Risperidone Sandoz 3 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risperidone Sandoz 1 mg film-coated tablets EFG

Risperidone Sandoz 3 mg film-coated tablets EFG

Risperidone Sandoz 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Risperidona Sandoz belongs to a group of medicines called "antipsychotics".

Risperidone is used to treat:

• schizophrenia, a condition in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused,
• mania, a condition in which you may feel extremely excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a disorder 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 (at least 5 years of age) and adolescents with conduct disorders.

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

2. What you need to know before taking Risperidone Sandoz

Do not take Risperidone Sandoz

• 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

Talk to your doctor or pharmacist before starting risperidone if:

• you have any heart problems. Examples include irregular heartbeat, or if you are prone to low blood pressure or if you are taking medications for blood pressure. Risperidone may reduce blood pressure. You may need a dose adjustment,
• you are aware of any risk factors that may predispose you to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain,
• 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 (which may or may not have been caused by other medications),
• you are diabetic,
• you have epilepsy,
• you are a man who has 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 abnormally high levels of the hormone prolactin in your blood or have a tumor that may be prolactin-dependent,
• you or someone in your family 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 using risperidone.

Very rarely, patients treated with risperidone have developed a dangerously low number of a type of white blood cell needed to fight 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 diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking risperidone, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar 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 blood prolactin levels is recommended.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. In addition, 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 must not take risperidone if your dementia is caused by 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 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 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 direct effect of the medicine or due to other reasons.

Other medicines and Risperidone Sandoz

Inform 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 talk to your doctor or pharmacist if you are taking any of the following medicines:

• medicines that act on your brain, such as those used to calm you (benzodiazepines), or some pain medicines (opioids), antihistamines (for allergies), as risperidone may increase their sedative effect,
• medicines capable of altering the electrical activity of your heart, such as those used for malaria, heart rhythm disorders, allergies (antihistamines), certain antidepressants, or other medicines for mental disorders,
• medicines that cause a slow heartbeat,
• medicines that cause low potassium levels in the blood (e.g., certain 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 decrease the effect of risperidone:

• rifampicin (a medicine used to treat certain infections),
• carbamazepine, phenytoin (medicines used to treat 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, and tricyclic antidepressants,
• medicines known as beta-blockers (used to treat high blood pressure),
• phenothiazines (e.g., 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 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 using risperidone.

Taking Risperidone Sandoz with food, drinks, and alcohol

You may take this medicine with or without food. You should avoid 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 using this medicine. Your doctor will decide whether you may 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 section 4 “Possible side effects”).

Driving and use of machines

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

Risperidone Sandoz 1 mg, 3 mg, and 6 mg contain lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; therefore, it is essentially “sodium-free.”

Risperidone Sandoz 6 mg contains Sunset Yellow FCF (E-110)

This medicine may cause allergic-type reactions.

3. How to take Risperidone Sandoz

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

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The starting dose is 2 mg per day; this may be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose depending on your response to treatment.
• Most patients respond well to daily doses of 4 mg to 6 mg.
• This total daily dose may be divided into one or two doses per day. Your doctor will tell you what is best for you.

Elderly patients

The usual starting dose is 0.5 mg twice daily.

Later, your doctor may gradually increase your dose to 1 mg or 2 mg twice daily, depending on your response to treatment.

Your doctor will tell you what is best for you.

For the treatment of mania

Adults

• The usual starting dose is 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most patients respond well to daily doses of 1 mg to 6 mg once daily.

Elderly patients

• The usual starting dose is 0.5 mg twice daily.
• Your doctor may gradually adjust your dose to 1 mg or 2 mg twice daily, depending on your response to treatment.

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

Adults (including elderly patients)

• The usual starting dose is 0.25 milligrams (0.25 ml of risperidone oral solution 1 mg/ml) twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most patients respond well to a dose of 0.5 milligrams twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer's type dementia should not exceed 6 weeks.

Use in children and adolescents

Children and adolescents under 18 years of age must not take risperidone for the treatment of schizophrenia or mania.

For the treatment of conduct disorders

The dose will depend on your child's weight:

If your child weighs less than 50 kg:

• The usual starting dose is 0.25 milligrams (0.25 ml of risperidone oral solution 1 mg/ml) once daily. The dose may be increased every other day in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 milligrams to 0.75 mg once daily.

If your child weighs 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 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once daily.

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

Children under 5 years of age must not take risperidone for the treatment of conduct disorders.

Patients with kidney or liver problems

Regardless of the condition being treated, all starting doses and subsequent doses of risperidone should be halved. Dose increases should be made more slowly in these patients.

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

Method of administration

Oral use.

You should swallow the medicine with a glass of water.

