0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg film-coated tablets
risperidone

What Risperidone Krka is and what it is used for

Risperidone Krka belongs to the group of antipsychotic drugs.

Risperidone Krka is used to treat:

  • 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 Krka can help relieve the symptoms of your illness and prevent the symptoms from returning.

Risperidone contained in Risperidone Krka 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 you use Risperidone Krka

Do not use Risperidone Krka

  • 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 the above applies to you, talk to your doctor or pharmacist before using Risperidone Krka.

Warnings and cautions

Before using Risperidone Krka, talk to your doctor or pharmacist about:

  • 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 Krka 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 because antipsychotic drugs 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 taking Risperidone Krka.

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. Your doctor may check your white blood cell levels.

Risperidone Krka may 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 Krka, 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 Krka 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 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 using this medicine.

Elderly people with dementia

Elderly patients with dementia are at greater risk of developing stroke. 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, 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 Risperidone Krka

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, such as sedatives ( benzodiazepines ), certain painkillers (opiates), or allergy medicines (certain antihistamines ) can, like risperidone, increase the sedative effect of all these medicines.
  • medicines that can affect the electrical activity of the heart, such as 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 (eg certain diuretics)
  • medicines for high blood pressure. Risperidone Krka may lower blood pressure
  • medicines for Parkinson’s disease (eg levodopa )
  • drugs that increase the activity of the central nervous system (psychostimulants, such as 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). Risperidone Krka 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

  • 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 sedatives)
  • 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 taking Risperidone Krka.

Risperidone Krka with food, drink, and alcohol

You can take this medicine with or without food. You should avoid drinking alcohol while using Risperidone Krka.

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 during the last trimester (the 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 Krka may increase your levels of a hormone called ‘prolactin’ which may affect fertility (see ‘Possible side effects).

Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with Risperidone Krka. 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 vigilance. 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Risperidone Krka contains lactose and sodium

Risperidone Krka film-coated tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

How to use Risperidone Krka

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dose:

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 dementia caused by 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 in patients with Alzheimer’s disease should not exceed 6 weeks.

Use for children and adolescents

  • Children and adolescents under 18 years of age should not be treated with Risperidone Krka for schizophrenia or mania.

Treatment of conduct disorder

Dosage one depends on how much your child weighs:

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 in patients with behavioral disorders should not exceed 6 weeks.

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

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.

Method of administration

Oral use

  • You should swallow the tablet with a little water.

If you use more Risperidone Krka 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, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.

If you forget to use Risperidone Krka

  • 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 using Risperidone Krka

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 less common side effects (which may affect up to 1 in 100 people) :

  • have dementia and experience a sudden mental change or sudden weakness or numbness in the face, arms, or legs, especially on one side, or slurred speech, even for a short period. This may be a sign of a stroke.
  • experiencing tardive dyskinesia (involuntary jerking movements of the face, tongue, or other parts of the body). Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Risperidone treatment may need to be stopped.

Tell your doctor immediately if you get any of the following rare side effects (affects up to 1 in 1000 people) :

  • get blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness of 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 consciousness (a condition called “malignant neuroleptic syndrome”). Immediate medical treatment may be needed.
  • is one and experiences persistent or painful erections. This is called priapism. Immediate medical treatment may be needed.
  • experiencing a severe allergic reaction with fever, swelling of the mouth, face, lips, or tongue, shortness of breath, itching, rash, or drop in blood pressure.

The following 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.
  • drowsiness 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 rare and may include swollen breasts in men, 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 (tremors)
  • 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, redness of the skin
  • muscle twitching, skeletal or muscle aches, back pain, joint pain
  • urinary incontinence
  • swelling in the body, arms or legs, fever, chest pain, weakness, fatigue, pain
  • case.

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

  • respiratory tract infection, bladder infection, eye infection, tonsillitis, nail fungus, skin infection, an infection confined 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, decrease in white blood cell count, decrease in platelets ( blood cells help to stop bleeding), anemia, decrease in red blood cells, and 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
  • exhilarated 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 disorders, 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
  • the feeling of spinning (dizziness), ringing in the ears, ear pain
  • 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, an 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 Krka 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, obstruction (congestion) in the airways, crackling breathing sounds, wheezing, voice disturbance, disturbance in the respiratory tract
  • gastrointestinal infection, stool incontinence, very hard stools, difficulty swallowing, increased flatulence
  • rash ( 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
  • increase in 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
  • erection difficulties, 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, discomfort from the breasts, 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 of 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 emotion, inability to orgasm
  • immobility and lack of reactivity in the awake state (catatonia)
  • problems with the blood vessels in the brain
  • coma due to uncontrolled diabetes
  • head tremors
  • 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 use or have used Risperidone Krka. If you are going to have cataract surgery, you must inform your ophthalmologist that you are using or have used this medicine.
  • dangerously low levels of a certain type of white blood cell needed to protect you from infection in the blood
  • dangerously excessive intake of water
  • irregular heartbeats
  • difficult to breathe during sleep ( sleep apnea ), rapid shallow breathing
  • inflammation of the pancreas, constipation
  • 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
  • lowered body temperature, cold in arms and legs
  • withdrawal symptoms of drugs
  • yellowing of the skin and eyes (jaundice).

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
  • absence of bowel movements that cause blockages

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 Krka: palpitations when standing up.

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.

How to store Risperidone Krka

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 after EXP. The expiration date is the last day of the specified month.

Risperidone Krka 0.5 mg film-coated tablets: Do not store above 30 ° C.

Risperidone Krka 1 mg, 2 mg, 3 mg, and 4 mg film-coated tablets: This medicine does not require any 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.

Contents of the package and other information

Content declaration

  • The active substance is risperidone .One film-coated tablet contains 0.5 mg risperidone .One film-coated tablet contains 1 mg risperidone .One film-coated tablet contains 2 mg risperidone .One film-coated tablet contains 3 mg risperidone .One film-coated tablet contains 4 mg risperidone .
  • The other ingredients are The core: lactose monohydrate, cellulose powder, microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate: Film coating: hypromellose, titanium dioxide (E 171), talc, propylene glycol.
    In addition, contains:0.5 mg: red iron oxide (E 172).2 mg tablets: red iron oxide (E 172), yellow iron oxide (E 172).3 mg tablets: quinoline yellow (E 104).4 mg tablets: quinoline yellow (E 104), indigotin (E 132). See section 2 “Risperidone Krka contains lactose and sodium”.

What the medicine looks like and the contents of the pack

Film-coated tablet:

0.5 mg tablet: Reddish-brown, oval, biconvex film-coated tablets with a partial notch on one side.

1 mg tablet: White, oval, biconvex film-coated tablets with an incision on one side.

2 mg tablet: Orange, oval, biconvex film-coated tablets with a partial notch on one side.

3 mg tablet: Yellow, oval, biconvex film-coated tablets with an incision on one side.

4 mg tablet: Green, oval, biconvex film-coated tablets with a partial notch on one side.

0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg: The tablet can be divided into two equal doses.

Packaging:

Blisters: 20, 28, 30, 50, 56, 60, and 100 film-coated blister tablets for all strengths in a carton.

Plastic jar: 500 film-coated tablets in a plastic jar containing 1 mg and 2 mg tablets in a carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Muhammad Nadeem

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