Risperidone Normon 3 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidone NORMON 3 mg film-coated tablets EFG

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

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

Contents of the leaflet

1. What Risperidone NORMON is and what it is used for
2. What you need to know before taking Risperidone NORMON
3. How to take Risperidone NORMON
4. Possible adverse effects
5. How to store Risperidone NORMON
6. Contents of the pack and other information

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

Risperidone Normon belongs to a group of medicines called "antipsychotics".

Risperidone is used to treat the following conditions:

• Schizophrenia, which may cause you to see, hear, or feel things that are not there, to believe things that are not true, or to feel particularly suspicious or confused.
• Mania, during which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a condition called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer-type dementia who harm themselves or others. Alternative non-pharmacological treatments should have been attempted previously.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorders.

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 medicine (listed in section 6).

If you are unsure, consult your doctor or pharmacist before using Risperidone Normon.

Warnings and precautions

Consult your doctor or pharmacist before starting Risperidone if:

• You have any heart problems. Examples include irregular heart rhythms, or if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidone may reduce blood pressure. You may need your dose adjusted.
• You have any risk factors that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain.
• You or a family member have a history of blood clots; these medicines may be associated with blood clot formation.
• You have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are male and have ever experienced a prolonged or painful erection. If this occurs 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 abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.

Contact your doctor immediately if you experience:

• Involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.
• Fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). You may require immediate medical treatment.

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

Risperidone may cause weight gain.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if your dementia is caused by a stroke.

During treatment with Risperidone, you should see your doctor regularly.

If you or your caregiver notice a sudden change in your mental state or sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or slurred speech, even if temporary, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for behavioral disorders.

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

Taking Risperidone NORMON with other medicines

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

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

• Medicines that act on the brain, such as those used to calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines capable of altering the electrical activity of your heart, such as those used for malaria, heart rhythm disorders (e.g., quinidine), allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
• Medicines that cause a slow heart rate.
• Medicines that cause low potassium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidone may lower blood pressure.
• Medicines for Parkinson's disease (e.g., levodopa).
• Diuretics used for heart problems or to treat swelling in certain parts of the body due to fluid retention (e.g., furosemide or hydrochlorothiazide). Risperidone, 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 used to treat certain 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 types of heart disease)
• 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 whether any of the above applies to you, consult your doctor or pharmacist before using Risperidone Normon.

Taking Risperidone NORMON with food, drinks, and alcohol

You may 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take it.
• Newborns of mothers who have taken Risperidone NORMON during the third trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Risperidone may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness, mean caution is advised when driving vehicles or operating dangerous machinery, especially until the individual patient's response to the medicine has been established.

Risperidone NORMON contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine 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; it may be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose depending on your response to treatment.
• Most people improve 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.

Elderly patients

• The initial dose is usually 0.5 mg twice daily.
• Later, your doctor may gradually increase your dose to 1 mg – 2 mg twice daily.
• Your doctor will tell you what is best for you.

Children and adolescents

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

For the treatment of mania

Adults

• The initial dose is usually 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people improve with daily doses of 1 to 6 mg.

Elderly patients

• The initial dose is usually 0.5 mg twice daily.
• Later, your doctor may gradually adjust your dose to 1 mg – 2 mg twice daily, depending on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years of age should not be treated with risperidone for bipolar mania.

For the long-term treatment of aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

• The initial dose is usually 0.25 mg twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most patients improve with a dose of 0.5 mg twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer-type 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 weight is less than 50 kg

• The initial dose is usually 0.25 mg once daily.
• The dose may be increased every other day in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once daily.

If weight is 50 kg or more

• The initial dose is usually 0.5 mg once daily.
• The dose may be increased every other day in increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once daily.

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

Children under 5 years of age should not be treated with Risperidone for conduct disorders.

Patients with liver or kidney problems

Regardless of the condition being treated, all initial 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 patient group.

How to take Risperidone NORMON

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, 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 condition and may vary from person to person. The amount of medicine you should take is explained above under the heading “How much to take.”

Risperidone NORMON film-coated tablets

• You must swallow the medicine with a glass of water.

If you take more Risperidone NORMON than you should

• In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 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 or 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. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.
• If you miss two or more doses, contact your doctor.

If you stop taking Risperidone NORMON

You should not stop treatment unless instructed by your doctor. Symptoms may reappear. If your doctor decides to discontinue treatment, your dose may be gradually reduced over several days.

