Ketofixal 25mg Granules for Oral Solutions in sachets

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

KETOPROFEN

Доступно од:

Midas Pharma GmbH Rheinstrasse 49, 55218 Ingelheim, Germany

АТЦ код:

M01AE03

INN (Међународно име):

KETOPROFEN 25 mg

Фармацеутски облик:

GRANULES FOR ORAL SOLUTION

Састав:

KETOPROFEN 25 mg

Тип рецептора:

POM

Терапеутска област:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Статус ауторизације:

Withdrawn

Датум одобрења:

2018-10-30

Информативни летак

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
KETOFIXAL 25 MG GRANULES FOR ORAL SOLUTION IN SACHETS
KETOFIXAL 50 MG GRANULES FOR ORAL SOLUTION IN SACHETS_ _
ketoprofen
_ _
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 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 Ketofixal is and what it is used for
2.
What you need to know before you take Ketofixal
3.
How to take Ketofixal
4.
Possible side effects
5.
How to store Ketofixal
6.
Contents of the pack and other information
1.
WHAT KETOFIXAL IS AND WHAT IT IS USED FOR
Ketofixal contains the active substance ketoprofen as lysine salt. It
belongs to a group of medicines
called non-steroidal anti-inflammatory drugs or NSAIDs.
Ketofixal is used in adolescents aged 16 years or older and in adults
for the symptomatic and short-
term treatment of
MILD TO MODERATE ACUTE PAIN
, such as:
•
headache
•
toothache
•
pain due to menstruation
•
pain after minor sprains and strains
ADULTS:
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days in case of
fever or 5 days for pain.
ADOLESCENTS
: You must talk to a doctor if adolescents do not feel better or feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KETOFIXAL
DO NOT TAKE KETOFIXAL IF YOU ARE/HAVE:
•
allergic to ketoprofen or any of the other ingredients of this
medicine (listed in section 6)
•
had an allergic reaction in the past after taking acetylsalicylic acid
or a painkiller, like
ketoprofen, ibuprofen or diclofenac, such as
-
asthma, difficulty breathing
-
swelling of the face, li

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ketofixal 25 mg granules for oral solution in sachets
Ketofixal 50 mg granules for oral solution in sachets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KETOFIXAL 25 MG GRANULES FOR ORAL SOLUTION IN SACHETS
Each sachet contains 25 mg of ketoprofen, equivalent to 40 mg of
ketoprofen lysine salt.
KETOFIXAL 50 MG GRANULES FOR ORAL SOLUTION IN SACHETS
Each bipartite sachet contains 50 mg ketoprofen, equivalent to 80 mg
ketoprofen lysine salt.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral solution in sachet.
White or yellowish granulate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketofixal is indicated for the short-term symptomatic treatment of
mild to moderate acute pain such
as:
•
headache
•
dental pain
•
menstrual pain (dysmenorrhea)
•
pain after minor sprains and strains.
Ketofixal is indicated in adolescents aged 16 years and older and in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_ _
_Adults and adolescents aged 16 years and older _
•
25 mg ketoprofen, up to three times a day, or
•
50 mg ketoprofen, up to two times a day
(corresponding to 40 mg ketoprofen lysine salt, up to three times a
day, or 80 mg ketoprofen lysine
salt, up to two times a day).
The interval between doses should not be less than 8 hours.
_Elderly _
The dose should be established carefully by the doctor, who may reduce
the dose indicated above, if
necessary (see section 4.4).
_ _
_Paediatric population _
Ketofixal is not recommended for the use in children and adolescents
below the age of 16 years.
For short-term use only.
If in adolescents of 16 years or older this medicinal product is
required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
If in adults this product is required for more than 3 days in case of
fever or for mo