Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using CLOPINE.
You must have strict and regular blood tests while taking CLOPINE.
Contact your doctor immediately if you develop a fever, signs and symptoms of an infection,
notice any changes to your bowel movements (poo) or become pregnant.
|
---|---|
Things you should not do
|
Do not stop using this medicine suddenly or lower the dosage, even if you are feeling
better, without checking with your doctor.
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how CLOPINE
affects you.
|
Drinking alcohol
|
Tell your doctor if you drink alcohol.
You should not drink alcohol while you are taking CLOPINE.
|
Looking after your medicine
|
Store CLOPINE tablets below 30°C. Protect from light.
Store CLOPINE suspension below 25°C.
|
WARNING:
Gastrointestinal hypomotility (reduced gastrointestinal movement)
Clozapine may cause slowing down of bowel (intestine) function, which may result in
blockage, perforation or tissue damage and cause reactions such as constipation; nausea
with or without vomiting; tenderness or swelling of the stomach, or bloating; gas/wind;
foul-smelling breath; stomach pains/spasms; leakage of diarrhoea or frequent and forceful
bowel movements (poo); bowel urges with no resulting movements; weight loss due to
lack of appetite; lower back pain; pain or pressure in your bottom and bleeding from
the bottom. These can lead to extremely severe outcomes. Your doctor must monitor
bowel function before prescribing and during your therapy with CLOPINE. It is extremely
important to immediately advise your doctor, coordinator, pharmacist, or any other
health professional, of any changes to your bowel movements.
Myocarditis/cardiomyopathy:
CLOPINE may cause myocarditis (inflammation of heart muscle), which may be fatal,
or another heart conditionand 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 monitor you during
treatment. If required, your doctor may want to refer you to a cardiologist for further
tests. If you feel any symptoms such as chest pain, speak to your doctor immediately.
|
Do not use CLOPINE:
Do not use CLOPINE if :
Tell your doctor if you have or have had any of the following medical conditions:
Check with your doctor if you:
Pregnancy and breastfeeding
How much to use
When to take CLOPINE
How to take CLOPINE
CLOPINE Tablets
CLOPINE Suspension
1. Unscrew and remove the cap from the bottle.
2. Push the bottle adaptor into the top of the bottle. Once the adaptor is in place it stays there.
3. Replace the cap and ensure it is tightening.
4. Before the first dose only, SHAKE THE BOTTLE for 90 seconds.
5. Note the expiry date on the product label in permanent marker as 90 days from the date of opening.
6. Leave the bottle to stand for 24 hours to ensure the bubbles formed during shaking have dissipated.
1. Ensure the cap is tightening.
2. SHAKE THE BOTTLE for 10 seconds.
3. Remove the cap from the bottle.
4. Draw air into the oral dispenser (syringe) equivalent to the volume of the dose required.
5. Insert the oral dispenser into the opening of the bottle adaptor. Expel all the air from the oral dispenser into the bottle.
6. Invert the bottle and slowly draw up the amount prescribed by your doctor.
7. Turn the bottle upright and detach the oral dispenser from the bottle adaptor.
8. Invert the oral dispenser to prevent spillage. Swallow the contents of the oral dispenser.
9. Leave the bottle adaptor in place on the bottle.
10. Replace the bottle cap over the bottle adaptor after use.
11. Wash the oral dispenser with warm soapy water after each use. Then rinse well with water.
If you forget to use CLOPINE
If you use too much CLOPINE
(by calling 13 11 26), or
Things you should do
Watch for important side effects
Contact your doctor immediately if you:
Things you should not do
Things to be careful of
Driving or using machines
Drinking alcohol
Looking after your medicine
Getting rid of any unwanted medicine
Side effects
Side effects
|
What to do
|
---|---|
tiredness, drowsiness
dizziness, or light headedness when standing up
constipation or fewer bowel movements than normal (if it seems to be getting worse,
check with your doctor immediately)
nausea, vomiting
stomach discomfort, especially after a meal
diarrhoea
dry mouth
too much saliva
difficulty in swallowing
swelling of the glands in the cheeks
heartburn
headache
mild fever
agitation, confusion, disorientation, vivid dreams
blurred vision
weight gain
changes in sexual function
painful menstrual periods
repetitive and ritualised behaviour (obsessive compulsive symptoms)
stuttering in speech
problems in passing or holding urine, dark urine, excessive urination, nocturnal bedwetting
for males, dry orgasm (retrograde ejaculation) where very little or no semen is ejaculated
as it enters the bladder instead. Urine will appear cloudy after an orgasm
increased or decreased sweating
skin reactions or change in skin colour
"butterfly" rash, joint pain, muscle pain, fever and fatigue
stuffy nose
uncontrolled bending of the body to one side
a strong urge to move the legs (restless legs syndrome) with an unpleasant feeling
in the legs
|
Speak to your doctor if you have any of these side effects and they worry you.
