5 mg and 10 mg film-coated tablets 
donepezil hydrochloride

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

Donepezil Orion (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.

Donepezil Orion is used to treating 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.

Donepezil Orion should only be used by adults.

Donepezil hydrochloride contained in Donepezil Orion 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.

What you need to know before you take Donepezil Orion

Do not take Donepezil Orion

  • 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 Orion if you have or have had:

  • gastric or duodenal ulcer
  • seizures or convulsions
  • any heart disease such as irregular or very slow heart rate
  • asthma or another so-called chronic lung disease
  • any liver disease or hepatitis (inflammation of the liver) (as does one may need to be adjusted)
  • difficulty attempting to urinate or kidney disease

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

Tell your doctor or pharmacist if you experience any of the above symptoms while taking Donepezil Orion.

Children and young people

Donepezil Orion should not be used in children and adolescents.

Other medicines and Donepezil Orion

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Always tell your doctor or pharmacist if you are taking any of the following medicines with Donepezil Orion:

  • other drugs used in Alzheimer’s disease, e.g. galantamine, rivastigmine
  • 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, itraconazole (medicines that destroy or inhibit fungal growth)
  • antidepressants (antidepressants), e.g. fluoxetine
  • medicines for seizures (medicines used to prevent several types of seizures), e.g. phenytoin, carbamazepine
  • medicines for heart disease, e.g. quinidine, beta-blockers (propranolol, atenolol)
  • muscle relaxants, e.g. diazepam , succinylcholine
  • anesthetics
  • over-the-counter medicines and (traditional) herbal medicines.

If you have a planned operation that requires you to be anesthetized (put to sleep), tell your doctor and anesthetist that you are using Donepezil Orion. This is because the drug can affect how much anesthetic is needed.

Donepezil Orion can be used by people with kidney disease or with mild to moderate liver disease. Tell your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take Donepezil Orion.

Donepezil Orion with food, drink, and alcohol

Donepezil Orion should be taken with liquid (a glass of water). Food intake does not affect the effectiveness of this medicine.

Do not use alcohol while taking donepezil as alcohol may affect the effect of donepezil.

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.

The use of Donepezil Orion in pregnant women is not recommended.

Breastfeeding women should not use Donepezil Orion.

Driving and using machines

Alzheimer’s disease can impair your ability to drive or operate machinery. You must not drive or use machines unless your doctor has told you to do so.

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.

Donepezil Orion 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.

3. How to take Donepezil Orion

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

The usual dose to start with is 5 mg (a white tablet) in the evening. After one month, your doctor may ask you to take 10 mg (one yellow tablet) in the evening instead. The strength of the tablet you are taking 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.

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

How long should you take Donepezil Orion?

You should always follow your doctor’s or pharmacist’s advice on how and when to take your medicine. Do not change the dose yourself without the advice of a doctor. Your doctor or pharmacist will tell you how long you should continue to take your tablets. You need to see your doctor from time to time to evaluate your treatment and assess your symptoms.

If you take more Donepezil Orion then you should

Do not take more than the recommended dose each 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.

Always take the remaining tablets and the medicine pack with you to the hospital so that your doctor knows which medicine you have taken.

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

If you forget to take Donepezil Orion

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

If you stop taking Donepezil Orion

Do not stop taking the tablets unless your doctor tells you to. If treatment is stopped, the beneficial effects of donepezil 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 Orion.

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).
  • Gastric or duodenal ulcer. Symptoms of stomach ulcers are stomach pain and stomach upset that is felt between the navel and the sternum (may occur in up to 1 in 100 users).
  • Bleeding in the stomach or intestines. Maybe manifested by black, tar-like stools or by clearly visible bleeding from the rectum (may affect 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 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).

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

  • diarrhea
  • nausea
  • headache.

Common (may affect up to 1 in 10 people)

  • cold
  • fatigue
  • loss of appetite
  • hallucinations (seeing or hearing things that do not exist)
  • restlessness
  • aggressive behavior
  • fainting
  • dizziness
  • vomiting
  • insomnia (insomnia)
  • the feeling of discomfort in the stomach
  • rash
  • itching
  • muscle cramps
  • difficulty keeping tight (urinary incontinence)
  • pain
  • accidents (patients may be more likely to fall and prone to accidental injuries)
  • unusual dreams including nightmares.

Uncommon (may affect up to 1 in 100 people)

  • slow heart rate
  • overproduction of saliva
  • increased levels of creatinine kinase in the blood (creatinine kinase is involved in muscle metabolism).

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

  • movement disorders, such as tremors/tremor, stiffness or uncontrolled movements especially of the face and tongue but also in the hands and legs
  • heart block

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Donepezil Orion

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 blister and carton after “EXP”. The expiration date is the last day of the specified month.

This medicine does not require any 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 hydrochloride5 mg: Each film-coated tablet contains 5 mg donepezil hydrochloride10 mg: Each film-coated tablet contains 10 mg donepezil hydrochloride
  • Other ingredients are:
    Tablet core: Colloidal anhydrous silica, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate.
    Film coating:5 mg: Hypromellose, titanium dioxide (E171), propylene glycol, talc.10 mg: Hypromellose, titanium dioxide (E171), propylene glycol, talc, yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

5 mg tablet: White to off-white, round, biconvex, film-coated tablets marked with “ML 89” on one side and unlabeled on the other side. The diameter is 7 mm-

10 mg tablet: Yellow, round, biconvex, film-coated tablets marked with “ML 88” on one side and unlabeled on the other side. The diameter is 9 mm.

Pack sizes:

14, 28, 30, 56, 84, 98, 100, 112 and 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd, medinfo@orionpharma.com

Muhammad Nadeem

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