SUMMARY CMI
TEVARIPIPRAZOLE®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using TEVARIPIPRAZOLE?
TEVARIPIPRAZOLE contains the active ingredient aripiprazole. TEVARIPIPRAZOLE is used to treat symptoms of schizophrenia.
For more information, see Section 1. Why am I using TEVARIPIPRAZOLE? in the full CMI.
2. What should I know before I use TEVARIPIPRAZOLE?
Do not use if you have ever had an allergic reaction to TEVARIPIPRAZOLE or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use TEVARIPIPRAZOLE? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with TEVARIPIPRAZOLE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use TEVARIPIPRAZOLE?
- Unless your doctor gives you other directions, you should take TEVARIPIPRAZOLE only once a day.
- Take TEVARIPIPRAZOLE at about the same time each day
More instructions can be found in Section 4. How do I use TEVARIPIPRAZOLE? in the full CMI.
5. What should I know while using TEVARIPIPRAZOLE?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using TEVARIPIPRAZOLE? in the full CMI.
6. Are there any side effects?
Common side effects are headache; indigestion; nausea; vomiting; insomnia; constipation; light-headedness; drowsiness; agitation; anxiety; inability to sit or stand still, restless movement of the arms and legs. Serious side effects include seizure; fits or convulsions; fainting; sudden increase in body temperature; sweating.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
TEVARIPIPRAZOLE® Tablets
Active ingredient(s): Aripiprazole
Consumer Medicine Information (CMI)
This leaflet provides important information about using TEVARIPIPRAZOLE. 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 TEVARIPIPRAZOLE.
Where to find information in this leaflet:
1. Why am I using TEVARIPIPRAZOLE?
2. What should I know before I use TEVARIPIPRAZOLE?
3. What if I am taking other medicines?
4. How do I use TEVARIPIPRAZOLE?
5. What should I know while using TEVARIPIPRAZOLE?
6. Are there any side effects?
7. Product details
1. Why am I using TEVARIPIPRAZOLE?
TEVARIPIPRAZOLE contains the active ingredient aripiprazole. TEVARIPIPRAZOLE is an antipsychotic agent which improves the symptoms of certain types of mental illness.
TEVARIPIPRAZOLE is used to treat symptoms of schizophrenia.
Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour.
Your doctor may have prescribed aripiprazole for another reason. Ask your doctor if you have any questions about why aripiprazole has been prescribed for you.
There is no evidence that aripiprazole is addictive.
This medicine is available only with a doctor's prescription.
Aripiprazole is not recommended for use in children under the age of 18, as safety and efficacy have not been established in this age group.
2. What should I know before I use TEVARIPIPRAZOLE?
Warnings
Do not use TEVARIPIPRAZOLE if:
- you are allergic to aripiprazole, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
- Symptoms of an allergic reaction include:
- rash, itching or hives on the skin
- shortness of breath, wheezing or difficulty breathing
- swelling of the face, lips, tongue, throat or other parts of the body
Check with your doctor if you:
- have any other medical conditions, especially the following:
- a reaction to some medicines with a sudden increase in body temperature, sweating, fast heartbeat, muscle stiffness and fluctuating blood pressure, which may lead to coma. This reaction is called neuroleptic malignant syndrome.
- a reaction to some medicines with abnormal movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks or jaw which may progress to the arms and legs. This reaction is called tardive dyskinesia.
- low blood pressure
- problems with your heart or blood vessels
- epilepsy, seizures or fits
- problems with your oesophagus (food pipe) such as difficulty in swallowing
- high blood sugar or diabetes mellitus
- Alzheimer's disease or dementia
- alcohol or drug abuse or dependence or a history of one of these
- venous thromboembolism or are at risk of venous thromboembolism
- have a history of or are at risk of sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
- lactose intolerance - take any medicines for any other condition.
- have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
Tell your doctor if you have past experience of excessive gambling.
- Tell your doctor if you drink alcohol.
Your doctor may advise you to avoid alcohol as it can magnify the side effects of this medicine.
Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. Caution should be taken.
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.
TEVARIPIPRAZOLE is not recommended for use during pregnancy. If you need to take TEVARIPIPRAZOLE during your pregnancy, your doctor will discuss with you the benefits and risks of taking it. Babies exposed to antipsychotics (including TEVARIPIPRAZOLE) during the third trimester of pregnancy are at risk of experiencing shaking, muscle stiffness, difficulty in feeding and/or withdrawal symptoms.
These symptoms may resolve spontaneously or require additional medical treatment.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is recommended that you do not breast-feed while taking TEVARIPIPRAZOLE, as it may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.
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 may interfere with TEVARIPIPRAZOLE and affect how it works. These include:
- medicines used to treat brain disorders such as, anxiety, depression, mood swings, epilepsy or seizures, Parkinson's disease or insomnia.
- medicines used to treat high blood pressure
- medicines used to treat fungal infections
- medicines used to treat heart rhythm disturbances
- medicines used to treat bacterial or viral infections
- a medicine called ciclosporin (Neoral®; Sandimmun®)
- a medicine called cimetidine (Tagamet®; Magicul®)
These medicines may be affected by TEVARIPIPRAZOLE, or may affect how well it works. Your doctor may need to adjust your dose of TEVARIPIPRAZOLE or of the other medicine.
Eating grapefruit or drinking grapefruit juice may affect how TEVARIPIPRAZOLE works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TEVARIPIPRAZOLE.
4. How do I use TEVARIPIPRAZOLE?
How much to take / use
- TEVARIPIPRAZOLE tablets should be swallowed whole and washed down with a glass of water.
