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Product

Therapeutic Category

Risperidon (Risperidone Tablets USP 2mg)
Risperidon (Risperidone Tablets USP 2mg) 3Risperidon (Risperidone Tablets USP 2mg) 4

Risperidone 2 MG USP Tablet

Risperidone is used for Treatment of sudden (acute) and long-term (chronic) schizophrenia and other types of related psychoses. Treatment of behavioral problems in patients with a decline in mental ability (dementia).


UK Generic Name

Risperidone


Packing

30


Therapeutic Category

Anti Psychotic


Storage

Keep in a dry place where the temperature stays below 25°C.


adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


What is Risperidone and used for?

Risperidone belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness.
Treatment of sudden (acute) and long-term (chronic) schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action.
Treatment of behavioral problems in patients with a decline in mental ability (dementia).
These problems include:
• aggression through words or action
• morbid suspiciousness
• agitation or wandering treatment of conduct and other disruptive behaviors such as aggression, impulsiveness and self-injury in children (over 5 years old), adolescents and adults who are intellectually disabled.
Risperidone helps to correct a chemical imbalance in the brain associated with these conditions.
Risperidone has been approved for the uses mentioned above. However, your doctor may prescribe this medicine for another use.
If you want more information, ask your doctor. It is only available with a doctor’s prescription.
Risperidone is not addictive.
Risperidone is used to treat the following:
*Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel
unusually suspicious, or confused.
* Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive Mania occurs in an illness
called “bipolar disorder”.
* Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm
themselves or others. Alternative (non-drug) treatments should have been used previously.
* Short-term treatment (up to 6 weeks) of long-term, aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder.
Risperidone can help alleviate the symptoms of your disease and stop your symptoms from coming back.

What you need to know before you take Risperidone

Do not take Risperidone
* If you are allergic (hypersensitive) to risperidone or any of the other ingredients of this medicine
* If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Risperidone .

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidone if:
* You have a heart problem. Examples include an an irregular heart rhythm or if you are prone to low blood pressure
or if you are using medicines for your blood pressure. Risperidone may cause low blood pressure. Your dose
may need to be adjusted.
* You know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular
disorder or blood vessel problems in the brain.
* You have ever experienced involuntary movements of the tongue mouth and face.
* You have ever had a condition whose symptoms include high temperature, muscle stiffness, sweating or a
lowered level of consciousness (also known as Neuroleptic Malignant Syndrome)
* You have Parkinson’s disease or dementia
* You know that you have had low levels of white blood cells in the past (which may of may not have been
caused by other medicines)
* You are diabetic
* You have epilepsy
* You are a man and you have ever had a prolonged or painful erection.
* You have problems controlling your body temperature or overheating
* You have kidney problems
* You have liver problems
* You have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin
dependent tumour.
* You or someone else in your family has a history of blood clots, as antipsychotics have been associated with
formation of blood clots.

Children and adolescents

Before treatment is started for conduct disorder, other causes of aggressive behaviour should have been ruled out. If during treatment with Risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
Before treatment is started your, or your child’s body weight may be measured and it may be regularly monitored during treatment.

Other medicines and Risperidone :

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to talk to your doctor or pharmacist if you are taking any of the following:
*Medicines that work on your brain such as to help you calm down (benzodiazepines) or some medicines for
pain (opiates), medicines for allergy (some antihistamines), as Risperidone may increase the sedative effect of
all of these.
* Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm
problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental
problems
* Medicines that cause a slow heart beat
* Medicines that cause low blood potassium (such as certain diuretics)
* Medicines to treat raised blood pressure. Risperidone can lower blood pressure
* Medicines for Parkinson’s disease (such as levodopa)
* Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too much
fluid (such as furosemide or chlorothiazide). Risperidone taken by itself or with furosemide, may have an
increased risk of stroke or death in elderly people with dementia.
The following medicines may reduce the effect of Risperidone
* Rifampicin (a medicine for treating some infections)
* Carbamazepine, phenytoin (medicines for epilepsy)
* Phenobarbital
If you start or stop taking such medicines you may need a different dose of Risperidone.
The following medicines may increase the effect of Risperidone
* Quinidine (used for certain types of heart disease)
* Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
* Medicines known as beta blockers (used to treat high blood pressure)
* Phenothiazines (such as medicines used to treat psychosis or to calm down)
* Cimetidine, ranitidine (blockers of the acidity of stomach)
If you start or stop taking such medicines you may need a different dose of Risperidone.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone.

Risperidone with food, drink and alcohol
You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone.

Pregnancy, breast-feeding and fertility

* If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine. Your doctor will decide if you can take it.
* The following symptoms may occur in newborn babies, of mothers that have used Risperidone in the last
trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness,
agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may
need to contact your doctor.
* Risperidone can raise your levels of a hormone called “prolactin” that may impact fertility (see possible side
effects).

Driving and using machines:

*Dizziness, tiredness, and vision problems may occur during treatment with Risperidone. Do not drive or use any
tools or machines without talking to your doctor first.

How to take Risperidone

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.

The recommended dose is as follows:
Adults
* The usual starting dose is 2 mg per day, this may be increased to 4 mg per day on the second day
* Your dose may then be adjusted by your doctor depending on how you respond to the treatment
* Most people feel better with daily doses of 4 to 6 mg
* This total daily dose can be divided into either one or two doses a day. Your doctor will tell you which the best
is for you.

Elderly people
* Your starting dose will normally be 0.5 mg twice a day
* Your dose may then be gradually increased by your doctor to 1 mg to 2 mg twice a day
* Your doctor will tell you which the best is for you.

