Memorion

Package Leaflet: Information for the Patient

Memorion, 5 mg, Film-Coated Tablets

Memorion, 10 mg, Film-Coated Tablets

Donepezil Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Memorion and What is it Used For
• 2. Important Information Before Taking 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 involved in memory, by slowing down its breakdown.
It is used to treat the symptoms of dementia in patients with mild to moderate Alzheimer's disease. The symptoms of the disease include increasing memory loss, disorientation, and changes in behavior. As a result, patients with Alzheimer's disease have increasing difficulty performing their usual daily activities.
Memorion is intended for use in adult patients only.

2. Important Information Before Taking 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 starting to take Memorion, discuss with your doctor or pharmacist if you have or have had:

• stomach or duodenal ulcers
• seizures or convulsions
• heart disease (such as irregular or very slow heart rate, heart failure, heart attack)
• a heart condition called "prolonged QT interval" or have been diagnosed with a certain type of irregular heartbeat, called torsade de pointes, or have a history of "QT interval prolongation"
• 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 to adjust the dose of the medicine)
• difficulty urinating or kidney disease.

You should also inform your doctor if you are pregnant or think you may be pregnant.
Before starting to take Memorion, inform your doctor or pharmacist if any of these conditions apply 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 the medicines you are taking now or have taken recently, as well as 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:

• medicines used to treat irregular heartbeat, such as amiodarone, sotalol
• medicines used to treat depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medicines used to treat psychosis, such as pimozide, sertindole, ziprasidone
• medicines used to treat bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• other medicines used to treat Alzheimer's disease, such as galantamine
• painkillers or medicines used to treat arthritis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• anticholinergic medicines, such as tolterodine
• antiepileptic medicines, such as phenytoin, carbamazepine
• medicines used to treat 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 planning to have surgery that requires general anesthesia, you should inform your doctor and anesthesiologist that you are taking Memorion, as this medicine may affect the doses of medicines required for anesthesia.
Memorion can be used in patients with kidney or mild to moderate liver disease. However, you should first inform your doctor if you have kidney or liver disease. Do not take Memorion if you have severe liver disease.

Memorion with Food, Drink, and Alcohol

Take Memorion with a drink of water (a glass of water). Food does not affect the action of the medicine.
Alcohol
While taking donepezil, you should limit your alcohol intake, as alcohol may change the effect of donepezil.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 for use in pregnant women.
Memorion should not be used during breastfeeding.

Driving and Using Machines

Do not drive or operate machinery, as Alzheimer's disease may impair your ability to drive or operate machinery; you can only perform these activities 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 tablets contain 83.5 mg of lactose (in the form of monohydrate), and the 10 mg tablets contain 167 mg of lactose (in the form of monohydrate). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to Take Memorion

Always take this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
Treatment usually starts with a dose of 5 mg (one white tablet) taken once daily in the evening. After one month, your doctor may recommend a dose of 10 mg (one yellow tablet), which should be taken 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 recommend the appropriate treatment period for you. You will need to visit your doctor from time to time to assess the effectiveness of the treatment and the symptoms of the disease.

Taking More Memorion Than Prescribed

Do not take more tablets than your doctor recommends.
If you have taken more Memorion than recommended, or a child has accidentally taken the medicine, contact your doctor immediately, go to the emergency department, or contact the poison control center for information on the risk and actions to be taken.
Always take the tablets and packaging with you to the hospital, so your doctor knows what medicine has been taken.
Symptoms of overdose include nausea and vomiting, salivation, sweating, slow heart rate, low blood pressure (feeling of emptiness in the head or dizziness when standing up), difficulty breathing, loss of consciousness, and seizures or convulsions.

Missing a Dose of 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 the missed tablet.
If you forget to take the medicine for more than a week, consult your doctor before resuming treatment.

Stopping Treatment with Memorion

Do not stop taking the tablets unless your doctor recommends it. After stopping treatment, the benefits of the medicine will gradually disappear.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patient's taking Memorion have reported the following side effects:

Severe Side Effects

Inform your doctor immediately if you experience any of the following severe side effects. You may need urgent medical attention.

• 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 occur in less than 1 in 1,000 people),
• stomach or duodenal ulcers. Symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the chest ( may occur in less than 1 in 100 people),
• bleeding from the stomach or intestines. Symptoms may include black stools or visible bleeding from the anus ( may occur in less than 1 in 100 people),
• seizures or convulsions ( may occur in less than 1 in 100 people),
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called malignant neuroleptic syndrome) ( may occur in less than 1 in 10,000 people),
• muscle weakness, tenderness, or pain, especially if it occurs with feeling 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 occur in less than 1 in 10,000 people).

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

• diarrhea
• headache
• nausea.

Common ( may occur in less than 1 in 10 people)

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

Uncommon ( may occur in less than 1 in 100 people)

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

Rare ( may occur in less than 1 in 1,000 people)

• movement disorders, such as tremors/shaking, 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 function visible on an ECG called "prolonged QT interval"
• rapid, irregular heartbeat, fainting, which may be symptoms of a condition called torsade de pointes, which can be life-threatening
• increased libido, hypersexuality
• a condition called "Pisa tower phenomenon" (involuntary muscle contraction with abnormal twisting of the body and head to one side).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the regulatory authority or to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the blister packs and carton.
The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Memorion Contains

• The active substance is donepezil hydrochloride. 5 mg tablet: each film-coated tablet contains 5 mg of donepezil hydrochloride. 10 mg tablet: each film-coated tablet contains 10 mg of donepezil hydrochloride.
• The other ingredients are: Tablet core:colloidal silica, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate. Tablet 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" embossed on one side and smooth on the other. The diameter of the tablet is 7 mm.
10 mg: Yellow, round, biconvex, film-coated tablets with "ML 88" embossed on one side and smooth on the other. The diameter of the tablet is 9 mm.
Packaging:
28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Estonia:
Donerion
Finland:
Donepezil Orion 5 mg kalvopäällysteiset tabletit
Donepezil Orion 10 mg kalvopäällysteiset tabletit
Lithuania:
Donerion 5 mg plėvele dengtos tabletės
Donerion 10 mg plėvele dengtos tabletės
Poland:
Memorion
Sweden:
Donepezil Orion 5 mg filmdragerade tabletter
Donepezil Orion 10 mg filmdragerade tabletter
Hungary:
Donefien 5 mg filmtabletta
Donefien 10 mg filmtabletta
Date of Last Revision of the Leaflet:20.10.2022