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 you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please 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 you use 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 maintenance treatment of schizophrenia, a condition in which patients see, hear, or feel things that do not exist, believe things that are not true, or experience unusual suspiciousness or confusion.
Risperidone Teva is intended for patients currently being treated with oral antipsychotic medicines (e.g. tablets, capsules).
Risperidone Teva may help to relieve 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 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 Risperidone Teva, discuss the following with your doctor or pharmacist:

• if the patient has heart problems, such as irregular heartbeat, or if the patient has low blood pressure or is taking medicines to control blood pressure. Risperidone Teva may cause a drop in blood pressure. A dose adjustment 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 had a condition characterised 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 a 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 problems regulating body temperature or is overheating
• if the patient has kidney problems
• if the patient has liver problems
• if the patient has abnormally high levels of the hormone prolactin in the blood or suspicion of a prolactin-dependent tumour
• if the patient or a family member has previously had blood clots, as use of medicines such as Risperidone Teva has been associated with blood clot formation.

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 certain types of white blood cells essential for fighting infections has been observed in patients taking Risperidone Teva.
Even if the patient previously tolerated oral risperidone, allergic reactions may rarely occur after injections of Risperidone Teva. Immediate medical help should be sought if the patient develops: 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 has 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 enlargement in men (see section "Possible side effects"). If such adverse effects occur, measurement of prolactin levels in the blood is recommended.
During cataract surgery, the pupil (the black circle in the centre of the eye) may not dilate sufficiently. Also, the iris (the coloured part of the eye) may be flaccid during surgery, which may result in eye damage. If the patient has planned eye surgery, they must inform the ophthalmologist about taking this medicine.
Elderly patients with dementia
Risperidone Teva must not be given to elderly patients with dementia.
Immediate medical help should be sought if the patient or caregiver notices a sudden change in mental state, sudden weakness or numbness of facial muscles, arms or legs, particularly on one side, or speech disturbances, even if they are brief. These symptoms may indicate a stroke.
Patients with kidney or liver problems
Studies have been conducted on oral administration of risperidone in patients with kidney or liver impairment, but no studies have been conducted on the use of Risperidone Teva. In these patient groups, 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 their doctor or pharmacist if they are taking
any of the following medicines:

• sedative medicines acting on the brain (benzodiazepines) or certain painkillers (opioids), antiallergic medicines (some antihistamines), as risperidone may enhance their sedative effect
• medicines that may cause changes in the electrical activity of the heart, 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 heart disease or to reduce swelling where excess fluid has accumulated (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 treatment with 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 gastric acid)
• itraconazole and ketoconazole (used in 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 treatment with 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 with food, drink and alcohol
Alcohol must not be consumed during treatment with Risperidone Teva.
Pregnancy, breastfeeding and 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: tremor, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties and feeding problems. If such symptoms are observed in the child, contact a doctor.
• Risperidone Teva may increase prolactin levels in the blood – a hormone that may affect fertility (see section "Possible side effects").

Driving and using machines
Dizziness, tiredness and vision disturbances may occur during treatment with Risperidone Teva. Therefore, without consulting a doctor, patients should not drive, use tools or operate machinery.
Risperidone Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg), i.e. this medicine is considered "sodium-free".

3. How to use Risperidone Teva

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the
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 time on the right side and the
next 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 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 received a higher than recommended dose of Risperidone Teva, the following symptoms have been observed: drowsiness, feeling of fatigue, abnormal body movements, difficulty maintaining 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 treatment with Risperidone Teva
The effect of the medicine will cease if the patient stops using it. Therefore, treatment should not be
discontinued 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.
If a patient is unable to attend an appointment, they should inform the doctor immediately to
arrange another date.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.
Use in children and adolescents
Risperidone Teva is not intended for use in individuals under 18 years of age.

4. Possible side effects

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

• In a patient with dementia, sudden change in mental status 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.
• Late dyskinesias (involuntary, jerking or twitching movements of the face, tongue or other parts of the body). Inform the doctor immediately if rhythmic involuntary movements of the tongue, mouth 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 side effects (may occur in less than 1 in 1,000 people):

• Blood clots in the veins, especially in the legs (symptoms include leg pain and redness); 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 side effects may also occur:
Very common side effects (may occur in more than 1 in 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 movement followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation and/or drooling, and expressionless face.
• Headache.

Common side effects (may occur in less than 1 in 10 people):

• Pneumonia, respiratory tract infection (bronchitis), sinus infection
• Urinary tract infection, flu-like symptoms, anaemia
• 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 disturbances. In women, these may include breast discomfort, milk discharge from the breasts, absence of menstrual periods, other menstrual cycle disturbances, or fertility problems.
• High blood sugar levels, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disturbances, irritability, decreased libido, restlessness, feeling drowsy or lethargic
• Dystonia: in this condition, slow or sustained involuntary muscle contractions occur. It may affect any part of the body (possibly resulting in abnormal posture), but dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements
• Dizziness
• Dyskinesia: in this condition, there are involuntary muscle movements, including repetitive, spasmodic, 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, diarrhoea, indigestion, dry mouth, toothache
• Rash
• Muscle cramps, 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)
• Fall.

