Prospecto: information for the patient

Risperidona ratio 1 mg film-coated tablets EFG

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

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

1.Risperidona ratio and its use

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

3.How to take Risperidona ratio

4.Adverse effects

1. Storage of Risperidona ratio

6.Contents of the package and additional information

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

Risperidona ratio 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 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. 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.

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

Do not take Risperidona ratio:

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

If you are unsure, consult your doctor or pharmacist before using Risperidona ratio.

Warnings and precautions

Consult your doctor or pharmacist before starting Risperidona ratio if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to low blood pressure or if you use medications for high blood pressure. Risperidone may lower 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 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 that may be dependent on prolactin
• If you or a family member has a history of blood clots, as antipsychotics have been associated with blood clot formation in the blood.

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

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. 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 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 can cause adverse effects such as menstrual disorders or fertility problems in women or breast enlargement in men (see section 4. "Possible adverse effects"). If these adverse effects appear, it is recommended to evaluate prolactin levels in the blood.

During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning to have eye surgery, be sure to inform your ophthalmologist that you are using 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 observe a sudden change in your mental state or the sudden appearance of weakness or numbness in the face, arms, or legs, especially on one side, or speak confusedly, even for a short time, seek immediate medical treatment. This may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for behavioral 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 an effect of the active substance or due to another reason.

Use of Risperidona ratio with other medications

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:

• 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 (such as quinidine), allergies (antihistamines), some antidepressants, or other medications for mental health problems
• Medications that cause a slow heartbeat
• Medications that cause low potassium levels in the blood (for example: some diuretics)
• Medications for high blood pressure. Risperidone 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 hydrochlorothiazide). Risperidone, 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, and tricyclic antidepressants
• Medications known as beta blockers (used to treat high blood pressure)
• Phenothiazines (for example, 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 using Risperidona ratio.

Taking Risperidona ratio with alcohol

You should avoid consuming alcohol while taking Risperidona ratio.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.Your doctor will decide if you can take it.
• Newborns of mothers who have used Risperidone in the last trimester (the last three months of pregnancy) may experience the following symptoms: tremor, muscle stiffness, weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn experiences any of these symptoms, contact your doctor.
• Risperidone may increase levels of a hormone called "prolactin" that can affect fertility (see section 4. "Possible adverse 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 ratio contains lactose and sodium

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

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

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

The recommended dose is:

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 people feel better with daily doses of 4 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.

Older adults

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

For the treatment of mania

Adults

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

Older adults

• The initial dose will usually be 0.5 mg, twice a day.
• Your doctor may later adjust the dose gradually to 1 mg - 2 mg, 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 usually be 0.25 mg (0.25 ml of a 1 mg/ml oral solution), twice a day.
• Your doctor may later change the dose gradually based on your response to treatment.
• Most people feel better with doses of 0.5 mg, 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

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

For the treatment of behavioral disorders

The dose will depend on your child's weight:

If your child weighs less than 50 kg

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

If your child weighs 50 kg or more

• The initial dose will usually be 0.5 mg, once a day.
• The dose can be increased, one day yes and one day no, in increments of 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 receive Risperidone treatment for behavioral disorders.

Patients with liver or kidney 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 method

For oral administration

You should swallow the medication with a glass of water.

You can take this medication with or without food.

The tablets can be divided into equal doses.

If you take more Risperidone than you should

Go to your doctor immediately. Bring the medication packaging with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

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

If you forget to take Risperidone

If you forget to take a dose, take it as soon as you remember. But if it's almost time for your 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 compensate for the missed doses.

If you interrupt treatment with Risperidone

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 product, 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 your face, arms, or legs, especially on one side, or it's hard for you to speak even for a short period of time. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or movements that cannot be controlled in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary rhythmic movements of your tongue, mouth, and face. You may need to stop taking risperidone.

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

Other side effects may also occur.

Very common (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 dragging feet, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Feeling drowsy or less attentive
• Headache

Common (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" 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 sex drive, or other sexual dysfunction. In women, they may include breast discomfort, milk secretion, missed periods, or other menstrual cycle problems, or 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.
• Dizziness
• 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, sore throat, cough, nasal bleeding, nasal congestion
• Abdominal pain, discomfort, nausea, vomiting, 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 (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 (a type of white blood cell)
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar, excessive water intake
• Weight loss, decreased appetite causing malnutrition and weight loss
• Increased cholesterol in the blood
• Euphoria (mania), confusion, decreased sex drive, 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 tingling, pinching, 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), 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, 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
• Missed periods, missed menstrual periods, or other menstrual cycle problems (women)
• Male breast development, milk secretion, 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," discomfort
• 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 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, corneal ulcers on the edge of the eyelid
• Eye problems during cataract surgery. During cataract surgery, you may experience a condition 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 medication.
• Pelvic inflammatory disease
• Excessive water intake
• Irregular heartbeat
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing
• Pancreatitis, intestinal obstruction
• Swollen 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 (may affect up to 1 in 10,000 people)

• Complications of uncontrolled diabetes, life-threatening
• Severe allergic reaction with swelling, which can affect the throat, causing breathing difficulty
• Intestinal obstruction due to muscle weakness.

Unknown frequency (cannot be estimated from available data)

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

The following side effects have appeared with the use of another medication called paliperidone, which is very similar to risperidone, so they are also expected to appear with Risperidone: Rapid heartbeat 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), diarrhea, 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 out of the sight and reach of children.

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

Do not store at a temperature above 25°C

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines thatyou no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Risperidona Ratio Composition

The active ingredient is risperidone.

Each film-coated tablet of Risperidona Ratio 1 mg contains 1 mg of risperidone.

The other components are:

Core tablet:lactose monohydrate, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose, pregelatinized cornstarch, sodium glycolate potato starch, magnesium stearate.

Coating:titanium dioxide (E-171), hypromellose, macrogol 6000, macrogol 400.

Appearance of the product and contents of the package

The film-coated risperidone 1 mg tablets are white, round, slightly biconvex, approximately 8 mm in diameter, and approximately 3.5 mm in thickness, with RIS 1 engraved and a groove on one face, and another groove on the other face.

The tablet can be divided into equal doses.

Risperidona Ratio 1 mg is presented in blisters. The package sizes are 10, 20, 30, 50, 60, 100 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Responsible manufacturer

Teva Pharmaceuticals Works Private Ltd. Co.

Pallagi út 13

4042 Debrecen

Hungary

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet: July 2023

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