Leonard Harry Goldberg, M.D., F.R.C.P. RESEARCH: A Study to Investigate the Efficacy and Safety of Valacyclovir (1000 mg and 500 mg, twice daily) Compared with Placebo in the Treatment of Recurrent HSV in Immunocompetent Patients Principal Investigator: Leonard H. Goldberg, M.D. Protocol to Compare Suppressive to Acute Acyclovir in the Management of Recurrent Genital Herpes. Prin
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Consumer Medicine Information
Do not take Stemetil if the packaging is torn or
Some medicines and Stemetil may interfere with shows signs of tampering.
This leaflet answers some common questions If you are not sure whether you should start
• some medicines used to control depression or taking Stemetil, talk to your doctor or
It does not contain all the available information.
It does not take the place of talking to your doctor Tell your doctor or pharmacist if you have
All medicines have risks and benefits. Your allergies to:
doctor has weighed the risks of you taking Stemetil against the benefits they expect it will • medicines used to treat Parkinson's disease If you have any concerns about taking this
• anticholinergic medicines which are used to medicine, ask your doctor or pharmacist.
Tell your doctor if you are pregnant or intend
relieve stomach cramps, spasms and travel to become pregnant.
Keep this leaflet with the medicine.
Like most phenothiazine medicines, Stemetil is • atropine, a medicine which may be used in not recommended for use during pregnancy. If there is a need to take Stemetil during your pregnancy, your doctor will discuss with you the • some oral medicines used to prevent your Stemetil belongs to a group of medicines called phenothiazines. It helps to correct chemical Tell your doctor or pharmacist if you are
• medicines used to treat high blood pressure imbalances in the brain, allowing it to function breastfeeding or plan to breastfeed.
correctly. These chemicals may also affect the It is recommended that you do not breastfeed parts of the brain which control nausea (feeling while taking Stemetil, as it is not known whether These medicines may be affected by Stemetil or may affect how well it works. You may needdifferent amounts of your medicine or you may Stemetil is used to treat nausea, vomiting and Tell your doctor or pharmacist if you have or need to take different medicines. Your doctor will dizziness due to various causes, including have had any medical conditions, especially the Your doctor may have prescribed Stemetil for • phaechromocytoma, a rare tumour of the information on medicines to be careful with or adrenal glands which sit near the kidneys.
Ask your doctor if you have any questions
• Parkinson's disease, a disease of the brain about why Stemetil has been prescribed for
affecting movement which causes trembling, rigid posture, slow movement and ashuffling, unbalanced walk.
This medicine is available only with a doctor's
Follow all directions given to you by your
• myasthenia gravis, a disease of the muscles doctor and pharmacist carefully.
They may differ from the information contained Stemetil is not recommended for use in children difficulty in speaking and swallowing and (under the age of 2 years or children under 10kg If you do not understand the instructions on
the pack, ask your doctor or pharmacist for
• heart and blood vessel problems, low blood Your doctor or pharmacist will tell you how Do not take Stemetil if you have an allergy to:
much Stemetil you will need to take each day.
This depends on your condition and whether or not you are taking any other medicines.
the group of medicines called phenothiazines • any of the ingredients listed at the end of this The usual recommended dose for nausea andvomiting is 1 or 2 tablets two to three times daily.
If you are not able to take a tablet, then one 25mg Symptoms of an allergic reaction to Stemetil may suppository or a 1mL (12.5mg) injection is the • glaucoma, a condition in which there is • shortness of breath, wheezing or difficulty in The usual recommended dose for dizziness is 1 or • neuroleptic malignant syndrome, a reaction 2 tablets three to four times daily.
• swelling of the face, lips, tongue or other to some medicines with a sudden increase in Tablets:
Swallow Stemetil tablets whole with a full glass You should not take Stemetil if you have any
of the following medical conditions:
Stemetil may be given as a suppository. First disease of the blood with a low number of wash your hands well with soap and water, Tell your doctor if you are about to have any
then follow these instructions: Go to the • yellowing of the skin and/or eye, also called surgery which requires a general anaesthetic.
toilet and empty your bowels if possible. Do If you have not told your doctor or pharmacist
Stemetil must not be given to anyone who is
about any of the above, tell them before you
Feel the suppository through its plastic shell.
unconscious or in a coma.
start taking Stemetil.
If it feels very soft, chill it in the fridge orcool it by holding it under cold water for Do not take any medicines that cause
drowsiness while you are taking Stemetil.
Tell your doctor or pharmacist if you are
Do not take Stemetil after the expiry date
taking any other medicines, including any that
Moisten the suppository by dipping it briefly (EXP) printed on the pack.
you buy without a prescription from your
If you take this medicine after the expiry date has pharmacy, supermarket or health food shop.
Put one foot up on the side of the bath or If you plan to have surgery that needs a
general anaesthetic, tell your doctor or dentist
Insert the suppository, pointed end first, that you are taking Stemetil.
If you become pregnant while taking Stemetil,
Try not to go to the toilet for at least one tell your doctor immediately.
hour to allow the suppository to work.
• trembling, rigid posture, mask-like face, slow movements and a shuffling unbalanced walk Injection:
Do not give Stemetil to anyone else, even if
Stemetil may be given as an injection into a they have the same condition as you.
muscle. Stemetil injection should only be given by a doctor, nurse or other trained person.
Do not take Stemetil to treat any other
complaints unless your doctor or pharmacist
The following side effects are less common: tells you to.
It does not matter if you take Stemetil before or Do not stop taking Stemetil, or lower the
dosage, even if you are feeling better, without
• swelling of the hands, ankles or feet If you are not sure what to do, ask your doctor
checking with your doctor.
