Tramadol Hydrochloride (AFT)

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Tramadol hydrochloride 50mg;  ;  

Tillgänglig från:

AFT Pharmaceuticals Ltd

INN (International namn):

Tramadol hydrochloride 50 mg

Dos:

50 mg

Läkemedelsform:

Capsule

Sammansättning:

Active: Tramadol hydrochloride 50mg     Excipient: Croscarmellose sodium Erythrosine Gelatin   Indigo carmine Iron oxide black Iron oxide yellow   Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opacode black S-1-27794 Titanium dioxide   Water  

Enheter i paketet:

Blister pack, PVC/PVdC/Al foil, 100 capsules

Klass:

Prescription

Receptbelagda typ:

Class C2 Controlled Drug

Tillverkad av:

Perrigo API Ltd

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al foil - 100 capsules - 48 months unopened stored at or below 25°C

Tillstånd datum:

2001-12-06

Bipacksedel

1
New Zealand Consumer Medicine Information
TRAMADOL HYDROCHLORIDE
_TRAMADOL HYDROCHLORIDE 50 MG CAPSULES _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Tramadol
Hydrochloride.
This leaflet answers some common questions about Tramadol
Hydrochloride. It does
not contain all the available information. It does not take the place
of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Tramadol Hydrochloride against the benefits they expect it will have
for you.
If you have any concerns about using this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT TRAMADOL HYDROCHLORIDE IS USED FOR
Tramadol Hydrochloride is used to relieve moderate to severe pain and
belongs to a
group of medicines called analgesics (pain relievers).
Your doctor may have prescribed Tramadol Hydrochloride for another
reason.
Ask your doctor if you have any questions about why Tramadol
Hydrochloride has
been prescribed for you.
This medicine is available only with a doctor's prescription.
Tramadol Hydrochloride is not normally addictive, although some cases
have been
reported.
BEFORE YOU USE TRAMADOL HYDROCHLORIDE
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Tramadol Hydrochloride if you:

are allergic to tramadol or other opioids or any of the other
ingredients listed at
the end of this leaflet;
2

have been drinking alcohol or taking other medicines that affect the
nervous
system such as hypnotics (used to relieve sleeplessness; e.g.,
nitrazepam),
opioids (used to relieve moderate to severe pain; e.g., morphine and
codeine)
or psychotropic drugs (e.g., chlorpromazine; used to treat
schizophrenia and
severe anxiety);

have had a head injury or feel faint from shock;

have uncontrolled epilepsy or epilepsy not adequately controlled by
treatment;

are also taking drugs known as monoamine oxidase inhibitors (e.g.,
phenelzine
and isocarboxazid), which are used to treat

Produktens egenskaper

1 of 14
NEW ZEALAND
DATA SHEET
1.
PRODUCT NAME
TRAMADOL 50MG CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg of tramadol hydrochloride.
Chemical Structure:
Chemical Name
:
(±) - cis-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-
cyclohexanol hydrochloride
Molecular Formula
:
C
16
H
25
NO
2
.HCl
Molecular Weight
:
299.84
CAS Registry Number:
36282-47-0.
Excipient with known effect: gelatin, methyl hydroxybenzoate, propyl
hydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Green/Yellow coloured hard gelatin capsules, size 3 filled with
homogeneous white to off-white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of moderate to severe pain.
2 of 14
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose of tramadol should be titrated to the severity of the pain
and the clinical response of the
individual patient.
Tramadol is approved for use in adults, adolescents, and children over
the age of 2 years. See the
Paediatric Use section below for children aged between 2 and 12 years.
For the treatment of moderate pain Tramadol 50 - 100 mg administered
two or three times daily
may be sufficient. Tramadol 50 mg may be adequate as the initial dose
for moderate pain.
For moderate to severe pain, 50 - 100 mg as needed for relief, every
four to six hours may be
administered. Tramadol 100mg is usually more effective as the initial
dose for more severe pain.
The maximum daily dose should not exceed 400mg per day.
PAEDIATRIC
USE
-
On
account
of
their
high
dosage
strengths,
Tramadol
capsules
are
not
recommended for use in children below the age of 12 years.
USE IN THE ELDERLY
- In subjects over the age of 75 years, serum concentrations are
slightly
elevated and the elimination half-life is slightly prolonged. Subjects
in this age group are also
expected to vary more widely in their ability to tolerate adverse drug
effects. Daily doses in
excess of 300 mg are not recommended in patients over 75 years.
RENAL INSUFFICIENCY
- in patients with renal insuf