Ricordo

PATIENT INFORMATION LEAFLET

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Ricordo, 5 mg,orodispersible tablets
Ricordo, 10 mg,orodispersible tablets
donepezil hydrochloride

Read the leaflet carefully before taking the medicine, 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 only. 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ricordo and what is it used for
• 2. Important information before taking Ricordo
• 3. How to take Ricordo
• 4. Possible side effects
• 5. How to store Ricordo
• 6. Contents of the pack and other information

1. What is Ricordo and what is it used for

Ricordo (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat the symptoms of dementia (disorders of rational behavior) in patients with diagnosed Alzheimer's disease (chronic mental illness) in mild to moderate severity.
It is intended for use in adult patients only.

2. Important information before taking Ricordo

When not to take Ricordo

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

Warnings and precautions

Before starting to take Ricordo, discuss this with your doctor or pharmacist:

• if you have ever had stomach or duodenal ulcers
• if you have ever had a seizure or convulsions
• if you have ever had heart problems (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
• if you have ever had a heart condition called "prolonged QT interval" or have previously had certain heart rhythm disorders called Torsade de Pointes or have a history of "QT interval prolongation"
• if you have ever had low magnesium or potassium levels in the blood
• if you have asthma (shortness of breath) or other chronic lung disease
• if you have ever had liver disease or hepatitis
• if you have difficulty urinating or mild kidney disease

Ricordo and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
medicines used to treat heart rhythm disorders, such as amiodarone, sotalol
medicines used to treat depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
antipsychotic medicines, 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 diclofenac sodium
• anticholinergic medicines, such as tolterodine
• antiepileptic medicines (medicines used to prevent certain types of seizures), 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 medicines

If you are scheduled to undergo surgery requiring general anesthesia, you should inform your doctor and anesthesiologist that you are taking Ricordo. The medicine may affect the amount of anesthetic needed.
Ricordo can be used in patients with kidney disease and mild or moderate liver impairment. You should immediately inform your doctor if you have kidney or liver disease. Patients with severe liver impairment should not take Ricordo.

Ricordo with food, drink, and alcohol

Ricordo can be taken with a glass of water after the tablet has dissolved on the tongue. Food does not affect the action of the medicine. During treatment with Ricordo, you should limit your alcohol consumption, as alcohol may decrease donepezil levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Using donepezil hydrochloride during pregnancy is contraindicated. Women taking donepezil hydrochloride should not breastfeed. .

Driving and using machines

Alzheimer's disease may impair your ability to drive or operate machinery; therefore, you should not perform these activities until your doctor determines that it is safe.
This medicine may also cause fatigue, dizziness, and muscle cramps. If you experience these symptoms, do not drive or operate machinery.

Ricordo contains aspartame

Ricordo, 5 mg contains 5 mg of aspartame in each orodispersible tablet.
Ricordo, 10 mg contains 10 mg of aspartame in each orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

Ricordo contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Ricordo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Ricordo

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 5 mg once daily, in the evening. After one month, your doctor may recommend taking 10 mg once daily, in the evening.
The maximum recommended dose is 10 mg once daily, in the evening.
Ricordo should be taken orally, with water, in the evening, just before bedtime. If you experience unusual dreams, nightmares, or difficulty falling asleep (see section 4), your doctor may recommend taking Ricordo in the morning.
Place the tablet on your tongue and let it dissolve, then swallow, with or without water, according to your preference.
Your doctor may recommend changing the strength of the tablets you are taking, depending on the duration of treatment. Always follow the advice of your doctor or pharmacist on how and when to take the medicine. Do not change the dose of the medicine without consulting your doctor. Your doctor or pharmacist will advise you on how long to continue taking the tablets. From time to time, you should consult your doctor to reassess your symptoms and the course of treatment.

Taking more than the recommended dose of Ricordo

Do not take more than one tablet per day. If you take more than the recommended dose, you may experience: nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure (dizziness or fainting when standing), breathing difficulties, collapse, and seizures. In this case, you should immediately inform your doctor or contact the nearest hospital emergency department. Always take the tablets and packaging with you to the hospital so that the doctor knows what medicine you have taken.

