RISPERIDONE NORMON 1 mg FILM-COATED TABLETS

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

Do not take Risperidone NORMON

• if you are allergic to the active substance or any of the other ingredients of this medicine (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 disturbances, or if you are prone to having low blood pressure or if you are taking medicines for 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 the brain
• If you or a family member has a history of blood clots, these medicines 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 are unsure about any of the above, 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 your 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 conduct disorders.

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

Taking Risperidone NORMON with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Medicines that act on your brain, such as those used to calm you down (benzodiazepines), or some pain medicines (opioids), allergy medicines (some antihistamines), as risperidone may increase their sedative effect
• Medicines that can change the electrical activity of your heart, such as those used for malaria, heart rhythm problems (such as quinidine), allergies (antihistamines), some antidepressants, or other medicines for mental problems
• Medicines that cause a slow heartbeat
• Medicines that cause low potassium levels in the blood (such as some diuretics)
• Medicines for high blood pressure. Risperidone may lower your blood pressure
• Medicines 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 medicines may decrease the effect of risperidone:

• Rifampicin (a medicine for some infections)
• Carbamazepine, phenytoin (medicines for 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 heart diseases)
• Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (e.g., used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)

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

If you are unsure about any of the above, consult your doctor or pharmacist before using Risperidone Normon.

Taking Risperidone NORMON with food, drinks, and alcohol

You can take this medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take it.
• Newborn babies of mothers who have used Risperidone NORMON in the last trimester of pregnancy may have the following symptoms: trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing and feeding problems. If your baby has any of these symptoms, contact your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Risperidone may cause symptoms such as drowsiness, dizziness, or changes in vision, and may affect your ability to react. These effects, as well as the disease itself, make it advisable to be cautious when driving vehicles or operating hazardous machinery, especially while you are not yet accustomed to the effects of the medicine.

Risperidone NORMON contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it 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 can 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 tell you 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 tell you 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 dementia

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 dementia should not exceed 6 weeks.

For the treatment of conduct 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 conduct disorders should not exceed 6 weeks.

Children under 5 years of age should not receive treatment with Risperidone for conduct disorders.

Patients with liver or kidney problems

Regardless of the disease being treated, all starting 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 of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Risperidone NORMON film-coated tablets

• You should swallow the medicine 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 medicine and the amount taken.
• 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 convulsions.

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 almost time for your 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 forgotten doses.

If you stop taking Risperidone NORMON

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Risperidone Normon can cause adverse effects, although not all people will experience them.

Very frequent: affects more than 1 in 10 people

Frequent: affects between 1 and 10 in 100 people

Infrequent: affects between 1 and 10 in 1,000 people

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

Very rare: affects 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 (affects 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 (affects 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
• Difficulty breathing, lung infection (pneumonia), flu, respiratory tract infection, blurred vision, nasal congestion, nosebleed, 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
• Rapid heartbeat, chest pain
• Increased concentration of prolactin hormone in the blood.

Infrequent (affects between 1 and 10 in 1,000 people):

• Excessive water consumption, fecal incontinence, thirst, very hard stools, hoarseness or voice disorder
• Lung infection caused by food passing into the airways, bladder infection, eye redness, sinusitis, viral infection, ear infection, tonsil infection, infection under the skin, eye infection, stomach infection, eye discharge, fungal infection of the nails.
• Anomaly in the electrical conduction of the heart, drop in blood pressure when standing up, decreased blood pressure, feeling of dizziness when changing position, anomaly of heart electrical activity (ECG), irregular heartbeat, feeling heartbeats, rapid or slow heartbeat.
• 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 eosinophils (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, dry eyes, 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, pseudoinfluenza disease, sinusitis.
• Absence of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with difficulty breathing, 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 (affects 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 edge, eye movement
• Absence of emotions
• 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 due to uncontrolled diabetes
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis.

Very rare (affects 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 difficulty breathing and shock
• Absence of granulocytes (a type of white blood cell that helps fight infections)
• Prolonged and painful erection
• Excessive and dangerous 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, seek medical attention 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 against bacterial infections
• Depression
• Seizures
• Eye twitching
• Feeling of spinning or swaying
• Slow heartbeat, increased blood pressure
• Toothache, tongue spasm
• Pain in the buttocks
• Weight loss.

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 CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the 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 will help protect the environment.

6. Package Contents and Additional Information

Risperidone NORMON Composition

The active ingredient is risperidone.

Each Risperidone Normon film-coated tablet contains 1 mg of risperidone.

The other ingredients 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.

Product Appearance and Package Contents

The 1 mg risperidone film-coated tablets are elongated, biconvex, scored, and white or almost white 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