מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Donepezil hydrochloride
DE Pharmaceuticals
N06DA02
Donepezil hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000
PACKAGE LEAFLET: INFORMATION FOR THE USER ARICEPT ® 10MG TABLETS (donepezil hydrochloride) YOU AND YOUR CAREGIVER SHOULD READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Aricept 10mg Tablets but will be referred to as Aricept throughout this leaflet. Please note that the leaflet also contains information about other strength Aricept 5mg Tablets. IN THIS LEAFLET: 1. WHAT ARICEPT IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE ARICEPT 3. HOW TO TAKE ARICEPT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ARICEPT 6. FURTHER INFORMATION 1. WHAT ARICEPT IS AND WHAT IT IS USED FOR Aricept (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the break down of acetylcholine. It is used to treat the symptoms of dementia in people diagnosed as having mild and moderately severe Alzheimer’s disease. The symptoms include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer’s disease find it more and more difficult to carry out their normal daily activities. Aricept is for use in adult patients only. 2. BEFORE YOU TAKE ARICEPT DO NOT TAKE ARICEPT if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Aricept listed in section 6. TAKE SPECIAL CARE WITH ARICEPT Tell your doctor or pharmacist before starting to take Aricept if you have or have had: stomach or duodenal ulcers seizures (fits) or convulsions a heart condit קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ARICEPT 10 mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil free base. Excipients with known effect: Each 10 mg tablet contains 174.33 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. ARICEPT 10 mg film coated tablets are yellow, round, biconvex tablets debossed ‘ARICEPT’ on one side and ‘10’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ARICEPT tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults/Elderly people_ Treatment is initiated at 5 mg/day (once-a-day dosing). The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following a one- month clinical assessment of treatment at 5 mg/day, the dose of ARICEPT EVESS can be increased to 10 mg/day (once-a-day dosing). The maximum recommended daily dose is 10 mg. Doses greater than 10 mg/day have not been studied in clinical trials. Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Diagnosis should be made according to accepted guidelines (e.g. DSM IV, ICD 10). Therapy with donepezil should only be started if a caregiver is available who will regularly monitor drug intake for the patient. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Therefore, the clinical benefit of donepezil should be reassessed on a regular basis. Discontinuation should be considered when evidence of a therapeutic effect is no longer present. Individual response to donepezil cannot be predicted. Upon discontinuation of קרא את המסמך השלם