Missing a dose of Ricordo

If you miss a dose, take one tablet the next day at the usual time. If you stop taking the medicine for more than a week, consult your doctor before taking it again. Do not take a double dose to make up for a missed dose.

Stopping treatment with Ricordo

Do not stop taking the medicine unless your doctor advises you to do so.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ricordo can cause side effects, although not everybody gets them.
In most cases, side effects are mild and temporary and do not require discontinuation of treatment.
Tell your doctor if you experience any of the following side effects and if they are too troublesome for you.
Patients taking donepezil have reported the following side effects:

Tell your doctor if you experience any of the following symptoms while taking Ricordo.

Serious side effects:

If you experience any of the following serious side effects, tell your doctor immediately. You may need to start treatment right away.

• rapid, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called Torsade de Pointes (frequency not known: cannot be estimated from the available data) liver damage, such as hepatitis. Symptoms of hepatitis are nausea, loss of appetite, malaise, fever, itching of the skin, yellowing of the skin and eyes, dark urine (frequency: rare, may occur in less than 1 in 1,000 patients) stomach or duodenal ulcers. Symptoms of peptic ulcer disease are stomach pain and discomfort (indigestion) felt between the navel and the breastbone (frequency: uncommon, may occur in less than 1 in 100 patients)
• bleeding from the stomach or intestines. You may see black, tarry stools or bleeding from the anus (likely to occur in less than 1 in 100 patients)
• seizures or convulsions (frequency: uncommon, may occur in less than 1 in 100 patients)
• fever and muscle stiffness, excessive sweating, or changes in consciousness (a condition called "neuroleptic malignant syndrome") (frequency: very rare, may occur in less than 1 in 10,000 patients)
• muscle weakness, tenderness, or pain, especially if it occurs with malaise, 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) (frequency: very rare, may occur in less than 1 in 10,000 patients)

Very common(may affect more than 1 in 10 patients):

• diarrhea
• nausea, vomiting
• headache

Common(may affect up to 1 in 10 patients)

• cold
• loss of appetite
• hallucinations (seeing or hearing things that are not real)
• vomiting
• agitation
• aggressive behavior
• fainting
• dizziness
• insomnia (difficulty falling asleep)
• accidents (patients may be more prone to falls and accidental injuries)
• indigestion
• hives
• itching
• muscle cramps
• urinary incontinence
• fatigue
• pain

Uncommon(may affect up to 1 in 100 patients)

• slow heart rate
• mild increase in muscle creatine kinase activity in the blood
• Rare(may affect up to 1 in 1,000 patients)
• stiffness or uncontrolled movements of the muscles, particularly of the face and tongue, but also of the limbs
• atrioventricular block, atrioventricular nodal block

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

• changes in heart function visible on an ECG called "prolonged QT interval"
• increased libido, hypersexuality
• a condition called "Pisa tower phenomenon" (characterized by involuntary muscle contraction with abnormal twisting of the body and head to one side)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Ricordo

Keep out of the sight and reach of children.
Do not use Ricordo after the expiry date stated on the blister and carton.
The expiry date refers to the last day of that month.
There are no special precautions for storage.
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 Ricordo contains

The active substance of the medicine is donepezil hydrochloride.
Each tablet contains 5 mg or 10 mg of donepezil hydrochloride.
The other ingredients of the medicine are:
Potassium polacrilin, microcrystalline cellulose, lactose monohydrate (spray-dried), anhydrous sodium citrate, aspartame (E 951), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, hydrochloric acid for pH adjustment.

What Ricordo looks like and contents of the pack

Orodispersible tablets 5 mg: white or almost white, round, flat tablets, with beveled edges, with "5" embossed on one side and smooth on the other.
Orodispersible tablets 10 mg: white or almost white, round, flat tablets, with beveled edges, with "10" embossed on one side and smooth on the other.
Packaging:
PVC/Aclar/Aluminum or Aluminum/Aluminum blister pack containing 14 tablets in a carton.
Ricordo, 5 mg:The pack contains 28 tablets.
Ricordo, 10 mg:The pack contains 28 or 56 tablets.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Genepharm S.A.
18 km Marathonos Avenue,
Pallini 15351, Attikis, Greece
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PL: Ricordo

Date of approval of the leaflet: 01.2023