|
Serious side effects
Serious side effects
|
What to do
|
---|---|
severe dull to sharp pain in the stomach, often accompanied by nausea with or without
vomiting, 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 your bottom and bleeding from the bottom.
signs of allergic reaction such as itching, skin rash, hives, swelling of the face,
lips or tongue, difficulty in swallowing or breathing
severe or prolonged constipation, which may be accompanied by tenderness or swelling
of the stomach, or bloating
fainting or loss of consciousness
falls due to seizure, drowsiness, fainting, muscle weakness
chest pain
fever, sore throat, mouth ulcers, "flu-like" symptoms (chills, aching joints, swollen
glands, lack of energy) or any other signs of infection
a fast or irregular heartbeat that is present even when you are resting, accompanied
by rapid breathing, shortness of breath, swelling of the feet or legs, dizziness or
light headedness, or chest pain
symptoms of neuroleptic malignant syndrome, with a sudden increase in body temperature,
sweating, fast heartbeat, muscle stiffness and fluctuating blood pressure which may
lead to coma
seizures or fits
signs of loss of blood sugar control (diabetes) such as excessive thirst, drinking
or eating large amounts, weakness, passing large amounts of urine, dry mouth and skin
spontaneous bleeding or bruising more easily than normal
signs that blood clots may have formed, such as sudden severe headache, sudden loss
of coordination, blurred vision or sudden loss of vision, slurred speech, numbness
in an arm or leg
jaundice, yellowing of the skin and/or eyes
rash, purplish-red spots, usually associated with fever or itching
difficulty in passing urine (pee) or blood in the urine
loss of bladder control
muscle stiffness, muscle weakness, muscle spasms, or muscle pain
muscle spasms associated with fever, red-brown urine
rigidity or stiffness in the arms and legs, shaking or tremor, feeling unable to sit
still
abnormal movements, inability to initiate movement, inability to remain motionless,
inner feeling of restlessness, stiff limbs, trembling hands
symptoms of tardive dyskinesia (uncontrolled movements of the tongue, face, mouth
or jaw such as puffing of the cheeks, puckering of the mouth, chewing movements, grimacing,
lip smacking, rapid eye blinking)
persistent painful erection or prolonged erection
signs of respiratory tract infection or pneumonia such as fever, coughing, difficulty
breathing, wheezing
signs of sepsis such as shivering, fever, rapid breathing and heart rate, a change
in your mental state such as confusion or disorientation
chest pain, cough, hiccups, rapid breathing
varying degrees of pain in the chest and stomach
pauses in breathing or periods of shallow breathing during sleep.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Reporting side effects
What CLOPINE contains
CLOPINE Tablets
Active ingredient
(main ingredient)
|
CLOPINE 25 tablets contain 25 mg of clozapine.
CLOPINE 50 tablets contain 50 mg of clozapine.
CLOPINE 100 tablets contain 100 mg of clozapine.
CLOPINE 200 tablets contain 200 mg of clozapine.
|
---|---|
Other ingredients
(inactive ingredients)
|
povidone
microcrystalline cellulose
lactose monohydrate
sodium starch glycollate
magnesium stearate
|
CLOPINE Suspension
Active ingredient
(main ingredient)
|
Each 1 mL of CLOPINE Suspension contains 50 mg of clozapine
|
---|---|
Other ingredients
(inactive ingredients)
|
sorbitol solution (70% w/w)
povidone
monobasic sodium phosphate dihydrate
sodium methyl hydroxybenzoate
sodium propyl hydroxybenzoate,
xanthan gum
glycerol
hydrochloric acid
sodium hydroxide
purified water
|