RisperiDONE M-Tab (Oral)

Risperidone is used to treat schizophrenia, bipolar disorder, or irritability associated with autistic disorder. This medicine should not be used to treat behavioral problems in older adults who have dementia.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your or your child's progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for side effects.

Contact your doctor immediately if you or your child experience any of the following symptoms while using this medicine: convulsions (seizures), difficulty breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be signs of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Contact your doctor immediately if you or your child notice any of the following symptoms: lip smacking or puckering, puffing of the cheeks, rapid or worm-like tongue movements, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood. Contact your doctor right away if you or your child experience increased thirst or increased urination. If you have diabetes, you may notice changes in your urine or blood sugar test results. If you have any questions, consult your doctor.

Dizziness, lightheadedness, or fainting may happen, especially when standing up suddenly from a lying or sitting position. Getting up slowly may help. If the issue continues or worsens, consult your doctor.

Risperidone can temporarily lower the number of white blood cells in your blood, which may increase your risk of getting an infection. If possible, avoid close contact with people who have infections. Contact your doctor immediately if you think you are getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause drowsiness, difficulty thinking, or trouble controlling body movements, which could lead to falls, fractures, or other injuries. Do not drive or engage in any activities that could be dangerous until you know how this medicine affects you.

This medicine may make it harder for your body to cool itself down. Be careful not to become overheated during exercise or in hot weather, as overheating may lead to heat stroke. Also, be cautious not to get too cold while taking risperidone. If you become too cold, you might feel drowsy, confused, or clumsy.

This medicine may cause weight gain in you or your child. Your doctor may want to check your or your child's weight regularly while using this medicine.

Do not stop taking this medicine without first consulting your doctor. Your doctor may want you to gradually decrease your dose before stopping it completely. This is to prevent side effects and to avoid worsening your condition.

Talk to your doctor before using this medicine with alcohol or other medications that affect the central nervous system (CNS). Using alcohol or other CNS-affecting medications with risperidone may worsen side effects, such as dizziness, poor concentration, drowsiness, unusual dreams, and sleep trouble. Examples of CNS-affecting medications include antihistamines or medications for allergies or colds, sedatives, tranquilizers, or sleeping medications, medications for depression, anxiety, prescription pain medications or narcotics, medications for attention deficit and hyperactivity disorder, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may increase prolactin blood levels if used for a long time. Consult your doctor if you experience breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss of sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or difficulty achieving or maintaining an erection.

If you plan to have children, speak with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Do not take other medications unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medications and herbal or vitamin supplements.

In deciding to use a medication, the chances of using the medication must be weighed against the good it will do. This is a decision you and your physician will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other drugs. As well tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children younger than 13 years of age with schizophrenia, in children younger than 10 years of age with bipolar disorder, or in children younger than 5 years of age with autistic disorder. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of risperidone have not been performed in the geriatric population, geriatric-specific issues are not expected to limit the usefulness of risperidone in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving risperidone.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this medication while breastfeeding.

Interactions with Medicines

Although certain medications should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially critical that your healthcare professional know if you are using any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not advised. Your clinician may decide not to treat you with this medicine or change some of the other medications you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Levoketoconazole
• Levomethadyl
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medication with any of the following medications is usually not recommended, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acecainide
• Adagrasib
• Ajmaline
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apalutamide
• Apomorphine
• Apomorphine Hydrochloride
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Bretylium
• Bromocriptine Mesylate
• Buprenorphine
• Bupropion
• Buserelin
• Carbamazepine
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Dexmethylphenidate
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duloxetine
• Efavirenz
• Encainide
• Encorafenib
• Enflurane
• Entrectinib
• Enzalutamide
• Erythromycin
• Escitalopram
• Etrasimod
• Fedratinib
• Fenoldopam Mesylate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Gemifloxacin
• Gepirone
• Ginkgo Biloba
• Glasdegib
• Gonadorelin
• Goserelin
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Linezolid
• Lithium
• Lofexidine
• Lorcainide
• Lumacaftor
• Macimorelin
• Mefloquine
• Methadone
• Methylphenidate
• Metronidazole
• Mirtazapine
• Mitotane
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Nortriptyline
• Octreotide
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Pramipexole Dihydrochloride
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quizartinib
• Relugolix
• Remifentanil
• Ribociclib
• Rifampin
• Rifapentine
• Ropinirole Hydrochloride
• Rotigotine
• Selpercatinib
• Sematilide
• Serdexmethylphenidate
• Sertindole
• Sertraline
• Sevoflurane
• Simvastatin
• Siponimod
• Solifenacin
• Sotalol
• Spiramycin
• St John's Wort
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telithromycin
• Terbinafine
• Tetrabenazine
• Tocilizumab
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Zotepine
• Zuclopenthixol

Using this drug with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your clinician may change the dose or how often you use one or both of the drugs.

• Cimetidine
• Lamotrigine
• Levorphanol
• Midodrine
• Ranitidine
• Ritonavir
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may additionally cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical issues may affect the use of this drug. Make sure you tell your physician if you have any other medical issues, especially:

• Allergic reaction to paliperidone (Invega®), history of—Should not be used in patients with this condition.

• Alzheimer disease or
• Dehydration or
• Heart attack, recent or history of or
• Heart or blood vessel disease or
• Heart failure, history of or
• Heart rhythm issue, or a history of or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood) or
• Stroke, history of or
• Trouble with swallowing—May cause adverse effects to become worse.

• Blood or bone marrow problems or
• Breast cancer, prolactin-dependent or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Hyperprolactinemia (high prolactin in the blood) or
• Neuroleptic malignant syndrome (NMS), history of or
• Parkinson disease or
• Priapism (sore or prolonged erection of the penis) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the drug from the body.

• Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make this condition worse.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Aggressive behavior
• agitation
• anxiety
• changes in vision, including blurred vision
• difficulty concentrating
• difficulty speaking or swallowing
• inability to move the eyes
• increase in amount of urine
• loss of balance control
• mask-like face
• memory problems
• muscle spasms of the face, neck, and back
• problems with urination
• restlessness or need to keep moving (severe)
• shuffling walk
• skin rash or itching
• stiffness or weakness of the arms or legs
• tic-like or twitching movements
• trembling and shaking of the fingers and hands
• trouble sleeping
• twisting body movements

Less common

• Back pain
• chest pain
• speech or vision problems
• sudden weakness or numbness in the face, arms, or legs

Rare

• Confusion
• dizziness
• drowsiness
• extreme thirst
• fast, shallow breathing
• fast, weak heartbeat
• headache
• increased thirst
• lip smacking or puckering
• loss of appetite
• muscle cramps
• pale, clammy skin
• poor coordination
• prolonged, painful, inappropriate erection of the penis
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• shivering
• talking, feeling, and acting with excitement and activity that cannot be controlled
• uncontrolled chewing movements
• uncontrolled twisting movements of neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions or body positions

Incidence not known

• Actions that are out of control
• bleeding gums
• bloating
• blood in the urine or stools
• bluish lips or skin
• change in mental status
• chills
• clay-colored stools
• clumsiness
• cold sweats
• constipation
• cool, pale skin
• cough
• dark or bloody urine
• decrease in the frequency of urination
• decrease in urine volume
• decreased awareness or responsiveness
• depression
• difficulty in passing urine (dribbling)
• dry mouth
• fainting
• fast or irregular heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• hives
• hostility
• increased hunger
• increased urination
• indigestion
• irregular heartbeat, recurrent
• irritability
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of consciousness
• low body temperature
• muscle ache, twitching, or weakness
• nausea
• nervousness
• nightmares
• painful urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• severe constipation
• severe sleepiness
• shakiness
• slurred speech
• stomach pain
• swelling of the face, ankles, or hands
• tightness in the chest
• troubled breathing
• unexplained weight loss
• unpleasant breath odor
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting
• vomiting of blood
• weak or feeble pulse
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• heartburn
• increased dream activity
• increased length of sleep
• sore throat
• stuffy or runny nose

Less common

• Absent, missed, or irregular menstrual periods
• body aches or pain
• breast swelling or soreness
• dandruff
• darkening of skin color
• decreased interest in sexual intercourse
• dry skin
• ear congestion
• inability to have or keep an erection
• increase in body movements
• increased watering of the mouth
• joint pain
• loss in sexual ability, desire, drive, or performance
• loss of voice
• oily skin
• pain or tenderness around the eyes and cheekbones
• sneezing
• stopping of menstrual bleeding
• toothache
• unusual breast milk production
• weight loss

Incidence not known

• Acne
• change in taste
• enlargement of the penis or testes
• growth of pubic hair
• loss of taste
• rapid increase in height
• sleepwalking
• thinning or loss of hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Risperdal
• Risperdal M-Tab
• RisperiDONE M-Tab

In Canada

• Act risperiDONE
• AG-risperiDONE
• APO-risperiDONE
• DOM-risperiDONE
• IPG-risperiDONE
• JAMP-risperiDONE
• MAR-risperiDONE
• MINT-Risperidon
• PRO-risperiDONE
• RAN-risperiDONE
• RisperDAL
• RIVA-risperiDONE

Available Dosage Forms:

• Tablet
• Tablet, Disintegrating
• Solution

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

You may take this medicine with or without food.

When using the oral liquid:

• Measure the dose with the measuring device provided with the container.
• Take the medicine directly from the measuring device or mix the liquid with a beverage (eg, water, coffee, orange juice, or low-fat milk). Do not mix the liquid with cola or tea. Drink all of the mixture.
• Rinse the empty measuring device with water. Place it back in its storage case. Put the plastic cap back on the bottle of medicine.

When using the orally disintegrating tablet:

• Do not open the package until you are ready to take the medicine. To remove one tablet, separate one of the 4 tablets by tearing it apart on the perforations.
• Bend the corner as shown on the package. Peel back the foil. Do not push the tablet through the foil because that could damage the tablet.
• With dry hands, take the tablet out of the package. Place it immediately on your tongue. Do not store the tablet once it is removed from the package.
• The tablet will disintegrate in seconds after it is placed on the tongue.
• You may swallow the tablet with or without liquid. Do not split or chew the tablet.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution, tablets, or orally disintegrating tablets): For bipolar disorder: Adults—At first, 2 to 3 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day. Older adults—At first, 0.5 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day. Children 10 to 17 years of age—At first, 0.5 mg once a day, in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day. Children younger than 10 years of age—Use and dose must be determined by your doctor. For irritability associated with autistic disorder: Children 5 to 16 years of age weighing 20 kilograms (kg) or greater—At first, 0.5 milligrams (mg) per day. Your doctor may adjust your dose as needed. Children 5 to 16 years weighing less than 20 kg—At first, 0.25 mg per day. Your doctor may adjust your dose as needed. Children younger than 5 years of age—Use and dose must be determined by your doctor. For schizophrenia: Adults—At first, 2 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 16 mg per day. Older adults—At first, 0.5 mg 2 times a day. Your doctor may adjust your dose as needed. Children 13 to 17 years of age—At first, 0.5 mg once a day, in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day. Children younger than 13 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What are the strongest sleeping pills?
• What drugs cause tardive dyskinesia?
• What is the difference between Perseris and Risperdal Consta?