RISPERDAL 1 mg Tabletki Powlekane

Treść ulotki

1. Risperdal 1, 2, 3 and 4 mg film-coated tablets, 1 mg/ml oral solution
   1. What is Risperdal and what is it used for
   2. What you need to know before taking Risperdal
   3. How to take Risperdal
   4. POSSIBLE SIDE EFFECTS
   5. How to store Risperdal
   6. Package contents and other information
2. Risperdal 25, 37.5 and 50 mg powder and solvent for prolonged-release injectable suspension
   1. What is Risperdal injectable and what it is used for
   2. What you need to know before using Risperdal injectable
   3. How to use Risperdal injectable
   4. Possible side effects
   5. How to store Risperdal injectable
   6. Content of the pack and other information

Risperdal 1, 2, 3 and 4 mg film-coated tablets, 1 mg/ml oral solution

risperidone

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Risperdal and what is it used for

Risperdal belongs to a group of medicines called “antipsychotics”.
Risperdal is used for:

• treatment of schizophrenia, a condition in which you may see, hear or feel things that are not there, believe things that are not true or feel suspicious in an unusual way or confused
• treatment of mania, a condition in which you may feel very excited, euphoric, agitated, elated or hyperactive. Mania occurs during an illness called “bipolar disorder”
• short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia, who harm themselves or others. Non-pharmacological alternatives must have been adopted before treatment
• short-term treatment (up to 6 weeks) of persistent aggression in children with intellectual disability (aged 5 years and over) and adolescents with conduct disorder. Risperdal can help relieve the symptoms of the illness and stop them from recurring.

2. What you need to know before taking Risperdal

Do not take Risperdal:

• if you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether the conditions mentioned above may apply to you, talk to your doctor or pharmacist before using Risperdal.

Warnings and precautions
Talk to your doctor or pharmacist before taking Risperdal if:

• You have a heart problem. Examples include an irregular heartbeat, or if you tend to have low blood pressure or are taking medicines for blood pressure. Risperdal can cause a drop in blood pressure. Your dose may need to be adjusted
• You are aware of any factors that may expose you to the risk of stroke, such as high blood pressure, cardiovascular disorders or circulatory disorders of the brain
• You have experienced involuntary movements of the tongue, mouth and face
• You have had a condition whose symptoms included fever, muscle rigidity, sweating or reduced level of consciousness (also known as Neuroleptic Malignant Syndrome)
• You suffer from Parkinson's disease or dementia
• You are aware of having had low levels of white blood cells in the blood in the past (which may or may not have been caused by other medicines)
• You are diabetic
• You suffer from epilepsy
• You are a male and have experienced a prolonged or painful erection
• You have difficulty controlling your body temperature or overheating
• You have kidney problems
• You have liver problems
• You have an abnormally high level of the hormone prolactin in your blood or have a possible prolactin-dependent tumor
• You or someone in your family has a history of blood clot formation (thrombi), because antipsychotic drugs have been associated with blood clot formation. If you are not sure whether any of the conditions mentioned above may apply to you, talk to your doctor or pharmacist before using Risperdal.

Because a dangerously low number of a certain type of white blood cells needed to fight infections in the blood has been observed very rarely in patients who have taken Risperdal, the doctor may check the count of the level of white blood cells in the blood.
Risperdal can cause weight gain. Significant weight gain can negatively affect your health. Your doctor should check your body weight regularly.
Because the onset or worsening of diabetes mellitus has been observed in patients taking Risperdal, the doctor should check for high blood glucose levels.
Blood glucose levels should be monitored regularly in patients with pre-existing diabetes mellitus.
Risperdal often increases the levels of a hormone called "prolactin". This can cause undesirable effects such as menstrual disorders and fertility problems in women, breast enlargement in men (see “Possible side effects”). If you experience such side effects, it is recommended to evaluate the level of prolactin in the blood.
During an eye operation for cataracts (clouding of the lens), the pupil (the black circle in the center of your eye) may not increase in size as needed. In addition, the iris (the colored part of the eye) may become flaccid during surgery, and this can cause damage to the eye. If you are planning to have an eye operation, be sure to inform the ophthalmologist that you are taking this medicine.

Elderly patients with dementia
There is an increased risk of stroke in elderly patients with dementia. If your dementia is caused by stroke, you should not take risperidone.
During treatment with risperidone you should see your doctor frequently.
If you or the person assisting you notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or incomprehensible speech, even for a short period of time, you should seek immediate medical attention. These may be signs of a stroke.

Children and Adolescents
Before starting treatment for behavioral disorder, other causes for aggressive behavior must be ruled out.
If fatigue occurs during treatment with risperidone, changing the time of administration of the drug may improve attention difficulties.
Before starting treatment, your body weight, or that of your child, must be measured and carefully monitored during treatment.
A small and not definitive study has recorded an increase in height in children who have taken risperidone, but it is not known if this is an effect of the drug or is due to some other reason.

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

It is particularly important to tell your doctor or pharmacist if you are taking any of the following:

• Medicines that act on your brain, to help you calm down (benzodiazepines), or some medicines for pain (opioids), medicines for allergies (some antihistamines), because risperidone can increase the sedative effects of all these medicines
• Medicines that can change the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm problems, for allergies (antihistamines), some antidepressants or other medicines for mental health problems
• Medicines that cause a slowing of the heartbeat
• Medicines that cause a lowering of potassium in the blood (such as some diuretics)
• Medicines to treat high blood pressure. Risperdal can cause a drop in blood pressure
• Medicines for Parkinson's disease (such as levodopa)
• Medicines that increase the activity of the central nervous system (stimulants such as methylphenidate)
• Medicines for urination (diuretics), used for heart problems or for swelling of parts of the body due to an accumulation of too much fluid (such as furosemide or chlorothiazide). Risperdal taken alone or with furosemide may increase the risk of stroke or death in elderly patients with dementia.

