NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
STEMZINE®
prochlorperazine maleate
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about Stemzine.
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 Stemzine against the benefits they expect it will 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 Stemzine is used for
Stemzine belongs to a group of medicines called phenothiazines.It helps to correct imbalances in the brain, allowing it to function correctly. These chemicals may also affect the parts of the brain which control nausea (feeling sick) and vomiting.
Stemzine is used to treat nausea, vomiting and dizziness due to various causes, including migraine (severe headache).
Your doctor may have prescribed Stemzine for another reason.
Ask your doctor if you have any questions about why Stemzine has been prescribed for you.
This medicine is available only with a doctor’s prescription.
Stemzine is not recommended for use in children (under the age of 2 years or children under 10kg in weight) because children may develop unusual face and body movements.
Before you take it
When you must not take it
Do not take Stemzine if you have an allergy to:
Stemzine
the group of medicines called phenothiazines
any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Stemzine may include:
shortness of breath, wheezing or difficulty in breathing
swelling of the face, lips, drug interactions with zoloft tongue or other parts of the body
rash, itching or hives on the skin
You should not take Stemzine if you have any of the following medical conditions:
shock
disease of the blood with a low number of blood cells
yellowing of the skin and/or eye, also called jaundice
Stemzine must not be given to anyone who is unconscious or in a coma.
Do not take any medicines that cause drowsiness while you are taking Stemzine.
Do not take Stemzine after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not take Stemzine if the packaging is torn or shows signs of tampering or the tablets do not look quite right.
If you are not sure whether you should start taking Stemzine, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
Tell your doctor if you are pregnant or intend to become pregnant.
Like most phenothiazine medicines, Stemzine is not recommended for use during pregnancy. If there is a need to take Stemzine during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed.
It is recommended that you do not breastfeed while taking Stemzine, as it is not known whether Stemzine passes into breast milk.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
phaechromocytoma, a rare tumour of the adrenal glands which sit near the kidneys.
Parkinson’s disease, a disease of the brain affecting movement which causes trembling, rigid posture, slow movement and a shuffling, unbalanced walk.
myasthenia gravis, a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs
kidney problems
heart and blood vessel problems, low blood pressure
blood clots
liver disease
prostate problems
bowel problems
epilepsy, seizures or fits
low blood calcium levels
decreased thyroid activity
glaucoma, a condition in which there is usually a build-up of fluid in the eye
neuroleptic malignant syndrome, a reaction to some medicines with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
a reaction to some medicines with uncontrollable twitching or jerking movements of the arms and legs.
dementia
diabetes
a low number of white blood cells.
Tell your doctor if you are about to have any surgery which requires a general anaesthetic.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Stemzine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Stemzine may interfere with each other. These include:
some medicines used to control depression or mood swings or mental illness such as lithium
medicines metabolised by CYP2D6 enzymes such as amitriptyline
alcohol
desferrioxamine, a drug used in iron overdose
medicines used for cancer such as procarbazine
some medicines used to control epilepsy such as phenobarbital and carbamazepine
antibiotics used to treat infections
medicines used to treat Parkinson’s disease such as levodopa
medicines used for the treatment of diabetes
anticholinergic medicines which are used to relieve stomach cramps, spasms and travel sickness
atropine, a medicine which may be used in some eye drops or cough and cold preparations
some oral medicines used to prevent your blood from clotting
medicines used to treat high blood pressure or heart problems such as clonidine, guanethidine and propranolol
medicines used to treat fluid build-up in your body.
medicines used to treat a fast or irregular heart beat e.g. amiodarone, quinidine, disopyramide.
medicines that can slow your heart beat e.g. diltiazem, verapamil.
medicines that can reduce potassium levels in the blood e.g. diuretics, laxatives.
other medicines that can affect your heart rate e.g. methadone, pentamidine.
antacids containing magnesium, aluminium and calcium salts, oxides and hydroxides
adrenaline used for severe allergic reactions
amfetamine.
These medicines may be affected by Stemzine or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Stemzine.
How to take it
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how much Stemzine to take, depending on your condition and whether or not you are taking any other medicines.
The usual recommended dose for nausea and vomiting is 1 or 2 tablets two to three times daily.
The usual recommended dose for dizziness is 1 or 2 tablets three to four times daily.
How to take it
Swallow Stemzine whole with a full glass of water.Do not chew the tablets.
When to take it
It does not matter if you take Stemzine before or after food.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
How long to take it
Continue taking the tablets for as long as your doctor tells you.
If you take too much (overdose)
Do not try to vomit.
Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital if you think that you, or anyone else, has taken too much Stemzine.Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of overdose may include the following:
coma
restlessness, shaking, muscle twitching, muscle weakness, spasm
confusion
excitement or agitation
low blood pressure
irregular or fast heart beat
decrease in body temperature
small or large pupils in the eye
difficulty in swallowing or breathing
blue skin
feeling of tiredness, drowsiness, or lack of energy
difficulty in speaking
convulsions.
