Risperidone teva

Package leaflet: Information for the user

Risperidone Teva, 25 mg, powder and solvent for suspension for prolonged-release injection
Risperidone Teva, 37.5 mg, powder and solvent for suspension for prolonged-release injection
Risperidone Teva, 50 mg, powder and solvent for suspension for prolonged-release injection
Risperidone

Please read all of this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Risperidone Teva is and what it is used for

Risperidone Teva belongs to a group of medicines called antipsychotics.
Risperidone Teva is used for the maintenance treatment of schizophrenia, a condition in which the patient sees, hears, or feels things that are not there, believes things that are not true, or experiences extreme suspicion or confusion.
Risperidone Teva is intended for patients currently being treated with oral antipsychotic medicines (e.g. tablets, capsules).
Risperidone Teva may help to reduce the symptoms of the illness and prevent their recurrence.

2. Important information before using Risperidone Teva

When not to use Risperidone Teva

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

Warnings and precautions

• if the patient has never previously used risperidone in any form, oral risperidone should be used first before starting treatment with Risperidone Teva.

Before starting treatment with Risperidone Teva, discuss the following with your doctor or pharmacist:

• if the patient has heart function disorders, such as irregular heartbeat, or if the patient is prone to low blood pressure, or is taking medicines to control blood pressure. Risperidone Teva may cause a drop in blood pressure. Dose adjustment of the medicine may be necessary
• if the patient is aware of any factors that may increase the risk of stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disorders
• if the patient has ever experienced involuntary movements of the tongue, mouth, or face
• if the patient has ever experienced a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as neuroleptic malignant syndrome)
• if the patient has Parkinson's disease or dementia
• if the patient has previously had low white blood cell count (which may or may not have been caused by other medicines)
• if the patient has diabetes
• if the patient has epilepsy
• if the patient is a man who has experienced prolonged or painful erection
• if the patient has disorders of body temperature regulation or is overheating
• if the patient has kidney function disorders
• if the patient has liver function disorders
• if the patient has abnormally high levels of the hormone prolactin in the blood or suspicion of a prolactin-dependent tumor
• if the patient or any of their relatives have previously had blood clots, as use of medicines such as Risperidone Teva is associated with an increased risk of blood clots.

If the patient is unsure whether any of the symptoms described above apply, they should consult a doctor or pharmacist before using Risperidone Teva.
The treating doctor may order a white blood cell count test, as very rarely, a dangerously low number of a certain type of white blood cells essential for fighting infections has been observed in patients using Risperidone Teva.
Even if the patient previously tolerated orally administered risperidone well, allergic reactions may rarely occur after injections of Risperidone Teva. Seek immediate medical help if the patient experiences: rash, throat swelling, itching, or difficulty breathing, as these may be symptoms of a severe allergic reaction.
Risperidone Teva may cause weight gain. Significant weight gain may negatively affect health. The treating doctor will regularly monitor the patient's body weight.
The doctor should check whether the patient shows symptoms of high blood glucose levels, as diabetes and worsening of pre-existing diabetes have been observed in patients taking risperidone. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Risperidone Teva often increases the level of a hormone called prolactin. This may cause adverse effects such as: menstrual disorders, fertility problems in women, breast swelling in men (see section "Possible side effects"). If such adverse effects occur, blood prolactin level testing is recommended.
During cataract removal surgery, the pupil (the black circle in the center of the eye) may not dilate sufficiently. Also, the iris (the colored part of the eye) may be flaccid during the procedure, which may lead to eye damage. If the patient has planned eye surgery, inform the ophthalmologist about using this medicine.

Elderly patients with dementia
Risperidone Teva must not be given to elderly patients with dementia.
Seek immediate medical help if the patient or caregiver observes sudden changes in mental status, sudden muscle weakness or numbness in the face, arms, or legs—especially on one side—or speech disturbances, even if they are short-lived. These symptoms may indicate a stroke.

Patients with kidney or liver function disorders
Studies have been conducted on oral administration of risperidone in patients with kidney or liver function disorders; however, no studies have been conducted on the use of Risperidone Teva. In this patient group, Risperidone Teva should be used with caution.

Risperidone Teva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patients should especially inform the doctor or pharmacist if they are taking any of the following medicines:

• sedative medicines acting on the brain (benzodiazepines) or certain painkillers (opioids), antiallergy medicines (some antihistamines), as risperidone may enhance their sedative effects
• medicines that may cause changes in the heart's electrical activity, such as antimalarial medicines, antiarrhythmics, antiallergic medicines (antihistamines), certain antidepressants, or other medicines used to treat other psychiatric disorders
• medicines that slow the heart rate
• medicines that reduce potassium levels in the blood (e.g., certain diuretics)
• medicines used to treat Parkinson's disease (e.g., levodopa)
• medicines that increase central nervous system activity (psychostimulants, such as methylphenidate)
• medicines used for high blood pressure. Risperidone Teva may lower blood pressure
• diuretics used in patients with heart disease or to relieve fluid accumulation (e.g., furosemide or chlorothiazide). Risperidone Teva, used alone or in combination 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 certain infections)
• carbamazepine, phenytoin (medicines for epilepsy)
• phenobarbital. When starting or stopping these medicines, a change in risperidone dose may be necessary.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart conditions)
• antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• beta-blockers (used to treat high blood pressure)
• phenothiazines (e.g., used to treat psychosis or for sedation)
• cimetidine, ranitidine (reducing stomach acid)
• itraconazole and ketoconazole (used for fungal infections)
• certain medicines used to treat HIV/AIDS, such as ritonavir
• verapamil, used to treat high blood pressure and (or) heart rhythm disorders
• sertraline and fluvoxamine, used to treat depression and other psychiatric disorders. When starting or stopping these medicines, a change in risperidone dose may be necessary.

If the patient is unsure whether they have taken or are taking any of the medicines listed above, they should consult a doctor or pharmacist before using Risperidone Teva.

Risperidone Teva, food, drink, and alcohol
Do not drink alcohol while using Risperidone Teva.

Pregnancy, breastfeeding, and effects on fertility

• if the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether the patient may use Risperidone Teva.
• newborns whose mothers used Risperidone Teva during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the child, contact the doctor.
• Risperidone Teva may increase blood levels of prolactin—a hormone that may affect fertility (see section "Possible side effects").

Driving and using machines
Dizziness, fatigue, and vision disturbances may occur while using Risperidone Teva. Therefore, without consulting a doctor, do not drive, use tools, or operate machinery.

Risperidone Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg), meaning it is considered "sodium-free".

3. How to use Risperidone Teva

This medicine should always be used exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Risperidone Teva is administered as an intramuscular injection into the arm or buttock every 2 weeks by a doctor or nurse. Injections should be alternated, one on the right side and then one on the left side. Intravenous administration is not allowed.
Recommended dose:
Adults
Initial dose
If the oral daily dose of risperidone (e.g. in tablet form) taken during the last 2 weeks was 4 mg or less, the initial dose of Risperidone Teva should be 25 mg.
If the oral daily dose of risperidone taken during the last 2 weeks was greater than 4 mg, the initial dose of Risperidone Teva may be 37.5 mg.
If the patient is currently being treated with an oral antipsychotic other than risperidone, the initial dose of Risperidone Teva will depend on the previous therapy. The doctor will decide and prescribe Risperidone Teva at a dose of either 25 mg or 37.5 mg.
The doctor will adjust the dose of Risperidone Teva according to the patient's individual needs.
Maintenance dose:

• The usual dose is 25 mg administered as an injection every two weeks.
• If necessary, a higher dose of 37.5 mg or 50 mg may be given. The doctor will adjust the dose of Risperidone Teva according to the patient's individual needs.
• The doctor may also recommend taking oral risperidone for three weeks following the first injection.

Use of a higher than recommended dose of Risperidone Teva

• In patients who have received a higher than recommended dose of Risperidone Teva, the following symptoms have been observed: somnolence, feeling of fatigue, abnormal body movements, difficulties with balance and walking, dizziness due to low blood pressure, and irregular heart rhythm. Cases of abnormal electrical conduction in the heart and seizures have also been reported.
• Medical advice should be sought immediately.

