Source: Registered Drug Product Database (NG) Revision Year: 2022 Publisher: MICRO LABS LIMITED, 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635 126, TAMILNADU, INDIA
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In a meta-analysis of 17 controlled trials of atypical antipsychotics, including Risperidone, elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo. 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 odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1). The mean age (range) of patients who died was 86 years (range 67-100). Data from two large observational studies showed that elderly people with dementia who are treated with conventional antipsychotics are also at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
In the Risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus Risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with Risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90). The increase in mortality in patients treated with furosemide plus Risperidone was observed in two of the four clinical trials.
Concomitant use of Risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
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 or co-treatment with other potent diuretics should be considered prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with Risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomized placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The pooled data from six placebo-controlled studies with Risperidone in mainly elderly patients (>65 years of age) with dementia showed that CVAEs (serious and non-serious, combined) occurred in 3.3% (33/1009) of patients treated with Risperidone and 1.2% (8/712) of patients treated with placebo. The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50). The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Risperidone should be used with caution in patients with risk factors for stroke.
The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer's dementia. Therefore, patients with other types of dementias than Alzheimer's should not be treated with Risperidone.
Physicians are advised to assess the risks and benefits of the use of Risperidone in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient. Patients/caregivers should be cautioned to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems. All treatment options should be considered without delay, including discontinuation of Risperidone.
Risperidone should only be used short term for persistent aggression in patients with moderate to severe Alzheimer's dementia to supplement non-pharmacological approaches which have had limited or no efficacy and when there is potential risk of harm to self or others.
Patients should be reassessed regularly, and the need for continuing treatment reassessed.
Due to the alpha-blocking activity of Risperidone, (orthostatic) hypotension can occur, especially during the initial dose-titration period. Clinically significant hypotension has been observed post marketing with concomitant use of Risperidone and antihypertensive treatment. Risperidone should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease), and the dosage should be gradually titrated as recommended. A dose reduction should be considered if hypotension occurs.
Events of leucopenia, neutropenia and agranulocytosis have been reported with antipsychotic agents, including Risperidone. Agranulocytosis has been reported very rarely (< 1/10,000 patients) during post-marketing surveillance.
Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of Risperidone 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 Risperidone and have their WBC followed until recovery.
Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterized by rhythmical involuntary movements, predominantly of the tongue and/or face. The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.
Neuroleptic Malignant Syndrome, characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics. Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. In this event, all antipsychotics, including Risperidone, should be discontinued.
Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including Risperidone, to patients with Parkinson's disease or Dementia with Lewy Bodies (DLB). Parkinson's disease may worsen with Risperidone. Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials. Manifestation of this increased sensitivity can include confusion, obtundation, and postural instability with frequent falls, in addition to extrapyramidal symptoms.
Hyperglycemia, diabetes mellitus, and exacerbation of pre-existing diabetes have been reported during treatment with Risperidone. In some cases, a prior increase in body weight has been reported which may be a predisposing factor. Association with ketoacidosis has been reported very rarely and rarely with diabetic coma. Appropriate clinical monitoring is advisable in accordance with utilized antipsychotic guidelines. Patients treated with any atypical antipsychotic, including Risperidone, should be monitored for symptoms of hyperglycemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control.
Significant weight gain has been reported with Risperidone use. Weight should be monitored regularly.
Hyperprolactinemia is a common side-effect of treatment with Risperidone 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 Galactorrhea).
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. Risperidone should be used with caution in patients with pre-existing Hyperprolactinemia and in patients with possible prolactin-dependent tumours.
QT prolongation has very rarely been reported post marketing. As with other antipsychotics, caution should be exercised when Risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.
Risperidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Priapism may occur with Risperidone treatment due to its alpha-adrenergic blocking effects.
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines. Appropriate care is advised when prescribing Risperidone 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 treatment with anticholinergic activity, or being subject to dehydration.
An antiemetic effect was observed in preclinical studies with Risperidone. This effect, if it occurs in humans, may mask the signs and symptoms of over dosage 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.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. 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 and preventative measures undertaken.
Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha1a-adrenergic antagonist effect, including Risperidone. IFIS may increase the risk of eye complications during and after the operation. Current or past use of medicines with alpha1a-adrenergic antagonist effect should be made known to the ophthalmic surgeon in advance of surgery. The potential benefit of stopping alpha1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy.
Before Risperidone is prescribed to a child or adolescent with conduct disorder they should be fully assessed for physical and social causes of the aggressive behavior such as pain or inappropriate environmental demands.
The sedative effect of Risperidone should be closely monitored in this population because of possible consequences on learning ability. A change in the time of administration of Risperidone could improve the impact of the sedation on attention faculties of children and adolescents.
Risperidone 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 8-16 years were on average approximately 3.0 to 4.8 cm taller than those who received other atypical anti-psychotic medications. 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 regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.
The film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
As with other antipsychotics, caution is advised when prescribing Risperidone with medicinal products known to prolong the QT interval, such as antiarrhythmics (e.g., quinidine, disopyramide, procainamide, propafenone, Amiodarone, sotalol), tricyclic antidepressants (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 (hypokalemia, hypomagnesaemia), bradycardia, or those which inhibit the hepatic metabolism of Risperidone. This list is indicative and not exhaustive.
Risperidone 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 may antagonize 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.
Clinically significant hypotension has been observed post marketing with concomitant use of Risperidone and antihypertensive treatment.
