SERENACE [Injection]

SERENACE [Injection]

Active ingredient(s): Haloperidol

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Consumer Medicine Information (CMI)

This leaflet provides important information about using SERENACE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using SERENACE.

Where to find information in this leaflet:

1. Why am I using SERENACE?
2. What should I know before I use SERENACE?
3. What if I am taking other medicines?
4. How do I use SERENACE?
5. What should I know while using SERENACE?
6. Are there any side effects?
7. Product details

1. Why am I using SERENACE?

SERENACE contains the active ingredient haloperidol. SERENACE is an antipsychotic which helps to correct chemical imbalances in the brain.

SERENACE is used to mental illnesses such as:

• Schizophrenia, an illness with disturbances in thinking, feelings and behaviour
• Mania, an illness where the patient experiences episodes of overactivity, elation or irritability
• Severe anxiety, tension or excitement and severe agitation, hyperactivity or aggression in patients with mental or emotional illness
• Behavioural problems in children with mental retardation or mental illness
• Nausea and vomiting (caused by cancer treatment)
• Anxiety and pain during surgery (neurolept anaesthesia)
• Tourette’s Syndrome, a condition with uncontrolled vocal outbursts and body movements (tics).

Your doctor may have prescribed it for another reason.

There is no evidence that this medicine is addictive.

2. What should I know before I use SERENACE?

• Before you receive SERENACE, your doctor may recommend that you have an electrocardiogram or ECG.
• Your doctor may also recommend that you have an ECG on a regular basis while taking SERENACE.

Warnings

Do not use SERENACE if:

• You are allergic to haloperidol, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine
• You have or have had any of the following medical conditions:
  – brain damage
  – Parkinson’s Disease
  – severe depression
  – alcohol or drug intoxication
  – spasticity, where a group of muscles are stiff and restricted in movement
  – Parkinsonian-like symptoms together with senility
  – breast cancer
  – serious heart condition e.g. heart attack, heart failure, unusual heartbeat
• You are taking medicines used to treat fast or irregular heartbeat (arrhythmia)
• The individual is unconscious or in a coma
• It is after the expiry date (EXP) printed on the pack.
• The packaging is torn or shows signs of tampering.

Symptoms of an allergic reaction to SERENACE may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; skin rash, itching or hives.

Check with your doctor if you:

Take any medicines or other conditions.

If you smoke as:

• Nicotine can affect the amount of haloperidol in your body. Sudden change in your usual smoking habits can also change the effects of haloperidol.

Will be in a hot environment or do a lot of exercise as:

• SERENACE may make you sweat less, causing your body to overheat.

Have any other medical conditions especially:

• Tumour of the pituitary gland, a small gland at the base of the brain
• Brain tumour
• Kidney problems
• Difficulty passing urine
• Heart and blood vessel problems
• Fast or irregular heart beats (arrhythmia)
• Unusual amount of salt in the body
• Liver disease
• Disease of the blood with a reduced number of red or white blood cells or platelets
• Prostate problems
• Breast cancer or a family history of breast cancer
• Breathing difficulties (asthma, emphysema, respiratory infections, silent pneumonia)
• Paralytic ileus, a condition where the small bowel does not work properly
• Blockage in your intestines
• Epilepsy, seizures or fits
• Diabetes
• Low blood pressure
• Sleep apnoea
• An overactive or underactive thyroid gland
• Glaucoma, a condition in which there is usually a build-up of fluid in the eye
• Eye problems, such as diseases of the retina or blurred vision
• Neuroleptic malignant syndrome, a reaction to some medicines with a sudden increase in body temperature, extremely high blood pressure and severe convulsions
• Tardive dyskinesia, a reaction to some medicines with worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks or jaws which may progress to the arms and legs
• Phaeochromocytoma, a rare tumour of the adrenal gland which is near the kidneys
• Subarachnoid haemorrhage, serious bleeding around the brain
• Serious starvation (lack of food)
• Alcoholism or drug dependence
• Dementia-related psychosis (loss of memory and other mental ability).

The elderly with dementia-related psychosis and taking SERENACE may have a rare increased risk of death. Talk to your doctor if you have any questions.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with 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.

Babies exposed to antipsychotic medicines including SERENACE during the third trimester of pregnancy are at risk of experiencing breathing problems, difficulty in feeding, spasms, restlessness, involuntary movements and/or withdrawal symptoms following delivery.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is no recommended for us while breastfeeding as it may pass into breast milk.

Use in Children

• SERENACE is not recommended for use in children under the age of 3 years, as there is not enough information on it effects in this age group.
• SERENACE should not be given to children under 12 years of age, unless directed by the child’s doctor.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and SERENACE may interfere with each other. These include:

• Alcohol
• Nicotine or tobacco smoke
• Pain killers
• Benzodiazepines and other medicines used to treat anxiety or to help you sleep
• Medicines used to treat hayfever, coughs and colds
• Anticonvulsants, medicines used to control epilepsy
• Medicines used to control depression or mood swings e.g. fluoxetine, fluvoxamine, nefazodone, paroxetine, venlafaxine, lithium, carbamazepine
• Antipsychotic medicines, used to treat mental illnesses
• Medicines used to treat high blood pressure (hypertension) and heart conditions
• Medicines used to treat fast or irregular heartbeat (arrhythmia)
• Medicines used to treat Parkinson’s Disease
• Anticholinergic medicines, used to prevent travel sickness, relieve stomach cramps or treat Parkinson’s Disease
• Anticoagulants, medicines used to prevent blood clots e.g. warfarin
• Medicines used as appetite suppressants
• Tacrine, medicine used to treat dementia in Alzheimer’s disease
• Stimulants such as amphetamine
• Adrenaline, a medicine used in emergency situations
• Rifampicin, antibiotic used to treat infections.

