0.25 mg film-coated tablets risperidone
What Risperidone Sandoz is and what it is used for
Risperidone Sandoz contains the active substance risperidone and belongs to the group of antipsychotic drugs.
Risperidone Sandoz is used to treating the following:
- Schizophrenia, can mean seeing, hearing, or feeling things that do not exist, believing things that are not real, or feeling unusually suspicious or confused.
- Manic periods can mean that you feel very excited, elated, upset, enthusiastic, or overactive. Mania occurs in a disease called “bipolar disorder”.
- Short-term treatment (up to 6 weeks) of long-term aggression in people with dementia caused by Alzheimer’s disease, which harms themselves or others. Alternative treatment without medication must have been tried before.
- Short-term treatment (up to 6 weeks) of long-term aggression in children (at least 5 years old) with impaired intellectual ability and adolescents with behavioral disorders.
Risperidone Sandoz can help relieve the symptoms of your illness and prevent the symptoms from returning.
Risperidone contained in Risperidone Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Risperidone Sandoz
Do not take Risperidone Sandoz:
- if you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone Sandoz.
Warnings and cautions
Talk to your doctor or pharmacist before taking Risperidone Sandoz if:
- you have heart problems. For example, it could be an irregular heartbeat or if you have a tendency to have low blood pressure, or if you are taking medication for your blood pressure. Risperidone Sandoz can cause low blood pressure. Your dose may need to be adjusted
- you know you have a risk factor for strokes, such as high blood pressure, cardiovascular disease, or a problem with a blood vessel in your brain
- you have ever experienced involuntary movements of the tongue, mouth, and face
- you have ever had a condition where the symptoms include high body temperature, muscle stiffness, sweating, or decreased level of consciousness (also called malignant neuroleptic syndrome)
- you have Parkinson’s disease or dementia
- you know you have had low white blood cell levels before (this may or may not have been caused by other medicines)
- you have diabetes
- you have epilepsy
- you are a man and have ever had a persistent or painful erection
- you have problems controlling your body temperature or getting too hot
- you have kidney problems
- you have liver problems
- you have abnormally high levels of the hormone et prolactin in your blood or if you have a tumor that may be prolactin dependent
- you or someone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone Sandoz.
In rare cases, a dangerously low level of a certain type of white blood cell needed to fight infection in the blood has been seen in patients taking Risperidone Sandoz. Your doctor may check your white blood cell levels.
Risperidone Sandoz can cause weight gain. Significant weight gain can hurt your health. Your doctor should check your body weight regularly.
Because diabetes mellitus or worsening of existing diabetes mellitus has been seen in patients taking Risperidone Sandoz, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus, blood glucose should be monitored regularly.
It is common for Risperidone Sandoz to increase the levels of a hormone called prolactin. This can lead to side effects such as menstrual disorders or fertility problems in women, and swelling of the breasts in men (see section 4 Possible side effects ). If such side effects occur, an assessment of prolactin levels in the blood is recommended.
In cataract surgery ( cataract ) it may happen that the pupil (the black circle in the middle of the eye) does not increase in size as much as needed. In addition, you can get reduced muscle tension in the iris (colored part of the eye) during the operation and it can lead to eye injuries. If you have an eye operation planned, you must inform your ophthalmologist that you are taking this medicine.
Elderly people with dementia
Elderly patients with dementia are at greater risk of having a stroke. You should not use Risperidone Sandoz if you have dementia caused by a stroke.
You should have regular contact with your doctor while you are being treated with Risperidone Sandoz.
Seek medical attention immediately if you or the person caring for you notice a sudden change in your mental state or if you suffer from sudden weakness or numbness in the face, arms, or legs, especially on one side, or slurred speech, even if it is only short-lived. The listed symptoms may be signs of a stroke.
Children and young people
Before initiating treatment for a behavioral disorder, other causes of the aggressive behavior must have been ruled out.
