Risperidone Stada 1 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidona Stada 0.5 mg film-coated tablets

Risperidona Stada 1 mg film-coated tablets EFG

Risperidona Stada 3 mg film-coated tablets EFG

Risperidona Stada 6 mg film-coated tablets EFG

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Package leaflet:

What Risperidona Stada is and what it is used for
What you need to know before taking Risperidona Stada
How to take Risperidona Stada
Possible side effects
How to store Risperidona Stada
Contents of the pack and other information

1. What Risperidona Stada is and what it is used for

Risperidone belongs to a group of medicines called "antipsychotics".

Risperidone is used to treat the following conditions:

Schizophrenia, which may cause you to see, hear, or feel things that are not there, to believe things that are not true, or to feel particularly suspicious or confused.
Mania, during which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a condition called "bipolar disorder".
Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer-type dementia who harm themselves or others. Alternative non-pharmacological treatments should have been attempted previously.
Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged at least 5 years) and adolescents with conduct disorders.

Risperidone may help reduce the symptoms of your condition and help prevent them from returning.

2. What you need to know before taking Risperidona Stada

Do not take Risperidona Stada:

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

If you are unsure, consult your doctor or pharmacist before starting risperidone.

Warnings and precautions

Consult your doctor or pharmacist before taking risperidone if:

You have any heart problems. Examples include irregular heart rhythm, low blood pressure, or if you are taking medications for blood pressure. Risperidone may lower blood pressure. You may need a dose adjustment.
You have any risk factors that may predispose you to stroke, such as high blood pressure, cardiovascular disease, or cerebrovascular disorders.
You have ever experienced involuntary movements of the tongue, mouth, or face.
You have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
You have Parkinson's disease or dementia.
You have previously had low levels of white blood cells in your blood (which may or may not have been caused by other medications).
You are diabetic.
You have epilepsy.
You are male and have previously experienced prolonged or painful erections.
You have difficulty regulating your body temperature or feel excessive heat.
You have kidney problems.
You have liver problems.
You have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
You or a family member has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

Very rarely, patients treated with risperidone have developed a dangerously low number of a type of white blood cell essential for fighting infections. Your doctor may monitor your white blood cell count.

Risperidone may cause weight gain. Significant weight gain may negatively affect your health. Your doctor will regularly monitor your weight.

Since cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking risperidone, your doctor should check for signs of elevated blood sugar levels. In patients with pre-existing diabetes mellitus, blood sugar levels should be monitored regularly.

Risperidone frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see Possible side effects). If these adverse effects occur, evaluation of prolactin levels in the blood is recommended.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may fail to dilate as needed. Additionally, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering 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. You should not take risperidone if your dementia is caused by stroke.

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

If you or your caregiver notice a sudden change in your mental state or sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or confusion in speech, even if brief, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

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

If you experience fatigue during treatment with risperidone, changing the time of administration may improve difficulties with attention.

Before starting treatment, your weight or your child's weight may be measured and should be monitored regularly during treatment.

A small, inconclusive study has reported increased height in children taking risperidone, but it is unknown whether this is a drug effect or due to other reasons.

Other medicines and Risperidona Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you speak with your doctor or pharmacist if you are taking any of the following:

Medicines that act on the brain, such as those used to calm you (benzodiazepines), or some pain medications (opioids), or allergy medications (some antihistamines), as risperidone may increase their sedative effect.
Medicines that can alter the electrical activity of your heart, such as those used for malaria, heart rhythm disorders, allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
Medicines that cause slow heart rate.
Medicines that cause low potassium levels in the blood (such as some diuretics).
Medicines for high blood pressure. Risperidone may lower blood pressure.
Medicines for Parkinson's disease (such as levodopa).
Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone, taken 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 types of heart disease).
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).
Some medicines used to treat HIV/AIDS, such as ritonavir.
Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

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

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

Taking Risperidona Stada with food, drinks, and alcohol

You may take this medicine with or without food. You should avoid consuming alcohol while taking risperidone.

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 medicine. Your doctor will decide whether you can take it.
The following symptoms may occur in newborn babies of mothers who have been treated with risperidone during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
Risperidone may increase levels of a hormone called "prolactin," which may affect fertility (see Possible side effects).

Driving and using machines

Risperidone may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special alertness until your doctor has assessed your response to this medicine.

Risperidona Stada film-coated tablets contain lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free."

3. How to take Risperidone Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

The usual starting dose is 2 milligrams once daily. This may be increased to 4 milligrams once daily on day two.
Your doctor may adjust your dose depending on how you respond to treatment.
Most people do well with daily doses of 4 to 6 milligrams.
This total daily dose may be given as a single or divided into two doses per day. Your doctor will tell you what is best for you.