Uncommon side effects (may occur in less than 1 in 100 people):

• Respiratory tract infection, 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 white blood cell count, decreased platelet count (blood cells that help stop bleeding), decreased red blood cell count
• Allergic reaction
• Presence of glucose 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, imbalance, poor coordination, dizziness upon standing, difficulty concentrating, speech difficulties, 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, redness of the eyes
• Dizziness, ringing in the ears, ear pain
• Atrial fibrillation (irregular heartbeat), conduction block between upper and lower heart chambers, abnormal electrical conduction in the heart, QT interval prolongation on ECG, slow heart rate, abnormal heart electrical activity on ECG, sensation of fluttering or pounding in the chest (palpitations)
• Low blood pressure upon standing (as a result, some patients taking Risperidone Teva may feel faint, dizzy, or lose consciousness when standing up or sitting up suddenly)
• Rapid, shallow breathing, congestion of the airways, rales, nosebleeds
• Faecal incontinence, difficulty swallowing, excessive passing of gas
• Itching, hair loss, rash, dry skin, redness of the skin, 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 disturbances (in women), breast enlargement in men, sexual disturbances, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, lips, eyes or mouth
• Chills, increased body temperature
• Change in gait
• Thirst, malaise, chest discomfort, feeling unwell
• Skin hardening
• Increased liver enzyme activity in blood
• Pain related to medical procedures.

Rare side effects (may occur in less than 1 in 1,000 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
• Trembling or nodding head movements
• 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 treated with 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 disturbances during sleep (sleep apnoea)
• Aspiration pneumonia (caused by food entering the airways), pulmonary congestion, crackling lung sounds, voice disturbances, respiratory tract disorders
• Pancreatitis, intestinal obstruction
• Very hard stools
• Drug rash
• Urticaria, skin thickening, seborrhoea, skin disorders, skin damage
• Muscle fibre breakdown and muscle pain (rhabdomyolysis)
• Abnormal posture
• Breast enlargement, milk discharge from the breasts
• 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 vision loss 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
• Symptoms of drug withdrawal.

Very rare (may occur in less than 1 in 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 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).

A side 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 side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side 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 container. The expiry date refers to the last day of the specified month.
Store the entire package in a refrigerator (2°C - 8°C). Outside the refrigerator, Risperidone Teva may be stored below 25°C for a maximum of 7 days prior to administration.
Store 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 administered immediately after preparation.
If not used immediately, the responsibility for storage duration and conditions lies with the user.
The prepared suspension may be stored for no longer than 6 hours at 25°C, unless the suspension was prepared under controlled and validated aseptic conditions.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack 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:
Composition of the powder:
Poly-(d,l-lactide-co-glycolide)
Composition of the solvent:
Polysorbate 20
Sodium carboxymethylcellulose
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 pack (set) 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 the powder (this powder contains the active substance risperidone).
• One pre-filled syringe containing a clear, colourless liquid (2 ml) added to the powder to prepare the 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 pack (set) 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 the powder (this powder contains the active substance risperidone).
• One pre-filled syringe containing a clear, colourless liquid (2 ml) added to the powder to prepare the 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 pack (set) 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 the powder (this powder contains the active substance risperidone).
• One pre-filled syringe containing a clear, colourless liquid (2 ml) added to the powder to prepare the 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 packs containing 1, 2 or 5 sets.
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Member country Name of medicinal product
Austria Risperidon ratiopharm 25 mg Powder and solvent for
preparation of a depot injection suspension
Risperidon ratiopharm 37.5 mg Powder and solvent for
preparation of a depot injection suspension
Risperidon ratiopharm 50 mg Powder and solvent for
preparation of a depot injection suspension
Belgium Risperidone Teva 25 mg, 37.5 mg & 50 mg Powder and solvent
for prolonged-release injectable suspension / Poudre et solvant
pour suspension injectable à libération prolongée / Pulver und
Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Bulgaria Speridan 37.5 mg powder and solvent for prolonged-release
injectable suspension
Speridan 50 mg powder and solvent for prolonged-release
injectable suspension
Germany Risperidon-ratiopharm 25 mg Powder and solvent for
preparation of a depot injection suspension
Risperidon-ratiopharm 37.5 mg Powder and solvent for
preparation of a depot injection suspension
Risperidon-ratiopharm 50 mg Powder and solvent for
preparation of a depot injection suspension
Denmark Risperidone Teva GmbH
Estonia 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
Finland Risperidon ratiopharm 25 mg dry substance and solvent for
injection suspension for depot use
Risperidon ratiopharm 37.5 mg dry substance and solvent for
injection suspension for depot use
Risperidon ratiopharm 50 mg dry substance and solvent for
injection suspension for depot use
France RISPERIDONE Teva L.P. 25 mg/2 ml, powder and solvent for
prolonged-release injectable suspension in pre-filled syringe
RISPERIDONE Teva L.P. 37.5 mg/2 ml, powder and solvent for
prolonged-release injectable suspension in pre-filled syringe
RISPERIDONE Teva L.P. 50 mg/2 ml, powder and solvent for
prolonged-release injectable suspension in pre-filled syringe
Croatia Risset 25 mg powder and solvent for prolonged-release
injectable suspension
Risset 37.5 mg powder and solvent for prolonged-release
injectable suspension
Risset 50 mg powder and solvent for prolonged-release
injectable suspension
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 powder and solvent for prolonged-release
injectable suspension
Risperidone Teva Group 37.5 mg powder and solvent for prolonged-release
injectable suspension
Risperidone Teva Group 50 mg powder and solvent for prolonged-release
injectable suspension
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 Risperidona Teva 25 mg pulbere și solvent pentru suspensie injectabilă
cu eliberare prelungită
Risperidona Teva 37.5 mg pulbere și solvent pentru suspensie
injectabilă cu eliberare prelungită
Risperidona 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 for healthcare professionals only
Important information
To ensure successful administration of Risperidone Teva medicinal product, carefully read the “Instructions for Use of the Device” (step by step).
Use only components of the set
The components of this set are specifically intended for use with the medicinal product Risperidone Teva. Only the solvent provided in the pack must be used to prepare the suspension of Risperidone Teva medicinal product.
Do not replace ANY of the components included in the pack.
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 medicinal product.

