Keral 25mg granules for oral solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
21-04-2023
Summary of Product characteristics
(SPC)
04-05-2023
Active ingredient:
Dexketoprofen
Available from:
Menarini International Operations Luxembourg S.A.
ATC code:
M01AE; M01AE17
INN (International Name):
Dexketoprofen
Dosage:
25 milligram(s)
Pharmaceutical form:
Granules for oral solution
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Propionic acid derivatives; dexketoprofen
Authorization status:
Marketed
Authorization date:
2011-09-02
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KERAL 25 MG GRANULES FOR ORAL SOLUTION
_ _
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 for short term symptomatic treatment of mild to moderate
acute pain, such as acute muscular pain
or joint 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 the 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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
04 May 2023
CRN00DH6V
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Keral 25mg granules for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of granules for oral solution contains dexketoprofen 12.5
mg or 25 mg, as dexketoprofen trometamol.
Excipients with known effect:
Sucrose: 2.418 g.
For the full list ofexcipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral solution,
lemon yellow coloured granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term symptomatic treatment of acute pain of mild to moderate
intensity, such as acute musculo-skeletal pain,
dysmenorrhoea and dental pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
According to the nature and severity of pain, the recommended dosage
is 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 is only intended for short 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 adult only after
good general tolerance has been ascertained. Due to
the possible adverse effect profile (see section 4.4), elderly
individuals should receive particularly close monitoring.
_Hepatic impairment_
Patients with mild to moderate hepatic impairment should start therapy
at reduced doses (50 mg total daily dose) and be
closely monitored. Keral 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). Keral should not be
used in patients with moderate to severe renal impairment
(creatinine cle
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