Risperidone Kern Pharma 6 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Risperidone Kern Pharma 6 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Risperidone Kern Pharma is 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 adverse effects
5. How to store Risperidone Kern Pharma
6. Contents of the pack and other information

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

Risperidone Kern Pharma belongs to a group of medicines called "antipsychotics".

Risperidone Kern Pharma is used to treat the following conditions:

• Schizophrenia, which may cause you to see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
• Mania, during which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a condition known as "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's type dementia who are at risk of harming 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 (aged at least 5 years) and adolescents with conduct disorders.

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

Do not take Risperidone Kern Pharma

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

If you are unsure, consult your doctor or pharmacist before using 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 irregular heartbeat, if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidone Kern Pharma may lower 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 have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are male and have ever experienced prolonged or painful erection. If this occurs while taking Risperidone Kern Pharma, contact your doctor immediately.
• You have difficulty regulating 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.
• You or a family member has a history of blood clots, as these medicines may be associated with clot formation.

Contact your doctor immediately if you experience

• Involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of Risperidone Kern Pharma 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 have any doubts about whether the above applies to you, consult your doctor or pharmacist before using Risperidone Kern Pharma.

Risperidone Kern Pharma 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 stroke.

During treatment with Risperidone Kern Pharma, 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 if you experience confusion, even briefly, seek immediate medical attention. These may be signs of 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 Kern Pharma with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use 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 that can alter 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 slow heart rate.
• Medicines that cause low potassium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidone Kern Pharma may lower blood pressure.
• Medicines for Parkinson's disease (e.g., levodopa).
• Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (e.g., 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 reduce 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 heart conditions)
• 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 have any doubts about whether the above applies to you, consult your doctor or pharmacist before using Risperidone Kern Pharma.

Taking Risperidone Kern Pharma with food, drinks, and alcohol

You may 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Newborns whose mothers have taken risperidone during the last trimester of pregnancy may experience symptoms such as tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, or 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 itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring 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 informed you of an intolerance to certain sugars, consult with them before taking this medicine.

Risperidone Kern Pharma contains sunset yellow FCF

This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Risperidone Kern Pharma

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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 how you respond to treatment.
• Most people do well 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 is normally 0.5 mg twice daily.
• Later, your doctor may gradually increase your dose to 1 mg to 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 Kern Pharma for schizophrenia.

For the treatment of mania

Adults

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

Elderly patients

• The initial dose is normally 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 Kern Pharma for bipolar mania.

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

Adults (including elderly patients)

• The initial dose is normally 0.25 mg twice daily.
• Your doctor may gradually change your dose later depending on your response to treatment.
• Most people do well with doses 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 normally 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 normally 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 Kern Pharma 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 Kern Pharma:

Always take Risperidone 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 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 section “How much to take.”

You should swallow the medicine with a drink of water.

If you take more Risperidone Kern Pharma than you should

• Seek medical advice immediately. Take the medicine pack with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy 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. However, if it is nearly time for your next dose, skip the missed dose and continue with your regular schedule.
• Do not take a double dose (two doses at once) to make up for forgotten doses.
• If you miss two or more doses, contact your doctor.

If you stop taking Risperidone Kern Pharma

Do not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to stop 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 Kern Pharma may produce adverse effects, although not everyone experiences them.

Very common: affects more than 1 in every 10 people
Common: affects between 1 and 10 in every 100 people
Uncommon: affects between 1 and 10 in every 1,000 people
Rare: affects between 1 and 10 in every 10,000 people
Very rare: affects fewer than 1 in every 10,000 people
Not known: cannot be estimated from 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 may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

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

• Parkinsonism. This is a medical term that includes several symptoms. Each individual symptom may occur less frequently than 1 in every 10 people. Parkinsonism includes: increased salivation or very wet mouth, musculoskeletal rigidity, drooling, pain when bending limbs, slower, reduced or difficult body movements, lack of facial expression, muscle tightness, torticollis, muscle stiffness, short, 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 every 100 people):

• Drowsiness, fatigue, tiredness, inability to remain still, irritability, anxiety, somnolence, dizziness, attention problems, feeling of exhaustion, sleep disturbances, tremor.
• Vomiting, diarrhoea, 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, 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 blood concentration of the hormone prolactin.

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

• Excessive water drinking, faecal 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, skin 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, abnormal electrical activity of the heart (ECG), abnormal heart rhythm, 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 (mania), lack of energy and interest.
• Increased blood glucose, increased liver enzymes, decreased number of white blood cells, decreased haemoglobin or number of red blood cells (anaemia), increased number of eosinophils (a special type of 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 injury, skin disorder, dry skin, intense 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, milk secretion from breasts, 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, oedema, speech disorder, chills, coordination abnormality.
• Painful sensitivity to light, increased blood flow in the eye, eye swelling, dry eyes, increased tearing.
• Respiratory tract disorder, pulmonary congestion, crackling lung sounds, respiratory tract congestion, difficulty speaking, difficulty swallowing, 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 oedema.

Rare (affects between 1 and 10 in every 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 edge of the eyelid, eye movement disorder.
• Absence of emotions.
• Altered consciousness with increased body temperature and muscle spasms, oedema throughout the body, drug withdrawal syndrome, decreased body temperature.
• Rapid and shallow breathing, breathing problems during sleep, chronic middle ear infection.
• Intestinal obstruction.
• Decreased blood flow to the brain.
• Decreased number of white blood cells, inappropriate 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).
• Inflammation of the pancreas.

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

• Life-threatening complications of uncontrolled diabetes.

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.

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 with 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, cells that help protect you from bacterial infections
• Depression
• Seizures
• Eye twitching
• Sensation of spinning or swaying
• Slow heartbeat, increased blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight loss

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

5. Storage of Risperidone 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 expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Risperidone Kern Pharma

• The active substance is risperidone. Each film-coated tablet of Risperidone Kern Pharma contains 6 mg of risperidone.
• The other components are:

Tablet core: pregelatinized maize 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), macrogol 400, talc, titanium dioxide (E-171), quinoline yellow (E-104), and orange yellow S (E-110).

Appearance of the product and contents of the pack

It is presented as yellow, film-coated, circular, biconvex tablets.

It is marketed in packs 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 leaflet was approved in October 2012

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/