Leaflet: information for the user

Risperidone Kern Pharma 3 mg film-coated tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Risperidone Kern Pharma and what it is used for

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

3. How to take Risperidone Kern Pharma

4. Possible side effects

5. Storage of Risperidone Kern Pharma

6. Contents of the pack and additional information

Risperidona Kern Pharma belongs to a group of medications known as “antipsychotics”.

Risperidona Kern Pharma is used to treat the following:

• Schizophrenia, with which you may see, hear, or feel things that are not there, believe in something that is not true, or feel particularly suspicious or confused.
• Mania, with which you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania appears in a disease called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease dementia, who harm themselves or others. They must have previously tried alternative non-pharmacological treatments.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years old), and adolescents with behavioral disorders.

Do not take Risperidona Kern Pharma

• If you are allergic (hypersensitive) to risperidone or any of the components of this medication (including those listed in section 6).

If you are unsure, consult your doctor or pharmacist before using Risperidona Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risperidona Kern Pharma 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 using blood pressure medications. Risperidona 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 diseases, or problems with blood vessels in the brain.
• You have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are a male and have had a prolonged or painful erection at any time. If you experience this while taking Risperidona Kern Pharma, contact your doctor immediately.
• You have difficulty controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• You or a family member has a history of blood clots, as these medications may be associated with their formation.

Consult your doctor immediately if you have

If you are unsure about whether the information above affects you, consult your doctor or pharmacist before using Risperidona Kern Pharma.

Risperidona Kern Pharma may cause you to gain weight.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of stroke.

You should not take risperidone if you have dementia caused by a stroke.

You should see your doctor regularly during treatment with Risperidona Kern Pharma.

If you or your caregiver notice a sudden change in your mental state or the sudden onset of weakness or numbness in the face, arms, or legs, especially on one side, or if you experience confusion, even for a short time, seek immediate medical treatment. This 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 times may help improve your attention difficulties.

Taking Risperidona Kern Pharma with other medications

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

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

Risperidona Kern Pharma, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may reduce the effect of risperidone:

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:

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

If you are unsure about whether the information above affects you, consult your doctor or pharmacist before using Risperidona Kern Pharma.

Taking Risperidona Kern Pharma with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Risperidone may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Risperidona Kern Pharma contains lactose

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take:

For the treatment of schizophrenia

Adults

Older adults

Children and adolescents

For the treatment of mania

Adults

Older adults

Children and adolescents

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

Adults (including older adults)

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If your child weighs less than 50 kg

If your child weighs 50 kg or more

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

Children under 5 years old should not receive treatment with Risperidona Kern Pharma for behavioral disorders.

Patients with liver or kidney problems

Unless the disease being treated is considered, 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 Risperidona Kern Pharma:

Take Risperidona Kern Pharma exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Your doctor will tell you how much medication to 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 earlier in the section "How much to take".

You should swallow the medication with a glass of water.

If you take more Risperidona Kern Pharma than you should

If you forgetto take Risperidona Kern Pharma

If you interrupt treatment with Risperidona Kern Pharma

You should not stop taking the treatment unless your doctor tells you to. Symptoms may reappear. If your doctor decides to stop treatment, your dose may be gradually reduced over a few days.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Risperidona Kern Pharma may cause side effects, although not everyone will experience them.

Very common:affect more than 1 in 10 people

Common:affect between 1 and 10 in 100 people

Uncommon: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 occur:

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.

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

• Parkinsonism. It 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 a very wet mouth, muscular skeletal rigidity, drooling, pain when bending the limbs, slower, reduced, or difficult body movements, lack of facial expression, muscle tension, torticollis, muscle rigidity, short and rapid steps, dragging the feet, and absence of normal arm movements, persistent blinking as a response to forehead taps (an abnormal reflex).
• Headache, difficulty staying or remaining asleep.

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

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

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

• Excessive water consumption, fecal incontinence, thirst, hard stools, hoarseness or voice disorder.
• Pneumonia caused by food passing into the respiratory tract, urinary tract infection, eye redness, sinusitis, viral infection, ear infection, tonsillitis, skin infection, eye infection, stomach infection, ocular secretion, fungal nail infection.
• Abnormal heart conduction, low blood pressure when standing, decreased blood pressure, sensation of dizziness when changing position, abnormal heart activity (ECG), abnormal heart rhythm, feeling of heartbeats, fast or slow heart rate.
• Urinary incontinence, painful urination, frequent urination.
• Confusion, attention disorder, low level of consciousness, excessive sleep, nervousness, manic state, 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 lesion, skin disorder, dry skin, intense itching, acne, hair loss, skin inflammation caused by mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, oily skin inflammation.
• Amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, breast enlargement in males, decreased sexual desire, irregular menstruation, vaginal secretion.
• Loss of consciousness, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling of "discomfort", balance disorder, allergy, edema, speech disorder, chills, coordination disorder.
• Photophobia, increased blood flow to the eye, eye swelling, dry eyes, increased tear production.
• Respiratory tract disorder, pulmonary congestion, lung crepitus, respiratory tract congestion, speech difficulty, swallowing difficulty, cough with sputum, hoarse or hissing sound when breathing, pseudogripal disease, sinusitis.
• Loss 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 (mini-stroke or cerebral attack), involuntary movements of the face, arms, or legs, tinnitus, facial edema.

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

• Inability to achieve orgasm, menstrual disorder.
• Dandruff.
• Medication allergy, coldness in arms and legs, lip swelling, lip inflammation.
• Glaucoma, decreased visual acuity, corneal crust formation, eye movement.
• Lack of emotions.
• Consciousness alteration with increased body temperature and muscle spasms, body edema, medication withdrawal syndrome, decreased body temperature.
• Fast and shallow breathing, respiratory problems during sleep, chronic otitis media.
• 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.
• Yellow skin and eyes (jaundice).
• Pancreatitis.

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

• Life-threatening complications of uncontrolled diabetes.

Unknown frequency of side 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.
• Excessive water intake.

Risperidona long-acting injectable:

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

• Intestinal infection
• Subcutaneous abscess, skin tingling, skin pinching, or numbness, skin inflammation
• Decreased white blood cell count, cells that help protect you from bacterial infections
• Depression
• Seizures
• Eye blinking
• Sensation of rotation or oscillation
• Slow heart rate, increased blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight loss.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

If you experience side effects, consult your doctor or pharmacist, even if it is not listed in this prospectus.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Risperidona Kern Pharma

Core of the tablet: pregelatinized cornstarch, 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), macrogol 400, talc, titanium dioxide (E-171), and quinoline yellow (E-104).

Appearance of the product and content of the packaging

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

It is marketed in packaging of 30 or 60 tablets.

Holder of the marketing authorization

Kern Pharma, S.L.

Polígono Ind. Colón II, Venus 72

08228 Terrassa (Barcelona)

Responsible for manufacturing

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 leaflet was approved in October 2012

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/