Skudexa 75 mg/25 mg film-coated tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Dexketoprofen; Tramadol hydrochloride

Доступна з:

Menarini International Operations Luxembourg S.A.

Код атс:

N02AJ; N02AJ14

ІПН (Міжнародна Ім'я):

Dexketoprofen; Tramadol hydrochloride

Дозування:

75 mg/25 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

Product subject to prescription which may not be renewed (A)

Терапевтична области:

Opioids in combination with non-opioid analgesics; tramadol and dexketoprofen

Статус Авторизація:

Marketed

Дата Авторизація:

2016-02-26

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SKUDEXA 75 MG/25 MG 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 NSAIDs
•
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,
or
respiratory di

Характеристики продукта

Health Products Regulatory Authority
09 January 2023
CRN00D9DD
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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 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 film-coated tablets 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 film-coated
tablet; additional doses can be taken as needed with
the minimum dose interval o