Skudexa 75 mg/25 mg granules for oral solution in sachet

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

TRAMADOL HYDROCHLORIDE, DEXKETOPROFEN TROMETAMOL

Tilgængelig fra:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

ATC-kode:

N02AJ14

INN (International Name):

TRAMADOL HYDROCHLORIDE 75 mg DEXKETOPROFEN TROMETAMOL 25 mg

Lægemiddelform:

GRANULES FOR ORAL SOLUTION

Sammensætning:

TRAMADOL HYDROCHLORIDE 75 mg DEXKETOPROFEN TROMETAMOL 25 mg

Recept type:

POM

Terapeutisk område:

ANALGESICS

Autorisation status:

Authorised

Autorisation dato:

2018-03-09

Indlægsseddel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SKUDEXA 75 MG/25 MG GRANULES FOR ORAL SOLUTION IN SACHET
tramadol hydrochloride/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.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Skudexa is and what it is used for
2.
What you need to know before you take Skudexa
3.
How to take Skudexa
4.
Possible side effects
5.
How to store Skudexa
6.
Contents of the pack and other information
1.
WHAT SKUDEXA IS AND WHAT IT IS USED FOR
Skudexa contains the active substances tramadol hydrochloride and
dexketoprofen.
Tramadol hydrochloride is a pain killer belonging to a group of
medicines called opioids that act on
the central nervous system. It relieves pain by acting on specific
nerve cells of the brain and spinal
cord.
Dexketoprofen is a pain killer and it belongs to a group of medicines
called non-steroidal anti-
inflammatory drugs (NSAIDs).
Skudexa is used for the symptomatic short term treatment of moderate
to severe acute pain in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SKUDEXA
DO NOT TAKE SKUDEXA:
•
if you are allergic to dexketoprofen, to tramadol hydrochloride or any
of the other ingredients of
this medicine (listed in section 6)
•
if you are allergic to acetylsalicylic acid or to other NSAID
•
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 in the nose due to
allergy), urticaria (skin
rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory
distress) or wheezing in the
chest aft

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Skudexa 75 mg/25 mg granules for oral solution in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains: 75 mg of tramadol hydrochloride and 25 mg of
dexketoprofen (as dexketoprofen
trometamol).
Excipient(s) with known effect: sucrose 2.7 g per sachet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral solution in sachet.
The granules are white to almost white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic short term treatment of moderate to severe acute pain in
adult patients whose pain is
considered to require a combination of tramadol and dexketoprofen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is one sachet (corresponding to 75 mg of
tramadol hydrochloride and 25 mg
of dexketoprofen). Additional doses can be taken as needed, with a
minimum dosing interval of 8
hours. The total daily dose should not exceed three sachets per day
(corresponding to 225 mg of
tramadol hydrochloride and 75 mg of dexketoprofen).
Skudexa is intended for short term use only and the treatment must be
strictly limited to the
symptomatic period and in any case not more than 5 days. Switching to
a single agent analgesia should
be considered according to pain intensity and response of the patient.
Undesirable effects may be minimised by using the lowest number of
doses for the shortest duration
necessary to control symptoms (see section 4.4).
_Elderly: _
In elderly patients the starting recommended dosage is one sachet;
additional doses can be taken as
needed with the minimum dose interval of 8 hours and not exceeding the
total daily dose of 2 sachets
(corresponding to 150 mg of tramadol hydrochloride and 50 mg of
dexketoprofen). The dosage may
be increased to a maximum of 3 sachets as recommended for the general
population only after good
general tolerance has been ascertained.
Limited data are available in patients over 75 years, therefore
Skudexa should be use