Your doctor or pharmacist has information on how to recognise and treat an overdose. Ask your doctor or pharmacist if you have any concerns.
While you are taking it
Things you must do
Tell your doctor immediately if you notice any uncontrolled movements of the tongue, face, mouth or jaw, such as puffing of the cheeks, puckering of the mouth or chewing movements.
These are symptoms of a very rare condition called tardive dyskinesia, which may develop in people taking phenothiazine medicines, including Stemzine.
The condition is more likely to occur during long term treatment with Stemzine, especially in elderly women. In very rare cases, this may be permanent.
Tell any other doctors, dentists and pharmacists who are treating you that you are takingStemzine.
If you are about to be started on any new medicines, tell your doctor, dentist or pharmacist that you are taking Stemzine.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking Stemzine.
If you become pregnant while taking Stemzine, tell your doctor immediately.
Things you must not do
Do not give Stemzine to anyone else, even if they have the same condition as you.
Do not take Stemzine to treat any other complaints unless your doctor or pharmacist tells you to.
Do not stop taking Stemzine, or lower the dosage, even if you are feeling better, without checking with your doctor.
If you stop taking Stemzine suddenly, your condition may worsen or your chance of getting an unwanted side effect may increase.To prevent this, your doctor may gradually reduce the amount of Stemzine you take each day before stopping completely.
Things to be careful of
Be careful driving or operating machinery until you know how Stemzine affects you.
As with other medicines, Stemzine may cause dizziness, light-headedness, tiredness, drowsiness in some people.
Make sure you know how you react to Stemzine before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.If this occurs do not drive.
If you drink alcohol, dizziness or light-headedness may be worse.
If Stemzine makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position.Getting up slowly may help.
Be careful when drinking alcohol while taking Stemzine.Combining Stemzine and alcohol can make you more sleepy, dizzy or lightheaded.
Your doctor may suggest you avoid alcohol while you are being treated with Stemzine.
It is advised to avoid exposure to direct sunlight during treatment. If outdoors, wear protective clothing and use at least a 15+ sunscreen.
Stemzine may cause your skin to be much more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness, or a severe sunburn. If your skin does appear to be burning, tell your doctor.
Make sure you keep cool in hot weather and keep warm in cool weather.
Stemzine may affect the way your body reacts to temperature changes.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel wellwhile you are taking Stemzine.
Stemzine helps most people with nausea, vomiting and dizziness, but it may have unwanted side effects in a few people.
All medicines can have side effects.
Sometimes they are serious, most of the time they are not.You may need medical treatment if you get some of the side effects.If you are over 65 years of age you may have an increased chance of getting side effects.
Ask your doctor or pharmacist to answer any questions you may have.
If you get any side effects, do not stop taking Stemzine without first talking to your doctor or pharmacist.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
constipation
dry mouth
drowsiness
restlessness
trembling, rigid posture, mask-like face, slow movements and a shuffling unbalanced walk
uncontrollable twitching, jerking or writhing movements
blurred vision
low blood pressure.
The following side effects are less common:
changes in heart beats
swelling of the hands, ankles or feet
skin rash
for females: unusual secretion of breast milk, irregular or stopping of periods
for males: breast enlargement, difficulty in ejaculating, getting or maintaining an erection, or persistent painful erection
severe pain in the stomach with bloating, gut cramps and vomiting
difficulty passing urine
yellowing of the skin and/or eyes
headache
insomnia
seizures
agitation
dizziness
difficulty in breathing
brownish deposits in the eyes
stuffy nose.
If any of the following happen, tell your doctor or pharmacist immediately or go to Accident and Emergency at your nearest hospital:
unusual muscle tone or spasms causing distortion of the body in children
shortness of breath, wheezing or difficulty in breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
sudden increase in body temperature, extremely high blood pressure and severe convulsions.
These are very serious side effects.
You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After using Stemzine
Storage
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack, they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.Protect from light.
Do not store Stemzine or any other medicine in the bathroom or near a sink.
Do not leave it in the car on hot days or on window sills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor or pharmacist tells you to stop taking Stemzine, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product Description
What it looks like
Stemzine tablets are white, round and marked with “S”.
Stemzine tablets are available in packs of 25.
Ingredients
The active ingredient in Stemzine tablets is prochlorperazine maleate (5mg).
The tablets also contain the following inactive ingredients:
wheat starch
calcium hydrogen phosphate dihydrate
magnesium stearate
sodium lauryl sulfate.
Manufacturer/Sponsor
Stemzine is supplied in Australia by
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Toll Free Number (medical information): 1800 818 806
Email: [email protected]
Registration No AUST R 67940
Date of preparation:
February 2019
stemzine-ccsiv4-cmiv11-08feb19
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