IXPRIM 37.5/325 Milligram Film Coated Tablet

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

TRAMADOL HYDROCHLORIDE, PARACETAMOL

Boleh didapati daripada:

Grünenthal Ltd

Kod ATC:

N02AJ13

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE, PARACETAMOL

Dos:

37.5/325 Milligram

Borang farmaseutikal:

Film Coated Tablet

Jenis preskripsi:

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

Kawasan terapeutik:

opiods in combination with non-opiod analgesics

Status kebenaran:

Authorised

Tarikh kebenaran:

2008-02-15

Risalah maklumat

Material No.
CMO Mat. No.
Class. No.
Customer Mat. No.
Laetus Code
Colors &
Collating Marks
93023396
–
50/036/23
–
93020310
9
GI IXPRIM FILMTABLETTEN EN IRL
20.07.2017 V3 | CPR
Previous Mat. No.
Product Name
Date/Version
8 pt
Font Size
Dimension
137 X 297 MM
Grain Direction
297 MM
BLACK ................. 7
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 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 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 m

Ciri produk

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
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 careful, regular
monitoring should take place (with breaks in the treatment,
where p