Consumer Medicine Information
This leaflet answers some common questions about SERENACE. 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 SERENACE 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.
SERENACE is used to treat mental illnesses such as:
It is also used to treat:
Your doctor may have prescribed SERENACE for another reason.
Ask your doctor if you have any questions about why SERENACE has been prescribed for you. SERENACE belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness. These chemicals may also affect the parts of the brain, which control nausea and vomiting.
There is no evidence that this medicine is addictive or habit forming.
This medicine is only available with a doctor’s prescription.
SERENACE is not recommended for use in children under the age of 3 years, as there is not enough information on its effects in this age group.
Do not take SERENACE if you have an allergy to:
Symptoms of an allergic reaction to SERENACE may include:
Do not take SERENACE if you have or have had any of the following medical conditions:
SERENACE should not be given to anyone who is unconscious or in a coma.
SERENACE should not be given to children under 12 years of age, unless directed by the child’s doctor. SERENACE is not recommended for use in children under 3 years of age.
Do not take it after the expiry date (EXP) printed on the pack.
Do not take it if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking SERENACE, talk to your doctor or pharmacist.
Tell your doctor if you are allergic to:
Tell your doctor if you are pregnant or intend to become pregnant. Like most antipsychotic medicines, SERENACE is not recommended for use during pregnancy.
However, if you need to take SERENACE during your pregnancy, your doctor will discuss the risks and benefits involved in taking it.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is not recommended for use while breast feeding as it may pass into breast milk.
Tell your doctor if you have or have had any other medical conditions, especially the following:
Tell your doctor if you will be in a hot environment or do a lot of vigorous exercise. SERENACE may make you sweat less, causing your body to overheat.
Tell your doctor if you smoke. Nicotine can affect the amount of haloperidol in your body. Sudden change in your usual smoking habits can also change the effects of haloperidol.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking SERENACE.
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 SERENACE may interfere with each other.
The above medicines may either reduce the effectiveness of SERENACE, reduce its own effectiveness, and/or react with SERENACE resulting in untoward or sometimes dangerous side effects.
This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking SERENACE.
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.
Adults: 1-15 mg per day depending on severity, up to 100 mg per day.
Elderly: 1-3 mg per day is usually sufficient.
Initial dose- 1-3 mg per day.
Maintenance dose- 0.05 mg per kg of body weight daily.
Your doctor or pharmacist will tell you how much SERENACE you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.
Swallow SERENACE tablets with a glass of water.
Shake the bottle well and accurately measure the dose with a medicine measure.
Shaking the bottle and using a medicine measure will make sure that you get the correct dose. You can buy a medicine measure from your pharmacist.
The carton also contains a dropper that delivers 1 mg per 10 drops.
Take SERENACE at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
It does not matter if you take SERENACE before or after food.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
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.
Continue taking the tablets or liquid for as long as your doctor tells you. SERENACE helps control your condition, but does not cure it. Therefore, it is important that you keep taking it every day.
Do not stop taking SERENACE unless your doctor tells you to, even if you feel better.
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much SERENACE. Do this even if there are no signs of discomfort or poisoning. Also, report any other medicine or alcohol which has been taken. You may need urgent medical attention. Keep telephone numbers for these places handy.
Symptoms of an overdose to SERENACE may include some of the side effects listed below (see “Side Effects” section), but are usually of a more severe nature.
Tell your doctor immediately if you notice any worm-like movements of the tongue, or other uncontrolled movements of the tongue, mouth, cheeks, or jaw, which may progress to the arms and legs. These are symptoms of a condition called tardive dyskinesia, which may develop in people taking antipsychotic medicines, including SERENACE.
This condition is more likely to occur during long term treatment with this medicine, especially in elderly women. In very rare cases, this may be permanent. However, if detected early, these symptoms are usually reversible.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking SERENACE.
If you are about to be started on any new medicine, remind your doctor, dentist or pharmacist that you are taking SERENACE.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking SERENACE.
Tell your doctor If you become pregnant while taking SERENACE.
If you need to have any medical tests while you are taking SERENACE, tell your doctor. It may affect the results of some tests.
Be sure to keep all of your doctor’s appointments so that your progress can be checked. Your doctor will check your progress and may want to take some blood/eye/skin tests from time to time. This helps to prevent unwanted side effects.
Do not give SERENACE to anyone else, even if their symptoms seem similar or they have the same condition as you.
Do not take SERENACE to treat any other complaints unless your doctor tells you to.
Do not stop taking SERENACE, or lower the dosage, even if you are feeling better, without checking with your doctor. If you stop taking SERENACE 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 SERENACE you take each day before stopping the medicine completely.
Do not take any medicines that cause drowsiness while you are taking SERENACE, unless recommended by your doctor.
Be careful driving or operating machinery until you know how SERENACE affects you. As with other antipsychotic medicines, SERENACE may cause dizziness, light-headedness, tiredness, and drowsiness in some people. Make sure you know how you react to SERENACE 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 this occurs, do NOT drive.
If SERENACE makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position. Getting up slowly may help. This will allow your body to get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.
Be careful when drinking alcohol while taking SERENACE. Combining SERENACE and alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest you avoid alcohol while you are taking SERENACE.
If outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use a sun lamp or tanning bed or booth. SERENACE 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 severe sunburn. If your skin does appear to be burning, tell your doctor immediately.
Make sure you keep cool in hot weather and keep warm in cool weather. SERENACE may affect the way your body reacts to temperature changes.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SERENACE. SERENACE helps most people with the conditions listed at the beginning of this leaflet, 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.
Young children or adolescents and the elderly may have an increased chance of getting side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
These are the more common side effects of SERENACE. They are usually mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.
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, while taking SERENACE. You may notice some side effects after you have finished taking SERENACE. The effects of SERENACE may last for days after you have stopped taking it.
Keep your tablets or liquid in their bottle until it is time to take them. If you take the tablets or the liquid out of the pack, they may not keep well.
Keep your tablets or liquid in a cool dry place where the temperature stays below 300C.
Do not store SERENACE or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on windowsills. 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.
If your doctor tells you to stop taking SERENACE or the medicine has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
SERENACE Tablets: (oral)
SERENACE Liquid: (oral)
SERENACE tablets contain:
SERENACE 0.5 mg ablets also contain:
SERENACE 5 mg tablets also contain:
SERENACE Liquid contains:
SERENACE products do not contain any sucrose, gluten, or tartrazine.
The Australian Product Registration Numbers for:
Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
This leaflet was revised in June 2012
Published by MIMS April 2014