Before starting treatment, you or your child may be weighed and the weight may be monitored regularly during treatment.
If fatigue occurs during treatment with risperidone, a change in the timing of drug intake may result in improved attention span.
A small and incomplete study has reported an increase in length in children taking risperidone, but whether this is an effect of the drug or due to something else is unknown.
Other medicines and Risperidone Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must talk to your doctor or pharmacist if you are taking any of the following:
- drugs that affect the brain, e.g. sedatives ( benzodiazepines ), certain painkillers (opiates), or allergy medicines (certain antihistamines ) as risperidone may increase the sedative effect of all these medicines.
- drugs that can affect the electrical activity of the heart, e.g. medicines for malaria, heart rhythm problems, allergies ( antihistamines ), certain medicines for depression or other medicines for mental problems
- drugs that cause slow heart rate/pulse
- drugs that reduce the level of potassium in the blood (such as certain diuretics)
- medicines for high blood pressure. Risperidone Sandoz may lower blood pressure
- medicines for Parkinson’s disease (eg levodopa )
- diuretics ( diuretics ) are used for heart problems or swelling in parts of the body due to the accumulation of too much fluid (eg furosemide or chlorothiazide). Risperidone Sandoz taken separately or with furosemide may increase the risk of stroke or death in elderly people with dementia.
- drugs that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
The following medicines may reduce the effect of risperidone
- Rifampicin (a medicine used to treat certain infections )
- Carbamazepine, phenytoin ( antiepileptic medicine )
- Phenobarbital
If you start or stop taking these medicines, you may need another dose of risperidone.
The following medicines may increase the effect of risperidone
- Quinidine (used in certain types of heart disease)
- Antidepressants, such as paroxetine, fluoxetine, and tricyclic antidepressants
- Medicines called beta-blockers (used to treat high blood pressure )
- Phenothiazines (used, for example, to treat psychosis or as a sedative)
- Cimetidine, ranitidine (counteracts stomach upset)
- Itraconazole and ketoconazole (medicines used to treat fungal infections)
- Some medicines used to treat HIV / AIDS, such as ritonavir
- Verapamil, is a medicine used to treat high blood pressure and/or abnormal heart rhythm
- Sertraline and fluvoxamine, are medicines used to treat depression and other mental disorders
If you start or stop taking these medicines, you may need another dose of risperidone.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone Sandoz.
Risperidone Sandoz with food, drink, and alcohol
You should avoid drinking alcohol while taking Risperidone Sandoz.
Pregnancy, breastfeeding, and fertility
- If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can use this medicine.
- The following symptoms may occur in newborns of mothers who have used Risperidone Sandoz during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, anxiety, difficulty breathing, and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.
- Risperidone Sandoz may increase your levels of a hormone called ‘prolactin’ which may affect fertility (see section 4 ‘Possible side effects)
Driving and using machines
Dizziness, fatigue, and vision problems may occur during treatment with Risperidone Sandoz. Do not drive or use any tools or machines without first talking to your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Risperidone Sandoz contains lactose and sodium
Risperidone Sandoz contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Risperidone Sandoz contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie essentially ‘sodium-free’. is almost “sodium-free”.
How to take Risperidone Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will tell you how much medicine to take and for how long. It depends on your condition and varies from person to person.
The recommended dose is:
Treatment of schizophrenia
Adults
- The usual starting dose is 2 mg per day. This can be increased to 4 mg per day during the second day.
- Dose one can then be regulated by your doctor depending on how you respond to the treatment.
- Most people feel better with daily doses ranging from 4 to 6 mg.
- This total daily dose can be divided into either 1 or 2 doses per day. Your doctor will tell you which is best for you.
Elderly
- The starting dose is usually 0.5 mg twice a day.
- Your doctor may then gradually increase the dose you should take to 1 to 2 mg twice daily.
- Your doctor will tell you which is best for you.
Treatment of mania
Adults
- The starting dose is usually 2 mg once a day.
