Source: Health Products Regulatory Authority (ZA) Publisher: Abex Pharmaceutica (Pty) Ltd, Suite C, Rubenstein Ridge, 617 Rubenstein Drive, Moreleta Park, 0181
Before prescribing, medical practitioners are advised to carefully assess the risks and benefits of the use of atypical antipsychotics in elderly patients with dementia, taking into account risk predictions for stroke in the individual patient (e.g. hypertension, diabetes, current smoking, atrial fibrillation, and age >80 years).
Where the use of antipsychotics in the elderly is considered essential, the lowest effective dose should be used. These patients should be carefully monitored to avoid or reduce hypotension, gait disturbances, oversedation and complications associated with hyperglycaemia.
Risperidone is not indicated in elderly patients with dementia exhibiting behavioural disturbances.
Elderly patients with dementia treated with atypical antipsychotic medicines have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotic medicines, including risperidone. In placebo-controlled trials with oral risperidone in this population, the incidence of mortality was 4,0% for risperidone-treated patients compared to 3,1% for placebo-treated patients. The mean age (range) of patients who died was 86 years (range 67 to 100).
In risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide and risperidone (7,3%; mean age 89 years, range 75 to 97) when compared to patients treated with risperidone alone (3,1%; mean age 84 years, range 70 to 96) or furosemide alone (4,1%; mean age 80 years, range 67 to 90). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised, and the risks and benefits of this combination should be considered prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant medicine with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
In placebo-controlled clinical trials in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse events (cerebrovascular accidents and transient ischaemic attacks), including fatalities, in patients treated with risperidone compared to patients receiving placebo (mean age 85 years; range 73 to 97 years).
Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during the initial dose titration period. Risperidone as in RISPIDE should be used with caution in patients with known cardiovascular disease, and the dosage should be gradually titrated as recommended. A dose reduction should be considered if hypotension occurs.
Events of leukopenia, neutropenia and agranulocytosis have been reported with risperidone as in RISPIDE. Agranulocytosis has been reported during post-marketing surveillance. Patients with a history of a clinically significant low white blood cell count (WBC) or a medicine-induced leukopenia/neutropenia should be monitored during therapy and discontinuation of RISPIDE should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1 X 109/L) should discontinue RISPIDE and have their WBC followed until recovery.
Cases of venous thromboembolism (VTE) have been reported with risperidone. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with risperidone as in RISPIDE and preventive measures undertaken.
Risperidone as in RISPIDE has been associated with the induction of tardive dyskinesia (TD) characterised by potentially irreversible rhythmical involuntary movements, predominantly of the tongue and/or face. It has been reported that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. TD appears to be most prominent in the elderly especially elderly females. If signs and symptoms of tardive dyskinesia appear, the discontinuation of RISPIDE should be considered.
Neuroleptic malignant syndrome, a potentially fatal symptom complex, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur in association with risperidone as in RISPIDE. Additional signs may include elevated creatine phosphokinase levels, myoglobinuria (rhabdomyolysis) and acute renal failure. In this event, RISPIDE should be discontinued.
Patients with Parkinson's disease or dementia with Lewy Bodies (DLB) have an increased risk of neuroleptic malignant syndrome (NMS) as well as having an increased sensitivity to antipsychotic medicines (see section 4.3). Manifestation of this increased sensitivity can include confusion, obtundation and postural instability with frequent falls, in addition to extrapyramidal symptoms. In addition, in clinical trials, elderly patients have a higher mortality than placebo-treated elderly patients (see section 4.3).
Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with risperidone as in RISPIDE.
Patients with an established diagnosis of diabetes mellitus who are starting on risperidone as in RISPIDE should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history of diabetes) who are starting treatment with RISPIDE should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycaemia during treatment with RISPIDE should undergo fasting blood glucose testing.
In some cases, hyperglycaemia has resolved when risperidone was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of risperidone.
Significant weight gain has been reported. Monitoring weight gain is advisable when RISPIDE is being used. Patients may be advised to refrain from excessive eating in view of the possibility of weight gain.
