Prospecto:information for the user

Risperidona Teva 25 mg powder and solvent for prolonged release injectable suspension EFG

Risperidona Teva 37.5 mg powder and solvent for prolonged release injectable suspension EFG

Risperidona Teva 50 mg powder and solvent for prolonged release injectable suspension EFG

Read this prospectus carefully before starting to use this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience adverse effects,consult your doctor or pharmacist,eveniftheyare not listed in this prospectus. See section 4.

1.What is Risperidona Tevaand what is it used for

2.What you need to knowbeforestarting touseRisperidona Teva

3.How to use Risperidona Teva

4.Possible adverse effects

5Storage of Risperidona Teva

6.Contents of the package and additional information

Risperidona belongs to a group of medicines called “antipsychotics”.

Risperidona is used in the maintenance treatment of schizophrenia, which is characterized by seeing, hearing or feeling things that are not present, believing something that is not true or unusually feeling distrust or confusion.

Risperidona is intended for patients who are currently being treated with oral antipsychotics (e.g., tablets, capsules).

Risperidona may help reduce the symptoms of your illness and prevent them from returning.

Do not use Risperidona Teva

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

Warnings and precautions

• If you have never taken risperidone in any of its forms, you should start with oral risperidone before starting this medicine.

Consult your doctor or pharmacist before starting to use Risperidona Teva if:

• You have a heart problem, for example an irregular heart rhythm, or if you are prone to having low blood pressure or if you are using medicines for high blood pressure. Risperidone may lower your blood pressure. Your dose may need to be adjusted
• You know that you are prone to having a stroke, such as high blood pressure (hypertension), cardiovascular disorders or cerebral circulation disorders
• You have ever had involuntary movements of the tongue, mouth and face
• You have ever had symptoms that include fever, muscle stiffness, sweating or a decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome)
• You have Parkinson's disease or dementia
• You have had low white blood cell counts in the past (which may or may not have been caused by other medicines)
• You are diabetic
• You have epilepsy
• You are a man and have ever had an erection that lasted too long or was painful
• You have difficulty controlling your body temperature or feel excessive heat
• You have kidney problems
• You have liver problems
• You have an abnormally high level of a hormone called prolactin in your blood or if you have a tumour that may be dependent on prolactin
• You or a member of your family has a problem with blood clots in the blood as this medicine has been associated with the formation of blood clots.

If you are unsure whether the information above affects you, talk to your doctor or pharmacist before using risperidone or Risperidona Teva powder and solvent for prolonged-release suspension for injection EFG.

Because in very rare cases, a dangerously low number of a type of white blood cell necessary to fight infections in the blood has been observed in patients treated with risperidone, your doctor may check your white blood cell count.

Rarely, allergic reactions occur after receiving injections of risperidone, even if you have previously tolerated oral risperidone. Seek medical attention immediately if you experience hives, swelling of the throat, itching or breathing difficulties as these may be symptoms of a severe allergic reaction.

Risperidone may cause you to gain weight. A significant weight gain may affect your health unfavourably. Your doctor will regularly monitor your weight.

Because diabetes mellitus or worsening of pre-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 sugar should be monitored regularly.

Risperidone frequently increases the levels of a hormone called “prolactin”. This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast swelling in men (see Possible adverse effects). If these adverse effects occur, it is recommended that blood prolactin levels be evaluated.

During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the coloured part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning to have eye surgery, make sure to inform your ophthalmologist that you are using this medicine.

Patients with advanced age and dementia

Risperidone is not used in patients with advanced age and dementia.

If you or your caregiver notice a sudden change in your mental state or the sudden appearance of weakness or numbness in the face, arms or legs, especially on one side, or confused speech, although only for a short time, seek medical treatment immediately. This may be a sign of a stroke.

Patients with kidney or liver problems

Although oral risperidone has been studied, Risperidona Teva powder and solvent for prolonged-release suspension for injection EFG has not been studied in patients with kidney or liver problems. Risperidone should be administered with caution in this group of patients.

Use of Risperidona Teva with other medicines

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine.

