ZYDOL tramadol hydrochloride 50mg capsule blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

tramadol hydrochloride, Quantity: 50 mg

Հասանելի է:

Arrotex Pharmaceuticals Pty Ltd

Դեղագործական ձեւ:

Capsule, hard

Կազմը:

Excipient Ingredients: magnesium stearate; titanium dioxide; iron oxide yellow; colloidal anhydrous silica; microcrystalline cellulose; Gelatin; sodium starch glycollate; sodium lauryl sulfate

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

6 capsules, 8 capsules, 10 capsules, 20 capsules

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

Zydol capsules are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Ապրանքի ամփոփագիր:

Visual Identification: Oblong, yellow/yellow, shiny hard gelatin capsules size 4 with snap fit closure; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Լիազորման կարգավիճակը:

Licence status A

Հաստատման ամսաթիվը:

2001-11-23

Տեղեկատվական թերթիկ

ZYDOL
1
ZYDOL
™
_tramadol hydrochloride_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WARNING
LIMITATIONS OF USE
ZYDOL 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
ZYDOL 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
ZYDOL 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 ZYDOL 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 ZYDOL
USING ZYDOL WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY SUCH AS
SLEEPING
CAPSULE (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 ZYDOL.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zydol capsules. 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 Zydol against
the benefits this medicine is expected
to have for you.
TALK TO YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ZYDOL IS USED FOR
ZYDOL is used to relieve severe
pain which

Ապրանքի հատկությունները

1
AUSTRALIAN PRODUCT INFORMATION – ZYDOL
™ (TRAMADOL
HYDROCHLORIDE) CAPSULE
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Zydol 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
Zydol 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 Zydol.
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 (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS)
DEPRESSANTS, INCLUDING ALCOHOL
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
Limit dosages and durations to the minimum required; and monitor
patients for signs and
symptoms of respiratory depression and sedation. Caution patients not
to drink alcohol while
taking Zydol.
2
1
NAME OF THE MEDICINE
Tramadol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zydol 50 mg capsules contain 50 mg of the active ingredient, tramadol
hydrochloride.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Oblong, yellow/yellow, shiny hard gelatin capsules size 4 with Snap
fit closure. The contents cons