film-coated tablets
risperidone

What Rispemyl is and what it is used for

Rispemyl belongs to the group of antipsychotic drugs.

Rispemyl is used to treat 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 Alzheimer’s disease with dementia, 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 contained in Rispemyl may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 using Rispemyl

Do not use Rispemyl

  • if you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Rispemyl:

  • if you are using furosemide (a diuretic used to reduce swelling and fluid retention caused by various diseases, including heart and liver disease).
  • if you have heart problems. Examples include if you have a weakened heart muscle ( heart failure ), have had a heart attack, if you tend to have low blood pressure, or are taking blood pressure medication. Rice powder can cause low blood pressure. Your dose may need to be adjusted.
  • if you or someone in your family has a history of irregular heartbeat, as this medication has been associated with potentially serious changes in your heartbeat.
  • if 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
  • if you know of any factors that make it more likely to develop a blood clot, such as if you smoke or have smoked, or if it is likely that you will be immobile for a long period (eg after surgery or illness ).
  • if you or anyone else in your family has a history of blood clots, as medications like this have been linked to blood clots.
  • if you have or have had, a low number of white blood cells in your blood, especially if this has happened when you have taken other medicines.
  • if you have ever experienced involuntary movements of the tongue, mouth, and face.
  • if you have ever had a condition in which the symptoms include high body temperature, muscle stiffness, sweating, or decreased level of consciousness (also called malignant neuroleptic syndrome).
  • if you have Parkinson’s disease (a disease of the brain that causes movement disorders such as tremors, stiffness, slow movements, and sluggish gait) or dementia (general impairment of all mental abilities such as memory impairment and other mental performance), especially Lewy body dementia (abnormal protein accumulation inside nerve cells in Parkinson’s disease ).
  • if you are diabetic, or at risk of developing diabetes (if you have elevated blood sugar levels).
  • if you have epilepsy.
  • if you are a man and have ever had a persistent or painful erection.
  • if you have problems controlling your body temperature, often overheat or are, or maybe, exposed to very high temperatures or intense exercise.
  • if you are, or during treatment, become dehydrated or have a low blood volume ( hypovolemia ).
  • if you have low levels of potassium or magnesium in your blood.
  • if you have kidney problems.
  • if you have liver problems.
  • if you have abnormally high levels of the hormone et prolactin in your blood or if you have a tumor that may be dependent on prolactin.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Rispemyl.

During treatment

Risperidone can cause changes in the number of white blood cells, which help counteract infection, and therefore your doctor may take blood samples before and during treatment.

Rice powder can cause weight gain. Significant weight gain can hurt your health. Your doctor should check your body weight regularly.

Because diabetes or worsening of existing diabetes has been seen in patients taking Rispemyl, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes, blood sugar ( glucose ) should be monitored regularly.

It is common for Rispemyl to increase the levels of a hormone called “prolactin”. This can lead to side effects such as menstrual disorders or fertility problems in women, swelling of the breasts in men, low sexual drive, impotence, and milk leakage from the breasts (see Possible side effects ). If such side effects occur, an assessment of the prolactin level in the blood is recommended.

If you are going to have eye/eye surgery, tell your doctor or hospital staff that you are taking this medicine. During cataract surgery (clouding of the lens of the eye), this drug can affect the pupil or iris (the colored part of the eye), which can lead to eye damage.

Elderly people with dementia

In elderly patients with dementia, there is an increased risk of stroke or mini-stroke (also called a transient ischemic attack or TIA ). You should not use risperidone if you have dementia caused by a stroke.

You should have regular contact with your doctor while you are being treated with risperidone.

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, vision problems, or slurred speech, even if it is only short-lived. The enumerating 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.

If fatigue occurs during treatment with risperidone, a change in the timing of drug intake may result in improved attention span.

Before starting treatment, you or your child may be weighed and the weight may be monitored regularly during treatment.

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 Rispemyl

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, herbal medicines, or other natural products.

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), allergy medicines (certain antihistamines ), and 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 (quinine, mefloquine), heart rhythm problems (such as quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), allergies ( antihistamines ), certain antidepressants or other medicines for mental problems (such as paroxetine, fluoxetine, sertraline, fluvoxamine, tricyclic antidepressant agents, (such as amitriptyline), tetracyclic antidepressants (such as maprotiline)) or other mental health medicines (such as paliperidone or phenothiazines used to treat psychosis or to calm down).
  • Medicines that cause a slow heartbeat/pulse, such as beta-blockers or verapamil (used to treat high blood pressure or angina).
  • Drugs that reduce the level of potassium or magnesium in the blood (eg certain diuretics).
  • Medicines for high blood pressure. Rice powder can lower blood pressure.
  • Medicines for Parkinson’s disease (eg levodopa ).
  • Drugs that increase the activity of the central nervous system (psychostimulants, for example, methylphenidate).
  • 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). Rice powder taken separately or together with furosemide may increase the risk of stroke or death in elderly people with dementia.

