IXPRIM 37.5/325 Milligram Tablets Effervescent

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

PARACETAMOL, TRAMADOL HYDROCHLORIDE

Tilgjengelig fra:

Grünenthal Ltd

ATC-kode:

N02AJ13

INN (International Name):

PARACETAMOL, TRAMADOL HYDROCHLORIDE

Dosering :

37.5/325 Milligram

Legemiddelform:

Tablets Effervescent

Resept typen:

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

Terapeutisk område:

opiods in combination with non-opiod analgesics

Autorisasjon status:

Authorised

Autorisasjon dato:

2008-12-12

Informasjon til brukeren

1. WHAT IXPRIM IS AND WHAT IT IS USED FOR
IXPRIM is a combination of two analgesics, tramadol hydrochloride
and paracetamol, which act together to relieve your pain.
IXPRIM is intended for use in the treatment of moderate to severe
pain when your doctor recommends that a combination of tramadol
hydrochloride and paracetamol is needed.
IXPRIM should only be taken by adults and adolescents over 12 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IXPRIM
DO NOT TAKE IXPRIM
– if you are allergic to tramadol hydrochloride, paracetamol, sunset
yellow or any of the other ingredients of this medicine (listed in
section 6);
– in acute poisoning with alcohol, sleeping pills, pain relievers or
other psychotropic medicines (medicines that affect mood and
emotions);
– if you are also taking MAO inhibitors (certain medicines used for
treatment of depression or Parkinson’s disease) or have taken them
in the last 14 days before treatment with IXPRIM;
– if you suffer from a severe liver disorder;
– if you have epilepsy that is not adequately controlled on your
current
medicine.
WARNINGS AND PRECAUSTIONS
TALK TO YOUR DOCTOR BEFORE TAKINGIXPRIM
– if you take other medicines containing paracetamol or tramadol
hydrochloride;
– if you have liver problems or liver disease or if you notice your
eyes
and skin turning yellow. This may suggest jaundice or problems with
your bile ducts.
– if you have kidney problems;
– if you have severe difficulties in breathing for example asthma or
severe lung problems;
– if you have epilepsy or have already experienced fits or seizures;
– if you have recently suffered from a head injury, shock or severe
headaches associated with vomiting;
– if you are dependent on any medicines including those used to
relieve pain, for example morphine;
– take
other
medicines
to
treat
pain
that
contain
buprenorphine,
nalbuphine or pentazocine;
– if you are going to have an anaesthetic. Tell your doctor or
dentist
that you are taking IXPRIM.
If any of the above-mentioned points applied to you

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
IXPRIM effervescent 37.5 mg/325 mg effervescent tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One effervescent tablet contains 37.5 mg tramadol hydrochloride and
325 mg paracetamol.
Excipients:
Each effervescent tablet contains 7.8 mmol (or 179.4 mg) of sodium (as
monosodium citrate, sodium
hydrogen carbonate, and saccharin sodium).
One effervescent tablet contains 0.4 mg sunset yellow.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet.
Off white to slightly rosy coloured with some coloured speckles of
round shape, flat with beveled edges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ixprim effervescent is indicated for the symptomatic treatment of
moderate to severe pain.
The use of Ixprim effervescent should be restricted to patients whose
moderate to severe pain is considered to require a
combination of tramadol hydrochloride and paracetamol (see also
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The use of Ixprim effervescent should be restricted to patients whose
moderate to severe pain is considered to require a
combination of tramadol hydrochloride and paracetamol.
The dose should be adjusted to intensity of pain and the sensitivity
of the individual patient. The lowest effective dose
for analgesia should generally be selected. The total dose of 8
tablets (equivalent to 300 mg tramadol hydrochloride and
2600 mg paracetamol) per day should not be exceeded. The dosing
interval should not be less than six hours.
Adults and adolescents (12 years and older)
An initial dose of two effervescent tablets of Ixprim effervescent
(equivalent to 75 mg tramadol hydrochloride and 650
mg paracetamol) is recommended.
Additional doses can be taken as needed, not exceeding 8 effervescent
tablets
(equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol)
per day.
The dosing interval should not be less than six hours.
Ixprim effervescent should under no circumstances be administe