DELTACORTRIL ENTERIC 5 mg gastro-resistant tablets

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Prednisolone

Fáanlegur frá:

Phoenix Labs

ATC númer:

H02AB; H02AB06

INN (Alþjóðlegt nafn):

Prednisolone

Skammtar:

5 milligram(s)

Lyfjaform:

Gastro-resistant tablet

Gerð lyfseðils:

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

Lækningarsvæði:

Glucocorticoids; prednisolone

Leyfisstaða:

Marketed

Leyfisdagur:

1977-03-01

Upplýsingar fylgiseðill

PATIENT INFORMATION LEAFLET
DELTACORTRIL® ENTERIC 2.5MG GASTRO-RESISTANT TABLETS
DELTACORTRIL® ENTERIC 5MG GASTRO-RESISTANT TABLETS
Active Ingredient: Prednisolone

DELTACORTRIL ENTERIC 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.

DELTACORTRIL ENTERIC CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read
Section 4 “Possible Side
Effects”). Some problems such as mode 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 the 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 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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious,
or if you notice any side effects not listed in this leaflet, please
tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Deltacortril Enteric is and what it is tak

Vara einkenni

Health Products Regulatory Authority
17 June 2021
CRN00CCYT
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DELTACORTRIL ENTERIC 5 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of prednisolone.
Also contains 31.6mg of lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-Resistant Tablet
Smooth, uniformly coloured maroon 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 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, 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 glomerulonephritis.
RESPIRATORY DISEASE: Al