Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Pfizer Healthcare Ireland
DONEPEZIL HYDROCHLORIDE
10 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-02-25
Page 1 of 6 2012-0001458 PACKAGE LEAFLET: INFORMATION FOR THE USER DONEPEZIL PFIZER 5 MG ORODISPERSIBLE TABLETS DONEPEZIL PFIZER 10 MG ORODISPERSIBLE 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. IN THIS LEAFLET: 1. WHAT DONEPEZIL PFIZER IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE DONEPEZIL PFIZER 3. HOW TO TAKE DONEPEZIL PFIZER 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DONEPEZIL PFIZER 6. FURTHER INFORMATION 1. WHAT DONEPEZIL PFIZER IS AND WHAT IT IS USED FOR DONEPEZIL PFIZER (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 breakdown 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. DONEPEZIL PFIZER is for use in adult patients only. 2. BEFORE YOU TAKE DONEPEZIL PFIZER DO NOT TAKE DONEPEZIL PFIZER if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the ot Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Pfizer 10mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil free base. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Yellow orodispersible tablet embossed with ‘10’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil Pfizer orodispersible tablets are indicated for the symptomatic treatment of - mild to moderately severe Alzheimer’s dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults/Elderly: Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil Pfizer should be taken orally, in the evening, just prior to retiring. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference. 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 Donepezil Pfizer 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 Baca dokumen lengkapnya