Versacloz

Versacloz is used in adults to treat schizophrenia when other treatments have not worked and to lower the risk of suicidal behavior in people with schizophrenia or similar disorders.

Versacloz may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Versacloz with or without food.

Shake the oral suspension (liquid) for 10 seconds before you measure a dose. Measure a dose with the supplied measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Versacloz affects your immune system and can have long lasting effects on your body. You may get infections more easily, even serious or fatal infections. You may need frequent medical tests while using this medicine and for a short time after your last dose.

You should not stop using Versacloz suddenly. Your blood will need to be tested often and your dose may be changed based on the results.

If you start taking Versacloz again after 2 or more days off the medicine, you may need to use a lower dose than when you stopped. Follow your doctor's dosing instructions very carefully.

You may be given other medications to help prevent serious side effects or allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.

Store the medicine at room temperature away from moisture and heat. Store the disintegrating tablets in the foil pouch. Throw the oral suspension away after 100 days of first opening the bottle, even if there is still medicine left inside. Do not refrigerate or freeze the oral suspension. Protect from light.

Versacloz affects your immune system. You may get infections more easily, including serious or life-threatening infections. Call your doctor if you have a fever, sore throat, weakness, or lack of energy.

Versacloz can cause serious heart problems and increase your risk of having a seizure. Call your doctor immediately if you experience chest pain, trouble breathing, fast or pounding heartbeats, or sudden dizziness.

Versacloz is not approved for use in older adults with dementia-related psychosis.

Versacloz may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

You should not take Versacloz if you are allergic to Versacloz or have low white blood cell counts.

Tell your doctor if you have ever had:

• if you smoke, heart problems, high blood pressure,
• a heart attack or stroke (including "mini-stroke"), long QT syndrome (in you or a family member);
• mouth sores, skin sores, sore throat, cough, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• a seizure, head injury, or brain tumor;
• high cholesterol or triglycerides, diabetes, or risk factors such as being overweight or having a family history of diabetes;
• an enlarged prostate or urination problems;
• glaucoma;
• a stomach ulcer, constipation or diarrhea, malnourishment or dehydration; or
• liver or kidney disease.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clozapine on the baby.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor if you are pregnant or plan to become pregnant. Do not stop the medicine without your doctor's advice.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

You may get infections more easily, including serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• mouth sores, skin sores, fever, flu-like symptoms, extreme weakness;
• new or worsening cough, trouble breathing; or
• pain or burning when you urinate, or vaginal itching or discharge.

Further doses may be delayed until your infection clears up.

High doses or long-term use of clozapine can cause a serious movement disorder that may not be reversible. The longer you use Versacloz, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Versacloz can increase your risk of seizures, especially at high doses. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

Versacloz may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• falls, a seizure (blackout or convulsions);
• severe constipation, dry or hard bowel movements, or painful gas;
• nausea, vomiting, stomach ulcer, stomach pain or bloating;
• heart problems--chest pain, fast or pounding heartbeats, fluttering in your chest, slow heartbeats, shortness of breath, swelling in your legs, feet, or ankles, and sudden dizziness (like you might pass out);
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Untreated constipation may lead to serious bowel complications, hospitalization, or death. Tell your doctor right away if you are not having bowel movements at least 3 times per week.

Common side effects of Versacloz may include:

• weight gain;
• fast heart rate, dizziness, tremor;
• nausea, constipation;
• dry mouth, or increased salivation;
• headache, drowsiness, vision problems; or
• fever, increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal. Overdose symptoms may include drowsiness, confusion, fast heartbeats, feeling light-headed, weak or shallow breathing, drooling, choking, or seizure.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or doing anything dangerous until you know how Versacloz will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

When you start or stop taking Versacloz, your doctor may need to change the doses of any other medicines you take regularly.

Versacloz can cause a serious heart problem. Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Taking Versacloz with other drugs that make you drowsy or slow your breathing can lead to dangerous side effects or death. Ask your doctor before using opioid medication, medicine for stomach issues, a sleeping pill, a muscle relaxer, cold or allergy medicine, or medicine for anxiety, Parkinson's disease, or seizures.

Many drugs can affect Versacloz. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Inform your doctor about all other medicines you are taking.