Hyperprolactinaemia is a common side effect of treatment with risperidone as in RISPIDE. Evaluation of the prolactin plasma level is recommended in patients with evidence of possible prolactin-related side effects (e.g., gynaecomastia, menstrual disorders, anovulation, fertility disorder, decreased libido, erectile dysfunction, and galactorrhoea).
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin. Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history. RISPIDE should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours.
Caution should be exercised when RISPIDE is prescribed in patients with a history of cardiac dysrhythmias, in patients with congenital long QT syndrome, and in concomitant use with medicines known to prolong the QT-interval.
Medicines with alpha-adrenergic blocking effects have been reported to induce priapism. Priapism has been reported with risperidone as in RISPIDE during post-marketing surveillance (see section 4.8).
Disruption of the body's ability to reduce core body temperature may occur. Appropriate care is advised when prescribing RISPIDE to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g. exercising strenuously, exposure to extreme heat, receiving concomitant medicines with anticholinergic activity, or being subject to dehydration.
An antiemetic effect was observed in preclinical studies with risperidone as in RISPIDE. This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicines or of conditions such as intestinal obstruction, Reye's syndrome, and brain tumour.
Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than adults with normal renal function. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone (see section 4.2).
Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha1a-adrenergic antagonist effect, including risperidone as in RISPIDE.
IFIS may increase the risk of eye complications during and after the operation. Current or past use of RISPIDE should be made known to the ophthalmic surgeon in advance of surgery. The potential benefit of stopping RISPIDE prior to cataract surgery has not been established and should be weighed against the risk of stopping RISPIDE therapy.
RISPIDE should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold .
Before risperidone as in RISPIDE is prescribed to a child or adolescent with conduct disorder they should be fully assessed for physical and social causes of the aggressive behaviour such as pain or inappropriate environmental demands.
The sedative effect of risperidone as in RISPIDE should be closely monitored in this population because of possible consequences on learning ability. A change in the time of administration of RISPIDE could improve the impact of the sedation on attention faculties of children and adolescents.
Risperidone as in RISPIDE was associated with mean increases in body weight and body mass index (BMI). Baseline weight measurement prior to treatment and regular weight monitoring are recommended. Changes in height in the long-term open-label extension studies were within expected age-appropriate norms. The effect of long-term risperidone treatment on sexual maturation and height has not been adequately studied.
Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in children and adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.
Results from a small post-marketing observational study showed that risperidone-exposed subjects between the ages of 8 to 16 years were on average approximately 3,0 to 4,8 cm taller than those who received other atypical antipsychotic medicines. This study was not adequate to determine whether exposure to risperidone had any impact on final adult height, or whether the result was due to a direct effect of risperidone on bone growth, or the effect of the underlying disease itself on bone growth, or the result of better control of the underlying disease with resulting increase in linear growth.
During treatment with risperidone as in RISPIDE regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.
RISPIDE contains 1,5 mg benzoic acid per 1 ml solution.
An increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).
The risk of using risperidone as in RISPIDE in combination with other medicines has not been systematically evaluated.
Caution is advised when prescribing risperidone with medicines known to prolong the QT-interval, such as antidysrhythmics (e.g., quinidine, dysopiramide, procainamide, propafenone, amiodarone, sotalol), tricyclic antidepressant (i.e., amitriptyline), tetracyclic antidepressants (i.e., maprotiline), some antihistamines, other antipsychotics, some antimalarials (i.e., quinine and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone. This list is indicative and not exhaustive.
Risperidone as in RISPIDE should be used with caution in combination with other centrally acting substances notably including alcohol, opiates, antihistamines, and benzodiazepines due to the increased risk of sedation.
Risperidone as in RISPIDE may antagonise the effect of levodopa and other dopamine agonists. If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
The combined use of psychostimulants (e.g. methylphenidate) with risperidone as in RISPIDE can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4).
Clinically significant hypotension has been observed post-marketing with concomitant use of risperidone as in RISPIDE and antihypertensive treatment.
