Risperdal M-Tab (Risperidone)
Risperdal (Risperidone) Dosage and Side Effects
RISPERDAL is used to treat the symptoms of schizophrenia and related psychotic disorders, which may include hallucinations (hearing or seeing things that are not there), delusions, unusual suspiciousness, emotional withdrawal. RISPERDAL may also be used for short-term treatment in dementia related to Alzheimer’s disease, specifically to control aggression or psychotic symptoms (such as believing things that are not true or seeing, feeling or hearing things that are not there) when there is a risk of harm to self or others. RISPERDAL may be used for the acute treatment of manic episodes associated with bipolar disorder.
Proper Use of this medication
- It is very important that you take/give RISPERDAL the way the doctor has prescribed it.
- The doctor has decided on the best dosage for you/the patient you are caring for based on individual needs. Dosage may be increased or decreased depending on the response.
- You may take/give RISPERDAL together with meals or between meals. Once a regular dose has been established, the total amount can be taken once a day, or divided into two intakes, one in the morning and one in the evening.
- Try to take/give RISPERDAL at the same time each day.
- RISPERDAL tablets should be swallowed with some water or other liquid.
- Before taking/giving RISPERDAL oral solution, Be sure to mix the exact dose of RISPERDAL oral solution that the doctor has prescribed in 100 mL of one of the following beverages: water, coffee, orange juice or low-fat milk; DO NOT MIX it in cola or tea.
- It is important that you keep taking/giving RISPERDAL even after your/the symptoms have improved or disappeared. Do not change or stop taking/giving RISPERDAL without consulting the doctor.
DO NOT give RISPERDAL to anyone else. The doctor has prescribed it for you/the patient you are caring for.
Directions for Use of RISPERDAL Oral Solution:
To open the bottle and use the pipette:
- The bottle comes with a child-proof cap, and should be opened as follows: push the plastic screw cap down while turning it counter-clockwise. Remove the unscrewed cap.
- Insert the pipette into the bottle. While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of millilitres or milligrams you need to give.
- Holding the bottom ring, remove the entire pipette from the bottle. Empty the pipette into at least 100 mL (3-4 ounces) of any non-alcoholic drink (see list below), by sliding the upper ring down. Stir the mixture thoroughly before consuming.
RISPERDAL oral solution is compatible with the following beverages: water, coffee, orange juice and low-fat milk. However, it is NOT compatible with cola or tea. Close the bottle and rinse the pipette with some water.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
In overdose, one or more of the following signs may occur: reduced consciousness, sleepiness, excessive trembling, excessive muscle stiffness, fast beating heart, dizziness or light-headedness when standing up.
If you miss a dose, try not to miss any more. DO NOT TAKE/GIVE TWO DOSES AT ONCE.
Like other medications, RISPERDAL can cause some side effects. Some side effects are minor and temporary; however, some may be serious and need medical attention. Many of the side effects are dose related, so it is important not to exceed your prescribed dose. Should you experience these symptoms, please consult your doctor.
Side effects that may occur very commonly are difficulty falling or staying asleep, trembling, decreased motor function or activity such as slight muscle stiffness, increased saliva and/or drooling, feeling sleepy or less alert, and headache.
Side effects that may occur commonly include: pneumonia, infections of eye, infections of ear, urinary tract infection, feeling like you have the flu, sleep disorder, depression, anxiety, irritability, dizziness, uncontrollable movements of the face or body, rigid muscles, slowness of movement and muscle stiffness or spasm, tremor, a sensation of tingling, prickling, or numbness of skin, blurry vision, faster heart rate, high blood pressure, abdominal pain, nausea/vomiting, constipation, diarrhea, indigestion, dry mouth, muscle spasms, loss of urine, swelling of the body, arms or legs, weakness, and fatigue.
RISPERDAL can raise your levels of a hormone called "prolactin" (measured with a blood test). In women, medicines of this type may cause changes in the regularity of their monthly period, breast discomfort, or leakage of milk from the breast even if they are not pregnant. In some men, there may be difficulty in getting or maintaining erections, or other sexual dysfunction and breast enlargement may be experienced.
Weight gain has been observed with RISPERDAL. Your doctor may check your body weight before starting RISPERDAL and during treatment.
Uncommon side effects may include: anemia, increased cholesterol in your blood, weight loss, loss of appetite resulting in malnutrition and low body weight, mania, a restless urge to move parts of your body, concentration difficulties, nightmares, itching, flushing, a sensation of tingling, pricking, or numbness of skin, muscle weakness, thirst, infection of the breathing passages, bladder infection, infection of the skin, fungal infection of the nails, crackly lung sounds, wheezing, breathing passage disorder, chills, vaginal discharge, joint swelling or stiffness, ringing in your ears, sensation of spinning (vertigo), being unresponsive to what is going on around you, difficulty with your voice, changes in taste, difficult or painful urination, bowel incontinence, gas, stomach or intestinal infection, low blood pressure, heartbeat irregularities, changes in body temperature, and increased liver transaminases in your blood.
High blood sugar, diabetes mellitus or worsening of diabetes have been reported. See your doctor if you experience symptoms such as excessive thirst or urination.
RISPERDAL may cause sudden dizziness or lightheadedness (symptoms of postural hypotension). You/the patient you are caring for should not rise rapidly after having been sitting or lying for prolonged periods, especially when you start taking RISPERDAL.
In rare cases, the following may happen: sugar in the urine, high blood triglycerides (a fat), chapped lips, eye rolling, glaucoma (increased pressure within the eyeball), eyelid margin crusting, swollen tongue, coldness in arms and legs, and low blood sugar.
