Risperidone Kern Pharma 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidone Kern Pharma 1 mg film-coated tablets EFG

Read all of 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side 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 side 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:

• Schizophrenia, a condition in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
• Mania, a condition in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a disorder 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 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 heart rhythms, if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidone Kern Pharma may reduce blood pressure. You may need your dose adjusted.
• You have any risk factors that may make you prone to a stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels 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 problems 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 tumour that may be prolactin-dependent.
• You or a family member have 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 are unsure whether any of 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 a 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 in speech, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

Other causes of aggressive behaviour should be ruled out before starting treatment for behavioural 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 that you speak with 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 down (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), certain 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., some 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 certain body parts 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 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 whether any of 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 are planning 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 tremors, 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 impair reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in any activity requiring special alertness until your doctor has assessed your response to this medicine.

Risperidone Kern Pharma contains lactose

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

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 usually 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 must not be treated with Risperidone Kern Pharma 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 do well with daily doses of 1 mg 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 must 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 usually 0.25 mg twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people do well 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 weighing 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 weighing 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 must 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 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 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 glass of water.

If you take more Risperidone Kern Pharma than you should

• Seek medical help immediately. Take the medicine pack with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating 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 a drop in 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 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 once) to make up for a missed dose.
• 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 can produce adverse effects, although not everyone will experience 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
Unknown: frequency cannot be estimated from available data

The following side effects may occur:

Blood clots in the veins, particularly 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.

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, 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 every 100 people):

• Drowsiness, fatigue, tiredness, inability to remain still, irritability, anxiety, somnolence, dizziness, attention disturbances, feeling of exhaustion, sleep disturbances, tremor.
• 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, arms, or 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 prolactin hormone in the blood.

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

• Excessive water intake, fecal incontinence, thirst, very hard stools, hoarseness or voice disorder.
• Lung infection due to 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), 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 (a type of white blood cell), 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, 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 "malaise", balance disorder, allergy, edema, 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, speech difficulties, 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 edema.

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, body-wide edema, 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 rupture 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 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 cell that helps 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 Risperidone injections:

• 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, talk to your doctor or pharmacist, even if these effects are not listed in this leaflet. You may also report them directly via 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 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 empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Risperidone Kern Pharma

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

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

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

Appearance of the medicinal product and contents of the container

The product is presented as film-coated, oblong, scored tablets, white in color. The score mark is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

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/