Risperdal

Package leaflet: Information for the user

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

risperidone
Please read all of this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 Risperdal is and what it is used for

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

• the treatment 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hear or feel things that are not present, believe things that are not true, or feel unusually suspicious, confused or withdrawn
• the treatment of mania, a condition in which you may feel extremely excited, euphoric, restless, elated or overactive. Mania occurs in the course of an illness called "bipolar disorder"
• short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's dementia who are harming themselves or others. Non-pharmacological alternatives should have been tried before treatment
• short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged 5 years and older) and adolescents with conduct disorder. Risperdal may help relieve symptoms of the illness and prevent their recurrence.

2. What you need to know before taking Risperdal

Do not take Risperdal:

• if you are allergic to risperidone or to any of the other ingredients of this medicine (listed in section 6). If you are unsure 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 condition. Examples include an irregular heartbeat, a tendency to have low blood pressure, or if you are taking medicines for blood pressure. Risperdal may cause a drop in blood pressure. Your dose may need adjustment.
• You are aware of any factors that may put you at risk of stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disorders.
• You have previously experienced involuntary movements of the tongue, mouth, or 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 know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
• You are diabetic.
• You have epilepsy.
• You are male and have experienced prolonged or painful erections.
• You have difficulty controlling your body temperature or are prone to overheating.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood or a possible prolactin-dependent tumour.
• You or someone in your family has a history of blood clots (thrombosis), as antipsychotic medicines have been associated with blood clot formation. If you are unsure whether any of the conditions listed above may apply to you, talk to your doctor or pharmacist before using Risperdal.

Since a dangerously low number of a certain type of white blood cells necessary to fight infections has been observed very rarely in patients taking Risperdal, your doctor may monitor your white blood cell count.
Risperdal may cause weight gain. A significant weight gain may negatively affect your health. Your doctor should regularly monitor your body weight.
Since the onset of diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking Risperdal, your 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 levels of a hormone called "prolactin". This may cause unwanted effects such as menstrual disorders and fertility problems in women, or breast enlargement in men (see "Possible side effects"). If such side effects occur, assessment of prolactin levels in the blood is recommended.
During eye surgery for lens opacity (cataract), the pupil (the black circle in the centre of your eye) may not dilate as required. Also, the iris (the coloured part of the eye) may become flaccid during surgery, which could lead to eye damage. If you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia
In elderly patients with dementia, there is an increased risk of stroke. If your dementia is caused by stroke, you must not take risperidone.
During treatment with risperidone, you should see your doctor frequently.
If you or the person caring for you notices a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs—especially on one side—or slurred speech, even if only briefly, seek immediate medical help. These may be signs of a stroke.

Children and adolescents
Before starting treatment for behavioural disorder, other causes of aggressive behaviour should be ruled out.
If tiredness occurs during treatment with risperidone, changing the time of administration may improve attention difficulties.
Before starting treatment, your body weight or that of your child should be measured and carefully monitored during treatment.
A small, non-definitive study reported increased height in children taking risperidone, but it is not known whether this is a drug effect or due to other reasons.

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 inform your doctor or pharmacist if you are taking any of the following:

• Medicines acting on your brain to help calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), because risperidone may increase the sedative effects of these medicines.
• Medicines that may alter the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm disorders, allergies (antihistamines), certain antidepressants, or other medicines for mental disorders.
• Medicines that cause a slowing of the heartbeat.
• Medicines that cause low potassium levels in the blood (such as certain diuretics).
• Medicines for high blood pressure. Risperdal may cause a drop in blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants such as methylphenidate).
• Medicines for urination (diuretics), used for heart problems or swelling of body parts due to fluid retention (such as furosemide or chlorothiazide). Risperdal, alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• Rifampicin (a medicine used to treat certain 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 may increase the effect of risperidone:

• Quinidine (used for certain heart conditions)
• 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 used to treat fungal infections)
• Certain 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 any of these medicines, you may need a different dose of risperidone.
If you are unsure whether any of the conditions listed above may apply to you, talk to your doctor or pharmacist before using Risperdal.

