Keral 12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexketoprofen

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

M01AE; M01AE17

INN (International Name):

Dexketoprofen

Dosage:

12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propionic acid derivatives; dexketoprofen

Authorization status:

Not marketed

Authorization date:

1998-03-06

Patient Information leaflet

1
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 (drugs used

Summary of Product characteristics

Health Products Regulatory Authority
07 October 2019
CRN009D0N
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Keral 12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: dexketoprofen 12.5 mg as dexketoprofen
trometamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets.
White, round film-coated tablets.
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 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 section 4.3).
_Paediatric Population_
Keral has not been studied in children and adolescent. Therefore the
safety and efficacy in children and