Skudexa 75mg/25mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Tramadol hydrochloride; Dexketoprofen

MAH:

A. Menarini Farmaceutica Internazionale SRL

ATC_code:

N02AJ15

INN:

Tramadol hydrochloride; Dexketoprofen

dosage:

75mg ; 25mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

Schedule 3 (CD No Register Exempt Safe Custody)

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 04070200; GTIN: 5038227000515 5038227000508

PIL

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 (aspirin) 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
resp

SPC

OBJECT 1
SKUDEXA 75 MG/25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 16-Jan-2018 | A. Menarini
Farmaceutica Internazionale
SRL
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.
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 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 of 8 hours and not
exceeding the total daily dose of 2
film-coated ta