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

Pregnancy, breastfeeding and fertility

• If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can use it.
• The following symptoms may occur in newborns whose mothers have taken Risperdal during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby shows any of these symptoms, contact your doctor.
• Risperdal may increase levels of a hormone called "prolactin", which may affect fertility (see Possible side effects).

Driving and using machines
During treatment with Risperdal, dizziness, tiredness, and vision problems may occur. Do not drive or operate tools or machinery without first discussing it with your doctor.

Risperdal film-coated tablets contain lactose
The film-coated tablets contain lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Risperdal 2 mg and 6 mg film-coated tablets also contain sunset yellow aluminium lake (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 may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Risperdal

Take this medicine exactly as prescribed by 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 initial dose is 2 mg per day, which may be increased to 4 mg daily from the second day

• Your doctor may then increase the dose depending on your response to treatment

• Most people feel better with daily doses between 4 and 6 mg

• The total daily dose may be taken as a single dose or divided into two doses. Your doctor will tell you which option is best for you. Elderly patients

• The initial dose is generally 0.5 mg twice daily

• Your doctor may gradually increase the dose up to 1–2 mg twice daily

• Your doctor will advise you on the best regimen for you.

For the treatment of mania
Adults

• The usual initial dose is 2 mg once daily
• Your doctor may gradually adjust the dose depending on your response to treatment
• Most people feel better with doses between 1 and 6 mg once daily.

Elderly patients

• The initial dose is generally 0.5 mg twice daily
• Your doctor may gradually adjust the dose up to 1–2 mg twice daily, depending on your response to treatment.

For the treatment of persistent aggression in patients with Alzheimer's dementia
Adults (including elderly patients)

• The usual initial dose is 0.25 mg (0.25 ml of Risperdal oral solution 1 mg/ml) twice daily
• Your doctor may gradually adjust the dose depending on your response to treatment
• Most people feel better with 0.5 mg twice daily. Some patients may require 1 mg twice daily
• 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 initial dose is generally 0.25 mg (0.25 ml of Risperdal oral solution 1 mg/ml) once daily
• The dose may be increased every other day in 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 1 mg/ml) once daily

For children weighing 50 kg or more:

• The initial dose is generally 0.5 mg once daily
• The dose may be increased every other day in increments of 0.5 mg per day
• The maintenance dose is usually between 0.5 mg and 1.5 mg once daily

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 being treated, all initial and subsequent risperidone doses
should be halved. Dose increases should be made more slowly in these patients.
Risperidone should be used with caution in this patient group.
Method of administration
For oral use
Risperdal film-coated tablets

• Swallow the tablet with a glass of water.
• The break line is only intended to assist you in splitting the tablet if you have difficulty swallowing it whole. Risperdal oral solution The oral solution is supplied with a syringe (pipette). This should be used to measure the exact amount of medicine you need.

Follow these steps:

1. Remove the child-resistant cap. Press down on the screw cap and turn it simultaneously counterclockwise (Figure 1)

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

Holding the lower ring steady, pull the upper ring upwards to the mark corresponding to the required amount in millilitres or mg (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 downward to dispense
6. Close the bottle
7. Rinse the syringe with some water.

If you take more Risperdal than you should

• Contact your doctor immediately. Take the medicine pack with you.
• In case of overdose, you may feel drowsy or tired, have unusual body movements, problems standing or walking, dizziness due to low blood pressure, or an abnormal 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 your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses together) to make up for a forgotten dose.

If you stop taking Risperdal
Do not stop taking this medicine unless your doctor tells you to. Your symptoms
may return. If your doctor decides to discontinue this medicine, the dose may be
gradually reduced over several days.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Contact 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, sudden weakness or numbness of the face, arms or legs (especially on one side), or if your speech becomes incomprehensible, even briefly. These may be signs of a stroke.
• You develop tardive dyskinesia (involuntary spasms or contractions of the face, tongue or other body parts). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of Risperdal may be necessary.
  Contact your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 people):
• You develop blood clots in the veins (thrombi), particularly in the legs (symptoms include swelling, pain and redness of the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
• You have fever, muscle rigidity, sweating or reduced level of consciousness (a condition called Neuroleptic Malignant Syndrome). Immediate medical treatment may be required.
• You are male and experience a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be required.
• You experience a severe allergic reaction characterised by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash or a sudden drop in blood pressure.

