PREGABALIN APOTEX pregabalin 25 mg capsule blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

pregabalin, Quantity: 25 mg

متاح من:

Southern Cross Pharma Pty Ltd

INN (الاسم الدولي):

Pregabalin

الشكل الصيدلاني:

Capsule, hard

تركيب:

Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; titanium dioxide; iron oxide black; purified talc; Gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; ethanol absolute; potassium hydroxide

طريقة التعاطي:

Oral

الوحدات في الحزمة:

20 capsules, 60 capsules, 56 capsules, 14 capsules

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

PREGABALIN APOTEX is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation PREGABALIN APOTEX is indicated for the treatment of neuropathic pain in adults.

ملخص المنتج:

Visual Identification: Size: 4 Hard gelatin capsule, cap: light grey, body: light grey with "25" printed in black ink; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

الوضع إذن:

Licence status A

تاريخ الترخيص:

2017-02-14

نشرة المعلومات

PREGABALIN APOTEX/MAY2021/CMI-2
WARNING: Before taking PREGABALIN APOTEX, tell your doctor if you have
a history of drug abuse. PREGABALIN
APOTEX poses risks of misuse, abuse and dependence. Using PREGABALIN
APOTEX with other medicines that can
make you feel drowsy such as sleeping tablets and other pain relievers
(e.g. benzodiazepines and opioids),
antihistamines, antidepressants, antipsychotics, cannabis, and alcohol
may result in severe drowsiness, decreased
awareness, breathing problems, coma and death. If you have any concern
about taking this medicine, speak to
your doctor.
PREGABALIN APOTEX
_contains the active ingredient pregabalin _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about PREGABALIN
APOTEX.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking PREGABALIN
APOTEX against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet. You may need to
read it again.
What PREGABALIN APOTEX
is used for
PREGABALIN APOTEX is used to
treat neuropathic pain, which is
pain caused by an abnormality of,
or damage to, the nerves.
PREGABALIN APOTEX is also used to
control epilepsy. Epilepsy is a
condition where you have repeated
seizures (fits). There are many
different types of seizures, ranging
from mild to severe.
PREGABALIN APOTEX belongs to a
group of medicines called
anticonvulsants.
These medicines are thought to
work by controlling brain chemicals
which send signals to nerves so
that seizures do not happen.
PREGABALIN APOTEX also has pain
relieving effects.
PREGABALIN APOTEX may be used
alone, or in combination with other
medicines, to treat your condition.
Your doctor may prescribe
PREGABALIN APOTEX in addition to
your current therapy when your
current treatment is no longer
working as well as before.
Y

خصائص المنتج

AUSTRALIAN PRODUCT INFORMATION
PREGABALIN APOTEX (PREGABALIN) CAPSULES
1.
NAME OF THE MEDICINE
Pregabalin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREGABALIN APOTEX capsules contain the active ingredient pregabalin.
Excipients with known effect:
-
Sugars as Lactose monohydrate (25 and 50 mg strengths);
-
Lactose monohydrate (all other strengths)
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
PREGABALIN APOTEX 25 mg capsules:
Size: 4 Hard gelatin capsule, cap: light grey, body: light grey with
“25” printed in black ink
PREGABALIN APOTEX 50 mg capsules*:
Size: 3 Hard gelatin capsule, cap: light grey, body: light grey with
“50” and a black line printed in black ink
PREGABALIN APOTEX 75 mg capsules:
Size: 4 Hard gelatin capsule, cap: light red, body: light grey with
“75” printed in black ink
PREGABALIN APOTEX 100 mg capsules*:
Size: 3 Hard gelatin capsule, cap: red, body: red with “100”
printed in black ink
PREGABALIN APOTEX 150 mg capsules:
Size: 2 Hard gelatin capsule, cap: light grey, body: light grey with
“150” printed in black ink
PREGABALIN APOTEX 200 mg capsules*:
Size: 1 Hard gelatin capsule, cap: red, body: red with “200”
printed in black ink
PREGABALIN APOTEX 225 mg capsules*:
Size: 1 Hard gelatin capsule, cap: red, body: light grey with
“225” printed in black ink
PREGABALIN APOTEX 300 mg capsules:
Size: 0 Hard gelatin capsule, cap: red, body: light grey with
“300” printed in black ink
*non-marketed presentations
WARNINGS
MISUSE, ABUSE POTENTIAL OR DEPENDENCE
PREGABALIN APOTEX is a potential drug of misuse, abuse, and
dependence. PREGABALIN APOTEX poses
risks of misuse, abuse and dependence which can lead to overdose and
death especially when used
concomitantly with opioids and other CNS depressants. Assess the
patient’s risk of misuse, abuse or
dependence before prescribing and monitor the patient regularly during
treatment, particularly amongst
patients with current or past misuse, abuse or dependence of opioids
and/or benzo