5 mg, 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 Donepezil Krka is and what it is used for 
2. What you need to know before you use Donepezil Krka 
3. How to use Donepezil Krka 
4. Possible side effects 
5. How to store Donepezil Krka 
6. Contents of the pack and other information 

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

Donepezil Krka contains the active substance donepezil hydrochloride. Donepezil Krka (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance ( acetylcholine ) in the brain, which is involved in memory function, by delaying the breakdown of acetylcholine.

It is used to treat the symptoms of dementia in mild and 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 Krka should only be used by adults.

Donepezil contained in Donepezil Krka may also be approved for the treatment of other diseases not mentioned in this leaflet. 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 you use Donepezil Krka

Do not use Donepezil Krka

  • 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 Donepezil Krka if you have or have had:

  • gastrointestinal ulcers
  • seizures or convulsions
  • any heart disease (irregular or very slow heart rate)
  • asthma or another long-term lung disease,
  • liver disease or hepatitis (hepatitis)
  • difficulty urinating or mild kidney disease

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

Children and young people

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

Other medicines and Donepezil Krka

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 Krka. This information is important as other medicines may reduce or increase the effect of Donepezil Krka.

You should be extra careful to tell your doctor if you are taking any of the following medicines:

  • other drugs for the treatment of Alzheimer’s disease, such as galantamine or rivastigmine
  • painkillers or arthritis , such as acetylsalicylic acid , so-called NSAIDs such as ibuprofen or diclofenac
  • anticholinergic drugs, such as tolterodine
  • antibiotics, eg erythromycin, rifampicin
  • medicines for fungal infections, such as ketoconazole or itraconazole
  • antidepressant drugs, such as fluoxetine
  • medicines for seizures, such as phenytoin, carbamazepine
  • drugs for cardiovascular diseases, such as quinidine, beta-blockers (propranolol and atenolol)
  • muscle relaxants, such as diazepam, succinylcholine
  • anesthetics
  • over-the-counter medicines, such as herbal medicines

If you are going to be hospitalized for an operation that requires you to be put to sleep, tell your doctor and anesthesiologist that you are using Donepezil Krka. This is because Donepezil Krka can affect the amount of anesthetic needed.

Donepezil Krka 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 Donepezil Krka.

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

Donepezil Krka with food, drink, and alcohol

Food intake does not affect the effect of Donepezil Krka.

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

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.

Breast-feeding women should not take Donepezil Krka.

Driving and using machines

Alzheimer’s disease can impair your ability to drive or operate machinery. You should not drive or use machines unless your doctor tells you to be safe.

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. 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 Krka contains lactose

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

How to use Donepezil Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much Donepezil Krka you should take

The recommended starting dose is 5 mg (one white tablet) every night. After one month, your doctor may ask you to take 10 mg (one yellow tablet) each night instead.

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 every night.

Always use Donepezil Krka exactly as your doctor or pharmacist has told you. Do not change the dose without the advice of a doctor.

How to use your medicine

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

Use for children and adolescents

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

If you use more Donepezil Krka then you should 

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice. Take this leaflet and the remaining tablets with you.

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 Donepezil Krka

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 dose.

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

If you stop using Donepezil Krka

Do not stop taking the tablets unless your doctor tells you to. If you stop taking Donepezil Krka, 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 Donepezil Krka

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 Donepezil Krka.

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

Serious side effects:

You must talk to a doctor immediately if you experience any of the following serious side effects. In such cases, you may need immediate medical attention.

  • Liver injury, such as 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).
  • Gastrointestinal or duodenal ulcer. Symptoms of stomach ulcers can be stomach pain and stomach upset that is 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 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 (this is a condition called malignant neuroleptic syndrome or neuroleptic malignant syndrome) (may occur in up to 1 in 10,000 users).
  • 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).

Other side effects are

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)
  • unusual dreams including nightmares
  • indignation
  • aggressive behavior
  • fainting
  • dizziness
  • the feeling of discomfort in the stomach
  • rash
  • itching
  • difficulty keeping tight (urinary incontinence)
  • pain
  • accidents (patients may be more likely to fall and injure themselves)

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 Donepezil Krka

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 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. Contents of the packaging and other information

Content declaration

  • The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg donepezil hydrochloride (as monohydrate) equivalent to 4.56 mg donepezil. Each film-coated tablet contains 10 mg donepezil hydrochloride (as monohydrate) equivalent to 9.12 mg donepezil.
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, hydroxypropyl cellulose and magnesium stearate in the tablet core, and titanium dioxide (E 171), hypromellose 5cp, and macrogol 400 in the film coating. The 10 mg tablets also contain yellow iron oxide (E 172) in the film coating. See section 2 “Donepezil Krka contains lactose”.

What the medicine looks like and the contents of the pack

5 mg tablets are white to off-white, round, approximately 7 mm in diameter, biconvex, film-coated tablets.

10 mg tablets are amber, round, about 9 mm in diameter, biconvex, film-coated tablets.

The tablets are available in cartons containing:

  • 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets in blisters.
  • 250 film-coated tablets in a plastic tablet jar with a sealed screw closure.

Not all pack sizes may be marketed.

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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