The following additional adverse effects may also occur:

Very common adverse 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, feeling of muscle stiffness or tension (causing jerky movements), and sometimes a sensation of movement starting and stopping. Other signs of parkinsonism include slow shuffling walk, resting tremor, increased saliva and/or drooling, and loss of facial expression
• Feeling drowsy 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" detected in a blood test (which may or may not cause symptoms). Symptoms due to high prolactin levels are not common and may include: (in men) breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire or other sexual dysfunction. In women, symptoms may include breast discomfort, milk leakage from the breasts, missed menstrual periods or other menstrual problems, or fertility issues
• Weight gain, increased appetite, decreased appetite
• Sleep disturbances, irritability, depression, anxiety, agitation
• Dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. While it may affect any part of the body (resulting in abnormal posture), dystonia often involves facial muscles, including abnormal movements of the eyes, mouth, tongue or jaw.
• Dizziness
• Dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, spasmodic or writhing movements or spasms.
• Tremor (shaking)
• Blurred vision, eye infection or conjunctivitis
• Rapid heart rate, high blood pressure, shortness of breath
• Sore throat, cough, nosebleeds, nasal congestion
• Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache
• Skin rash, skin redness
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence (lack of control)
• Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Falls

Uncommon adverse 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 skin area or body part, viral infection, skin inflammation caused by mites
• Decrease in blood levels 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), anaemia, reduced number of red blood cells, increased eosinophils (a specific type of 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 leading to malnutrition and low body weight
• Increased cholesterol in the blood
• Euphoria (mania), confusion, reduced sexual drive, nervousness, nightmares
• Lack of response to stimuli, loss of consciousness, reduced level of consciousness
• Seizures (fits), fainting
• An urgent need to move a body part, balance problems, abnormal coordination, dizziness when standing up, attention disturbance, language problems, loss or abnormal sense of taste, reduced skin sensitivity to pain and touch, a sensation of tingling, prickling or numbness of the skin
• Light sensitivity of the eyes, dry eyes, increased tearing, eye redness
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (an abnormal heart rhythm), interruption of electrical conduction between the upper and lower chambers of the heart, abnormal heart electrical conduction, QT interval prolongation on ECG, slow heart rate, abnormal heart electrical pattern (electrocardiogram or ECG), sensation of rapid heartbeat or chest pulsations (palpitations)
• Low blood pressure, low blood pressure when standing up (as a result, some patients taking Risperdal may feel faint, dizzy or may faint when standing up or sitting down suddenly), hot flushes
• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory congestion, rattling sounds in the lungs, wheezing, voice problems, respiratory tract disorders
• Stomach or intestinal infection, faecal incontinence, hard stools, difficulty swallowing, excessive passing of gas or air
• Hives, itching, hair loss, skin thickening, eczema, dry skin, skin discolouration, acne, scalp or skin flaking and itching, skin disorder, skin lesion
• Increased levels of CPK (creatine phosphokinase) in the blood, an enzyme sometimes released when muscle damage occurs
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent urination, inability to urinate, pain during urination
• Erectile dysfunction, ejaculation disorders
• Loss of menstrual cycle, absence of menstruation or menstrual problems (females)
• Breast development in males, milk leakage from breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes or lips
• Chills, increased body temperature
• Change in walking pattern
• Feeling of thirst, feeling unwell, chest pain, feeling down
• Increased liver transaminases in the blood, increased GGT in the blood (a liver enzyme called gamma-glutamyl transferase), increased liver enzymes in the blood
• Procedural pain

