Tramake 50mg Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Tramadol hydrochloride

Disponible des:

Galen Pharma Ireland Limited

Codi ATC:

N02AX; N02AX02

Designació comuna internacional (DCI):

Tramadol hydrochloride

Dosis:

50 milligram(s)

formulario farmacéutico:

Tablet

Área terapéutica:

Other opioids; tramadol

Estat d'Autorització:

Not marketed

Data d'autorització:

2000-02-04

Informació per a l'usuari

1.3.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAMAKE 50MG TABLETS
TRAMAKE 100MG TABLETS
TRAMADOL HYDROCHLORIDE
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tramake is and what it is used for
2.
What you need to know before you take Tramake
3.
How to take Tramake
4.
Possible side effects
5.
How to store Tramake
6.
Contents of the pack and other information
1.
WHAT TRAMAKE IS AND WHAT IT IS USED FOR
Tramake is one of a group of medicines called analgesics or
painkillers. It is used to treat and
prevent severe pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMAKE
DO NOT TAKE TRAMAKE:
-
if you are allergic to tramadol hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
-
if you are taking monoamine oxidase inhibitor (MAOI) antidepressants
(examples include
moclobemide, tranylcypromine, phenelzine and isocarboxazid) or if you
have taken this
medicine in the last two weeks
- if you are taking buprenorphine, nalbuphine or pentazocine (strong
pain killers)
-
if you are pregnant, planning to become pregnant or breast-feeding
-
if you have recently taken alcohol, sleeping tablets, other strong
pain killers or medicines to
treat mental illness
-
if you suffer from epilepsy (fits) that is not adequately controlled
by treatment.
WARNINGS AND PRECAUTIONS
Tramadol is transformed in the liver by an enzyme. Some people have a
variation of this
enzyme and this can affect people in different ways. In some people,
they may not get enough
pain r

Fitxa tècnica

Health Products Regulatory Authority
22 September 2021
CRN00CJCM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramake 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Tramadol hydrochloride 50 mg.
Excipient(s) with known effect: contains 50mg of lactose monohydrate
per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White uncoated tablets marked ‘T50’ on one side and the other side
is plain and unmarked.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramake 50mg Tablets are indicated in adults and adolescents aged 12
years and over for the treatment and prevention of
severe pain. Tramadol has been found to be of benefit in both acute
and chronicpain states.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Tramake 50mg Tablets should not be used in children aged 0 to 12
years.
Older children (aged 12 years and over) and adults: 50-100mg every 4-6
hours.
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.
For acute pain a starting dose of 100mg is most often required.
Chronic conditions usually respond to 50mg starting dose.
Treatment periods should be short and intermittent as dependence can
occur with tramadol. The benefits of continued use
should be reviewed in order to ensure that they outweigh the risks of
dependence (see sections 4.4 and 4.8).
No more than 400mg orally is usually necessary for pain management in
any 24 hour period.
Elderly patients
A dose adjustment is not usually necessary in patients up to 75 years
without clinically manifest hepaticor renal insufficiency.In
elderly patients over 75 years elimination may be prolonged.
Therefore, if necessary the dosage interval is to be extended
according to the patient's requirements.
Renal insufficiency/dialysis and hepatic impairment
In patients with renal and/or hepatic insufficiency the elimination of
tramadol is delayed.