5 mg, 10 mg film-coated tablets 
donepezil hydrochloride

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

  • Save this leaflet, 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 Donepezil Sandoz is and what it is used for 
2. What you need to know before taking Donepezil Sandoz 
3. How to take Donepezil Sandoz 
4. Possible side effects 
5. How to store Donepezil Sandoz 
6. Contents of the packaging and other information 

1. What Donepezil Sandoz is and what it is used for

Donepezil Sandoz 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.

Donepezil Sandoz is used to treating the symptoms of dementia in people who have been diagnosed with mild to moderately severe 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 Sandoz should only be used by adults.

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

2. What you need to know before you take Donepezil Sandoz

Do not take this medicine

if you are allergic to

  • donepezil hydrochloride or
  • piperidine derivatives, which are similar substances to donepezil, or
  • soy, peanut, or any of the other ingredients of Donepezil Sandoz (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Donepezil Sandoz.

If any of the following applies to you, you or your healthcare provider should inform your doctor or pharmacist.

  • gastric ulcer or ulcer of duodenum a
  • seizures or convulsions
  • any heart disease (irregular or very slow heart rate).
  • asthma or other long-term lung disease
  • liver problem or jaundice
  • difficulty urinating or mild kidney disease

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

Other medicines and Donepezil Sandoz

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 also applies to other medicines that you may take at some point in the future if you continue to use Donepezil Sandoz. This information is important as some other medicines may reduce or increase the effect of Donepezil Sandoz.

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
  • 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 admitted to the hospital for an operation that requires you to be put to sleep, tell your doctor and the doctor performing the operation that you are using Donepezil Sandoz. This is because Donepezil Sandoz can affect the amount of anesthetic needed.

Donepezil Sandoz 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 Sandoz.

Tell your doctor who your guardian is. Your guardian can help you use your medicine according to your doctor’s prescription.

Intake of Donepezil Sandoz with food, drink, and alcohol

Food intake does not affect the effect of Donepezil Sandoz.

Do not drink alcohol during treatment with Donepezil Sandoz as this may reduce the effect of the medicine.

Pregnancy, breastfeeding, and fertility

Breast-feeding women should not take Donepezil Sandoz.

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 lower your ability to drive or use machines. You should therefore first discuss with your doctor if you intend to drive or operate machinery. This medicine can cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment and when increasing the dose. If you are affected, you must 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.

Donepezil Sandoz contains excipients

Donepezil Sandoz contains lactose monohydrate and corn starch (glucose source).

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

3. How to take Donepezil Sandoz

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The usual dose is:

Adult and elderly patients

5 mg tablets:

  • Starting dose: 1 film-coated tablet every night
  • After one month: possible increase to 2 film-coated tablets every night
  • Maximum dose: 2 film-coated tablets every night

10 mg tablets:

  • Starting dose: ½ film-coated tablet every night
  • After one month: possible increase to 1 film-coated tablet every night
  • Maximum dose: 1 film-coated tablet every night

Do not change the dose yourself without the consent of your doctor.

Patients with renal impairment

You can take the usual dose as described above. No dose adjustment is required.

Patients with mild to moderate hepatic impairment

Your doctor will check how well you tolerate Donepezil Sandoz before increasing the dose.

Patients with severe hepatic impairment

Your doctor will decide if Donepezil Sandoz is right for you.

Method of administration

Take the tablets in the evening before going to bed, with or without food. Swallow the tablets together with a glass of water.

Duration of treatment

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.

If you take more Donepezil Sandoz then you should

DO NOT TAKE more than 10 mg donepezil hydrochloride 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 for risk assessment and advice. Bring the tablets, this information sheet, and/or the tablet pack so that your doctor can see 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 or convulsions.

If you forget to take Donepezil Sandoz

If you forget to take a 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, consult a doctor before taking any more medicine.

If you stop taking Donepezil Sandoz 

Do not stop taking this medicine unless your doctor tells you to. The positive treatment results can gradually decrease if the treatment is stopped.

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 with Donepezil Sandoz. Tell your doctor if you get any of these side effects while using Donepezil Sandoz.

Serious side effects:

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).
  • Ulcers or sores on the duodenum one. Symptoms may include abdominal pain and stomach discomfort felt between the navel and sternum (may affect up to 1 in 100 people).
  • Bleeding in the gastrointestinal tract. Maybe manifested by carbon black stools 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. These are symptoms of a condition called neuroleptic malignant syndrome or neuroleptic malignant syndrome (may affect up to 1 in 10,000 people).
  • Muscle weakness, soreness, or pain, especially if you also feel sick, have a high fever, or dark urine. 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).

Reported side effects are listed below according to the following frequencies:

Very common, may affect more than 1 user in 10:

  • diarrhea
  • nausea
  • headache

Common, may affect up to 1 in 10 users:

  • muscle cramps
  • fatigue
  • insomnia (insomnia)
  • cold
  • loss of appetite
  • hallucinations (seeing or hearing things that do not exist)
  • unusual dreams and nightmares
  • indignation
  • aggressive behavior
  • fainting
  • dizziness
  • the feeling of discomfort in the stomach
  • rash
  • itching
  • difficulty keeping tight (urinary incontinence)
  • pain
  • accidents (patients may find it easier to fall and to inadvertently injure themselves in other ways).

Uncommon, may affect up to 1 in 100 people:

  • slow heart rate

Rare may affect up to 1 in 1,000 users:

  • tremors, stiffness, or uncontrollable movements, especially in the face and tongue but also in the arms and legs

5. How to store Donepezil Sandoz

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 the label of the plastic jar after EXP. and EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not use Donepezil Sandoz after 6 months from the first opening of the plastic jar.

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. 
    One film-coated tablet contains 5 mg donepezil hydrochloride. 
    One film-coated tablet contains 10 mg donepezil hydrochloride.
  • Other ingredients are Tablet core:
    microcrystalline cellulose 
    lactose monohydrate
    corn starch 
    magnesium stearate
    Tablet coating:
    5 mg: 
    polyvinyl alcohol 
    talc 
    titanium dioxide (E 171) 
    macrogol 3350 
    soy lecithin
    10 mg: 
    polyvinyl alcohol 
    talc 
    titanium dioxide (E 171) 
    macrogol 3350 
    soy lecithin 
    yellow iron oxide (E 172)

What the medicine looks like and the contents of the pack

Donepezil Sandoz 5 mg film-coated tablets are white and round (7 mm diameter).

Donepezil Sandoz 10 mg film-coated tablets are yellow and round (9 mm diameter) with a scoreline. They can be divided into two equal doses.

Donepezil Sandoz is available in the following pack sizes:

  • blister pack sizes of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 100×1 or 120 film-coated tablets
  • plastic jar with screw cap pack sizes of 100 or 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Muhammad Nadeem

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