Tramal Oral Drops

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Tramadol hydrochloride 100 mg/mL

Commercializzato da:

Seqirus (NZ) Ltd

INN (Nome Internazionale):

Tramadol hydrochloride 100 mg/mL

Dosaggio:

100 mg/mL

Forma farmaceutica:

Oral solution

Composizione:

Active: Tramadol hydrochloride 100 mg/mL Excipient: Aniseed flavour (87122) Glycerol Mint oil, partially dementholised Polyethylene glycol hydrogenated castor oil Potassium sorbate Propylene glycol Purified water Saccharin sodium Sodium cyclamate Sucrose

Confezione:

Bottle, Metered Dose Pump, 30 mL

Classe:

Prescription

Tipo di ricetta:

Class C2 Controlled Drug

Prodotto da:

Proto Chemicals AG

Indicazioni terapeutiche:

Relief of moderate to severe pain.

Dettagli prodotto:

Package - Contents - Shelf Life: Bottle, dropper, - 10 mL - 36 months from date of manufacture stored at or below 30°C protect from light

Data dell'autorizzazione:

2003-12-18

Foglio illustrativo

TRAMAL

ORAL DROPS
1
TRAMAL

ORAL DROPS
Tramadol hydrochloride: 100 mg is contained in each mL of the solution
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET?
This leaflet answers some
common questions about
Tramal
®
oral drops. 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 taking
this medicine against the
benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET. You may
need to read it again.
WHAT TRAMAL
®
ORAL
DROPS IS USED FOR
Tramal
®
oral drops are used to
relieve moderate to severe
pain. This medicine belongs to
a group of medicines called
analgesics (pain relievers).
Your doctor may have
prescribed Tramal
®
oral drops
for another reason. Ask your
doctor why this medicine has
been prescribed for you.
Tramal
®
oral drops are not
usually addictive. However,
rarely, addiction to tramadol
has been reported.
This medicine is available only
with a doctor’s prescription.
NOTE: DO NOT GIVE THIS
MEDICINE TO ANY CHILD
BETWEEN THE AGES OF 2 AND 12
YEARS UNLESS YOUR DOCTOR
TELLS YOU TO DO SO.
BEFORE YOU USE
TRAMAL
®
ORAL DROPS
_WHEN YOU MUST NOT USE _
_THIS MEDICINE_
DO NOT TAKE TRAMAL
®
ORAL
DROPS IF YOU:

know you have an allergy
to Tramal
®
oral drops or
any of the ingredients listed
at the end of this leaflet.

know you have an allergy
to any other medicines
known as opioid analgesics
e.g. morphine or codeine.

are taking medicine for
depression containing a
“monoamine oxidase
inhibitor” (such as Nardil
®
,
Parnate
®
), or have taken
one within the past two
weeks.
DO NOT TAKE TRAMAL
®
ORAL
DROPS

AFTER THE EXPIRY DATE
PRINTED ON THE PACK OR

IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF
TAMPERING.
If it is after the expiry date, or
the packaging is damaged,
return it to your pharmacist for
disposal.
DO NOT GIVE TRAMAL
®
ORAL
DROPS TO CHIL

Scheda tecnica

1
NEW ZEALAND DATA SHEET
TRAMAL
®
CAPSULES
TRAMAL
®
SOLUTION FOR INJECTION
TRAMAL
®
SR TABLETS
1.
PRODUCT NAME
Tramal
®
(tramadol hydrochloride) immediate release capsules 50 mg
Tramal
®
(tramadol hydrochloride) solution for injection 50 mg/mL, 100 mg/2mL
Tramal
®
SR tablets (tramadol hydrochloride) sustained release tablets) 50 mg,
100 mg, 150
mg, 200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRAMAL
®
50 MG CAPSULES ARE YELLOW-YELLOW CAPSULES CONTAINING: 50 mg tramadol
hydrochloride.
TRAMAL
®
50 MG AND 100 MG INJECTIONS CONTAIN: tramadol hydrochloride 50 mg/mL.
TRAMAL
®
SR SUSTAINED RELEASE TABLETS CONTAIN: tramadol hydrochloride in the
following
dose strengths: 50, 100, 150 and 200 mg.
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
Tramal
®
capsules, Tramal
®
solution for injection, and Tramal
®
SR tablets contain tramadol
hydrochloride which is ( +) -
_cis_-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol
hydrochloride. Tramadol hydrochloride is an odourless, white to
off-white crystalline powder
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Tramal
®
should only be used in
patients for whom other treatment options, including non-opioid
analgesics, are
ineffective, not tolerated or otherwise inadequate to provide
appropriate management of
pain (see _section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE_).
HAZARDOUS AND HARMFUL USE
Tramal
®
poses risks of hazardous and harmful use which can lead to overdose
and death.
Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor the
patient regularly during treatment (see _section 4.4. SPECIAL WARNINGS
AND _
_PRECAUTIONS FOR USE_).
LIFE THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening or fatal respiratory depression may occur
with the use of Tramal
®
.
Be aware of situations which increase the risk of respiratory
depression, modify dosing in
patients at risk and monitor patients closely, especially on
initiation or following a dose
increase (