Keral 25 mg granules in sachet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexketoprofen

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

M01AE17

INN (International Name):

Dexketoprofen

Dosage:

25 milligram(s)

Pharmaceutical form:

Granules in sachet

Therapeutic area:

dexketoprofen

Authorization status:

Not marketed

Authorization date:

2021-02-19

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KERAL 25 MG GRANULES IN SACHET
_ _
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 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 sign 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 in adults for the short term symptomatic treatment of mild
to moderate acute pain, such as pain
affecting muscles or joints (e.g. backache, sprains and acute trauma),
menstrual pain and dental pain.
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

Summary of Product characteristics

Health Products Regulatory Authority
05 April 2023
CRN00D69L
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Keral 25 mg granules in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains: dexketoprofen 25 mg as dexketoprofen trometamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules in sachet.
Slightly yellow to white granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term symptomatic treatment of acute pain of mild to moderate
intensity, such as musculo-skeletal pain, dysmenorrhoea,
dental pain.
Keral granules in sachet is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
_Adults_
According to the nature and severity of pain, the recommended dosage
is generally 25 mg every 8 hours. The total daily dose
should not exceed 75 mg.
Keral granules in sachet 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.
The elderly patients should be monitored particularly carefully due to
the possible undesirable effect profile (see section 4.4).
_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 granules in sachetshould not be used in
patients with severe hepatic dysfunction (see section 4.3).
_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 granules in
sachetshould not be used in patients with moderate to severe
renal dysfunction (cr