Keral 12.5mg 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 12.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DEXKETOPROFEN 12.5 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-03-21

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
KERAL 12.5 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 (

Summary of Product characteristics

_ _
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Keral 12.5 mg film-coated tablets
Keral 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: dexketoprofen 12.5 mg or 25 mg as dexketoprofen
trometamol.
For the full list of
_ _
excipients, see section
_ _
6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Keral 12.5 mg: white, round film-coated tablet.
Keral 25 mg: white, round, scored film-coated tablet. 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
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).
Keral tablets are 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 dysfunction should start
therapy at reduced doses (50
mg total daily dose) and be closely monitored. Keral tablets should
not be used in patients with
severe hepatic dysfunction.
_Renal impairment _
The initial dosage should be reduced to 50 mg total daily dose in
patients with mildly impaired
_ _
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renal function (creatinine clearance 60 – 89 ml / min) (see section
4.4). Keral tablets should
not be used in patients with moderate to severe renal dysfunction
(creatinine clearance <59 ml
/ min) (see se