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Gatalin XL (Galantamine) Prolonged-release Capsules Prescribing Information (please refer to the full SmPC before prescribing)
Indications: Gatalin XL is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. Available Strengths: Gatalin XL (galantamine) 8, 16 and 24mg x 28 capsules. Dosage and method of use: Prior to treatment the diagnosis of Alzheimer type dementia should be adequately confirmed according to current clinical guidelines by an experienced physician. Therapy with Gatalin XL should occur under supervision of a physician, and where a suitable carer is available who will regularly monitor medicinal product intake. Gatalin XL should be taken once daily in the morning preferably with food, and swallowed whole with liquid. Adequate fluid intake during treatment should be ensured. The recommended starting dose is 8mg/day for 4 weeks. The initial maintenance dosing is 16mg/day and patients should be maintained on 16mg/day for at least 4 weeks. An increase of the maintenance dose to 24mg/day should be considered on an individual basis after appropriate assessment. In patients not showing an increased response or not tolerating 24mg/day, a dose reduction to 16mg/day should be considered. The tolerance and dosing of galantamine should be reassessed on a regular basis within the first 3 months of treatment. Thereafter, the clinical benefit of galantamine and patient’s tolerance should be reassessed on a regular basis according to current clinical guidelines. Discontinuation should be considered when evidence of a therapeutic effect is no longer present or the patient does not tolerate treatment. There is no rebound effect after abrupt discontinuation of treatment. If the patient is switching from galantamine immediate-release to Gatalin XL, it is recommended that the same total daily dose is administered. Patients switching to a once-daily regimen should take their last dose of immediate-release tablets/oral solution in the evening, and start Gatalin XL once daily the following morning. In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered. In patients with moderately impaired hepatic function (Child-Pugh score 7-9) it is recommended that dosing start with 8mg once every other day, preferably taken in the morning, for 1 week, thereafter patients should proceed with the usual starting dose, daily dose should not exceed 16mg in these patients. Contraindications: Gatalin XL is contraindicated in patients with hypersensitivity to galantamine or any of the excipients, and is contraindicated in patients who have both significant renal and hepatic dysfunction. The use of galantamine is contraindicated in patients with creatinine clearance less than 9ml/min and in patients with severe hepatic impairment (Child-Pugh score greater than 9). Gatalin XL should not be given concomitantly with other cholinomimetics and has the potential to antagonise the effect of anticholinergic medicinal products. Special warnings and cautions for use: Serious skin conditions have been reported in patients receiving galantamine, and it is recommended that patients be informed about the signs of serious skin reactions, and that galantamine should be discontinued at the first appearance of a skin rash. During therapy, patient’s weight should be monitored. Caution should be exercised when administering Gatalin XL to patients with cardiovascular diseases. It is not recommended in patients with gastrointestinal obstruction or recovering from gastrointestinal surgery, and in patients with urinary outflow obstruction or recovering from bladder surgery. Patients at increased risk of developing peptic ulcers should be monitored for symptoms. Seizures have been reported with galantamine. In patients with Alzheimer’s dementia treated with galantamine cerebrovascular events were uncommonly observed, this should be considered when administering galantamine to patients with cerebrovascular disease. Cholinomimetics should be prescribed with care in patients with a history of severe asthma or obstructive pulmonary disease or active pulmonary infections. Caution should be taken with medicinal products that have potential to cause torsades de pointes, in such cases an ECG should be considered. Gatalin XL, as a cholinomimetic, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia. Gatalin XL should not be used in women who breast-feed, and caution should be exercised in pregnant women. Gatalin XL has a minor or moderate influence on the ability to drive and use machines. Gatalin XL is not recommended in children. Side effects: For the full list of side effects consult the SmPC for Gatalin XL. ‘Very Common’ ‘Common’ and ‘Serious’ side effects are included in the prescribing information. Very common (≥1/10) side effects include vomiting and nausea. Common (≥1/100 to <1>
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148. 1010067334 v 1.0 January 2018