It is especially important to talk to your doctor or pharmacist if you take any of the following

• Medicines that act on the brain used to calm down (benzodiazepines) or some pain medicines (opioids), allergy medicines (some antihistamines), as risperidone may increase the sedative effect of all these
• Medicines capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other medicines for mental health problems
• Medicines that may cause a decrease in heartbeats
• Medicines that may cause a decrease in potassium in the blood (such as certain diuretics)
• Medicines for Parkinson's disease (such as levodopa)
• Medicines that increase the activity of the central nervous system (psycho-stimulants, such as methylphenidate)
• Medicines for the treatment of high blood pressure. Risperidone may lower blood pressure
• Diuretics used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone

• Rifampicin (a medicine used to treat some infections)
• Carbamazepine, phenytoin (medicines used to treat epilepsy)
• Phenobarbital.

If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone

• Quinidine (a medicine used to treat certain types of heart problems)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (such as medicines used to treat psychosis or to calm down)
• Cimetidine, ranitidine (medicines used to treat stomach acid)
• 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 health disorders.

If you start or stop taking these medicines, you may need a different dose of risperidone.

If you are unsure whether the information above affects you, talk to your doctor or pharmacist before using risperidone.

Use of Risperidona Teva with food, drinks and alcohol

You should avoid consuming alcohol while using risperidone.

Pregnancy, breastfeeding and fertility

• If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can use it
• The following symptoms may occur in newborn babies, in mothers who have been treated with risperidone in the last three months of pregnancy (last three months of your pregnancy): shivering, stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If your baby develops any of these symptoms, you should contact your doctor
• Risperidone may increase the levels of a hormone called “prolactin” which may affect your fertility (see Possible adverse effects).

Driving and operating machinery

Dizziness, fatigue and vision problems have been observed during treatment with risperidone. Do not drive or use tools or machinery without consulting your doctor first.

Risperidona Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Risperidona Teva is administered by intramuscular injection in the arm or buttock every two weeks by a healthcare professional. The injections should be alternated between the left and right sides and should not be administered intravenously.

The recommended dose is as follows:

Adults

Initial dose

If your daily dose of oral risperidone (e.g., tablets) was 4 milligrams or less during the two weeks prior, your initial dose should be 25 milligrams of Risperidona Tevapowder and solventfor long-acting injectable suspension EFG.

If your daily dose of oral risperidone (e.g., tablets) was more than 4 milligrams during the two weeks prior, you may be given a dose of 37.5 milligrams of Risperidona Tevapowder and solventfor long-acting injectable suspension EFGas the initial dose.

If you are currently being treated with another oral antipsychotic that is not risperidone, your initial dose of Risperidona Tevapowder and solventfor long-acting injectable suspension EFGwill depend on your current treatment. Your doctor will choose Risperidona Teva 25 mg or 37.5 mg.

Your doctor will decide if this dose of risperidone is suitable for you.

Maintenance dose

• The usual dose is an injection of 25 milligrams every two weeks
• A higher dose of 37.5 or 50 mg may be necessary. Your doctor will decide which dose of risperidone is most suitable for you
• Your doctor may prescribe oral risperidone for the first three weeks after the first injection.

If you use more Risperidona Teva than you should

• People who have used more risperidone than they should have experienced the following symptoms: drowsiness, fatigue, abnormal body movements, difficulty standing and walking, feeling of dizziness due to decreased blood pressure, and abnormal heartbeats. Cases of abnormal heart conduction and seizures have been reported
• Consult your doctor immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you interrupt treatment with Risperidona Teva

You will lose the effects of this medication. Do not stop using this medication unless your doctor has told you to, as you may experience symptoms again. Make sure to receive your injections every two weeks. If you cannot attend your appointments, contact your doctor immediately to schedule another appointment when you can.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Use in children and adolescents

Children and adolescents under 18 years old should not receive risperidone.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 100 patients):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness in your face, arms, or legs, especially on one side, or it's hard for you to speak even for a short period of time. These may be signs of a stroke
• You experience tardive dyskinesia (involuntary spasms or movements that cannot be controlled in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary, rhythmic movements of your tongue, mouth, and face. You may need to stop taking risperidone.

Inform your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 patients):

• You experience blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which may travel through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately
• You experience fever, muscle rigidity, sweating, or a decrease in your level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or a drop in blood pressure. Although you may have previously tolerated oral risperidone, in rare cases, allergic reactions may occur after receiving risperidone injections.

