Memorion

Package leaflet: Information for the patient

Memorion, 5 mg, film-coated tablets
Memorion, 10 mg, film-coated tablets
Donepezili hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Memorion is and what it is 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 Memorion is and what it is used for

Memorion (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the concentration in the brain of a substance (acetylcholine) involved in memory processes by slowing its breakdown.
It is used in the symptomatic treatment of dementia in patients diagnosed with mild to moderate Alzheimer's disease. The symptoms of the disease include progressive memory loss, disorientation, and changes in behaviour. These lead to increasing difficulties in performing everyday activities in patients with Alzheimer's disease.
Memorion is intended for use in adult patients only.

2. Important information before taking Memorion

When not to take Memorion

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

Warnings and precautions
Before starting to take Memorion, discuss this with the doctor or pharmacist if the patient has or has ever had:

• stomach or duodenal ulcers
• seizures or convulsions
• heart diseases (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
• a heart condition known as "prolonged QT interval" or previously diagnosed certain rhythm disorders called torsade de pointes, or a history of "prolonged QT interval"
• low levels of magnesium or potassium in the blood
• bronchial asthma or other chronic lung disease
• liver disease or hepatitis (in such cases the patient may require dose adjustment)
• difficulty in passing urine or kidney disorders.

Patients who are pregnant or suspect they may be pregnant should also inform their doctor.
Before starting treatment with Memorion, inform the doctor or pharmacist if any of the conditions listed above apply to the patient.
Children and adolescents
Memorion is not intended for use in children and adolescents.
Memorion and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Always inform the doctor or pharmacist if, in addition to Memorion, the patient is taking or has been prescribed any of the following medicines:

• medicines used to treat heart rhythm disorders, e.g. amiodarone, sotalol
• medicines used to treat depression, e.g. citalopram, escitalopram, amitriptyline, fluoxetine
• medicines used to treat psychosis, e.g. pimozide, sertindole, ziprasidone
• medicines used to treat bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, e.g. ketoconazole
• other medicines used in Alzheimer's disease, e.g. galantamine
• painkillers or medicines used to treat joint inflammation, e.g. acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• anticholinergic medicines, e.g. tolterodine
• anticonvulsant medicines, e.g. phenytoin, carbamazepine
• medicines used for heart conditions, e.g. quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, e.g. diazepam, succinylcholine
• general anaesthetics
• over-the-counter medicines, e.g. herbal remedies.

If a surgical procedure requiring general anaesthesia (general anaesthetic) is planned, the patient should inform the doctor and anaesthetist about taking Memorion, as this medicine may affect the doses of anaesthetic medicines required.
Memorion may be used in patients with kidney disease or mild to moderate liver disease. However, the doctor should be informed first if the patient has kidney or liver disease. Memorion should not be used in patients with severe liver disease.
Memorion with food, drink and alcohol
Memorion should be taken with liquid (a glass of water). Food does not affect the action of the medicine.
Alcohol
Alcohol consumption should be limited during treatment with donepezil, as alcohol may alter the effects of donepezil.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Memorion is not recommended for use during pregnancy.
Memorion should not be used during breastfeeding.
Driving and operating machinery
Patients should not drive or operate machinery, as Alzheimer's disease may impair the ability to drive and operate machinery; such activities should only be performed with the doctor's approval. Treatment with this medicine may also cause fatigue, dizziness, and muscle cramps; if these symptoms occur, the patient should not drive or operate machinery.
Memorion contains lactose
The 5 mg tablets contain 83.5 mg of lactose (monohydrate form), and the 10 mg tablets contain 167 mg of lactose (monohydrate form). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Memorion

