IXPRIM effervescent 37.5 mg/325 mg effervescent tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Paracetamol; Tramadol hydrochloride

থেকে পাওয়া:

Grunenthal Pharma Ltd

এটিসি কোড:

N02AJ; N02AJ13

INN (আন্তর্জাতিক নাম):

Paracetamol; Tramadol hydrochloride

ডোজ:

37.5/325 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Effervescent tablet

প্রেসক্রিপশন টাইপ:

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

থেরাপিউটিক এলাকা:

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

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2008-12-12

তথ্য লিফলেট

Ixprim 37.5mg / 325mg effervescent tablets
March 2023
Type II variation – FR/H/xxxx/WS/357
1
CONTAINS PARACETAMOL
PACKAGE LEAFLET: INFORMATION FOR THE USER
IXPRIM® EFFERVESCENT 37.5 MG/325 MG EFFERVESCENT 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:
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 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 epilep

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
21 December 2023
CRN00DJXS
Page 1 of 13
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 179.3 mg)
of sodium (as monosodium citrate, sodium hydrogen
carbonate, and saccharin sodium).
One effervescent tablet contains 0.4 mg sunset yellow E110. One
effervescent tablet contains up to 0.00085 mg sulphite per
tablet.
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 hydrochlorid