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

• Infection
• Inappropriate secretion of the hormone controlling urine volume
• Sleepwalking
• Sleep-related eating disorder
• Absence of movement or response while awake (catatonia)
• Sugar in the urine
• Low blood sugar, elevated triglyceride levels (a type of fat)
• Lack of emotion, inability to achieve orgasm
• Problems with cerebral blood vessels
• Coma due to uncontrolled diabetes
• Head shaking
• Glaucoma (increased pressure within the eyeball). Eye movement problems, eye rotation, crusts on the eyelid margin
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken Risperdal. If you are scheduled for cataract surgery, make sure to inform your doctor if you are taking 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 water intake
• Irregular heartbeat
• Breathing problems during sleep (sleep apnoea), rapid and shallow breathing
• Inflammation of the pancreas
• Colon obstruction
• Tongue swelling, chapped lips, drug rash
• Dandruff
• Muscle fibre breakdown and muscle pain (rhabdomyolysis)
• Delay in menstrual cycle, enlargement of mammary glands, breast enlargement, milk leakage from breasts
• Increased insulin levels (a hormone that controls blood sugar levels)
• Skin hardening
• Very low body temperature, cold arms and legs
• Drug withdrawal syndrome
• Yellowing of the skin and eyes (jaundice)

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

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

Not known: frequency cannot be estimated from the available data

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

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

Additional adverse effects in children and adolescents
In general, the type of adverse effects expected in children is similar to those observed in adults.
The following adverse effects have been reported more frequently in children and adolescents (aged 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, diarrhoea and urinary incontinence (loss of control).

If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse 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, packaging or bottle.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Risperdal film-coated tablets
Blister pack: store in the original packaging to protect from light.
Risperdal oral solution
Do not refrigerate or freeze.
After opening the bottle, any unused product should be discarded after 3 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Risperdal contains
The active substance is risperidone.
Each film-coated tablet of Risperdal contains 1 mg, 2 mg, 3 mg, or 4 mg of risperidone.

The other components are:
Risperdal 1 mg film-coated tablets
Tablet core: monohydrate lactose, maize 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: monohydrate lactose, maize 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: monohydrate lactose, maize 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: monohydrate lactose, maize 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), indigo carmine aluminium lake (E132).

1 ml of Risperdal oral solution contains 1 mg of risperidone.
The other components are:
tartaric acid, benzoic acid, sodium hydroxide, purified water.

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

Risperdal film-coated tablets:

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

The film-coated tablets are engraved on one side with RIS 0.5, RIS 1, RIS 2, RIS 3, RIS 4, and RIS 6 respectively. Additionally, JANSSEN may be engraved on the opposite side.

Risperdal film-coated tablets are available in the following pack sizes:
0.5 mg: blisters containing 20 or 50 tablets and bottles containing 500 tablets
1 mg: blisters containing 6, 20, 50, 60 or 100 tablets and bottles containing 500 tablets
2 mg: blisters containing 10, 20, 50, 60 or 100 tablets and bottles containing 500 tablets
3 mg: blisters containing 20, 50, 60 or 100 tablets
4 mg: blisters containing 10, 20, 30, 50, 60 or 100 tablets
6 mg: 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 child-resistant caps containing 30 ml, 60 ml, 100 ml or 120 ml of clear, colourless liquid. A graduated pipette is also supplied.

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. Graduation marks on the pipette are at 0.25 ml intervals (corresponding to 0.25 mg of oral solution), increasing 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. Graduation marks on the pipette are at 0.25 ml intervals (corresponding to 0.25 mg of oral solution), increasing 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 S.p.A.
Via M. Buonarroti, 23
20093 Cologno Monzese (MI)

Manufacturer
Film-coated tablets and orodispersible tablets
Janssen Cilag S.p.A.
Via C. Janssen
Borgo San Michele
04100 Latina, Italy

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

Marketing authorisation for this medicinal product has been granted in the EEA Member States
under 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 0.5 mg; 6 mg / RISPERDAL QUICKLET 0.5 mg Schmelztabletten / RISPERDAL QUICKLET 1 mg; 2 mg; 3 mg; 4 mg / Risperdal Lösung 1 mg/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:

Patient Information Leaflet: Information for the User

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

(Risperdal injectable)
risperidone
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult 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 using 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 Risperdal Injectable Is and What It Is Used For

Risperdal Injectable belongs to a group of medicines called "antipsychotics".
Risperdal Injectable is used for the maintenance treatment of schizophrenia, a condition in which you
may see, hear, or experience things that are not present, believe things that are not true, or feel
unusually suspicious or confused.
Risperdal Injectable is intended for patients who are currently being treated with oral antipsychotics
(e.g.: tablets, capsules).
Risperdal can help relieve the symptoms of the illness and prevent its recurrence.

