This medication is used to treat a certain mental/mood disorder (schizophrenia). Zuclopenthixol 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 taking zuclopenthixol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. Swallow the tablets whole with a glass of water. Your doctor may direct you to take a low dose at first, gradually increasing the dose to lower the chance of side effects such as drowsiness. Your doctor will adjust your dose to find the best dose for you. When you first start the medication, your doctor may direct you to divide your dose and take the drug 2 to 3 times a day. After you have been taking the medication for some time, your doctor may direct you to take your medication as a single dose, usually once daily at bedtime. Follow your doctor's directions carefully.

The dosage is based on your medical condition and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually reduced.

This medication does not work right away. It may take up to 1 to 2 weeks before you experience the full benefits. Tell your doctor if your symptoms do not get better or if they get worse.

See also Warning section.

Dizziness, lightheadedness, drowsiness, constipation, headache, dry mouth, blurred vision, difficulty urinating, and tiredness may occur. If these effects last or get worse, tell 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.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

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.

In rare cases, zuclopenthixol may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped 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 uncontrollable facial/muscle twitching/movements such as tongue thrusting, chewing movements, unusual movements of the mouth/lips, or shaking.

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

• nausea/vomiting that doesn't stop
• stomach/abdominal pain
• yellowing eyes/skin

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

• slow heartbeat
• chest pain
• severe dizziness
• fainting
• seizures

A very serious allergic reaction to this product 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 taking zuclopenthixol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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 number of red cells, white cells, or platelets)
• brain injury/tumor
• narrow-angle glaucoma
• a certain adrenal gland tumor (pheochromocytoma)
• breast cancer
• breathing problems (such as asthma, bronchitis)
• slowed gut movement (such as chronic constipation, ileus, blockage)
• heart problems (such as angina, irregular heartbeat)
• kidney disease
• liver disease
• certain muscle problem (myasthenia gravis)
• neuroleptic malignant syndrome
• Parkinson's disease
• pituitary tumor
• regular/heavy use of alcohol/sedatives
• overactive thyroid (hyperthyroidism)
• seizures
• difficulty urinating (such as due to prostate problems)

Zuclopenthixol 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 zuclopenthixol, 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 zuclopenthixol safely.

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

Before having procedures with injected dye (such as certain X-ray procedures) or surgery, tell your doctor, radiologist, or dentist that you are taking zuclopenthixol.

This medication can reduce sweating, making you more likely to get heatstroke. Avoid hard work and exercise in hot weather.

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.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, difficulty urinating, and heart effects such as 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) 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.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug. 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:

• alpha blockers (such as doxazosin, prazosin, terazosin)
• metoclopramide
• piperazine
• certain drugs for high blood pressure (methyldopa, guanethidine, guanadrel, hydralazine)

Many drugs besides zuclopenthixol may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Before using zuclopenthixol, report all medications you are currently using to your doctor or pharmacist.

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.

Do not share this medication with others.

Lab and/or medical tests (such as eye exams) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.