Risperidone 3mg Tablets, 30 Tablets

Tell your doctor immediately if you experience any of the following common side effects (may affect up to 1 in 10 people):

• 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. Withdrawal of risperidone may be needed.
• Dyskinesia: This is a condition involving muscle movements, and can include repetitive, spastic or writhing movement, or twitching. Withdrawal of risperidone may be needed.

Tell your doctor immediately if you experience any of the following uncommon side effects (may affect up to 1 in 100 people):

• 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 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 Tablets may be needed.
• 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. Signs may include any unexplained bruising or bleeding, sudden fever, sore throat, or mouth ulcers.

Tell your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 people):

• 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.
• 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 severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash or drop in blood pressure.
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
• Yellowing of the skin and the eyes (jaundice).
• Inflammation of the pancreas, (pancreatitis) signs include severe abdominal pain and nausea.

The following other side effects may also happen:

Very Common side effects (may affect more than 1 in 10 people):

• 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 side effects (may affect up to 1 in 10 people):

• Pneumonia, Infection of the chest (bronchitis), Common cold symptoms, Sinus infection, Urinary tract infection, Ear infection, Feeling like you have the flu
• Risperidone Tablets can raise your levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). Symptoms of high prolactin occur uncommonly and may include in men breast swelling, difficulty in getting or maintaining erections, decreased sexual desire 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 or fertility problems.
• Weight gain, Increased appetite, Decreased appetite
• Sleep disorder, Depression, Anxiety, Agitation
• Dizziness
• 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 (feeling sick), Constipation, Diarrhoea, 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
• Falling down.

Uncommon side effects (may affect up to 1 in 100 people):

• 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
• 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
• Sudden loss of blood supply to brain (stroke or “mini” stroke)
• Unresponsive to stimuli, Loss of consciousness, Low level of consciousness
• Convulsions (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 Risperidone Tablets 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 wind
• 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
• An increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown
• Abnormal posture, Joint stiffness, Joint swelling, Muscle weakness, Neck pain
• Frequent passing of urine, Inability to pass urine, Pain when passing urine
• Erectile dysfunction, Ejaculation disorder
• Loss of menstrual periods, Missed menstrual periods or other problems with your cycle (females)
• Development of breasts in men, Leakage of milk from the breasts, Sexual dysfunction, Breast pain, Breast discomfort, Vaginal discharge
• Swelling of the face, mouth, eyes or lips
• Chills, An increase in body temperature
• A change in the way you walk
• Feeling thirsty, Feeling unwell, Chest discomfort, Feeling “out of sorts”, Discomfort
• Changes in the way your liver works (which shows up in blood tests)
• Procedural pain (pain during treatment procedure)

Rare side effects (may affect up to 1 in 1,000 people):

• Infection
• Inappropriate secretion of a hormone that controls urine volume
• Sleep walking
• Sleep-related eating disorder
• Sugar in the urine, Low blood sugar, High blood triglycerides (a fat)
• Lack of emotion, Inability to reach orgasm
• Not moving or responding while awake (catatonia)
• Blood vessel problems in the brain
• Coma due to uncontrolled diabetes
• Shaking of the head
• Glaucoma (increased pressure within the eyeball), Problems with movement of your eyes, Eye rolling, Eyelid margin crusting
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Risperidone. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine.
• Dangerously excessive intake of water
• Irregular heart beat
• Trouble breathing during sleep (sleep apnea), Fast,shallow breathing
• Swollen tongue, Chapped lips, Rash on skin related to drug
• Dandruff
• A delay in menstrual periods, Enlargement of the glands in your breasts, Breast enlargement, Discharge from the breasts
• Increased insulin (a hormone that controls blood sugar levels) in your blood
• Decreased body temperature, Coldness in arms and legs
• Symptoms of drug withdrawal

Very rare side effects (may affect up to 1 in 10,000 people):

• Life threatening complications of uncontrolled diabetes.
• Serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing.
• Lack of bowel muscle movement that causes blockage.

The following side effect has been seen with the use of another medicine called paliperidone that is very similar to risperidone, so these can also be expected with Risperidone Tablets; Rapid heartbeat upon standing.

Additional side effects in children and adolescents

In general, side effects in children are expected to be similar to those in adults.

The following side effects were reported more often in children and adolescents (5 to 17 years) than in adults: feeling sleepy, or less alert, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhoea, and incontinence (lack of control) of urine.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.