The following medicines can reduce the effect of risperidone

• Rifampicin (a medicine to treat some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines can increase the effect of risperidone

• Quinidine (used for some heart diseases)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines for the treatment of 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 not sure whether any of the conditions mentioned above may apply to you, talk to your doctor or pharmacist before using Risperdal.

Risperdal with food, drinks and alcohol
You can take this medicine with or without food. During treatment with Risperdal you should avoid drinking alcohol.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide if you can use it.
• The following symptoms may occur in newborns born to mothers who have taken Risperdal during the last trimester (the last three months of pregnancy): tremor, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby shows any of these symptoms, contact your doctor.
• Risperdal can increase the levels of a hormone called "prolactin" which can affect fertility (see Possible side effects). Driving and using machinesDuring treatment with Risperdal, dizziness, fatigue and vision problems may occur. Do not drive, or use tools or machinery, until you have spoken to your doctor.

Risperdal coated tablets contain lactose
The coated tablets contain lactose, a type of sugar. If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine.

Risperdal 2 mg and 6 mg coated tablets also contain aluminum yellow sunset-lacca (E110),which may cause allergic reactions.

Risperdal 1 ml oral solution contains benzoic acid (E 210).
This medicine contains 2 mg of benzoic acid in each ml of oral solution. Benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Risperdal

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

The recommended dose is as follows:
For the treatment of schizophrenia
Adults

• The usual starting dose is 2 mg per day, which may be increased to 4 mg daily from the second day
• The dose may then be increased by your doctor depending on how you respond to the treatment
• Most people feel better with daily doses between 4 and 6 mg
• The total daily dose may be divided into one or two administrations. Your doctor will tell you which is the best solution for you. Elderly
• The starting dose will generally be 0.5 mg twice a day
• The dose may then be gradually increased by your doctor to 1-2 mg twice a day
• Your doctor will tell you which is the best way for you.

For the treatment of mania
Adults

• The usual starting dose will be 2 mg once a day
• The dose may then be gradually adjusted by your doctor, depending on your response to the treatment
• Most people will feel better with doses between 1 and 6 mg once a day.

Elderly

• The starting dose will generally be 0.5 mg twice a day
• The dose may then be gradually adjusted by your doctor to 1 - 2 mg twice a day, depending on your response to the treatment.

Adults (including the elderly)

• The usual starting dose will be 0.25 mg (0.25 ml of Risperdal oral solution 1mg/ml) twice a day
• The dose may then be gradually adjusted by your doctor, depending on your response to the treatment
• Most people will feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day
• The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks.

Children and adolescents

• Children and adolescents under 18 years of age should not be treated with Risperdal for schizophrenia or mania. For the treatment of conduct disorder

The dose will depend on the child's weight:
For children weighing less than 50 kg:

• The starting dose will generally be 0.25 mg (0.25 ml of Risperdal oral solution 1mg/ml) once a day
• The dose may be increased on alternate days with increments of 0.25 mg per day
• The maintenance dose is usually between 0.25 mg and 0.75 mg (0.25 to 0.75 ml of Risperdal oral solution 1mg/ml) once a day

For children weighing 50 kg or more:

• The starting dose will generally be 0.5 mg once a day
• The dose may be increased on alternate days with increments of 0.5 mg per day
• The maintenance dose is usually between 0.5 mg and 1.5 mg once a day

The duration of treatment in patients with conduct disorder should not exceed 6 weeks.
Children under 5 years of age should not be treated with Risperdal for conduct disorder.

Patients with kidney or liver problems
Regardless of the condition to be treated, all initial doses and subsequent doses of risperidone
must be halved. Dose increases should occur more slowly in these patients.
Risperidone should be used with caution in this group of patients.

Method of administration
For oral use
Risperdal film-coated tablets

• You must swallow the tablet with a glass of water.
• The notch is only to help you break the tablet if you have difficulty swallowing it whole. Risperdal oral solutionThe oral solution is supplied with a syringe (dropper). This must be used to help you measure the exact amount of medicine you need.

Follow these procedures:

• 1. Remove the child-resistant cap. Press down on the screw cap and rotate it simultaneously in an anti-clockwise direction (Figure 1)

• 2. Insert the syringe into the bottle (Figure 2)

Holding the lower ring firmly, pull up the upper ring until it reaches the mark corresponding to the
amount in milliliters or mg to be taken (Figure 3)

• 4. Holding the lower ring, remove the entire syringe from the bottle (Figure 4)

• 5. Empty the contents of the syringe into any non-alcoholic beverage, except tea. Slide the upper ring down
• 6. Close the bottle
• 7. Rinse the syringe with a little water.

If you use more Risperdal than you should

• Consult your doctor immediately. Bring the medicine packaging with you
• In case of overdose, you may feel sleepy or tired or have strange movements of your body, difficulty standing and walking, dizziness caused by low blood pressure, or irregular heartbeat or seizures.

If you forget to take Risperdal

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose and continue as usual. If you forget two or more doses, contact your doctor
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

If you stop taking Risperdal
Do not stop taking this medicine unless your doctor tells you to do so. Your symptoms
may return. If your doctor decides to stop this medicine, the dose may be gradually reduced over a few days.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following uncommon side effects
(may affect up to 1 in 100 people):

• You have dementia and notice a sudden change in your mental state or a sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech is unintelligible, even if for a short period. These may be signs of a stroke.
• You develop tardive dyskinesia (spasms or contractions of the face, tongue or other parts of your body that you cannot control). Tell your doctor immediately if you develop involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop Risperdal. Tell your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1000 people):
• You develop blood clots in the veins (thrombi), particularly in the legs (symptoms include swelling, pain and redness of the legs), which can move along the blood vessels to the lungs causing chest pain and difficulty breathing). If you notice any of these symptoms, consult your doctor immediately.
• You have a fever, muscle rigidity, sweating or reduced level of consciousness (a condition called Neuroleptic Malignant Syndrome). Immediate medical treatment may be necessary.
• You are male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash or a drop in blood pressure. The following additional side effects may also occur: Very common side effects (may affect more than 1 in 10 people)
• Difficulty falling asleep or staying asleep
• Parkinsonism: this condition may include: slow or impaired body movements, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes also a feeling of movement that stops and then restarts. Other signs of parkinsonism include a slow walk with shuffling feet, a tremor at rest, increased saliva and/or loss of saliva, and a loss of facial expression
• Feeling sleepy or reduced alertness
• Headache.

