EDALEN (RISPERDAL) INDICATIONS
Edalen is used for treating schizophrenia or bipolar disorder. It is used to treat irritability caused by autistic disorder.Edalen is an atypical antipsychotic. It works by affecting certain substances in the brain.
EDALEN (RISPERDAL) INSTRUCTIONS
Use Edalen as directed by your doctor.
- Take Edalen by mouth with or without food.
- Take Edalen on a regular schedule to get the most benefit from it. Taking Edalen at the same time each day will help you remember to take it.
- Continue to take Edalen even if you feel well. Do not miss any dose.
- If you miss a dose of Edalen, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Edalen.
EDALEN (RISPERDAL) STORAGE
Store Edalen between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Edalen out of the reach of children and away from pets.
Active Ingredient: Risperidone.
Do NOT use Edalen if:
- you are allergic to any ingredient in Edalen.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Edalen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of seizures, heart problems (eg, heart failure, slow or irregular heartbeat), abnormal electrocardiogram (ECG), heart attack, stroke, blood vessel problems, high or low blood pressure, or low white blood cell levels
- if you have a history of kidney or liver problems, stomach or bowel problems (eg, narrowing, blockage), neuroleptic malignant syndrome (NMS), suicidal thoughts or attempts, or alcohol abuse or dependence
- if you have diabetes or are very overweight, or if a family member has had diabetes
- if you have Alzheimer disease, dementia, Parkinson disease, or esophagus problems (eg, trouble swallowing)
- if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk for breast cancer
- if you are dehydrated, drink alcohol, or will be exposed to very high or very low temperatures.
Some medicines may interact with Edalen. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Alpha-blockers (eg, doxazosin) or medicine for high blood pressure because the risk of low blood pressure and fainting may be increased
- Anticholinergics (eg, scopolamine) because the risk of overheating may be increased
- Tramadol because the risk of seizures may be increased
- Clozapine or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine) because they may increase the risk of Edalen's side effects
- Carbamazepine, phenobarbital, phenytoin, or rifampin because they may decrease Edalen's effectiveness
- Dopamine receptor agonists (eg, pramipexole) or levodopa because their effectiveness may be decreased by Edalen.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Edalen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Important safety information:
- Edalen may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Edalen with caution. Do not drive or perform other possibl unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking Edalen.
- Check with your doctor before taking medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Edalen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Edalen may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not become overheated in hot weather or while you are being active; heatstroke may occur.
- Patients who have bipolar (manic-depressive) illness, or if their family members have had it, may be at increased risk for suicidal thoughts or actions. Watch patients who take Edalen closely. Contact the doctor at once if new, worsened, or sudden symptoms such as anxious, restless, or irritable behavior; depressed mood; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Edalen may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Edalen may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- NMS is a possibly fatal syndrome that can be caused by Edalen. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; or sweating. Contact your doctor at once if you have any of these symptoms.
- Some patients who take Edalen may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Edalen in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Edalen.
- Edalen may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
- Edalen may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Lab tests, including fasting blood glucose and complete blood cell counts, may be performed while you use Edalen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Edalen with caution in the elderly; they may be more sensitive to its effects, especially dizziness when standing or uncontrolled muscles movements.
- Edalen should be used with extreme caution in children younger 5 years; safety and effectiveness in these children have not been confirmed.
- Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Edalen while you are pregnant. Edalen is found in breast milk. Do not breastfeed while taking Edalen.
All medicines may cause side effects, but many people have no, or minor, side effects.
Check with your doctor if any of these most common side effects persist or become bothersome:
Anxiety; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; indigestion; lightheadedness; nausea; restlessness; runny nose; stomach pain or upset; trouble sleeping; vomiting; weight gain.
Seek medical attention right away if any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; confusion; drooling; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; increased sweating; new or worsening mental or mood changes (eg, aggression, agitation, depression, severe anxiety); seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.