HEALTHCARE PROFESSIONALS

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Enter the number of patients you wish to switch at each strength, to see the savings available from Biquelle XL (quetiapine prolonged release tablets). Or alternatively, enter your Rx spend on generic quetiapine XL tablets, to see the savings available when you brand by Biquelle XL (quetiapine XL prolonged released tablets).

Savings based on patient numbers

Enter the number of patients to switch Galantamine XL tablets Drug Tariff Price capsules (28)* Gatalin XL Price capsules (28)* Cost Saving for switch to Gatalin XL* % Saving for switch to Gatalin XL*
8mg 50%
16mg 50%
24mg 50%
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Or savings based on prescribing spend

Enter a generic XL tablet prescribing spend Galantamine XL tablets Cost Saving for switch to Gatalin XL* % Saving for switch to Gatalin XL*
8mg 50%
16mg 50%
24mg 50%
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*Based on 50% saving on the cost of Category C galantamine prolonged-release capsules in the UK Drug Tariff
References
1. January 2018 UK Drug Tariff

Further information at www.gatalin.co.uk

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

*56% saving on the cost of Category C quetiapine prolonged-release tablets in the UK Drug Tariff.
References 3) November 2016 UK Drug Tariff.
Biquelle XL (Quetiapine) Tablets Prescribing Information (please refer to the full SmPC before prescribing)
Indications: Schizophrenia; moderate to severe manic and major depressive episodes in bipolar disorder; prevention of recurrence of manic or depressed episodes in bipolar patients who have previously responded to quetiapine treatment; add-on treatment of major depressive episodes in patients with major depressive disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. Available strengths: 50, 150, 200, 300 and 400mg x60 tablets. Dosage: Schizophrenia, moderate to severe manic episodes in bipolar disorder: Administer at least one hour before meal. 300mg day 1, 600mg day 2; recommended daily dose 600mg; max dose 800mg daily. Major depressive episodes in bipolar disorder: Administer at bedtime. 50mg day 1; 100mg day 2; 200mg day 3, 300mg day 4. Recommended daily dose 300mg; Doses over 300mg at experienced physician’s discretion. Preventing recurrence in bipolar disorder: continue on the same dose between 300-800mg at bedtime. For add-on treatment of major depressive episodes in MDD: Administer prior to bedtime. 50mg – day 1 & 2, 150mg – day 3 & 4, dose may be increased to 300mg/day on individual patient evaluation. Maintain at the lowest effective dose. Administration: Once daily without food. Swallow tablets whole – do not split, chew, or crush. Patients on quetiapine immediate-release tablets may be switched to quetiapine prolonged-release tablets at equivalent total daily dosage taken once daily. Contraindications: Patients with hypersensitivity to active substance or excipients; concomitant use of cytochrome P450 CYP 3A4 inhibitors (e.g., HIV protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin, nefazodone). Special warnings and precautions for use: Elderly – use with caution. Rate of titration may need to be slower and daily dose lower. Start on 50mg/day. Efficacy and safety not evaluated in bipolar patients over 65 with depressive episodes. Not recommended for use in children and adolescents <18 years old. No dosage adjustment necessary in renal impairment. Use with caution if known hepatic impairment – start on 50mg/day. Monitor patients for risk of suicidal thoughts, particularly in early treatment and following dose changes; assess metabolic parameters and weight at initiation of and throughout treatment; observe for hyperglycaemia; diabetic patients should have glucose control monitored regularly; consider dose reduction or discontinuation if symptoms of tardive dyskinesia; discontinue if neuroleptic malignant syndrome; if develop akathisia, increasing dose may be detrimental; caution in cardiovascular disease, risk factors for VTE, cerebrovascular disease, other conditions predisposing to hypotension, patients receiving concomitant CNS depressants and those at risk for sleep apnoea e.g. overweight/male,  history of seizures, risk factors for neutropenia, concomitant use of medications with anti-cholinergic (muscarinic) effects, diagnosis or history of urinary retention, prostatic hypertrophy, intestinal obstruction/related conditions, increased intraocular pressure/narrow angle glaucoma, family history of QT prolongation, risk factor for stroke, suspected cardiomyopathy or myocarditis, risk of aspiration pneumonia, congenital long QT syndrome, use with medicinal products known to cause electrolyte imbalance or increase QT interval, congestive heart failure, heart hypertrophy, hypokalaemia, hypomagnesaemia, history of alcohol or drug abuse, in combination with other centrally acting medicinal products, alcohol, or with neuroleptics in the elderly. Discontinue if neutrophil count <1.0×109/L – monitor neutrophil count and for signs of infection. Contains lactose; do not use if rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Do not consume grapefruit juice. Monitor if severe somnolence and consider discontinuation. Advise not to drive or operate machinery until individual susceptibility to quetiapine affecting a patient’s mental alertness is known. False positive results reported in enzyme immunoassays for methadone and tricyclic antidepressants. Recommend confirmation of questionable immunoassay screening results by an appropriate chromatographic technique. If receiving a hepatic enzyme inducer, initiation of quetiapine should only occur if benefits outweigh risks of removing hepatic enzyme inducer. Concomitant use with strong hepatic enzyme inducer could affect efficacy.  Consult SmPC for dose reduction/titration or discontinuation. Advise gradual withdrawal over 1-2 weeks. Only use during pregnancy if benefits outweigh risks; use during lactation not recommended. Side effects: For full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects included in this prescribing information. Very common (≥1/10): decreased haemoglobin, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL), decreases in HDL cholesterol, weight gain, dizziness, somnolence, headache, extrapyramidal symptoms, dry mouth and withdrawal (discontinuation) symptoms. Common (≥1/100 to <1/10): leucopenia, decreased neutrophil count, eosinophils increased, hyperprolactinemia, decreases in total T4, decreases in free T4, decreases in total T3, increases in TSH, increased appetite, increased blood glucose to hyperglycaemic levels, abnormal dreams and nightmares, suicidal ideation and suicidal behaviour, dysarthria, tachycardia, palpitations, blurred vision, orthostatic hypotension, dyspnoea, constipation, dyspepsia, vomiting, elevations in serum alanine aminotransferase, elevations in  gamma-GT levels, mild asthenia, peripheral oedema, irritability and pyrexia. Serious uncommon/rare/very rare/not known: neutropenia, thrombocytopenia, anaemia, hypersensitivity (including allergic skin reactions), hyponatraemia, Diabetes Mellitus, exacerbation of pre-existing diabetes, seizure, tardive dyskinesia, syncope, QT prolongation, elevations in serum aspartate aminotransferase, bradycardia, agranulocytosis, metabolic syndrome, venous thromboembolism, pancreatitis, intestinal obstruction/ileus,  hepatitis, priapism, neuroleptic malignant syndrome, hypothermia, elevations in blood creatine phosphokinase, anaphylactic reaction, inappropriate antidiuretic hormone secretion, angioedema, Stevens-Johnson syndrome, rhabdomyolysis, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), drug withdrawal syndrome neonatal. MA number: PL 35533/0051-55. Cost: £29.45 for 50mg, £49.45 for 150mg, £49.45 for 200mg, £74.45 for 300mg, £98.95 for 400mg (x60 pack). MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Legal category: POM. Date last reviewed: August 2018. Version Number: 1010269093 v 6.0.

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For further information please call: 01730 231148,
email: customerservices@aspirepharma.co.uk or visit www.aspirepharma.co.uk
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
For more information about Gatalin XL, please see the abbreviated prescribing information.
Revision reference – Gatalin XL_22_09/11/2018

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