Elderly patients

The starting dose is usually 0.5 milligrams twice daily.
Your doctor may later gradually increase your dose to 1 to 2 milligrams twice daily.
Your doctor will tell you what is best for you.

For the treatment of mania

Adults

The starting dose is usually 2 milligrams once daily.
Your doctor may gradually adjust your dose depending on your response to treatment.
Most people do well with daily doses of 1 to 6 milligrams once daily.

Elderly patients

The starting dose is usually 0.5 milligrams twice daily.
Your doctor may later gradually adjust your dose to 1 to 2 milligrams twice daily, depending on your response to treatment.

For the long-term treatment of aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

The starting dose is usually 0.25 milligrams twice daily.
Your doctor may gradually adjust your dose depending on your response to treatment.
Most people do well with a dose of 0.5 milligrams twice daily. Some patients may require 1 milligram twice daily.
The duration of treatment in patients with Alzheimer-type dementia should not exceed 6 weeks.

Use in children and adolescents

Children and adolescents under 18 years of age should not be treated with risperidone for schizophrenia or mania.

For the treatment of conduct disorders

The dose will depend on your child's weight:

If weight is less than 50 kilograms

The usual starting dose is 0.25 milligrams once daily.
The dose may be increased every other day in increments of 0.25 milligrams per day.
The usual maintenance dose is 0.25 to 0.75 milligrams once daily.

If weight is 50 kilograms or more

The usual starting dose is 0.5 milligrams once daily.
The dose may be increased every other day in increments of 0.5 milligrams per day.
The usual maintenance dose is 0.5 to 1.5 milligrams once daily.

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

Children under 5 years of age should not be treated with risperidone for conduct disorders.

Patients with kidney or liver problems

Regardless of the condition being treated, all initial 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 patient group.

Instructions for administration

Oral use.

Risperidone Stada film-coated tablets

Take the medicine with a glass of water.
The 0.5 mg, 1 mg, and 3 mg tablets may be divided into equal doses.

If you take more Risperidone Stada than you should

In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or experience abnormal heartbeats or seizures.

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Risperidone Stada

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 with your regular schedule. If you miss two or more doses, contact your doctor.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Risperidone Stada

Do not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to discontinue treatment, your dose may be gradually reduced over several days.

If you have any further questions about the use of this medicine, ask 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 adverse 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 of 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 develop tardive dyskinesia (involuntary spasms or spasmodic movements of the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.

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

You develop 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 develop fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
You are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

The following side effects may also occur:

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

Difficulty falling or staying asleep.
Parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a "freezing" sensation in movement that later resumes. Other signs of parkinsonism include shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
Feeling drowsy or less alert.
Headache.

Common (may affect up to 1 in 10 people):

Pneumonia, chest infection (bronchitis), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu.
Increased levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin are rare and may include, in men, breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, symptoms may include breast discomfort, milk secretion from the breasts, missed periods, or other menstrual cycle or fertility problems.
Weight gain, increased appetite, decreased appetite.
Sleep disturbances, irritability, depression, anxiety, restlessness.
Dystonia: A condition involving involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (and may result in abnormal postures), dystonia often affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
Dizziness.
Dyskinesia: A condition involving involuntary muscle movements, which may include repetitive, spasmodic, or twisting movements, or spasms.
Tremor (agitation).
Blurred vision, eye infection, or "red eye."
Rapid heartbeat, increased blood pressure, shortness of breath.
Sore throat, cough, nosebleeds, nasal congestion.
Abdominal pain, stomach discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
Skin rash, skin redness.
Muscle spasms, bone or muscle pain, back pain, joint pain.
Urinary incontinence (loss of bladder control).
Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
Falls.

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

Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or body, viral infection, skin inflammation caused by mites.
Decrease in a type of white blood cell that helps fight infections, decrease in white blood cell count, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell) in the blood.
Allergic reaction.
Diabetes or worsening of diabetes, high blood sugar, excessive water intake.
Weight loss, loss of appetite leading to malnutrition and reduced body weight.
Increased blood cholesterol.
Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.
Lack of response to stimuli, loss of consciousness, decreased level of consciousness.
Seizures (epileptic fits), fainting.
Restlessness causing body movements, balance disorder, abnormal coordination, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, 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 (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation on the heart, slow heartbeat, abnormal electrical conduction of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).
Decreased blood pressure, decreased blood pressure upon standing (as a result, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when standing or sitting up suddenly), flushing.
Pneumonia due to aspiration of food, pulmonary congestion, respiratory tract congestion, crackling lung sounds, wheezing, voice disorder, breathing difficulty.
Stomach or intestinal infection, fecal incontin ence, very hard stools, difficulty swallowing, excess gas or flatulence.
Hives (or "urticaria"), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly and itchy scalp or skin, skin disorder, skin lesion.
Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown.
Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
Frequent urination, inability to urinate, pain during urination.
Erectile dysfunction, ejaculation disorder.
Loss of menstruation, missed periods, or other menstrual cycle problems (in women).
Breast development in men, 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 walking pattern.
Thirst, malaise, chest discomfort, feeling "unwell," general discomfort.
Increased liver transaminases in blood, increased GGT (an enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood.
Procedure-related pain.

