5 mg and 10 mg film-coated tablets 
Donepezil hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aricept is and what it is used for 
2. What you need to know before you use Aricept 
3. How to use Aricept 
4. Possible side effects 
5. How to store Aricept 
6. Contents of the packaging and other information 

1. What Aricept is and what it is used for

Aricept contains the active substance donepezil hydrochloride. Aricept (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors.

Donepezil increases the levels of a substance in the brain ( acetylcholine ), which is involved in memory function, by delaying the breakdown of acetylcholine.

Aricept is used to treat the symptoms of dementia in mild to moderate

Alzheimer’s disease. These symptoms include increasing memory loss, confusion, and behavioral changes. As a consequence of these symptoms, those suffering from Alzheimer’s disease find it more and more difficult to perform normal daily activities.

Aricept should only be used by adults.

Donepezil hydrochloride contained in Aricept may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Aricept

Do not use Aricept

  • if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Aricept if you have or have had:

  • gastric ulcer
  • seizures or convulsions
  • any heart disease (irregular or very slow heart rate)
  • asthma or other so-called chronic lung diseases
  • any liver disease or hepatitis (hepatitis)
  • difficulty trying to urinate or mild kidney disease

Also, tell your doctor if you are pregnant or think you may be pregnant.

Children and young people

Aricept is not recommended for use in children and adolescents (younger than 18 years).

Other medicines and Aricept

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This includes other medicines that you may take at some point in the future if you continue to use Aricept. This information is important as some other medicines may reduce or increase the effect of Aricept.

You should be extra careful to tell your doctor if you are taking:

  • other drugs used in Alzheimer’s disease, e.g. galantamine
  • medicines for pain or arthritis, e.g. acetylsalicylic acid, so-called NSAIDs such as ibuprofen or diclofenac
  • anticholinergic drugs, e.g. tolterodine
  • certain antibiotics, e.g. erythromycin, rifampicin
  • drugs against fungal infections, e.g. ketoconazole
  • antidepressant drugs, e.g. fluoxetine
  • medicines for seizures, e.g. phenytoin, carbamazepine
  • drugs for cardiovascular disease, e.g. quinidine, beta-blockers (propranolol, atenolol)
  • muscle relaxants, such as diazepam, succinylcholine
  • anesthetics
  • over-the-counter medicines and herbal medicines.
    If you are planning to be hospitalized for an operation that requires you to be put to sleep, tell your doctor and the doctor performing the operation that you are using Aricept. This is because Aricept can affect the amount of anesthetic needed.
    Aricept can be used by people with impaired kidney function or with mild to moderate hepatic impairment. Tell your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not use Aricept.
    Tell your doctor who your guardian is. Your guardian can help you use your medicine according to the doctor’s prescription.

Aricept with food, drink, and alcohol

Food intake does not affect the effect of Aricept

You should avoid alcohol as it may affect the effect of Aricept.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding women should not use Aricept.

Driving and using machines

Alzheimer’s disease can impair your ability to drive or operate machinery. You must therefore first discuss with your doctor if you intend to drive or operate machinery.

It may be that the medicine makes you feel tired and dizzy and that you may have muscle cramps. If you experience any of these symptoms, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Aricept contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Aricept.

3. How to use Aricept

Dosage

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. The recommended dose to start with is 5 mg (one white tablet) in the evening before going to bed. After one month, your doctor may ask you to take 10 mg (one yellow tablet) in the evening before going to bed.

The tablet strength you should take may change depending on how long you have been taking the medicine and what your doctor recommends. The maximum recommended dose is 10 mg in the evening.

Always follow the advice of your doctor or pharmacist on how and when to take your medicine. Do not change the dose without the advice of a doctor.

How to use your medicine

Aricept tablets should be swallowed whole with a glass of water in the evening before going to bed.

Use for children and adolescents

Aricept is not recommended for use in children and adolescents (younger than 18 years).

Symptoms of overdose may include nausea and vomiting, involuntary drooling, sweating, slow heart rate, low blood pressure (intoxication or dizziness when standing), difficulty breathing, loss of consciousness, and seizures or convulsions.

If you forget to use Aricept

If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop using Aricept

Do not stop taking the tablets unless your doctor tells you to. If you stop taking Aricept, the benefits of treatment will gradually diminish.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

How long to use Aricept

Your doctor or pharmacist will tell you how long to use the tablets. You need to see your doctor regularly to evaluate your treatment and assess your symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported during treatment with Aricept.

Tell your doctor if you get any of these side effects while using Aricept.

Serious side effects are

Contact a doctor immediately if you get these serious side effects. You may need immediate medical attention.

  • liver damage, e.g. liver inflammation ( hepatitis ). Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and whites of the eyes, and dark-colored urine (may affect up to 1 in 1,000 people)
  • stomach ulcer. Symptoms of stomach ulcers can be stomach pain and stomach problems that are felt between the navel and the sternum (may occur in up to 1 in 100 users)
  • bleeding and ulcers in the gastrointestinal tract. Maybe manifested by carbon black feces or by clearly visible bleeding from the rectum during toilet visits (may occur in up to 1 in 100 users)
  • seizures or convulsions (may affect up to 1 in 100 people)
  • fever with muscle stiffness, sweating, or decreased consciousness (this is a condition called ‘malignant neuroleptic syndrome’ or ‘neuroleptic malignant syndrome’) (may affect up to 1 in 10,000 users)
  • muscle weakness, soreness, or pain, especially if you feel sick, have a high fever, or dark urine at the same time. The symptoms can be caused by an abnormal breakdown of the muscles which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis ) (can occur in up to 1 in 10,000 users)

Other side effects are

Very common side effects (may affect more than 1 user in 10):

  • diarrhea
  • headache

Common side effects (may affect up to 1 in 10 people):

  • muscle cramps
  • fatigue
  • insomnia (insomnia)
  • cold symptoms
  • hallucinations (seeing or hearing things that do not exist)
  • unusual dreams including nightmares
  • restlessness
  • aggressive behavior
  • fainting
  • dizziness
  • a feeling of discomfort in the stomach
  • rash
  • difficulty keeping tight (urinary incontinence)
  • pain
  • accident (due to risk of falling)

Uncommon (may affect up to 1 in 100 people):

  • slow heart rate
  • overproduction of saliva

Rare (may affect up to 1 in 1,000 people):

  • stiffness, tremors or uncontrolled movements especially of the face and tongue but also in the hands and legs

5. How to store Aricept

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister or jar after “EXP” or “EXP”. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is donepezil hydrochloride. There are two different strengths available. Each film-coated tablet contains 5 mg and 10 mg donepezil hydrochloride, respectively.
  • The other ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide (E171).
  • In addition, 10 mg film-coated tablet contains yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

  • Aricept 5 mg film-coated tablets are white, round, biconvex, and marked “ARICEPT” on one side and “5” on the other side.
  • Aricept 10 mg film-coated tablets are yellow, round, biconvex, and marked “ARICEPT” on one side and “10” on the other side.

Aricept is available in packs of:

  • 7, 14, 28, 30, 50, 56, 60, 84, 98, 112 and 120 film-coated tablets in blister packs
  • 28, 30, and 100 film-coated tablets in HDPE jars

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

Fareva Amboise

Industrial Zone

29route des Industries

37530 Pocé-sur-Cisse

France

Muhammad Nadeem

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