Common (may affect up to 1 in 10 people)

• Pneumonia, chest infection (bronchitis), cold symptoms, sinusitis
• Urinary tract infection
• Ear infection, feeling as if you have the flu
• Increased levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). Symptoms due to a high level of prolactin do not commonly occur and may include: (in men) breast enlargement, difficulty having or maintaining erections, decreased sexual desire or other sexual dysfunction. In women they may include breast discomfort, leakage of milk from the breasts, missing periods or other problems with the cycle, or fertility problems
• Weight gain, increased appetite, decreased appetite
• Sleep disorders, irritability, depression, anxiety, agitation
• Dystonia: this is a condition involving a slow or prolonged involuntary muscle contraction. While it can involve any part of the body (resulting in an abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
• Dizziness
• Dyskinesia: this is a condition involving involuntary muscle movements and can include repetitive, jerky or contorted movements or spasms.
• Tremor (shaking)
• Blurred vision, eye infection or conjunctivitis
• Rapid heart rate, high blood pressure, shortness of breath
• Sore throat, cough, nosebleed, stuffy nose
• Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Skin rash, redness of the skin
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence (loss of control)
• Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Falls.

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

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, infection of a single area of skin or part of the body, viral infection, skin inflammation caused by mites.
• Decrease in the blood of a type of white blood cell that helps protect the body from infections
• Reduced number of white blood cells, reduced platelets (blood cells that help stop bleeding), anemia, reduced number of red blood cells, increased eosinophils (particular white blood cells) in the blood
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake, weight loss, loss of appetite resulting in malnutrition and low body weight
• Increased cholesterol in the blood
• Euphoria (mania), confusion, reduced sexual drive, nervousness, nightmares
• Unresponsiveness to stimuli, loss of consciousness, reduced level of consciousness
• Convulsions (seizures), fainting
• An urgent need to move a part of the body, balance disorders, abnormal coordination, dizziness when getting up, attention problems, speech problems, loss or abnormal sense of taste, reduced sensitivity of the skin to pain and touch, a sensation of tingling, prickling or numbness of the skin
• Hypersensitivity of the eyes to light, dry eyes, increased tearing, redness of the eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (an abnormal heart rhythm), a disruption of the conduction of the heart between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, slow heart rate, abnormal heart tracing (electrocardiogram or ECG), a sensation of a fast heartbeat or palpitations in the chest
• Low blood pressure, low blood pressure when getting up (consequently, some patients taking Risperdal may feel faint, dizzy or may faint when getting up or sitting up suddenly), hot flushes
• Pneumonia caused by inhaling food, congestion of the lungs, congestion of the airways, crackling sounds in the lungs, wheezing, problems with voice, airway disorder
• Stomach or intestinal infection, fecal incontinence, hard stools, difficulty swallowing, excessive passing of gas or air
• Hives, itching, hair loss, thickening of the skin, dry skin, skin discoloration, acne, scaling and itching of the scalp or skin, skin disorder, skin lesion
• An increase in the levels of CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage
• Abnormal posture, stiff joints, swollen joints, muscle weakness, neck pain
• Frequent urination, inability to urinate, pain during urination
• Erectile dysfunction, ejaculation disorders
• Loss of menstrual cycle, missed menstrual period or problems with the cycle (females),
• Development of breast tissue in men, leakage of milk from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes or lips
• Chills, increased body temperature
• Change in the way of walking
• Feeling thirsty, feeling unwell, chest pain, feeling down, discomfort
• Increased liver transaminases in the blood, increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood
• Procedural pain

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

• Infection
• Inappropriate secretion of the hormone that controls urine volume
• Sleepwalking
• Eating disorder related to sleep
• Absence of movements or responses when awake (catatonia)
• Sugar in the urine
• Low blood sugar levels, high levels of triglycerides (a fat)
• Lack of emotion, inability to reach orgasm
• Problems with blood vessels in the brain
• Coma due to diabetes not kept under control
• Head shaking
• Glaucoma (increased pressure inside the eyeball). Problems with eye movement, eye rotation, crusts on the eyelid margin
• Problems with the eyes during cataract surgery. During cataract surgery, a condition called iris flag syndrome (IFIS) may occur if you take or have taken Risperdal. If you are to undergo cataract surgery, be sure to inform your doctor if you take or have taken this medicine
• Dangerously low number of a certain type of white blood cells in the blood needed to fight infections
• Dangerously excessive intake of water
• Irregular heartbeat
• Breathing problems during sleep (sleep apnea), fast and shallow breathing
• Inflammation of the pancreas
• Blockage of the colon
• Swelling of the tongue, chapped lips, drug rash
• Dandruff
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis)
• A delay in the menstrual cycle, enlargement of the mammary glands, breast enlargement, leakage from the breasts
• Increased levels of insulin (a hormone that controls blood sugar levels)
• Hardening of the skin
• Very low body temperature, cold arms and legs
• Drug withdrawal syndrome
• Yellowing of the skin and eyes (jaundice)

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

• Life-threatening complications of uncontrolled diabetes
• Severe allergic reaction with swelling that can involve the throat and lead to difficulty breathing
• Lack of intestinal muscle movement causing blockage

Not known: frequency cannot be estimated based on available data

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

The following side effects have been observed with the use of another medicine called paliperidone
which is very similar to risperidone, so these effects can be expected with Risperdal as well: fast
heartbeat when getting up.

Additional side effects in children and adolescents
In general, the type of side effects in children is expected to be similar to that observed in
adults.
The following side effects have been reported more frequently in children and adolescents (ages
5 to 17 years) compared to adults: feeling sleepy or less alert, fatigue, headache, increased
appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness,
cough, fever, tremor, diarrhea and urinary incontinence (loss of control).
If any side effect occurs, including those not listed in this leaflet, please
tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Risperdal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, the carton, or the bottle. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.

