Dexketoprofen Rowex 25 mg Film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
03-11-2021
Summary of Product characteristics
(SPC)
03-11-2021
Active ingredient:
Dexketoprofen trometamol
Available from:
Rowex Ltd
ATC code:
M01AE; M01AE17
INN (International Name):
Dexketoprofen trometamol
Dosage:
25 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Propionic acid derivatives; dexketoprofen
Authorization status:
Marketed
Authorization date:
2013-10-11
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXKETOPROFEN ROWEX 25MG FILM-COATED TABLETS
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 Dexketoprofen Rowex is and what it is used for
2. What you need to know before you take
Dexketoprofen Rowex
3. How to take Dexketoprofen Rowex
4. Possible side effects
5. How to store Dexketoprofen Rowex
6. Contents of the pack and other information
1. WHAT DEXKETOPROFEN ROWEX IS AND WHAT IT IS USED FOR
Dexketoprofen Rowex is a pain killer from the group of medicines
called non-steroidal anti-
inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscular pain,
painful periods (dysmenorrhoea),
toothache.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXKETOPROFEN ROWEX
DO NOT TAKE DEXKETOPROFEN ROWEX IF YOU
are allergic to dexketoprofen or any of the other ingredients of this
medicine (listed in section 6)
are allergic to acetylsalicylic acid or to other non-steroidal
anti-inflammatory medicines
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
have suffered from photoallergic or phototoxic reactions (a particular
form of reddening and/or
blistering of the skin exposed to sunlight) whi
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
02 November 2021
CRN009XSJ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexketoprofen Rowex 25 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 36.9 mg of dexketoprofen trometamol,
corresponding to 25 mg dexketoprofen.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film coated tablets.
White, biconvex cylindric shaped scored tablets debossed with 'DT2' in
one side. The tablets can be divided into equal doses.
Tablet dimensions are: 3,9 mm x 9,3 mm ± 0,3 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of pain of mild to moderate intensity, such as
musculo-skeletal pain, dysmenorrhoea, dental pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
According to the nature and severity of pain, the recommended dose 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).
Dexketoprofen Rowex is not intended for long term use and the
treatment must be limited to the symptomatic period.
_Paediatric population_
Dexketoprofen trometamol has not been studied in children and
adolescents. Therefore, the safety and efficacy in children and
adolescents have not been established and the product should not be
used in children and adolescents.
_Elderly _
In elderly patients it is recommended to start the therapy at the
lower end of the dose range (50 mg total daily dose). The dose
may be increased to that recommended for the general population only
after good general tolerance has been ascertained.
_Hepatic dysfunction_
Patients with mild to moderate hepatic dysfunction should start
therapy at reduced doses (50 mg total daily dose) and be
closely monitored. Dexketoprofen Rowex should not be used in patients
with severe hepatic dysfunction.
_Renal dysfunction_
The in
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