Donepezil Bluefish

Package Leaflet: Information for the User

Donepezil Bluefish, 5 mg, film-coated tablets

Donepezil Bluefish, 10 mg, film-coated tablets

Donepezil hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

• 1. What is Donepezil Bluefish and what is it used for
• 2. Important information before taking Donepezil Bluefish
• 3. How to take Donepezil Bluefish
• 4. Possible side effects
• 5. How to store Donepezil Bluefish
• 6. Package Contents and Other Information

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

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.
The medicine is used to treat the symptoms of dementia in people with mild to moderate Alzheimer's disease. Symptoms include memory loss, disorientation, and changes in behavior. As a result of these symptoms, people with Alzheimer's disease have increasing difficulty performing everyday activities.
Donepezil is intended for use in adult patients only.

2. Important information before taking Donepezil Bluefish

When not to take Donepezil Bluefish

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

Warnings and precautions

Before taking Donepezil Bluefish, discuss with your doctor, pharmacist, or nurse if you have or have had:

• stomach or duodenal ulcers,
• seizures or seizure attacks,
• heart problems (such as irregular or very slow heart rhythm, heart failure, heart attack),
• a heart condition called "prolonged QT interval" or have been told that you have a condition that affects your heart rhythm, called torsades de pointes, or have had "prolonged QT interval" in the past,
• low levels of magnesium or potassium in the blood,
• asthma or other chronic lung disease,
• liver problems or liver inflammation,
• difficulty urinating or mild kidney problems.

Donepezil Bluefish can be used in patients with mild to moderate kidney or liver problems.
Tell your doctor if you have kidney or liver problems.
Patient with severe liver problems should not take Donepezil Bluefish.

Donepezil Bluefish with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
Other medicines may reduce or increase the effect of Donepezil Bluefish.
It is particularly important to tell your doctor if you are taking any of the following medicines:

• medicines used to treat irregular heart rhythms, 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, such as phenytoin, carbamazepine,
• medicines used to treat heart conditions, such as quinidine, beta-blockers (propranolol and atenolol),
• muscle relaxants, such as diazepam, succinylcholine,
• medicines used for general anesthesia,
• over-the-counter medicines, such as herbal preparations.

If you are planning to have surgery that requires general anesthesia, tell your doctor and anesthesiologist that you are taking Donepezil Bluefish, as this medicine may affect the amount of anesthetic needed.
Tell your doctor or pharmacist the name of your caregiver. The caregiver will help you take the medicine as directed.

Donepezil Bluefish with food, drink, and alcohol

Food does not affect the action of Donepezil Bluefish.
Do not drink alcohol while taking Donepezil Bluefish, as alcohol may change the effect of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Donepezil Bluefish if you are pregnant, unless it is absolutely necessary.
Do not take Donepezil Bluefish if you are breastfeeding.

Driving and using machines

Alzheimer's disease may affect your ability to drive or operate machinery; therefore, do not perform these activities until your doctor tells you it is safe.
This medicine may also cause drowsiness, dizziness, and muscle cramps. If you experience these symptoms, do not drive or operate machinery.
Donepezil Bluefish contains lactose.
If you have been told that you have an intolerance to some sugars, contact your doctor before taking Donepezil Bluefish.

3. How to take Donepezil Bluefish

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you.
If you are not sure, ask your doctor, pharmacist, or nurse.
Treatment usually starts with 5 mg (one white tablet) once a day, in the evening. After one month, your doctor may tell you to take 10 mg (one yellow tablet) once a day, in the evening.
Take Donepezil Bluefish in the evening, before bedtime, with a glass of water.
The strength of the tablet you take may be changed, depending on the length of time you have been taking the medicine and your doctor's instructions. The maximum recommended dose is 10 mg, taken once a day, in the evening.

How long to take Donepezil Bluefish

Your doctor or pharmacist will tell you how long to take the tablets. You will need to see your doctor from time to time to check how well the medicine is working and to check for any side effects.

Taking more Donepezil Bluefish than prescribed

Do not take more than one tablet per day. If you take more Donepezil Bluefish than prescribed, contact your doctor immediately. If this is not possible, contact the emergency department of your nearest hospital. Always take the tablets and the package with you to the hospital, so the doctor knows what medicine you have taken.
Symptoms of overdose include nausea and vomiting, excessive saliva production, sweating, slow heart rate, low blood pressure (feeling dizzy or dizzy when standing up), breathing difficulties, loss of consciousness, and seizures or convulsions.

Missing a dose of Donepezil Bluefish

If you forget to take a tablet, take it the next day at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you forget and do not take the medicine for more than a week, contact your doctor before taking the medicine again.