- Your doctor can then gradually adjust the dose depending on how you respond to the treatment.
- Most people feel better with daily doses ranging from 1 to 6 mg.
Elderly
- The starting dose is usually 0.5 mg twice a day.
- Your doctor may then gradually adjust the dose from 1 to 1 mg to 2 mg twice daily, depending on how you respond to treatment.
Treatment of long-term aggression in people with Alzheimer’s disease
Adults (including the elderly)
- The starting dose is usually 0.25 mg twice daily.
- Your doctor can then gradually adjust the dose depending on how you respond to the treatment.
- Most people feel better with a dose of 0.5 mg twice daily. Some patients may need 1 mg twice daily.
- The duration of treatment for patients with Alzheimer’s disease should not exceed 6 weeks.
People with kidney or liver problems
Regardless of the disease being treated, all starting doses and subsequent doses of risperidone should be halved. Dose increases should be slower in these patients.
Risperidone should be used with caution in this patient population.
Use for children and adolescents
- Children and adolescents under 18 years of age should not be treated with Risperidone Sandoz for schizophrenia or mania.
- Dose one for the treatment of behavioral disorder depends on the weight of the child:
Children weighing less than 50 kg
- The starting dose is usually 0.25 mg once a day.
- Dose one can be increased every other day by 0.25 mg per day.
- The usual maintenance dose is 0.25 mg to 0.75 mg per day.
Children weighing 50 kg or more
- The starting dose is usually 0.5 mg once a day.
- Dose one can be increased every other day by 0.5 mg per day.
- The usual maintenance dose is 0.5 mg to 1.5 mg per day.
The treatment time for patients with behavioral disorders should not exceed 6 weeks.
Children under 5 years of age should not be treated with Risperidone Sandoz for behavioral disorders.
Method of administration
To be taken by mouth.
You should swallow the tablet with a little water.
Risperidone Sandoz can be taken with or without food.
If you take more Risperidone Sandoz than you should
- Seek medical attention immediately. Take the medicine pack with you.
- If you have taken an overdose, you may feel sleepy or tired, you may have abnormal body movements or problems with standing and walking, you may feel dizzy due to low blood pressure and you may also have abnormal heartbeats or seizures.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Risperidone Sandoz
- If you forget to take a dose, take it as soon as you remember. But if it is almost time for you to take the next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.
- Do not take a double dose (two doses at the same time) to compensate for a missed dose.
If you stop taking Risperidone Sandoz
You should not stop taking this medicine unless you have been asked to do so by your doctor. If you stop treatment, your symptoms may return. If your doctor decides to stop the treatment, it can be done by gradually reducing the dose over a few days.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you get any of the following serious side effects:
Uncommon (may affect up to 1 in 100 people):
- Tardive dyskinesia (involuntary twitching movements of the face, tongue, or other parts of the body). Take immediate action if you experience involuntary rhythmic movements of the tongue, mouth, or face. Risperidone treatment may need to be stopped.
- A sudden change in your mental state or if you suffer from sudden weakness or numbness in the face, arms, or legs, especially on one side, or slurred speech, even if it is only short-lived. The listed symptoms may be signs of stroke or ministroke due to sudden loss of blood flow to the brain. You are at particular risk if you suffer from dementia.
Rare (may affect up to 1 in 1,000 people):
- Malignant neuroleptic syndrome (confusion, decreased level of consciousness or loss of consciousness, high fever, and marked muscle stiffness). You may need medical attention immediately.
- Priapism (a persistent or painful erection that may require surgical treatment).
Very rare (may affect up to 1 in 10,000 people):
- Life-threatening complications of poorly regulated diabetes
- Severe allergic reaction with swelling that may include the throat and lead to difficulty breathing.