Risperdal film-coated tablets
Blister: store in the original package to protect from light.

Risperdal oral solution
Do not refrigerate or freeze.
Once opened, any unused product should be discarded after 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Risperdal contains
The active ingredient is risperidone
Each film-coated tablet of Risperdal contains 1 mg, 2 mg, 3 mg or 4 mg of risperidone.
The other ingredients are:

Risperdal 1 mg film-coated tablets

Tablet core:lactose monohydrate, corn starch, microcrystalline cellulose (E460),
hypromellose (E464), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Coating:
hypromellose (E464), propylene glycol (E490).

Risperdal 2 mg film-coated tablets

Tablet core:lactose monohydrate, corn starch, microcrystalline cellulose (E460),
hypromellose (E464), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Coating:
hypromellose (E464), propylene glycol (E490), talc (E553B), titanium dioxide (E171), sunset yellow-
aluminium lake (E110).

Risperdal 3 mg film-coated tablets

Tablet core:lactose monohydrate, corn starch, microcrystalline cellulose (E460),
hypromellose (E464), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Coating:
hypromellose (E464), propylene glycol (E490), talc (E553B), titanium dioxide (E171), quinoline yellow
(E104).

Risperdal 4 mg film-coated tablets

Tablet core:lactose monohydrate, corn starch, microcrystalline cellulose (E460),
hypromellose (E464), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Coating:
hypromellose (E464), propylene glycol (E490), talc (E553B), titanium dioxide (E171), quinoline yellow
(E104), aluminium indigotine disulfonate-aluminium lake (E132).
1 ml of Risperdal oral solution contains 1 mg of risperidone
The other ingredients are:
tartaric acid, benzoic acid, sodium hydroxide, purified water.

Description of the appearance of Risperdal and contents of the pack
Risperdal film-coated tablets are packaged in PVC/LDPE/PVDC aluminium blister packs
and in HDPE bottles with a child-resistant screw cap.
Risperdal film-coated tablets

• The 0.5 mg risperidone tablets are reddish-brown, oblong, biconvex, with a fracture line of 9 mm x 5 mm
• The 1 mg risperidone tablets are white, oblong, biconvex, with a fracture line of 10.5 mm x 5 mm
• The 2 mg risperidone tablets are orange, oblong, biconvex, with a fracture line of 10.5 mm x 5 mm
• The 3 mg risperidone tablets are yellow, oblong, biconvex, with a fracture line of 13.5 mm x 6.5 mm
• The 4 mg risperidone tablets are green, oblong, biconvex, with a fracture line of 15 mm x 6.5 mm
• The 6 mg risperidone tablets are white, round 8 m

The film-coated tablets have RIS 0.5, RIS 1, RIS 2, RIS 3, RIS 4 and RIS 6 engraved on one side
respectively. Furthermore, JANSSEN may be engraved on the opposite side.
Risperdal film-coated tablets is available in the following pack sizes:
0.5 mg: in blisters containing 20 or 50 tablets and bottles containing 500 tablets
1 mg: in blisters containing 6, 20, 50, 60 or 100 tablets and bottles containing 500 tablets
2 mg: in blisters containing 10, 20, 50, 60 or 100 tablets and bottles containing 500 tablets
3 mg: in blisters containing 20, 50, 60 or 100 tablets
4 mg: in blisters containing 10, 20, 30, 50, 60 or 100 tablets
6 mg: in blisters containing 10, 28, 30 or 60 tablets
Not all pack sizes may be marketed.

Oral solution
Risperdal oral solution is available in amber glass bottles with a child-resistant cap
containing 30 ml, 60 ml, 100 ml or 120 ml of clear and colourless liquid. A graduated
pipette is also provided.
The pipette supplied with the 30 ml, 60 ml and 100 ml bottles is graduated in milligrams and millilitres with
a minimum volume of 0.25 ml and a maximum volume of 3 ml. Graduations are printed on the pipette in
increments from 0.25 ml (corresponding to 0.25 mg of oral solution) up to 3 ml
(corresponding to 3 mg of oral solution)
The pipette supplied with the 120 ml bottle is graduated in milligrams and millilitres with a minimum volume of
0.25 ml and a maximum volume of 4 ml. Graduations are printed on the pipette in increments from 0.25 ml
(corresponding to 0.25 mg of oral solution) up to 4 ml (corresponding to 4 mg of
oral solution).
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Janssen-Cilag SpA
Via M.Buonarroti, 23
20093 Cologno Monzese (MI)

Manufacturer

Film-coated tablets and orodispersible tablets
Janssen Cilag SpA
Via C. Janssen
Borgo San Michele
04100 Latina, Italy

Oral solution
Janssen Pharmaceutica NV
Turnhoutseweg, 30
B-2340 Beerse (Belgium)

The marketing authorisation for this medicinal product has been granted in the EEA Member States
with the following names:
Austria: Risperdal / Risperdal Quicklet
Belgium: RISPERDAL / RISPERDAL Instasolv
Cyprus: RISPERDAL
Czech Republic RISPERDAL
Denmark: RISPERDAL
Estonia: RISPOLEPT
Finland: RISPERDAL / RISPERDAL INSTASOLV
France: RISPERDAL / RISPERDALORO
Germany: RISPERDAL 1 mg; 2 mg; 3 mg; 4 mg/ Risperdal Filmtabletten
0,5mg;6mg / RISPERDAL QUICKLET 0,5 mg Schmelztabletten/
RISPERDAL QUICKLET 1 mg; 2 mg, 3 mg;4 mg/ Risperdal Lösung 1mg/ml
Greece: RISPERDAL / RISPERDAL QUICKLET
Hungary: RISPERDAL
Iceland: RISPERDAL
Ireland: RISPERDAL / RISPERDAL Quicklet
Italy: RISPERDAL
Lithuania: RISPOLEPT
Latvia: RISPOLEPT / RISPERDAL Quicklet
Luxembourg: RISPERDAL /RISPERDAL Instasolv
Malta: RISPERDAL
Netherlands: RISPERDAL / RISPERDAL Quicklet
Norway: RISPERDAL / RISPERDAL smeltetabletter
Poland: RISPOLEPT
Portugal: RISPERDAL / RISPERDAL QUICKLET
Romania: RISPOLEPT
Slovenia: RISPERDAL
Spain: RISPERDAL / RISPERDAL FLAS
Sweden: RISPERDAL
United Kingdom: RISPERDAL / RISPERDAL Quicklet