You may also experience the following side effects:

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

• Common cold symptoms

• Difficulty staying or falling asleep
• Depression, anxiety
• Parkinsonism: This condition may include: slow or altered movement, feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly dragging your feet, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Headache

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

• Pneumonia, chest infection (bronchitis), sinusitis
• Urinary tract infection, feeling like you have the flu, anemia
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin appear rarely and in men may include breast swelling, difficulty getting or maintaining erections, decreased sex drive, or other sexual dysfunction. In women, symptoms may include breast discomfort, milk secretion from the breasts, missed periods, or other menstrual cycle problems or fertility issues
• Increased blood sugar, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disorder, irritability, decreased sex drive, restlessness, feeling drowsy or less alert
• Dystonia. This is a condition that involves involuntary, slow, or continuous muscle contractions. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or jaw
• Dizziness
• Dyskinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic, or writhing movements, or spasms
• Tremor (agitation)
• Blurred vision
• Fast heart rate
• Decreased blood pressure, chest pain, increased blood pressure
• Labored breathing, sore throat, cough, nasal congestion
• Abdominal pain, abdominal discomfort, vomiting, nausea, stomach or intestinal infection, constipation, diarrhea, indigestion, dry mouth, toothache
• Skin rash
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence
• Erectile dysfunction
• Missed periods
• Milk secretion from the breasts
• Swelling of the body, arms, or legs, fever, weakness, fatigue (tiredness)
• Pain
• A reaction at the injection site, including itching, pain, or swelling
• Increased liver enzymes in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood
• Falls

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

• Respiratory tract infection, urinary tract infection, ear infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or part of the body, viral infection, skin inflammation caused by mites, abscess under the skin
• Decreased white blood cell count, decreased platelet count, decreased red blood cell count
• Allergic reaction
• Excessive sugar in the urine, diabetes, or worsening of diabetes
• Loss of appetite causing malnutrition and weight loss
• Increased triglycerides in the blood (fat), increased cholesterol in the blood
• Euphoria (mania), confusion, inability to achieve orgasm, nervousness, nightmares
• Loss of consciousness, seizures (epileptic crises), fainting
• Anxiety that causes movement of parts of the body, balance disorder, abnormal coordination, dizziness when standing up, attention disorder, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, feeling of tingling, pinching, or numbness of the skin
• Eye infection or "red eye", dry eyes, increased tear production, eye redness
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, abnormal heart activity, prolonged QT interval in the heart, slow heart rate, abnormal heart conduction (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure when standing up (as a result, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly)
• Fast, shallow breathing, respiratory tract congestion, gasping, nasal bleeding
• Fecal incontinence, difficulty swallowing, excessive gas or flatulence
• Itching, hair loss, eczema, dry skin, skin redness, skin discoloration, acne, scaly or itchy skin or scalp
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle breakdown
• Joint stiffness, joint swelling, muscle weakness, neck pain
• Urinating frequently, inability to urinate, painful urination
• Ejaculation disorder, delayed menstruation, missed periods, or other menstrual cycle problems (women), breast development in men, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes, or lips
• Chills, increased body temperature
• Change in gait
• Sensation of thirst, feeling unwell, chest discomfort, feeling "off"
• Thickening of the skin
• Increased liver enzymes in the blood
• Pain due to the procedure

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

• Decreased white blood cell count that helps fight infections
• Inadequate secretion of a hormone that controls urine volume
• Low blood sugar
• Excessive water intake
• Somnambulism
• Sleep-related eating disorder
• Loss of movement or response while awake (catatonia)
• Lack of emotions
• Decreased level of consciousness
• Head agitation
• Eye movement problems, eye rotation, light sensitivity of the eyes
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken risperidone. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication
• Irregular heartbeat
• Life-threatening low white blood cell count, increased eosinophils (a type of white blood cell) in the blood
• Difficulty breathing during sleep (sleep apnea)
• Pneumonia caused by aspiration of food, lung congestion, lung crepitus, voice disorder, respiratory tract disorder
• Pancreatitis, intestinal obstruction
• Hard stools
• Medication-related skin rash
• Hives (urticaria), skin thickening, dandruff, skin disorder, skin injury
• Muscle fiber rupture and muscle pain (rhabdomyolysis)
• Postural anomaly
• Breast enlargement, breast discharge
• Decreased body temperature, feeling unwell
• Yellow skin and eyes (jaundice)
• Excessive water intake
• Increased insulin (a hormone that controls blood sugar levels) in the blood
• Brain blood vessel problems
• No response to stimuli
• Coma due to uncontrolled diabetes
• Sudden loss of vision or blindness
• Glaucoma (increased pressure in the eyeball), corneal ulcers
• Redness, swelling of the tongue
• Cracked lips
• Breast enlargement
• Decreased body temperature, coldness in the arms and legs
• Withdrawal symptoms from medications

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

• Complications of uncontrolled diabetes, life-threatening
• Severe allergic reaction with swelling, which may affect the throat, causing difficulty breathing
• Loss of movement of the intestinal muscles, causing obstruction

The following side effect has occurred with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to occur with risperidone: Fast heart rate when standing up.

