Memorion

Package Leaflet: Information for the Patient

Memorion, 5 mg, Film-Coated Tablets

Memorion, 10 mg, Film-Coated Tablets

Donepezil Hydrochloride

Read All of This Leaflet Carefully Before Taking This Medicine.

• You should keep 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What is Memorion and What is it Used For
• 2. Before You Take Memorion
• 3. How to Take Memorion
• 4. Possible Side Effects
• 5. How to Store Memorion
• 6. Contents of the Pack and Other Information

1. What is Memorion and What is it Used For

Memorion (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the amount of a substance (acetylcholine) in the brain which is involved in memory. It is used to treat the symptoms of dementia in patients with mild to moderate Alzheimer's disease. The symptoms of Alzheimer's disease include memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease may have difficulty performing their usual daily activities.

2. Before You Take Memorion

When Not to Take Memorion

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

Warnings and Precautions

Before taking Memorion, tell your doctor or pharmacist if you have or have had:

• stomach ulcers or bleeding in the stomach or duodenum
• seizures or epilepsy
• heart problems (such as irregular or very slow heart rate, heart failure, heart attack)
• a heart condition called "prolonged QT interval" or have had in the past certain types of irregular heart rhythm, called torsade de pointes, or have had in the past a "prolonged QT interval"
• low levels of magnesium or potassium in the blood
• asthma or other chronic lung disease
• liver disease or hepatitis (in which case you may need a dose adjustment)
• difficulty urinating or kidney disease.

You should also tell your doctor if you are pregnant or think you might be pregnant. Before taking Memorion, tell your doctor or pharmacist if any of the above applies to you.

Children and Adolescents

Memorion is not intended for use in children and adolescents.

Memorion and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take. Always tell your doctor or pharmacist if you are taking or have been prescribed any of the following:

• medicines for irregular heart rhythm, such as amiodarone, sotalol
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, such as pimozide, sertindole, ziprasidone
• antibiotics for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• other medicines for Alzheimer's disease, such as galantamine
• painkillers or medicines for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium
• anticholinergic medicines, such as tolterodine
• antiepileptic medicines, such as phenytoin, carbamazepine
• medicines for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics
• over-the-counter medicines, such as herbal remedies.

If you are going to have surgery that requires general anesthesia, tell your doctor and anesthesiologist that you are taking Memorion, as this medicine may affect the doses of other medicines needed for anesthesia.

Memorion with Food, Drink, and Alcohol

Take Memorion with a drink of water. Food does not affect the medicine.

Alcohol

While taking donepezil, limit your intake of alcohol, as alcohol may change the effect of donepezil.

Pregnancy and Breast-Feeding

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.

Memorion is not recommended during pregnancy.

Memorion should not be used during breast-feeding.

Driving and Using Machines

Do not drive or operate machinery, as Alzheimer's disease may impair your ability to drive or operate machinery; you may only do so with your doctor's consent. Taking the medicine may also cause fatigue, dizziness, and muscle cramps; if these symptoms occur, do not drive or operate machinery.

Memorion Contains Lactose

The 5 mg tablet contains 83.5 mg of lactose (as monohydrate), and the 10 mg tablet contains 167 mg of lactose (as monohydrate). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to Take Memorion

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Treatment usually starts with a dose of 5 mg (one white tablet) once daily in the evening. After one month, your doctor may increase the dose to 10 mg (one yellow tablet) once daily in the evening.

The dose of the medicine (tablet strength) may be changed depending on the duration of treatment and your doctor's recommendations. The maximum recommended daily dose is 10 mg per day before bedtime.

Take Memorion orally, with water, in the evening before bedtime.

If you experience unusual dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Memorion in the morning.

How Long to Take Memorion

Always follow your doctor's or pharmacist's instructions on how to take the medicine. Do not change the dose without consulting your doctor. Your doctor or pharmacist will tell you how long to take the medicine. You will need to see your doctor from time to time to review the effectiveness of the treatment and the appearance of any side effects.

If You Take More Memorion Than You Should

Do not take more tablets than your doctor has recommended. If you have taken more Memorion than you should, or if a child has swallowed some of the medicine by mistake, contact your doctor or go to the hospital immediately. Take the medicine pack with you.

If You Forget to Take Memorion

If you forget to take a dose, 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 Stop Taking Memorion

Do not stop taking the tablets unless your doctor tells you to do so. After stopping treatment, the benefits of the medicine will gradually fade away.

4. Possible Side Effects

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

Serious Side Effects

Stop taking the medicine and seek immediate medical attention if you experience any of the following serious side effects:

• liver damage, such as hepatitis. Symptoms of hepatitis are nausea or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark urine (may affect up to 1 in 1,000 people)
• stomach ulcers or duodenal ulcers. Symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breastbone (may affect up to 1 in 100 people)
• bleeding from the stomach or intestines. Symptoms may include black stools or visible bleeding from the anus (may affect up to 1 in 100 people)
• seizures or convulsions (may affect up to 1 in 100 people)
• fever with muscle stiffness, sweating, or reduced consciousness (a condition called neuroleptic malignant syndrome) (may affect up to 1 in 10,000 people)
• muscle weakness, tenderness, or pain, especially if it occurs with general feeling of being unwell, high fever, or dark urine. This may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)

Very Common (may affect more than 1 in 10 people)

• diarrhea
• headache
• nausea

Common (may affect up to 1 in 10 people)

• common cold
• fatigue
• loss of appetite
• hallucinations (seeing or hearing things that are not there)
• agitation
• aggressive behavior
• fainting
• dizziness
• vomiting
• insomnia (difficulty sleeping)
• stomach discomfort
• skin rash
• itching
• muscle cramps
• incontinence
• pain
• accidents (patients may be more prone to falls and accidental injuries)
• unusual dreams and nightmares

Uncommon (may affect up to 1 in 100 people)

• slow heart rate
• excessive saliva production
• increased creatine kinase activity in the blood (creatine kinase affects muscle metabolism)

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

• movement disorders, such as tremors/shakiness, stiffness, or uncontrolled movements, especially of the face and tongue, but also of the limbs
• heart block

Frequency Not Known (frequency cannot be estimated from the available data)

• changes in heart activity seen on an electrocardiogram (ECG) called "prolonged QT interval"
• fast, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes
• increased libido, hypersexuality
• a condition called "Pisa syndrome" (involuntary muscle contraction with abnormal posture and movement of the head and body to one side)

Reporting of Side Effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to Store Memorion

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.

The expiry date refers to the last day of that month.

No special precautions for storage are necessary.

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 protect the environment.

6. Contents of the Pack and Other Information

What Memorion Contains

• The active substance is donepezil hydrochloride. Each 5 mg tablet contains 5 mg of donepezil hydrochloride. Each 10 mg tablet contains 10 mg of donepezil hydrochloride.
• The other ingredients are: Core:colloidal anhydrous silica, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate. Coating:5 mg film-coated tablets: hypromellose 5 CP, titanium dioxide (E 171), propylene glycol, talc. 10 mg film-coated tablets: hypromellose 5 CP, titanium dioxide (E 171), propylene glycol, talc, yellow iron oxide (E 172).

What Memorion Looks Like and Contents of the Pack

5 mg: White or almost white, round, biconvex film-coated tablets with "ML 89" engraved on one side and plain on the other. The diameter of the tablet is 7 mm.

10 mg: Yellow, round, biconvex film-coated tablets with "ML 88" engraved on one side and plain on the other. The diameter of the tablet is 9 mm.

Packaging:

28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer/Importer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland