Package Insert: Information for the User

Risperdal Consta 25 mg Powder and Diluent for Long-Acting Injectable Suspension

risperidone

Read this package insert carefully before starting to use this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Risperdal Consta and how is it used

2. What you need to know before starting to use Risperdal Consta

3. How to use Risperdal Consta

4. Possible adverse effects

5. Storage of Risperdal Consta

6. Contents of the package and additional information

Risperdal Consta belongs to a group of medicines called “antipsychotics”.

Risperdal Consta is used in the maintenance treatment of schizophrenia, which is characterized by seeing, hearing or feeling things that are not present, believing in something that is not true or unusually feeling distrust or confusion.

Risperdal Consta is intended for patients who are currently being treated with oral antipsychotics (e.g., tablets, capsules).

Risperdal Consta may help reduce the symptoms of your illness and prevent them from returning.

No use Risperdal Consta

• If you are allergic to risperidone or any of the other components of this medication (listed in section 6).

Warnings and precautions

• If you have never taken Risperdal in any of its forms, you should start with Risperdal oral before starting with Risperdal Consta.

Consult your doctor or pharmacist before using Risperdal Consta if:

• You have a heart problem, for example, an irregular heart rhythm, or if you are prone to having low blood pressure or if you are using blood pressure medications. Risperdal Consta may lower blood pressure. Your dose may need to be adjusted
• You know you are prone to having a stroke, such as high blood pressure (hypertension), cardiovascular disorders, or cerebral circulation disorders
• You have ever had involuntary movements of the tongue, mouth, and face
• You have ever had symptoms that include fever, muscle stiffness, sweating, or a decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome)
• You have Parkinson's disease or dementia
• You have had low white blood cell counts in the past (which may or may not have been caused by other medications)
• You are diabetic
• You have epilepsy
• You are a male and have ever had a prolonged or painful erection
• You have difficulty controlling your body temperature or feel excessive heat
• You have kidney problems
• You have liver problems
• You have an abnormally high level of a hormone called prolactin in your blood or if you have a tumor that may be dependent on prolactin
• You or a family member has blood clotting problems, as this medication has been associated with blood clotting in the blood.

If you are unsure whether the information above affects you, speak with your doctor or pharmacist before using Risperdal or Risperdal Consta.

Because in very rare cases, a dangerously low number of a type of white blood cell necessary to fight infections in the blood has been observed in patients treated with Risperdal Consta, your doctor may check your white blood cell count.

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

Risperdal Consta may cause you to gain weight. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

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

Risperdal Consta frequently increases levels of a hormone called "prolactin." This can cause adverse effects such as menstrual disorders or fertility problems in women or breast enlargement in men (see Possible Adverse Effects). If these adverse effects appear, it is recommended to evaluate prolactin levels in the blood.

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

Patients with advanced age and dementia

Risperdal Consta is not used in people with advanced age and dementia.

If you or your caregiver observe a sudden change in your mental state or the sudden appearance of weakness or numbness in the face, arms, or legs, especially on one side, or confused speech, even for a short time, seek medical treatment immediately. It may be a sign of a stroke.

People with kidney or liver problems

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

Use of Risperdal Consta with other medications

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

It is especially important to speak with your doctor or pharmacist if you take any of the following

• Medications that act on the brain used to calm down (benzodiazepines) or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase the sedative effect of all these
• Medications capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medications for mental health problems
• Medications that may cause a decrease in heartbeats
• Medications that may cause a decrease in potassium levels in the blood (such as certain diuretics)
• Medications for Parkinson's disease (such as levodopa)
• Medications that increase the activity of the central nervous system (psychoestimulants, such as methylphenidate)
• Medications for the treatment of high blood pressure. Risperdal Consta may lower blood pressure
• Diuretics used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperdal Consta, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may reduce the effect of risperidone

• Rifampicin (a medication used to treat some infections)
• Carbamazepine, phenytoin (medications used to treat epilepsy)
• Fenobarbital.

