Novus^® is a prescription medicine used: 

• To treat people 13 years of age or older with schizophrenia 

• Alone to treat people 10 years of age and older with depressive episodes that happen with Bipolar I Disorder (bipolar depression).

• With the medicine lithium or valproate to treat adults with depressive episodes that happen with Bipolar I Disorder (bipolar depression).

It is not known if lurasidone is safe and effective in children: 

- Less than 13 years of age with schizophrenia 

- Less than 10 years of age with bipolar depression 

- For the treatment of irritability associated with autistic disorder.

Do not take Novus^® if you are:

• Allergic to lurasidone hydrochloride or any of the ingredients in Novus^®. See the end of this package leaflet for a complete list of ingredients in Novus^®.

• Taking certain other medicines called CYP3A4 inhibitors or inducers including ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, rifampin, avasimibe, St. John’s wort, phenytoin, or carbamazepine. Ask your healthcare provider if you are not sure if you are taking any of these medicines.

Warnings and precautions

Before taking Novus^®, tell your healthcare provider about all of your medical conditions, including if you:

• Have or have had heart problems or stroke 

• Have or have had low or high blood pressure 

• Have or have had diabetes or high blood sugar or have a family history of diabetes or high blood sugar. 

• Have or have had high levels of total cholesterol or triglycerides 

• Have or have had high prolactin levels 

• Have or have had low white blood cell count 

• Have or have had seizures 

• Have or have had kidney or liver problems 

• Are pregnant or plan to become pregnant. It is not known if lurasidone will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take lurasidone during pregnancy. Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Novus^®

• Are breastfeeding or plan to breastfeed. It is not known if lurasidone passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during the treatment with lurasidone.

Other medicines and Novus^®

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Novus^® and other medicines may affect each other causing possible serious side effects. Novus^® may affect the way other medicines work, and other medicines may affect how Novus^® works.

Your healthcare provider can tell you if it is safe to take Novus^® with your other medicines. Do not start or stop any other medicines during treatment with Novus^® without talking to your healthcare provider first.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

Novus^® with food, drink and alcohol

Avoid eating grapefruit or drinking grapefruit juice during treatment with Novus^®. Grapefruit and grapefruit juice may affect the amount of Novus^® in your blood.

Driving and using machines

Do not drive, operate heavy machinery, or do other dangerous activities until you know how Novus^® affects you. Novus^® may make you drowsy.

Pregnancy and breast-feeding

Before taking Novus^®, tell your healthcare provider if you:

Are pregnant or plan to become pregnant. It is not known if lurasidone will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take lurasidone during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Novus^®.

Are breastfeeding or plan to breastfeed. It is not known if lurasidone passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with lurasidone.

Take Novus^® exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking Novus^® without first talking to your healthcare provider.

Take Novus^® by mouth, with food (at least 350 calories).

If you take too much Novus^®, call your healthcare provider or poison control center or go to the nearest hospital emergency room right away.

What should I avoid while taking Novus^®

Do not drive, operate heavy machinery, or do other dangerous activities until you know how Novus^® affects you. Novus^® may make you drowsy

Avoid eating grapefruit or drinking grapefruit juice during treatment with Novus^®. Grapefruit and grapefruit juice may affect the amount of Novus^® in your blood.

• Do not become too hot or dehydrated during treatment with Novus^®

• Do not exercise too much. 

• In hot weather, stay inside in a cool place if possible. 

• Stay out of the sun. 

• Do not wear too much clothing or heavy clothing. 

• Drink plenty of water.

Serious side effects:

• Increased risk of death in elderly people with dementia-related psychosis. Medicines like Novus^® can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Lurasidone is not approved for the treatment of people with dementia-related psychosis. 

• Increased risk of suicidal thoughts or actions in children and young adults. Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed.

• Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or a history of suicidal thoughts or actions. 

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? 

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. 

• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. 

• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. 

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: 

- Thoughts about suicide or dying 

- Attempts to commit suicide 

- New or worse depression 

- New or worse anxiety 

- Feeling very agitated or restless 

- Panic attacks 

- Trouble sleeping (insomnia) 

- New or worse irritability 

- Acting aggressive, being angry, or violent 

- Acting on dangerous impulses 

- An extreme increase in activity and talking (mania) 

- Other unusual changes in behavior or mood

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Possible side effects:

This medicine may cause serious side effects, including:

• See “Serious side effects”

• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.

• Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

- High fever 

- Stiff muscles 

- Confusion 

- Increased sweating 

- Changes in your breathing, heart rate, and blood pressure

• Uncontrolled body movements (tardive dyskinesia). Novus^® may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Novus^®. Tardive dyskinesia may also start after you stop taking Novus^®.

• Problems with your metabolism such as:

- High blood sugar (hyperglycemia) and diabetes. Increase in blood sugar can happen in some people who take Novus^®. Extremely high blood sugar can lead to coma or death. if you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with Novus^®

- Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Novus^®:

- Feel very thirsty 

- Need to urinate more than usual 

- Feel very hungry 

- Feel weak or tired 

- Feel sick to your stomach

- Feel confused, or your breath smells fruity 

- Increased fat levels (cholesterol and triglycerides) in your blood.

- Weight gain. You and your healthcare provider should check your weight regularly during treatment with Novus^®.

• Increased prolactin levels in your blood (hyperprolactinemia). Your healthcare provider may do blood tests to check your prolactin levels during treatment with Novus^®. Tell your healthcare provider if you have any of the following signs of hyperprolactinemia:

Females: 

- Absence of your menstrual cycle 

- Secretion of breast milk when you are not breastfeeding

Males: 

- Problems getting or maintaining an erection (erectile dysfunction) 

- Enlargement of breasts (gynecomastia)

• Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with Novus^®

• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

• Falls. Novus^® may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension) and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

• Seizures (convulsions)

• Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking Novus^®”.

• Mania or hypomania (manic episodes) in people with a history of bipolar disorder. Symptoms may include:

- Greatly increased energy 

- Severe problems sleeping 

- Racing thoughts 

- Reckless behavior 

- Unusually grand ideas

- Excessive happiness or irritability 

- Talking more or faster than usual

• Difficulty swallowing

The most common side effects of lurasidone in adults include:

Adults with schizophrenia:

- Sleepiness or drowsiness 

- Restlessness and feeling like you need to move around (akathisia) 

- Difficulty moving, slow movements, muscle stiffness, or tremor 

- Nausea

Children 13 to 17 years of age with schizophrenia

- Sleepiness or drowsiness 

- Nausea 

- Restlessness and feeling like you need to move around (akathisia)

- Difficulty moving, slow movements, muscle stiffness, or tremor 

- Runny nose 

- Vomiting

Adults with bipolar depression

- Restlessness and feeling like you need to move around (akathisia) 

- Difficulty moving, slow movements, muscle stiffness, or tremor 

- Sleepiness or drowsiness

Children 10 to 17 years of age with bipolar depression

- Nausea 

- Weight gain 

- Problems sleeping (insomnia)

These are not all of the possible side effects of lurasidone.

Call your doctor for medical advice about side effects.

• Keep out of the sight and reach of children.

• Do not store above 30º C.

• Do not use this medicine after the expiry date which is stated on the packaging after “Do not use after:” or EXP.:” The expiry date refers to the last day of that month.

• Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.