Package Insert: Information for the Patient

Risperidona Sandoz 1 mg Film-Coated Tablets

Risperidona Sandoz 3 mg Film-Coated Tablets

Risperidona Sandoz 6 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to refer to 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 Risperidona Sandoz and how is it used

2.What you need to know before starting to take Risperidona Sandoz

3.How to take Risperidona Sandoz

4.Possible adverse effects

5.Storage of Risperidona Sandoz

6.Contents of the package and additional information

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

Risperidona is used for the treatment of:

• 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 condition 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. They must have tried alternative non-pharmacological treatments 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.

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

Do not take Risperidona Sandoz

• if you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor or pharmacist before starting to take risperidone.

Warnings and precautions

Consult your doctor or pharmacist before starting to take risperidone if:

• you have any heart problems. Examples include irregular heart rhythms, or if you are prone to having low blood pressure or if you are taking medicines for high blood pressure. Risperidone 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 the blood vessels in your 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,
• if you have had low white blood cell counts in the past (which may or may not have been caused by other medicines),
• you are diabetic,
• you have epilepsy,
• you are a man and have ever had an erection that lasted for a long time or was painful,
• you have problems 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 tumour that may be dependent on prolactin,
• you or a member of your family has a history of blood clotting problems as antipsychotics have been associated with the formation of blood clots.

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

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 risperidone, your doctor may check your white blood cell count.

Risperidone may cause you to gain weight. A significant weight gain may affect your health unfavourably. Your doctor will regularly monitor your weight.

Because diabetes mellitus or worsening of pre-existing diabetes mellitus has been seen 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 regularly monitored.

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 swelling in men (see “Possible side effects”). If these adverse effects appear, it is recommended that blood prolactin levels be evaluated.

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 coloured part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning to have eye surgery, be sure to inform your ophthalmologist that you are taking this medicine.

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 behaviour should be ruled out before starting treatment for conduct disorders.

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

Before starting treatment, your weight or that of your child may be measured and 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 due to the medicine or another reason.

Other medicines and Risperidona Sandoz

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

It is especially important to 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), allergy medicines (some antihistamines), as risperidone may increase their sedative effect,
• medicines capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other mental health medicines,
• medicines that cause a slow heart rate,
• medicines that cause low potassium levels in the blood (for example: some diuretics),
• medicines for high blood pressure. Risperidone may lower your blood pressure,
• medicines for Parkinson's disease (such as levodopa),
• medicines that increase the activity of the central nervous system (psycho-stimulants, 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). 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 for treating some infections),
• carbamazepine, phenytoin (medicines for treating 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 for treating high blood pressure),
• phenothiazines (for example, used for treating psychosis or as sedatives),
• cimetidine, ranitidine (gastric acid blockers),
• itraconazole and ketoconazole (medicines used for treating fungal infections),
• some medicines used for treating HIV/AIDS, such as ritonavir,
• verapamil, a medicine used for treating high blood pressure and/or abnormal heart rhythm,
• sertraline and fluvoxamine, medicines used for treating depression and other mental health disorders.

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

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

Taking Risperidona Sandoz with food, drinks and alcohol

You can 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can take it.
• Babies born to mothers who have been treated with risperidone in the last three months of pregnancy (last three months of your pregnancy) may experience the following symptoms: trembling, 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.
• Risperidone may increase levels of a hormone called “prolactin” which may affect fertility (see section 4 “Possible side effects”).

Driving and operating machinery

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

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

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

Risperidona Sandoz 6 mg contains Yellow Iron Oxide (E 172)

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

Advanced age

The initial dose is 0.5 mg, twice a day, usually.

Your doctor will gradually increase the dose to 1 mg or 2 mg, twice a day, depending on your response to treatment.

Your doctor will indicate what is best for you.

For the treatment of mania

Adults

• The initial dose is 2 mg, once a day, usually.
• Your doctor may adjust the dose gradually based on your response to treatment.
• Most patients find relief with daily doses of 1 mg to 6 mg, once a day.

Advanced age

• The initial dose is 0.5 mg, twice a day, usually.
• Your doctor may adjust the dose gradually to 1 mg or 2 mg, twice a day, depending on your response to treatment.

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

Adults (including elderly patients)

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

Use in children and adolescents

Childrenand adolescentsunder 18 years should not take risperidone for the treatment of schizophrenia or mania.

For the treatment of behavioral disorders

The dose will depend on your child's weight:

If they weigh less than50 kg:

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

If they weigh50 kilogramsor more

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

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

Children under 5 years should not take risperidone for the treatment of behavioral disorders.

Patients with kidney or liver problems

Unless the disease being treated is considered, 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.

