Keral 12.5mg granules for oral solution

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:

GRANULES FOR ORAL SOLUTION

Composition:

DEXKETOPROFEN 12.5 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2016-11-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KERAL 12.5 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
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

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

You must talk to a doctor if you do not feel better or if you feel
worse after 3-4 days.
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 trometamol or any of the other
ingredients of this medicine (listed in
section 6);

If you are allergic to the acetylsalicylic acid (aspirin) 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 aspirin
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 th

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
KERAL 12.5 mg granules for oral solution.
KERAL 25 mg 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 with colloidal silica: 1.20 – 1.22 g or 2.40 – 2.44 g
respectively.
For the full list of_ _excipients, 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 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 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 dysfunction:
Patients with mild to moderate hepatic dysfunction 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
dysfunction.
Renal dysfunction:
The initial dosage should be reduced to 50 mg total daily dose in
patients with mildly impaired renal
function (creatinine clearance 59 – 89 ml / min) (see section 4.4).
KERAL should