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 reduced performance.
Pack contents (set)

Step 1 Assemble the set
Remove Connect vial to connector (adapter)
packaging

Wait Remove cap from Prepare connector Connect adapter to vial
30 minutes vial vial (adapter)
Place vial on a hard
Before surface and hold at
preparing Remove the colour cap from the vial. Tear open the blister base. Position adapter centrally over the
the suspension Remove the packaging pack and remove the connector and wipe grey stopper. Push adapter straight down until it clicks firmly into place on the vial neck.
from the refrigerator with a gauze pad soaked in alcohol. Never touch the spike tip or the luer connection point.
and leave at room Do not reattach the adapter at an angle, as this may cause leakage of the solvent during introduction into the vial.
temperature for at least 30 minutes. Allow to dry. Do not remove the grey rubber stopper.
Do not heat in a microwave. Do not reattach the adapter in any other way.

Combination of the vial-syringe with the adapter
Wipe the connection point Hold the vial upright to prevent leakage. While holding the vial by its base, wipe the connection point of the adapter (blue circle) with an alcohol-soaked swab and allow it to dry before connecting the syringe. Do not shake. Do not touch the exposed luer connection point in the adapter. This may result in contamination.	Properly hold the vial-syringe Hold by the white flange at the end of the vial-syringe. Do not hold the glass cylinder during connection.	Remove the cap Holding by the white flange, snap off the white cap. Do not unscrew or cut off the white cap. Do not touch the tip of the vial-syringe. This may result in contamination. The removed cap can be discarded.	Connect the vial-syringe to the adapter Firmly hold the adapter by its housing. Holding the vial-syr游戏副本 Step 2 Preparing the suspension Inject Disperse the powder Transfer the suspension Remove the adapter solvent in the solvent to the syringe- vial syringe Inject the entire contents Holding the plunger Press the vial upside down. Holding the white of solvent contained in the vigorously shake for at least 10 seconds , Rotate the vial until the collar of the syringe- syringe-vial into the vial. as shown. plunger, slowly pull the vial is completely vial, unscrew the plunger to withdraw mixed. syringe-vial from the entire volume of suspension from the vial into the syringe-vial. the adapter. Examine the suspension. The suspension will be properly mixed, homogeneous, thick, and milky in appearance. The powder will be visible in the liquid. Proceed immediately to the next step to prevent sedimentation. Step 3 Attaching the needle Select the appropriate needle Attach the needle Mix the suspension again Select the needle according to the injection site (gluteal or deltoid muscle). Partially tear open the blister and grasp the base of the needle, as shown. Holding the syringe-vial by the white collar, connect it to the luer hub of the needle by screwing clockwise until firmly attached. Do not touch the luer hub of the needle, as this may contaminate it. Immediately before injection, shake the syringe-vial again, as sedimentation may have occurred. Step 4 Administering the dose Remove the Remove air Inject Dispose of properly transparent bubbles the needle needle cover Remove air bubbles by gently tapping the syringe-vial until the bubbles rise to the top. Then slowly depress the plunger to expel the air. Immediately inject the entire contents of the syringe-vial. Hold the syringe-vial by the white collar. Remove the transparent needle cover by bending the needle shield away from the syringe-vial, as shown. Do not twist or bend the transparent needle cover, as this may loosen the luer-lock connection. Do not administer intravenously. Insert the needle into the selected muscle (gluteal or deltoid) at a 45-degree angle (intramuscularly – im.). For gluteal injection, target the upper outer quadrant of the buttock. Insert the needle quickly and firmly with a decisive motion so that the needle is fully inserted. Avoid needle-stick injury: Do not use two hands. Do not intentionally disengage the needle safety feature or handle it improperly. Do not attempt to straighten bent or damaged needles or re-cap them. After injection, press the safety shield forward with the palm of your hand until you hear a click, ensuring the needle is fully enclosed within the protective cover. Dispose of the used syringe-vial with the needle attached in a designated medical waste container. Also dispose of the unused second dose provided in the package.