Stopping Risperidone Teva
The effect of the medicine will cease if the patient stops using it. Therefore, do not discontinue treatment without explicit instruction from the doctor, as this may lead to relapse of the illness.
Patients should always attend medical appointments every two weeks to receive the next dose of the medicine. If a patient is unable to attend an appointment, they should inform the doctor immediately to arrange an alternative date.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
Use in children and adolescents
Risperidone Teva is not intended for use in individuals under 18 years of age.

4. Possible adverse effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.
You must inform the doctor immediately if the patient experiences any of the following
uncommon adverse effects (may occur in less than 1 out of 100 people):

• In a patient with dementia, sudden change in mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or speech disturbances, even if brief. These symptoms may indicate a stroke.
• Tardive dyskinesia (involuntary, repetitive, jerking movements of the face, tongue or other parts of the body). You should immediately inform the doctor if rhythmic involuntary movements of the tongue, lips or face occur. Discontinuation of Risperidone Teva may be necessary.

You must inform the doctor immediately if the patient experiences any of the following
rare adverse effects (may occur in less than 1 out of 1000 people):

• Blood clots in the veins, especially in the legs (symptoms include pain and redness of the leg); these clots may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help.
• Fever, muscle stiffness, sweating or decreased level of consciousness (a condition called neuroleptic malignant syndrome). Immediate treatment may be required.
• In men, prolonged or painful erection. This condition is known as priapism. Immediate treatment may be necessary.
• Severe allergic reaction characterized by fever, swelling of the lips, face, tongue or throat, breathing difficulties, skin itching, rash or drop in blood pressure. Even if the patient previously tolerated oral risperidone, allergic reactions may rarely occur after injections of Risperidone Teva.

Other adverse effects may also occur:
Very common adverse effects (may occur in more than 1 out of 10 people):

• Cold-like symptoms
• Difficulty falling asleep or waking up
• Depression, anxiety
• Parkinsonism: this condition may include slow or abnormal movements, feeling of stiffness or muscle tension (causing uneven movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation and/or drooling, and expressionless face.
• Headache.

Common adverse effects (may occur in less than 1 out of 10 people):

• Pneumonia, respiratory tract infection (bronchitis), sinus infection
• Urinary tract infection, flu-like symptoms, anemia
• Increased blood levels of the hormone prolactin (with or without symptoms). Symptoms of increased prolactin levels are uncommon and may include in men: breast swelling, difficulty achieving or maintaining erection, decreased libido or other sexual disorders. In women, these may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding, other menstrual cycle disorders or fertility problems.
• High blood sugar levels, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disturbances, irritability, decreased libido, restlessness, feeling sleepy or drowsy
• Dystonia: in this condition, slow or sustained involuntary muscle contractions occur. These may affect any part of the body (possibly leading to abnormal posture), but dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements
• Dizziness
• Dyskinesia: in this condition, involuntary muscle movements occur, including repetitive, spasmodic or twisting movements or jerks
• Tremor
• Blurred vision
• Rapid heartbeat
• Low blood pressure, chest pain, high blood pressure
• Shortness of breath, sore throat, cough, nasal congestion
• Abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, stomach or intestinal infection, constipation, diarrhea, indigestion, dry mouth, toothache
• Rash
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence
• Erectile dysfunction
• Absence of menstruation
• Milk discharge from the breasts
• Swelling of the body, arms or legs, fever, weakness, fatigue (tiredness)
• Pain
• Injection site reaction, including itching, pain or swelling
• Increased blood levels of aminotransferases, increased blood levels of GGT enzyme (liver enzyme – gamma-glutamyl transferase)
• Falls.

Uncommon adverse effects (may occur in less than 1 out of 100 people):

