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Therapeutic Category


Donepezil hydrochloride USP is a prescription medicine to treat mild, moderate, and severe Alzheimer’s disease (up to 10 mg).

UK Generic Name




Therapeutic Category

Anti Psychotic


Store Donepezil hydrochloride USP at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F)

adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Product Overview

What Donepezil Hydrochloride tablets are and what they are used for?

Donepezil hydrochloride USP comes as Donepezil hydrochloride USP film-coated tablets in dosage strengths of 5 mg and 10 mg.

Donepezil hydrochloride USP is a prescription medicine to treat mild, moderate, and severe Alzheimer’s disease (up to 10 mg). Donepezil hydrochloride USP can help with mental function and with doing daily tasks. Donepezil hydrochloride USP does not work the same in all people.
Some people may:
• Seem much better
• Get better in small ways or stay the same
• Get worse over time but slower than expected
• Not change and then get worse as expected

Donepezil hydrochloride USP does not cure Alzheimer’s disease. All patients with Alzheimer’s disease get worse over time, even if they take Donepezil hydrochloride USP.
Donepezil hydrochloride USP has not been approved as a treatment for any medical condition in children.

Before you take Donepezil Hydrochloride USP?

The patient should not take Donepezil hydrochloride USP if allergic to any of the ingredients in Donepezil hydrochloride or to medicines that contain piperidines. Ask your doctor if you an USPre not sure. See the end of this leaflet for a list of ingredients in Donepezil Hydrochloride Tablets USP.

What should I tell the doctor before taking Donepezil Hydrochloride Tablets USP? Tell the doctor about all your present or past health problems.


• Any heart problems including problems with irregular, slow, or fast heartbeats
• Asthma or lung problems
• A seizure
• Stomach ulcers
• Difficulty passing urine
• Liver or kidney problems
• Trouble swallowing tablets
• Present pregnancy or plans to become pregnant. It is not known if Donepezil hydrochloride USP can harm an unborn baby.
• Present breast-feeding. It is not known if Donepezil hydrochloride passes into breast milk.
Donepezil hydrochloride USP is not for women who are breast-feeding.

Tell the doctor about all the medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal products. Donepezil hydrochloride USP and other medicines may affect each other.

Be particularly sure to tell the doctor if you take aspirin or medicines called non steroidal anti-inflammatory drugs (NSAIDs). There are many NSAID medicines, both prescription and non-prescription. Ask the doctor or pharmacist if you are not sure if any of your medicines are NSAIDs. Taking NSAIDs and Donepezil hydrochloride USP together may make the patient more likely to get stomach ulcers.

Donepezil hydrochloride USP taken with certain medicines used for anaesthesia may cause side effects. Tell the responsible doctor or dentist if you take Donepezil hydrochloride USP before you have:
• Surgery
• Medical procedures
• Dental surgery or procedures.

Know the medicines that you take. Keep a list of all your medicines. Show it to the doctor or pharmacist before you start a new medicine.

How to take Donepezil Hydrochloride

• Give Donepezil hydrochloride USP exactly as prescribed by the doctor. Do not stop Donepezil hydrochloride or change the dose yourself. Talk with the doctor first.
• Give Donepezil hydrochloride one time each day. Donepezil Hydrochloride Tablets USP can be taken with or without food.
• Donepezil Hydrochloride Tablets USP should be swallowed whole without the tablets being broken or crushed.
• If you miss a dose of Donepezil hydrochloride USP, just wait. Take only the next dose at the usual time. Do not give 2 doses at the same time.
• If Donepezil hydrochloride USP is missed for 7 days or more, talk with the doctor before starting again.
• If you take too much Donepezil hydrochloride USP at one time, call the doctor or poison control center, or go to the emergency room right away.

What are the possible side effects of Donepezil hydrochloride USP?

Donepezil hydrochloride USP may cause the following serious side effects:

• Slow heartbeat and fainting. This happens more often in people with heart problems. Call the doctor right away if the patient faints while taking Donepezil hydrochloride USP.
• More stomach acid. This raises the chance of ulcers and bleeding. The risk is higher for patients who had ulcers, or take aspirin or other NSAIDs.
• worsening of lung problems in people with asthma or other lung disease.
• Seizures.
• Difficulty passing urine.

Call the doctor right away if you have:

• Fainting.
• Heartburn or stomach pain that is new or won’t go away.
• Nausea or vomiting, blood in the vomit, dark vomit that looks like coffee grounds.
• Bowel movements or stools that look like black tar.
• New or worse asthma or breathing problems.
• Seizures.
• Difficulty passing urine.

The most common side effects of Donepezil hydrochloride USP are:

• Nausea
• diarrhea
• not sleeping well
• vomiting
• muscle cramps
• feeling tired
• not wanting to eat

These side effects may get better after the you take Donepezil hydrochloride USP for a while. This is not a complete list of side effects with Donepezil hydrochloride USP. For more information, ask the doctor or pharmacist. Call your doctor for medical advice about side effects.

How to store Donepezil Hydrochloride

Store Donepezil hydrochloride USP at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See Controlled Room Temperature]Keep Donepezil hydrochloride and all medicines out of the reach of children.

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