Uniphazil Orally Disintegrating Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dosage, and after evaluating the clinical response during this period, it may be increased to 10 mg. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions. This medication is an orally disintegrating tablet that can be placed on the tongue to dissolve and taken with water or without.

Child dose

There is no experience of use in children.

This medication contains the artificial sweetener aspartame, which is broken down into phenylalanine in the body. Therefore, patients with the genetic disorder phenylketonuria should not take this medication. The maximum daily intake of aspartame contained in this medication should be limited to less than 40 mg per kg of body weight, as recommended by WHO, and for adults, care should be taken not to exceed a maximum of 2.4 g per day. This medication should not be used by individuals allergic to donepezil hydrochloride or other components of this medication, pregnant women or those likely to become pregnant, and women who are breastfeeding. Patients with heart disease or those with slow or irregular heartbeats should be cautious when taking this medication, as it can cause problems such as bradycardia or arrhythmia. Patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be careful when using this medication due to the risk of gastrointestinal bleeding or worsening ulcers. Patients with asthma or obstructive lung disease may experience bronchoconstriction and increased mucus secretion, so caution is advised. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication carefully, as it may worsen their symptoms. This medication can cause various side effects, and in severe cases, symptoms such as fainting, heart block, liver dysfunction, cerebrovascular problems, movement disorders, difficulty breathing, acute pancreatitis, and acute renal failure may occur. If any unusual symptoms appear, consult a doctor immediately. Although this medication is used for dementia treatment, it is advisable to discontinue treatment if there is no effect, and during use, regular evaluations of effectiveness and side effects should be conducted. Caution is needed while driving or operating machinery, as dizziness or fatigue may occur. This medication may interact with other drugs, especially when taken with heart medications or drugs affecting liver metabolism; consult a doctor in such cases. It is safest for pregnant or breastfeeding women not to use this medication, and if necessary, it should be used only after consulting a specialist. Safety has not been established for children, so it should not be administered to them. In case of overdose, serious side effects such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate emergency treatment, and atropine may be used as an antidote if necessary. This medication should be taken by dissolving it in the mouth, kept out of reach of children, and protected from light exposure.

Serious side effects

• Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure and other cardiovascular abnormalities.
• Peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding.
• Hepatitis, liver dysfunction, jaundice.
• Cerebral seizures (epilepsy, convulsions), cerebral hemorrhage, cerebrovascular disorders, cerebrovascular anomalies, cerebral infarction, cerebral ischemia.
• Extrapyramidal disorders (movement dysfunction, ataxia, movement disorder, dystonia, tremor, involuntary movements, gait disturbances, abnormal posture, speech disorders).

Mild side effects

• Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, muscle pain, dizziness, insomnia, drowsiness, itching, rash, swelling, increased blood pressure, urinary incontinence, frequent urination, urinary retention, and other common mild adverse reactions.
• Hallucinations, excitement, aggressive behavior, anxiety, increased libido, talking excessively, mania, nightmares, nervousness, nonsensical speech, delusions, depression, confusion, apathy, hyperactivity, excessive sexual desire, tremor, gait disturbances, involuntary movements, difficulties in concentration.

This medication should be stored in a tightly sealed container that is air-tight, at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a long time.

Appearance

White round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)