Label: information for the user

Risperdal 1, 3 and 6 mg film-coated tablets

risperidone

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

1.What is Risperdal and what it is used for

2.What you need to know before starting to take Risperdal

3.How to take Risperdal

4.Possible side effects

5.Storage of Risperdal

6.Contents of the pack and additional information

Risperdal belongs to a group of medications known as “antipsychotics”.

Risperdal is used to treat the following:

• Schizophrenia, with which you may see, hear, or feel things that are not there, believe in something that is not true, or feel particularly suspicious or confused
• Mania, with which you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania appears in a disease called “bipolar disorder”
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease dementia, who harm themselves or others. Alternative non-pharmacological treatments must have been tried previously
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with behavioral disorders.

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

Do not take Risperdal

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

If you are unsure, consult your doctor or pharmacist before starting to take Risperdal.

Warnings and precautions

Consult your doctor or pharmacist before taking Risperdal if:

• You have any heart problems. Examples include heart rhythm disturbances or if you are prone to having low blood pressure or if you are taking blood pressure medications. Risperdal may lower your blood pressure. You may need to have your dose adjusted
• You know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain
• 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 prolactin in your blood or if you have a tumor, which may be dependent on prolactin
• You or a family member has a history of blood clotting problems, as antipsychotics have been associated with blood clotting

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before taking Risperdal.

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, your doctor may check your white blood cell count.

Risperdal 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 regularly monitored.

Risperdal 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 cataract surgery, 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 taking this medication.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of having a stroke. Do not take risperidone if you have dementia caused by a stroke.

During treatment with risperidone, you should see your doctor frequently.

If you or your caregiver notice 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 speak confusedly, even for a short time, seek medical treatment immediately. This may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for conduct disorders.

If during treatment with risperidone you experience fatigue, changing the administration times may improve your difficulties in paying attention.

Before starting treatment, your weight or that of your child may be measured, and this should be regularly monitored during treatment.

A small, inconclusive study has reported an increase in the height of children who took risperidone, but it is unknown whether this is a side effect of the medication or due to another reason.

Other medications and Risperdal

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Medications that act on your brain, such as those used to calm you (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase their sedative effect
• 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 cause a slow heart rate
• Medications that cause low potassium levels in the blood (such as some diuretics)
• Medications for high blood pressure. Risperdal may lower blood pressure
• Medications for Parkinson's disease (such as levodopa)
• Medications that increase the activity of the central nervous system (psychoestimulants, such as methylphenidate)
• Diuretics, which are used for heart problems or to treat swelling in some parts of the body due to fluid retention (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 medications may reduce the effect of risperidone

• Rifampicin (a medication for treating some infections)
• Carbamazepine, phenytoin (medications for epilepsy)
• Phenobarbital.

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 (used for certain types of heart disease)
• 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 as sedatives)
• Cimetidine, ranitidine (gastric acid blockers)
• 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 psychiatric disorders.

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

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before taking Risperdal.

Use of Risperdal with food, drinks, and alcohol

You can take this medication with or without food. You should avoid consuming alcohol while taking Risperdal.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication
• Your doctor will decide if you can take it
• The following symptoms may occur in newborn babies of mothers who have been treated with Risperdal in the last trimester of pregnancy (last three months of pregnancy): tremor, 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 may increase levels of a hormone called "prolactin" that can affect fertility (see Possible Adverse Effects).

Driving and using machines

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

Risperdal coated tablets contain lactose and sodium

The coated tablets contain lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

The coated tablets contain less than 1 mmol of sodium (23 mg) per dose; that is, they are essentially "sodium-free".

Risperdal 6 mg coated tablets contain yellow-orange S (E110)which may cause allergic reactions.

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

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The usual initial dose is 2 milligrams per day, which can be increased to 4 milligrams per day on the second day.
• Your doctor may adjust your dose based on your response to treatment.
• Most people find relief with daily doses of 4 to 6 milligrams.
• This total daily dose can be divided into one or two doses per day. Your doctor will tell you what is best for you.

Older adults

• The initial dose will be 0.5 milligrams twice a day, usually.
• Your doctor may increase the dose gradually from 1 to 2 milligrams twice a day.
• Your doctor will tell you what is best for you.

For the treatment of mania

Adults

• The initial dose will be 2 milligrams once a day, usually.
• Your doctor may adjust the dose gradually based on your response to treatment.
• Most people find relief with doses of 1 to 6 milligrams once a day.

Older adults

• The initial dose will be 0.5 milligrams twice a day, usually.
• Your doctor may adjust the dose gradually from 1 milligram to 2 milligrams twice a day based on your response to treatment.

For the treatment of long-term aggression in people with Alzheimer's disease

Adults (including older adults)

• The initial dose will be 0.25 milligrams (0.25 ml of Risperdal oral solution 1 mg/ml) twice a day, usually.
• Your doctor may adjust the dose gradually based on your response to treatment.
• Most people find relief with doses of 0.5 milligrams twice a day. Some patients may need 1 milligram twice a day.
• The duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years old should not receive treatment with Risperdal for schizophrenia or mania.

