PEVANTI

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

PREDNISOLONE

Доступна с:

Mercury Pharmaceuticals Ltd

код АТС:

H02AB06

ИНН (Международная Имя):

PREDNISOLONE

дозировка:

2.5 Milligram

Фармацевтическая форма:

Tablets

Тип рецепта:

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

Терапевтические области:

prednisolone

Статус Авторизация:

Not Marketed

Дата Авторизация:

2015-01-30

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PEVANTI 2.5 MG TABLETS
PEVANTI 5 MG TABLETS
PEVANTI 10 MG TABLETS
PEVANTI 20 MG TABLETS
PEVANTI 25 MG TABLETS
PREDNISOLONE
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, pharmacist or
nurse.
• 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, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
• Your doctor may have given you this medicine before from another
company. It may have looked
slightly different. However, either brand will have the same effect.
The name of your medicine is Pevanti 2.5 mg Tablets, Pevanti 5 mg
Tablets, Pevanti 10 mg Tablets,
Pevanti 20 mg Tablets, Pevanti 25 mg Tablets. It will be referred to
as Pevanti Tablets for ease
hereafter.
IMPORTANT THINGS YOU NEED TO KNOW ABOUT PEVANTI TABLETS
•
PEVANTI IS A STEROID MEDICINE
. This can be 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.
•
PEVANTI CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section 4 for more information). Some side
effects 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 THIS MEDICINE FOR MORE THAN 3 WEEKS, YOU WILL BE GIVEN A
BLUE ‘STEROID CARD’:
always
keep it with you a

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pevanti 2.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg of prednisolone
Excipient with known effect
Contains lactose monohydrate 39.5mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
2.5mg: 6 mm, white, round, biplane tablet, scored on one side. The
tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prednisolone is indicated for the treatment and/or suppression of
inflammatory and allergic disorders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In adults and the elderly: The lowest effective dose should be used
for the minimum period in order to minimise side
effects.
In children:
Prednisolone should be used only when specifically indicated, in a
minimum dosage and for the shortest
possible time.
The initial
dosage of Prednisolone Tablets may vary from 5mg to 60mg or more
depending on the disorder being
treated. Divided daily dosage is usually used.
The following therapeutic guidelines should be kept in mind for all
therapy with corticosteroids:
Corticosteroids
are palliative symptomatic treatment
by virtue of
their
anti-inflammatory effects;
they are never
curative.
The appropriate individual dose must be determined by trial and error
and must be re-evaluated regularly according to
activity of the disease.
As corticosteroid therapy becomes prolonged and as the dose is
increased,
the incidence of
disabling side-effects
increases.
In general, initial dosage shall be maintained or adjusted until the
anticipated response is observed. The dose should be
gradually reduced until the lowest dose which will maintain an
adequate clinical response is reached. Use of the lowest
effective dose may also minimise side-effects (see section 4.4).
In patients
who have received more than physiological
dose for
systemic corticosteroids
(approximately 7.5mg
prednisolone or equivalent) for greater than 3 weeks, withdrawal
should not be abrupt. How dose red