This leaflet was last updated on:

Risperdal 25, 37.5 and 50 mg powder and solvent for prolonged-release injectable suspension

prolonged
(Risperdal injectable)
risperidone

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Risperdal injectable and what it is used for

Risperdal injectable belongs to a group of medicines called “antipsychotics”.
Risperdal injectable is used for the maintenance therapy of schizophrenia, a condition in which you may see, hear or feel things that are not present, believe things that are not true or feel
suspicious in an unusual way or confused.
Risperdal injectable is intended for patients who are currently being treated with oral antipsychotics
(for example: tablets, capsules).
Risperdal can help to relieve the symptoms of the illness and to stop them from recurring

2. What you need to know before using Risperdal injectable

Do not use Risperdal injectable:

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

Warnings and precautions

• If you have never taken any form of Risperdal, you must start with Risperdal oral, before undergoing treatment with Risperdal injectable. Talk to your doctor or pharmacist before taking Risperdal injectable if:
• You have a heart problem. Examples include an irregular heartbeat, or if you tend to have low blood pressure or if you are taking medicines for blood pressure. Risperdal injectable can cause a lowering of blood pressure. Your dose may need to be adjusted
• You are aware of any factors that may expose you to the risk of stroke, such as high blood pressure, cardiovascular disorders or circulatory disorders of the brain
• You have experienced involuntary movements of the tongue, mouth and face
• You have had a condition whose symptoms included fever, muscle stiffness, sweating or reduced level of consciousness (also known as Neuroleptic Malignant Syndrome)
• You suffer from Parkinson's disease or dementia
• You are aware of having had low levels of white blood cells in the blood in the past (which may or may not have been caused by other medicines)
• You are diabetic
• You suffer from epilepsy
• You are a male and you have experienced a prolonged or painful erection
• You have difficulty controlling your body temperature or excessive heating
• You have kidney problems
• You have liver problems
• You have an abnormally high level of the hormone prolactin in your blood or have a possible prolactin-dependent tumor
• You or someone else in your family has a history of blood clot formation (thrombosis), because antipsychotic drugs have been associated with blood clot formation. If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Risperdal or Risperdal injectable.

Since a dangerously low number of a certain type of white blood cells necessary to fight infections in the blood has been observed very rarely in patients who have taken Risperdal injectable, the doctor may check the count of the level of white blood cells in the blood.
Even if you have previously tolerated oral risperidone, allergic reactions rarely occur after receiving injections of Risperdal injectable. Contact your doctor immediately if you develop a rash, swelling of the throat, itching or breathing problems, as these may be signs of a serious allergic reaction.
Risperdal injectable can cause weight gain. Significant weight gain can negatively affect your health. Your doctor should check your body weight regularly.
Since the onset of diabetes mellitus or a worsening of pre-existing diabetes mellitus has been observed in patients taking Risperdal, the doctor must check for high levels of glucose in the blood. Glucose levels in the blood should be monitored regularly in patients with pre-existing diabetes mellitus.
Risperdal injectable often increases the levels of a hormone called "prolactin". This can cause undesirable effects such as menstrual disorders and fertility problems in women, breast enlargement in men (see “Possible side effects”). If you experience such side effects, it is recommended to evaluate the level of prolactin in the blood.
During an eye operation for cataracts, the pupil (the black circle in the center of your eye) may not increase in size as needed. In addition, the iris (the colored part of the eye) may become flaccid during surgery and this can cause damage to the eye. If you are planning to undergo eye surgery, be sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia
Risperdal injectable is not intended for use in elderly patients with dementia.
If you or the person assisting you notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or incomprehensible speech, even for a short period of time, you should seek immediate medical attention. These may be signs of a stroke.

Kidney or liver problems
Although oral risperidone has been studied, Risperdal injectable has not been studied in patients with kidney or liver problems. Risperdal injectable should be administered with caution in this group of patients.

Other medicines and Risperdal injectable
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

It is particularly important to inform your doctor or pharmacist if you are taking any of the following

• Medicines that act on your brain, to help you calm down (benzodiazepines), or some medicines for pain (opioids), medicines for allergies (some antihistamines), because risperidone can increase the sedative effects of all these medicines
• Medicines that can change the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm problems, for allergies (antihistamines), some antidepressants or other medicines for mental health problems
• Medicines that cause a slowing of the heartbeat
• Medicines that cause a lowering of potassium in the blood (such as some diuretics)
• Medicines for Parkinson's disease (such as levodopa)
• Medicines that increase the activity of the central nervous system (stimulants such as methylphenidate)
• Medicines to treat high blood pressure. Risperdal injectable can cause a lowering of blood pressure
• Medicines to urinate (diuretics), used for heart problems or for swelling of parts of the body, due to an accumulation of too much fluid (such as furosemide or chlorothiazide). Risperdal injectable taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia. The following medicines can reduce the effect of risperidone
• Rifampicin (a medicine to treat some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital If you start or stop taking these medicines, you may need a different dose of risperidone

The following medicines can increase the effect of risperidone

• Quinidine (used for some heart diseases)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medicines known as beta-blockers (used in the treatment of high blood pressure)
• Phenothiazines (such as medicines used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acidity blockers)
• Itraconazole and ketoconazole (medicines for the treatment of fungal infections)
• Some medicines used in the treatment of 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 not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Risperdal injectable.