Lack of bowel muscle movement that causes blockage may occur very rarely.
During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken RISPERDAL. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken RISPERDAL.
Your doctor may take blood tests before starting RISPERDAL and during treatment, and may monitor blood sugar and the number of infection-fighting white blood cells.
If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.
Do not be alarmed by this list of possible side effects. You may not experience any of them. If any of these side effects are experienced, they are usually mild and temporary. However, do not hesitate to report any undesired side effects to your doctor.
If you have taken RISPERDAL in the last three months of your pregnancy and you notice that your newborn baby develops shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding, seek immediate emergency medical attention.
Warnings and Precautions
Serious Warnings and Precautions
Studies with various medicines of the group to which RISPERDAL belongs, when used in elderly patients with dementia, have been associated with an increased rate of death. Some of these studies included treatment with RISPERDAL.
BEFORE you use RISPERDAL, talk to your doctor or pharmacist if you/the patient you are caring for:
- have/has a history of stroke, mini-strokes, high cholesterol or high blood pressure;
- have/has diabetes or a family history of diabetes;
- are/is pregnant or planning to become pregnant;
- are/is breast-feeding;
- have/has ever had blackouts or seizures;
- have/has a history of kidney or liver problems;
- have/has a history of problems with the heart and/or blood vessels;
- are/is prone to hypotension;
- have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives ("The Pill'');
- have had low white blood cell counts in your blood. Let your doctor know right away if you develop a fever or infection while being treated with RISPERDAL.
- have/has Parkinson's disease;
- are/is taking or planning to take any other medicines (prescription or over-the-counter medicines);
- drink/drinks alcoholic beverages or use/uses drugs;
- have/has or have had/has had breast cancer;
- have/has pituitary tumours;
- suffer/suffers from Alzheimer's Disease;
- suffer/suffers from Lewy body dementia;
- are/is dehydrated;
- exercise/exercises strenuously;
- are/is planning to have an operation on the eye.
Elderly Patients with Dementia:
Studies in elderly patients with dementia have shown that RISPERDAL taken by itself or with furosemide is associated with a higher rate of death (see Serious Warnings and Precautions Box).
Tell your doctor if you are taking furosemide. Furosemide is a medicine which is sometimes used to treat high blood pressure, some heart problems, or to treat swelling of parts of the body caused by the build-up of too much fluid.
In elderly patients with dementia, a sudden change in mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or instances of slurred speech have been seen. If any of these should occur, even for a short period of time, seek medical attention right away.
If you are taking blood pressure medication:
Low blood pressure can result from using RISPERDAL together with medications used to treat high blood pressure. If you need to use both RISPERDAL and medications used to reduce blood pressure, consult your doctor.
Effects on newborns:
In some cases, babies born to a mother taking risperidone during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.
Very rarely, 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.
During long-term treatment, RISPERDAL might cause involuntary twitching in the face. Should this happen, consult your doctor.
Since medications of this type may interfere with the ability of the body to adjust to heat, it is best to avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking RISPERDAL.
RISPERDAL should be used with caution, and only after consultation with your doctor, 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.
Because some people experience drowsiness, you should not drive or operate machinery until you are reasonably certain that RISPERDALdoes not affect your ability to carry out these activities.
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 colored 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 this medicine.
It is important for the doctor to have all the above information before prescribing treatment and dosage. This list should be carefully reviewed by you/the caregiver and discussed with the doctor.
Interactions with this medication
Inform all doctors, dentists and pharmacists who are treating you that you are taking RISPERDAL.
Inform them if you are taking or are planning on taking any other medicine. They will tell you which medicines you can take with RISPERDAL.
RISPERDAL can increase the effect of alcohol and medicines that reduce the ability to react (e.g., “tranquillizers”, narcotic painkillers, certain antihistamines, certain antidepressants). It is recommended that you DO NOT drink alcohol when you are taking RISPERDAL. You should only take these other medicines when they have been prescribed by your doctor.
Some medicines, when they are taken together with RISPERDAL, may increase or decrease the level of RISPERDAL in your blood. Therefore, tell your doctor if you start and/or stop taking any of the below medicines, since your doctor may need to change the dose:
- Dopamine agonists, e.g., levodopa (antiparkinsonian agent), as these may decrease the effect of RISPERDAL.
- Phenothiazines and some heart medications (e.g., medication for high blood pressure, antiarrhythmics, or beta-blockers), as these may interact with RISPERDAL to cause your blood pressure to drop too low.
- RISPERDAL should be used with caution when taking medications that may change the electrical activity of the heart (QT prolongation), such as but not restricted to: medicines for malaria, heart rhythm disorders, allergies, other antipsychotics, antidepressants, water tablets or other medicines affecting body salts (sodium, potassium, magnesium).
- Carbamazepine and topiramate (anticonvulsants), as these may change the effect of RISPERDAL.
- PROZAC (fluoxetine), PAXIL (paroxetine) (antidepressants) and CLOZARIL (clozapine), as these may increase the level ofRISPERDAL in your blood.
- LASIX (furosemide): Studies in elderly patients with dementia have shown that taking RISPERDAL with furosemide, a medicine which is sometimes used to treat high blood pressure, some heart problems, or to treat swelling of parts of the body caused by the build-up of too much fluid, is associated with an increased rate of death
- Itraconazole and ketoconazole, medicines for treating fungal infections.
- Certain medicines used in the treatment of HIV/AIDS, such as NORVIR (ritonavir).
- Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
- Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.
- Rifampicin, a medicine for treating some infections.
RISPERDAL oral solution is not compatible with cola or tea.
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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.