ALZEPIL 10 mg 28 tablets

ALZEPIL International Nonproprietary Name - donepezil Clinical-Pharmacological Group - Agents for Alzheimer's disease Composition and Dosage Form 5 mg tablets #28 10 mg tablets #28 - Each film-coated tablet contains the active substance of the preparation - 5 or 10 mg donepezil hydrochloride. - Excipients: Core: microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate. Coating: Opadry Y-1-7000 White: hypromellose, titanium dioxide (E 171), macrogol 400. Packaging Form 5 mg tablets: White or almost white, round, biconvex, odorless or almost odorless film-coated tablets, with a stylized inscription "E 381" on one side. 10 mg tablets: White or almost white, round, biconvex, odorless or almost odorless film-coated tablets, with a stylized inscription "E 382" on one side. Indications The active component of ALZEPIL, donepezil hydrochloride, belongs to a group of substances called acetylcholinesterase inhibitors. It is used to treat the symptoms of dementia in individuals diagnosed with mild to moderate Alzheimer's disease. This preparation may improve memory and thinking. It is used only in adult patients. Dosage and Administration Always use ALZEPIL as directed by your doctor. If you are unsure about anything, consult your doctor or pharmacist. Inform your doctor or pharmacist of your caregiver's full name. The caregiver will help you take the preparation as prescribed. ALZEPIL is taken orally, in the evening, before bedtime, with water. ALZEPIL can be taken independently of food, as food does not affect its efficacy. Usually, the starting dose is: 5 mg once daily. After one month, your doctor may prescribe 10 mg of the preparation every evening. The maximum recommended daily dose is 10 mg. Always follow your doctor's instructions regarding the method and timing of administration. Do not change the dose independently without your doctor's prescription and do not stop taking the tablets without your doctor's advice. Your doctor will decide on the duration of tablet use. They will inform you when to stop taking the tablets. You should consult your doctor periodically to assess the symptoms of the disease and monitor the course of treatment. The use of the preparation is not recommended in children and adolescents under 18 years of age. Side Effects Like other medicinal preparations, ALZEPIL may cause side effects, although they do not occur in all patients. If any of the following effects occur, consult your doctor. Very common (in 1 to 10 out of 10 patients): diarrhea, nausea, headache. Common (in 1 to 10 out of 100 patients): cold, anorexia (loss of appetite), hallucinations, agitation, aggressive behavior (hallucinations, agitation, and aggressive behavior disappear after dose reduction or discontinuation of donepezil), syncope, dizziness, insomnia (difficulty falling asleep), nausea, gastrointestinal disturbances, skin rash, itching, muscle spasms, urinary incontinence, fatigue, pain, accidental injury. Uncommon (in less than 1 out of 100 patients): convulsive seizures, bradycardia (slow heart rate), gastrointestinal bleeding, duodenal or gastric ulcers, changes in laboratory parameters (slight increase in muscle creatine kinase in blood plasma). Rare (in less than 1 out of 1000 patients): extrapyramidal symptoms (tremor, involuntary movements or stiffness of the face, tongue, or limbs), sinoatrial block, cardiac arrhythmia (heart block), liver dysfunction, including hepatitis (infectious liver damage). If severe side effects or effects not described in this instruction occur, please consult your doctor. Contraindications If you are hypersensitive to donepezil hydrochloride, similar agents known as piperidine derivatives, or any other component of ALZEPIL film-coated tablets. ALZEPIL requires special caution. Before using the preparation, inform your doctor if you have any of the following conditions: - If you have heart problems (arrhythmia or block) (donepezil may cause a slowing of the heart rate); - If you have a history of stomach and duodenal ulcers, or if you are taking concomitant anti-inflammatory drugs; - If you have difficulty urinating; - If you have ever had convulsive seizures (donepezil may cause recurrence of seizures) or fainting episodes; - If you have asthma or other chronic lung diseases; - If you have severe liver dysfunction; - If you have ever had extrapyramidal symptoms (involuntary movements of the body or face). If you are scheduled for surgery requiring general anesthesia, you must inform your doctor and anesthesiologist that you are using ALZEPIL. Pregnancy and Lactation Before using any medicinal preparation, seek advice from your doctor or pharmacist. If there is no need to use ALZEPIL (as prescribed by your doctor), the preparation should not be used during pregnancy, as there is insufficient data for this group of patients. Donepezil is not used during lactation. Special Instructions ALZEPIL with food and alcoholic beverages The tablets are taken in the evening, before bedtime, with water. ALZEPIL can be taken independently of food, as food does not affect its efficacy. Do not consume alcoholic beverages during the course of donepezil treatment, as alcohol may reduce its effectiveness. Driving and Operating Machinery The disease may impair the ability to drive vehicles and operate machinery. At the beginning of treatment or when the dose is increased, the preparation may cause fatigue, dizziness, and muscle spasms. Therefore, your treating physician should continuously assess your ability to drive vehicles and operate complex machinery. Your doctor will decide on a case-by-case basis at which dose of ALZEPIL you will be able to drive vehicles and operate machinery. Overdose Do not take more than one tablet per day. If you have taken an overdose, seek medical attention immediately. If you cannot contact a doctor, go to the nearest emergency room immediately. Take the tablets or the box with you to the hospital so the doctor knows what you have taken. If you Forget to Take ALZEPIL Do not take a double dose to compensate for a missed dose. Continue to take the preparation as prescribed by your doctor. If you have missed taking the preparation for one week or more, contact your doctor to resume taking the preparation. If You Stop Taking ALZEPIL After discontinuing the course of treatment, a gradual weakening of the effect of ALZEPIL is observed. There is no withdrawal effect after abrupt discontinuation of the preparation. Do not stop taking the preparation without your doctor's advice, even if you feel better. If you have any further questions regarding the use of the preparation, consult your doctor. Interactions with Other Medicines Inform your doctor about any medicines you are taking or have recently taken, including medicines obtained without a prescription. Inform your doctor if you are taking other medicines, especially: - Pain and anti-inflammatory drugs; - Medications for arthritis; - Antibiotics, such as erythromycin or rifampicin; - Antifungal drugs (agents that destroy fungi or inhibit their growth), such as ketoconazole or itraconazole; - Muscle relaxants; - Antidepressants, such as fluoxetine; - Anticonvulsants, such as phenytoin or carbamazepine; - Medications for heart disease; - Certain medications for lowering blood pressure (beta-blockers); - Other preparations with a similar mechanism of action to donepezil (e.g., galantamine or rivastigmine), as well as some medications for diarrhea, Parkinson's disease, or asthma. Storage Conditions and Expiry Dates Keep the preparation out of reach of children. 8-15ºC Shelf life 3 years. Do not use ALZEPIL after the expiry date indicated on the packaging. The expiry date is the last day of the month indicated. Dispensing from Pharmacy By prescription Do not dispose of medicinal products in household waste or running water. If you need to dispose of a preparation that is no longer needed, seek advice from a pharmacist. Such measures will help prevent environmental pollution. Manufacturer, Country Pharmaceutical Plant Egis Plc, Hungary