IXPRIM 37.5 mg/325 mg, film coated-tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Tramadol hydrochloride; Paracetamol

थमां उपलब्ध:

Grunenthal Pharma Ltd

ए.टी.सी कोड:

N02AJ; N02AJ13

INN (इंटरनेशनल नाम):

Tramadol hydrochloride; Paracetamol

डोज़:

37.5/325 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

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

चिकित्सीय क्षेत्र:

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

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2008-02-15

सूचना पत्रक

Material No.
CMO Mat. No.
Class. No.
Customer Mat. No.
Laetus Code
Colors &
Collating Marks
93038682
–
50/047/23
–
93035305
87
GI IXPRIM FILMTABLETTEN EN IRL
04.11.2022 V1
Previous Mat. No.
Product Name
Date/Version
9 pt
Font Size
Dimension
137 x 594 mm
(gefalzt auf 137 x 297 mm)
Grain Direction
594 mm
BLACK ................. 2/17
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:
1. What IXPRIM is and what it is used for
2. What you need to know before you take IXPRIM
3. How to take IXPRIM
4. Possible side effects
5. How to store IXPRIM
6. Contents of the pack and other information
1. 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.
2. 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

उत्पाद विशेषताएं

Health Products Regulatory Authority
18 November 2022
CRN00CRX8
Page 1 of 12
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
monohydrate (= 1.784mg lactose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pale yellow film-coated tablet, marked with the manufacturers logo d
on one side and ‘T5’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ixprim tablets are indicated for the symptomatic treatment of moderate
to severe pain.
The use of Ixprim should be restricted to patients whose moderate to
severe pain is considered to require a combination of
tramadol and paracetamol (see also Section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The use of Ixprim should be restricted to patients whose moderate to
severe pain is considered to require a combination of
tramadol 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 tablets of Ixprim is recommended Additional
doses can be taken as needed, not exceeding 8 tablets
(equivalent to 300 mg tramadol and 2600 mg paracetamol) per day.
The dosing interval should not be less than six hours.
Ixprim should under no circumstances be administered for longer than
is strictly necessary (see also section 4.4 - Special
warnings and precautions for use). If repeated use or long term
treatment with Ixprim is required as a result of the nature and
severity of the illness, then caref