• Respiratory tract infection, urinary bladder infection, ear infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection, viral infection, skin inflammation caused by mites, subcutaneous abscess
• Decreased number of white blood cells, decreased number of platelets (blood cells that help stop bleeding), decreased number of red blood cells
• Allergic reaction
• Presence of sugar in urine, onset of diabetes or worsening of existing diabetes
• Loss of appetite leading to malnutrition and low body weight
• Increased blood triglyceride levels (fats), increased blood cholesterol levels
• Irritable mood (mania), confusion, inability to achieve orgasm, nervousness, nightmares
• Loss of consciousness, seizures, fainting
• Irresistible urge to move body parts, balance disorders, lack of coordination, dizziness upon standing, concentration difficulties, speech problems, loss or altered sense of taste, reduced sensitivity to pain and touch on the skin, tingling, prickling or numbness of the skin
• Eye infection or conjunctivitis, dry eyes, excessive tearing, red eyes
• Dizziness, ringing in the ears, ear pain
• Atrial fibrillation (irregular heartbeat), conduction block between upper and lower parts of the heart, abnormal electrical conduction in the heart, QT interval prolongation in the heart, slow heart rate, abnormal electrocardiogram (ECG), sensation of fluttering or pounding in the chest (palpitations)
• Low blood pressure upon standing (as a result, some patients taking Risperidone Teva may faint, feel dizzy or lose consciousness when standing up or sitting up suddenly)
• Rapid, shallow breathing, congestion of the airways, crackling sounds in the lungs, nosebleeds
• Fecal incontinence, difficulty swallowing, excessive passing of gas
• Itching, hair loss, rash, dry skin, skin redness, skin discoloration, acne, scaly and itchy skin of the scalp or other body parts
• Increased blood levels of creatine kinase, an enzyme sometimes released from damaged muscles
• Joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent urination, inability to urinate, painful urination
• Ejaculation disorders, delayed menstruation, absence of menstruation and other menstrual cycle disorders (in women), breast enlargement in men, sexual disorders, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, lips, eyes or mouth
• Chills, increased body temperature
• Change in walking pattern
• Thirst, general malaise, chest discomfort, feeling "unwell"
• Skin hardening
• Increased liver enzyme activity in blood
• Pain related to medical procedures.

Rare adverse effects (may occur in less than 1 out of 1000 people):

• Decreased number of certain types of white blood cells responsible for fighting infections
• Abnormal secretion of the hormone regulating urine production
• Low blood sugar levels
• Excessive water drinking
• Sleepwalking (somnambulism)
• Eating disorders related to sleep
• Lack of movement or unresponsiveness while awake (catatonia)
• Lack of emotion
• Low level of consciousness
• Shaking or nodding movements of the head
• Eye movement disorders, rotational eye movements, light sensitivity
• Eye complications during cataract surgery. During this procedure, Intraoperative Floppy Iris Syndrome (IFIS) may occur if the patient is currently or previously taking Risperidone Teva. If the patient is scheduled for cataract surgery, it is essential to inform the ophthalmologist about current or past use of this medicine.
• Irregular heartbeat
• Dangerously low number of certain white blood cells responsible for fighting infections, increased number of eosinophils (a type of white blood cell) in blood
• Breathing disorders during sleep (sleep apnea)
• Aspiration pneumonia (caused by food entering the airways), blood congestion in the lungs, crackling lung sounds, voice disorders, respiratory tract disorders
• Pancreatitis, intestinal obstruction
• Very hard stools
• Drug rash
• Urticaria, skin thickening, psoriasis, skin disorders, skin damage
• Muscle fiber breakdown and muscle pain (rhabdomyolysis)
• Abnormal posture
• Breast enlargement, breast discharge
• Low body temperature, discomfort
• Yellowing of the skin and eyes (jaundice)
• Dangerously excessive water drinking
• Increased blood insulin levels (hormone regulating blood sugar)
• Cerebrovascular disorders
• Lack of response to stimuli
• Coma due to uncontrolled diabetes
• Sudden loss of vision or blindness
• Glaucoma (increased pressure in the eyeball), ulceration of the eyelid margins (with crust formation)
• Flushing attacks, tongue swelling
• Dry lips
• Enlargement of mammary glands
• Low body temperature, cold hands and feet
• Withdrawal symptoms.

Very rare (may occur in less than 1 out of 10,000 people):

• Life-threatening complications related to uncontrolled diabetes
• Severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties
• Loss of intestinal function, leading to intestinal obstruction.