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

Infection.
Inappropriate secretion of a hormone that controls urine volume.
Sleepwalking.
Sleep-related eating disorder.
Sugar in urine, low blood sugar, increased blood triglycerides (a type of fat).
Absence of emotions, inability to reach orgasm.
Lack of movement or response while awake (catatonia).
Problems with blood vessels in the brain.
Coma due to uncontrolled diabetes.
Head agitation.
Glaucoma (increased pressure in the eyeball), eye movement problems, eye rolling, crusts at the edge of the eyelid.
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 risperidone. If you need cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.
Dangerously low number of a type of white blood cell needed to fight infections in the blood.
Dangerously excessive water intake.
Irregular heartbeat.
Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
Pancreatitis, intestinal obstruction.
Swelling of the tongue, cracked lips, drug-related skin rash.
Dandruff.
Muscle fiber breakdown and muscle pain (rhabdomyolysis).
Delayed menstruation, enlarged mammary glands, breast enlargement, breast discharge.
Increased insulin (a hormone that controls blood sugar levels) in blood.
Skin hardening.
Decreased body temperature, coldness in arms and legs.
Medication withdrawal syndrome.
Yellowing of the skin and eyes (jaundice).

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

Life-threatening complications of uncontrolled diabetes.
Severe allergic reaction with swelling, which may affect the throat and cause breathing difficulty.
Lack of movement in intestinal muscles causing obstruction.

Frequency not known: cannot be estimated from available data

Severe or life-threatening blistering and peeling skin rash 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 adverse effect has been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, it is also expected to occur with risperidone: rapid heartbeat upon standing.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those seen in adults.

The following adverse effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, symptoms of a common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (lack of bladder control).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Stada

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risperidone Stada

The active substance is risperidone.

Each Risperidone Stada 0.5 mg film-coated tablet contains 0.5 mg of risperidone.

Each Risperidone Stada 1 mg film-coated tablet contains 1 mg of risperidone.

Each Risperidone Stada 3 mg film-coated tablet contains 3 mg of risperidone.

Each Risperidone Stada 6 mg film-coated tablet contains 6 mg of risperidone.

The other components are:

Tablet core: lactose, corn starch, pregelatinized starch (from corn), sodium lauryl sulfate, microcrystalline cellulose, sodium croscarmellose, colloidal hydrated silica, and magnesium stearate.

Coating:

Risperidone 0.5 mg: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 400.

Risperidone 1 mg: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and macrogol 400.

Risperidone 3 mg: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), and macrogol 400.

Risperidone 6 mg: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), and macrogol 400.

Nature of the product and pack sizes

Risperidone Stada 0.5 mg film-coated tablets are packaged in Al/Al, PVC/Al blisters.

Risperidone Stada 1 mg, 3 mg, and 6 mg film-coated tablets are packaged in Al-Al, PVDC-Al, and PVC-Al blisters.

Risperidone 0.5 mg film-coated tablets are oblong, biconvex, brown in colour, with the imprint “0.5” on one side and a score line on the other. The tablet can be divided into equal halves.

Risperidone 1 mg film-coated tablets are oblong, biconvex, orange in colour, with the imprint “1” on one side and a score line on the other. The tablet can be divided into equal halves.

Risperidone 3 mg film-coated tablets are oblong, biconvex, yellow in colour, with the imprint “3” on one side and a score line on the other. The tablet can be divided into equal halves.

Risperidone 6 mg film-coated tablets are oblong, biconvex, salmon-coloured, with the imprint “6” on one side.

Pack sizes:

Risperidone Stada 0.5 mg film-coated tablets are available in the following pack sizes: 28 or 56 tablets.

Risperidone Stada 1 mg and 3 mg film-coated tablets are available in the following pack sizes: 20 or 60 tablets.

Risperidone Stada 6 mg film-coated tablets are available in the following pack sizes: 30 or 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent revision of this leaflet: July 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es