CLOPINE SUSPENSION clozapine 50 mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clozapine, Quantity: 50 mg/mL

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

clozapine

Pharmaceutical form:

Oral Liquid, suspension

Composition:

Excipient Ingredients: povidone; sodium propyl hydroxybenzoate; purified water; sodium methyl hydroxybenzoate; xanthan gum; glycerol; monobasic sodium phosphate dihydrate; sodium hydroxide; hydrochloric acid; sorbitol solution (70 per cent) (crystallising)

Administration route:

Oral

Units in package:

100 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment with CLOPINE is indicated only in people with treatment-resistant schizophrenia, ie. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs. Non-responsiveness is defined as lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations. Intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).

Product summary:

Visual Identification: A free flowing yellow suspension; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2008-05-16

Patient Information leaflet

WARNING: GASTROINTESTINAL HYPOMOTILITY WITH SEVERE COMPLICATIONS:
Clozapine may cause slowing down or blockage of intestine function,
causing reactions such as constipation; nausea with or
without vomiting; tenderness or swelling of the abdomen, or bloating;
gas/wind; foul-smelling breath; stomach pains/
spasms; leakage of diarrhoea or frequent and forceful bowel movements;
bowel urges with no resulting movements; weight
loss due to lack of appetite; lower back pain; pain or pressure in the
rectum and bleeding from the rectum. These can lead to
extremely severe outcomes. Your doctor must monitor intestine function
before prescribing and during your therapy with
Clopine. It is extremely important to immediately advise your doctor,
coordinator, pharmacist, or any other health professio-
nal, of any changes to your bowel movements.
MYOCARDITIS/CARDIOMYOPATHY:
Cases of myocarditis (heart inflammation) and cardiomyopathy (disease
of heart muscles) have been reported in patients on
clozapine, some being very severe. Please advise your doctor if you
have, or previously had, any heart problems. Your
doctor will also monitor for this. If you feel any symptoms such as
chest pain, please speak to your doctor immediately.
CLOPINE
®
_clozapine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CLOPINE.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
THE INFORMATION IN THIS LEAFLET WAS
LAST UPDATED ON THE DATE LISTED ON
THE FINAL PAGE. MORE RECENT
INFORMATION ON THE MEDICINE MAY
BE AVAILABLE. YOU SHOULD ENSURE
THAT YOU SPEAK TO YOUR PHARMACIST
OR DOCTOR TO OBTAIN THE MOST UP TO
DATE INFORMATION ON THE MEDICINE.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking CLOPINE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING T

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION –
CLOPINE
® (CLOZAPINE)
WARNING
_CLOZAPINE _
_INDUCED _
_GASTROINTESTINAL _
_HYPOMOTILITY:_
SEVERE
GASTROINTESTINAL
ADVERSE
REACTIONS HAVE OCCURRED WITH THE USE OF CLOZAPINE RESULTING IN
POTENTIAL OUTCOMES OF
HOSPITALISATION, SURGERY AND DEATH (SEE SECTION 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE, AND SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). PRIOR TO
INITIATING AND DURING
TREATMENT OF CLOPINE, SCREEN FOR CONSTIPATION AND IF NECESSARY, MANAGE
AS PER CURRENT
CLINICAL GUIDELINES.
_MYOCARDITIS/CARDIOMYOPATHY_: CASES OF MYOCARDITIS, SOME OF WHICH HAVE
BEEN FATAL, AND
CARDIOMYOPATHY HAVE BEEN REPORTED IN PATIENTS ON CLOZAPINE (SEE
SECTION 4.4 SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR
USE
AND
SECTION
4.8
ADVERSE
EFFECTS
(UNDESIRABLE
EFFECTS)). IF MYOCARDITIS OR CARDIOMYOPATHY IS SUSPECTED, CLOZAPINE
TREATMENT SHOULD BE
STOPPED AND THE PATIENT IMMEDIATELY REFERRED TO A CARDIOLOGIST.
GENERALLY, PATIENTS WITH
A
HISTORY
OF
CLOZAPINE-ASSOCIATED
MYOCARDITIS
OR
CARDIOMYOPATHY
SHOULD
NOT
BE
RECHALLENGED WITH CLOZAPINE.
1.
NAME OF THE MEDICINE
Clozapine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CLOPINE
®
25
Each 25 mg tablet contains 25 mg clozapine.
CLOPINE
®
50
Each 50 mg tablet contains 50 mg clozapine.
CLOPINE
®
100
Each 100 mg tablet contains 100 mg clozapine.
CLOPINE
®
200
Each 200 mg tablet contains 200 mg clozapine.
CLOPINE
®
Suspension
Each 1 mL of suspension contains 50 mg clozapine.
EXCIPIENTS WITH KNOWN EFFECT:
_TABLETS:_
Contains Sugars (as lactose monohydrate).
_SUSPENSION:_
sorbitol solution (70 per cent) (crystallising), sodium methyl
hydroxybenzoate
and sodium propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of excipients.
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Supersedes: pfpcloia10120
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3.
PHARMACEUTICAL FORM
CLOPINE
®
25 – 25 mg tablets: Round, yellow, flat, beveled edge tablets
engraved with ‘25’
over a pressure sensitive breakline on one face. The other face plain.