Risperidone Alter 6 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidone Alter 6 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Risperidone Alter 6 mg is and what it is used for
2. Before you take Risperidone Alter 6 mg
3. How to take Risperidone Alter 6 mg
4. Possible side effects
5. How to store Risperidone Alter 6 mg
6. Further information

1. What is RISPERIDONE ALTER 6 mg and what is it used for?

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

Risperidone is used to treat the following conditions:

• Schizophrenia, 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, in which you may feel overly 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 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 (aged at least 5 years) and adolescents with conduct disorders.

2. BEFORE TAKING RISPERIDONE ALTER 6 mg

Do not take Risperidone Alter if:

• You are allergic (hypersensitive) to the active substance or to any of the components of Risperidone Alter (listed in section 6 below).

If you are unsure whether this applies to you, consult your doctor or pharmacist before using Risperidone Alter.

Take special care with Risperidone Alter

Consult your doctor or pharmacist before taking Risperidone if:

• You have any heart problems. Examples include irregular heart rhythms, a tendency to low blood pressure, or if you are taking medications for blood pressure. Risperidone may lower blood pressure. You may require a dose adjustment.
• You or a family member have a history of blood clots. These medicines may be associated with an increased risk of clot formation.
• You have any risk factors that may predispose you to stroke, such as high blood pressure, cardiovascular disease, or cerebrovascular disorders.
• You have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are a male who has previously experienced prolonged or painful erections. If this occurs while taking Risperidone, 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.

Contact your doctor immediately if you experience:

• Involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of Risperidone may be necessary.
• Fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition known as "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 Alter.

Risperidone 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, 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 a 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.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription and herbal products.

It is especially important that you discuss 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 (benzodiazepines), or certain pain medications (opioids), or antihistamines used for allergies, as risperidone may enhance their sedative effects.
• Medicines that can alter the electrical activity of your heart, such as those used for malaria, heart rhythm disorders (e.g., quinidine), antihistamines, certain antidepressants, or other psychiatric medications.
• 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 may lower blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Diuretics used for heart problems or to treat swelling in certain body parts due to fluid retention (e.g., furosemide or chlorothiazide). Risperidone, alone or in combination 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 require 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 (e.g., used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)

If you start or stop taking these medicines, you may require 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 Alter.

Taking Risperidone Alter with food and drinks

You may take this medicine with or without food. You should avoid alcohol while taking Risperidone.

Pregnancy and breastfeeding

Consult your doctor before using Risperidone if you are pregnant, trying to become pregnant, or breastfeeding. Your doctor will decide whether you may take it.

Newborns of mothers who have taken Risperidone during the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and 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

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

Important information about some of the components of Risperidone Alter 6 mg tablets

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

3. HOW TO TAKE RISPERIDONE ALTER 6 mg

How much to take

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day; this may be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose depending on your response to treatment.
• Most people respond best to daily doses of 4 to 6 mg.
• This total daily dose may be divided into one or two doses per day. Your doctor will tell you what is best for you.

Elderly patients

• The usual initial dose is 0.5 mg twice daily.
• Your doctor may gradually increase your dose later to 1 mg–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 for schizophrenia.

For the treatment of mania

Adults

• The usual initial dose is 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people respond best to daily doses of 1 to 6 mg.

Elderly patients

• The usual initial dose is 0.5 mg twice daily.
• 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 for bipolar mania.

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

Adults (including elderly patients)

• The usual initial dose is 0.25 mg twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people respond best to 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 weight is less than 50 kg

• The usual initial dose is 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 usual initial dose is 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 for conduct disorders.

Patients with liver or kidney problems

Regardless of the condition being treated, all initial and subsequent doses of risperidone should be halved. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this patient group.

How to take Risperidone Alter

Always take Risperidone Alter 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 condition and may vary from person to person. The amount of medicine you should take is explained above under the heading “How much to take.”

Risperidone Alter film-coated tablets

• You should swallow the tablet with a glass of water.

If you take more Risperidone Alter than you should

• Seek medical help immediately. Take the medicine package 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 Alter

• 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 the same time) to make up for a missed dose.
• If you miss two or more doses, contact your doctor.

If you stop taking Risperidone Alter

Do not stop treatment unless your doctor tells you to. Symptoms may return. If your doctor decides to discontinue 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 can cause adverse effects, although not everyone will experience them.

Very common: affects more than 1 in 10 people
Common: 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 fewer than 1 in 10,000 people
Not known: frequency cannot be estimated from available data

The following side effects may occur:

Very common (affects more than 1 in 10 people)

• Parkinsonism. This 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 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, shuffling steps when walking with feet dragging, 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 100 people):

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

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

• Excessive water intake, fecal 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, low blood pressure, dizziness when changing position, abnormal electrical activity of the heart (ECG), irregular heartbeat, awareness of heartbeat, rapid 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 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, 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 hypersensitivity to light, increased blood flow to 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, flu-like 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 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, crusting at the eyelid margin, eye movement disorder
• Absence of emotions
• Altered consciousness with increased body temperature and muscle spasms, whole-body 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 breakdown 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 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
• 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, contact your doctor immediately.

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, 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.

If you think any of the adverse effects you are experiencing are severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of RISPERIDONE ALTER 6 mg

Do not store above 30 °C.

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the container, following 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 the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Risperidona Alter

The active substance is risperidone.

Each risperidone 6 mg film-coated tablet contains 6 mg of risperidone.

The other components are:

Tablet core:

Monohydrate lactose, pregelatinized starch, microcrystalline cellulose, hydroxypropylmethylcellulose, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.

Coating:

Hydroxypropylmethylcellulose, titanium dioxide, and triacetin.

Appearance of Risperidona Alter and contents of the container

Risperidone 6 mg film-coated tablets are oblong and white.

They are marketed in packs of 30 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

This leaflet was last reviewed in September 2012

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