Frequency not known: (cannot be estimated from available data)

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

An adverse effect observed during use of another medicine – paliperidone, very similar to risperidone – which may also occur during use of Risperidone Teva:
rapid heartbeat upon standing up.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Risperidone Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store the entire package in a refrigerator (2ºC - 8ºC). Outside the refrigerator, Risperidone Teva may be stored at temperatures below 25°C for a maximum of 7 days prior to administration.
Keep in the original packaging to protect from light.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, the medicine should be used immediately after preparation.
If not used immediately, the responsibility for the storage period and conditions lies with the user.
The prepared suspension may be stored for no longer than 6 hours at 25ºC, unless the suspension was prepared under controlled and validated aseptic conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Risperidone Teva contains
The active substance is risperidone.
Each vial of powder for the preparation of a prolonged-release injectable suspension of Risperidone Teva contains 25 mg, 37.5 mg or 50 mg of risperidone.
The other ingredients are:
Powder composition:
Poly-(d,l-lactide-co-glycolide)
Solvent composition:
Polysorbate 20
Sodium carmellose
Disodium phosphate dihydrate
Citric acid
Sodium chloride
Sodium hydroxide
Water for injections

What Risperidone Teva looks like and contents of the pack
Risperidone Teva, 25 mg
Each single-dose package (kit) contains the following components placed together on a plastic tray:

• One small vial with a grey stopper, sealed with a pink flip-off aluminium cap, containing powder (the active substance risperidone is contained in this powder);
• One pre-filled syringe containing a clear, colourless liquid (2 ml) to be added to the powder for the preparation of a prolonged-release injectable suspension;
• One vial adapter for preparing the suspension;
• Two Terumo SurGuard®3 needles for intramuscular injection: one 21G UTW 1-inch (0.8 mm x 25 mm) safety needle for injection into the deltoid muscle; one 20G TW 2-inch (0.9 mm x 51 mm) safety needle for injection into the gluteal muscle.

Risperidone Teva, 37.5 mg
Each single-dose package (kit) contains the following components placed together on a plastic tray:

• One small vial with a grey stopper, sealed with a green flip-off aluminium cap, containing powder (the active substance risperidone is contained in this powder);
• One pre-filled syringe containing a clear, colourless liquid (2 ml) to be added to the powder for the preparation of a prolonged-release injectable suspension;
• One vial adapter for preparing the suspension;
• Two Terumo SurGuard®3 needles for intramuscular injection: one 21G UTW 1-inch (0.8 mm x 25 mm) safety needle for injection into the deltoid muscle; one 20G TW 2-inch (0.9 mm x 51 mm) safety needle for injection into the gluteal muscle.

Risperidone Teva, 50 mg
Each single-dose package (kit) contains the following components placed together on a plastic tray:

• One small vial with a grey stopper, sealed with a blue flip-off aluminium cap, containing powder (the active substance risperidone is contained in this powder);
• One pre-filled syringe containing a clear, colourless liquid (2 ml) to be added to the powder for the preparation of a prolonged-release injectable suspension;
• One vial adapter for preparing the suspension;
• Two Terumo SurGuard®3 needles for intramuscular injection: one 21G UTW 1-inch (0.8 mm x 25 mm) safety needle for injection into the deltoid muscle; one 20G TW 2-inch (0.9 mm x 51 mm) safety needle for injection into the gluteal muscle.

Risperidone Teva is available in packages containing 1, 2 or 5 kits.

Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer:
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia
Pharmathen International S.A
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
Pharmathen S.A
Dervenakion 6,
Pallini Attiki,
15351, Greece

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. +48 22 345 93 00

This medicine is authorised for marketing in the European Economic Area countries under the following names:

