Risnia Side Effects

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Answer the side-effect intent for risnia without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Risnia?

Risnia contains the active ingredient Risperidone.

• Active ingredient — Risperidone
• Registration number — A41/2.6.5/0445; A41/2.6.5/0446; A41/2.6.5/0468; A41/2.6.5/0469
• Registration holder — Pharma Dynamics (Pty) Ltd

It is approved 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

Common side effects of Risnia

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

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)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• 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)

Use with care, and tell your doctor, if

• 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. For the treatment of conduct disorder, the doctor will prescribe the suitable dose and treatment duration according to the patient’s weight. Children under 5 years should not be treated with ZOXADON for conduct disorder. A small and inconclusive study has reported an increase in height in children who took ZOXADON, but whether this is an effect of the medicine or due to some other reason is not known

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist, or other healthcare provider for advice before taking this medicine
• The safety of ZOXADON in pregnancy and breastfeeding women has not yet been established
• If you are pregnant or if you are planning to become pregnant, you should inform your doctor, who will decide if you can take ZOXADON
• Shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding, have been observed in newborns, if a mother used ZOXADON in the last trimester of her pregnancy
• Do not breastfeed if you are taking ZOXADON
• ZOXADON can raise your levels of a hormone called prolactin that may impact fertility (see

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines that work on your brain, such as to help you calm down (benzodiazepines) or some medicines for pain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these
• Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other medicines for mental problems
• Do not take alcohol as this may make you sleepy
• Medicines for Parkinson’s disease (such as levodopa), as ZOXADON may cause these medicines to be less effective
• Medicines to treat raised blood pressure. ZOXADON can lower blood pressure
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)
• Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build-up of too much fluid (such as furosemide or chlorothiazide). ZOXADON taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia
• Paliperidone (used to treat schizophrenia) is not recommended for use with ZOXADON. The following medicines may reduce the effect of ZOXADON
• Rifampicin (a medicine for treating some infections)
• Carbamazepine, phenytoin medicine mainly used for epilepsy or trigeminal neuralgia (severe pain attacks in the face), may change the effect of ZOXADON. Therefore, inform your doctor if you start or stop taking carbamazepine. If you start or stop taking such medicines, you may need a different dose of ZOXADON. The following medicines may increase the effect of ZOXADON
• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (such as medicines used to treat psychosis or to calm down)
• Cimetidine and ranitidine, two medicines used to reduce stomach acid, may slightly increase the level of ZOXADON in your blood, but they are unlikely to change the effect of ZOXADON
• Itraconazole and ketoconazole (medicines for treating fungal infections)
• ZOXADON can enhance the effect of medicines that reduce the ability to react (e.g., tranquilisers, narcotic painkillers, certain antihistamines, certain antidepressants), only take these medicines if your doctor prescribes them
• Certain medicines used in the treatment of HIV/AIDS, such as ritonavir
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm. If you start or stop taking such medicines, you may need a different dose of ZOXADON. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using ZOXADON. ZOXADON with food, drink, and alcohol Refer to section 3. ZOXADON can enhance the effects of alcohol, so do not drink alcohol whilst taking ZOXADON

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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