Ketoprofen Pharmexon 50 mg granules for oral solution in sachet

Држава: Малта

Језик: Енглески

Извор: Malta Medicines Authority

Доступно од:

Pharmexon Consulting s.r.o. Pitterova 2855/7, Zizkov, Prague, 130 00, Czech Republic

АТЦ код:

M01AE03

INN (Међународно име):

KETOPROFEN 50 mg

Фармацеутски облик:

GRANULES FOR ORAL SOLUTION

Састав:

KETOPROFEN 50 mg

Тип рецептора:

POM

Терапеутска област:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Резиме производа:

Licence number in the source country: NOT APPLICAPABLE

Статус ауторизације:

Authorised

Датум одобрења:

2022-05-17

Информативни летак

PAGE 1 OF 8
PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
KETOPROFEN PHARMEXON 50 MG GRANULES FOR ORAL SOLUTION IN SACHET
ketoprofen (as lysine salt)
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 Ketoprofen lysine is and what it is used for
2.
What you need to know before you use Ketoprofen lysine
3.
How to use Ketoprofen lysine
4.
Possible side effects
5.
How to store Ketoprofen lysine
6.
Contents of the pack and other information
1.
WHAT KETOPROFEN LYSINE IS AND WHAT IT IS USED FOR
Ketoprofen lysine 50 mg granules for oral solution in sachet contains
the active substance ketoprofen,
which belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs), used to
relieve pain and inflammation.
Ketoprofen lysine is used in
ADULTS
for symptomatic treatment of pain and inflammation in conditions such
as:
-
rheumatoid arthritis (chronic, inflammatory disease that causes the
immune system to attack the
joints)
-
long-term inflammation of the joints of the spine
-
painful inflammation of joints
-
rheumatic disease affecting the structures outside the joints
-
inflammation after injury
-
painful inflammatory conditions in the mouth or teeth, throat, nose,
ears, urinary tract and
respiratory track.
ADOLESCENTS AGED 16 YEARS AND ABOVE
for
symptomatic and short-term treatment of pain and
inflammation, with or without fever, such as:
-
conditions affecting bones and joints
-
pain after surgery
-
ear inflammation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KETOPROF

Карактеристике производа

PAGE 1 OF 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ketoprofen Pharmexon 50 mg granules for oral solution in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoprofen Pharmexon 50 mg granules for oral solution in sachet
Each bipartite sachet contains: 50 mg of ketoprofen (equivalent to 80
mg of ketoprofen lysine salt).
Excipients with known effect:
Mannitol (E421)
1700 mg
Sodium 9,55 mg
Sucrose
9 mg
For the full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral solution in sachet
White to ivory granules with light mint odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Ketoprofen Pharmexon is indicated in adults for the symptomatic
treatment of inflammatory states
associated
with
pain,
among
which:
rheumatoid
arthritis,
ankylosing
spondylitis,
painful
arthritis,
extraarticular rheumatism, post-traumatic inflammation, painful
inflammatory conditions in dentistry,
otorhinolaryngology, urology and pneumology.
Paediatric population
Ketoprofen Pharmexon 50 mg is indicated in adolescents aged 16 years
and older for the symptomatic and
short-term treatment of pain and inflammation, with or without fever,
in conditions such as those affecting
the osteoarticular system, post-operative pain and otitis.
4.2
POSOLOGY AND ROUTE OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the shortest duration
necessary to control symptoms (see
section 4.4).
PAGE 2 OF 16
_ _
_Adults and adolescents aged 16 years and older _
It is recommended to take one whole bipartite sachet, equivalent to 50
mg of ketoprofen, corresponding to
80 mg ketoprofen lysine salt, three times a day, preferably with
meals.
The maximum daily dosage is 200 mg of ketoprofen, corresponding to 320
mg of ketoprofen lysine salt.
The risk-benefit ratio should be carefully considered before starting
treatment with the daily dose of 200
mg of ketoprofen and higher doses are not recommended (see also
section 4.4).
_Elderly _
The dose should be carefully prescribed by the doctor who s