Eisai_ad_Layout 1 25/01/2010 11:23 Page 7
FACE THE FEAR
THE EARLIER YOU DIAGNOSE
ALZHEIMER’S DISEASE,
THE SOONER YOU CAN DO
SOMETHING ABOUT IT.
ABBREVIATED PRESCRIBING INFORMATION
ARICEPT
®
(donepezil hydrochloride fi lm-coated tablet)
ARICEPT EVESS
®
(donepezil hydrochloride orodispersible tablet)
Aricept
film-coated tablets
contain lactose and should not be used
Please refer to the SmPC before prescribing ARICEPT 5 mg, ARICEPT 10 mg, ARICEPT EVESS 5 mg or in patients with rare hereditary problems of galactose
ARICEPT EVESS 10 mg. Indication: Symptomatic treatment of mild to moderately severe Alzheimer’s intolerance, the Lapp lactase defi ciency or glucose-galactose malabsorption.
dementia. Dose and administration: Adults/elderly; 5 mg daily which may be increased to 10 mg Donepezil has minor or moderate infl uence on ability to drive/use machines so this
once daily after at least one month. Aricept Evess orodispersible tablets should be placed on the should be routinely evaluated. Drug interactions: Interaction possible with inhibitors or inducers
tongue and allowed to disintegrate before swallowing with or without water. Aricept fi lm-coated of cytochrome P450; use such combinations with care. May interfere with anticholinergic agents.
tablets are taken orally. Treatment with Aricept or Aricept Evess should be initiated and supervised Possible synergistic activity with succinylcholinetype muscle relaxants, beta-blockers, cholinergic
by a physician with experience of Alzheimer’s dementia. A caregiver should be available to monitor agents. Side effects: Most commonly diarrhoea, muscle cramps, fatigue, nausea, vomiting, and
compliance. Monitor regularly to ensure continued therapeutic benefi t, consider discontinuation insomnia. Very common effects ( *1/10): diarrhoea, nausea, headache. Common effects ( *1/100,
when evidence of a therapeutic effect ceases. No dose adjustment necessary for patients with renal <1/10): common cold, anorexia, hallucinations, agitation, aggressive behaviour, syncope, dizziness,
impairment. Dose escalation, according to tolerability, should be performed in patients with mild insomnia, vomiting, abdominal disturbance, rash, pruritis, muscle cramps, urinary incontinence,
to moderate hepatic impairment. Children; Not recommended. Contraindications: Hypersensitivity fatigue, pain, accident. Uncommon effects ( *1/1,000, <1/100): seizure, bradycardia, gastrointestinal
to donepezil, piperidine derivatives or any excipients used in Aricept or Aricept Evess. Pregnancy: haemorrhage, gastric & duodenal ulcers, minor increases in serum creatine kinase. Rare ( *1/10,000,
Donepezil should not be used unless clearly necessary. Lactation: Excretion into human breast milk <1/1,000): extrapyramidal symptoms, sinoatrial block, atrioventricular block, liver dysfunction
unknown. Women on donepezil should not breast feed. Warnings and precautions: Exaggeration including hepatitis. Presentation and basic NHS cost: Blister packed in strips of 14. ARICEPT
of succinylcholinetype muscle relaxation. Avoid concurrent use of anticholinesterases, cholinergic 5 mg; white, fi lm-coated tablets marked 5 and Aricept, packs of 28 £63.54. ARICEPT 10 mg; yellow,
agonists, cholinergic antagonists. Possibility of vagotonic effect on the heart which may be particularly fi lm-coated tablets marked 10 and Aricept, packs of 28 £89.06. ARICEPT EVESS 5 mg; white,
important with “sick sinus syndrome”, and supraventricular conduction conditions. There have been embossed, orodispersible tablets marked 5 and Aricept, packs of 28 £63.54. ARICEPT EVESS 10 mg;
reports of syncope and seizures – in such patients the possibility of heart block or long sinusal pauses yellow, embossed, orodispersible tablets marked 10 and Aricept, packs of 28 £89.06. Marketing
should be considered. Careful monitoring of patients at risk of ulcer disease including those receiving authorisation numbers: ARICEPT 5 mg; PL 10555/0006. ARICEPT 10 mg; PL 10555/0007. ARICEPT
NSAIDs. Cholinomimetics may cause bladder outfl ow obstruction. Seizures occur in Alzheimer’s EVESS 5 mg; PL 10555/0019. ARICEPT EVESS 10 mg; PL 10555/0020. Marketing authorisation
disease and cholinomimetics have the potential to cause seizures and they may also have the potential holder: Eisai Ltd. Further Information from/Marketed by: Eisai Ltd, Hammersmith International
to exacerbate or induce extrapyramidal symptoms. Care in patients suffering from asthma and Centre, 3 Shortlands, London, W6 8EE and Pfi zer Limited, Walton Oaks, Dorking Road, Tadworth,
obstructive pulmonary disease. No data available for patients with severe hepatic impairment. In three Surrey KT20 7NS. Legal category: POM. Date of preparation: June 2008.
6-month clinical trials in individuals with vascular dementia (VaD), the combined mortality rate was
numerically higher in the donepezil group (1.7%) than in the placebo group (1.1%), but this difference Adverse events should be reported. Reporting forms and information can be found at
was not statistically signifi cant. In pooled Alzheimer’s disease studies (n=4146), and in Alzheimer’s www.yellowcard.gov.uk. Adverse events should also be reported to Eisai Ltd on
disease studies pooled with other dementia studies including vascular dementia studies (total 0208 600 1400 or
Lmedinfo@eisai.net.
n=6888), the mortality rate was numerically higher in the placebo group than in the donepezil group.
ARI-2415 ARI 1251 Preparation date: January 2009
JNPP 297x210.indd 1 4-05-2009 11:30:05
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132