5 mg, 10 mg film-coated tablets 
Donepezil hydrochloride

1. WHAT DONEPEZIL ACCORD IS AND WHAT IT IS USED FOR

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.

Donepezil Accord is used to treat dementia symptoms in patients with 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.

Donepezil should only be used by adults.

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

2. BEFORE YOU USE DONEPEZIL ACCORD

Do not use Donepezil Accord

  • if you are allergic (hypersensitive) to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of Donepezil Accord.

Take special care with Donepezil Accord

Talk to your doctor or pharmacist before taking Donepezil Accord. You must tell your doctor if you have or have had:

  • gastric ulcer or ulcer of duodenum a
  • seizures or convulsions
  • some form of heart disease (irregular or very slow heart rate)
  • asthma or another chronic lung disease
  • any form of liver disease or hepatitis (hepatitis)
  • difficulty urinating, or mild kidney disease

Donepezil Accord can be used by people with renal impairment 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 Donepezil Accord.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking any of the following medicines:

  • other drugs for Alzheimer’s disease, such as galantamine
  • painkillers or medicines for arthritis  such as acetylsalicylic acid and non-steroidal anti-inflammatory drugs ( NSAIDs ) such as ibuprofen or diclofenac
  • anticholinergic drugs (drugs that affect and reduce the amount of the neurotransmitter acetylcholine in the brain) eg tolterodine.
  • certain antibiotics, such as erythromycin, rifampicin
  • medicines for fungal infections, such as ketoconazole
  • antidepressant drugs, such as fluoxetine
  • medicines for seizures, such as phenytoin, carbamazepine
  • drugs for cardiovascular disease, eg quinidine, beta-blockers (propranolol, atenolol)
  • muscle relaxants, such as diazepam, succinylcholine
  • anesthetics
  • over-the-counter and herbal remedies

If you are going to have an operation under anesthesia, you must inform your doctor and the anesthetist that you are using Donepezil Accord as Donepezil Accord may affect the amount of anesthetic needed.

Taking Donepezil Accord with food and drink

Food intake does not affect the effect of the Donepezil Accord.

You should avoid alcohol as it may affect the effectiveness of the Donepezil Accord.

Pregnancy and breastfeeding

Donepezil Accord should be used during pregnancy only if clearly needed.

Breast-feeding women should not take the Donepezil Accord.

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.

Driving and using machines

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

It can make you tired and dizzy, and 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. Descriptions 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

Important information about some of the ingredients of the Donepezil Accord

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Donepezil Accord.

3. HOW TO USE DONEPEZIL ACCORD

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Normally, treatment starts with 5 mg (one white tablet) in the evening. After one month, your doctor may ask you to take 10 mg (one yellow tablet) in the evening instead.

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

The tablet strength you have been prescribed 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 use Donepezil Accord exactly as your doctor has told you.

Do not change the dose other than on the advice of your doctor.

How long should Donepezil Accord be used?

Your doctor or pharmacist will tell you how long to use the tablets. You need to visit your doctor regularly so that he can evaluate your treatment and assess your symptoms.

If you use more Donepezil Accord then you should 

Do not take more than one tablet a day. If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice.

If you can not contact your doctor, see a hospital without delay. Always take tablets and packaging to the hospital so that the doctor knows what you have taken.

Symptoms of overdose 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 and convulsions.

If you forget to take Donepezil Accord

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

If you forget to take your medicine for more than a week, call your doctor before taking another dose.

If you stop using Donepezil Accord

Do not stop taking your tablets unless your doctor tells you to. If you stop taking Donepezil Accord, the treatment effect will gradually diminish.

