Keral 25mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXKETOPROFEN

Available from:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

ATC code:

M01AE17

INN (International Name):

DEXKETOPROFEN 25 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DEXKETOPROFEN 25 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2006-03-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KERAL 25 MG FILM-COATED TABLETS
_ _
Dexketoprofen
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 Keral is and what it is used for
2.
What you need to know before you take Keral
3.
How to take Keral
4.
Possible side effects
5.
How to store Keral
6.
Contents of the pack and other information
1.
WHAT KERAL IS AND WHAT IT IS USED FOR
Keral is a pain killer from the group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscular pain,
painful periods (dysmenorrhoea), toothache.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KERAL
DO NOT TAKE KERAL:
•
If you are allergic to dexketoprofen or any of the other ingredients
of this medicine (listed in section 6);
•
If you are allergic to acetylsalicylic acid or to other non-steroidal
anti-inflammatory medicines;
•
If you have asthma or have suffered attacks of asthma, acute allergic
rhinitis (a short period of inflamed
lining of the nose), nasal polyps (lumps within the nose due to
allergy), urticaria (skin rash), angioedema
(swollen face, eyes, lips, or tongue, or respiratory distress) or
wheezing in the chest after taking
acetylsalicylic acid or other non-steroidal anti-inflammatory
medicines;
•
If you have suffered from photoallergic or phototoxic reactions (a
particular form of reddening and/or
blistering of the skin exposed to sunlight) while taking ketoprofen (a
non-steroidal anti-inflammatory drug)
or fibrates (drugs used to

Summary of Product characteristics

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Keral 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: dexketoprofen 25 mg as dexketoprofen trometamol.
For the full list of
_ _
excipients, see section
_ _
6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
White, round, scored film-coated tablet, with convex sides. The
tablets can be divided into equal
doses
_._
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain of mild to moderate intensity, such as
musculo-skeletal pain,
dysmenorrhoea, dental pain.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ _
_Adults: _
According to the nature and severity of pain, the recommended dosage
is generally <12.5 mg
(half a tablet) every 4-6 hours or> 25 mg every 8 hours. The total
daily dose should not exceed
75 mg.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
Dexketoprofen is not intended for long term use and the treatment must
be limited to the
symptomatic period.
_ _
_Elderly _
In elderly patients it is recommended to start the therapy at the
lower end of the dosage range (50
mg total daily dose). The dosage may be increased to that recommended
for the general population
only after good general tolerance has been ascertained.
_Hepatic impairment _
Patients with mild to moderate hepatic impairment should start therapy
at reduced doses (50 mg
total daily dose) and be closely monitored. Dexketoprofen should not
be used in patients with
severe hepatic impairment.
_Renal impairment _
The initial dosage should be reduced to 50 mg total daily dose in
patients with mildly impaired
renal function (creatinine clearance 60 – 89 ml / min) (see section
4.4). Dexketoprofen should not
_ _
be used in patients with moderate to severe renal impairment
(creatinine clearance <59 ml / min)
(see section 4.3).
_Paediatric population: _
Dexketoprofen has not been studied in children and adoles