Donepezil (Oral route)
- Tablet, Disintegrating
Central Nervous System Agent
Cholinesterase Inhibitor, Centrally Acting
Uses of This Medicine:
Donepezil is used to treat dementia (memory loss and mental changes) associated with mild, moderate, or severe Alzheimer's disease. Donepezil will not cure Alzheimer's disease, and it will not stop the disease from getting worse. However, it can improve thinking ability in some patients.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of donepezil in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of donepezil in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amdinocillin Pivoxil
- Arsenic Trioxide
- Belladonna Alkaloids
- Conjugated Estrogens
- Esterified Estrogens
- Ethinyl Estradiol
- Mefenamic Acid
- Nalidixic Acid
- Peginterferon Alfa-2b
- Penicillin G
- Penicillin V
- Perflutren Lipid Microsphere
- Polyestradiol Phosphate
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Bitter Orange
- Grapefruit Juice
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Asthma, history of or
- Lung disease, history of or
- Peptic ulcers, or history of or
- Seizures, or history of or
- Urinary tract blockage or difficult urination Donepezil may make these conditions worse.
- Heart problems Donepezil may have unwanted effects on heart rate.
- Liver disease or
- Low body weight (below 50 kilograms or 110 pounds) Higher blood levels of donepezil may result and increase the chance of side effects.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor in order to improve your condition as much as possible. Do not take more of it or less of it, and do not take it more or less often than your doctor ordered.
Donepezil should be taken at bedtime unless otherwise directed by your doctor. It may be taken with or without food, on a full or empty stomach.
Swallow the tablet whole. Do not crush, break, or chew it.
For patients using the oral disintegrating tablet form of this medicine:
- Make sure your hands are dry.
- Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
- Immediately place the tablet on top of the tongue.
- Do not swallow the tablet whole. The tablet will dissolve in seconds, and you may swallow it with your saliva. You should drink a glass of water after the tablet has dissolved.
For patients taking the oral solution form of this medicine:
- Shake the bottle well before measuring the dose.
- Use a specially marked measuring spoon, a plastic syringe, or a small marked measuring cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.
- If your dose is 5 mg, you should take 5 mL of this medicine.
- If your dose is 10 mg, you should take 10 mL of this medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (oral disintegrating tablets, oral solution, and tablets):
- For mild to moderate Alzheimer's disease:
- Adults 5 milligrams (mg) taken at bedtime. Your doctor may increase your dose as needed. However, the dose usually is not more than 10 mg per day.
- Children Use and dose must be determined by your doctor.
- For moderate to severe Alzheimer's disease:
- Adults 10 milligrams (mg) taken at bedtime. Your doctor may increase your dose as needed. However, the dose usually is not more than 23 mg per day.
- Children Use and dose must be determined by your doctor.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using This Medicine:
It is important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to reduce any unwanted effects.
Before you have any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking donepezil together with certain medicines that are used during surgery or dental or emergency treatments may increase the effects of those medicines and cause unwanted effects.
This medicine may cause some people to become dizzy or drowsy, to have blurred vision, or to have problems with clumsiness or unsteadiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see clearly.
Some people who have used this medicine developed problems such as nausea, severe vomiting, loss of appetite, diarrhea, and weight loss. Talk with your doctor before using this medicine if you have any concerns.
Tell you doctor right away if you have bloody or black tarry stools, constipation, severe stomach pain, or vomiting of blood or material that looks like coffee grounds. These may be symptoms of stomach or bowel bleeding.
If you think that you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine may cause convulsions (seizures) or serious effects on your heart and your breathing. Signs of overdose include increased watering of mouth, increased sweating, low blood pressure, muscle weakness, severe nausea, severe vomiting, slow heartbeat, and troubled breathing.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- More common
- loss of appetite
- muscle cramps
- trouble in sleeping
- unusual tiredness or weakness
- Less common
- Abnormal dreams
- frequent urination
- joint pain, stiffness, or swelling
- mental depression
- unusual bleeding or bruising
- weight loss
- Black, tarry stools
- bloody or cloudy urine
- blurred vision
- burning, prickling, or tingling sensations
- clumsiness or unsteadiness
- decreased urination
- difficult or painful urination
- dryness of mouth
- eye irritation
- flushing of skin
- frequent urge to urinate
- high or low blood pressure
- hot flashes
- increase in sexual desire or performance
- increased heart rate and breathing
- increased sweating
- increased urge to urinate during the night
- irregular heartbeat
- loss of bladder control
- loss of bowel control
- mood or mental changes, including abnormal crying, aggression, agitation, delusions, irritability, nervousness, or restlessness
- nasal congestion
- pain in chest, upper stomach, or throat
- problems with speech
- runny nose
- severe thirst
- shortness of breath
- sore throat
- sunken eyes
- tightness in chest
- troubled breathing
- wrinkled skin
- Incidence not known
- Back, leg, or stomach pains
- bleeding gums
- chest pain or discomfort
- dark urine
- difficulty breathing
- fast or irregular heartbeat
- general body swelling
- general tiredness and weakness
- high fever
- increased thirst
- light-colored stools
- muscle pain or cramps
- nausea and vomiting
- pains in stomach, side, or abdomen, possibly radiating to the back
- pale skin
- seeing, hearing, or feeling things that are not there
- severe muscle stiffness
- severe nausea
- slow or irregular heartbeat
- stomach pain
- swelling of face, ankles, or hands
- unusually pale skin
- upper right abdominal or stomach pain
- yellow eyes and skin
- Symptoms of overdose
- Convulsions (seizures)
- increased sweating
- increased watering of mouth
- increasing muscle weakness
- low blood pressure
- severe nausea
- severe vomiting
- slow heartbeat
- troubled breathing
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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