For the treatment of behavioral disorders

The dose will depend on your child's weight:

If they weigh less than50 kilograms

• The initial dose will be 0.25 milligrams (0.25 ml of Risperdal oral solution 1 mg/ml) once a day, usually.
• The dose can be increased one day yes and one day no in increments of 0.25 milligrams per day.
• The usual maintenance dose is 0.25 milligrams to 0.75 milligrams (0.25 ml to 0.75 ml of Risperdal oral solution 1 mg/ml) once a day.

If they weigh50 kilograms or more

• The initial dose will be 0.5 milligrams once a day, usually.
• The dose can be increased one day yes and one day no in increments of 0.5 milligrams per day.
• The usual maintenance dose is 0.5 milligrams to 1.5 milligrams once a day.

The duration of treatment in patients with behavioral disorders should not exceed 6 weeks.

Children under 5 years old should not receive treatment with Risperdal for behavioral disorders.

Patients with kidney or liver problems

Unless the disease being treated is taken into account, all initial doses and subsequent doses of risperidone should be reduced by half. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this group of patients.

Administration form

ORAL ROUTE

Risperdal film-coated tabletswith a film coating

• Swallow the medication with a glass of water.
• The groove is only for breaking the tablet if it is difficult to swallow whole.

If you take more Risperdal than you should

• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing and walking, feel dizzy due to decreased blood pressure, or have irregular heartbeats or seizures.
• Consult your doctor, pharmacist, or call the Toxicology 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 forget to take Risperdal

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

If you interrupt treatment with Risperdal

Do not stop taking this medication unless your doctor tells you to. Symptoms may reappear.If your doctor decides to discontinue this treatment, your dose may be gradually reduced over a few days.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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 rare side effects (may affect up to 1 in 100 patients):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness in the 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 the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary, rhythmic movements of the tongue, mouth, and face. Risperdal may need to be discontinued

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

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through the blood vessels to the 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 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

Other side effects may also occur:

• Very common side effects (may affect more than 1 in 10 people):
• Difficulty staying or falling asleep
• Parkinsonism: This condition may include: slow or altered movement, feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly with feet dragging, resting tremor, increased saliva and/or drooling, and loss of facial expression
• Feeling drowsy or less attentive
• Headache

• Common side effects (may affect up to 1 in 10 people):
• Pneumonia, chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, ear infection, feeling like you have the flu
• Increased levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactinoccur rarely and,may include in men: breast swelling, difficulty achieving or maintaining erections,decreased libidoor other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods or other problems with the cycleor fertility problems
• Weight gain, increased appetite, decreased appetite
• Sleep disorders, irritability, depression, anxiety, restlessness
• 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 facial muscles, including abnormal movements of the eyes, mouth, tongue, or jaw
• Vertigo
• Dyskinesia: A condition that involves involuntary muscle movements and may include repetitive, spasmodic, or writhing movements, or spasms
• Tremor (agitation)
• Blurred vision, eye infection, or "red eye"
• Fast heart rate, increased blood pressure, labored breathing
• Throat pain, cough, nasal bleeding, nasal congestion
• Abdominal pain, discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Rash, skin redness
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Falls

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

• Respiratory tract infections, urinary tract infections, eye infections, tonsillitis, fungal nail infections, skin infections, localized skin infections or part of the body, viral infections, skin inflammation caused by mites
• Decreased white blood cell count, decreased white blood cell count, decreased platelet count, anemia, decreased red blood cell count, increased eosinophil count in the blood
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar, excessive water intake
• Weight loss, loss of appetite causing malnutrition and weight loss
• Increased cholesterol in the blood
• Euphoria (mania), confusion, decreased libido, nervousness, nightmares
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness
• Seizures (epileptic crises), fainting
• Anxiety that causes movement of parts of the body, balance disorder, abnormal coordination, dizziness when standing up, attention disorder, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of pins and needles, or numbness of the skin
• Increased sensitivity of the eyes to light, dry eyes, increased tear production, eye redness
• Sensation of spinning (vertigo), buzzing 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, prolonged 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, decreased blood pressure when standing up, as a result, some people taking Risperdal may feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly, flushing
• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crepitant sounds of the lungs, wheezing, voice disorder, difficulty breathing
• Stomach or intestinal infection, fecal incontinence, hard stools, difficulty swallowing, excessive gas or flatulence
• Hives (urticaria), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly skin or scalp with itching, skin disorder, skin injury
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle degradation
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent urination, inability to urinate, painful urination
• Erectile dysfunction, ejaculation disorder
• Loss of menstrual periods, loss of menstrual periods or other problems with the cycle (women)
• Male breast development, milk secretion 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 gait
• Sensation of thirst, feeling unwell, chest discomfort, feeling "off," discomfort
• Increased liver transaminases in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood
• Pain due to the procedure

