Zoxadon 0,5 mg Tablets

Risperidone is an atypical antipsychotic. ZOXADON is indicated for:

• acute and chronic schizophrenia (where you may see, hear, or feel things that are not there, believe things that are not true or feel unusually suspicious or confused) and related psychosis in which positive symptoms and/or the negative symptoms are prominent
• mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive, decreased need for sleep, pressured speech, racing thoughts, distractibility, or poor judgment including disruptive or aggressive behaviours. Mania occurs in an illness called ‘bipolar disorder’
• conduct and other disruptive behaviour disorders in children (aged 5 -12 years), with sub-average intellectual functioning or mental retardation in whom destructive behaviours are prominent.

Do not take ZOXADON:

• if you are hypersensitive (allergic) to risperidone, or to any of the other ingredients of ZOXADON (listed in section 6)
• Do not give this medicine to children under 5 years with conduct and other disruptive behaviour disorders
• if you have Parkinson’s disease (muscle weakness, muscle stiffness, impaired and slow movement and shaking)
• if you have Lewy body dementia (a form of progressive dementia).

Warnings and precautions

Take special care with ZOXADON: Tell your doctor:

• if you know of any factors which would increase your chance of you having a stroke, such as high blood pressure, cardiovascular disorder, or blood vessel problems in the brain
• if you suffer from heart disease (examples include an irregular heart rhythm) or if you have low blood pressure or if you are taking furosemide (medicine for your blood pressure). ZOXADON can cause low blood pressure. Your dose needs to be adjusted
• if your doctor has told you that you have a low white blood cell count. Your doctor may check your white blood cell counts during therapy
• if you or someone else in your family has a history of blood clots, as ZOXADON has been associated with formation of blood clots
• if you have a condition called tardive dyskinesia: characterised by jaw movements, chewing-like movements, tongue movements, smacking of the lips or involuntary rapid arm or leg movements
• if you are taking a medicine called methylphenidate together with ZOXADON, as this combination may increase the risk of unwanted side effects
• if you experience any of the following symptoms of neuroleptic malignant syndrome (NMS): muscle spasms, irregular pulse or blood pressure, high fever, irregular heart rate, increased heart rate and increased sweating (perspiration)
• if you suffer from Parkinson's disease. ZOXADON may worsen the symptoms of these conditions
• if you suffer from epilepsy: fits/seizures. ZOXADON may worsen the symptoms of these conditions
• if you have diabetes: high blood sugar. As diabetes mellitus or worsening of pre-existing diabetes mellitus has been seen in patients taking ZOXADON, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus, blood glucose should be monitored regularly
• if you have a tendency to gain weight easily
• if you experience any of the following: excessive or inappropriate production or breastmilk, enlargement of a man’s breasts, disturbances in the menstrual cycle
• if you experience persistent and painful erections of the penis
• you have problems controlling your body temperature or overheating
• if you are planning to have an eye operation, intraoperative floppy iris syndrome may increase the risk of eye complications during and after cataract surgery
• if you suffer from kidney or liver function impairment.

Elderly people with dementia: In elderly patients with dementia, there is an increased risk of stroke. You should not take ZOXADON if you have dementia caused by stroke. During treatment with ZOXADON you should frequently see your doctor. Medical treatment should be sought straight away if your caregiver notices a sudden change in your mental state or sudden weakness or numbness of your face, arms, or legs, especially on one side, or slurred speech, even for a short period of time. Studies in elderly patients with dementia have shown that ZOXADON taken by itself or with furosemide, is associated with a higher rate of death. Tell your doctor if you are taking furosemide. Furosemide is a medicine which is sometimes used to treat high blood pressure, some heart problems or to treat swelling of parts of the body caused by the build-up of too much fluid.

Children and adolescents

Children and adolescents under 15 years should not be treated with ZOXADON for schizophrenia or mania. Before treatment is started for conduct disorder, other causes of aggressive behaviour should have been ruled out. If during treatment with ZOXADON tiredness occurs, a change in the time of administration might improve attention difficulties. Before treatment is started your, or your child’s body weight may be measured, and it may be regularly monitored during treatment.

