorders.
Authorization status:
Not Marketed
Authorization date:
2013-01-04
Patient Information leaflet
1
PACKAGE INFORMATION LEAFLET
DILACORT
® 2.5MG AND 5MG GASTRO-RESISTANT TABLETS
(Prednisolone)
DILACORT LEAFLET - HEADLINES
DILACORT 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.
DILACORT 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 Possible Side
Effects 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
.
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.
WHAT IS IN THIS LEAFLET
1.
What Dilacort Tablets are and what they are used for
2.
What you need to know before you take Dilacort Tablets
3.
How to take Dilacort Tablets
4.
Possible side effects
5.
How to store Dilacort Tabl
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dilacort 2.5mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg prednisolone.
Excipients: Each tablet also contains 69.50 mg of lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant Tablet.
Dark brown, circular, deep biconvex, enteric coated tablets.
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 thrombo-cytopenic 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_:
Read the complete document