- It does not matter whether you take TEVARIPIPRAZOLE with or without food
- The label put on the carton by the pharmacist will tell you how much you should take.
- Follow the instructions provided and use TEVARIPIPRAZOLE until your doctor tells you to stop.
- Continue taking TEVARIPIPRAZOLE for as long as your doctor tells you. TEVARIPIPRAZOLE helps to control your condition but does not cure it. Therefore you must take TEVARIPIPRAZOLE every day. Improvement in symptoms may take several days to some weeks to occur. Even if you feel better do not stop taking TEVARIPIPRAZOLE unless your doctor tells you to.
When to take / use TEVARIPIPRAZOLE
- Take TEVARIPIPRAZOLE at about the same time each day.
- Taking the medicine at the same time each day will have the best effect. It will also help you remember when to take it.
If you forget to use TEVARIPIPRAZOLE
TEVARIPIPRAZOLE should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
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.
If you use too much TEVARIPIPRAZOLE
If you think that you have used too much TEVARIPIPRAZOLE, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(In Australia 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 TEVARIPIPRAZOLE?
Things you should do
Remind any doctor, dentist, pharmacist, surgeon or any other health professional you visit that you are using TEVARIPIPRAZOLE.
Be sure to keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
- Become pregnant while taking ABILIFY
Things you should not do
- Do not give TEVARIPIPRAZOLE to anyone else, even if their symptoms seem similar or they have the same condition as you.
- Do not take TEVARIPIPRAZOLE to treat any other complaints unless your doctor or pharmacist tells you to.
- Do not stop taking TEVARIPIPRAZOLE or lower the dosage, even if you are feeling better, without checking with your doctor. If you stop taking TEVARIPIPRAZOLE suddenly your condition may worsen.
- Do not take more of this medicine and do not take it more often than your doctor has ordered.
Hot or cool weather
Make sure you keep cool in hot weather and keep warm in cool weather.
TEVARIPIPRAZOLE may affect the way your body reacts to temperature changes. It may prevent sweating, even during heatwaves. You may feel dizzy or faint if you are too hot. To stay cool in hot weather, try to do the following:
- wear light clothing
- spend time in air-conditioned environments (or keep windows open and use electric fans)
- drink plenty of water
- take cool baths or showers and avoid hot baths and saunas
- try to restrict exercise or heavy work to cool parts of the day
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TEVARIPIPRAZOLE affects you.
TEVARIPIPRAZOLE may cause some people to become drowsy or less alert than they are normally or cause light-headedness, dizziness or tiredness. If this occurs do not undertake the activity.
If ABILIFY makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position.
Getting up slowly may help.
Drinking alcohol
Be careful when drinking alcohol while taking TEVARIPIPRAZOLE.
Your doctor may suggest you avoid alcohol while you are being treated with TEVARIPIPRAZOLE.
Looking after your medicine
- Store TEVARIPIPRAZOLE in a cool place where the temperature stays below 25°C.
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.
When to discard your medicine
Be sure that any discarded medicine is out of the reach of children.
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.
TEVARIPIPRAZOLE is generally well-tolerated and the side effects are often hard to distinguish from disease symptoms. It is important that you tell your doctor as soon as possible about any unwanted effects.
Less serious side effects
Less serious side effects | What to do |
Gastrointestinal related:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Pain related:
| 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. |
Tell your doctor if you have obsessive (recurring) thoughts or behaviours, or trouble controlling impulsive urges or while taking TEVARIPIPRAZOLE.
Obsessive compulsive behaviours (feeling the need to check things repeatedly or having certain thoughts repeatedly), gambling urges, sexual urges, compulsive spending, binge or compulsive eating and other urges have occurred in some patients.
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.
Also, while taking TEVARIPIPRAZOLE, some elderly patients with dementia have suffered serious side effects such as a "mini" stroke, stroke, pneumonia or heart problems. These serious side effects can be life threatening.
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.
Do not be alarmed by this list of possible side effects.
You may not experience any or only some of them.
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 TEVARIPIPRAZOLE contains
Active ingredient (main ingredient) | Aripiprazole |
Other ingredients (inactive ingredients) |
The following colorants are also present in the tablets:
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Potential allergens | TEVARIPIPRAZOLE contains sugars (as lactose). TEVARIPIPRAZOLE does not contain sucrose, gluten, tartrazine or any other azo dyes. |
Do not take this medicine if you are allergic to any of these ingredients.
What TEVARIPIPRAZOLE looks like
TEVARIPIPRAZOLE 5 mg uncoated tablet | Light yellow coloured round flat faced bevelled edge tablet debossed '5' on one side and plain on the other side. AUST R 238013 |
TEVARIPIPRAZOLE 10 mg uncoated tablet | Pink to light pink coloured, oblong tablet with debossed '10' on one side and breakline on the other side. AUST R 238014 |
TEVARIPIPRAZOLE 15 mg uncoated tablet | Light yellow coloured, round flat faced bevelled edged tablets with debossed '15' on one side and breakline on the other side. AUST R 238032 |
TEVARIPIPRAZOLE 20 mg uncoated tablet | White to off white or pale cream coloured, capsule shaped biconvex table with debossed '20' on one side and breakline on the other side. AUST R 238033 |
TEVARIPIPRAZOLE 30 mg uncoated tablet | Pink to light pink coloured, round biconvex tablets with debossed '30' on one side and breakline on the other side. AUST R 238034 |
Who distributes TEVARIPIPRAZOLE
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
This leaflet was prepared in July 2021.
Published by MIMS August 2021