You should 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 Risperidona Sandoz than you should

• In case of overdose, you may feel drowsy or tired, have abnormal body movements, have trouble standing and walking, feel dizzy due to decreased blood pressure, or have irregular heartbeats or convulsions.
• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional

If you forgot to take Risperidona Sandoz

• If you forget to take a dose, take it as soon as you remember. But if it's almost time for your next dose, do not take the missed dose 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 Risperidona Sandoz

You should not stop taking the medication unless your doctor tells you to. Symptoms may reappear.If your doctor decides to stop 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 (which 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 your face, arms or legs, especially on one side, or have difficulty speaking even for a short period of time. This may be a sign 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 risperidone.

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

• You experience blood clots in your veins, especially in your legs (symptoms include swelling, pain and redness of the leg), which may 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 stiffness, 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 characterised by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash or low blood pressure.

You may also experience the following side effects:

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

• Difficulty staying or falling asleep,
• 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 dragging your feet, tremor at rest, increased saliva and/or drooling and loss of facial expression,
• Feeling drowsy or less attentive,
• Headache.

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

• 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" that is detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin occur rarely and may include in men, breast swelling, difficulty getting or maintaining erections, decreased sexual desire or other sexual dysfunction. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods or other problems with the cycle or fertility,
• Weight gain, increased appetite, decreased appetite,
• Sleep disorders, irritability, depression, anxiety, restlessness,
• Dystonia: A condition that involves involuntary slow or continuous muscle contraction. 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: This condition 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, laboured breathing,
• Throat pain, cough, nasal bleeding, nasal congestion,
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, 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 (may affect up to 1 in 100 patients):

• Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal nail infection, skin infection, localised infection in a single area of the skin or part of the body,

• Viral infection, skin inflammation caused by mites,,
• Decreased white blood cell count, decreased white blood cell count, decreased platelet count, anaemia, decreased red blood cell count, increased eosinophil count (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 causing malnutrition and weight loss,
• 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 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, feeling of pins and needles, numbness or tingling of the skin,
• Increased sensitivity of the eyes to light, 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, prolonged QT interval in the heart, slow heart rate, abnormal conduction of the heart (electrocardiogram or ECG), feeling of fluttering or pounding in the chest (palpitations),
• Decreased blood pressure, decreased blood pressure when standing up, 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 tract congestion, lung crepitus, wheezing, voice disorder, breathing difficulty,
• Stomach or intestinal infection, faecal incontinence, hard stools, difficulty swallowing, excessive gas or flatulence,
• Hives (urticaria), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly and itchy skin or scalp, skin disorder, skin injury,
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle breakdown,
• 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,
• Feeling thirsty, feeling unwell, chest discomfort, feeling "off colour", feeling unwell,
• Increased liver enzymes 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 (may affect up to 1 in 1,000 patients):

• Infection,
• Incorrect secretion of a hormone that controls urine volume,
• Somnambulism,
• Sleep-related eating disorder,
• Hyperglycaemia, hypoglycaemia, 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 edge of the eyelid,
• Eye problems during cataract surgery. During cataract surgery, you may experience an alteration called intraoperative floppy iris syndrome (IFIS) 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,
• Very low count of a type of white blood cell necessary to fight infections in the blood,
• Excessive water intake,
• Irregular heartbeat,
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing,
• Pancreatitis, intestinal obstruction,
• Swelling of the tongue, cracked lips, skin rash related to the medicine,
• Dandruff,
• Muscle fibre 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 (may affect up to 1 in 10,000 patients):

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

Frequency unknown: cannot be estimated from available data

• Severe skin eruption 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).

Thefollowing side effect has appeared with the use of another medicine called paliperidone that is very similar to risperidone, therefore, it is also expected to appear with risperidone:

• 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 to 17 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), diarrhoea and urinary incontinence.

Reporting of 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 theSpanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute toproviding more information on the safety of this medicine.

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

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Risperidone Sandoz Composition

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

The other components are:

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

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

Covering(Risperidone Sandoz 3 mg):hypromellose5cp, macrogol 400, titanium dioxide (E-171), yellowof quinoline (E-104) and talc.

Covering(Risperidone Sandoz 6 mg):hypromellose5cp, macrogol 400, talc, titanium dioxide (E-171), yellowof quinoline (E-104)and yellow-orange S (E-110).

Product appearance and packaging contents

The 1 mg risperidone film-coated tablets are oblong, biconvex, scored and white. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Packaging sizes: 20 or 60 tablets.

The 3 mg risperidone film-coated tablets are oblong, biconvex, scored and yellow. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Packaging sizes: 20 or 60 tablets.

The 6 mg risperidone film-coated tablets are round, biconvex and yellow.

Packaging sizes: 30 or 60 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Laboratorios Tedec Meiji Farma, S.A.

Ctra. M-300, km30,500

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

Last review date of thisleaflet:February 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es