25 mg, 37.5 mg, 50 mg powder and solvent for solution for injection prolonged-release suspension
risperidone

What Risperidone Teva GmbH is and what it is used for

Risperidone Teva GmbH belongs to the group of antipsychotic drugs.

Risperidone Teva GmbH is used for the maintenance treatment of schizophrenia, a disease that can involve seeing, hearing, or feeling things that do not exist, thinking things that are not real, or feeling unusually suspicious or confused.

Risperidone Teva GmbH is indicated for patients who are currently being treated with oral (eg tablets, capsules) antipsychotic drugs.

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

Risperidone contained in Risperidone Teva GmbH 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 take Risperidone Teva GmbH

You should not be given Risperidone Teva GmbH

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

Warnings and cautions

  • if you have never taken risperidone in any form, you should start with risperidone given orally (ie orally) before starting treatment with Risperidone Teva GmbH.

Talk to your doctor or pharmacist before taking Risperidone Teva GmbH about:

  • you have heart problems. For example, it could be an irregular heartbeat or if you tend to have low blood pressure or you are taking medication for your blood pressure  Risperidone Teva GmbH may 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 problems with blood circulation in the 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 taking risperidone or Risperidone Teva GmbH.

In very 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 using Risperidone Teva GmbH. Your doctor may check your white blood cell levels 

Even if you have previously tolerated risperidone taken by mouth, in rare cases allergic reactions occur after injection with Risperidone Teva GmbH. Seek medical attention immediately if you experience a rash, swelling in the throat, itching, or difficulty breathing as this may be a sign of a severe allergic reaction 

Risperidone Teva GmbH may cause weight gain. Significant weight gain can hhurtyour 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 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 Teva GmbH 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 ), the pupil the black circle in the middle of the eye) may 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

Risperidone Teva GmbH is not intended for use by elderly people with dementia.

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 

Kidney or liver problems

Although risperidone given orally (orally) has been studied, Risperidone Teva GmbH has not been studied in patients with kidney or liver problems. Risperidone Teva GmbH should be administered with caution to this patient group.

Special patient groups

Other medicines and Risperidone Teva GmbH

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

IYou must talkto a 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 rrate/pulsemedicines that reduce the level of potassium in the blood (eg certain diuretics)
  • medicines for Parkinson’s disease (eg levodopa )
  • drugs that increase the activity of the central nervous system (psychostimulants, eg methylphenidate)
  • medicines for high blood pressure  Risperidone Teva GmbH may lower blood pressure 
  • diuretics ( diuretics ) are sed for heart problems or swelling in parts of the body due to the accumulation of too much fluid (eg furosemide or chlorothiazide). Risperidone Teva GmbH 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 bbeta-blockers(used to treat high blood pressure )
  • PPhenothiazines(used 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, ais medicine used to treat high blood pressure aand/orabnormal heart rhythm
  • Sertraline and fluvoxamine, mare edicines 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 Teva GmbH.

Risperidone Teva GmbH with food, drink ,and alcohol

You should avoid drinking alcohol while using Risperidone Teva GmbH.

Pregnancy, breastfeeding ,and fertility

  • If you are pregnant or bbreastfeeding 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 Teva GmbH 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 Teva GmbH may increase your levels of a hormone called “prolactin” which may affect fertility (see “Possible side effects”)

Driving and using machines

Dizziness, fatigue, and vision problems may occur during treatment with Risperidone Teva GmbH. Do not drive or use any tools or machines without first talking to your doctor.

Risperidone Teva GmbH contains sodium

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

How to use Risperidone Teva GmbH

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

Risperidone Teva GmbH is given as an intramuscular injection into one of the arms or the buttocks every two weeks. The injections are is given by healthcare professionals. The injections should be varied between the right and left sides, and should not be given intravenously.

Recommended dose:

Adults

Starting dose

If your daily dose of oral risperidone (eg tablets) has been 4 mg or less for the last 2 weeks, your starting dose should be 25 mg Risperidone Teva GmbH.

If your daily dose of oral risperidone (eg tablets) has been higher than 4 mg in the last 2 weeks, you may be given 37.5 mg Risperidone Teva GmbH as a starting dose.

If you are currently being treated with oral antipsychotic drugs other than risperidone your starting dose of Risperidone Teva GmbH will depend on your current treatment. Your doctor will choose Risperidone Teva GmbH 25 mg or 37.5 mg.

Your doctor will decide which dose of Risperidone Teva GmbH is best for you.

Dose during maintenance treatment

  • The usual dose is 25 mg every two weeks in the form of an injection.
  • A higher dose of 37.5 mg or 50 mg may be necessary in some cases. Your doctor will decide which dose of Risperidone Teva GmbH is best for you.
  • Your doctor may prescribe oral risperidone for the first three weeks after your first injection.