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

  • Cimetidine, ranitidine (counteracts acid stomach)
  • Itraconazole and ketoconazole (medicines used to treat fungal infections)
  • Some medicines used to treat HIV / AIDS, such as ritonavir

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 Rispemyl.

Rice millet with alcohol

You should avoid drinking alcohol when using Rispemyl.

Pregnancy, breastfeeding, and fertility

  • The following symptoms may occur in newborns of mothers who have used Rispemyl during the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, fatigue, anxiety, difficulty breathing, and feeding problems. If your child has any of these symptoms, you may need to contact your doctor.

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 take it.

Rispemyl may increase your levels of a hormone called “prolactin” which may affect the fertility of both female and male patients (see section 4 “Possible side effects”).

Driving and using machines

Dizziness, fatigue, and vision problems may occur during treatment with Rispemyl. 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.

Rice powder 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. 

Rispemyl film-coated tablets also contain para-orange (E110), which may cause allergic reactions. 

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to use Rispemyl

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. This depends on your condition and varies from person to person.

As Respimyl is only available in strength 2mg film-coated tablets, not all dosages are possible. If other strengths or pharmaceuticals are needed, other risperidone products should be used.

Recommended dose

Treatment of schizophrenia

Adults

  • The recommended 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 dose is best for you.

Elderly

  • The recommended starting dose is usually 0.5 mg twice daily.
  • Your doctor may then gradually increase the dose you should take to 1-2 mg twice a day.
  • Your doctor will tell you which dose is best for you.

Use in children and adolescents

  • Children and adolescents under 18 years of age should not be treated with Rispemyl for schizophrenia.

Treatment of mania

Adults

  • The recommended 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 recommended starting dose is usually 0.5 mg twice daily.
  • 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.

Children and young people

  • Children and adolescents under 18 years of age should not be treated with Rispemyl for mania.

Treatment of long-term aggression in people with Alzheimer’s disease

Adults (including the elderly)

  • The recommended 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 a day.
  • The duration of treatment in patients with Alzheimer’s disease should not exceed 6 weeks.

Treatment of behavioral disorders in children and adolescents

Dosage one depends on how much your child weighs:

Children weighing less than 50 kg

  • The recommended 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 once a day.

Children weighing 50 kg or more

  • The recommended 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 once a day.

The treatment time in patients with behavioral disorders should not exceed 6 weeks.

Children under 5 years of age should not be treated with risperidone for behavioral disorders.

People with kidney or liver problems

Regardless of why you are taking this medicine, 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.

How to use Rispemyl

  • You should swallow the tablet with a little water
  • Risperidone can be taken with or without food

The tablet can be divided into two equal doses.

If you use more Rispemyl 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 experience rapid or abnormal heartbeat or seizures.

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

If you forget to take Rispemyl

  • 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 Rispemyl

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 or go to the hospital emergency room if you:

Common (may affect up to 1 in 10 people):

  • Develops lung infections, including serious lung infections such as pneumonia – you may have a high fever, cough up mucus that may be bloody or frothy, and feel very ill

Uncommon (may affect up to 1 in 100 people):

  • Experiencing a sudden change in your mental state, sudden weakness or numbness in the face, arms, or legs, especially on one side, vision problems, or slurred speech, even for a short time. These may be signs of a stroke, mini-stroke ( transient ischemic attack), or decreased blood flow to the brain
  • Experiencing an abnormal heart rhythm, such as heart fibrillation (fibrillation) or very slow or abnormal heartbeat (heart block). These can be caused by abnormal electrical conduction in the heart and can be seen as abnormal electrical activity tracking in the heart ( ECG ). In some cases, this can be life-threatening
  • Does not respond to stimuli (changes in the internal or external environment), has a low level of consciousness or becomes unconscious, or has seizures (convulsions)
  • Experiences involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to stop taking risperidone
  • Develops diabetes – a condition in which the body can not control blood sugar levels properly. You may feel very thirsty and still urinate a lot, have an increased appetite and still feel tired and lethargic. If left untreated, you could go into a coma or develop potentially life-threatening complications caused by uncontrolled diabetes.
  • Experiencing an increased number of infections, e.g. sore throat, cold sores, etc., can be caused by a decrease in the number of white blood cells, including those that help protect you from bacterial infection.
  • Develops a lung infection caused by having inhaled food into the airways or having a lung stasis (eg due to mucus formation)
  • Notes an infection under the skin, usually in the fat layers on the thigh and buttocks ( cellulite ).
  • Can not urinate or empty the bladder completely
  • Has severe constipation, which can be caused by a bowel obstruction or a severe hardening and compression of the stool

