Enantyum 25 mg oral solution in sachet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexketoprofen

Available from:

Laboratorios Menarini S.A.

ATC code:

M01AE; M01AE17

INN (International Name):

Dexketoprofen

Dosage:

25 milligram(s)

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propionic acid derivatives; dexketoprofen

Authorization status:

Not marketed

Authorization date:

2017-05-12

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENANTYUM 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.

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.
<[To be completed nationally]>
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 for short term symptomatic treatment of mild to moderate
acute pain, such as acute muscular pain or
joint pain, painful periods (dysmenorrhoea), toothache. Enantyum is
indicated in adult patients.
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 aspirin or
other non-steroidal anti-inflammatory medicines;

If you have suffered from photoallergic or phototoxic reactions (a
particular form of reddenin

Summary of Product characteristics

Health Products Regulatory Authority
05 November 2019
CRN009FS0
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enantyum 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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution in sachet.
Slightly coloured solution with lemon odour andsweet
lemon-citrusflavour.
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.
Enantyum is indicated in adult patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
Enantyum oral solution in sachet 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 dysfunction _
Patients with mild to moderate hepatic dysfunction should start
therapy at reduced doses (50 mg total daily dose) and be
closely monitored. Enantyum oral solution in sachet 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 impai