Unknown frequency:(cannot be estimated from available data)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). If refrigeration is not available, the packaging can be stored below 25°C for a maximum of 7 days before administration.

Store in the original packaging to protect it from light.

After reconstitution:

Physical and chemical stability has been demonstrated for use over 24 hours at 25°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage conditions and times before use are the responsibility of the user and should normally not exceed 6 hours at 25°C, unless reconstitution was performed in controlled and validated aseptic conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Risperidona Teva

• The active ingredient is risperidone.
• Each Risperidona Teva powder and solvent for prolonged-release injectable suspension EFG contains 25 mg, 37.5 mg, or 50 mg of risperidone.
• The other excipients are:

Powder for injection suspension:

Poly-(D, L-lactide-co-glycolide)

Solvent (solution):

Polysorbate 20, sodium carmellose, dihydrogen phosphate disodium dihydrate, citric acid, sodium chloride, sodium hydroxide, water for injections.

Appearance of the product and contents of the package

Risperidona 25 mg:

Each package contains the following components grouped in a plastic tray:

• A small bottle with a gray stopper, sealed with a pink aluminum cap, containing the powder (in this powder is the active ingredient, risperidone).
• A pre-loaded syringe with 2 ml of transparent, colorless liquid to add to the prolonged-release injection suspension powder.
• A vial adapter for reconstitution.
• Two Terumo SurGuard 3 injection needles: one 21G UTW 1-inch (0.8 mm x 25 mm) safety needle with a needle protection device for deltoid administration and one 20G TW 2-inch (0.9 mm x 51 mm) safety needle with a needle protection device for gluteal administration.

Risperidona 37.5 mg:

Each package contains the following components grouped in a plastic tray:

• A small bottle with a gray stopper, sealed with a green aluminum cap, containing the powder (in this powder is the active ingredient, risperidone).
• A pre-loaded syringe with 2 ml of transparent, colorless liquid to add to the prolonged-release injection suspension powder.
• A vial adapter for reconstitution.
• Two Terumo SurGuard 3 injection needles: one 21G UTW 1-inch (0.8 mm x 25 mm) safety needle with a needle protection device for deltoid administration and one 20G TW 2-inch (0.9 mm x 51 mm) safety needle with a needle protection device for gluteal administration.

Risperidona 50 mg:

Each package contains the following components grouped in a plastic tray:

• A small bottle with a gray stopper, sealed with a blue aluminum cap, containing the powder (in this powder is the active ingredient, risperidone).
• A pre-loaded syringe with 2 ml of transparent, colorless liquid to add to the prolonged-release injection suspension powder.
• A vial adapter for reconstitution.
• Two Terumo SurGuard 3 injection needles: one 21G UTW 1-inch (0.8 mm x 25 mm) safety needle with a needle protection device for deltoid administration and one 20G TW 2-inch (0.9 mm x 51 mm) safety needle with a needle protection device for gluteal administration.

Risperidona Teva is available in packages containing 1, 2, or 5 doses.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Responsible manufacturer

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

or

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

or

Pharmathen S.A

Dervenakion 6,

Pallini Attiki,

15351,Greece

Last revision date of thisleaflet:March 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Important information

Risperidona Teva requires careful attention at each step of the “Instructions for Use” to help ensure a successful administration.

Use of the provided components

The components of the package are specifically designed for use with Risperidona Teva.

Risperidona Teva must be reconstituted only with the solvent provided in the package.

Do notsubstitute any of the components of this package.

Do notstore the suspension after reconstitution.

Administer the dose as soon as possible after reconstitution, to avoid sedimentation.

Adequate dose

The entire contents of the vial must be administered to ensure that the adequate dose of Risperidona Teva is administered.

Do not re-use

Medical devices require materials with specific characteristics to function properly. These characteristics have been verified for single use. Any attempt to reprocess the device for subsequent reuse may affect the integrity of the device or lead to deterioration of its function.

Components of the package