Enantyum 12.5 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-04-2018
Summary of Product characteristics
(SPC)
06-11-2019
Active ingredient:
Dexketoprofen
Available from:
Laboratorios Menarini S.A.
ATC code:
M01AE; M01AE17
INN (International Name):
Dexketoprofen
Dosage:
12.5 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:
Not marketed
Authorization date:
1998-04-03
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENANTYUM 12.5 MG 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 Enantyum is and what it is used for
2.
What you need to know before you take Enantyum
3.
How to take Enantyum
4.
Possible side effects
5.
How to store Enantyum
6.
Contents of the pack and other information
1.
WHAT ENANTYUM IS AND WHAT IT IS USED FOR
Enantyum 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 ENANTYUM
DO NOT TAKE ENANTYUM:
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) while taking ketoprofen (a
non-steroidal anti-inflammatory
drug
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
05 November 2019
CRN009FS0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
Laboratorios Menarini S.A. Alfonso XII, 587 - 08918 Barcelona Spain
1 NAME OF THE MEDICINAL PRODUCT
Enantyum 12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: dexketoprofen 12.5 mg as dexketoprofen
trometamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Enantyum 12.5 mg: white, round, film-coated tablet.
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 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).
Enantyum 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.
Enantyum tablets should not be used in patients with severe hepatic
dysfunction.
_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). Enantyum tablets should
not be used in patients with moderate to severe renal
dysfunction (creatinine clearance ≤59 ml / min) (see section 4.3).
_Paediatric Population_
Enantyum
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