Risperdal ® Consta 25 mg Suspension

RISPERDAL CONSTA is used to treat a group of disorders called psychoses (e.g. schizophrenia). It is also used to treat bipolar disorder, formerly called manic depressive illness. Both sets of conditions are brain function disorders.

You should not be administered RISPERDAL CONSTA :

• If you are hypersensitive (allergic) to risperidone or any of the other ingredients. Allergy to RISPERDAL CONSTA can be recognised, for instance, by skin rash, itching, shortness of breath, or swollen face. If any of these occur, see your doctor.
• If you are under 18 years of age.

Tell your doctor or healthcare professional before being given the injection if :

• If you have never taken any form of RISPERDAL, you should begin with oral RISPERDAL before beginning treatment with RISPERDAL CONSTA.
• If you are taking furosemide. Studies in elderly patients with dementia have shown that RISPERDAL taken by itself or with furosemide, is associated with a higher rate of death. Furosemide is a diuretic medicine which is sometimes used to treat high blood pressure.
• If you suffer with dementia you should not receive RISPERDAL CONSTA.
• Low blood pressure can result from using RISPERDAL CONSTA especially when taken with medications to treat high blood pressure. So, if you need to use both RISPERDAL CONSTA and medications to reduce blood pressure, consult your doctor.
• Tell your doctor if you or someone else in your family has a history of blood clots. Blood clots in the lungs and legs have been seen in patients taking RISPERDAL CONSTA. Blood clots in the lungs can be fatal.
• During long-term treatment, RISPERDAL CONSTA might cause involuntary twitching in the face. Should this happen, consult your doctor.
• A state of confusion, reduced consciousness, high fever or stiff muscles might occur. If this should happen, contact a doctor right away and tell him or her that you are receiving RISPERDAL CONSTA.
• As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen with patients taking RISPERDAL CONSTA, your doctor may check your white blood cell counts. Tell your doctor if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• High blood sugar has been reported. Contact your doctor if you experience symptoms, such as excessive thirst or urination or if you are diabetic inform your medical doctor.
• RISPERDAL CONSTA should be used with caution, if you have heart problems, particularly irregular heart rhythm, abnormalities in electrical activity of the heart, or if using medications that can change the heart’s electrical activity.
• During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage. If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking RISPERDAL CONSTA.
• Allergic reactions Even if you have previously tolerated oral risperidone, very rarely allergic reactions occur after receiving injections of RISPERDAL CONSTA. Seek medical attention right away if you experience a rash, swelling of your throat, itching, or problems breathing as these may be signs of a serious allergic reaction.
• Weight gain Try to eat moderately, since RISPERDAL CONSTA can cause weight gain.
• Parkinson's disease, Lewy body dementia, or Neuroleptic Malignant Syndrome If you are suffering from any of these disorders, inform your doctor. Medical supervision might be necessary while you receive RISPERDAL CONSTA and your dose may have to be adjusted.
• Elderly people and people with impaired kidney or liver function See “How to receive RISPERDAL CONSTA and how much”.
• Pregnancy and Breastfeeding :

Do not share medicines prescribed for you with others RISPERDAL CONSTA is given as an intramuscular injection in the buttock or upper shoulder every two weeks. Injections should be alternated between right and left sides, and should not be given intravenously.

Your doctor may prescribe oral risperidone for the first three weeks following your first injection.

Adults The recommended dose is 25 mg every two weeks as an injection. A higher dose of 37,5 or 50 mg may be necessary. The maximum dose should not exceed 50 mg every two weeks. Your doctor may prescribe oral risperidone for the first three weeks following your first injection.

Elderly people The recommended dose is 25 mg by injection every two weeks. Your doctor may prescribe oral risperidone for the first three weeks following your first injection.

People with impaired kidney or liver function RISPERDAL CONSTA has not been studied in people with impaired kidney or liver function.

Children RISPERDAL CONSTA has not been studied in children younger than 18 years.

If you are given more RISPERDAL CONSTA than you should : In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center. While overdose is less likely to occur with injections than with oral medication, information pertaining to oral is presented. One or more of the following signs may occur: reduced consciousness, drowsiness, sleepiness, excessive trembling or excessive muscle stiffness, fast beating heart and low blood pressure. Cases of abnormal electrical conduction in the heart (QT prolongation) and convulsion have been reported. Overdose can happen if you are taking other medication with RISPERDAL. However, you should contact your doctor.

RISPERDAL CONSTA can have side effects. Should you experience these side effects, please consult your doctor. Not all side effects reported for RISPERDAL CONSTA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RISPERDAL CONSTA, please consult your doctor, pharmacist or other health care professional for advice.