If you stop taking Stemetil suddenly, yourcondition may worsen or your chance of getting • for females: unusual secretion of breast milk, If you have trouble remembering to take your
an unwanted side effect may increase. To prevent medicine, ask your pharmacist for some hints.
this, your doctor may gradually reduce the • for males: breast enlargement, difficulty in amount of Stemetil you take each day before Continue taking Stemetil for as long as your
• severe pain in the stomach with bloating, doctor tells you.
Be careful driving or operating machinery
Do not try to vomit.
until you know how Stemetil affects you.
As with other medicines, Stemetil may cause Immediately telephone your doctor or
dizziness, light-headedness, tiredness, drowsiness pharmacist or the Poisons Information Centre
(telephone 13 11 26) or go to Accident and
Emergency at your nearest hospital if you
Make sure you know how you react to Stemetil think that you, or anyone else, has taken too
before you drive a car, operate machinery, or do much Stemetil. Do this even if there are no
anything else that could be dangerous if you are If any of the following happen, tell your doctor
signs of discomfort or poisoning.
dizzy or light-headed. If this occurs do not drive.
or pharmacist immediately or go to Accident
You may need urgent medical attention.
If you drink alcohol, dizziness or light- and Emergency at your nearest hospital:
• Unusual muscle tone or spasms causing If Stemetil makes you feel light-headed, dizzy
or faint, be careful when getting up from a
These are very serious side effects.
sitting or lying position. Getting up slowly may
Be careful when drinking alcohol while taking
All of these side effects are very rare.
Stemetil. Combining Stemetil and alcohol can
make you more sleepy, dizzy or light-headed.
Other side effects not listed above may occur
Your doctor may suggest you avoid alcohol while in some patients. Tell your doctor or
pharmacist if you notice anything that is
you are being treated with Stemetil.
making you feel unwell.
If outdoors, wear protective clothing and use
at least a 15+ sunscreen.
Do not be alarmed by this list of possible side
Stemetil may cause your skin to be much more effects.
• difficulty in swallowing or breathing sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, Your doctor or pharmacist has information on redness, or severe sunburn. If your skin does how to recognise and treat an overdose. Ask your appear to be burning, tell your doctor.
doctor or pharmacist if you have any concerns.
Make sure you keep cool in hot weather and
keep warm in cool weather.
Stemetil ampoules for injection should be
stored at a pharmacy or hospital. The injection
Stemetil may affect the way your body reacts totemperature changes.
should be kept below 25°C and protected from
Tell your doctor immediately if you notice any
Keep Stemetil suppositories in a cool dry place
uncontrolled movements of the tongue, face,
where the temperature stays below 25°C.
Tell your doctor or pharmacist as soon as
mouth or jaw, such as puffing of the cheeks,
Protect from light.
possible if you do not feel well while you are
puckering of the mouth or chewing
Keep Stemetil tablets in a cool dry place where
Stemetil helps most people with nausea, vomiting the temperature stays below 30°C. Protect
These are symptoms of a very rare condition and dizziness, but it may have unwanted side from light.
called tardive dyskinesia, which may develop in Keep your Stemetil in the pack until it is time
people taking phenothiazine medicines, including to take them.
All medicines can have side effects.
If you take the tablets or suppositories out of the The condition is more likely to occur during long Sometimes they are serious, most of the time they term treatment with Stemetil, especially in elderly are not. You may need medical treatment if you Do not store Stemetil or any other medicine in
get some of the side effects. If you are over 65 the bathroom or near a sink.
years of age you may have an increased chance ofgetting side effects.
Do not leave it in the car on hot days or on
Tell any other doctors, dentists and
pharmacists who are treating you that you are
Ask your doctor or pharmacist to answer any
Heat and dampness can destroy some medicines.
questions you may have.
Keep it where children cannot reach it.
If you are about to be started on any new
If you get any side effects, do not stop taking
A locked cupboard at least one-and-a-half metres medicines, tell your doctor, dentist or
Stemetil without first talking to your doctor or
above the ground is a good place to store pharmacist that you are taking Stemetil.
Tell your doctor or pharmacist if you notice
any of the following and they worry you:
If your doctor or pharmacist tells you to stop
taking Stemetil, or the medicine has passed its
expiry date, ask your pharmacist what to do
with any that are left over.
Stemetil tablets* are white, round and markedwith "S". Tablets are available in packs of 25.
Stemetil suppositories are cream, smooth, torpedoshaped and are available in packs of 5.
Stemetil for injection is a clear liquid in a 1mLglass ampoule, in a pack of 10 ampoules.
prochlorperazine maleate 5mg (active ingredient),wheat starch, calcium hydrogen phosphate,magnesium stearate, sodium lauryl sulfate.
prochlorperazine base equivalent to 25mgprochlorperazine maleate (active ingredient),suppository base (saturated vegetable fat).
prochlorperazine mesylate 12.5 mg/mL (activeingredient), sodium chloride, sodium sulphiteanhydrous, sodium metabisulphite, ethanolamine,water for injection.
Stemetil is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Stemetil is supplied in New Zealand by:
sanofi-aventis new zealand limited
Level 8, James and Wells Tower
56 Cawley Street
Stemetil suppositories25mg - AUST R 27557 Stemetil ampoules for injectionAUST R 27555 * Stemetil tablets currently not available in NewZealand
Vito J. Bruscato, in his capacity as the guardian of Victor Bruscato, appealsfrom the order of the Superior Court of DeKalb County, which granted summaryjudgment to Victor Bruscato’s psychiatrist, Derek Johnson O’Brien, M.D., in thismedical malpractice case.1 The superior court concluded that Bruscato’s malpracticeclaims were barred either by the application of the “impact rule” or o