Ixprim 37.5 mg/325 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tramadol hydrochloride; Paracetamol

Available from:

LTT Pharma Limited

ATC code:

N02AJ; N02AJ13

INN (International Name):

Tramadol hydrochloride; Paracetamol

Dosage:

37.5/325 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Opioids in combination with non-opioid analgesics; opiods in combination with non-opiod analgesics

Authorization status:

Authorised

Authorization date:

2014-07-18

Patient Information leaflet

IXPRIM 37.5 MG/325 MG FILM-COATED TABLETS
(tramadol hydrochloride/paracetamol)
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, please ask your doctor or
pharmacist.
*
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 or pharmacist. This
includes
any possible side effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET:
What Ixprim is and what it is used for
What you need to know before you take Ixprim
How to take Ixprim
Possible side effects
How to store Ixprim
Contents of the pack and other information
WHAT IXPRIM IS AND WHAT IT IS USED FOR
Ixprim is a combination of two analgesics, tramadol 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 and paracetamol is needed. Ixprim should only
be
taken by adults and adolescents over 12 years.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IXPRIM
DO NOT TAKE IXPRIM
*
if you are allergic to tramadol hydrochloride, paracetamol 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 PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING IXPRIM:
*
if you take other medicines containing paracetamol or tramadol;
*
if you have liver problems or liver dise

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ixprim 37.5 mg/325 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325
mg paracetamol.
Excipients: One film coated tablet contains 1.878 mg lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pale yellow film-coated tablet, marked with the manufacturers logo
on one side and ‘T5’ on the other side.
4 CLINICAL PARTICULARS
As per PA1189/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1189/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Powdered cellulose
Pregelatinised starch (potato, corn and rice)
Sodium starch glycolate (potato) (type A)
Maize starch
Magnesium stearate
Hypromellose
Lactose monohydrate
Titanium dioxide (E171)
Macrogol 6000
Yellow iron oxide (E172)
Propylene glycol
Talc
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Ixprim tablets are packed in paper/PET/aluminium-PVC blist