Taking Risperdal injectable with food, drinks and alcohol
During treatment with Risperdal injectable you should avoid drinking alcohol.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
• The following symptoms have been observed in newborns born to mothers who have taken Risperdal injectable during the last trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby shows any of these symptoms, contact your doctor.
• Risperdal injectable can increase the levels of a hormone called "prolactin" which can impact fertility (see “Possible side effects”).

Driving and using machines
During treatment with Risperdal injectable, dizziness, fatigue and vision problems may occur. Do not drive, or use tools or machinery, until you have spoken to your doctor.

Risperdal injectable contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially sodium-free.

3. How to use Risperdal injectable

Use this medicine following exactly the instructions of your doctor. If you have any doubts consult your
doctor or pharmacist. Risperdal injectable is administered by a healthcare professional as
an intramuscular injection in the arm or buttock every two weeks. The injections should be alternated
between the right and left side, and the product must not be administered intravenously.

The recommended dose is as follows
Adults
Initial dose
If the daily dose of risperidone oral (for example tablets) you were taking in the last two
weeks was equal to or less than 4 mg, your initial dose of Risperdal injectable should be 25 mg.
If the daily dose of risperidone oral (for example tablets) you were taking in the last two
weeks was more than 4 mg, you may be prescribed an initial dose of Risperdal
injectable of 37.5 mg.
If you are currently taking other oral antipsychotics, other than risperidone, the initial dose of
Risperdal injectable will depend on the treatment you are taking. The doctor will choose
Risperdal injectable 25 mg or 37.5 mg.
The doctor will decide the dose of Risperdal injectable that is right for you.
Maintenance dose

• The usual dose is 25 mg every two weeks as an injection.
• You may also need a lower dose, of 12.5 mg or a higher dose, of 37.5 or 50 mg. The doctor will decide what dosage of Risperdal injectable is most suitable for you.
• The doctor may prescribe Risperdal oral for the first three weeks after the first injection.

If you are given more Risperdal injectable than you should

• Patients who have been given a dose of Risperdal injectable higher than expected have experienced the following symptoms: drowsiness, fatigue, abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure and abnormal heartbeats. Cases of abnormal electrical conduction of the heart
  and seizures have been reported.

blood pressure and irregular heartbeats. Cases of abnormal heart electrical conduction
and seizures have been reported.

• Consult your doctor immediately. Stopping treatment with Risperdal injectableYou will lose the effects of the medicine. Do not stop treatment with this medicine unless your doctor tells you to, because your symptoms may return. Make sure you do not forget your appointments to receive injections every two weeks. If you cannot make your appointment, be sure to contact your doctor immediately to find another date to have the injection. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Use in children and adolescents
Risperdal injectable should not be given to patients under 18 years of age.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor immediately if you experience any of the following uncommon side effects (may affect up to 1 in 100 people):

• You suffer from dementia and notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech is unintelligible, even if for a short period. These may be signs of a stroke.
• You develop tardive dyskinesia (contractions or spasms of your face, tongue or other parts of your body that you cannot control). Inform your doctor immediately if you develop involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue treatment with Risperdal injectable. Inform your doctor immediately if you experience any of the following rare side effects(may affect up to 1 in 1000 people):
• You believe you have blood clots (thrombi) in the veins, particularly in the legs (symptoms include swelling, pain and redness of the legs), which can travel up the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
• You have a fever, muscle rigidity, sweating or a reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be necessary.
• You are male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash or a drop in blood pressure. Even if you have previously tolerated oral risperidone, allergic reactions rarely occur after receiving Risperdal injections. The following additional side effects may also occur:

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

• Cold symptoms
• Difficulty falling asleep or staying asleep
• Depression, anxiety
• Parkinsonism: this condition may include: slow or impaired body movements, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes also a feeling of movement that stops and then restarts. Other signs of

parkinsonism include a slow walk dragging the feet, a tremor at rest,
increased saliva and/or loss of saliva and a loss of facial expression

• Headache

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

• Pneumonia, chest infection (bronchitis), sinusitis
• Urinary tract infection, feeling as if you have the flu, anemia
• Increased levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). Symptoms due to a high level of prolactin are not commonly observed and these may include, in men, breast enlargement, difficulty having or maintaining erections, decreased sexual desire or other sexual dysfunction. In women they may include breast discomfort, milk production from the breasts, missed periods or other problems with the cycle or fertility problems
• High blood sugar, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disorders, irritability, decreased sexual drive, agitation, feeling drowsy or reduced alertness
• Dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. While it can involve any part of the body (resulting in an abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw
• Dizziness
• Dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or contorted movements or spasms
• Tremor (shaking)
• Blurred vision
• Rapid heartbeat
• Low blood pressure, chest pain, high blood pressure
• Shortness of breath, sore throat, cough, stuffy nose
• Abdominal pain, abdominal discomfort, 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 (loss of control)
• Erectile dysfunction
• Loss of menstrual cycle
• Milk production from the breasts
• Swelling of the body, arms or legs, fever, weakness, fatigue (tiredness)
• Pain
• Reaction at the injection site, including itching, pain or swelling
• Increased levels of transaminases in the blood, increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), in the blood
• Falls