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

• Infection
• Incorrect secretion of a hormone that controls urine volume
• Somnambulism
• Sleep-related eating disorder
• High blood sugar, decreased blood sugar, increased triglycerides in the blood (a type of fat)
• Lack of emotions, inability to achieve orgasm
• Catatonia (lack of movement or response while awake)
• Problems with blood vessels in the brain
• Diabetic coma due to uncontrolled diabetes
• Head agitation
• Glaucoma (increased pressure in the eyeball), eye movement problems, eye rotation, crusts on the eyelid border
• Eye problems during cataract surgery
• Number of white blood cells necessary to fight infections in the blood is dangerously low
• Excessive water intake
• Irregular heartbeat
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing
• Pancreatitis, intestinal obstruction
• Swelling of the tongue, chapped lips, skin rash related to the medication
• Dandruff
• Muscle fiber rupture and muscle pain (rhabdomyolysis)
• Delayed menstrual periods, breast enlargement, breast secretion
• Increased insulin (a hormone that controls blood sugar levels) in the blood
• Skin hardening
• Decreased body temperature, coldness in arms and legs
• Medication withdrawal syndrome
• Yellow skin and eyes (jaundice).

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 may affect the throat, causing difficulty breathing
• Lack of movement of the intestinal muscles, causing obstruction

Frequency not known: cannot be estimated from available data

• Severe rash or mortality with blisters and skin peeling that may 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 appeared with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to appear with Risperdal: Fast heart rate when standing up.

Other side effects in children and adolescents

In general, it is expected that side effects in children will be similar to those that appeared in adults.

The following side effects were reported more frequently in children and adolescents (5 to17 years) than in adults: feeling drowsy, or less attentive, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhea, and urinary incontinence.

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.

Do not store above30°C.

Blister packs: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 theSIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Risperdal

The active ingredient is risperidone

Each film-coated tablet of Risperdal contains 1, 3 or 6 milligrams of risperidone.

The other components are:

Risperdal 1 mg film-coated tablets:

Core of the tablet: Lactose monohydrate, Cornstarch, Microcrystalline cellulose (E460), Hypromellose (E464), Magnesium stearate, Colloidal anhydrous silica, Sodium lauryl sulfate.

Coating: Hypromellose (E464), Propylene glycol (E490).

Risperdal 3 mg film-coated tablets:

Core of the tablet: Lactose monohydrate, Cornstarch, Microcrystalline cellulose (E460), Hypromellose (E464), Magnesium stearate, Colloidal anhydrous silica, Sodium lauryl sulfate.

Coating: Hypromellose (E464), Propylene glycol (E490), Titanium dioxide (E171), Talc (E553B), Quinoline yellow (E104).

Risperdal 6 mg film-coated tablets:

Core of the tablet: Lactose monohydrate, Cornstarch, Microcrystalline cellulose (E460), Magnesium stearate, Colloidal anhydrous silica, Sodium lauryl sulfate.

Coating: Hypromellose (E464), Propylene glycol (E490), Titanium dioxide (E171), Talc (E553B), Quinoline yellow (E104), Sunset yellow FCF (E110).

Appearance of Risperdal and packaging contents

Risperdal film-coated tablets are packaged in PVC/LDPE/PVDC/aluminum blisters and HDPE bottles with a plastic child-resistant cap.

Film-coated tablets

• The 1 mg film-coated tablets of risperidone are biconvex, oblong, scored and white, measuring 10.5 mm x 5 mm.
• The 3 mg film-coated tablets of risperidone are biconvex, oblong, scored and yellow, measuring 13.5 mm x 6.5 mm.
• The 6 mg film-coated tablets of risperidone are biconvex, round and yellow, measuring 8 mm.

The film-coated tablets are engraved with "RIS 1", "RIS 3" and "RIS 6" respectively on one side, and may also be engraved with "JANSSEN" on the other side.

Packaging sizes

Risperdal film-coated tablets are available in the following packaging sizes:

• 1 mg: blister packs containing 6, 20, 50, 60 or 100 tablets, and bottles of 500 tablets.
• 3 mg: blister packs containing 20, 50, 60 or 100 tablets.
• 6 mg: blister packs containing 28, 30 or 60 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder

JANSSEN-CILAG, S.A.

Paseo de Las Doce Estrellas, 5-7

28042 Madrid, España

+34 917228100

+34 917228101

Responsible for batch release

Janssen Cilag S.P.A.

Via C. Janssen (Borgo San Michelle, Latina) - I 04100 – Italia

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:

Bélgica:

Chipre:

República Checa:

Dinamarca:

Estonia:

Finlandia:

Francia:

Alemania:

Grecia:

Hungría:

Islandia:

Irlanda:

Italia:

Lituania:

Letonia:

Luxemburgo:

Malta:

Países Bajos:

Noruega:

Polonia:

Portugal:

Rumanía:

Eslovenia:

España:

Suecia:

Reino Unido (Irlanda del Norte):

Last update of this leaflet: August 2022.

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).