Concomitant use of oral risperidone as in RISPIDE with paliperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive active antipsychotic fraction exposure.
Food does not affect the absorption of risperidone.
Risperidone is mainly metabolised through CYP2D6, and to a lesser extent through CYP3A4. Both risperidone and its active metabolite 9-hydroxyrisperidone are substrates of P-glycoprotein (P-gp). Substances that modify CYP2D6 activity, or substances strongly inhibiting or inducing CYP3A4 and/or P-gp activity, may influence the pharmacokinetics of the risperidone active antipsychotic fraction.
Co-administration of risperidone as in RISPIDE with a strong CYP2D6 inhibitor may increase the plasma concentrations of risperidone, but less so of the active antipsychotic fraction. Higher doses of a strong CYP2D6 inhibitor may elevate concentrations of the risperidone active antipsychotic fraction (e.g., paroxetine, see below). It is expected that other CYP2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way. When concomitant paroxetine, quinidine, or another strong CYP2D6 inhibitor, especially at higher doses, is initiated or discontinued, the medical practitioner should re-evaluate the dosing of RISPIDE.
Co-administration of risperidone as in RISPIDE with a strong CYP3A4 and/or P-gp inhibitor may substantially elevate plasma concentrations of the risperidone active antipsychotic fraction. When concomitant itraconazole or another strong CYP3A4 and/or P-gp inhibitor is initiated or discontinued, the medical practitioner should re-evaluate the dosing of RISPIDE.
Co-administration of risperidone with a strong CYP3A4 and/or P-gp inducer may decrease the plasma concentrations of the risperidone active antipsychotic fraction. When concomitant carbamazepine or another strong CYP3A4 and/or P-gp inducer is initiated or discontinued, the medical practitioner should re-evaluate the dosing of RISPIDE. CYP3A4 inducers exert their effect in a time-dependent manner and may take at least 2 weeks to reach maximal effect after introduction. Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
When risperidone as in RISPIDE is taken together with highly protein-bound medicines, there is no clinically relevant displacement of either medicine from the plasma proteins. When using concomitant medicines, the corresponding label should be consulted for information on the route of metabolism and the possible need to adjust dosage.
Interaction studies have only been performed in adults. The relevance of the results from these studies in paediatric patients is unknown.
The combined use of psychostimulants (e.g., methylphenidate) with risperidone as in RISPIDE in children and adolescents did not alter the pharmacokinetics and efficacy of risperidone.
Donepezil and galantamine, both CYP2D6 and CYP3A4 substrates, do not show a clinically relevant effect on the pharmacokinetics of risperidone and the active antipsychotic fraction.
Phenothiazines may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Protease inhibitors: No formal study data are available; however, since ritonavir is a strong CYP3A4 inhibitor and a weak CYP2D6 inhibitor, ritonavir and ritonavir-boosted protease inhibitors potentially raise concentrations of the risperidone active antipsychotic fraction.
Some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Verapamil, a moderate inhibitor of CYP3A4 and an inhibitor of P-gp, increases the plasma concentration of risperidone and the active antipsychotic fraction.
H2-receptor antagonists: Cimetidine and ranitidine, both weak inhibitors of CYP2D6 and CYP3A4, increased the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction.
Risperidone does not show a clinically relevant effect on the pharmacokinetics of valproate or topiramate.
Aripiprazole, a CYP2D6 and CYP3A4 substrate: Risperidone tablets or injections did not affect the pharmacokinetics of the sum of aripiprazole and its active metabolite, dehydroaripiprazole.
Risperidone does not show a clinically relevant effect on the pharmacokinetics of digoxin.
Risperidone does not show a clinically relevant effect on the pharmacokinetics of lithium.
There is increased mortality in elderly patients with dementia concomitantly receiving furosemide and risperidone as in RISPIDE (see section 4.4).
The safety of risperidone as in RISPIDE in pregnancy and breastfeeding women has not been established.
Although, in experimental animals, risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed. No teratogenic effect of risperidone was noted in any study.