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 below).

Warnings and precautions

• If you have never taken any form of Risperdal before, you must start with oral Risperdal before beginning treatment with Risperdal injectable. Talk to your doctor or pharmacist before using Risperdal injectable if:
• You have a heart condition. Examples include irregular heartbeat, a tendency to low blood pressure, or if you are taking medicines for blood pressure. Risperdal injectable may cause a drop in blood pressure. Your dose may need adjustment.
• You are aware of any factors that may put you at risk of stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular circulation problems.
• You have experienced involuntary movements of the tongue, mouth, or 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 have Parkinson’s disease or dementia.
• You know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
• You have diabetes.
• You have epilepsy.
• You are male and have experienced prolonged or painful erections.
• You have difficulty controlling your body temperature or are prone to overheating.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood or a possible prolactin-dependent tumour.
• You or someone in your family has a history of blood clots (thrombosis), as antipsychotic medicines have been associated with blood clot formation.
  If you are unsure whether any of the conditions listed 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 needed to fight infections has been observed very rarely in patients treated with Risperdal injectable, your doctor may monitor your white blood cell count.
Even if you previously tolerated oral risperidone, allergic reactions may rarely occur after receiving injections of Risperdal injectable. Contact your doctor immediately if you develop a rash, swelling of the throat, itching, or breathing difficulties, as these may be signs of a serious allergic reaction.
Risperdal injectable may cause weight gain. Significant weight gain may negatively affect your health. Your doctor should regularly monitor your body weight.
Since the onset or worsening of diabetes mellitus has been observed in patients treated with Risperdal, your doctor should check for high blood glucose levels. Blood glucose levels should be monitored regularly in patients with pre-existing diabetes mellitus.
Risperdal injectable often increases levels of a hormone called "prolactin". This may cause side effects such as menstrual disorders and fertility problems in women, or breast enlargement in men (see "Possible side effects"). If such side effects occur, assessment of blood prolactin levels is recommended.
During cataract surgery (an operation to remove clouding of the lens), the pupil (the black circle in the centre of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become floppy during surgery, which could lead to eye damage. If you are planning eye surgery, make 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 someone caring for you notices a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs—especially on one side—or slurred speech, even if only briefly, 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 these patient groups.

Other medicines and Risperdal injectable
Inform 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 calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), because risperidone may increase the sedative effects of these medicines.
• Medicines that may alter the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm disorders, allergy medicines (antihistamines), certain antidepressants, or other medicines for mental disorders.
• Medicines that cause a slowing of the heart rate.
• Medicines that reduce potassium levels in the blood (such as certain diuretics).
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
• Medicines for high blood pressure. Risperdal injectable may cause a drop in blood pressure.
• Medicines used to increase urine production (diuretics), used for heart problems or swelling of body parts due to fluid accumulation (such as furosemide or chlorothiazide). Risperdal injectable, alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

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

The following medicines may increase the effect of risperidone:

• Quinidine (used for certain heart conditions)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (such as medicines used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines used to treat fungal infections)
• Certain 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 any of these medicines, you may need a different dose of risperidone.

If you are unsure whether any of the conditions listed 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, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
• The following symptoms have been observed in newborns whose mothers took Risperdal injectable during the third trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
• Risperdal injectable may increase levels of a hormone called "prolactin", which may affect 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 operate tools or machinery without first discussing this with your doctor.

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

3. How to use Risperdal Consta

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Risperdal Consta is administered by a healthcare professional as an intramuscular injection in the arm or buttock every two weeks. Injections must be alternated between the right and left side, and the product must not be administered intravenously.

Recommended dose
Adults
Initial dose
If your daily oral risperidone dose (e.g. tablets) taken during the last two weeks was equal to or less than 4 mg, your initial dose of Risperdal Consta should be 25 mg.
If your daily oral risperidone dose (e.g. tablets) taken during the last two weeks was greater than 4 mg, you may be prescribed an initial dose of Risperdal Consta of 37.5 mg.
If you are currently taking other oral antipsychotics different from risperidone, the initial dose of Risperdal Consta will depend on your current treatment. Your doctor will choose between Risperdal Consta 25 mg or 37.5 mg.
Your doctor will decide the appropriate dose of Risperdal Consta for you.