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

• Respiratory tract infection, bladder infection, ear infection, eye infection, tonsillitis, fungal nail infection, skin infection, infection of a single area of skin or part of the body, viral infection, skin inflammation caused by mites, subcutaneous abscess
• Reduced number of white blood cells, reduced platelets (blood cells that help stop bleeding), reduced number of red blood cells
• Allergic reaction
• Sugar in the urine, diabetes or worsening of diabetes
• Loss of appetite resulting in malnutrition and low body weight
• High levels of triglycerides (a fat), increased cholesterol in the blood
• Euphoria (mania), confusion, inability to reach orgasm, nervousness, nightmares
• Tardive dyskinesia (spasms or jerking movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop Risperdal injectable
• Sudden loss of blood flow to the brain (stroke or “mini” stroke)
• Loss of consciousness, reduced level of consciousness, fainting
• An urgent need to move a part of the body, balance disorders, abnormal coordination, dizziness when standing up, attention problems, speech problems, loss or abnormal sense of taste, reduced sensitivity of the skin to pain and touch, a tingling, prickling or numbing sensation of the skin
• Eye infection or conjunctivitis, dry eyes, increased tearing, red eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (an abnormal heart rhythm), a disruption of the conduction of the heart between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, slow heart rate, abnormal heart tracing (electrocardiogram or ECG), a feeling of a fast or pounding heartbeat (palpitations)
• Low blood pressure when standing up (consequently, some patients taking Risperdal injectable may feel faint, dizzy or may faint when getting up or sitting down suddenly)
• Fast and shallow breathing, congestion of the airways, wheezing, nosebleed
• Fecal incontinence, difficulty swallowing, excessive passing of gas or air
• Itching, hair loss, eczema, dry skin, redness of the skin, skin discoloration, acne, scaling and itching of the scalp or skin
• An increase in CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage
• Joint stiffness, swollen joints, muscle weakness, neck pain
• Frequent urination, inability to urinate, pain when urinating
• Disorders of ejaculation, delayed menstrual cycle, absence of menstrual cycle or problems with the cycle (females), development of breast in men, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes or lips
• Chills, increased body temperature
• Change in the way you walk
• Feeling thirsty, feeling unwell, chest pain, feeling down
• Hardening of the skin
• Increased levels of liver enzymes in the blood
• Procedural pain

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

• Decrease in a certain type of white blood cells in the blood that help fight infections
• Inappropriate secretion of the hormone that controls urine volume
• Low blood sugar
• Excessive intake of water
• Sleepwalking
• Eating disorder related to sleep
• Absence of movement or responses when awake (catatonia)
• Lack of emotion
• Low level of consciousness
• Head shaking
• Problems with eye movement, 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 use or have used Risperdal injectable. If you are going to have cataract surgery, be sure to tell your doctor if you use or have used this medicine
• Irregular heartbeat
• Dangerously low number of a certain type of white blood cells needed to fight infections, increased eosinophils (particular white blood cells) in the blood, blood clots in the legs, blood clots in the lungs
• Breathing problems during sleep (sleep apnea)
• Pneumonia caused by aspiration of food, pulmonary congestion, crackling sounds in the lungs, problems with voice, airway disorder
• Inflammation of the pancreas, blockage of the colon
• Very hard stools
• Drug-induced skin rash
• Urticaria, thickening of the skin, dandruff, skin problem, skin lesion
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis)
• Abnormal posture
• Breast enlargement, milk production from the breasts
• Decreased body temperature, cold arms and legs
• Drug withdrawal syndrome

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

• Potentially life-threatening complications of uncontrolled diabetes
• Severe allergic reaction with swelling that can involve the throat and lead to difficulty breathing
• Lack of movement of intestinal muscles causing blockage

Not known: frequency cannot be estimated from available data

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

The following side effects have been observed with the use of another medicine called
paliperidone which is very similar to risperidone, so these effects may also be expected with
Risperdal injectable: fast heartbeat when standing up.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more
information on the safety of this medicine

5. How to store Risperdal injectable

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date
refers to the last day of that month.
Store the entire package in a refrigerator (2-8 °C). If refrigeration is not available,
the product may be stored at a temperature not exceeding 25 °C for a
maximum period of 7 days before administration.
Use within 6 hours of reconstitution (if stored at a temperature equal to or less than 25°C).
Store in the original package in order to protect it from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Risperdal injectable contains
The active ingredient is risperidone.
Each pack of Risperdal powder and solvent for prolonged-release injectable suspension
contains 25 mg, 37.5 mg or 50 mg of risperidone.
The excipients are:

Powder for injectable suspension:
poly-(d, 1-Lactide-co-Glycolide).

Solvent (solution):
polysorbate 20, sodium carboxymethylcellulose, disodium hydrogen phosphate dihydrate, anhydrous citric acid, sodium chloride,
sodium hydroxide, water for injections.

Description of the appearance of Risperdal injectable and contents of the pack

• A vial containing the powder (this powder contains the active ingredient, risperidone).
• A pre-filled syringe with 2 ml of clear and colourless aqueous solution to be added to the powder for prolonged-release injectable suspension.
• An adapter system for the vial for reconstitution.
• Two Terumo SurGuard 3 needles for intramuscular injection (one 21G UTW safety needle 1-inch (0.8 mm x 25 mm) with needle protection device for administration into the deltoid and one 20G TW 2-inch (0.9 mm x 51 mm) needle with needle protection device for administration into the gluteus).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Janssen-Cilag SpA
Via M. Buonarroti, 23
20093 Cologno Monzese (MI)

Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse (Belgium)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria: RISPERDAL CONSTA
Belgium: RISPERDAL CONSTA
Bulgaria: PHCHO.JTEHT KOHCTATM
Cyprus: RISPERDAL CONSTA
Czech Republic: RISPERDAL CONSTA
Denmark: RISPERDAL CONSTA
Estonia: RISPOLEPT CONSTA
Finland: RISPERDAL CONSTA
France: RISPERDALCONSTA LP
Germany: RISPERDALCONSTA 25mg, 37,5mg, 50mg
Greece: RISPERDAL CONSTA
Hungary: RISPERDALCONSTA
Iceland: RISPERDAL CONSTA
Ireland: RISPERDAL CONSTA
Italy: RISPERDAL
Lithuania: RISPOLEPT CONSTA
Latvia: RISPOLEPT CONSTA
Liechtenstein: RISPERDAL CONSTA
Luxembourg: RISPERDAL CONSTA
Malta: RISPERDAL CONSTA
Netherlands: RISPERDAL CONSTA
Norway: RISPERDAL CONSTA
Poland: RISPOLEPT CONSTA
Portugal: RISPERDAL CONSTA
Romania: RISPOLEPT CONSTA
Slovakia: RISPERDAL CONSTA
Slovenia: RISPERDALCONSTA
Spain: RISPERDAL CONSTA
Sweden: RISPERDAL CONSTA
United Kingdom: RISPERDAL CONSTA
IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS

Important information
Risperdal injectable requires particular attention to the steps in “Instructions for Use” to
ensure successful administration and avoid difficulties in using the kit.