Has been reported (occurs in an unknown number of users):
- Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), can move via the blood vessels to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
The following additional side effects may occur:
Very common (may affect more than 1 user in 10):
- Difficulty falling asleep or sleeping without interruption
- Parkinsonism: this condition can include slow or impaired mobility, feeling tense or stiff muscles (which make your movements jerky), and sometimes even a feeling that the movement stops and then resumes. Other signs of parkinsonism include slow procrastination, tremors at rest, increased salivation and/or drooling, and a lack of facial expressions.
- Sleepiness or less alert
- Headache.
Common (may affect up to 1 in 10 people):
- Pneumonia, respiratory tract infection ( bronchitis ), cold symptoms, sinusitis, urinary tract infection, ear infection, flu-like sensation
- Increased levels of a hormone called “prolactin” which is seen with a blood test (this can, but does not have to, cause symptoms). Symptoms of high prolactin levels are less common and in men may include swollen breasts, difficulty getting or maintaining an erection, decreased sex drive, or other sexual dysfunction. In women, the symptoms can be breast discomfort, milk leakage, missed periods or other problems with the menstrual cycle, or fertility problems.
- Weight gain, increased appetite, decreased appetite
- Sleep disturbance, irritation, depression, anxiety, restlessness
- Dystonia: this is a condition that involves slow or persistent involuntary muscle contractions. Dystonia can affect any part of the body (and lead to an abnormal posture) but often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
- Dizziness
- Dyskinesia: this is a condition that involves involuntary muscle movements and may include repeated, convulsive or distorted movements or twitches.
- Tremor (shaking)
- Blurred vision, an eye infection, or red eyes
- Fast heart rate, high blood pressure, shortness of breath
- Sore throat, cough, nosebleeds, nasal congestion
- Abdominal discomfort or pain, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
- Skin rash, reddening of the skin
- Muscle twitching, skeletal or muscle aches, back pain, joint pain
- Urinary incontinence
- Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue, pain
- Case.
Uncommon (may affect up to 1 in 100 people):
- Infection of the respiratory tract, infection of the bladder, eye infection, inflammation of the tonsils, nail fungus, skin infection, an infection limited to a single area of the skin or part of the body, viral infection, dermatitis caused by mites
- Decrease in the type of white blood cells that help protect you from infection, decreased white blood cell count, decrease in platelets ( blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell ) in the blood
- Allergic reaction
- Diabetes or worsening diabetes, high blood sugar, excessive water drinking
- Weight loss, loss of appetite with malnutrition, and low body weight
- Increased cholesterol in your blood
- Excited mood (mania), confusion, decreased sexual desire, nervousness, nightmares
- Lack of response to stimuli, loss of consciousness, low level of consciousness
- Seizures, fainting
- A restless need to touch parts of the body, balance disorder, abnormal coordination, dizziness when standing up, attention difficulties, speech difficulties, loss of taste or abnormal taste experience, decreased sensation in the skin for touch and pain, irritating or stinging sensation or numbness in the skin
- Hypersensitivity to light, dry eyes, increased tear flow, red eyes
- Feeling of dizziness (dizziness), ringing in the ears, earache
- Atrial fibrillation (an abnormal heart rhythm), disturbance in the conduction between the upper and lower parts of the heart, abnormal electrical conduction in the heart, prolonged QT interval from the heart, low pulse, abnormal electrical signal in the heart ( electrocardiogram or ECG ), a fluttering or throbbing sensation in the chest (palpitations)
- Low blood pressure, low blood pressure when you get up (consequently some people who use risperidone may feel weak, dizzy, or faint when they suddenly stand up or sit up), flushing (feeling hot and redness of the skin)
- Pneumonia due to inhalation of food narrowed airways, blockage (obstruction) in the airways, crackling breathing sounds, wheezing, voice disturbance, disturbance in the respiratory tract
- Gastrointestinal infection, fecal incontinence, very hard stools, difficulty swallowing, increased flatulence
- Hives, itching, hair loss, thickening of the skin, eczema, dry skin, discoloration of the skin, acne, flaking, itchy scalp or skin, skin disease, skin changes
- Increased creatine phosphokinase in the blood, an enzyme that is sometimes released during muscle breakdown
- Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
- Frequent urination, inability to urinate, the pain of urination
- Erectile Dysfunction, Ejaculation Disorder (Ejaculation)
- Loss of menstruation missed periods, or other problems with the menstrual cycle (women)
- Breast development in men, milk leakage from the breasts, sexual dysfunction, breast pain, breast discomfort, discharge from the abdomen
- Swelling of the face, mouth, eyes, or lips
- Chills, increase in body temperature
- Change in the way of walking
- Feeling thirsty, feeling sick, feeling uncomfortable in the chest, feeling being “out of the thread”, discomfort
- Increased levels of liver transaminases in the blood, increased gamma-GT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased levels of liver enzymes in the blood
- Pain during treatment.
