Ketonal 25mg Granules for Oral Solutions in sachets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

KETOPROFEN

Available from:

Midas Pharma GmbH Rheinstrasse 49, 55218 Ingelheim, Germany

ATC code:

M01AE03

INN (International Name):

KETOPROFEN 25 mg

Pharmaceutical form:

GRANULES FOR ORAL SOLUTION

Composition:

KETOPROFEN 25 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2018-10-26

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
KETONAL 25 MG GRANULES FOR ORAL SOLUTION IN SACHETS
KETONAL 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 Ketonal is and what it is used for
2.
What you need to know before you take Ketonal
3.
How to take Ketonal
4.
Possible side effects
5.
How to store Ketonal
6.
Contents of the pack and other information
1.
WHAT KETONAL IS AND WHAT IT IS USED FOR
Ketonal contains the active substance ketoprofen as lysine salt. It
belongs to a group of medicines
called non-steroidal anti-inflammatory drugs or NSAIDs.
Ketonal is used in
•
ADULTS
for symptomatic treatment of
PAIN
and
INFLAMMATION
in conditions such as:
-
inflammation due to injury
-
painful inflammatory conditions in the mouth/teeth, throat, nose,
ears, urinary tract and
respiratory tract
-
painful joint inflammation with breakdown of cartilage and underlying
bone
-
a chronic, inflammatory disorder that causes the immune system to
attack the joints
-
long term inflammation of the joints of the spine
-
rheumatic diseases affecting the structures outside the joints
•
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 TAKE KETONAL
DO NOT TAKE KETONAL IF YOU ARE/HAVE:
•
allergic to ketoprofen or any of the other ingredients

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ketonal 25 mg granules for oral solution in sachets
Ketonal 50 mg granules for oral solution in sachets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketonal 25 mg granules for oral solution in sachets
Each sachet contains 25 mg of ketoprofen equivalent to 40 mg of
ketoprofen lysine salt.
_ _
Ketonal 50 mg granules for oral solution in sachets
Each bipartite sachet contains 50 mg of ketoprofen equivalent to 80 mg
of 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
Adults
Ketonal is indicated in adults for the symptomatic treatment of pain
and inflammation in conditions
such as:
•
post-traumatic inflammation
•
painful inflammatory conditions in dentistry, otolaryngology, urology
and pulmonology.
•
painful osteoarthritis
•
rheumatoid arthritis
•
ankylosing spondylitis
•
extra-articular rheumatism
Paediatric population
Ketonal 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.
Page 2 of 13
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the shortest duration
necessary to control symptoms
(see section 4.4).
_ _
_Adults and adolescents aged 16 years and older _
Ketonal 25 mg granules for oral solution in sachets:
Two sachets equivalent to a total of 50 mg ketoprofen, three times a
day (corresponding to 80 mg
ketoprofen lysine salt, three times a day).
Ketonal 50 granules for oral solution in sachets:
One sachet equivalent to 50 mg ketoprofen, three times a day
(corresponding to 80 mg ketoprofen
lysine salt, three times a day).
The maximum daily dose is 200 mg ketoprofen. The balance of risks and
benefits should be
carefully con