BTC PREGABALIN pregabalin 300 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pregabalin

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Pregabalin

Authorization status:

Registered

Patient Information leaflet

BTC PREGABALIN/122020/CMI-2
1
BTC PREGABALIN
_contains the active ingredient pregabalin _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about BTC PREGABALIN.
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 BTC PREGABALIN
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 BTC PREGABALIN is
used for
BTC APOTEX is used to treat
neuropathic pain, which is pain
caused by an abnormality of, or
damage to, the nerves.
BTC 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.
BTC PREGABALIN 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.
BTC PREGABALIN also has pain
relieving effects.
BTC PREGABALIN may be used
alone, or in combination with other
medicines, to treat your condition.
Your doctor may prescribe BTC
PREGABALIN in addition to your
current therapy when your current
treatment is no longer working as
well as before.
Your doctor, however, may use
BTC PREGABALIN for another
purpose.
Ask your doctor if you have any
questions about why it has been
given to you.
This medicine is available only with
a doctor's prescription.
USE IN CHILDREN
There is not enough information to
recommend the use of this
medicine in children under the age
of 18 years.
Before you take BTC
PREGABALIN
_WHEN YOU MUST NOT BE TAKE IT _
DO NOT TAKE BTC PREGABALIN IF
YOU ARE ALLERGIC TO PREGABALIN OR
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or h

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BTC PREGABALIN (PREGABALIN) CAPSULES
_ _
1. NAME OF THE MEDICINE
Pregabalin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BTC Pregabalin capsules contain the active ingredient pregabalin.
25 mg capsules: each capsule contains 25 mg of pregabalin.
75 mg capsules: each capsule contains 75 mg of pregabalin.
150 mg capsules: each capsule contains 150 mg of pregabalin.
300 mg capsules: each capsule contains 300 mg of pregabalin.
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
BTC PREGABALIN 25 mg capsules:
Size: 4 Hard gelatin capsule, cap: light grey, body: light grey with
“25” printed in black ink
BTC PREGABALIN 75 mg capsules:
Size: 4 Hard gelatin capsule, cap: light red, body: light grey with
“75” printed in black ink
BTC PREGABALIN 150 mg capsules:
Size: 2 Hard gelatin capsule, cap: light grey, body: light grey with
“150” printed in black ink
BTC PREGABALIN 300 mg capsules:
Size: 0 Hard gelatin capsule, cap: red, body: light grey with
“300” printed in black ink
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
BTC PREGABALIN is indicated for the treatment of neuropathic pain in
adults.
BTC PREGABALIN is indicated as adjunctive therapy in adults with
partial seizures with or without
secondary generalisation.
4.2. DOSE AND METHOD OF ADMINISTRATION
The dose range is 150 to 600 mg per day given in two divided doses.
BTC Pregabalin capsules may be taken with or without food.
NEUROPATHIC PAIN
Pregabalin treatment can be started at a dose of 150 mg per day, given
as two divided doses. Based on
individual patient response and tolerability, the dosage may be
increased to 300 mg per day, given as two
BTC Pregabalin – AUSTRALIAN PRODUCT INFORMATION
2
divided doses, after an interval of 3 to 7 days, and if needed, to a
maximum dose of 600 mg per day after an
additional 7-day interval.
Since diabetes is frequently complicated by renal disease, patients
with diabetic neuropathy, in acc