Prednisolone 5mg Tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

PREDNISOLONE

थमां उपलब्ध:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ए.टी.सी कोड:

H02AB06

INN (इंटरनेशनल नाम):

PREDNISOLONE 5 mg

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

PREDNISOLONE 5 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

CORTICOSTEROIDS FOR SYSTEMIC USE

प्राधिकरण का दर्जा:

Withdrawn

प्राधिकरण की तारीख:

2006-08-23

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 1MG AND 5MG TABLETS
(Referred to as Prednisolone Tablets in the remainder of the leaflet)
_ _
Prednisolone is a steroid medicine, prescribed for many different
conditions, including serious illnesses.
•
You need to take it regularly to get the maximum benefit.
•
Do not stop taking this medicine without talking to your doctor –
you may need to reduce the dose gradually.
•
Prednisolone Tablets can cause side effects in some people (read
section 4. Possible side effects for more
information). Some problems such as mood changes (feeling depressed,
or ‘high’), or stomach problems
may be experienced straight away. If you feel unwell in any way, keep
taking your tablets, but see your
doctor straight away.
•
Some side effects only occur 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 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.
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.
You should keep this leaflet throughout your course of treatment.
IN THIS LEAFLET:
1)
What Prednisolone_ _Tablets are and what they are used for
2)
Before you take Prednisolone Tablets
3)
How to take Prednisolone Tablets
4)
Possible side effects
5)
How to store Prednisolone Tablets
6)
Further information
1. WHAT PREDNISOLONE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Prednisolone Tablets.
The active ingredient in your medicine is prednisolone. Prednisolone
belongs to a group of medicines called
steroids. There full name

उत्पाद विशेषताएं

Page 1 of 11
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prednisolone 5.0mg
Excipients: Lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White circular, flat faced tablets with break line and PL5 on one face
and CP on
the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Suppression of inflammatory and allergic disorders
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration - Oral
_Adults including the elderly _
The lowest effective dose should be used for the minimum period in
order to
minimise side effects (see 4.4 Special Warnings and Precautions for
use)
_Initially: _
5mg to 60mg daily in divided doses, as a single dose in the morning
after
breakfast, or as a double dose on alternate days. They should be taken
with or
after food. The dose can often be reduced within a few days but may
need to be
continued for several weeks or months.
_Maintenance: _
2.5 to 15mg daily, but higher doses may be needed. Cushingoid
side-effects more
likely above 7.5mg daily.
_Children _
_ _
Page 2 of 11
_ _
Prednisolone should be used only when specifically indicated, in a
minimal
dosage and for the shortest possible time (see other special warnings
and
precautions)
4.3
CONTRAINDICATIONS
Systemic
infection
unless
specific
anti-infective
therapy
is
employed.
Hypersensitivity to any ingredient.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A patient information leaflet should be supplied with this product
Undesirable effects may be minimised by using the lowest effective
dose for the
minimum period, and by administering the daily requirement as a single
morning
dose or whenever possible as a single morning dose on alternate days.
Frequent
patient review is required to appropriately titrate the dose against
disease activity
(see dosage section)
Adrenal suppression.
Adrenal cortical atrophy develops during prolonged therapy and may
persist for
years after stopping treatment. Withdrawa