Prednisolone Tablets 30mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PREDNISOLONE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

H02AB06

INN (International Name):

PREDNISOLONE 25 mg

Pharmaceutical form:

TABLET

Composition:

PREDNISOLONE 25 mg

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2016-04-29

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 2.5 MG TABLETS
PREDNISOLONE 5 MG TABLETS
PREDNISOLONE 10 MG TABLETS
PREDNISOLONE 20 MG TABLETS
PREDNISOLONE 25 MG TABLETS
PREDNISOLONE 30 MG TABLETS
Prednisolone
-
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 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 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 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 Prednisolone is and what it is used for
2.
What you need to know before you take Prednisolone
3.
How to take Prednisolone
4.
Possible side effects

Summary of Product characteristics

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prednisolone 2.5 mg tablets
Prednisolone 5 mg tablets
Prednisolone 10 mg tablets
Prednisolone 20 mg tablets
Prednisolone 25 mg tablets
Prednisolone 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg prednisolone.
Each tablet contains 5 mg prednisolone.
Each tablet contains 10 mg prednisolone.
Each tablet contains 20 mg prednisolone.
Each tablet contains 25 mg prednisolone.
Each tablet contains 30 mg prednisolone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
2.5mg tablet
Yellow, 7mm, round, flat, tablet, with a score line on one side,
imprinted with “A610” on one side
and “2.5” on the other.
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.
10mg tablet
Red, 7mm, round, flat, tablet, with a score line on one side,
imprinted with “A630” on one side and
“10” on the other.
20mg tablet
Red, 9mm, round, flat, tablet, with a score line on one side,
imprinted with “A640” on one side and
“20” on the other.
25mg tablet
White, 9mm, round, flat, tablet, with a score line on one side,
imprinted with “A650” on one side
and “25” on the other.
30mg tablet
Yellow, 9mm, round, flat, tablet, with a score line on one side,
imprinted with “A670” on one side
and “30” on the other.
4.
CLINICAL PARTICULARS
2
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 infar