This medicine should always be taken as directed by the doctor or pharmacist.
If in doubt, consult the doctor or pharmacist.
The usual starting dose is 5 mg (one white tablet) taken once daily in the evening. After one month,
the doctor may recommend increasing the dose to 10 mg (one yellow tablet), which should be taken
once daily in the evening.
The dose of the medicine (tablet strength) may be adjusted depending on the duration of treatment
and the doctor's recommendations. The maximum recommended daily dose is 10 mg taken once
daily before bedtime.
Memorion should be taken orally with water in the evening before going to sleep.
If the patient experiences unusual dreams, nightmares, or difficulty sleeping (see section 4), the
doctor may advise taking Memorion in the morning instead.
How long should Memorion be taken?
Always follow the doctor's or pharmacist's instructions regarding how to take the medicine.
Do not change the dose without consulting the doctor. The doctor or pharmacist will advise the
patient on the appropriate duration of treatment. Periodic visits to the doctor are necessary to
evaluate the effectiveness of treatment and the course of the disease.
Taking more Memorion than prescribed
Do not take more tablets than prescribed by the doctor.
If the patient has taken more than the prescribed dose of Memorion, or if a child has accidentally
swallowed the medicine, contact a doctor immediately, go to the nearest hospital emergency
department, or contact a poison control center for information on the risks involved and the
necessary actions to take.
Always bring the tablets and the medicine packaging to the hospital so the doctor knows which
medicine has been taken.
Symptoms of overdose may include nausea and vomiting, excessive salivation, sweating, slowed
heart rate, low blood pressure (feeling of dizziness or lightheadedness upon standing), breathing
difficulties, loss of consciousness, and seizures or convulsions.
If a dose of Memorion is missed
If the patient forgets 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 the patient has missed taking the medicine for more than one week, contact the doctor before
resuming treatment.
Stopping Memorion treatment
Do not stop taking the tablets unless advised by the doctor. After stopping treatment, the benefits
of the medicine gradually diminish.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported in patients taking Memorion:

Serious adverse effects
Inform the doctor immediately if any of the following serious adverse effects occur. The patient may require immediate medical attention.

• Liver damage, e.g. hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (may occur in no more than 1 in 1,000 people),
• Gastric or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (dyspepsia) felt between the navel and the chest (may occur in no more than 1 in 100 people),
• Bleeding from the stomach or intestines. Symptoms may include black, tarry stools or visible rectal bleeding (may occur in no more than 1 in 100 people),
• Seizure or convulsions (may occur in no more than 1 in 100 people),
• Fever with muscle rigidity, sweating, or reduced level of consciousness (a condition known as neuroleptic malignant syndrome) (may occur in no more than 1 in 10,000 people),
• Muscle weakness, tenderness or pain, especially when occurring together with malaise, high fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney dysfunction (a condition called rhabdomyolysis) (may occur in no more than 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 do not exist in reality)
• Agitation
• Aggressive behaviour
• Fainting
• Central dizziness
• Vomiting
• Insomnia (difficulty falling asleep)
• Stomach discomfort
• Skin rash
• Itching
• Muscle cramps
• Involuntary urination
• 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)

• Slowed heart rate
• Excessive salivation
• Increased blood creatine kinase activity (creatine kinase is involved in muscle metabolism)

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

• Movement disorders such as tremors/shaking, stiffness, or involuntary movements, particularly of the face and tongue, but also of the limbs
• Heart block

Frequency not known (frequency cannot be estimated from available data)

• Changes in heart function seen on ECG known as "QT interval prolongation"
• Rapid, irregular heartbeat and fainting, which may be symptoms of a potentially life-threatening condition called torsade de pointes
• Increased libido, hypersexuality
• The "Leaning Tower of Pisa" sign (involuntary muscle contractions causing abnormal twisting of the body and head to one side)

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Marketing Authorisation Holder or to the Department for Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Memorion

This medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blisters and the carton.
The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 coated tablet contains 5 mg of donepezil hydrochloride.
  10 mg tablet: Each coated tablet contains 10 mg of donepezil hydrochloride.
• Other components are:
  Tablet core: Anhydrous colloidal silicon dioxide, monohydrate lactose, microcrystalline cellulose, pregelatinized starch, magnesium stearate.
  Tablet coating:
  5 mg coated tablets: hypromellose 5 CP, titanium dioxide (E 171), propylene glycol, talc.
  10 mg 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 coated tablets imprinted with
"ML 89" on one side and smooth on the other. The tablet diameter is 7 mm.
10 mg: Yellow, round, biconvex coated tablets imprinted with "ML 88" on one
side and smooth on the other. The tablet diameter is 9 mm.
Pack sizes:
28 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries 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