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

The following medications may increase the effect of risperidone

• Quinidine (a medication used to treat certain types of heart problems)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medications known as beta-blockers (used to treat high blood pressure)
• Fenothiazines (such as medications used to treat psychosis or to calm down)
• Cimetidine, ranitidine (medications used to treat stomach acid)
• Itraconazole and ketoconazole (medications used to treat fungal infections)
• Some medications used to treat HIV/AIDS, such as ritonavir
• Verapamil, a medication used to treat high blood pressure and/or abnormal heart rhythm
• Sertraline and fluvoxamine, medications used to treat depression and other mental health disorders.

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

If you are unsure whether the information above affects you, speak with your doctor or pharmacist before using Risperdal Consta.

Use of Risperdal Consta with foods, beverages, and alcohol

You should avoid consuming alcohol while using Risperdal Consta.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can use it
• The following symptoms may occur in newborn babies, in mothers who have been treated with Risperdal Consta in the last trimester of pregnancy (last three months of your pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding.If your baby develops any of these symptoms, you should contact your doctor
• Risperdal Consta may increase levels of a hormone called "prolactin" that could affect your fertility (see Possible Adverse Effects).

Driving and using machines

Dizziness, fatigue, and vision problems have been observed during treatment with Risperdal Consta. Do not drive or use tools or machinery without consulting your doctor first.

Risperdal Consta contains sodium

This medication contains less than 23mg of sodium (1mmol) per dose; this is, essentially "sodium-free."

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Risperdal Consta is administered via intramuscular injection in the arm or buttock every two weeks by a healthcare professional. The injections should be alternated between the left and right sides and should not be administered intravenously.

The recommended dose is as follows:

Adults

Initial dose

If your daily dose of oral risperidone (e.g., tablets) was 4 milligrams or less during the past two weeks, your initial dose should be 25 milligrams of Risperdal Consta.

If your daily dose of oral risperidone (e.g., tablets) was more than 4 milligrams during the past two weeks, you may be given a dose of 37.5 milligrams of Risperdal Consta as the initial dose.

If you are currently being treated with another oral antipsychotic that is not risperidone, your initial dose of Risperdal Consta will depend on your current treatment. Your doctor will choose Risperdal Consta 25 mg or 37.5 mg.

Your doctor will decide if this dose of Risperdal Consta is suitable for you.

Maintenance dose

• The usual dose is a 25 milligram injection every two weeks
• A higher dose of 37.5 or 50 mg may be necessary. Your doctor will decide which dose of Risperdal Consta is most suitable for you
• Your doctor may prescribe Risperdal oral for the first three weeks after the first injection.

If you use more Risperdal Consta than you should

• People who have used more Risperdal Consta than they should have experienced the following symptoms: drowsiness, fatigue, abnormal body movements, difficulty standing and walking, feeling of dizziness due to decreased blood pressure, and abnormal heartbeats. Cases of abnormal heart conduction and seizures have been reported
• Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you interrupt treatment with Risperdal Consta

You will lose the effects of this medication. Do not stop using this medication unless your doctor has told you to, as you may experience the symptoms again. Make sure to receive your injections every two weeks. If you cannot attend your appointments, contact your doctor immediately to schedule another appointment when you can. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Use in children and adolescents

Children and adolescents under 18 years old should not receive Risperdal Consta.

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 side effects that are uncommon (may affect up to 1 in 100 people):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness in your face, arms, or legs, especially on one side, or have difficulty speaking even for a short period of time. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or movements that cannot be controlled in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary, rhythmic movements of your tongue, mouth, and face. You may need to stop taking Risperdal Consta.

Inform your doctor immediately if you experience any of the following side effects that are rare (may affect up to 1 in 1,000 people):

• You experience blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You experience fever, muscle rigidity, sweating, or a decrease in your level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or a drop in blood pressure. Although you may have previously tolerated oral risperidone, in rare cases, allergic reactions can occur after receiving injections of Risperdal Consta.

