Dilacort 2.5 mg gastro-resistant tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Prednisolone

Доступно од:

Crescent Pharma International Limited

АТЦ код:

H02AB; H02AB06

INN (Међународно име):

Prednisolone

Дозирање:

2.5 milligram(s)

Фармацеутски облик:

Gastro-resistant tablet

Терапеутска област:

Glucocorticoids; prednisolone

Статус ауторизације:

Not marketed

Датум одобрења:

2013-01-04

Информативни летак

1
PACKAGE INFORMATION LEAFLET
Dilacort 2.5mg and 5mg Gastro-Resistant Tablets
(prednisolone)
Dilacort Gastro-Resistant Tablets Leaflet - Headlines
•
Dilacort Gastro-Resistant Tablets 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 Gastro-Resistant Tablets can cause side effects in some
people (Read Section 4).
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, developing a rounder face (Read Section 4).
•
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. This
leaflet was last revised in April
2021.
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 leafl

Карактеристике производа

Health Products Regulatory Authority
03 June 2021
CRN00C9L0
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dilacort 2.5 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg prednisolone.
Excipients with known effect:
This medicine contains lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
[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 Graves disease.
_ _
_Renal dis