Use for children and adolescents

Risperidone Teva GmbH is not intended for use in persons under 18 years of age.

If you take more Risperidone Teva GmbH than you should

  • People who have received more Risperidone Teva GmbH than intended have reported the following symptoms: drowsiness, fatigue, abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, and abnormal heartbeat. Cases of abnormal electrical conduction in the heart and seizures have been reported.
  • Contact a doctor immediately.

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

If you stop using Risperidone Teva GmbH

You will miss the effect of the medicine. You should not stop taking this medicine unless you have been asked to do so by your doctor, as your symptoms may return. Be careful not to miss any of the visits every two weeks as you will be getting an injection  If at any time you can not come, remember to contact your doctor immediately to determine a new time when you can come and get an injection 

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 ( whichmay 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. Treatment with Risperidone Teva GmbH 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. Even if you have previously tolerated risperidone taken by mouth, rare allergic reactions may occur after you have been injected with Risperidone Teva GmbH.

The following other side effects may also occur:

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

  • common cold symptoms
  • difficulty falling asleep or sleeping without interruption
  • depression, anxiety
  • 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.
  • headache.

Common side effects (may affect up to 1 in 10 people)

  • pneumonia  respiratory tract infection ( bronchitis ), sinusitis
  • urinary tract infection, flu-like sensation, anemia
  • increased levels of a hormone called “prolactin” which is detected by 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.
  • high blood sugar, weight gain, increased appetite, weight loss, decreased appetite
  • sleep disturbance, irritation, decreased sexual desire, restlessness, drowsiness, or less alert
  • 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)
  • dimsyn
  • fast pulse
  • low blood pressure, chest pain, high blood pressure
  • shortness of breath, sore throat, cough, nasal congestion
  • abdominal pain, stomach upset, vomiting, nausea, gastrointestinal infection, constipation, diarrhea, indigestion, dry mouth, toothache
  • rash
  • muscle twitching, skeletal or muscle aches, back pain, joint pain
  • urinary incontinence
  • erection difficulties
  • missed periods of menstruation
  • milk leakage from the breasts
  • swelling in the body, arms or legs, fever, weakness, fatigue
  • pain
  • an injection site reaction, including itching, pain, or swelling
  • increased levels of liver transaminases in the blood,increased gamma-GT (a liver enzyme called gamma-glutamyltransferase) in the blood
  • case.

Uncommon side effects ( may affect up to 1 in 100 people)

  • respiratory tract infection  bladder infection, ear infection, 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, abscess under the skin
  • decreased white blood cell count, decreased platelet count ( blood cells that help stop bleeding), decreased red blood cell count
  • allergic reaction
  • sugar in the urine, diabetes, or worsening diabetes
  • loss of appetite with malnutrition and low body weight
  • high levels of triglycerides (a type of blood fat), increased blood cholesterol
  • elated mood (mania), confusion, inability to orgasm, nervousness, nightmares
  • loss 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
  • eye infection or inflammation of the conjunctiva of the eye, dry eyes, increased tear flow, red eyes
  • fthe eeling 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 when you get up (consequently some people who use Risperidone Teva GmbH may feel weak, dizzy, or faint when standing or sitting up suddenly)
  • rapid shallow breathing, obstructed airways, wheezing, nosebleeds
  • stool incontinence, difficulty swallowing, increased flatulence
  • itching, hair loss, eczema, dry skin, reddening of the skin, discoloration of the skin, acne, flaky, itchy scalp or skin
  • increase in creatine phosphokinase in the blood, an enzyme that is sometimes released during muscle breakdown
  • joint stiffness, joint swelling, muscle weakness, neck pain
  • frequent urination, inability to urinate, pthe ain of urination
  • ejaculation disorder (ejaculation), delay of menstrual periods, missed periods or other problems with the menstrual cycle (women), development of breasts in men, 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 being “out of the thread”
  • hardening of the skin
  • increased levels of liver enzymes in the blood
  • pain during treatment.