Maintenance dose

• The usual dose is 25 mg administered every two weeks as an injection.
• A lower dose of 12.5 mg or a higher dose of 37.5 mg or 50 mg may also be required. Your doctor will determine the most suitable dosage of Risperdal Consta for you.
• Your doctor may prescribe oral Risperdal for the first three weeks following the first injection.

If you are given more Risperdal Consta than you should

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

• Contact your doctor immediately. Stopping treatment with Risperdal Consta You will lose the medicine's effects. Do not stop treatment with this medicine unless your doctor tells you to do so, as symptoms may return. Make sure you do not miss your scheduled appointments for the injections every two weeks. If you are unable to attend an appointment, contact your doctor immediately to arrange another date for the injection. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Use in children and adolescents
Risperdal Consta must not be used in patients under 18 years of age.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform 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, sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech becomes incomprehensible, even briefly. These may be signs of a stroke.
• You develop tardive dyskinesia (involuntary contractions or spasms of your face, tongue or other parts of your body). Inform your doctor immediately if you develop involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of treatment with Risperdal injectable may be necessary. Inform your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 people):
• You suspect you have blood clots (thrombi) in the veins, particularly in the legs (symptoms include swelling, pain and redness of the legs), which may travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
• You have fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• You are male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be required.
• You experience a severe allergic reaction characterised by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash or a sudden drop in blood pressure. Even if you previously tolerated oral risperidone, allergic reactions may 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, feeling of muscle stiffness or tension (resulting in jerky movements), and sometimes a sensation of movement starting and stopping. Other signs of
  parkinsonism include shuffling gait with dragging of the feet, resting tremor,
  increased saliva and/or drooling, and loss of facial expression

• Headache

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

• Pneumonia, chest infection (bronchitis), sinusitis
• Urinary tract infection, feeling as if you have the flu, anaemia
• Increased levels of a hormone called “prolactin” detected in a blood test (which may or may not cause symptoms). Symptoms due to high prolactin levels are not common and may include, in men, breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire or other sexual dysfunction. In women, symptoms may include breast tenderness, milk discharge from the breast, missed menstrual periods or other menstrual problems or fertility issues
• High blood sugar, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disorders, irritability, reduced sexual drive, agitation, drowsiness or reduced alertness
• Dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. While it may affect any part of the body (resulting in abnormal posture), dystonia often involves the facial muscles, including abnormal eye, mouth, tongue or jaw movements
• Dizziness
• Dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or twisting movements or spasms
• Tremor (shaking)
• Blurred vision
• Rapid heart rate
• Low blood pressure, chest pain, high blood pressure
• Shortness of breath, sore throat, cough, nasal congestion
• Abdominal pain, abdominal discomfort, vomiting, nausea, stomach or intestinal infection, constipation, diarrhoea, indigestion, dry mouth, toothache
• Rash
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence (lack of control)
• Erectile dysfunction
• Loss of menstrual period
• Milk discharge from the breast
• Body swelling, swelling of arms or legs, fever, weakness, fatigue (tiredness)
• Pain
• Injection site reaction, including itching, pain or swelling
• Increased transaminase levels in blood, increased GGT in blood (a liver enzyme called gamma-glutamyltransferase)
• Fall