The above medicines may either reduce the effectiveness of SERENACE, reduce its own effectiveness, and/or react with it resulting in untoward or sometimes dangerous side effects.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SERENACE.

4. How do I use SERENACE?

How much is given

• Your doctor will decide what dose you will receive.
  This depends on your condition and other factors such as your weight.

How it is given

• Except under unusual circumstances, SERENACE is given as an injection into a muscle, or as a slow injection into a vein, by a health care professional.

How long is it given for

• SERENACE injection should be administer as recommended by your doctor.

If you use too much SERENACE (overdose)

As SERENACE injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

If you are given too much SERENACE you may have coma, breathing difficulty, low or high blood pressure, drowsiness, muscle weakness or stiffness, unusual heartbeat, unusual or uncontrollable movements such as shaking and trembling.

If you experience any side effects after being given SERENACE injection, tell your doctor immediately or go to Accident and Emergency at your nearest hospital.

Symptoms of an overdose to SERENACE include some of the side effects listed under Section 6. Are there any side effects?

If you think that you have used too much SERENACE, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using SERENACE?

Things you should do

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 immediately 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 doctors appointments so that your progress can be checked. Your doctor may want to take some blood or request eye or skin tests to check your progress from time to time. This helps prevent unwanted side effects.

Call your doctor straight away if you:

Notice any worm-like movements of the togue, 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.

Remind any doctor, dentist or pharmacist you visit that you are using SERENACE.

Things you should not do

Do not give SERENACE to anyone else even if their symptoms seem similar or they have the same condition as you.

Do not use SERENACE to treat any other complaints unless your doctor tells you to.

Do not stop using SERENACE or lower the dosage, even if you are feeling better, without checking with your doctor.

• If you stop using 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 use each day before stopping the medicine completely.

Do not take any medicines that cause drowsiness while you are using SERENACE, unless recommended by your doctor.

Dizziness

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.

Sun and Temperature Sensitivity

If outdoors, wear protective clothing and use at least a SPF 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.

Driving or using machines

Be careful before you drive or use any machines or tools 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.

Drinking alcohol

Tell your doctor if you drink alcohol.

Combining SERENACE and alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest you avoid alcohol while you are being treated with SERENACE.

Looking after your medicine

• Keep the injections in a cool dry place where the temperature stays below 30°C
• SERENACE injections should be kept in their pack until it is time for them to be given. If you take the injections out of the pack they may not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Young children or adolescents and the elderly may have an increased chance of getting side effects.

Less serious side effects

Less serious side effects

What to do

Redness and pain at the injection site Drowsiness or tiredness Restlessness, agitation, anxiety or excitement Confusion Headaches Inability to sleep Muscle weakness Difficulty in speaking and/or swallowing Increased or decreased sweating Dry mouth Indigestion Nausea and/or vomiting Increased appetite Loss of appetite Weight changes Constipation Diarrhoea Increased salivation Blurred vision or difficulty focusing Changes in skin colour (pale skin) Hot, dry skin Swelling of your hands, feet and/or ankles Painful, swollen breasts or breast enlargement in men Unusual secretion of breast milk Changes in your menstrual periods Impaired sexual function in men Loss of blood sugar control, including in diabetes.

Speak to your doctor if you have any of these less serious side effects and they worry you. These are the more common side effects of SERENACE. They are usually mild and short lived.

Serious side effects

Serious side effects

What to do

Skin rash Pinkish, itchy swellings on the skin, also called hives or nettle rash Red, itchy spots which may blister or form raised, red, pale-centered marks Extremely high body temperature (fever) Symptoms of sunburn (such as redness, itching, swelling or blistering of the skin) which occur more quickly than normal Dizziness or spinning sensation (vertigo) Unable to pass urine Fast breathing Fast, pounding or irregular heart beats Signs of frequent infections such as fever, chills, sore throat or mouth ulcers Asthma and other breathing difficulties Bleeding or bruising more easily than normal Tiredness, headaches, being short of breath when exercising, dizziness and looking pale (anaemia) Yellowing of the skin and/or eyes Unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of arms and legs Sudden onset of uncontrollable muscle spasms affecting the eyes, head, neck and body Persistent painful erection (priapism) Seeing, feeling or hearing things that are not there (hallucinations) 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 Regular episodes of irregular heartbeat, dizziness and loss of consciousness. The below are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare. Sudden signs of allergy such as skin rash, itching or hives; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing Severe spasms in the muscles of the shoulders, neck and upper body (dystonia) Convulsions, fits or seizures Sudden increase in body temperature, with sweating, fast heart beat, muscle stiffness and fluctuating blood pressure which may lead to coma (neuroleptic malignant syndrome Very fast, uneven or forceful heartbeat (palpitations), weakness, fainting (symptoms relating to QT prolongation and Torsade de Pointes) Collapse

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. Serious side effects are rare.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

You may notice some side effects after you have finished using SERENACE. The effects of it may last for days after you have stopped use.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What SERENACE contains

Active ingredient (main ingredient)	Each 1 mL ampoule contains 5mg haloperidol
Other ingredients (inactive ingredients)	(S)-lactic acid Sodium hydroxide Water for injections

Do not take this medicine if you are allergic to any of these ingredients.

SERENACE injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

What SERENACE looks like

SERENACE injection is a clear, colourless solution practically free of visible particle in amber coloured 1 mL glass ampoules.

Packs of 10 ampoules.

(Aust R 188367).

Who distributes SERENACE

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards, NSW 2065
Australia

This leaflet was prepared in October 2022.