Tramadol /Paracetamol Rowa 37.5 mg/325 mg Film-coated Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Tramadol hydrochloride; Paracetamol

可用日期:

Rowa Pharmaceuticals Limited

ATC代码:

N02AJ; N02AJ13

INN（国际名称）:

Tramadol hydrochloride; Paracetamol

剂量:

37.5/325 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

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

治疗领域:

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

授权状态:

Marketed

授权日期:

2017-07-07

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER TRAMADOL/PARACETAMOL ROWA 37.5 MG/325 MG FILM- COATED TABLETS
tramadol hydrochloride/paracetamol
WHAT IS IN THIS LEAFLET:
1. What Tramadol/Paracetamol Rowa is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol Rowa
3. How to take Tramadol/Paracetamol Rowa
4. Possible side effects
5. How to store Tramadol/Paracetamol Rowa
6. Contents of the pack and other information
1. WHAT TRAMADOL/PARACETAMOL ROWA IS AND WHAT IT IS USED FOR
Tramadol/Paracetamol Rowa is a combination of two analgesics, tramadol
and paracetamol, which act together
to relieve your pain.
Tramadol/Paracetamol Rowa 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 Rowa should only be taken by adults and
adolescents over 12 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL/PARACETAMOL ROWA
DO NOT TAKE TRAMADOL/PARACETAMOL ROWA
- if you have had an allergic reaction (for instance skin rash,
swelling of the face, wheezing or difficulty
breathing) after taking tramadol or 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
Tramadol/Paracetamol Rowa
- if you suffer from a severe liver disorder
- if you have epilepsy that is not adequately controlled on your
current medicine.
WARNINGS AND PRECAUTIONS
Check with your pharmacist or doctor before taking
Tramadol/Paracetamol Rowa if you:
- take other medicines containing paracetamol or tramadol
- 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.
- have kidney problems

产品特点

Health Products Regulatory Authority
10 January 2024
CRN00DZ8K
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol /Paracetamol Rowa 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.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellowish, cylindrical, biconvex, film-coated tablet of 11mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol/Paracetamol Rowa tablets are indicated for the symptomatic
treatment of moderate to severe pain.
The use of Tramadol/Paracetamol Rowa 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_
Adults and adolescents (12 years and older):
The use of Tramadol/Paracetamol Rowa 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 the intensity of the pain and the
sensitivity of the individual patient. The lowest effective dose for _
_analgesia should generally be selected._
An initial dose of two tablets of Tramadol/Paracetamol Rowa 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.
Tramadol/Paracetamol Rowa 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 Rowa 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 possible), to
assess whether continuation of the treatment is necessary.
Paediatric population
The effective and safe use of Tramadol/Parace