Skudexa 75 mg/25 mg film-coated tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

DEXKETOPROFEN TROMETAMOL, TRAMADOL HYDROCHLORIDE

Saadav alates:

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

ATC kood:

N02AJ14

INN (Rahvusvaheline Nimetus):

DEXKETOPROFEN TROMETAMOL 36.90 mg TRAMADOL HYDROCHLORIDE 75 mg

Ravimvorm:

FILM-COATED TABLET

Koostis:

DEXKETOPROFEN TROMETAMOL 36.90 mg TRAMADOL HYDROCHLORIDE 75 mg

Retsepti tüüp:

POM

Terapeutiline ala:

ANALGESICS

Volitamisolek:

Authorised

Loa andmise kuupäev:

2016-01-19

Infovoldik

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SKUDEXA 75 MG/25MG FILM-COATED TABLETS
_ _
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.
You must talk to a doctor if you do not feel better or if you feel
worse.
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 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,

Toote omadused

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Skudexa 75 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 75 mg of tramadol hydrochloride and 25 mg of
dexketoprofen.
Excipients with known effects: each tablet contains 33.07 mg
croscarmellose sodium and 1.83 mg
sodium stearyl fumarate.
For the full list of
_ _
excipients, see section
_ _
6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Skudexa: almost white to slightly yellow, oblong, film-coated tablets
with a break-mark on one side
and a debossed “M” on the other side. The dimension of the
film-coated tablet is ca. 14 mm lengths
and ca. 6 mm width.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
_ _
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 film-coated tablet (corresponding to 75
mg of tramadol hydrochlo-
ride 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
film-coated tablets per day (corre-
sponding 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 sympto-
matic 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 film-coated
tablet; additional doses can be
taken as needed with the minimum dose interval of 8 hours and not
exceeding the to