You may also experience the following side effects:

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

• Common cold symptoms
• Difficulty staying or falling asleep
• Depression, anxiety
• Parkinsonism: This condition may include: slow or altered movement, feeling of stiffness or tension in your muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly with your feet dragging, 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 like you have the flu, anemia
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin appear rarely and in men may include breast swelling, difficulty achieving or maintaining erections, decreased libido, or other sexual dysfunction. In women, symptoms may include breast discomfort, milk secretion from the breasts, missed periods, or other menstrual cycle problems or fertility issues.
• Increased blood sugar, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disorder, irritability, decreased libido, restlessness, feeling drowsy or less alert
• Dystonia: A condition that involves involuntary, slow, or continuous muscle contractions. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness
• Dyskinesia: A condition that involves involuntary muscle movements and may include repetitive, spasmodic, or writhing movements, or spasms
• Tremor (agitation)
• Blurred vision
• Fast heart rate
• Decreased blood pressure, chest pain, increased blood pressure
• Labored breathing, sore throat, cough, nasal congestion
• Abdominal pain, discomfort, nausea, vomiting, stomach or intestinal infection, constipation, diarrhea, indigestion, dry mouth, toothache
• Skin rash
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence
• Erectile dysfunction
• Missed periods
• Milk secretion 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 liver enzymes in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood
• Falls.

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

• Respiratory tract infection, urinary tract infection, ear infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or part of the body, viral infection,skin inflammation caused by mites, abscess under the skin

• Decreased white blood cell count, decreased platelet count, decreased red blood cell count
• Allergic reaction
• Excessive sugar in the urine, diabetes, or worsening of diabetes
• Loss of appetite leading to malnutrition and weight loss
• Increased triglycerides in the blood (fat), increased cholesterol in the blood
• Euphoria (mania), confusion, inability to achieve orgasm, nervousness, nightmares
• Loss of consciousness, seizures (epileptic crises), fainting
• Restlessness that causes movement of parts of the body, abnormal balance, coordination, dizziness when standing up, altered attention, speech problems, loss or alteration of taste,decreased skin sensitivity to pain or touch, feeling of pins and needles, numbness, or tingling of the skin
• Eye infection or "red eye", dry eyes, increased tear production,eye redness
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart,abnormal heart activity,prolongation of the QT interval in the heart, slow heart rate,abnormal heart conduction (electrocardiogram or ECG),sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure when standing up (as a result, some people taking Risperdal Consta may feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly)
• Shallow, rapid breathing, congested airways, gasping, nasal bleeding
• Fecal incontinence, difficulty swallowing, excessive gas or flatulence
• Itching, hair loss, eczema, dry skin, skin redness, skin discoloration, acne, scaly or itchy skin or scalp
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle breakdown
• Joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent urination, inability to urinate, painful urination
• Sexual dysfunction, delayed menstruation, missed periods, or other menstrual cycle problems (women), development of breasts in men, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes, or lips
• Chills, increased body temperature
• Change in gait
• Sensation of thirst, feeling unwell, chest discomfort, feeling "off-color"
• Thickening of the skin
• Increased liver enzymes in the blood

• Pain due to the procedure.

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

• Decreased white blood cell count that helps fight infections
• Inadequate secretion of a hormone that controls urine volume
• Low blood sugar
• Excessive water intake
• Somnambulism
• Sleep-related eating disorder
• Catatonia (lack of movement or response while awake)
• Apathy (lack of emotions)
• Decreased level of consciousness
• Head agitation
• Eye movement problems, eye rotation, light sensitivity of the eyes
• Problems with eye surgery during cataract surgery.During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken Risperdal Consta. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication
• Irregular heartbeat
• Life-threatening low white blood cell count, increased eosinophils (a type of white blood cell) in the blood
• Difficulty breathing during sleep (sleep apnea)
• Pneumonia caused by aspiration of food, congested lungs, crackling sounds in the lungs, voice disorder, respiratory tract disorder
• Pancreatitis, intestinal obstruction
• Hard stools
• Medication-related skin rash
• Hives (urticaria), skin thickening, dandruff, skin disorder, skin injury
• Muscle fiber rupture and muscle pain (rhabdomyolysis)
• Abnormal posture
• Increased breast size, breast discharge
• Decreased body temperature, feeling unwell
• Yellow skin and eyes (jaundice)
• Excessive water intake
• Increased insulin (a hormone that controls blood sugar levels) in the blood
• Problems with blood vessels in the brain
• No response to stimuli
• Diabetes coma
• Sudden loss of vision or blindness
• Glaucoma(increased pressure in the eyeball), corneal ulcers on the edge of the eyelid
• Redness, swelling of the tongue
• Cracked lips
• Increased breast size
• Decreased body temperature, coldness in the arms and legs
• Symptoms of withdrawal from medications.

