0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg film-coated tablets
risperidone

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Risperidone Actavis is and what it is used for
2. What you need to know before you use Risperidone Actavis
3. How to take Risperidone Actavis
4. Possible side effects
5. How to store Risperidone Actavis
6. Contents of the pack and other information

What Risperidone Actavis is and what it is used for

Risperidone Actavis belongs to a group of medicines called antipsychotics.

Risperidone Actavis is used to treat:

  • Schizophrenia, which 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, which 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 harm 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 in adolescents with behavioral disorders.

Risperidone Actavis can help relieve the symptoms of your illness and prevent the symptoms from returning.

Risperidone contained in Risperidone Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Risperidone Actavis

Do not use Risperidone Actavis

  • 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.

Warnings and cautions

Talk to your doctor or pharmacist before taking Risperidone Actavis 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 that you are taking medication for your blood pressure . Risperidone Actavis may cause low blood pressure . Your dose may need to be adjusted.
  • You know that you have a risk factor for stroke , such as high blood pressure , cardiovascular disease or a problem with a blood vessel in your brain.
  • if you have ever experienced involuntary movements of the tongue, mouth and face
  • if you have ever had a condition where the symptoms include high body temperature, muscle stiffness, sweating or decreased consciousness (also called malignant neuroleptic syndrome)
  • you have Parkinson’s disease or dementia.
  • if you know you have had low white blood cell counts 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 know you are 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 dependent on prolactin .
  • if you or someone in your family has had a blood clot in the past, as 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 using Risperidon Actavis.

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 Actavis. Your doctor may check your white blood cell levels.

Risperidone Actavis may cause weight gain. Significant weight gain can have a negative impact on 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 Actavis, 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 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 (see Possible side effects ). If such side effects occur, assessment of prolactin levels in the blood is recommended.

In cataract surgery ( cataract ) it may happen that the pupil one (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 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.

If fatigue occurs during treatment with risperidone , a change in 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 Actavis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important that you 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 (eg certain diuretics).
  • medicines for high blood pressure . Risperidone Actavis may lower blood pressure .
  • medicines for Parkinson’s disease (eg levodopa ).
  • drugs that increase the activity of the central nervous system (psychostimulants, eg methylphenidate)
  • diuretics ( diuretics ) used for heart problems or swelling in parts of the body due to accumulation of too much fluid (eg furosemide or chlorothiazide). Risperidone Actavis taken separately or 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 .
  • Drugs called beta- blockers (used to treat high blood pressure ).
  • Phenothiazines (used, for example, to treat psychosis or as sedatives).
  • Cimetidine, ranitidine (counteracts acid stomach).
  • Itraconazole and ketoconazole (medicines used to treat fungal infections)
  • Some medicines used to treat HIV / AIDS, such as 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 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 Risperidon Actavis.

Risperidone Actavis with food and alcohol

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, 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 Actavis 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 Actavis 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 Actavis. 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 . 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 Actavis 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.

How to use Risperidone Actavis

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

The recommended dose is as follows:

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 (0.25 ml of 1 mg / ml oral solution) twice a day.
  • 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 Actavis 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 (0.25 ml of 1 mg / ml oral solution) 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 (0.25 ml to 0.75 ml of 1 mg / ml oral solution) once daily.

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 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 Actavis 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

You should swallow the tablet with a little water. 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.

If you use more Risperidone Actavis 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. a child ingested the medicine accidentally contact a doctor, hospital or the Poison Information Center (tel.112) for risk assessment and advice.

If you forget to use Risperidone Actavis

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 Actavis

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.

4. 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 (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 in the tongue, mouth or face. Treatment with Risperidone Actavis 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, 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 consciousness (a condition called “malignant neuroleptic syndrome”). Immediate medical treatment may be needed.
  • is a man and experiences persistent and painful erections . This is called priapism. Immediate medical treatment may be needed.
  • experiencing severe allergic reaction with fever, swelling of mouth, face, lips or tongue, shortness of breath, itching , rash or drop in blood pressure.

The following other side effects may also 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 a 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 your 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 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, 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 , 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
  • 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 , 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 Actavis may feel weak, dizzy or faint when they suddenly stand up or sit up), flushing (feeling hot and reddened in 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, 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 Actavis. 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, a lowering of 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 and is very similar to risperidone , so it can also be expected when treated with Risperidone Actavis: 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.Postal address

5. How to store Risperidone Actavis

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, carton or tablet jar after EXP. The expiration date is the last day of the specified month.

0.25 mg and 0.5 mg:

Do not store above 25 ° C.

1 mg, 2 mg, 3 mg, 4 mg and 6 mg:

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.

6. Contents of the package and other information

Content declaration

  • The active substance is risperidone . One Risperidone Actavis film-coated tablet contains 0.25 mg; 0.5 mg; 1 mg; 2 mg; 3 mg, 4 mg or 6 mg risperidone .
  • The other ingredients are anhydrous lactose , microcrystalline cellulose, pregelatinised maize starch, magnesium stearate, hypromellose, macrogol and titanium dioxide (E171).The 0.25 mg and 0.5 mg tablets also contain yellow iron oxide (E172).

What the medicine looks like and contents of the pack

0.25 mg tablet: Light yellow, round, biconvex film-coated tablets, marked “T”, diameter 6 mm.

0.5 mg tablet: Light yellow, oval, biconvex film-coated tablets, marked “T” with a score line, 8×5 mm.

The tablet can be divided into two equal doses .

1 mg tablet: White, oval, biconvex film-coated tablets, marked “T1” with a score line, 8×5 mm.

The tablet can be divided into two equal doses .

2 mg tablet: White, oval, biconvex film-coated tablets, marked “T2” with a score line, 10×5 mm.

The tablet can be divided into two equal doses .

3 mg tablet: White, oval, biconvex film-coated tablets, marked “T3” with a score line, 11×6.5 mm.

The tablet can be divided into two equal doses .

4 mg tablet: White, oval, biconvex film-coated tablets, marked “T4” with a score line, 14×7.5 mm.

The tablet can be divided into two equal doses .

6 mg tablet: White, oval, biconvex film-coated tablets, marked “T” with a score line, 16×8.5 mm.

The tablet can be divided into two equal doses .

Packaging:

Blister pack: 6, 10, 20, 28, 30, 50, 60, 98, 100 film-coated tablets.

Plastic jar: 100 and 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorisation Holder

Actavis Group PTC ehf.,

Reykjavikurvegur 76-78

IS-220 Hafnarfjörður

Iceland

Manufacturer

Actavis Ltd.

BT16 Bulebel Industrial Estate

Newspaper

Malta

Balkanpharma – Dupnitsa AD

3 Samokovsko Schosse Str.

Dupnitsa 2600

Bulgaria

Local representative

Teva Sweden AB

Box 1070

251 10 Helsingborg

Muhammad Nadeem

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