Xymel Comp 37.5mg/325mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tramadol hydrochloride; Paracetamol

Available from:

Clonmel Healthcare Ltd

ATC code:

N02AJ; N02AJ13

INN (International Name):

Tramadol hydrochloride; Paracetamol

Dosage:

37.5/325 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2013-04-18

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XYMEL COMP 37.5 MG/325 MG FILM-COATED TABLETS
Tramadol hydrochloride 37.5 mg
Paracetamol 325 mg
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. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Xymel Comp is and what it is used for
2. What you need to know before you take Xymel Comp
3. How to take Xymel Comp
4. Possible side effects
5. How to store Xymel Comp
6. Contents of the pack and other information
1. WHAT XYMEL COMP IS AND WHAT IT IS USED FOR
Xymel Comp is a combination of two analgesics, tramadol and
paracetamol, which act together to
relieve your pain.
Xymel Comp 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.
Xymel Comp should only be taken by adults and adolescents over 12
years.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYMEL COMP
DO NOT
take Xymel Comp

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 the
treatment of depression or
Parkinson’s disease) or have taken them in the last 14 days before
treatment with Xymel Comp.

If you suffer from a severe liver disorder.

If you have epilepsy that is not adequately controlled on your current
medicine.
WARNINGS AND PRECAUTIONS
Tal

Summary of Product characteristics

Health Products Regulatory Authority
02 August 2022
CRN00CX6D
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xymel Comp 37.5mg/325mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 37.5 mg tramadol hydrochloride and
325 mg paracetamol
Excipient with known effect
Each film-coated tablet contains 0.34 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, oblong, biconvex, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol/paracetamol is indicated for the symptomatic treatment of
moderate to severe pain.
The use of tramadol/paracetamol 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 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 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 is recommended.
Additional doses can be taken as needed, not
exceeding 8 tablets (equivalent to 300 mg tramadol and 2,600 mg
paracetamol) per day.
The dosing interval should not be less than six hours.
Tramadol/paracetamol 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
is required as a result of the nature and severity of the
illness, then careful, regular monitoring should take place (wit