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Rivastigmine Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Rivastigmine Rosemont 2mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear yellow solution containing rivastigmine hydrogen tartrate corresponding to 2mg/ml rivastigmine. Therapeutic Indications: Symptomatic treatment of mild to moderately severe Alzheimer’s dementia and idiopathic Parkinson’s disease. Posology and Method of Administration: Treatment should only be initiated by a physician experienced in the diagnosis and treatment of the indicated conditions in adult patients. Rivastigmine oral solution should be administered twice a day, with morning and evening meals. Initial dose: 1.5 mg twice a day. Maintenance dose: The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be titrated at 2 weekly minimum intervals and maintained on their highest well tolerated dose. The recommended maximum daily dose is 6 mg twice a day. Re-initiation of therapy If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily and re-titrated. Renal and hepatic impairment No dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment. Patients with severe hepatic impairment have not been studied, however rivastigmine may be used in this patient population provided close monitoring is exercised. Paediatric population: There is no relevant use of Rivastigmine in the paediatric population in the treatment of Alzheimer’s disease. Contra-indications: Hypersensitivity to rivastigmine, other carbamate derivatives or to any of the excipients. Excipient warnings: Sodium Benzoate, Citric Acid Monohydrate, Sodium Citrate and Quinoline Yellow. Drug interactions: Rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia. Caution is recommended when selecting anaesthetic agents. Should not be given concomitantly with other cholinomimetic substances and might interfere with the activity of anticholinergic medicinal products. Caution should be exercised when in combination with beta-blockers and other bradycardia agents. Observe caution with torsade de pointes inducing medicinal products. May inhibit the butyrylcholinesterase mediated metabolism of other substances. Special Warnings and Precautions for use: The most common adverse reactions especially in female patients are gastrointestinal disorders such as nausea, vomiting and diarrhoea, which tend to be dose-related, and may occur particularly when initiating treatment and/or increasing the dose. Dehydration can be associated with serious outcomes. Patient’s weight should be monitored. Appropriate dose adjustments must be made in cases of severe vomiting Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes. Care must be taken with sick sinus syndrome or cardiac conduction defects. May cause increased gastric acid secretions. Care should be exercised in treating patients with active gastric or duodenal ulcers or patients predisposed to these conditions, and also patients with a history of asthma or obstructive pulmonary disease. May induce or exacerbate urinary obstruction and seizures. May exacerbate or induce extrapyramidal symptoms. Worsening and an increased incidence or severity of tremor have been observed in patients with dementia associated with Parkinson’s disease. Patients with clinically significant renal or hepatic impairment might experience more adverse reactions. Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions. FertilityPregnancy and Lactation: No clinical data. Rivastigmine should not be used during pregnancy unless clearly necessary. Women on rivastigmine should not breast-feed. Effects on human fertility are not known. Effects on Ability to Drive and Use Machines: Rivastigmine can induce dizziness and somnolence and therefore rivastigmine has minor or moderate influence on the ability to drive and use machines. Undesirable Effects: Very common: Anorexiadizziness, nausea, vomiting, diarrhoea, tremor, and fall. Common: Decreased appetite, nightmares, agitation, confusion, anxiety, headache, somnolence, abdominal pain and dyspepsia, hyperhidrosis, fatigue and asthenia, malaise, weight loss, dehydration, insomnia, restlessness, visual hallucinations, depression, Parkinson’s disease worsening, bradykinesia, dyskinesia, hypokinesia, cogwheel rigidity, bradycardia, hypertension, salivary hypersecretion, gait disturbance, Parkinson gait. Uncommon:  Syncope, elevated liver function tests, dystonia, atrial fibrillation, atrioventricular block, and hypotension. Rare: Seizures, angina pectoris, gastric duodenal ulcers, rash. Very rare: Urinary infection, hallucinations, extrapyramidal symptoms, cardiac arrhythmia, gastrointestinal haemorrhage, and pancreatitis. Not known: aggression, restlessness, sick sinus syndrome, hepatitis, pruritus, allergic dermatitis, aggression. Overdose: Most cases of accidental overdose have not been associated with any clinical signs or symptoms. Cholinergic toxicity has been reported with muscarinic symptoms that are observed at moderate poisonings. Some symptoms have included nausea, vomiting and diarrhoea, hypertension or hallucinations. Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur. In more severe cases nicotinic effects might develop. It is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours. If overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered. Symptomatic treatment for other adverse reactions should be given as necessary. In massive overdose, atropine can be used. Use of scopolamine as an antidote is not recommended. Shelf Life and storage: 4 years, use within 1 month of opening the bottle. Do not store above 30°c. Do not refrigerate or freeze. Legal Category: POM Pack Size and NHS Price: 120ml £85.00. Marketing Authorisation Number: PL00427/0232. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: Feb – 2021.

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400