Risperidone (By mouth)

Introduction

Risperidone (ris-PER-i-done)

Treats schizophrenia and certain problems caused by bipolar disorder.

Brand Name(s)

Risperdal, Risperdal M-TAB, Risperdal M-Tab, Risperidone M-Tab

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet, Liquid, Dissolving Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. You may mix your dose with water, low-fat milk, coffee, or orange juice. Do not mix with cola or tea.
• If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a drink of water.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze the oral liquid.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many other medicines that you should not use while you are taking risperidone. Taking risperidone with certain other medicines may be dangerous, even life-threatening. Make sure your doctor and your pharmacist knows about all other medicines you are using.
• Make sure your doctor knows if you are taking carbamazepine (Tegretol®), cimetidine, furosemide (Lasix®), levodopa, fluoxetine (Prozac®), paroxetine (Paxil®), phenobarbital, ranitidine, or valproate (Depakene®, Depakote®). Tell your doctor if you are using clozapine (Clozaril®), quinidine, phenytoin (Dilantin®), or rifampin (Rifadin®). Make sure your doctor knows if you are also using medicine to lower blood pressure. Some blood pressure medicines are atenolol, hydrochlorothiazide (HCTZ), lisinopril, metoprolol, quinapril, Accupril®, Cozaar®, Diovan®, Lotrel®, Norvasc®, Toprol®, and Zestril®.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, plan to become pregnant, or if you are breast feeding. Tell your doctor if you have a history of liver disease, kidney disease, stroke, or breast cancer. Make sure your doctor knows if you have heart problems, Parkinson's disease, seizures, or trouble swallowing.
• Make sure your doctor knows if you have a family history of a heart condition called congenital long QT syndrome. Tell your doctor if you have ever had Neuroleptic Malignant Syndrome (NMS) caused by other antipsychotic medicines.
• This medicine may cause an increase in your blood sugar. If you have diabetes, you may need to check your blood sugar more often. If you are using medicine for diabetes, your doctor may need to change your dose.
• This medicine is not approved to treat behavior disorders in older people who have dementia. Using this medicine to treat this problem could increase the risk of death. This risk has not been shown for the approved uses of this medicine.
• Some side effects are more likely to happen in elderly people who have memory problems or other reduced mental skills. Make sure the doctor knows if the person who will be using this medicine has Alzheimer's disease or similar problems (often called "dementia").
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and cannot cool down.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Risperdal® M-Tab® contains aspartame (phenylalanine). If you have phenylketonuria (PKU), talk to your doctor before using this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate.
• Confusion, weakness, and muscle twitching.
• Constant muscle movement that you cannot control (often in your lips, tongue, arms, or legs).
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting.
• Fast, slow, irregular (uneven), or pounding heartbeat.
• Fever, sweating, muscle stiffness.
• In males: Painful, prolonged erection of your penis.
• Lightheadedness, fainting, or seizures.
• Severe diarrhea, vomiting, or stomach pain.
• Skin rash.
• Sudden or severe headache, problems with vision, speech, or walking.
• Twitching or muscle movements you cannot control (often in your eyes, jaw, neck or upper body).
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Anxiety, trouble sleeping, increased dreaming.
• Constipation, diarrhea, nausea, or upset stomach.
• Darkening of your skin.
• Drooling, or stuffy nose.
• In women: Unusually heavy bleeding during your menstrual period.
• Severe tiredness.
• Trouble having sex.
• Weight gain.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088