Leaflet: information for the user

Risperidone NORMON 3 mg film-coated tablets EFG

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

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

1. What Risperidone NORMON is and for what it is used

2. What you need to know before starting to take Risperidone NORMON

3. How to take Risperidone NORMON

4. Possible side effects

5. Storage of Risperidone NORMON

6. Contents of the pack and additional information

Risperidona Normon belongs to a group of medicines called “antipsychotics”.

Risperidona is used to treat the following:

• Schizophrenia, with which you may see, hear, or feel things that are not there, believe in something that is not true, or feel particularly suspicious or confused.
• Mania, with which you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania appears in a disease called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease dementia, who harm themselves or others. 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 old), and adolescents with behavioral disorders.

Do not take Risperidona NORMON

• if you are allergic to the active ingredient 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 Normon.

Warnings and precautions

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

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to having low blood pressure or if you are using blood pressure medications. Risperidona may lower your blood pressure. You may need to have your dose adjusted.
• You know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain.
• If you or a family member has a history of blood clots, these medications may be associated with their formation
• You have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are a male and have had a prolonged or painful erection at any time. If you experience this while taking Risperidona, contact your doctor immediately.
• 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.

Consult your doctor immediately if you have:

• involuntary rhythmic movements of the tongue, mouth, or face. Risperidona may need to be discontinued
• fever, severe muscle stiffness, sweating, or low level of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment

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

Risperidona may cause you to gain weight.

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 risperidona if you have dementia caused by a stroke.

You should see your doctor regularly during treatment with Risperidona.

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 if you are confused, 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 conduct disorders.

If you experience fatigue while taking risperidona, changing the administration times may help improve your attention difficulties.

Taking Risperidona NORMON with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Medications that act on your brain, such as those used to calm down (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidona 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 heart rate.
• Medications that cause low potassium levels in the blood (for example: some diuretics).
• Medications for high blood pressure. Risperidona may lower your blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• 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). Risperidona, taken alone or with furosemide, may increase the risk of stroke or death in patients with advanced age and dementia.

The following medications may reduce the effect of risperidona:

• 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 risperidona.

The following medications may increase the effect of risperidona:

• 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)
• Fenothiazines (for example, used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (gastric acid blockers)

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

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

Taking Risperidona NORMON with food, drinks, and alcohol

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

Pregnancy and breastfeeding

• 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.
• Newborn babies of mothers who have used Risperidona NORMON in the last trimester of pregnancy may experience the following symptoms: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn baby experiences any of these symptoms, contact your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Risperidona may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying condition, make it advisable to exercise caution when driving vehicles or operating hazardous machinery, especially until your individual sensitivity to the medication has been established.

Risperidona NORMON contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

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

How much to take

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day, which may be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose based on how you respond to treatment.
• Most people find relief with daily doses of 4 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.

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor will later increase your dose gradually to 1 mg - 2 mg, taken twice a day.
• Your doctor will tell you what is best for you.

Children and adolescents

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

For the treatment of mania

Adults

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

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor may later adjust your dose gradually to 1 mg - 2 mg, taken twice a day based on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years old should not receive treatment with Risperidone for bipolar mania.

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, taken twice a day.
• Your doctor may later change your dose gradually based on your response to treatment.
• Most people find relief with doses of 0.5 mg, taken twice a day. Some patients may need 1 mg taken twice a day.
• The duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

For the treatment of behavioral disorders in children and adolescents

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, taken once a day.
• The dose may be increased, one day yes and one day no, by 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg, taken once a day.

If your child weighs 50 kg or more

• The initial dose will usually be 0.5 mg, taken once a day.
• The dose may 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, taken once a day.

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

Children under 5 years old should not receive treatment with Risperidone 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.

How to take Risperidone NORMON

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how much medication to take and for how long. This will depend on your disease and varies from person to person. The amount of medication you should take is explained earlier in the heading "How much to take".

Risperidone NORMON film-coated tablets

• You should swallow the medication with a glass of water.

If you take more Risperidone NORMON than you should

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

If you forget to take Risperidone NORMON

• 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 make up for the missed doses.

If you interrupt treatment with Risperidone NORMON

Do 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, Risperidona Normon can cause side effects, although not everyone will experience them.

Very common:affect more than 1 in 10 people

Common:affect between 1 and 10 in 100 people

Uncommon:affect between 1 and 10 in 1000 people

Rare:affect between 1 and 10 in 10,000 people

Very rare:affect less than 1 in 10,000 people

Unknown:the frequency cannot be estimated from available data

The following side effects may occur:

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

• Parkinsonism. It is a medical term that includes several symptoms. Each individual symptom may occur less frequently than 1 in 10 people. Parkinsonism includes: increased salivation or a very wet mouth, muscle stiffness, drooling, pain when bending the limbs, slower, reduced, or difficult body movements, facial expressionlessness, muscle tension, torticollis, muscle stiffness, short and rapid steps, dragging the feet, and absence of normal arm movements, persistent blinking as a response to forehead taps (an abnormal reflex).
• Headache, difficulty staying or remaining asleep.

