PREGABALIN SANDOZ pregabalin 25mg capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
18-08-2021
Summary of Product characteristics
(SPC)
18-08-2021
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
pregabalin, Quantity: 25 mg
Available from:
Sandoz Pty Ltd
INN (International Name):
Pregabalin
Pharmaceutical form:
Capsule
Composition:
Excipient Ingredients: iron oxide red; iron oxide yellow; titanium dioxide; Gelatin; iron oxide black; maize starch; pregelatinised maize starch; purified talc
Administration route:
Oral
Units in package:
56 capsules
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
PREGABALIN SANDOZ is indicated for the treatment of neuropathic pain in adults. PREGABALIN SANDOZ is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Product summary:
Visual Identification: skin coloured hard gelatin capsule; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2015-12-01
Patient Information leaflet
PREGABALIN SANDOZ
®
1
PREGABALIN
SANDOZ
®
_pregabalin capsules _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pregabalin Sandoz.
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 Pregabalin
Sandoz 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 WITH THE MEDICINE.
You may need to read it again.
WHAT PREGABALIN
SANDOZ IS USED FOR
Pregabalin Sandoz is used to treat
neuropathic pain, which is pain
caused by an abnormality of, or
damage to, the nerves.
Pregabalin Sandoz 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 Sandoz 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 Sandoz also has analgesic
effects (relieves pain).
Pregabalin Sandoz may be used
alone, or in combination with other
medicines, to treat your condition.
Your doctor may prescribe
Pregabalin Sandoz in addition to
your current therapy when your
current treatment is no longer
working as well as before.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PREGABALIN
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
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
PREGABALIN SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PREGABALIN SANDOZ IF
YOU HAVE AN ALLERGY TO:
•
pregabalin, the active ingredient
in Pregabalin Sandoz or
•
any of the ingredients listed at
Read the complete document
Summary of Product characteristics
210809-pregabalin-sandoz-pi
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
PREGABALIN SANDOZ
® (PREGABALIN)
1
NAME OF THE MEDICINE
Pregabalin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pregabalin Sandoz
®
25 mg capsule contains 25 mg pregabalin.
Each Pregabalin Sandoz
®
75 mg capsule contains 75 mg pregabalin.
Each Pregabalin Sandoz
®
150 mg capsule contains 150 mg pregabalin.
Each Pregabalin Sandoz
®
300 mg capsule contains 300 mg pregabalin.
_Not all strengths may be marketed. _
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pregabalin Sandoz 25 mg capsules are skin coloured hard gelatin
capsules.
Pregabalin Sandoz 75 mg capsules are hard gelatin capsules with red
cap and white body.
Pregabalin Sandoz 150 mg capsules are white hard gelatin capsules.
Pregabalin Sandoz 300 mg capsules are hard gelatin capsules with red
cap and skin coloured
body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Pregabalin Sandoz is indicated for the treatment of neuropathic pain
in adults.
Pregabalin Sandoz is indicated as adjunctive therapy in adults with
partial seizures with or
without secondary generalisation.
WARNINGS
MISUSE, ABUSE POTENTIAL OR DEPENDENCE
Pregabalin Sandoz is a potential drug of misuse, abuse and dependence.
Pregabalin Sandoz
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 benzodiazepines (see Section 4.4
Special warnings and
precautions for use).
210809-pregabalin-sandoz-pi
Page 2 of 22
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The dose range is 150 to 600 mg per day given in two divided doses.
Pregabalin may be taken with or without food.
_50, 100, 200 and 225 mg strength capsules are available in other
brands. _
_NEUROP
Read the complete document