Rare (may affect up to 1 in 1,000 people):

  • Rash, itching or rash, swelling of the face, lips, tongue, or throat, shortness of breath, difficulty breathing, dizziness, or shock. This may be a symptom of a severe allergic reaction or angioedema
  • Get blood clots, especially in the legs (symptoms are swelling, pain, and redness on the legs), which can move through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately
  • Experiencing fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called “malignant neuroleptic syndrome”). Immediate medical treatment may be needed.
  • Are you experience persistent and painful erections. This is called priapism, immediate medical treatment may be needed
  • Has severe abdominal pain that reaches around the back. This may be a sign of inflammation of the pancreas
  • Develops increased pressure in the eye ( glaucoma ), which can cause problems with the visual field and more long-term and serious problems with vision
  • A lower dose of sodium than usual in the blood, can make you feel weak and confused and feel muscle aches. This can be caused by inadequate secretion of a hormone ( ADH ) which allows the body to retain fluid and dilute the blood, reducing the amount of sodium. This can be associated with dangerously high water consumption (more than 2 liters a day)
  • Notes severe weakness or pain in the muscles, which may be caused by the degradation of muscle tissue ( rhabdomyolysis )

Very rare (may affect up to 1 in 10,000 people):

  • Experiencing decreased appetite, unexplained weight loss, nausea, vomiting, abdominal pain, difficulty breathing, decreased heart rate, unusual muscle pain or feeling of weakness, fatigue, or feeling of discomfort. This can be a symptom of an unusual life-threatening complication of poorly regulated diabetes called diabetic ketoacidosis.

Tell your doctor immediately if you experience any of the above side effects.

The following side effects may also occur:

Very common (may affect more than 1 user in 10):

  • Parkinsonism. This is a medical term that includes many symptoms. Each symptom can occur in less than 1 in 10 people. Parkinsonism includes: increased salivation or watery mouth, musculoskeletal stiffness, drooling, jerking when bending joints, slow, decreased, or weakened body movements, lack of facial expressions, tense muscles, neck tension, muscle stiffness, gait with small, short, and fast steps and lack of normal steps oscillating movements with the arms, persistent blinking as a result of tapping the forehead (an abnormal reflex)
  • Headache, difficulty falling asleep or continuing to sleep
  • Drowsiness, drowsiness

Common (may affect up to 1 to 10 users):

  • Fatigue, general weakness ( asthenia ), feeling tired, drowsiness or drowsiness ( lethargy ), restlessness, difficulty sitting still, anxiety, depression, agitation, dizziness, feeling tired, drowsiness
  • Vomiting, diarrhea, constipation, nausea, heartburn or indigestion, abdominal pain or discomfort, sore throat, dry mouth, toothache
  • Weight gain, increase in body temperature (fever), decrease in appetite, increase in appetite
  • Difficulty breathing, flu, blurred vision, infection of or allergic reactions in the eye, which may produce a sticky discharge, sinus infections, nasal congestion, or clogged sinuses
  • Urinary tract infection, bedwetting, inability to control urination ( incontinence ), inability to urinate
  • Tremor, muscle spasm, involuntary movements of the face, arms, or legs, repetitive movements or abnormal posture associated with muscle cramps and pain in joints and muscles, back pain, fluid retention in the body (eg swelling in arms and legs), pain in arms and legs
  • Skin rash, redness of the skin, ear infections
  • Fast heart rate, chest pain, high blood pressure
  • Case
  • Elevated levels of the hormone et prolactin in the blood

Uncommon (may affect up to 1 to 100 users):

