Laroza 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 l Disorder (bipolar depression).

·  With the medicine lithium or valproate to treat adults with depressive episodes that happen with Bipolar l 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 Laroza

·  Allergic to lurasidone hydrochloride or any of the ingredients in Laroza. See the end of this package leaflet for a complete list of ingredients in Laroza.

· 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 Laroza, 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 Laroza

· 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 Laroza

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Laroza and other medicines may affect each other causing possible serious side effects. Laroza may affect the way other medicines work, and other medicines may affect how Laroza works.

Your healthcare provider can tell you if it is safe to take Laroza with your other medicines. Do not start or stop any other medicines during treatment with Laroza 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.

Laroza with food, drink and alcohol

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

Driving and using machines

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

Pregnancy and breast-feeding

Before taking Laroza, 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 Laroza

·  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.

Laroza contains lactose monohydrate.

Laroza contains lactose monohydrate.

Each 20 mg film-coated tablet contains 31.80 mg lactose monohydrate.

Each 40 mg film-coated tablet contains 63.60 mg lactose monohydrate.

Each 80 mg film-coated tablet contains 127.20 mg lactose monohydrate.

Each 120 mg film-coated tablet contains 190.80 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

·    Take Laroza by mouth, with food (at least 350 calories).

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

What should I avoid while taking Laroza

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

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

·    Do not become too hot or dehydrated during treatment with Laroza

-    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.

Lurasidone may cause serious side effects, including:

·    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). Laroza 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 Laroza.  Tardive dyskinesia may also start after you stop taking Laroza.

·    Problems with your metabolism such as:

-    High blood sugar (hyperglycemia) and diabetes. Increase in blood sugar can happen in some people who take Laroza. 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 Laroza

Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Laroza:

-    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 Laroza.

·    Increased prolactin levels in your blood (hyperprolactinemia). Your healthcare provider may do blood tests to check your prolactin levels during treatment with Laroza. 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 Laroza

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

·    Falls. Laroza 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 Laroza”.

·    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 this medicine out of the sight and reach of children.

Do not store above 30°C.

Store in the original package.

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

Do not use this medicine if you notice any visible signs of deterioration.

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