Neonates exposed to antipsychotic medicines (including risperidone) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms that may vary in severity following delivery. These symptoms in the neonates may include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Therefore, RISPIDE should only be used during pregnancy if the benefits outweigh the risks.
In animal studies risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk. Therefore, women receiving RISPIDE should not breastfeed.
Risperidone elevates prolactin levels. Hyperprolactinaemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients.
RISPIDE may impair mental alertness. Patients should therefore be advised not to drive or operate machinery until their individual susceptibility is known.
The most frequently reported adverse drug reactions (ADRs) are parkinsonism, sedation/somnolence, headache, and insomnia. The ADRs that appeared to be dose-related included parkinsonism and akathisia.
| System Organ Class | Frequent | Less frequent |
|---|---|---|
| Infections and infestations | pneumonia, influenza, bronchitis, upper respiratory tract infection, urinary tract infection, sinusitis, ear infection | viral infection, tonsillitis, cellulitis, otitis media, eye infection, localised infection, acarodermatitis, respiratory tract infection, cystitis, onychomycosis, chronic otitis media |
| Blood and lymphatic system disorders | anaemia, neutropenia, granulocytopenia, white blood cell count decreased, thrombocytopenia, haematocrit decreased, eosinophil count increased, agranulocytosis | |
| Immune system disorders | hypersensitivity, anaphylactic reaction, angioedema | |
| Endocrine disorders | Hyperprolactinaemia (which can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, anovulation, galactorrhoea, fertility disorder, decreased libido, erectile dysfunction) | inappropriate antidiuretic hormone secretion, glucose urine present |
| Metabolism and nutrition disorders | weight increased, increased appetite, decreased appetite | diabetes mellitus, hyperglycaemia, polydipsia, weight decreased, anorexia, blood cholesterol increased, water intoxication, hypoglycaemia, hyperinsulinemia, blood triglycerides increased, diabetic ketoacidosis |
| Psychiatric disorders | insomnia1, sleep disorder, agitation, depression, anxiety | mania, confusional state, libido decreased, nervousness, nightmare, catatonia, somnambulism, sleep related eating disorder, blunted affect, anorgasmia |
| Nervous system disorders | Sedation/somnolence, parkinsonism1, headache, akathisia1, dystonia1, dizziness, dyskinesia1, tremor | tardive dyskinesia, cerebral ischaemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, cerebrovascular accident, transient ischaemic attack, convulsion1, syncope, psychomotor hyperactivity, balance disorder, coordination abnormal, dizziness postural, disturbance in attention, dysarthria, dysgeusia, hypoaesthesia, paraesthesia, neuroleptic malignant syndrome, cerebrovascular disorder, diabetic coma, head titubation |
| Eye disorders | vision blurred, conjunctivitis | photophobia, dry eye, lacrimation increased, ocular hyperaemia, glaucoma, eye movement disorder, eye rolling, eyelid margin crusting, floppy iris syndrome (intraoperative) |
| Ear and labyrinth disorders | vertigo, tinnitus, ear pain | |
| Cardiac disorders | tachycardia | atrial fibrillation, atrioventricular block, conduction disorder, electrocardiogram QT prolonged, bradycardia, electrocardiogram abnormal, palpitations, sinus dysrhythmia |
| Vascular disorders | hypertension | hypotension, orthostatic hypotension, flushing, pulmonary embolism, venous thrombosis |
| Respiratory, thoracic and mediastinal disorders | dyspnoea, pharyngolaryngeal pain, cough, epistaxis, nasal congestion | pneumonia aspiration, pulmonary congestion, respiratory tract congestion, rales, wheezing, dysphonia, respiratory disorder, sleep apnoea syndrome, hyperventilation |
| Gastrointestinal disorders | abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, dyspepsia, dry mouth, toothache | faecal incontinence, faecaloma, gastroenteritis, dysphagia, flatulence, pancreatitis, intestinal obstruction, swollen tongue, ileus, cheilitis |
| Skin and subcutaneous tissue disorders | rash, erythema | urticaria, pruritus, alopecia, hyperkeratosis, eczema, dry skin, skin discolouration, acne, seborrheic dermatitis, skin disorder, skin lesion, drug eruption, dandruff |
| Musculoskeletal and connective tissue disorders | muscle spasms, musculoskeletal pain, back pain, arthralgia | blood creatine phosphokinase increased, posture abnormal, joint stiffness, joint swelling, muscular weakness, neck pain, rhabdomyolysis |