Concomitant use of oral Risperidone 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 metabolized 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 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). It is expected that other CYP 2D6 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 physician should re-evaluate the dosing of Risperidone.
Co-administration of Risperidone 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 physician should re-evaluate the dosing of Risperidone.
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 physician should re-evaluate the dosing of Risperidone. 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 is taken together with highly protein-bound drugs, there is no clinically relevant displacement of either drug from the plasma proteins.
When using concomitant medication, 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 Psychostimulant (e.g., methylphenidate) with Risperidone in children and adolescents did not alter the pharmacokinetics and efficacy of Risperidone.
Examples of drugs that may potentially interact or that were shown not to interact with Risperidone are listed below:
Effect of other medicinal products on the pharmacokinetics of Risperidone
Antibacterials:
Anticholinesterases:
Antiepileptics:
Antifungals:
Antipsychotics:
Antivirals:
Beta blockers:
Calcium channel blockers:
Gastrointestinal drugs:
SSRIs and Tricyclic antidepressants:
Antiepileptics:
Antipsychotics:
Digitalis glycosides:
Lithium:
See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.
There are no adequate data from the use of Risperidone in pregnant women. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen. The potential risk for humans is unknown.
Neonates exposed to antipsychotics (including Risperidone) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Risperidone should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly.
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 in small quantities. There are no data available on adverse reactions in breast-feeding infants. Therefore, the advantage of breast-feeding should be weighed against the potential risks for the child.
As with other drugs that antagonize dopamine D2 receptors, Risperidone elevates prolactin level. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroid genesis in both female and male patients.
There were no relevant effects observed in the non-clinical studies.
Risperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects. Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
The most frequently reported adverse drug reactions (ADRs) (incidence ≥10%) are: Parkinsonism, sedation/somnolence, headache and insomnia.
The ADRs that appeared to be dose-related included Parkinsonism and akathisia.
The following are all the ADRs that were reported in clinical trials and post marketing experience with Risperidone by frequency category estimated from RISPERIDONE clinical trials. The following terms and frequencies are applied: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| System Organ Class | Adverse Drug Reaction | ||||
|---|---|---|---|---|---|
| Frequency | |||||
| Very Common | Common | Uncommon | Rare | Very Rare | |
| Infections and infestations | pneumonia, bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, ear infection, influenza | respiratory tract infection, cystitis, eye infection, tonsillitis, onychomycosis, cellulitis localised infection, viral infection, acarodermatitis | infection | ||
| Blood and lymphatic system disorders | neutropenia, white blood cell count decreased, thrombocytopenia, anaemia, haematocrit decreased, eosinophil count increased | agranulocytosis | |||
| Immune system disorers | hypersensitivity | anaphylactic reaction | |||
| Endocrine disorders | Hyperprolactinemiaa | inappropriate antidiuretic hormone secretion, glucose urine present | |||
| Metabolism and nutrition disorders | weight increased, increased appetite, decreased appetite | diabetes mellitusb, hyperglycaemia, polydipsia, weight decreased, anorexia, blood cholesterol increased | water intoxication, hypoglycaemia, hyperinsulinemia, blood triglycerides increased | diabetic ketoacidosis | |
| Psychiatric disorders | insomnia | sleep disorder, agitation, depression, anxiety | mania, confusional state, libido decreased, nervousness, nightmare | blunted affect, anorgasmia | |
| Nervous system disorders | sedation/ somnolence, parkinsonismd, headache | akathisiad, dystoniad, dizziness, dyskinesiad, tremor | tardive dyskinesia, cerebral ischemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, convulsion, 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)c | ||
| 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 arrhythmia | ||
| 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, cheilitis | ileus | |
| Skin and subcutaneous tissue disorders | rash, erythema | urticaria, pruritus, alopecia, hyperkeratosis, eczema, dry skin, skin discolouration, acne, seborrhoeic dermatitis, skin disorder, skin lesion | drug eruption, dandruff | angioedema | |
| 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 | drug withdrawal syndrome neonatal | ||||
| Reproductive system and breast disorders | erectile dysfunction, ejaculation disorder, amenorrhoea, menstrual disordered, gynaecomastia, Galactorrhea, sexual dysfunction, breast pain, breast discomfort, vaginal discharge | priapism, menstruation delayed, breast engorgement, breast enlargement, breast discharge | |||
| General disorders and administration site conditions | oedema, 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-glutamyl transferase increased, hepatic enzyme increased | jaundice | |||
| Injury, poisoning and procedural complications | fall | procedural pain | |||
a Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, anovulation, Galactorrhea, fertility disorder, decreased libido, erectile dysfunction.
b In placebo-controlled trials diabetes mellitus was reported in 0.18% in Risperidone-treated subjects compared to a rate of 0.11% in placebo group. Overall incidence from all clinical trials was 0.43% in all Risperidone-treated subjects.
c Not observed in Risperidone clinical studies but observed in post-marketing environment with Risperidone.
d Extrapyramidal disorder may occur: Parkinsonism (salivary hyper secretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hyperkinesia, 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 are 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.
Cardiac disorders: Postural orthostatic tachycardia syndrome
As with other antipsychotics, very rare 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 arrhythmia, 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 drugs (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 5-12 years of age is 3 to 5 kg per year. From 12-16 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.
Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below:
Elderly patients with dementia:
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.
Paediatric population:
In general, 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.
Not applicable.
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