Tramal SR

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Tramadol hydrochloride 150mg

Предлага се от:

Seqirus (NZ) Ltd

INN (Международно Name):

Tramadol hydrochloride 150 mg

дозиране:

150 mg

Лекарствена форма:

Modified release tablet

Композиция:

Active: Tramadol hydrochloride 150mg Excipient: Colloidal silicon dioxide Hypromellose   Iron oxide red Lactose monohydrate Macrogol 6000 Magnesium stearate Microcrystalline cellulose Propylene glycol Purified talc Quinoline yellow Titanium dioxide

Броя в опаковка:

Blister pack, Al/PVC/PVDC or Al/PP, 20 tablets

Клас:

Prescription

Вид предписание :

Class C2 Controlled Drug

Произведено от:

Proto Chemicals AG

Терапевтични показания:

Relief of moderate to severe pain.

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, Al/PVC/PVDC or Al/PP - 20 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, Al/PVC/PVDC or al/PP - 60 tablets - 60 months from date of manufacture stored at or below 30°C

Дата Оторизация:

1999-07-07

Листовка

New Zealand Consumer Medicine Information
TRAMAL
®
SR
Tramadol hydrochloride
Sustained Release Tablets
WARNING
Limitations of use
TRAMAL
®
SR should only be used when your doctor decides that other treatment
options are
not able to effectively manage your pain or you cannot tolerate them.
Hazardous and
harmful use
TRAMAL
®
SR poses risks of abuse, misuse and addiction which can lead to
overdose and
death. Your doctor will monitor you regularly during treatment.
Life threatening respiratory depression
TRAMAL
®
SR can cause life-threatening or fatal breathing problems (slow,
shallow, unusual
or no breathing), even when used as recommended. These problems can
occur at any time
during use, but the risk is higher when first starting TRAMAL
®
SR and after a dose increase, if
you are older, or have an existing problem with your lungs. Your
doctor will monitor you and
change the dose as appropriate.
Use of other medicines while using TRAMAL
®
SR
Using TRAMAL
®
SR with other medicines that can make you feel drowsy such as
sleeping tablets (e.g. benzodiazepines), other pain relievers,
antihistamines,
antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and
pregabalin),
cannabis and alcohol may result in severe drowsiness, decreased
awareness,
breathing problems, coma and death. Your doctor will minimise the dose
and duration of
use; and monitor you for signs and symptoms of breathing difficulties
and sedation. You must
not drink alcohol while using TRAMAL
®
SR.
What is in this leaflet?
This leaflet answers some common questions about TRAMAL
®
SR. It does not contain all the
available information. It does not replace talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
TRAMAL
®
against the benefits this medicine 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 is TRAMAL
®
SR used for
TRAMAL
®
SR is used to reliev

Данни за продукта

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 (