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

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Tramadol hydrochloride; Dexketoprofen

Sẵn có từ:

Menarini International Operations Luxembourg S.A.

Mã ATC:

N02AJ; N02AJ14

INN (Tên quốc tế):

Tramadol hydrochloride; Dexketoprofen

Liều dùng:

75mg/25 milligram(s)

Dạng dược phẩm:

Granules for oral solution in sachet

Loại thuốc theo toa:

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

Khu trị liệu:

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

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

2018-04-06

Tờ rơi thông tin

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

Đặc tính sản phẩm

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 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 a