  • Need to drink large amounts of water, thirst, fecal incontinence, gas, hoarseness, or voice disturbance.
  • High blood sugar.
  • Bladder infection, viral and other infections, tonsillitis, a stomach infection, and fungal infection of the nails.
  • Drop-in blood pressure after standing up, low blood pressure, feeling of dizziness after changing body position, awareness of heartbeat, decreased heart rate.
  • Pain when urinating, need to urinate frequently.
  • Confusion, attention deficit disorder, increased need for sleep, nightmares, nervousness, and elated mood (mania).
  • Elevated liver enzymes, low value of hemoglobin or red blood cells ( anemia ), increase in eosinophilic cells (especially white blood cells ), the increased value of creatinine phosphokinase in the blood, and decrease in platelets ( blood cells that help to stop bleeding), elevated cholesterol levels.
  • Muscle weakness, severe restlessness along with muscle cramps and tremors, earache, neck pain, joint swelling, abnormal posture, joint stiffness, chest discomfort
  • Skin damage, skin problems, dry skin, intense skin itching, acne, hair loss, eczema (skin inflammation) that can be caused by mites, discoloration of the skin, thickening of the skin, redness, stinging sensations, decreased skin sensitivity to pain or touch, inflammation of oily skin (seborrheic eczema ).
  • Loss of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, secretion from the breast, breast enlargement in men, chest pain or discomfort, decreased sexual drive, irregular or delayed menstruation, and discharge from the vagina.
  • Fainting, gait disturbance (gait), inertia, weight gain, loss of appetite with malnutrition, and low body weight, as a result, feeling of being “out of the threads”, balance disorder, allergies, chills, coordination difficulties, abnormal taste experience.
  • Painful hypersensitivity to light increased blood flow to the eyes, dry eyes, and increased tear flow.
  • Crunching breathing sounds, difficulty speaking, difficulty swallowing, and hhorse/whistlingsound when breathing.
  • Ringing in the ears, feeling of dizziness and dizziness (dizziness), swelling of the face (facial edema).

Rare (may affect up to 1 in 1,000 users):

  • Inability to have an orgasm, enlarged breasts, or swollen, hot and tender breasts
  • Dandruff
  • Cold arms and legs, tongue swelling, lip inflammation, hardening of body parts, e.g. skin
  • Immobility and lack of reactivity in the awake state (catatonia)
  • Sleepwalking
  • Sleep-related eating disorder
  • Crust formation in the eyelid rim, eye-rolling, problems with eye movements, complications during cataract surgery
  • Emotional blunting
  • Drug withdrawal syndrome
  • Lowered body temperature
  • Rapid shallow breathing, difficulty breathing during sleep, sinus arrhythmia (normal change in heart rhythm caused by breathing)
  • Head tremor
  • Yellowing of the skin and eyes (jaundice)
  • Presence of blood sugar ( glucose ) in the urine, low blood sugar, elevated levels of insulin fats or ( triglycerides ) in the blood

Drugs such as risperidone have also been reported to cause a decrease in blood pressure after standing, which is associated with a very high increase in heart rate as the body recovers.

Additional side effects 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 (involuntary urine leakage).

How to store Rispemyl

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 blister or carton after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

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.

Package contents and other experiences

Content declaration

The active substance is risperidone.

One Rispemyl film-coated tablet contains 2 mg risperidone.

Other ingredients are: 

Tablet core: lactose monohydrate, pregelatinized maize starch, microcrystalline cellulose (E460), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.

Film coating: Hypromellose (E464), propylene glycol (E490), titanium dioxide (E171), talc (E553B), para-orange aluminum lacquer (E110).

What the medicine looks like and the contents of the pack

Orange, round, biconvex, film-coated tablet marked with “2” on one side and a breaker notch on the other side

Pack sizes

Rispemyl 2 mg film-coated tablets are supplied in blister packs of 20, 28, 30, 50, 56, 60, or 100 film-coated tablets.

Rispemyl 2 mg film-coated tablets are supplied in unit dose blisters in packs of (28×1), (30×1), (56×1), (60×1) or (100×1) film-coated tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Mylan AB, Box 23033, 104 35 Stockholm

Manufacturer

Mylan Hungary Kft.

H-2900,

Komarom,

Mylan utca 1.

Hungary

Gerard Laboratories.

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13

Ireland

Generics [UK] Ltd.

Station Close.

Potters Bar,

Hertfordshire,

ENG 1TL,

UK

Mylan Dublin

Newenham Court

Northern Cross

Malahide Road

Dublin 17

Ireland

Logiters, Logistica Portugal, SA

Estrada dos Arneiros, 4,

Azambuja, 2050-544

Portugal

Mylan Germany GmbH

Branch drop Bad Homburg Benzstrasse 1,

Page 46 of 46

61352 Bad Homburg vd Höhe,

Germany

Muhammad Nadeem

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