Enantyum 25 mg granules for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Patient Information leaflet Patient Information leaflet (PIL)
11-06-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
11-06-2019

Active ingredient:

Dexketoprofen

Available from:

Laboratorios Menarini S.A.

ATC code:

M01AE; M01AE17

INN (International Name):

Dexketoprofen

Dosage:

25 milligram(s)

Pharmaceutical form:

Granules for 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:

2011-07-08

Patient Information leaflet

                                1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENANTYUM 25 MG GRANULES FOR ORAL SOLUTION
_ _
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 for short term symptomatic treatment of mild to moderate
acute pain, such as acute muscular pain
or joint 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 the 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
                                
                                Read the complete document

Summary of Product characteristics

                                HealthProductsRegulatoryAuthority
10June2019
CRN008SSM
Page1of8
SUMMARYOFPRODUCTCHARACTERISTICS
1NAMEOFTHEMEDICINALPRODUCT
Enantyum25mggranulesfororalsolution
2QUALITATIVEANDQUANTITATIVECOMPOSITION
Eachsachetofgranulesfororalsolutioncontainsdexketoprofen12.5mgor25mg,asdexketoprofentrometamol.
Excipientswithknowneffect:
Sucrose:2.418g.
Forthefulllistofexcipients,seesection6.1.
3PHARMACEUTICALFORM
Granulesfororalsolution,
lemon yellowcolouredgranules.
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anddentalpain.
4.2POSOLOGYANDMETHODOFADMINISTRATION
_Posology_
Adults
Accordingtothenatureandseverityofpain,therecommendeddosageis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isonlyintendedforshort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adult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m
                                
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Active ingredient Dexketoprofen

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INN (International Name) Dexketoprofen

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Enantyum 25 mg granules for oral solution