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 if 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 RISPERDAL CONSTA 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. Even if you have previously tolerated oral risperidone, rarely allergic reactions occur after receiving injections of RISPERDAL CONSTA. Seek medical attention right away if you experience a rash, swelling of your throat, itching, or problems breathing as these may be signs of a serious allergic reaction.
• Are considering cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can occur if you take or have taken RISPERDAL CONSTA. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine.

FREQUENT SIDE EFFECTS · - Sleep disorder, irritability, decreased sexual drive, restlessness, feeling sleepy, or less alert. - Depression, anxiety. - 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. - Headache. - Pneumonia, infection of the chest (bronchitis), sinus infection, feeling like you have the flu, common cold symptoms. - Urinary tract infection. - Anaemia. - Increase blood prolactin (symptoms of high prolactin 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). - High blood sugar, weight gain, increased appetite, weight loss, decreased appetite - Dizziness. - Dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, or twitching. - Tremor (shaking). - Blurry vision. - Rapid heart rate. - Low blood pressure, chest pain, high blood pressure. - Abdominal pain, abdominal discomfort, vomiting, nausea, stomach or intestinal infection,constipation, diarrhoea, indigestion, dry mouth, toothache. - Rash. - Muscle spasms, bone or muscle ache, back pain, joint pain. - Incontinence (lack of control) of urine. - Erectile dysfunction. - Swelling of the body, arms or legs, fever, weakness, fatigue (tiredness), chest discomfort - Pain. - A reaction at the injection site, including itching, pain or swelling. - Increased liver transaminases in your blood, Increased GGT (a liver enzyme called gammaglutamyltransferase) in your blood. - Fall.

LESS FREQUENT SIDE EFFECTS - Ear infection. - Eye infection, tonsillitis, fungal infection of the nails, infection of the skin, infection, an infection confined to a single area of skin or part of the body, viral infection, skin inflammation caused by mites, abscess under the skin. - White blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding). - Sugar in the urine, diabetes or worsening of diabetes. - High blood triglycerides (a fat), increased cholesterol in your blood. - Elated mood (mania), confusion, inability to reach orgasm, nervousness, nightmares. - Loss of consciousness, convulsion (fits), fainting. - Restless urge to move parts of the body, balance disorder. - 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 of skin. - Eye infection or "pink eye", dry eye, increased tears, redness of the eyes. - Sensation of spinning (vertigo), ringing in the ears, ear pain. - Atrial fibrillation (an abnormal heart rhythm), palpitations - Low blood pressure upon standing. - Fast, shallow breathing, congestion of breathing passages, wheezing, nosebleeds. - Stool incontinence, difficulty swallowing, excessive passing of gas or wind itching, hair loss, eczema, dry skin, skin redness, skin discolouration, acne, flaky, itchy scalp or skin. - Joint stiffness, joint swelling, muscle weakness, neck pain. - Frequent passing of urine, inability to pass urine, pain when passing urine. - Breast pain, breast discomfort, vaginal discharge. - Chills, an increase in body temperature. - Inappropriate secretion of a hormone that controls urine volume. - Low blood sugar. - Excessive drinking of water. - Sleep walking. - Sleep -related eating disorder. - Not moving or responding while awake (catatonia). - Problems with movement of your eyes, eye rolling, oversensitivity of the eyes to light. - Increase in eosinophils (a type of white blood cell) in your blood. - Trouble breathing during sleep (sleep apnea). - Inflammation of the pancreas, a blockage in the bowels. - Hives (or "nettle rash"), Thickening of skin, dandruff, skin disorder, skin lesion. - Breakdown of muscle fibers and pain in muscles (rhabdomyolysis). - Yellowing of the skin and the eyes (jaundice). - Increased insulin (a hormone that controls blood sugar levels) in your blood. - Coma due to uncontrolled diabetes. - Sudden loss of vision or blindness. - Glaucoma (increased pressure within the eyeball), eyelid margin crusting. - Enlargement of the glands in your breasts. - A decrease in body temperature, coldness in arms and legs. - Symptoms of drug withdrawal. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children.

• The entire dose pack should be stored in the refrigerator at 2  C – 8  C in the original package in order to protect from light. If refrigeration is unavailable, RISPERDAL CONSTA can be stored at temperatures below 25  C for no more than 7 days before administration.
• Do not expose un-refrigerated product to temperatures above 25  C.
• Do not use after the expiry date stated on the label.
• Return all unused medicines to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g.toilets).