RISPERIDONE NORMON 3 mg FILM-COATED TABLETS

2. What you need to know before taking Risperidone NORMON

Do not take Risperidone NORMON

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

If you are not sure, consult your doctor or pharmacist before using Risperidone Normon.

Warnings and precautions

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

• You have any heart problems. Examples include heart rhythm disorders, or if you are prone to having low blood pressure or if you use medications for 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 the blood vessels in the brain.
• If you or a family member has a history of blood clots, these medications may be associated with the formation of clots.
• You have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are male and have ever had a prolonged or painful erection. If you experience this while taking Risperidone, contact your doctor immediately.
• 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 the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.

Consult your doctor immediately if you have:

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

If you have doubts about whether what you have read affects you, consult your doctor or pharmacist before using Risperidone Normon.

Risperidone may cause you to gain weight.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of having a stroke. You should 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 confused speech, even if only for a short time, seek medical attention immediately. It 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 attention difficulties.

Taking Risperidone NORMON with other medications

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

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

• Medications that act on your brain, such as those used to calm you down (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase their sedative effect.
• Medications that can modify 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 problems.
• Medications that cause a slow heartbeat.
• Medications that cause low potassium levels in the blood (such as some diuretics).
• Medications for high blood pressure. Risperidone may lower blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• Diuretics, which are used for heart problems or to treat swelling of 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 decrease the effect of risperidone:

• Rifampicin (a medication for 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 (e.g., used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)

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

If you have doubts about whether what you have read affects you, consult your doctor or pharmacist before using Risperidone Normon.

Taking Risperidone NORMON with food, drinks, and alcohol

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

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 NORMON in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn presents with any of these symptoms, contact your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Risperidone may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction ability. These effects, as well as the disease itself, make it advisable to be cautious when driving vehicles or operating hazardous machinery, especially while you have not yet established your particular sensitivity to the medication.

Risperidone NORMON contains lactose and sodium

This medication contains lactose. 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 of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Risperidone NORMON

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 depending on how you respond 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.

Elderly patients

• The initial dose will normally be 0.5 mg, twice a day.
• Later, your doctor may gradually increase your dose to 1 mg - 2 mg, twice a day.
• Your doctor will indicate what is best for you.

Children and adolescents

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

For the treatment of mania

Adults

• The initial dose will normally be 2 mg, once a day.
• Later, your doctor may gradually adjust your dose depending on your response to treatment.
• Most people feel better with daily doses of 1 to 6 mg.

Elderly patients

• The initial dose will normally be 0.5 mg, twice a day.
• Later, your doctor may gradually adjust your dose to 1 mg - 2 mg, twice a day, depending on your response to treatment.

Children and adolescents

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

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

Adults (including elderly patients)

• The initial dose will normally be 0.25 mg, twice a day.
• Later, your doctor may gradually change your dose depending 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.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If they weigh less than 50 kg

• The initial dose will normally be 0.25 mg, once a day.
• The dose may be increased, one day yes and one day no, in increments of 0.25 mg per day.
• The normal maintenance dose is 0.25 mg to 0.75 mg, once a day.

If they weigh 50 kg or more

• The initial dose will normally be 0.5 mg, once a day.
• The dose may be increased, one day yes and one day no, in increments of 0.5 mg per day.
• The normal 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 of age should not receive treatment with Risperidone for behavioral disorders.

Patients with liver or kidney problems

Regardless of the disease being treated, 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 your doctor's or pharmacist's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

Your doctor will indicate how much medication you should take and for how long. This will depend on your disease and may vary from person to person. The amount of medication you should take is explained above in the "How much to take" section.

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, have abnormal body movements, problems standing or walking, dizziness due to low 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 is close to the time of the next dose, skip 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 missed doses.

If you stop taking Risperidone NORMON

You should not stop taking the treatment unless your doctor tells you to. The symptoms may return. If your doctor decides to stop the treatment, your dose may be gradually decreased over a few days.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Risperidone Normon can cause adverse effects, although not all people suffer from them.