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

  • reduction of the type of white blood cells that help protect you from infection
  • insufficient secretion of a hormone that controls urine volume
  • low blood sugar
  • excessive water drinking
  • sleepwalking
  • sleep-related eating disorder
  • immobility and lack of reactivity in the awake state (catatonia)
  • lack of emotion
  • decreased level of consciousness
  • head tremors
  • problems with eye movements, eye-rolling, hypersensitivity to light
  • eye problems during cataract surgery ( cataracts ). During cataract surgery, a condition called “Intraoperative Floppy Iris Syndrome (IFIS)” may occur if you use or have used Risperidone Teva GmbH. If you are going to have cataract surgery, you must inform your ophthalmologist that you are using or have used this medicine.
  • irregular heartbeats
  • dangerously low levels of a certain type of white blood cell needed to protect you from infection in the blood, increase in eosinophils (a type of white blood cell ) in the blood
  • difficulty breathing during sleep ( sleep apnea )
  • pneumonia due to inhalation of food, narrowed airways, crackling breathing sounds, voice disturbance, disturbance in the respiratory tract
  • inflammation of the pancreas, constipation
  • very hard stools
  • skin rash related to drug use
  • rash ( hives ), thickening of the skin, dandruff, skin disease, skin changes
  • degradation of muscle fibers and pain in muscles ( rhabdomyolysis )
  • abnormal posture
  • breast augmentation, secretion from the breasts
  • decreased body temperature, discomfort
  • yellowing of the skin and eyes (jaundice)
  • dangerously excessive intake of water
  • increased insulin levels in the blood ( insulin is a hormone that regulates blood sugar levels)
  • problems with the blood vessels in the brain
  • lack of response to stimuli
  • coma due to uncontrolled diabetes
  • sudden loss of vision or blindness
  • glaucoma (increased pressure inside the eye), ulceration at the edge of the eyelid
  • redness  swollen tongue
  • chapped lips
  • enlargement of the mammary glands
  • lowering of body temperature, cold in arms and legs
  • withdrawal symptoms of drugs.

Very rare side effects ( 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
  • lack of bowel movements causing a stop.

Has been reported (occurs in an unknown number of users):

  • severe or life-threatening rash with blisters and flaky skin that may start in and around the mouth, nose, eyes, or genitals and spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis ).

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 during treatment with Risperidone Teva GmbH: palpitations when standing up.

How to store Risperidone Teva GmbH

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.

Store the entire package in a refrigerator (2 ° C ‑ 8 ° C). If a refrigerator is not available, the package can be stored below 25 ° C for a maximum of 7 days before use.

Store in the original package. Sensitive to light.

After preparation:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25 ° C.

From a microbiological point of view, medicine should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 6 hours at 25 ° C, unless reconstitution has taken place under controlled and validated aseptic conditions.

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 reconstituted Risperidone Teva GmbH prolonged-release injection contains either 25 mg, 37.5 mg, or 50 mg risperidone.
  • Other ingredients are Powder for suspension: Poly- (D, L-lactide-co-glycolide)Diluent (solution): Polysorbate 20, carmellose sodium, disodium hydrogen phosphate dihydrate, citric acid, sodium chloride, sodium hydroxide, water for injections.

What the medicine looks like and cthe ontents of the pack

Risperidone 25 mg:

Each dose pack contains the following components co-packaged in a plastic tray:

  • A small vial with a gray stopper, sealed with a pink aluminum cap, with powder (the powder contains the active substance risperidone ).
  • A syringe filled with 2 ml of clear, colorless liquid is to be added to the powder for solution for injection.
  • A vial adapter for preparation 
  • Two Terumo SurGuard ® 3 injection needles for intramuscular injection: a 21G UTW (0.8 mm × 25 mm [1 “]) safety cannula with needle guard for administration in the deltoid and a 20G TW (0.9 mm × 51 mm [2”]) safety needle with needle guard for gluteal administration 

Risperidone 37.5 mg:

Each dose pack contains the following components co-packaged in a plastic tray:

  • A small vial with a gray stopper, sealed with a green aluminum cap, with powder (the powder contains the active substance risperidone ).
  • A syringe filled with 2 ml of clear, colorless liquid is to be added to the powder for solution for injection.
  • A vial adapter for preparation 
  • Two Terumo SurGuard®3 intramuscular injection needles: a 21G UTW (0.8 mm × 25 mm [1 “]) safety cannula with needle guard for administration in the deltoid and a 20G TW (0.9 mm × 51 mm [2”]) safety needle with needle guard for gluteal administration 

Risperidone 50 mg:

Each dose pack contains the following components co-packaged in a plastic tray:

  • A small vial with a gray stopper, sealed with a blue aluminum cap, with powder (the powder contains the active substance risperidone ).
  • A syringe filled with 2 ml of clear, colorless liquid is to be added to the powder for solution for injection.
  • A vial adapter for preparation 
  • Two Terumo SurGuard®3 intramuscular injection needles: a 21G UTW (0.8 mm × 25 mm [1 “]) safety cannula with needle guard for administration in the deltoid and a 20G TW (0.9 mm × 51 mm [2”]) safety needle with needle guard for gluteal administration 

Risperidone Teva GmbH is available in packs containing 1, 2, or 5 dose packs.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Teva GmbH

Graf-Arco-Str. 3

Ulm

89079

Germany

Manufacturer

PLIVA Hrvatska doo (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

Pharmathen International SA

Industrial Park Sapes

Rodopi Prefecture, Block No 5

Rodopi 69300

Greece

Pharmathen SA

Dervenakion 6

Pallini Attiki 15351

Greece

Muhammad Nadeem

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