| Renal and urinary disorders | urinary incontinence | pollakiuria, urinary retention, dysuria |
| Pregnancy, puerperium, and neonatal conditions | neonatal medicine withdrawal syndrome | |
| Reproductive system and breast disorders | erectile dysfunction, ejaculation disorder, amenorrhoea, menstrual disorder1, gynaecomastia, galactorrhoea, sexual dysfunction, breast pain, breast discomfort, vaginal discharge, priapism, menstruation delayed, breast engorgement, breast enlargement, breast discharge | |
| General disorders and administration site conditions | oedema1, pyrexia, chest pain, asthenia, fatigue, pain | face oedema, chills, body temperature increased, gait abnormal, thirst, chest discomfort, malaise, feeling abnormal, discomfort, hypothermia, body temperature decreased, peripheral coldness, drug withdrawal syndrome, induration |
| Hepatobiliary disorders | transaminases increased, gamma- glutamyltransferase increased, hepatic enzyme increased, jaundice | |
| Injury, poisoning and procedural complications | fall | procedural pain |
Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal, parkinsonian rest tremor), akathisia (akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia. Dystonia includes dystonia, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus. It should be noted that a broader spectrum of symptoms is included, that do not necessarily have an extrapyramidal origin. Insomnia includes: initial insomnia, middle insomnia; Convulsion includes: Grand mal convulsion; Menstrual disorder includes: Menstruation irregular, oligomenorrhoea; Oedema includes: generalised oedema, oedema peripheral, pitting oedema.
Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another. In addition to the above adverse reactions, the following adverse reaction has been noted with the use of paliperidone products and can be expected to occur with risperidone as in RISPIDE.
Postural orthostatic tachycardia syndrome.
Cases of QT-prolongation have been reported post-marketing with risperidone. Other class-related cardiac effects reported with antipsychotics which prolong QT-interval include ventricular dysrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest, and Torsades de Pointes.
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic medicines (frequency unknown).
The proportions of risperidone and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of ≥7% of body weight were compared in a pool of 6- to 8-week, placebo-controlled trials, revealing a statistically significantly greater incidence of weight gain for risperidone (18%) compared to placebo (9%). In a pool of placebo-controlled 3-week studies in adult patients with acute mania, the incidence of weight increase of ≥7% at endpoint was comparable in the risperidone (2,5%) and placebo (2,4%) groups and was slightly higher in the active-control group (3,5%).
In a population of children and adolescents with conduct and other disruptive behaviour disorders, in long-term studies, weight increased by a mean of 7,3 kg after 12 months of treatment. The expected weight gain for normal children between 5 to 12 years of age is 3 to 5 kg per year. From 12 to 16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.
ADRs that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below.
Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1,4% and 1,5%, respectively, in elderly patients with dementia. In addition, the following ADRs were reported with a frequency ≥5% in elderly patients with dementia and with at least twice the frequency seen in other adult populations: urinary tract infection, peripheral oedema, lethargy, and cough.
In general, the type of adverse reactions in children is expected to be similar to those observed in adults.
The following ADRs were reported with a frequency ≥5% in paediatric patients (5 to 17 years) and with at least twice the frequency seen in clinical trials in adults: somnolence/sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhoea, and enuresis.
The effect of long-term risperidone treatment on sexual maturation and height has not been adequately studied (see 4.4, subsection "Paediatric population")
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the "6.04 Adverse Drug Reactions Reporting Form", found online under SAHPRA's publications: https://www.sahpra.org.za/Publications/Index/8.
Incompatible with most types of tea, including black tea.
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