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

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 Donepezil Accord:

Serious side effects:

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

  • gastric ulcer or ulcer of duodenum a. Symptoms of stomach ulcers can include abdominal pain and upset stomach in the area between the navel and sternum (may affect up to 1 in 100 people).
  • bleeding in the gastrointestinal tract. This can manifest itself as carbon black feces or through 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)
  • liver damage, for example, 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)
  • fever with muscle stiffness, sweating or decreased consciousness (a condition called ‘Neuroleptic malignant syndrome’ (may affect up to 1 in 1,000 people)
  • 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 that may occur:

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

  • diarrhea
  • nausea
  • headache

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

  • muscle cramps
  • fatigue
  • insomnia (insomnia)
  • cold symptoms
  • loss of appetite
  • hallucinations (seeing or hearing things that do not exist)
  • abnormal dreams and nightmares
  • restlessness
  • aggressive behavior
  • fainting
  • dizziness
  • discomfort in the stomach
  • vomiting
  • rash
  • itching
  • difficulty keeping tight (urinary incontinence)
  • pain
  • accidents (due to increased risk of falls and injuries)

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

  • slow heart rate
  • easier increase of muscular creatine kinase in serum
  • seizures (convulsions)

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

  • stiffness, tremors and uncontrolled movements, especially in the face and tongue but also in the arms and legs
  • disturbances in the rhythm of the heart

5. HOW TO STORE DONEPEZIL ACCORD

  • Keep out of sight and reach of children.
  • Use this medicine before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
  • No special storage instructions.
  • 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. FURTHER INFORMATION

Content declaration

The active substance is donepezil hydrochloride. One tablet contains donepezil hydrochloride monohydrate equivalent to 5 mg / 10 mg donepezil hydrochloride.

Other ingredients are:

Tablet cores: lactose monohydrate , corn starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose, magnesium stearate

Film coating:

5 mg: Hypromellose (E464), titanium dioxide (E171), Macrogol 400, talc (E553b)

10 mg: Hypromellose (E464), titanium dioxide (E171), Macrogol 400, talc (E553b), yellow iron oxide (E172)

What the medicine looks like and the contents of the pack

Donezepil Accord is available as 5 mg and 10 mg tablets. The tablets are described below.

5 mg: White to off-white, round, approximately 7.14 mm in diameter, beveled, biconvex film-coated tablets, marked “5” on one side and unmarked on the other side.

10 mg: Yellow, round, about 8.73 mm in diameter, biconvex film-coated tablets, marked “10” on one side and unmarked on the other side.

Donezepil Accord 5 mg / 10 mg tablets are supplied in the following pack sizes:

PVC / aluminum blister in outer carton: 7, 10, 28, 30, 50, 56, 60, 84, 98 and 120 tablets

HDPE jar: 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer:

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF,

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

This medicinal product is authorized under the European Economic Area under the names:

Name of Member State  Name of the medicine 
Bulgaria  Donepezil Hydrochloride Accord 5 mg / 10 mg Filming tablets 
Cyprus Donepezil Accord 5 mg / 10 mg Reciprocal Drug Therapy
Denmark Donepezil Hydrochloride Accord 5 mg / 10 mg film-coated tablets
Estonia Donepezil Accord
Finland Donepezil Accord 5 mg / 10 mgkalvopäällysteinen tablets / film-coated tablets
Ireland Donepezil 5 mg / 10 mg Film-coated Tablets
Italy Donepezil Accord 5 mg / 10 mg Ccompresse Rvestite Ccon Film
Lithuania  Donepezil Accord 5 mg / 10 mg tablets are given as tablets
Malta Donepezil 5 mg / 10 mg Film-coated Tablets
Norway Donepezil Accord 5 mg / 10 mg Film-coated tablets
Poland  Donepestan
Slovakia  Donepezil Accord 5 mg / 10 mg film orally tablets
Slovenia  Donepezilijev chloride Accord 5 mg / 10 mg film-free tablet
UK Donepezil Hydrochloride 5 mg / 10 mg Film-coated Tablets
Czech Republic  Donepezil Accord 5 mg / 10 mg Potahované tablets
Hungary  Donepezil Hydrochloride Accord 5 mg / 10 mg Film Tablet
Austria Donepezil Accord 5 mg / 10 mg film tablets

Muhammad Nadeem

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