Tramacet 37.5mg/325mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol; Tramadol hydrochloride

Available from:

Grunenthal Ltd

ATC code:

N02AJ13

INN (International Name):

Paracetamol; Tramadol hydrochloride

Dosage:

325mg ; 37.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 4032129026735

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAMACET
® 37.5MG/325MG 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, 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 TRAMACET is and what it is used for
2.
What you need to know before you take TRAMACET
3.
How to take TRAMACET
4.
Possible side effects
5.
How to store TRAMACET
6.
Contents of the pack and other information
1.
WHAT TRAMACET IS AND WHAT IT IS USED FOR
TRAMACET is used to treat moderate to severe pain when your doctor
recommends that a
combination of tramadol hydrochloride and paracetamol is needed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMACET
DO NOT TAKE TRAMACET

if you are allergic
to tramadol hydrochloride, paracetamol or any of the other ingredients
of this
medicine (listed in section 6)

in cases of acute alcohol poisoning

if you are taking sleeping pills, pain relievers or medicines that
affect mood and emotions

if you are also taking medicines called monoamine oxidase inhibitors
(MAOIs) or have taken
MAOIs in the last 14 days before treatment with TRAMACET. MAOIs are
used in the
treatment of depression or Parkinson’s disease.

if you have a severe liver disorder

if you have epilepsy that is not adequately controlled by your current
medicine.
WARNINGS AND PRECAUTIONS
2
TALK TO YOUR DOCTOR BEFORE TAKING TRAMACET

if you take other medicines containing paracetamol or tramadol

if you have liver problems or disease as your eyes and skin may turn
yellow, which may
suggest jaund

Summary of Product characteristics

OBJECT 1
TRAMACET 37.5 MG/ 325 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 25-Jul-2017 | Grunenthal
Ltd
1. Name of the medicinal product
TRAMACET 37.5mg/325mg Film coated tablets
Tramadol hydrochloride/Paracetamol 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.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Pale yellow film-coated tablet, marked with the manufacturer's logo
on one side and 'T5' on
the other side.
4. Clinical particulars
4.1 Therapeutic indications
Tramadol hydrochloride/Paracetamol tablets are indicated for the
symptomatic treatment of moderate to
severe pain.
The use of Tramadol hydrochloride/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 Hydrochloride/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 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 Tramadol hydrochloride/Paracetamol
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 hydrochloride/Paracetamol should under no circumstances be
administered for longer than is
strictly necessary (see