The score line is intended only for breaking the tablet if you have difficulty swallowing it whole.

If you take more Risperidone Sandoz 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 have abnormal heartbeats or seizures.
• In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating 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 Sandoz

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take 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 once) to make up for a forgotten dose.

If you stop taking Risperidone Sandoz

Do not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to stop 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 gets them.

Tell 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. These may be signs of a stroke,
• you develop tardive dyskinesia (involuntary spasms or twitching 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.

Tell 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 bloodstream,
• 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.

Other side effects that may also occur:

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

• difficulty falling or staying asleep,
• parkinsonism. This condition may include: slow or impaired movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a "freezing" of 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 patients):

• 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 occur rarely and may include, in men, breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems or fertility issues,
• weight gain, increased appetite, decreased appetite,
• sleep disturbances, irritability, depression, anxiety, restlessness,
• dystonia: This condition involves involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (leading to abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements,
• dizziness,
• dyskinesia: This condition involves involuntary muscle movements and may include repetitive, twitching, or writhing 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,
• 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 patients):

• 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 cholesterol in the blood,
• 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 movement of body parts, balance disorder, abnormal coordination, dizziness upon standing, attention disturbance, speech problems, loss or alteration of 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 up or sitting down suddenly, flushing,
• pneumonia caused by aspiration of food, pulmonary congestion, respiratory congestion, crackling lung sounds, wheezing, voice disorder, breathing difficulty,
• stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excess gas or flatulence,
• hives (or "urticaria"), itching, hair loss, thickening of the skin, 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,
• cessation of menstruation, loss of menstrual 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,
• sensation of thirst, feeling unwell, chest discomfort, feeling "under the weather", malaise,
• increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyl transferase) in blood, increased liver enzymes in blood,
• pain due to the procedure.

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

• infection,
• inappropriate secretion of a hormone that controls urine volume,
• sleepwalking,
• sleep-related eating disorder,
• sugar in urine, decreased blood sugar, increased triglycerides in blood (a type of fat),
• absence of emotions, inability to achieve 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 eye), eye movement problems, eye rolling, crusts at the edge of the eyelid,
• eye problems during cataract surgery. During cataract surgery, a disturbance called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken risperidone. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine,
• dangerously low count 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 menstrual periods, enlarged mammary glands, breast enlargement, milk secretion from the breasts,
• increased insulin (a hormone that controls blood sugar levels) in blood,
• hardening of the skin,
• decreased body temperature, coldness in arms and legs,
• drug withdrawal syndrome,
• yellowing of the skin and eyes (jaundice).

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

• life-threatening complications of uncontrolled diabetes,
• severe allergic reaction with swelling, which may affect the throat causing breathing difficulty,
• lack of movement in intestinal muscles leading to obstruction.

Frequency not known: cannot be estimated from the available data

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

The following adverse reaction has been observed with 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 observed in adults.

The following adverse effects were reported more frequently in children and adolescents (aged 5 to 17 years) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Sandoz

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging, following CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risperidone Sandoz

• The active substance is risperidone.
• Each tablet contains 1 mg, 3 mg or 6 mg of risperidone.

The other components are:

Tablet core: pregelatinized corn starch, lactose monohydrate, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate and magnesium stearate.

Coating (Risperidone Sandoz 1 mg): hypromellose 5cp and macrogol 400.

Coating (Risperidone Sandoz 3 mg): hypromellose 5cp, macrogol 400, titanium dioxide (E-171), quinoline yellow (E-104) and talc.

Coating (Risperidone Sandoz 6 mg): hypromellose 5cp, macrogol 400, talc, titanium dioxide (E-171), quinoline yellow (E-104) and sunset yellow FCF (E-110).

Nature of the product and pack sizes

Film-coated 1 mg risperidone tablets are oblong, biconvex, scored and white in colour. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Pack sizes: 20 or 60 tablets.

Film-coated 3 mg risperidone tablets are oblong, biconvex, scored and yellow in colour. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Pack sizes: 20 or 60 tablets.

Film-coated 6 mg risperidone tablets are round, biconvex and yellow in colour.

Pack sizes: 30 or 60 tablets.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios Tedec Meiji Farma, S.A.

Ctra. M-300, km 30,500

28802 (Alcalá de Henares) Madrid

Spain

or

Farmalider, S.A.

San Rafael, 3

28108 (Alcobendas) Madrid

Spain

or

Generis Farmacêutica S.A.

Rua de João de Deus, nº 19 Venda-Nova

Amadora, 2700-487

Portugal

or

Toll Manufacturing Services, S.L.

C/ Aragoneses 2, 28108 – Madrid

Spain

Date of the most recent revision of this leaflet: February 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es