RISPERIDONE FARMALIDER 3 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Risperidone Farmalider 3 mg film-coated tablets

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

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

Risperidone is used to treat:

• Schizophrenia, where you may see, hear, or feel things that are not there, believe in things that are not true, or feel unusually suspicious or confused.
• Mania, where you may feel very 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 people with Alzheimer's disease, who may harm themselves or others. Other non-drug treatments should have been tried first.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years old) and adolescents with conduct disorders.

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

Do not take Risperidone Farmalider if:

• You are allergic (hypersensitive) to the active substance or any of the other ingredients of Risperidone Farmalider (listed in section 6).

If you are not sure, talk to your doctor or pharmacist before taking Risperidone Farmalider.

Be especially careful with Risperidone Farmalider

Talk to your doctor or pharmacist before taking Risperidone:

• If you have any heart problems. Examples include heart rhythm disturbances, or if you are prone to low blood pressure or take blood pressure medications. Risperidone may lower your blood pressure. You may need to have your dose adjusted.
• If you or a family member has a history of blood clots, these medications may be associated with their formation.
• If 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 have Parkinson's disease or dementia.
• If you are diabetic.
• If you have epilepsy.
• If you are male and have ever had a prolonged or painful erection. If you experience this while taking Risperidone, contact your doctor immediately.
• If you have problems controlling your body temperature or feel excessive heat.
• If you have kidney problems.
• If you have liver problems.
• If 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.

Talk to your doctor immediately:

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

If you are unsure about any of the above, talk to your doctor or pharmacist before taking Risperidone Farmalider.

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

Taking Risperidone Farmalider 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 to 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 medications (opioids), allergy medications (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 medications 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 conditions).
• 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, talk to your doctor or pharmacist before taking Risperidone Farmalider.

Using Risperidone Farmalider 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

• Talk to your doctor before taking Risperidone if you are pregnant, trying to become pregnant, or breastfeeding. Your doctor will decide if you can take it.
• Tremors, muscle stiffness, and feeding problems, all of which are reversible, have been seen in newborns whose mothers took Risperidone during the last trimester of pregnancy.
• Newborns of mothers who have used Risperidone Farmalider in the last trimester of pregnancy may present with the following symptoms: tremor, muscle stiffness and/or weakness, somnolence, agitation, breathing problems, and feeding problems. If your newborn presents with any of these symptoms, contact your doctor.

Talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

Dizziness, fatigue, and vision problems have been observed during treatment with Risperidone. Do not drive or operate tools or machines without consulting your doctor first.

Important information about some of the ingredients of Risperidone Farmalider

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

3. How to take Risperidone Farmalider

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 usually 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 old should not receive treatment with Risperidone for schizophrenia.

For the treatment of mania

Adults

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

Elderly patients

• The initial dose will usually be 0.5 mg, twice a day.
• Later, your doctor may adjust your dose gradually to 1 mg - 2 mg, twice a day, depending 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 long-term treatment of aggression in people with Alzheimer's disease

Adults (including elderly patients)

• The initial dose will usually 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 conduct disorders in children and adolescents

The dose depends on your child's weight.

If they weigh less than 50 kg

• The initial dose will usually be 0.25 mg, 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, once a day.

If they weigh 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 conduct disorders should not exceed 6 weeks.

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

Patients with liver or kidney problems

Regardless of the disease 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 group of patients.

How to take Risperidone Farmalider

Always take Risperidone Farmalider exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how much medicine to take and for how long. This will depend on your illness 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 Farmalider film-coated tablets

• Swallow the medicine with a drink of water.

If you take more Risperidone Farmalider than you should

• In case of overdose or accidental ingestion, talk to 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 and walking, dizziness due to low blood pressure, or have abnormal heartbeats or seizures.

If you forget to take Risperidone Farmalider

• If you forget to take a dose, take it as soon as you remember. But if it is close to the 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 to make up for forgotten doses.

If you stop taking Risperidone Farmalider

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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Risperidona Farmalider can produce adverse effects, although not all people suffer from them.

Very frequent: affect more than 1 in 10 people

Frequent: affect between 1 and 10 out of 100 people

Infrequent: affect between 1 and 10 out of 1000 people

Rare: affect between 1 and 10 out of 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 (may 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 humid 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 remaining asleep.

Frequent (may affect up to 1 in 10 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, throat pain, dry mouth
• Weight gain, increased body temperature, decreased appetite
• Difficulty breathing, lung 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
• Rapid heartbeat, chest pain
• Increased concentration of the prolactin hormone in the blood.

Infrequent (may affect up to 1 in 100 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, decrease in blood pressure, feeling of dizziness when changing position, anomaly in the electrical activity of the heart (ECG), abnormal heart rhythm, feeling the 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 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, pain in the chest muscles and bones, 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 hypersensitivity to light, increased blood flow to the eye, eye swelling, eye dryness, increased tearing
• Respiratory tract disorder, lung congestion, lung crackling sounds, respiratory tract congestion, speech problems, difficulty swallowing, cough with sputum, wheezing or whistling sound when breathing, pseudogrippal illness, 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 (may affect up to 1 in 1000 people):

• Inability to reach 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 otitis
• Intestinal obstruction,
• Decreased blood flow to the brain
• Decreased number of white blood cells, 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 (may affect up to 1 in 10,000 people):

• Complications of uncontrolled diabetes, with risk to life

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
• 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 immediately to your doctor.

A small increase in the number of deaths has been reported in elderly patients with dementia treated with antipsychotics, compared to those who do not receive this treatment.

Risperidona Long-Acting Injectable

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

• Intestinal infection
• Abscess under the skin, tingling, pinching, or numbness of the skin, skin inflammation
• Decreased number of white blood cells, cells that help protect against bacterial infections

• Depression
• Seizures
• Eye twitching
• Feeling of spinning or swaying
• Slow heartbeat, increased blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight loss.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Risperidona Farmalider

It does not require special storage conditions.

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

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Risperidona Farmalider Composition

• The active ingredient is risperidona. Each film-coated tablet of Risperidona Farmalider contains 3 mg of risperidona.

• The other components are:

Core of the tablet:

Pregelatinized cornstarch, lactose, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate, and magnesium stearate.

Coating:

Hypromellose, macrogol 400, talc, titanium dioxide (E-171), and quinoline yellow (E-104)

Appearance of the Product and Package Contents

The 3 mg risperidona Farmalider film-coated tablets are oblong, biconvex, scored, and yellow in color. The score line is to facilitate breaking the tablet to swallow it better, and not to divide the tablet into equal doses.

They are marketed in packages of 20 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider, S.A.

C/ La Granja, 1 3ª Planta

1. Alcobendas. Madrid

Spain

Manufacturer

Laboratorios Tedec Meiji Farma, S.A.

Ctra. M-300, km 30,500

28802 Alcalá de Henares (Madrid)-Spain

Or

Farmalider S.A

Aragoneses, 2

28108 Alcobendas (Madrid), Spain

Or

Generis Farmacêutica S.A.

Rua de João de Deus, nº 19

Venda-Nova. Amadora 2700-487 -Portugal

Or

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid), Spain

This prospectus was revised in September 2013

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

www.aemps.gob.es