If you have any further questions about 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 everyone experiences them.

Very common: affects more than 1 in 10 people

Common: affects between 1 and 10 in 100 people

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

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

Very rare: affects fewer than 1 in 10,000 people

Not known: frequency cannot be estimated from available data

The following side effects may occur:

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

• Parkinsonism. This 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 very wet mouth, musculoskeletal rigidity, drooling, pain when bending limbs, slowed, reduced, or difficult body movements, lack of facial expression, muscle tightness, torticollis, muscle stiffness, short and rapid steps when walking, shuffling gait, absence of normal arm movements, persistent blinking in response to tapping the forehead (an abnormal reflex).
• Headache, difficulty falling or staying asleep.

Common (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 disturbances.
• Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth.
• Weight gain, increased body temperature, decreased appetite.
• Breathing difficulty, lung infection (pneumonia), flu, respiratory tract infection, blurred vision, nasal congestion, nosebleeds, 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 the hormone prolactin in the blood.

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

• Excessive water intake, fecal incontinence, thirst, very hard stools, hoarseness or voice disorder.
• Lung infection caused by food entering the airways, bladder infection, eye redness, sinusitis, viral infection, ear infection, tonsillitis, subcutaneous infection, eye infection, stomach infection, eye discharge, fungal nail infection.
• Abnormality in the heart's electrical conduction, drop in blood pressure upon standing, decreased blood pressure, dizziness when changing position, abnormality in the heart's electrical activity (ECG), irregular heartbeat, awareness of heartbeat, fast or slow heartbeat.
• Urinary incontinence, painful urination, frequent urination.
• Confusion, attention disturbance, reduced level of consciousness, excessive sleepiness, restlessness, elevated mood state (mania), lack of energy and interest.
• Increased blood glucose, increased liver enzymes, decreased number of white blood cells, decreased hemoglobin or number of red blood cells (anemia), increased number of eosinophils (special white blood cells), increased creatine phosphokinase, decreased number of platelets (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, severe itching, acne, hair loss, skin inflammation due to mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, greasy skin inflammation.
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge, breast enlargement in males, decreased sexual desire, irregular menstruation, vaginal discharge.
• Fainting, gait disturbance, inactivity, reduced appetite with malnutrition and weight loss, feeling of "indisposition", balance disorder, allergy, edema, speech disorder, chills, coordination abnormality.
• Painful hypersensitivity to light, increased blood flow to the eye, eye swelling, dry eyes, increased tearing.
• Respiratory tract disorder, pulmonary congestion, crackling lung sounds, respiratory tract congestion, speech difficulties, swallowing difficulty, cough with sputum, hoarse or wheezing breathing sounds, pseudoinfluenza illness, sinusitis.
• Absence of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with breathing difficulty, sudden weakness or numbness of face, arms or legs, especially on one side, or episodes 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):

• Inability to achieve orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip inflammation
• Glaucoma, decreased visual acuity, crust formation at the eyelid margin, eye movement disorder
• Absence of emotions
• Altered consciousness with increased body temperature and muscle spasms, generalized edema, drug withdrawal syndrome, decreased body temperature
• Rapid and shallow breathing, breathing problems during sleep, chronic middle ear infection
• Intestinal obstruction
• Reduced blood flow to the brain
• Decreased number of white blood cells, inadequate secretion of a hormone that controls urine volume
• Muscle fiber breakdown and muscle pain (rhabdomyolysis), movement disorder
• Coma due to uncontrolled diabetes
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis.

Very rare (affects fewer than 1 in 10,000 people):

• Complications of uncontrolled diabetes, which may be life-threatening

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Severe allergic reaction leading to breathing difficulty and shock
• Absence of granulocytes (a type of white blood cells that help 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 may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

Long-acting injectable Risperidone

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

• Intestinal infection
• Skin abscess, tingling, prickling, or numbness of the skin, skin inflammation
• Decreased number of white blood cells, which help protect against bacterial infections
• Depression
• Seizures
• Eye twitching
• Sensation of spinning or oscillation
• Slow heartbeat, increased blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight loss.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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

5. Storage of Risperidone NORMON

Do not store above 30 °C.

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

Do not use after the expiry date stated on the packaging, following Exp. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Risperidone NORMON

The active substance is risperidone.

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

The other components are:

Tablet core: lactose monohydrate, corn starch, 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 contents of the container

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

They are marketed in packs 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 most recent revision of this leaflet: May 2012

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