Rare (may affect up to 1 in 1,000 people):
- Infection
- Abnormal secretion of a hormone that controls urine volume
- Sleepwalking
- Sleep-related eating disorder
- Sugar in the urine, low blood sugar, high triglycerides in the blood (a type of blood fat)
- Lack of emotions, inability to have an orgasm
- Immobility and lack of reactivity in the awake state (catatonia)
- Problems with the blood vessels in the brain
- Cause of uncontrolled diabetes
- Shakes of the head
- Glaucoma (increased pressure inside the eye), problems with eye movements, rolling of the eyes, ulceration at the edge of the eyelid
- Eye problems during cataract surgery ( cataract ). During cataract surgery, a condition called “Intraoperative Floppy Iris Syndrome (IFIS)” may occur if you are taking or have taken risperidone. If you are going to have cataract surgery, you must inform your ophthalmologist that you are taking or have taken this medicine.
- Dangerously low levels of a certain type of white blood cell needed to protect you from infection in the blood
- Severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, shortness of breath, itching, rash, and sometimes a drop in blood pressure
- Dangerously excessive intake of water
- Irregular heartbeats
- Blood clots in the legs, blood clots in the lungs
- Difficulty breathing during sleep ( sleep apnea ), rapid shallow breathing
- Inflammation of the pancreas, intestinal obstruction
- Swollen tongue, chapped lips, rash related to drug use
- Dandruff
- Degradation of muscle fibers and pain in muscles ( rhabdomyolysis )
- Delay of menstrual periods, enlargement of the mammary glands, breast enlargement, secretion from the breasts
- Increased insulin levels in your blood (a hormone that regulates blood sugar levels)
- Hardening of the skin
- A decrease in body temperature, cold in the arms and legs
- Withdrawal symptoms from medication
- Yellowing of the skin and eyes (jaundice).
Very rare (may affect up to 1 in 10,000 people):
- Lack of bowel movements that cause bowel obstruction.
The following side effect has been seen with the use of another drug called paliperidone which is very similar to risperidone, so it can also be expected when treated with Risperidone Sandoz: palpitations when standing up.
Additional side effects are in children and adolescents
Side effects in children are generally 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: drowsiness or less alertness, fatigue, headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremors, diarrhea, and urinary incontinence.
How to store Risperidone Sandoz
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, on the blister pack / on the label of the HDPE jar after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Use no later than 6 months after the first opening of the HDPE jar.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substance is risperidone.
Each film-coated tablet contains 0.25 mg of risperidone.
Other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, anhydrous colloidal silica
Tablet cover: yellow iron oxide (E172), microcrystalline cellulose, hypromellose, stearic acid, titanium dioxide (E171)
What the medicine looks like and the contents of the pack
The film-coated tablets are ocher yellow and oval.
Risperidone Sandoz is available in PVC / ACLAR / Al or PVC / PE / PVDC / Al blister packs of 10, 20, 30, 40, 50, 60, or 100 film-coated tablets and HDPE cans with PP screw caps containing 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark