Keral 25 mg oral solution in sachet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXKETOPROFEN TROMETAMOL

Available from:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

ATC code:

M01AE17

INN (International Name):

DEXKETOPROFEN TROMETAMOL 25 mg

Pharmaceutical form:

ORAL SOLUTION

Composition:

DEXKETOPROFEN TROMETAMOL 25 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-04-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KERAL 25 MG ORAL SOLUTION IN SACHET
_ _
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
This medicinal product 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. This medicinal
product is indicated in adult patients.
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

Summary of Product characteristics

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Keral 25 mg oral solution in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of oral solution contains: dexketoprofen 25 mg as
dexketoprofen trometamol.
Excipients with known effect: 2 g of sucrose and 20 mg of methyl
parahydroxybenzoate (E 218).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution in sachet.
Slightly coloured solution with lemon odour and sweet lemon-citrus
flavour.
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, dental pain.
This medicinal product is indicated in adult patients.
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.
This medicinal product is only intended for short term use and the
treatment must be limited to
the symptomatic period.
_Elderly:_
In elderly 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.
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. Dexketoprofen 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). Dexketoprofen should n