Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Krka d.d., Novo mesto
DONEPEZIL HYDROCHLORIDE
10 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-04-22
Navodila prepognjena na sredini z vidno prvo stranjo (naslovom); pharma kodi, ki izhajata iz sredine navodila, morata biti vidni! smer vlaken smer branja kode 70 mm ± 0,5 mm 70 mm ± 0,5 mm smer branja kode _ - PMS-433U-KRKA_ _NA. DONEPEZIL KRKA ODT IE_ prva stran PACKAGE LEAFLET: INFORMATION FOR THE USER Donepezil Krka 5 mg orodispersible tablets Donepezil Krka 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 gets 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 Krka is and what it is used for 2. Before you take Donepezil Krka 3. How to take Donepezil Krka 4. Possible side effects 5. How to store Donepezil Krka 6. Further information 1. What Donepezil Krka is and what it is used for Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil Krka is used to treat the symptoms of dementia in people diagnosed as having mild to moderately severe Alzheimer’s disease. 2. Before you take Donepezil Krka DO NOT TAKE DONEPEZIL KRKA • if you are allergic (hypersensitive) to donepezil hydrochloride or to piperidine derivatives, or any of the other ingredients of Donepezil Krka. TAKE SPECIAL CARE WITH DONEPEZIL KRKA Tell your doctor or pharmacist before starting to take Donepezil Krka if you have or have had: • stomach or duodenal ulcers • seizures (fits) or convulsions • a heart problem (especially irregular or very slow heart beat) • asthma or other long term lung disease • liver problems or hepatitis • difficulty passing urine or mild kidney disease. If Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Krka 10mg Orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains donepezil hydrochloride monohydrate equivalent to 10 mg donepezil hydrochloride. Excipient: Each orodispersible tablet contains 1.50 mg aspartame (E951), 0.60 mg glucose, 0.50 mg sucrose and 0.04 mg sorbitol (E420). For a full list of excipients,see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. White round orodispersible tablets, bevel-edged. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil Krka 10mg Orodispersible tablets is 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 Krka 10mg Orodispersible tablets 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 Krka 10mg Orodispersible tablets 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, IC Lue koko asiakirja