RISPERIDONE KERN PHARMA 1 mg FILM-COATED TABLETS

2. What you need to know before you take Risperidone Kern Pharma

Do not take Risperidone Kern Pharma

• If you are allergic (hypersensitive) to risperidone or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, consult your doctor or pharmacist before taking Risperidone Kern Pharma.

Warnings and precautions

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

• You have any heart problems. Examples include heart rhythm disturbances, if you are prone to low blood pressure or if you are taking medicines for high blood pressure. Risperidone Kern Pharma 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.
• 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 Kern Pharma, 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.
• You or a family member have a history of blood clots, as these medicines may be associated with the formation of blood clots.

Consult your doctor immediately if you

• Experience rhythmic involuntary movements of the tongue, mouth, or face. It may be necessary to discontinue Risperidone Kern Pharma.
• Have a 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, consult your doctor or pharmacist before taking Risperidone Kern Pharma.

Risperidone Kern Pharma 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 Kern Pharma, 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 if you have slurred speech, even if it is 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 while taking risperidone, changing the administration schedule may improve your attention difficulties.

Taking Risperidone Kern Pharma with other medicines

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

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

• 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 can cause a slow heartbeat.
• Medicines that can cause low potassium levels in the blood (such as some diuretics).
• Medicines for high blood pressure. Risperidone Kern Pharma 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 certain parts of the body due to fluid retention (such as furosemide or hydrochlorothiazide).

Risperidone Kern Pharma, 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 used to treat 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 types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants.
• Medicines known as beta-blockers (used to treat high blood pressure).
• Phenothiazines (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 taking Risperidone Kern Pharma.

Taking Risperidone Kern Pharma with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Newborn babies of mothers who have used risperidone in the last trimester of pregnancy may have the following symptoms: trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn 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 your own illness, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor has assessed your response to this medicine.

Risperidone Kern Pharma contains lactose

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

3. How to take Risperidone Kern Pharma

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

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 mg 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 to 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 Kern Pharma for schizophrenia.

For the treatment of mania

Adults

• The initial dose will usually 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 mg to 6 mg.

Elderly patients

• The initial dose will usually be 0.5 mg, twice a day.
• Later, your doctor may gradually adjust your dose to 1 mg to 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 Kern Pharma for bipolar mania.

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

Adults (including elderly patients)

• The initial dose will usually be 0.25 mg, twice a day.
• Later, your doctor may gradually adjust 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.
• Treatment duration 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 usually 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 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 may 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.

Treatment duration in patients with conduct disorders should not exceed 6 weeks.

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

Patient 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 Kern Pharma:

Always take Risperidone Kern Pharma 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.

Swallow the medicine with a drink of water.

If you take more Risperidone Kern Pharma than you should

• Go to your doctor immediately. Take the medicine pack with you. You can also 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 Kern Pharma

• 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 the same time) to make up for missed doses.

If you stop taking Risperidone Kern Pharma

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 product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Risperidona Kern Pharma can cause adverse effects, although not all people suffer from them.

Very frequent: affects more than 1 in 10 people

Frequent: 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 less than 1 in 10,000 people

Unknown: the frequency cannot be estimated from the available data

The following side effects may appear:

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.

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 remaining 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, tremor.
• 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, 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, arm and leg pain.
• Rash, skin redness.
• Fast heartbeat, chest pain.
• Increased concentration of the hormone prolactin in the blood.

Uncommon (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, 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, fast 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 muscles and bones of the chest, 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, lung 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 difficulty breathing, sudden weakness or numbness of face, arms, or legs, especially on one side, or cases of confused speech that last 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 otitis media.
• 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 (affects less than 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.

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 are not receiving 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 an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

If you experience adverse effects, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus.

5. Storage of Risperidona Kern Pharma

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

No special storage conditions are required.

Do not use this medicine 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 down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Risperidona Kern Pharma Composition

• The active ingredient is risperidone. Each film-coated Risperidona Kern Pharma tablet contains 1 mg of risperidone.
• The other components are:

Core of the tablet: pregelatinized corn starch, lactose monohydrate, hypromellose (E-464), microcrystalline cellulose (E-460i), anhydrous colloidal silica, sodium lauryl sulfate, and magnesium stearate (E-470b).

Coating: hypromellose 5 cp (E-464) and macrogol 400.

Appearance of the Product and Package Contents

It is presented in the form of film-coated tablets, oblong, scored, and white in color. The score line is to facilitate breaking the tablet to swallow it better, and not to divide the tablet into equal doses.

It is marketed in packages of 30 or 60 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Polígono Ind. Colón II, Venus 72

08228 Terrassa (Barcelona)

Manufacturer

Laboratorios Farmalider, S.A.

C/Aragoneses, nº 2

28108 Alcobendas (Madrid)

or

Laboratorios Tedec Meiji Farma, S.A.

Ctra. M-300, km 30,500

28802 Alcalá de Henares (Madrid)

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 approved in October 2012

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

http://www.aemps.gob.es/