RISPERIDONE TEVA 37.5 mg POWDER AND SOLVENT FOR PROLONGED-RELEASE INJECTABLE SUSPENSION

2. What you need to know before you use Risperidone Teva

Do not use Risperidone 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 must start with oral risperidone before starting with this medicine.

Talk to your doctor or pharmacist before starting to use Risperidone Teva if:

• You have a heart problem. For example, an irregular heartbeat, or if you are prone to having low blood pressure or if you are using medicines for blood pressure. Risperidone may lower your blood pressure. Your dose may need to be adjusted.
• You know you have any factor that makes you prone to having a stroke, such as high blood pressure, 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 the 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 medications).
• You are diabetic.
• You have epilepsy.
• You are male and have ever had a prolonged or painful erection.
• 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 tumor that may be dependent on prolactin.
• You or a family member have blood clotting problems, as medications like this have been associated with the formation of blood clots.

If you are unsure about any of the above, talk to your doctor or pharmacist before using risperidone or Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG.

Because it has been rarely observed in patients treated with risperidone that there is a dangerously low number of a type of white blood cells necessary to fight infections in the blood, your doctor may check your white blood cell count.

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

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

Because diabetes mellitus or a worsening of pre-existing diabetes mellitus has been seen in patients taking risperidone, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

Risperidone often increases the levels of a hormone called “prolactin”. This can cause side effects such as menstrual disorders or fertility problems in women, or breast swelling in men (see Possible side effects). If these side effects occur, it is recommended to evaluate prolactin levels in the blood.

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

Elderly patients with dementia

Risperidone is not used in elderly patients with 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, even if only for a short time, seek medical attention immediately. It may be a sign of a stroke.

Patients with kidney or liver problems

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

Using Risperidone Teva with other medicines

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

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

• Medicines that act on the brain used to calm down (benzodiazepines) or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase the sedative effect of all these.
• Medicines that can modify the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medicines for mental problems.
• Medicines that can cause a decrease in heart rate.
• Medicines that can cause a decrease in potassium levels 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 (psychostimulants, such as methylphenidate).
• Medicines for high blood pressure. Risperidone may lower blood pressure.
• Diuretics used for heart problems or to treat swelling of some parts of the body due to fluid retention (such as furosemide or chlorthiazide). 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 psychiatric disorders.

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

If you are unsure about any of the above, talk to your doctor or pharmacist before using risperidone.

Using Risperidone 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 plan 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 of mothers who have been treated with risperidone in the last trimester of pregnancy (last three months of pregnancy): trembling, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.
• Risperidone may increase the levels of a hormone called “prolactin” that could affect your fertility (see Possible side effects).

Driving and using machines

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.

Risperidone Teva contains sodium

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

3. How to use Risperidone Teva

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Risperidone 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 side 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 Risperidone Teva powder and solvent for prolonged-release 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 Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG as the initial dose.

If you are currently being treated with another oral antipsychotic that is not risperidone, your initial dose of Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG will depend on your current treatment. Your doctor will choose Risperidone 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 Risperidone Teva than you should

• People who have used more risperidone than they should have experienced the following symptoms: drowsiness, fatigue, abnormal body movements, problems standing and walking, feeling dizzy due to low blood pressure, and abnormal heartbeats. There have been reports of anomalies in the electrical conduction of the heart and seizures.
• Consult your doctor immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you stop using Risperidone Teva

You will lose the effects of this medicine. Do not stop using this medicine unless your doctor tells you to, as you may experience the return of symptoms. 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 further questions about the use of this medicine, ask your doctor or pharmacist.

Use in children and adolescents

Children and adolescents under 18 years of age should not receive risperidone.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor if you experience any of the following rare adverse 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 of the face, arms, or legs, especially on one side, or have difficulty speaking even for a short period. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or rhythmic movements that cannot be controlled in the face, tongue, or other parts of the body). Report to your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to withdraw risperidone.

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

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You experience fever, muscle stiffness, sweating, or a decrease in the 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. Even if you have previously tolerated oral risperidone, in rare cases, allergic reactions may occur after receiving risperidone injections.

The following adverse effects may also occur:

Very Common Adverse Effects(may affect more than 1 in 10 people)

• Common cold symptoms
• Difficulty staying or falling asleep
• Depression, anxiety
• Parkinsonism: This disease may include slow or altered movement, feeling of stiffness or tightness of the muscles (making sudden movements), and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, resting tremor, increased saliva and/or drooling, and loss of facial expressiveness.
• Headache.

Common Adverse 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 having or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast tenderness, milk secretion from the breasts, loss of menstrual periods, or other problems with the cycle or fertility issues.
• Increased blood sugar, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disorder, irritability, decreased sexual desire, restlessness, feeling drowsy or less attentive
• Dystonia. This disease involves slow or continuous involuntary contraction of the muscles. Although any part of the body can be affected (and can cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness
• Discinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremor (shakiness)
• Blurred vision
• Rapid heartbeat
• Decreased blood pressure, chest pain, increased blood pressure
• Shortness of breath, 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
• Loss of menstrual periods
• Milk secretion from the breasts
• Body swelling, arm or leg swelling, fever, weakness, fatigue
• Pain
• A reaction at the injection site, including itching, pain, or swelling
• Increased liver transaminases in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood
• Falls.