| Member State | Product Name | |--------------|--------------| | Austria | Risperidon ratiopharm 25 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Risperidon ratiopharm 37.5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Risperidon ratiopharm 50 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension | | Belgium | Risperidone Teva 25 mg, 37.5 mg & 50 mg Poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte / Poudre et solvant pour suspension injectable à libération prolongée / Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension | | Bulgaria | Сперидан 37.5 mg прах и разтворител за инжекционна суспензия с удължено освобождаване
Сперидан 50 mg прах и разтворител за инжекционна суспензия с удължено освобождаване | | Germany | Risperidon-ratiopharm 25 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Risperidon-ratiopharm 37.5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Risperidon-ratiopharm 50 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension | | Denmark | Risperidone Teva GmbH | | Estonia | RISPERIDONA TEVA 25 MG POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE DE LIBERACION PROLONGADA EFG
RISPERIDONA TEVA 37.5 MG POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE DE LIBERACION PROLONGADA EFG
RISPERIDONA TEVA 50 MG POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE DE LIBERACION PROLONGADA EFG | | Finland | Risperidon ratiopharm 25 mg injektiokuiva-aine ja liuotin, depotsuspensiota varten
Risperidon ratiopharm 37.5 mg injektiokuiva-aine ja liuotin, depotsuspensiota varten
Risperidon ratiopharm 50 mg injektiokuiva-aine ja liuotin, depotsuspensiota varten | | France | RISPERIDONE Teva L.P. 25 mg/2ml, poudre et solvant pour suspension injectable à libération prolongée en seringue préremplie
RISPERIDONE Teva L.P. 37.5 mg/2 ml, poudre et solvant pour suspension injectable à libération prolongée en seringue préremplie
RISPERIDONE Teva L.P. 50 mg/2 ml, poudre et solvant pour suspension injectable à libération prolongée en seringue préremplie | | Croatia | Risset 25 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
Risset 37.5 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
Risset 50 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem | | Hungary | Risperidone Teva 25 mg por és oldószer retard szuszpenziós injekcióhoz
Risperidone Teva 37.5 mg por és oldószer retard szuszpenziós injekcióhoz
Risperidone Teva 50 mg por és oldószer retard szuszpenziós injekcióhoz | | Iceland | Risperidone Teva GmbH | | Italy | Risperidone Teva Group 25 mg polvere e solvente per sospensione iniettabile a rilascio prolungato
Risperidone Teva Group 37.5 mg polvere e solvente per sospensione iniettabile a rilascio prolungato
Risperidone Teva Group 50 mg polvere e solvente per sospensione iniettabile a rilascio prolungato | | Lithuania | Risperidone Teva 25 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai
Risperidone Teva 37.5 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai
Risperidone Teva 50 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai | | Luxembourg | Risperidon-ratiopharm 25 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Risperidon-ratiopharm 37.5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Risperidon-ratiopharm 50 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension | | Netherlands | Risperidon Teva 25 mg, poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte
Risperidon Teva 37.5 mg, poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte
Risperidon Teva 50 mg, poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte | | Norway | Risperidone Teva GmbH | | Poland | Risperidone Teva | | Portugal | Risperidona ratiopharm | | Romania | Risperidonă Teva 25 mg pulbere și solvent pentru suspensie injectabilă cu eliberare prelungită
Risperidonă Teva 37.5 mg pulbere și solvent pentru suspensie injectabilă cu eliberare prelungită
Risperidonă Teva 50 mg pulbere și solvent pentru suspensie injectabilă cu eliberare prelungită | | Sweden | Risperidone Teva GmbH | | Slovenia | Risset 25 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Risset 37.5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Risset 50 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem | | Slovakia | Risperidon Teva 25 mg prášok a vehikulum na injekčnú suspenziu s predĺženým uvoľňovaním
Risperidon Teva 37.5 mg prášok a vehikulum na injekčnú suspenziu s predĺženým uvoľňovaním
Risperidon Teva 50 mg prášok a vehikulum na injekčnú suspenziu s predĺženým uvoľňovaním |

The following information is intended exclusively for healthcare professionals

Important information
To ensure successful administration of Risperidone Teva medicinal product, carefully follow (step by step) the “Instructions for Use of the Device”.

Use only components of the kit
The components of this kit are specifically intended for use with the medicinal product Risperidone Teva. Only the solvent provided in the package must be used to prepare the suspension of Risperidone Teva.
Do not substitute ANY component of the kit provided in the package.

Do not store the suspension after preparation
The suspension should be administered as soon as possible after preparation to avoid sedimentation.

Proper administration
The entire contents of the vial must be administered to ensure the patient receives the correct dose of Risperidone Teva.

Do not reuse
Medical devices require specific material properties to function as intended. These properties have been verified only for single use. Any attempt to reuse the device may lead to device damage or impaired performance.

