Brand Name Choices
No generic medication is available for Risperdal M (Risperidone ODT)
What Risperdal M is and what it is used for
Risperdal Consta belongs to a group of medicines called ‘antipsychotics’. Risperdal Consta is used to maintain the treatment of 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. Risperdal Consta is intended for patients who are currently treated with oral (e.g. tablets, capsules) antipsychotics. Risperdal Consta can help alleviate the symptoms of your disease and stop your symptoms from coming back
How to take Risperdal M
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Risperdal Consta is given as an intramuscular injection either in the arm or buttock every two weeks,
administered by a health care professional. Injections should be alternated between the right and left
sides, and should not be given intravenously.
The recommended dose is as follows:
If your daily dose of oral (e.g. tablets) risperidone was 4 mg or less for the last two weeks, your
starting dose should be 25 mg Risperdal Consta.
If your daily dose of oral (e.g. tablets) risperidone was more than 4 mg for the last two weeks, you
may be given 37.5 mg Risperdal Consta as a starting dose.
If you are currently treated with other oral antipsychotics than risperidone, your starting dose of
Risperdal Consta will depend on your current treatment. Your doctor will choose Risperdal Consta
25 mg or 37.5 mg.
Your doctor will decide on the dose of Risperdal Consta that is right for you.
• The usual dose is 25 mg every two weeks as an injection.
• A higher dose of 37.5 or 50 mg may be necessary. Your doctor will decide on the dose of Risperdal Consta that is right for you.
• Your doctor may prescribe oral Risperdal for the first three weeks following your first injection. If you are given more Risperdal Consta than you should
• People who have been given more Risperdal Consta than they should have experienced the following symptoms: sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats. Cases of abnormal electrical conduction in the heart and convulsion have been reported.
• See a doctor right away. If you stop using Risperdal Consta You will lose the effects of the medicine. You should not stop this medicine unless told to do so by your doctor as your symptoms may return. Be sure not to miss your appointments when you are supposed to receive your injections every two weeks. If you cannot keep your appointment, be sure to contact your doctor right away to discuss another date when you can come in for your injection. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Use in children and adolescents Risperdal Consta is not for people who are under 18 years old.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 Risperdal Consta may be needed 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. Even if you have previously tolerated oral risperidone, rarely allergic reactions occur after receiving injections of Risperdal Consta. The following other side effects may also happen:
Very common side effects (may affect more than 1 in 10 people)
Common cold symptoms
• Difficulty falling or staying asleep
• 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.
Common side effects (may affect up to 1 in 10 people)
• Pneumonia, infection of the chest (bronchitis), sinus infection
• Urinary tract infection, feeling like you have the flu, anemia
• Raised 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.
• High blood sugar, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disorder, irritability, decreased sexual drive, restlessness, feeling sleepy, or less alert
• 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.
• 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
• Shortness of breath, sore throat, cough, stuffy nose
• Abdominal pain, abdominal discomfort, vomiting, nausea, stomach or intestinal infection, constipation, diarrhea, indigestion, dry mouth, toothache
• Muscle spasms, bone or muscle ache, back pain, joint pain
• Incontinence (lack of control) of urine
• Erectile dysfunction
• Loss of menstrual periods
• Leakage of milk from the breasts
• Swelling of the body, arms or legs, fever, weakness, fatigue (tiredness)
• A reaction at the injection site, including itching, pain or swelling
• Increased liver transaminases in your blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in your blood
Uncommon side effects (may affect up to 1 in 100 people)
• Infection of the breathing passages, bladder infection, ear 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, abscess under the skin
• White blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding), decrease in red blood cells
• Allergic reaction
• Sugar in the urine, diabetes or worsening of diabetes
• Loss of appetite resulting in malnutrition and low body weight
• 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
• 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 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), 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 upon standing (consequently, some people using Risperdal Consta may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
• 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
• An increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown
• Joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent passing of urine, inability to pass urine, pain when passing urine
• Ejaculation disorder, a delay in menstrual periods, missed menstrual periods or other problems with your cycle (females), development of breasts in men, 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"
• Hardening of the skin
• Increased liver enzymes in your blood
• Procedural pain.
Rare side effects (may affect up to 1 in 1,000 people)
• Decrease in the type of white blood cells that help to protect you against infection
• Inappropriate secretion of a hormone that controls urine volume
• Low blood sugar
• Excessive drinking of water
• Sleep walking
• Sleep-related eating disorder
• Lack of emotion
• Low level of consciousness
• Shaking of the head
• Problems with movement of your eyes, eye rolling, oversensitivity of the eyes to light
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you use or have used Risperdal Consta. If you need to have cataract surgery, be sure to tell your eye doctor if you use or have used this medicine
• Irregular heart beat
• Dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood, increase in eosinophils (a type of white blood cell) in your blood
• Trouble breathing during sleep (sleep apnea)
• Pneumonia caused by inhaling food, lung congestion, crackly lung sounds, voice disorder breathing passage disorder
• Inflammation of the pancreas, a blockage in the bowels
• Very hard stool
• Rash on skin-related to drug
• Hives (or "nettle rash"), thickening of skin, dandruff, skin disorder, skin lesion
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
• Abnormal posture
• Breast enlargement, discharge from the breasts
• Decreased body temperature, discomfort
• Yellowing of the skin and the eyes (jaundice)
• Dangerously excessive intake of water
• Increased insulin (a hormone that controls blood sugar levels) in your blood
• Blood vessel problems in the brain
• Unresponsive to stimuli
• Coma due to uncontrolled diabetes
• Sudden loss of vision or blindness
• Glaucoma (increased pressure within the eyeball), eyelid margin crusting
• Flushing, swollen tongue
• Chapped lips
• Enlargement of the glands in your breasts
• A decrease in 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 Risperdal Consta: Rapid heartbeat upon standing.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] By reporting side effects you can help provide more information on the safety of this medicine
How to Store Risperdal M
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store the entire dose pack in the refrigerator (2-8°C). If refrigeration is unavailable, the pack can be stored below 25°C for a maximum of 7 days before use. Use within 6 hours of reconstitution (if stored at or below 25°C). Store in the original package in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
2 to 3 weeks on average
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