Do not share medicines prescribed for you with any other person. Always use ZOXADON exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Treatment of schizophrenia

If you are already using an antipsychotic medicine, your doctor may gradually discontinue this treatment when switching to ZOXADON. If you are receiving a depot injection, your doctor will initiate ZOXADON treatment in place of the next scheduled injection.

You may take ZOXADON either once daily or twice daily.

Initial adult dose:

The usual dose is 2 mg per day. Your doctor may increase the dosage to 4 mg per day on the second day.

Maintenance dose:

Your doctor will decide what the optimum maintenance dose is based on your response. The usual maintenance dose is 4 mg to 8 mg daily, but your doctor may increase the total dose up to 16 mg per day.

Elderly patients and patients with kidney or liver problems:

The starting dose is usually 0,5 mg twice daily. Your doctor may increase the dose up to 1 - 2 mg twice daily.

Children:

Not suitable for the treatment of schizophrenia in children under the age of 15. For children older than 15, doses similar to that for adults may be administered.

Treatment for mania in bipolar disorders

Initial adult dose:

The usual dose is 2 mg or 3 mg per day.

Maintenance dose:

Your doctor may decide to increase your dosage, based on your response. The usual maintenance dose is 1 - 6 mg daily.

Use in children and adolescents

Children and adolescents under 18 years old should not be treated with ZOXADON for bipolar mania.

Conduct and other disruptive behaviour disorders in children 5 - 12 years of age

The usual starting dose is 0,01 mg per kg once daily. The doctor may increase the dose by 0,01 mg/kg every other day, if needed, to a maintenance dose of 0,02 - 0,04 mg per kg once daily. Your doctor will tell you how long your treatment with ZOXADON will last. Do not stop treatment early because your symptoms may return. If you have the impression that the effect of ZOXADON is too strong or too weak, tell your doctor or pharmacist.

If you take/use more ZOXADON than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include: feeling sleepy or tired, abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heartbeats.

If you forget to take/use ZOXADON

If you missed a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue to take the tablet at the usual time. Do not take a double or larger dose to make up for forgotten individual doses. If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

If you stop taking/using ZOXADON

You should not stop taking ZOXADON unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop ZOXADON, your dose may be decreased gradually over a few days.

ZOXADON can have side effects. Not all side effects reported for ZOXADON are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using ZOXADON, please consult your healthcare provider for advice.

If any of the following happens, stop using ZOXADON and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ZOXADON. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• swelling, pain, and redness in the leg, difficulty breathing, tight chest, discoloured lips – signs of a blood clot in the leg or lungs
• dangerously lowered white blood cell count that leads to severe infection (agranulocytosis) with symptoms that may include fever and chills, muscle weakness and fatigue, low blood pressure (feeling dizzy), ulcers in the mouth or throat
• a condition that causes the body to retain water and certain levels of electrolytes in the blood to fall (such as sodium)
• dangerously excessive intake of water
• life threatening complications of uncontrolled diabetes (high blood sugar)
• confusion (or change in mental state), depression, staying still, fast, or strange movements, difficulty in expressing emotions, manic episodes

Tell your doctor if you notice any of the following:

Frequent side effects:

• pneumonia, infection of the chest (bronchitis), common cold symptoms, urinary tract infection, feeling like you have the flu
• increased levels of a hormone called prolactin found on a blood test (which may or may not cause symptoms, common symptoms may include breast swelling in men, difficulty in getting or maintaining erections, or other sexual dysfunction; breast discomfort, leakage of milk from the breasts, missed or other problems with menstrual periods in women
• weight gain, increased appetite, decreased appetite
• insomnia, sleep disorders, depression, anxiety, agitation
• dizziness, sleepiness, headache, drowsiness, muscle quivering, restlessness, and inability to sit still, involuntary movements of muscles, the eyes, mouth, tongue, or jaw (dystonia), tremors
• blurred vision
• high blood pressure
• breathing difficulty, sore throat, cough, nose bleeds, stuffy nose
• abdominal pain or discomfort, vomiting, nausea, constipation, diarrhoea, indigestion dry mouth, toothache
• skin rash or itching
• muscle spasms, bone or muscle ache, back pain, joint pain
• incontinence (lack of control of urine)
• general swelling, fever, chest pain, asthenia (general weakness), fatigue, swelling in your lower legs or hands
• fall.