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, infection of a single skin area or body part, viral infection, skin inflammation caused by mites, subcutaneous abscess
• Decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), decreased number of red blood cells
• Allergic reaction
• Sugar in urine, diabetes or worsening of diabetes
• Loss of appetite resulting in malnutrition and low body weight
• High triglyceride levels (a type of fat), increased cholesterol in blood
• Euphoria (mania), confusion, inability to reach orgasm, restlessness, nightmares
• Tardive dyskinesia (spasms or jerky 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. Discontinuation of Risperdal injectable may be necessary
• Sudden loss of blood flow to the brain (stroke or "mini" stroke)
• Loss of consciousness, reduced level of consciousness, fainting
• Urgent need to move a body part, balance disorders, abnormal coordination, dizziness when standing up, attention disorder, language problems, loss or altered sense of taste, reduced skin sensitivity to pain and touch, tingling, prickling or numbness of the skin
• Eye infection or conjunctivitis, dry eyes, increased tearing, eye redness
• Sensation of spinning (dizziness), ringing in the ears, ear pain
• Atrial fibrillation (abnormal heart rhythm), interruption of electrical conduction between upper and lower parts of the heart, abnormal heart electrical conduction, QT interval prolongation, slow heart rate, abnormal heart electrical tracing (electrocardiogram or ECG), sensation of rapid heartbeat or pounding in the chest (palpitations)
• Low blood pressure when standing up (as a result, some patients taking Risperdal injectable may feel faint, dizzy or may faint when standing up or sitting down suddenly)
• Rapid and shallow breathing, respiratory congestion, wheezing, nosebleed
• Faecal incontinence, difficulty swallowing, excessive passing of gas or air
• Itching, hair loss, eczema, dry skin, skin redness, skin discolouration, acne, scalp or skin flaking and itching
• Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released when muscle damage occurs
• Joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent urination, inability to urinate, pain during urination
• Ejaculation disorders, delayed menstrual cycle, absence of menstrual cycle or menstrual problems (females), breast development in males, sexual dysfunction, breast pain, breast tenderness, vaginal discharge
• Swelling of the face, mouth, eyes or lips
• Chills, increased body temperature
• Change in walking pattern
• Feeling of thirst, feeling unwell, chest pain, feeling down
• Skin hardening
• Increased liver enzymes in 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 controlling urine volume
• Low blood sugar
• Excessive water intake
• Sleepwalking
• Sleep-related eating disorder
• Lack of movement or response when awake (catatonia)
• Lack of emotion
• Low level of consciousness
• Head shaking
• Eye movement problems, eye rolling, light sensitivity of the eyes
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are using or have used Risperdal injectable. If you are to undergo cataract surgery, make sure to inform your doctor if you are using or have used this medicine
• Irregular heartbeat
• Dangerously low number of a certain type of white blood cells in the blood needed to fight infections, increased eosinophils (a type of white blood cells) in blood, blood clots in legs, blood clots in lungs
• Breathing problems during sleep (sleep apnoea)
• Pneumonia caused by aspiration of food, pulmonary congestion, rattling sounds in lungs, voice problems, respiratory tract disorder
• Pancreatitis, colon obstruction
• Very hard stools
• Drug rash
• Hives, skin thickening, dandruff, skin problem, skin lesion
• Muscle fibre breakdown and muscle pain (rhabdomyolysis)
• Abnormal posture
• Breast enlargement, milk discharge from breasts
• Decreased body temperature, discomfort
• Yellowing of skin and eyes (jaundice)
• Dangerously excessive water intake
• Increased insulin levels (a hormone controlling blood sugar levels)
• Problems with cerebral blood vessels
• No response to stimuli
• Coma due to uncontrolled diabetes
• Sudden vision loss or blindness
• Glaucoma (increased pressure inside the eyeball), crusts on eyelid margin
• Hot flushes, tongue swelling
• Cracked lips
• Enlargement of mammary glands
• 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 may involve the throat and lead to breathing difficulties
• Lack of intestinal muscle movement causing blockage

Not known: frequency cannot be estimated from the available data

• Severe or life-threatening skin rash with blisters and skin peeling that may 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: rapid heartbeat when standing up.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 Consta

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

6. Package Contents and Other Information

What Risperdal Injectable Contains
The active substance 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,l-lactide-co-glycolide).
Solvent (solution):
polysorbate 20, sodium carmellose, 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

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

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 European Economic Area Member States under the following names:
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 described in the “Instructions for Use” to ensure successful administration and to avoid difficulties in using the kit.

Use the Components Provided
The components supplied with the kit are specifically designed for use with Risperdal.
Risperdal must be reconstituted exclusively with the solvent supplied in the pack.
Do not substitute ANY component of the pack.

Do Not Store the Suspension After Reconstitution
Administer the dose immediately after reconstitution to prevent sedimentation of the suspension.

Administration of the Correct Dose
To ensure the intended dose of Risperdal is delivered, the entire contents of the vial must be administered.

