CIPLA PREGABALIN pregabalin 225 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pregabalin, Quantity: 225 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: purified talc; maize starch; pregelatinised maize starch; titanium dioxide; brilliant blue FCF; purified water; sunset yellow FCF; allura red AC; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

500 - bulk pack, 30, 90 - bulk pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to off white powder filled in size 1 hard gelatin light orange opaque and white opaque capsule linear printed in black ink with Cipla 225 mg on the cap and 684 on the body.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-04-15

Patient Information leaflet

Cipla Pregabalin
1
CIPLA PREGABALIN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING CIPLA PREGABALIN?
Cipla 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.
For more information, see Section 1. Why am I using Cipla Pregabalin?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA PREGABALIN?
Do not use if you have ever had an allergic reaction to pregabalin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Cipla Pregabalin? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Pregabalin and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CIPLA PREGABALIN?
•
The usual dose range is 150 mg per day to 600 mg per day given in two
divided doses.
More instructions can be found in Section 4. How do I use Cipla
Pregabalin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA PREGABALIN?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cipla Pregabalin.
THINGS YOU SHOULD NOT
DO
•
Do not stop using this medicine suddenly unless you have discussed it
with your doctor.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Cipla
Pregabalin affects you.
DRINKING ALCOHOL
•
If you drink alcohol, symptoms such as dizziness and drowsiness may be
worse
LOOKING AFTER YOUR
MEDICINE
•

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CIPLA PREGABALIN
(PREGABALIN) CAPSULES
WARNINGS
MISUSE, ABUSE POTENTIAL OR DEPENDENCE
Pregabalin
is a potential drug of misuse, abuse, and dependence.
Pregabalin
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).
1.
NAME OF THE MEDICINE
Pregabalin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipla pregabalin 25 mg hard gelatin capsules
Each hard capsule contains 25 mg of pregabalin.
Cipla pregabalin 50 mg hard gelatin capsules
Each hard capsule contains 50 mg of pregabalin.
Cipla pregabalin 75 mg hard gelatin capsules
Each hard capsule contains 75 mg of pregabalin.
Cipla pregabalin 100 mg hard gelatin capsules
Each hard capsule contains 100 mg of pregabalin.
Cipla pregabalin 150 mg hard gelatin capsules
Each hard capsule contains 150 mg of pregabalin.
Cipla pregabalin 200 mg hard gelatin capsules
Each hard capsule contains 200 mg of pregabalin.
Cipla pregabalin 225 mg hard gelatin capsules
Each hard capsule contains 225 mg of pregabalin.
Cipla pregabalin 300 mg hard gelatin capsules
Each hard capsule contains 300 mg of pregabalin.
For the full list of excipients, see section 6.1.
Description
Pregabalin is a white to off-white solid, crystalline solid. It is
sparingly soluble in water and basic and
acidic aqueous solutions.
3.
PHARMACEUTICAL FORM
Hard capsules.
Cipla pregabalin 25 mg capsules: white to off white powder filled in
size ‘4’ hard gelatin white opaque
and white opaque capsule linear printed in black ink with 'Cipla 25
mg' on the cap and ‘677’ on the
body.
Cipla pregabalin 50 mg capsules: white to off white powder filled in
size ‘3’ hard gelatin white opaque
a