This medication is used to treat certain mental/mood disorders (such as schizophrenia, psychosis). Flupentixol decanoate is a long-acting form of flupentixol. It may be used by people who have trouble remembering to take medication every day. Flupentixol belongs to a class of drugs known as antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

Read the Patient Information Leaflet if available from your pharmacist before you start using flupentixol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a muscle by a health care professional as directed by your doctor, usually every 2 to 3 weeks. Do not inject into a vein.

The dosage is based on your medical condition and response to treatment. Your doctor will adjust your dose to find the best dose for you. Your first injection may be a lower dose than your routine dose. A second dose may be given 4 to 10 days later. Your doctor may direct you to take the oral form of this medication by mouth until the injected form starts to work.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Do not stop using this medication without consulting your doctor. Your condition may become worse if the drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your symptoms do not get better or if they get worse.

See also Warning section.

Injection site reactions (such as pain, swelling), drowsiness, dizziness, lightheadedness, restlessness, or trouble sleeping may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Tell your doctor right away if any of these side effects occur: muscle spasm/stiffness, shaking (tremor), restlessness, mask-like expression of the face, drooling/trouble swallowing, or shuffling walk. Your doctor may prescribe another medication to decrease these side effects.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• unusual mental/mood changes (such as depression, mania, worsening of psychosis)
• difficult urination
• vision problems
• signs of infection (such as sore throat that doesn't go away, fever)
• easy bruising/bleeding
• stomach/abdominal pain
• yellowing eyes/skin
• severe constipation

Rarely, this medication may increase your level of a certain hormone (prolactin). For females, this effect may result in unwanted breast milk, missing/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).

Get medical help right away if you have any very serious side effects, including:

• chest pain
• severe dizziness
• fainting
• seizures

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using flupentixol, tell your doctor or pharmacist if you are allergic to it; or to other thioxanthenes (such as thiothixene, zuclopenthixol); or if you have any other allergies. This product may contain inactive ingredients (such as medium chain triglycerides), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood problems (such as low white blood cell count, anemia)
• high or low blood pressure
• brain problems (injury/tumor, confusion with difficulty staying awake)
• blood flow problems (such as chest pain, heart attack, stroke)
• breast cancer
• glaucoma
• slowed gut movement (such as chronic constipation, ileus, blockage)
• kidney problems
• liver problems
• Parkinson's disease
• a certain adrenal gland tumor (pheochromocytoma)
• seizures
• difficulty urinating (such as due to enlarged prostate)
• drug/alcohol dependency

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Avoid contact with certain types of insecticides (organophosphates).

Flupentixol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using flupentixol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using flupentixol safely.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, muscle spasms/stiffness/twitching, uncontrolled movements (tardive dyskinesia), and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as schizophrenia, psychosis) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

Flupentixol passes into breast milk and may harm a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• certain drugs for high blood pressure (methyldopa, guanethidine, guanadrel, hydralazine)
• lithium

Many drugs besides flupentixol may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: loss of consciousness, seizures, fast/irregular heartbeat, slow/shallow breathing.

Lab and/or medical tests (such as liver function, complete blood counts) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.