TRAMAPINE 100 Milligram Tablet Prolonged Release

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

TRAMADOL HYDROCHLORIDE

Dostupno od:

Pinewood Laboratories Ltd,

INN (International ime):

TRAMADOL HYDROCHLORIDE

Doziranje:

100 Milligram

Farmaceutski oblik:

Tablet Prolonged Release

Tip recepta:

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

Status autorizacije:

Authorised

Datum autorizacije:

0000-00-00

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAMAPINE 100 MG PROLONGED RELEASE 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 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 Tramapine 100 mg Prolonged-release Tablets are and what
they are used for.
  2.  What you need to know before you take Tramapine 100 mg
Prolonged-release Tablets.
  3.  How to take Tramapine 100 mg Prolonged-release Tablets.
  4. Possible side effects.
  5.  How to store Tramapine 100 mg Prolonged-release Tablets.
  6.  Contents of the pack and other information.
1.     WHAT TRAMAPINE 100 MG PROLONGED-RELEASE TABLETS ARE AND WHAT
THEY ARE USED FOR
Tramadol - the active substance in Tramapine 100 mg Prolonged-release
Tablets is a pain killer belonging to the class of opioids that acts
on the central nervous 
system. It relieves pain by acting on specific nerve cells of the
brain and spinal cord.
Tramapine 100 mg Prolonged-release Tablets are used for the treatment
of moderate to severe pain.
2.     WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMAPINE 100 MG
PROLONGED-RELEASE TABLETS
DO NOT TAKE TRAMAPINE 100 MG PROLONGED-RELEASE TABLETS:
  •  If you are allergic to tramadol hydrochloride 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 fo

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramapine 100 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 100 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Tramapine 100 mg prolonged release tablets are off white, round biconvex tablets, 9.1 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
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.
Unless otherwise prescribed, Tramapine prolonged-release tablets should be given as follows:
_Adults and adolescents older than 12 years:_
The usual initial dose is 50 - 100 mg tramadol hydrochloride twice daily, morning and evening.
If pain relief is insufficient, the dose may be titrated upwards to 150 mg or 200 mg tramadol hydrochloride twice daily.
For doses not practicable with this strength, other strengths of this medicinal product are available.
Tramapine prolonged-release tablets should be swallowed completely, without breaking or chewing, independent of
meals, with sufficient liquid.
Daily doses of 400 mg of active substance should not be exceeded, except in special clinical circumstances.
Under no circumstances should Tramapine be used for longer than absolutely necessary.
If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and
regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether, and to what
extent, further treatment is necessary.
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