Stopping Donepezil Bluefish treatment

Do not stop taking Donepezil Bluefish unless your doctor tells you to. If you stop taking Donepezil Bluefish, the benefits of the treatment will gradually disappear.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Donepezil Bluefish can cause side effects, although not everybody gets them.

Tell your doctor if you experience any of the following side effects while taking Donepezil Bluefish.

Severe side effects:

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

• 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 affect up to 1 in 10,000 people).
• liver damage, such as hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, feeling unwell, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 10,000 people).
• stomach or duodenal ulcers. Symptoms of stomach ulcers include pain and discomfort (indigestion), felt in the upper part of the stomach between the navel and the ribs (may affect up to 1 in 100 people).
• bleeding from the stomach or intestines. This may cause black stools or visible bleeding from the back passage (may affect up to 1 in 100 people).
• seizures or convulsions (may affect up to 1 in 100 people).
• tell your doctor immediately if you experience fever with stiff muscles, excessive sweating, or decreased consciousness (a condition called neuroleptic malignant syndrome) (may affect up to 1 in 10,000 people).

Other possible side effects:

Very common side effects:may affect more than 1 in 10 people

• diarrhea
• nausea, vomiting
• headache

Common side effects:may affect up to 1 in 10 people

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

Uncommon side effects:may affect up to 1 in 100 people

• slow heart rate

Rare side effects:may affect up to 1 in 1,000 people

• tremors, stiffness, or uncontrolled movements, especially of the face and tongue, but also of the limbs

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

• changes in heart function seen on an ECG called "prolonged QT interval"
• fast, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsades de pointes

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Donepezil Bluefish

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after "Expiry Date" or "EXP". The expiry date refers to the last day of that month.
• There are no 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. This will help protect the environment.

6. Package Contents and Other Information

What Donepezil Bluefish contains

The active substance is donepezil hydrochloride.
Each Donepezil Bluefish 5 mg tablet contains donepezil hydrochloride monohydrate, equivalent to 5 mg of donepezil hydrochloride.
Each Donepezil Bluefish 10 mg tablet contains donepezil hydrochloride monohydrate, equivalent to 10 mg of donepezil hydrochloride.
The other ingredients are:
Tablet core:lactose monohydrate, corn starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate.

Coating:

5 mg tablets: Opadry OY-38951 white: hypromellose (6cp), titanium dioxide (E 171), macrogol 400, talc.
10 mg tablets: Opadry 03B32654 yellow: hypromellose (6cp), macrogol 400, talc, titanium dioxide (E 171), iron oxide, yellow (E 172).

What Donepezil Bluefish looks like and contents of the pack

Donepezil Bluefish is available as 5 mg and 10 mg tablets. The tablets are described below.
5 mg: white to off-white, round, biconvex, film-coated tablets with a beveled edge, with "5" engraved on one side and smooth on the other side, approximately 7.14 mm in diameter.
10 mg: yellow, round, biconvex, film-coated tablets with a beveled edge, with "10" engraved on one side and smooth on the other side, approximately 8.73 mm in diameter.
Donepezil Bluefish 5 mg and 10 mg is available in the following packs:
PVC/Aluminum blisters:
5 mg: 7, 28, 56, 98, 119, 120 tablets
10 mg: 28, 56, 98, 119, 120 tablets
HDPE bottles with PP closure and seal: 100 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bluefish Pharmaceuticals AB, P.O. Box 490 13, 100 28 Stockholm, Sweden

Manufacturer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden

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

Austria
Donepezil Bluefish 5 mg Filmtabletten
Donepezil Bluefish 10 mg Filmtabletten
France
Donepezil Bluefish 5 mg comprimés peliculés
Donepezil Bluefish 10 mg comprimés peliculés
Iceland
Donepezil Bluefish 5 mg filmuhúðaðar töflur
Donepezil Bluefish 10 mg filmuhúðaðar töflur
Germany
Donepezilhydrochlorid Bluefish 5 mg Filmtabletten
Donepezilhydrochlorid Bluefish 10 mg Filmtabletten
Italy
Donepezil Bluefish 5 mg Compresse rivestita con film
Donepezil Bluefish 10 mg Compresse rivestita con film
Portugal
Donepezil Bluefish
Spain
Donepezil Bluefish 5 mg Comprimido revestido por película
Donepezil Bluefish 10 mg Comprimido revestido por película
Ireland
Donepezil Hydrochloride Bluefish 5 mg film-coated Tablets
Donepezil Hydrochloride Bluefish 10mg film-coated Tablets
Poland
Donepezil Bluefish
Date of last revision of the package leaflet:12/2021