Less frequent side effects:

• sinusitis, ear infection, chest infection, bladder infection, eye infection, tonsillitis, ear infection, fungal infection in the nails, infection of the skin, viral infections
• abnormal blood test results, anaemia, decrease in red/white blood cells
• glucose present in the urine (determined through urine tests)
• anorexia, excess thirst, high blood sugar levels (hyperglycaemia), weight loss
• decreased libido, nervousness, nightmares, delayed, infrequent or absent orgasms
• Tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body), disturbance in attention, lack of taste
• dizziness when standing up, slurred speech, numbness, tingling or pricking sensation (pins and needles), increased duration of sleep, speech disorder, uncontrollable nodding of your head, diabetic coma, movement disorder (problems with physical coordination, trouble walking, episodes of uncontrolled movements, muscle weakness, twitching, or muscle spasm), pacing around the room, tapping your toes, or rapid talking
• changes in vision, pink eye, eye oversensitivity to light, dry eye, eye watering (increased tears), red eyes, eye movement disorder, dilation pupils or glaucoma (high eye pressure), eye rolling, eye discharge and eyelid crusting, eye swelling
• vertigo, ringing in the ears, ear pain
• low blood pressure, drop in blood pressure when standing up, flushing
• pneumonia caused by inhaling food, lung congestion, congestion of breathing passages, crackly lung sounds, wheezing, voice disorder, breathing passage disorder, hyperventilation
• stomach or intestinal infection, stool incontinence, very hard stool, difficulty swallowing, excessive passing of gas or wind, swollen tongue, lip swelling
• increased liver transaminases in your blood, increased GGT (a liver enzyme called gamma-glutamyl transferase) in your blood, increased liver enzymes in your blood
• hives (nettle rash), itching, thickening of skin, eczema, dry skin, skin discolouration, acne, dandruff, skin disorder, skin lesion, painless swelling under the skin
• an increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown
• abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• frequent urination or increase in amount of urine, pain when passing urine
• sexual dysfunction (erectile and ejaculation dysfunction), menstrual disorders, abnormal absence of menstruation, unusual secretion of milk; breast enlargement in men, milky nipple discharge, breast discomfort, enlargement, pain or engorgement, vaginal discharge, decreased sexual desire
• swollen or puffy face, chills, increased or decreased body temperature, coldness in arms and legs, abnormal gait (change in the way you walk), thirst, chest discomfort, general feeling of discomfort, illness, or unease, discomfort, drug withdrawal symptoms, hardening of the skin, flu-like sickness, sluggishness
• procedural pain.

The following side effects have been reported but the frequency for them to occur is not known:

• diabetes or worsening of diabetes, increased cholesterol, low blood sugar, blood triglycerides (a type of fat) increased
• mania (mental illness marked by periods of great excitement or euphoria, delusions, and over activity)
• sleep walking, sleep related eating disorder, altered taste
• eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken ZOXADON. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken ZOXADON
• irregular heart rhythm that can be seen on an electrocardiogram (extended interval between the heart contracting and relaxing)
• sleep apnoea (a potentially serious sleep disorder in which breathing repeatedly stops and starts)
• intestinal obstruction, pancreatitis (inflammation of the pancreas with symptoms including abdominal pain, nausea, vomiting), paralytic ileus (occurs when the muscle contractions that move food through your intestines are temporarily paralyzed)
• hair loss
• neonatal drug withdrawal syndrome
• prolonged and painful erection of the penis
• hypothermia (an abnormally, typically dangerously low body temperature).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 25 °C. For tablets in blisters: Keep the blisters in the carton until required for use. For tablets in containers: keep well closed in the original container. Do not store in a bathroom. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).