TRAMAPINE

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

TRAMADOL HYDROCHLORIDE

Tilgængelig fra:

Pinewood Laboratories Ltd,

ATC-kode:

N02AX02

INN (International Name):

TRAMADOL HYDROCHLORIDE

Dosering:

50 Milligram

Lægemiddelform:

Capsules Hard

Recept type:

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

Terapeutisk område:

tramadol

Autorisation status:

Marketed

Autorisation dato:

2001-07-13

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tramapine 50 mg capsules
tramadol hydrochloride
Read all of this leaflet carefully before you start taking this
medicine.
-
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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1.
What Tramapine 50 mg capsules are and what they are used for
2.
What you need to know before you take Tramapine 50 mg capsules
3.
How to take Tramapine 50 mg capsules
4.
Possible side effects
5.
How to store Tramapine 50 mg capsules
6.
Contents of the pack and other information
1.
What Tramapine 50 mg Capsules are and what they are used for
Tramapine 50 mg capsules contain the active ingredient tramadol
hydrochloride, which belongs to a group of pain-relieving medicines
called opioid analgesics, used for
the treatment and prevention of severe pain.
2.
What you need to know before you take Tramapine 50 mg Capsules
Do NOT take Tramapine 50 mg capsules:
•
if you are allergic (hypersensitive) to tramadol or any of the other
ingredients in the product (
_see Section 6_
)
•
if you are allergic (hypersensitive) to other opioids
•
if you have taken any medicines or alcohol that make you sleepy or
less alert:
o
including sleeping pills, analgesics or drugs that act on the nervous
system such as morphine and codeine (tramadol should not be used for
opioid withdrawal treatment),
•
if you are taking or have recently taken (within the last two weeks)
an antidepressant known as a monoamine oxidase inhibitor (MAOI)
•
If you are an epileptic and your fits are not adequately controlled by
treatment;
•
as a substitute in drug withdrawal.
These capsules should NOT be used in children under 1 year of age.
Take special care with Tramapine 50 mg ca

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramapine 50mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50mg of Tramadol hydrochloride.
Excipient: Also contains 103mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules
Green and yellow gelatin capsules, printed ‘TRA 50’ on both cap
and body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management (treatment and prevention) of severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
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 Warnings & Precautions for Use
and Undesirable Effects Sections).
_Adults and children over the age of 14 years:_
Depending upon the severity of the pain, the initial dose is 50 to 100
mg tramadol, then 50 mg to 100 mg 4-6 hourly. If
tramadol is used for the treatment of acute pain, it should be taken
into account that the effect starts slightly later than
that of other analgesics. For acute pain an initial dose of 100 mg is
usually required. For pain associated with chronic
conditions, an initial dose of 50 mg is recommended. A total daily
dose of more than 400 mg is not usually required.
_Geriatric patients_
A dose adjustment
is not
usually necessary in patients up to 75 years without
clinically manifest
hepatic or 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. In these patients prolongation
of the dosage intervals sho