Very frequent: affect more than 1 in 10 people

Frequent: affect between 1 and 10 in 100 people

Infrequent: 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 the available data

The following side effects may appear:

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

• Parkinsonism. It is a medical term that includes several symptoms. Each individual symptom may occur with less frequency than 1 in 10 people. Parkinsonism includes: increased saliva secretion or very moist mouth, musculoskeletal stiffness, drooling, pain when bending limbs, slower, reduced, or difficult body movements, lack of facial expression, muscle tension, torticollis, muscle stiffness, short and rapid steps when walking, dragging feet, and absence of normal arm movements, persistent blinking as a response to forehead tapping (an abnormal reflex).
• Headache, difficulty staying or falling asleep.

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

• Drowsiness, fatigue, tiredness, inability to remain still, irritability, anxiety, somnolence, 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, pulmonary infection (pneumonia), flu, respiratory tract infection, blurred vision, nasal congestion, nasal bleeding, cough.
• Urinary tract infection, bedwetting.
• Muscle cramps, involuntary movements of the face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs.
• Rash, skin redness.
• Fast heart rate, chest pain.
• Increased concentration of prolactin hormone in the blood.

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

• Excessive water consumption, fecal incontinence, thirst, very hard stools, hoarseness or voice disorder.
• Pulmonary infection caused by food passing into the airways, bladder infection, eye redness, sinusitis, viral infection, ear infection, tonsil infection, subcutaneous infection, eye infection, stomach infection, ocular discharge, fungal infection of the nails.
• Anomaly in the electrical conduction of the heart, decrease in blood pressure when standing up, decrease in blood pressure, feeling of dizziness when changing position, anomaly of heart electrical activity (ECG), abnormal heart rhythm, feeling heartbeats, fast or slow heart rate.
• Urinary incontinence, pain when urinating, frequent urination.
• Confusion, attention disorder, low level of consciousness, excessive sleepiness, nervousness, elevated mood (mania), 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 injury, skin disorder, skin dryness, intense itching, acne, hair loss, skin inflammation caused by mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, fatty skin inflammation.
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, increased breast size in males, decreased sexual desire, irregular menstruation, vaginal discharge.
• Fainting, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling of "indisposition", balance disorder, allergy, edema, speech disorder, chills, coordination anomaly.
• Painful sensitivity to light, increased blood flow to the eye, eye swelling, eye dryness, increased tearing.
• Respiratory tract disorder, pulmonary congestion, lung crackling sounds, respiratory tract congestion, speech problems, difficulty swallowing, cough with sputum, wheezing or whistling sound when breathing, pseudocroup, sinusitis.
• Absence 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 (called mini-stroke or stroke), involuntary movements of face, arms, or legs, ringing in the ears, facial edema.

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

• Difficulty reaching orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip inflammation
• Glaucoma, decreased visual acuity, crust formation on the eyelid margin, eye movement
• Apathy
• Altered consciousness with increased body temperature and muscle spasms, edema throughout the body, drug withdrawal syndrome, decreased body temperature
• Rapid and shallow 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
• Diabetic coma
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis

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

• Complications of uncontrolled diabetes, life-threatening

Unknown frequency of adverse effects (the frequency cannot be estimated from the 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
• Dangerously excessive water intake
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to your doctor immediately.

Risperidone Long-Acting Injectable

The following adverse effects have been reported with the use of Risperidone Long-Acting Injectable. If you experience any of the following effects, talk to your doctor, even if you are not receiving treatment with long-acting Risperidone injections:

• Intestinal infection
• Abscess under the skin, tingling, pinching, or numbness of the skin, skin inflammation
• Decreased white blood cell count, cells that help protect you from bacterial infections
• Depression
• Seizures
• Eye twitching
• Feeling of spinning or swaying
• Slow heart rate, increased blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight loss.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

5. Storage of Risperidone NORMON

Do not store at a temperature above 30 °C.

Keep this medicine out of sight and reach of children.

Do not use after the expiration date shown on the packaging, after Exp. The expiration date is the last day of the month indicated.

Medicines should not be thrown away in drains or trash. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Risperidone NORMON

The active ingredient is risperidone.

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

The other components are:

Core of the tablet:lactose monohydrate, cornstarch, microcrystalline cellulose, hypromellose, magnesium stearate, sodium lauryl sulfate. Coating:hypromellose, titanium dioxide (E-171), talc, Macrogol 6000, and quinoline yellow lake (E-104).

Appearance of the Product and Package Contents

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 packages of 20 or 60 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus: May 2012

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