Contents of the package (kit)

Step 1: Assembly of the kit
Remove Connect vial to connector (adapter)
package

Wait 30 minutes Remove cap from vial Prepare vial connector (adapter) Connect adapter to vial
Place the vial on a hard
Before preparing surface and hold at the base.
the suspension, remove the Place the vial on a hard surface.
package from the refrigerator Remove the coloured cap from the vial.
and leave at room temperature for at least 30 minutes. Do not warm in a microwave.
Wipe the grey rubber stopper with an alcohol-soaked swab. Let it dry. Never touch the tip of the spike or the luer connection point.
Remove the blister pack and take out the adapter. Hold the adapter centrally above the grey rubber stopper. Press the adapter straight down until it clicks firmly into place on the vial.
Do not remove the grey rubber stopper.
Do not attach the adapter at an angle, as this may cause leakage of solvent during its introduction into the vial.

Combination of the vial-syringe with the adapter
Disinfect the connection site Hold the vial upright to prevent leakage. Holding the vial by its base, wipe the connection point of the adapter (the blue circle) with an alcohol-impregnated swab and allow it to dry before connecting the syringe. Do not shake. Do not touch the exposed luer connection site in the adapter, as this will contaminate it.	Properly hold the vial-syringe Hold the vial-syringe by the white flange at its end. Do not hold the glass cylinder during connection.	Remove the cap Holding the white flange, snap off the white cap. Do not unscrew or cut the white cap. Do not touch the tip of the vial-syringe, as this will contaminate it. The removed cap can be discarded.	Connect the vial-syringe to the adapter Stably hold the adapter by its protective sleeve. Holding the vial-syr游戏副本e by the white flange, insert and push its tip into the blue circle of the vial connector, then turn it clockwise to secure the connection between the syringe and the vial connector (avoid over-tightening). Do not hold the glass cylinder of the vial-syringe, as this may loosen or detach the white flange.

Step 2 Preparing the Suspension

Inject Disperse the powder Transfer the suspension Remove the adapter
solvent into the solvent into the prefilled
syringe
Inject the entire contents of the Hold the plunger depressed Shake the vial vigorously for at least 10 seconds, Turn the vial upside down. Holding the white collar of the prefilled
solvent from the prefilled syringe as shown. Pull slowly on the plunger to withdraw the entire volume of suspension from the vial into the prefilled syringe. Remove both the vial and the adapter properly.
into the vial.
Examine the suspension. The suspension should be The powder will be visible in the liquid.
homogeneously mixed, thick, and milky in appearance.
Proceed immediately to the next step to prevent sedimentation.

Step 3 Attaching the Needle

Select the appropriate needle Attach the needle Re-mix the suspension
Select the needle according to the injection site (gluteal or deltoid muscle). Partially tear the blister and grasp the base of the needle as shown. Completely remove the blister.
Holding the prefilled syringe by the white collar, attach it to the luer hub of the needle by screwing clockwise until firmly secured.
Do not touch the luer hub of the needle, as this may cause contamination.
Immediately before injection, shake the prefilled syringe again, as sedimentation may have occurred.

Step 4 Administering the Dose

Remove the Remove Inject Safely dispose Dispose of
transparent air bubbles the needle properly
needle cover after injection
Immediately inject the entire contents of the prefilled syringe. Holding the prefilled syringe in one hand, check that the needle is fully enclosed in the safety shield.
Bend the needle guard away from the prefilled syringe as shown. Holding the prefilled syringe with the needle pointing upwards, gently tap the syringe to move air bubbles to the top. Remove air by slowly pressing the plunger until liquid appears at the tip of the needle.
Do not twist the transparent needle cover, as this may loosen the luer connection.
Do not administer intravenously.
Remove the transparent cover from the needle. Remove air from the prefilled syringe.
Do not use two hands.
Inject into the selected muscle (gluteal or deltoid) intramuscularly – at a 45-degree angle. Press the plunger firmly and steadily.
For gluteal injections, target the upper outer quadrant of the buttock. Push the plunger completely until the needle is fully retracted.
Avoid needlestick injury:
Do not intentionally disengage the needle safety mechanism or handle it improperly.
Do not attempt to straighten bent or damaged needles or recap them.
Dispose of the used needle and syringe in a designated medical waste container. Also dispose of the unused second needle provided in the packaging.