Use the supplied components
The components supplied with the kit are specifically designed for use with Risperdal.
Risperdal must be reconstituted exclusively with the solvent supplied with the pack.

Do notreplace ANY component of the pack.

Do not store the suspension after reconstitution
Administer the dose immediately after reconstitution to avoid the suspension settling.

Administration of the correct dose
To ensure the intended dose of Risperdal is released, it is necessary to administer all the
contents of the vial.

Do not reuse.
Medical devices require specific material characteristics to function correctly. These
characteristics have only been verified for single use. Any attempt to reuse the device for a
subsequent use may negatively affect the integrity of the device or lead to a deterioration in
performance.

SINGLE-USE DEVICE
Contents of the pack

Step 1Assemble the components
Remove the dose from the packConnect the vial adapter to the vial

Wait 30 minutes
Take the pack
of Risperdal injectable
out of the refrigerator and
bring it to room
temperature
approximately

30 minutesbefore
reconstitution.

Do notheat in any
other way.

Prepare
the vial adapter
Hold the sterile blister
as shown.
Peel and remove the
backing film.

Do notremove the
vial adapter from the
blister.

Do nottouch the
spike tip of the
device. This would
lead to contamination.

Remove the cap from
the vial.Remove the
coloured protective
cap from the vial.
Clean the top of the
grey stopper with a
cotton wool ball
soaked in alcohol.
Let it air dry.

Do notremove the
grey rubber stopper.

Connect the vial
adapter to the
vial
Place the vial
on a rigid surface
and hold the base of
the vial. Place the
vial adapter in the
centre over the grey
rubber stopper.
Push the adapter
straight down onto
the top of the vial until
it is firmly attached.

Do notangle the
vial adapter otherwise
the diluent may
leak when transferred
to the vial.

Connect the pre-filled syringe to the vial adapter

Remove the
cap
Remove the sterile
blister
Hold
correctly
Connect the syringe
to the adapter for the
Hold the white
collar on the tip
of the syringe.

Do nothold the
syringe by the glass
body during
assembly.
Holding the white
collar, snap off the
white cap.

Do notrotate or cut the
white cap.

Do nottouch the tip
of the syringe. This
would lead to
contamination.

vial
Hold the retaining
ring of the adapter to
keep it steady.
Hold the syringe by the
white collar then
insert the tip
into the luer opening
of the adapter.

Do nothold the
syringe by the glass
body.
The white collar
may loosen or
detach.
Attach the syringe
to the adapter by turning
clockwisewith a
firm movement until it
clicks into place.

Do nottighten
excessively. Forcing it
may cause the syringe
tip to break.

Step 2
Keep the vial
vertical to prevent
leakage.
Hold the base of
the vial and lift the
sterile blister.

Do notshake.

Do nottouch the luer
opening of the vial
adapter that is exposed.
This would lead to
contamination.

The cap removed can
be discarded.

Reconstitution of the microspheres

Suspend the
microspheres in the diluent
Continuing to hold
down the plunger,

shake vigorously for
at least 10 seconds,
as shown.
Check the
suspension. If
mixed correctly,
the suspension appears
uniform, dense and
milky. The
microspheres will be
visible within the
liquid.
Proceed
immediately to the
next step so that the
suspension does not
settle.

Inject the diluent
Inject the entire
contents of the
syringe into the vial.

Transfer the
suspension into the
syringe
Turn the vial
completely over. Slowly
and gently pull the
plunger to draw all the
contents from the vial
into the syringe

Remove
the vial adapter
Hold the white
collar of the syringe and
unscrew it from the
adapter.
Remove the part of
the label from the vial
at the puncture site.
Apply the detached
part of the label to the
syringe for
identification.
Dispose of both the
vial and the vial
adapter appropriately

appropriately

Step 3
Attach the needle

Resuspend the microspheres
Remove the
needle pack completely.
Just before injection,
shake the syringe again
vigorously, as the
reconstituted product will
have settled in the
meantime.

Attach the needle
Peel back part of the
opening of the needle
pack and use it to
hold the base of the
needle, as shown.

Holding the white
collar of the syringe,attach the
syringe to the luer
connection of the needle by turning
clockwisewith a
firm movement until it
clicks into place.

Do nottouch the luer
opening of the needle. This
would lead to
contamination.

Select the appropriate needle
Choose the needle based on
the injection site (gluteus or
deltoid).

Step 4Inject the dose

Dispose of the needles
appropriately
Check that
the needle is
fully inserted into
the safety device.
Dispose of in an
approved
container.
Also dispose of the
unused needle
supplied in the
pack.

Remove air
bubbles
Hold the syringe in
a vertical position
and gently tap to
allow any air
bubbles to rise to
the top.
Slowly and carefully
press the plunger
upwards to expel
the air.

Close the needle in the
safety device
With one hand,
position the
needle safety
device at a 45
degree angle on a
rigid and flat
surface. Press
down with a
quick and firm
motion until
the needle has
entered
completely into the

Remove the
transparent needle
cover
Move the
needle safety
device towards the
syringe, as shown.
Then hold the
white collar of the
syringe and, with
caution but with a
decisive movement,
remove the
transparent cover.

Do notrotate the
injection
Inject
immediately
the entire contents
of the syringe
intramuscularly, into
the gluteus or the
deltoid of the
patient.
The injection into
the gluteus must be
performed in the
upper outer
quadrant of the
gluteal area.

Do not
administer through
the cover, as the
luer connection
may loosen.
safety device.

Avoid injury
Do notuse two
hands.

Do notdetach or
tamper with the
needle safety
device.

Do notattempt to
straighten the needle or
to attach the
safety device if the
needle is
bent or
damaged.

intravenously.