Children and adolescents
* Children and adolescents under 18 years old should not be treated with Risperidone for schizophrenia.
For the treatment of mania

Possible side effects

This medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you:
* Experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the
leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you
notice any of these symptoms seek medical advice immediately.
* Have dementia and experience a sudden change in your mental state or sudden weakness or numbness of your
face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs
of a stroke
* Experience fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic
Malignant Syndrome”). Immediate medical treatment may be needed
* Are a man and experience prolonged or painful erection. This is called priapism. Immediate medical treatment
may be needed
* Experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of Risperidone may be
needed
* Experience severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of
breath, itching, skin rash or drop in blood pressure.

The following side effects may happen:
Very Common (affects more than 1 user in 10):
* Difficulty falling or staying asleep
* Parkinsonism. This condition may include slow or impaired movement, sensation of stiffness or tightness of
the muscles (making your movements jerky), and sometimes even a sensation of movement “freezing up” and
then restarting. Other signs of parkinsonism include a slow, shuffling walk, a tremor while at rest, increased
saliva and/or drooling, and a loss of expression on the face. Feeling sleepy, or less alert
* Headache.

Common (affects 1 to 10 users in 100):
* Pneumonia, infection of the chest (bronchitis), common cold symptoms, sinus infection urinary tract infection
ear infection, feeling like you have the flu
* Risperidone can raise your levels of a hormone called “prolactin” found on a blood test (which may or may not
cause symptoms). When symptoms of high prolactin occur, they may include in men breast swelling, difficulty
in getting or maintaining erections, or other sexual dysfunction. In women they may include breast discomfort,
leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle.
* Weight gain, Increased appetite, Decreased appetite
* Sleep disorder, Irritability, Depression, Anxiety, Restlessness
* Dystonia: This is a condition involving slow or sustained involuntary contraction of muscles. While it can
involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face,
including abnormal movements of the eyes, mouth, tongue or jaw.
* Dizziness
* Dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or
writhing movements, or twitching.
* Tremor (shaking)
* Blurry vision, Eye infection or “pink eye”
* Rapid heart rate, High blood pressure, Shortness of breath
* Sore throat, Cough, Nosebleeds, Stuffy nose
* Abdominal pain, Abdominal discomfort, Vomiting, Nausea, Constipation, Diarrhea, Indigestion, Dry mouth,
Toothache
* Rash, Skin redness
* Muscle spasms, Bone or muscle ache, Back pain, Joint pain
* Incontinence (lack of control) of urine
* Swelling of the body, arms or legs, Fever, Chest pain, Weakness, Fatigue (tiredness), Pain
* Fall.

Uncommon (affects 1 to 10 users in 1000):
* Infection of the breathing passages, Bladder infection, ‘Eye infection, Tonsillitis, Fungal infection of the nails,
Infection of the skin, An infection confined to a single area of skin or part of the body, Viral infection, Skin
inflammation caused by mites
* Decrease in the type of white blood cells that help to protect you against infection, White blood cell count
decreased Decrease in platelets (blood cells that help you stop bleeding), Anemia, Decrease in red blood cells,
Increase in eosinophils (a type of white blood cell) in your blood
* Allergic reaction
* Diabetes or worsening of diabetes, high blood sugar, Excessive drinking of water Weight loss, Loss of appetite
resulting in malnutrition and low body weight
* Increased cholesterol in your blood
* Elated mood (mania), Confusion, Decreased sexual drive, Nervousness, Nightmares
* Tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts
of your body). Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue,
mouth and face. Withdrawal of risperidone may be needed
* Sudden loss of blood supply to brain (stroke or “mini” stroke) Unresponsive to stimuli, Loss of consciousness,
Low level of consciousness
* Unresponsive to stimuli, Loss of consciousness, Low level of consciousness
* Convulsion (fits), Fainting
* A restless urge to move parts of your body, Balance disorder, Abnormal coordination, Dizziness upon standing,
Disturbance in attention, Problems with speech, Loss or abnormal sense of taste, Reduced sensation of skin to
pain and touch, A sensation of tingling, pricking, or numbness skin
* Oversensitivity of the eyes to light, Dry eye, Increased tears, Redness of the eyes
* Sensation of spinning (vertigo), ringing in the ears, Ear pain
* Atrial fibrillation (an abnormal heart rhythm), An interruption in conduction between the upper and lower parts
of the heart, Abnormal electrical conduction of the heart, Prolongation of the QT interval from your heart, Slow
heart rate, Abnormal electrical tracing of the heart (electrocardiogram or ECG), A fluttering or pounding feeling
in your chest (palpitations)
* Low blood pressure, Low blood pressure upon standing (consequently, some people taking taking Risperidone
may feel faint, dizzy, or may pass out when they stand up or sit up suddenly, Flushing
* Pneumonia caused by inhaling food, Lung congestion, Congestion of breathing passages, Crackly lung sounds,
Wheezing, Voice disorder, Breathing passage disorder
* Stomach or intestinal infection, Stool incontinence, Very hard stool, Difficulty swallowing, Excessive passing
of gas or win
* Hives (or “nettle rash”), Itching, Hair loss, Thickening of skin, Eczema, Dry skin, Skin discoloration, Acne,
Flaky, itchy scalp or skin, Skin disorder, Skin lesion
Risperidone 2 MG USP Tablet – Taj Dearob Pharma | Risperidone belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness.
Risperidone 2 MG USP Tablet – Taj Dearob Pharma | Risperidone belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness.
Risperidone 2 MG USP Tablet – Taj Dearob Pharma | Risperidone belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness.

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