Tramadol/Paracetamol Krka 37.5mg/325mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Paracetamol; Tramadol hydrochloride

Boleh didapati daripada:

KRKA, d.d., Novo mesto

Kod ATC:

N02AJ; N02AJ13

INN (Nama Antarabangsa):

Paracetamol; Tramadol hydrochloride

Dos:

37.5 mg/325 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

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

Kawasan terapeutik:

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

Status kebenaran:

Marketed

Tarikh kebenaran:

2015-01-23

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRAMADOL/PARACETAMOL KRKA 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, 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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tramadol/Paracetamol Krka is and what it is used for
2.
What you need to know before you take Tramadol/Paracetamol Krka
3.
How to take Tramadol/Paracetamol Krka
4.
Possible side effects
5.
How to store Tramadol/Paracetamol Krka
6.
Contents of the pack and other information
1.
WHAT TRAMADOL/PARACETAMOL KRKA IS AND WHAT IT IS USED FOR
Tramadol/Paracetamol Krka is a combination of two analgesics (pain
killers) tramadol and paracetamol,
which act together to relieve your pain.
Tramadol/Paracetamol Krka 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.
Tramadol/Paracetamol Krka
should only be taken by adults and adolescents over 12 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL/PARACETAMOL KRKA
DO NOT TAKE TRAMADOL/PARACETAMOL KRKA IF YOU
-
are allergic to tramadol hydrochloride, paracetamol or any of the
other ingredients of this
medicine (listed in section 6)
-
are in acute poisoning with alcohol, sleeping pills, pain relievers or
other psychotropic medicines
(medicines that affect mood and emotions)
-
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
Tramadol/Paracetamol Krka
-

Ciri produk

Health Products Regulatory Authority
22 August 2023
CRN00DJ30
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol/Paracetamol Krka 37.5mg/325mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 37.5 mg tramadol hydrochloride
equivalent to 32.94 mg tramadol and 325 mg paracetamol.
Excipient with known effect
Each film-coated tablet contains 1.25 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Tablets are yellow-brown, oval, slightly biconvex.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol/Paracetamol Krka tablets are indicated for the symptomatic
treatment of moderate to severe pain.
The use of Tramadol/Paracetamol Krka 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 Tramadol/Paracetamol Krka 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 and 2 600 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 Tramadol/Paracetamol Krka is
recommended. Additional doses can be taken as needed, not
exceeding 8 tablets (equivalent to 300 mg tramadol hydrochloride and
2600 mg paracetamol) per day.
The dosing interval should not be less than six hours.
Tramadol/Paracetamol Krka should under no circumstances be
administered for longer than is strictly necessary (see also
section 4.4). If repeated use or long term treatment with
Tramadol/Paracetamol Krka is required as a result of the nat