Fenodex 12.5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXKETOPROFEN

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

M01AE17

INN (International Name):

DEXKETOPROFEN 12.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DEXKETOPROFEN 12.5 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:

2021-10-19

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FENODEX 12.5 MG FILM-COATED TABLETS
FENODEX 25 MG FILM-COATED TABLETS
{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 has 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 3-4 days.
WHAT IS IN THIS LEAFLET
1.
What Fenodex is and what it is used for
2.
What you need to know before you take Fenodex
3.
How to take Fenodex
4.
Possible side effects
5.
How to store Fenodex
6.
Contents of the pack and other information
1.
WHAT FENODEX IS AND WHAT IT IS USED FOR
Fenodex contains dexketoprofen, which is a pain killer from the group
of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs).
It is used in adults to treat mild to moderate pain, such as muscular
pain, painful periods
(dysmenorrhoea), toothache.
You must talk to a doctor if you do not feel better or if you feel
worse after 3-4 days
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENODEX
DO NOT TAKE FENODEX
-
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 photoaller

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fenodex 12.5 mg film-coated tablets
Fenodex 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains dexketoprofen 12.5 mg or 25 mg (as
dexketoprofen trometamol).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Fenodex 12.5 mg film-coated tablets are yellow round, biconvex with
diameter 7mm.
Fenodex 25 mg film-coated tablets are white round, biconvex, scored,
embossed “MC” with diameter
10mm.
The 25mg tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain of mild to moderate intensity, such as
musculo-skeletal pain,
dysmenorrhoea, dental pain.
Fenodex is indicated in adults.
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).
Fenodex 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. Fenodex tablets should not be
used in patients with severe
hepatic dysfunction.
PAGE 2 OF 11
_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).
Fenodex tablets should not be used in
patients with