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

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

Frequency not known: cannot be estimated from available data:

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

The following side effect has occurred with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to occur with Risperdal Consta: Fast heart rate when standing up.

Reporting side effects:

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

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). If refrigeration is not available, the packaging can be stored below 25°C for a maximum of 7 days before administration. Administer within 6 hours after reconstitution (if stored at 25°C or less).

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Risperdal Consta

The active ingredient is risperidone.

Each Risperdal Consta powder and solvent for prolonged-release suspension for injection contains 25 milligrams of risperidone.

The other components are:

Powder

poly‑(d,l‑lactide‑co‑glycolide).

Solvent (solution):

Polysorbate 20, Sodium Carmellose, Dihydrated Disodium Phosphate, Anhydrous Citric Acid, Sodium Chloride, Sodium Hydroxide, Injection Water.

Appearance of Risperdal Consta and contents of the package

• A small vial containing thepowder (in this powder, the active ingredient, risperidone, is found). A preloaded syringe containing 2 ml of transparent and colorless liquid that is added to thepowder for prolonged-release suspension for injection.
• A vial adapter for reconstitution
• Two Terumo SurGuard®3 injection needles (one safety 21G UTW 1 inch (0.8 mm × 25 mm) needle with a safety needle protector for deltoid administration and a safety 20G TW 2 inch (0.9 mm × 51 mm) needle with a safety needle protector for gluteal administration).

Risperdal Consta is available in packs containing 1 to 5 grouped containers.

Only some sizes of containers may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

JANSSEN-CILAG, S.A.

Paseo de Las Doce Estrellas, 5-7

28042 Madrid, Spain

+34 917228100

+34 917228101

Manufacturer responsible

Janssen Pharmaceutica, N.V

Turnhoutseweg, 30

B-2340, Beerse

Belgium

This medicinal product has been authorized in the Member States of the EEA with the following names:

Austria:RISPERDALCONSTA

Belgium:RISPERDALCONSTA

Cyprus:RISPERDALCONSTA

Czech Republic:RISPERDAL CONSTA

Denmark:RISPERDALCONSTA

Estonia:RISPOLEPTCONSTA

Finland:RISPERDALCONSTA

France:RISPERDAL CONSTA LP

Germany:RISPERDAL CONSTA 25mg, 37.5mg, 50mg

Greece:RISPERDALCONSTA

Hungary:RISPERDAL CONSTA

Iceland:RISPERDALCONSTA

Ireland:RISPERDALCONSTA

Italy:RISPERDAL

Lithuania:RISPOLEPTCONSTA

Latvia:RISPOLEPTCONSTA

Liechtenstein:RISPERDALCONSTA

Luxembourg:RISPERDALCONSTA

Malta:RISPERDALCONSTA

Netherlands:RISPERDALCONSTA

Norway:RISPERDAL CONSTA

Poland:RISPOLEPTCONSTA

Portugal:RISPERDAL CONSTA

Romania:RISPOLEPT CONSTA

Slovakia:RISPERDALCONSTA

Slovenia:RISPERDAL CONSTA

Spain:RISPERDAL CONSTA

Sweden:RISPERDALCONSTA

United Kingdom:RISPERDALCONSTA

This leaflet was last revised in:April 2021.

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es
IMPORTANT INFORMATION FOR THE HEALTHCARE PROFESSIONAL

Important information

RISPERDAL CONSTA requires careful attention at every step of the “Instructions for Use” to help ensure a successful administration.

Use of the provided components

The components of the package are specifically designed for use with RISPERDAL CONSTA. RISPERDAL CONSTA must be reconstituted only with the solvent provided in the package.

Do not substitute ANY of the components of the package.

Do not store the suspension after reconstitution

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

Adequate dose

The entire contents of the vial must be administered to ensure that the adequate dose of RISPERDAL CONSTA is administered.

Do not re-use.The medical devices require materials with specific characteristics to function properly. These characteristics have been verified for single use. Any attempt to re-process the device for subsequent re-use may negatively affect the integrity of the device or lead to deterioration of its functioning.

Components of the package

Couple the preloaded syringe to the vial adapter