SINGLE-USE DEVICE
Do not reuse.
Medical devices require specific material characteristics to function properly. These characteristics have been verified only for single use. Any attempt to reuse the device for a subsequent administration may negatively affect the device's integrity or lead to impaired performance.

Contents of the Pack

Step 1: Assemble the Components
Remove the dose from the pack Attach the vial adapter to the vial

Wait 30 minutes Remove the cap from Prepare Attach the vial
Remove the Risperdal the vial. Remove the the vial adapter adapter to the vial
injectable pack from the coloured protective cap from the vial. Hold the sterile blister as shown. Place the vial on a rigid surface.
refrigerator and allow it to reach room temperature for approximately 30 minutes before reconstitution.
Do not heat in any other way.
Clean the top of the grey rubber stopper with an alcohol-impregnated swab.
Do not remove the vial adapter from the blister.
Do not remove the grey rubber stopper. This could lead to contamination.
Do not touch the spike tip of the device.
Do not orient the vial adapter at an angle, otherwise the diluent may leak during transfer to the vial.
Leave the cap to dry in the air.
Push the vial adapter straight down onto the top of the vial until it clicks securely into place.

Attach the pre-filled syringe to the vial adapter

Remove the sterile Hold correctly Remove the Attach the syringe
blister white cap to the vial adapter
Hold the white collar on the syringe tip.
Do not rotate or cut the white cap.
Do not touch the syringe tip. This could lead to contamination.
Do not hold the syringe by the glass barrel during assembly.
Keep the vial in an upright position to avoid leakage.
Hold the vial adapter collar firmly.
Hold the syringe by the white collar and insert the tip into the luer opening of the vial adapter.
Do not hold the syringe by the glass barrel.
The white collar may loosen or detach.
Do not touch the exposed luer opening of the vial adapter. This could lead to contamination.
Attach the syringe to the vial adapter by turning clockwise with a firm motion until it feels securely attached.
Do not overtighten. Excessive force may break the syringe tip.

Step 2: Reconstitution of the Microspheres

Inject the diluent Suspend the microspheres in the diluent
Transfer the suspension into the syringe Remove the vial adapter

Inject the entire contents of the syringe into the vial.
While keeping the plunger fully depressed, shake the vial vigorously for at least 10 seconds, as shown.
Slowly pull back the plunger to aspirate all the reconstituted suspension from the vial into the syringe.
Check the suspension: if properly mixed, it should appear uniform, thick, and milky in appearance. The microspheres will be visible within the liquid.
Proceed immediately to the next step to prevent sedimentation of the suspension.
Remove the vial adapter label portion at the perforation.
Attach the detached label portion to the syringe for identification.
Discard both the vial and the vial adapter appropriately.

Step 3: Attach the Needle

Attach the needle Resuspend the microspheres
Select the appropriate needle
Partially peel open the needle packaging. Immediately before injection, shake the syringe vigorously once more, as the reconstituted product may have sedimented.
Holding the base of the needle as shown, remove the packaging completely.
Holding the white collar of the syringe, attach the syringe to the needle’s luer connection by turning clockwise with a firm motion until it clicks securely into place.
Do not touch the luer opening of the needle. This could lead to contamination.

Step 4: Administer the Dose

Remove the transparent Remove air bubbles Inject Engage the needle Dispose of needles
needle shield Hold the syringe vertically and tap gently to allow any air bubbles to rise upwards. Then, holding the white collar of the syringe, slowly and carefully press the plunger upwards to expel the air.
Do not administer intravenously.
Do not rotate the needle shield, as the luer connection may loosen.
Carefully but firmly, holding the white collar, pull the transparent needle shield away from the syringe, as shown.
Do not use two hands.
Do not disengage or tamper with the needle safety device.
Do not attempt to straighten the needle or re-engage the safety device if the needle is bent or damaged.
Immediately inject the full contents of the syringe intramuscularly into the gluteal muscle or deltoid of the patient.
The gluteal injection must be administered into the upper outer quadrant of the buttock.
With one hand, engage the needle safety device by pressing it down firmly and quickly onto a flat, rigid surface until the needle is fully enclosed.
Check that the needle is completely enclosed within the safety device.
Dispose of used needles in an approved sharps container.
Also dispose of any unused needle supplied in the pack.