Common (affect between 1 and 10 in 100 people):

• Drowsiness, fatigue, tiredness, inability to remain calm, irritability, anxiety, drowsiness, dizziness, attention problems, feeling of exhaustion, sleep disturbance.
• Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth.
• Weight gain, increased body temperature, decreased appetite.
• Respiratory difficulty, pneumonia, flu, respiratory tract infection, blurred vision, nasal congestion, nasal bleeding, cough.
• Urinary tract infection, bedwetting.
• Muscle cramps, involuntary facial or arm and leg movements, joint pain, back pain, swelling of arms and legs, arm and leg pain.
• Rash, skin redness.
• Fast heart rate, chest pain.
• Increased prolactin concentration in the blood.

Uncommon (affect between 1 and 10 in 1000 people):

• Excessive water consumption, fecal incontinence, thirst, hard stools, hoarseness or voice disorder.
• Pneumonia caused by food passing through the respiratory tract, urinary tract infection, eye redness, sinusitis, viral infection, ear infection, tonsillitis, skin infection, eye infection, stomach infection, ocular secretion, fungal nail infection.
• Abnormal heart conduction, decreased blood pressure when standing, decreased blood pressure, sensation of dizziness when changing position, abnormal heart activity (ECG), abnormal heart rhythm, feeling heartbeats, fast or slow heart rate.
• Urinary incontinence, painful urination, frequent urination.
• Confusion, attention disorder, decreased level of consciousness, excessive sleep, nervousness, manic state, lack of energy and interest.
• Increased blood glucose, increased liver enzymes, decreased white blood cell count, decreased hemoglobin or red blood cell count (anemia), increased eosinophil count (special white blood cells), increased creatine phosphokinase, decreased platelet count (blood cells that help stop bleeding).
• Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest muscle and bone pain, chest discomfort.
• Skin lesion, skin disorder, dry skin, intense itching, acne, skin inflammation caused by mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, oily skin inflammation.
• Menstrual absence, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, breast enlargement in males, decreased sexual desire, irregular menstruation, vaginal secretion.
• Loss of consciousness, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling unwell, balance disorder, allergy, edema, speech disorder, chills, coordination disorder.
• Light sensitivity, increased blood flow to the eye, eye swelling, dry eyes, increased tear production.
• Respiratory tract disorder, pulmonary congestion, lung crepitant sounds, respiratory tract congestion, speech difficulty, swallowing difficulty, cough with sputum, hoarse or hissing sound while breathing, pseudogripal disease, sinusitis.
• Loss of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with respiratory difficulty, sudden weakness or numbness of face, arms, or legs, especially on one side, or cases of confused speech lasting less than 24 hours (mini-stroke or cerebral attack), involuntary facial, arm, or leg movements, tinnitus, facial edema.

Rare (affect between 1 and 10 in 10,000 people):

• Inability to achieve orgasm, menstrual disorder
• Dandruff
• Medication allergy, coldness in arms and legs, lip swelling, lip inflammation
• Glaucoma, decreased visual acuity, corneal crust formation, eye movement
• Lack of emotions
• Consciousness alteration with increased body temperature and muscle spasms, body-wide edema, medication withdrawal syndrome, decreased body temperature
• Shallow and rapid breathing, respiratory problems during sleep, chronic middle ear infection
• Intestinal obstruction,
• Decreased blood flow to the brain
• Decreased white blood cell count, inadequate secretion of a hormone that controls urine volume
• Muscle fiber rupture and muscle pain (rhabdomyolysis), movement disorder
• Diabetes coma due to uncontrolled diabetes
• Yellow skin and eyes (jaundice)
• Pancreatitis inflammation.

Very rare (affect less than 1 in 10,000 people):

• Life-threatening complications of uncontrolled diabetes

Unknown frequency of side effects (frequency cannot be estimated from available data):

• Severe allergic reaction leading to respiratory difficulty and shock
• Absence of granulocytes (a type of white blood cell that helps fight infections)
• Prolonged and painful erection
• Excessive water intake
• Coagulation of blood in veins, especially in legs (symptoms include swelling, pain, and redness in the leg), these clots can move through blood vessels to the lungs, causing chest pain and breathing difficulty. If you experience any of these symptoms, seek immediate medical attention.

Risperidone long-acting injectable

The following side effects have been reported with the use of Risperidone long-acting injectable. If you experience any of the following side effects, talk to your doctor, even if you are not receiving long-acting injectable Risperidone:

• Intestinal infection
• Subcutaneous abscess, skin tingling, skin pinching, or numbness, skin inflammation
• Decreased white blood cell count, cells that help protect you from bacterial infections
• Depression
• Seizures
• Eye blinking
• Sensation of rotation or oscillation
• Slow heart rate, increased blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight loss.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Do not store at a temperature above 30 °C.

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

Do not use after the expiration date that appears on the packaging, after 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 medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Risperidona NORMON

The active ingredient is risperidone.

Each film-coated tablet of Risperidona Normon contains 3 mg of risperidone.

The other components are:

Tablet core:monohydrate lactose, cornstarch, microcrystalline cellulose, hypromellose, magnesium stearate, sodium lauryl sulfate.Covering:hypromellose, titanium dioxide (E-171), talc, Macrogol 6000, and yellow quinoline lake (E-104).

Appearance of the product and content of the packaging

The 3 mg risperidone film-coated tablets are elongated, biconvex, scored, and yellow in color. The tablet can be divided into two equal halves.

They are marketed in packs of 20 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: May 2012

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)www.aemps.gob.es