Risperdal M-Tab

Generic name: Risperidone
Drug class: Atypical antipsychotics

Usage of Risperdal M-Tab

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.

Risperdal M-Tab side effects

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.

Before taking Risperdal M-Tab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also 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 problems are not expected to limit the usefulness of risperidone in the elderly. However, 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 risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines 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 taking this medicine, it is especially important that your healthcare professional know if you are taking 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 recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil

Bromopride

Cisapride

Dronedarone

Levoketoconazole

Levomethadyl

Mesoridazine

Metoclopramide

Pimozide

Piperaquine

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

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

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 medicines may also 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 medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Relate drugs

How to use Risperdal M-Tab

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.

Warnings

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

Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with 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 symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you or your child have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Risperidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are taking risperidone. If you become too cold, you may feel drowsy, confused, or clumsy.

This medicine may increase your or your child's weight. Your doctor may need to check your or your child's weight on a regular basis while using this medicine.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to prevent side effects and to keep your condition from becoming worse.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with risperidone may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

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

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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