Uncommon Adverse Effects(may affect up to 1 in 100 people)

• Respiratory tract infection, bladder infection, ear infection, eye infection, tonsillitis, fungal infection of the nails, skin infection, localized infection in a single area of the skin or body part, viral infection, skin inflammation caused by mites, abscess under the skin
• Decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), decreased red blood cells
• Allergic reaction
• Sugar in the urine, diabetes, or worsening of diabetes
• Lack of appetite that causes malnutrition and weight loss
• Increased triglycerides in the blood (fat), increased cholesterol in the blood
• Euphoria (mania), confusion, inability to reach orgasm, nervousness, nightmares
• Loss of consciousness, seizures (epileptic fits), fainting
• A restlessness that causes movement of body parts, balance disorder, abnormal coordination, dizziness when standing up, attention disturbance, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of tingling, pinching, or numbness of the skin
• Eye infection or "red eye," dry eyes, increased tearing, eye redness
• Feeling that everything is 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, anomaly in the electrical activity of the heart, prolonged QT interval in the heart, slow heartbeat, anomaly in the electrical conduction of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure when standing up (as a consequence, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when getting up or sitting down suddenly)
• Rapid breathing, shallow breathing, respiratory congestion, wheezing, nasal bleeding
• Fecal incontinence, difficulty swallowing, excess 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
• Frequent urination, inability to urinate, painful urination
• Ejaculation disorder, delayed menstruation, loss of menstrual periods, or other problems with the cycle (women), development of breasts in men, sexual dysfunction, breast pain, breast tenderness, vaginal discharge
• Facial swelling, mouth, eye, or lip swelling
• Chills, increased body temperature
• Change in gait
• Feeling of thirst, feeling of discomfort, chest discomfort, feeling "unwell"
• Hardening of the skin
• Increased liver enzymes in the blood
• Pain due to the procedure.

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

• Decrease in a type of white blood cell that helps fight infections
• Inadequate secretion of a hormone that controls urine volume
• Low blood sugar
• Excessive water intake
• Sleepwalking
• Sleep-related eating disorder
• Lack of movement or response while awake (catatonia)
• Lack of emotions
• Decreased level of consciousness
• Head agitation
• Eye movement problems, eye rotation, hypersensitivity of the eyes to light
• 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, be sure to inform your ophthalmologist if you are taking or have taken this medication.
• Irregular heartbeat
• Dangerously low number of a type of white blood cell necessary to fight infections in the blood, 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, crackling sounds in the lungs, voice disorder, respiratory tract disorder
• Pancreatitis, intestinal obstruction
• Very hard stools
• Drug-related skin rash
• Hives (or "urticaria"), skin thickening, dandruff, skin disorder, skin lesion
• Muscle fiber breakdown and muscle pain (rhabdomyolysis)
• Posture abnormality
• Breast enlargement, milk secretion from the breasts
• Decreased body temperature, discomfort
• Yellowing of the 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
• Diabetic coma
• Sudden loss of vision or blindness
• Glaucoma (increased eye pressure), crusts on the eyelid margin
• Flushing, tongue swelling
• Cracked lips
• Breast enlargement
• Decreased body temperature, coldness in the arms and legs
• Drug withdrawal symptoms.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

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

The following adverse effect has appeared with the use of another medicine called paliperidone, which is very similar to risperidone, so it is also expected to appear with risperidone: Rapid heartbeat when standing up.

Frequency Not Known:(cannot be estimated from the available data)

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

Reporting of Adverse Effects

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

5. Storage of Risperidona Teva

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

Do not use this medicine 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 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If it is not used immediately, the conditions and storage times before use are the responsibility of the user and should not be more than 6 hours at 25°C, unless reconstitution has been carried out in controlled and validated aseptic conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Contents of the pack and additional information

Composition of Risperidone Teva

• The active substance is risperidone.
• Each Risperidone 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, disodium hydrogen phosphate dihydrate, citric acid, sodium chloride, sodium hydroxide, water for injectables.

Appearance of the product and pack contents

Risperidone 25 mg:

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

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

Risperidone 37.5 mg:

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

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

Risperidone 50 mg:

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

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

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

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

Date of the last revision of thisleaflet:March 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Important information

Risperidone Teva requires detailed attention at each step of the "Instructions for Use" to help ensure successful administration.

Use of the provided components

The pack components are specifically designed for use with Risperidone Teva.

Risperidone Teva should only be reconstituted with the solvent supplied in the pack.

Do notsubstitute anyof the components of this pack.

Do not store the suspension after reconstitution

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

Appropriate dose

All the contents of the vial must be administered to ensure that the appropriate dose of Risperidone Teva is administered.

Do not reuse

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 negatively affect the integrity of the device or lead to deterioration of its function.

Pack components