Donatine

Package Leaflet: Information for the Patient

Donatine, 5 mg, Film-Coated Tablets

Donatine, 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Donatine and What is it Used For
• 2. Important Information Before Taking Donatine
• 3. How to Take Donatine
• 4. Possible Side Effects
• 5. How to Store Donatine
• 6. Package Contents and Other Information

1. What is Donatine and What is it Used For

Donepezil belongs to a group of medications called acetylcholinesterase inhibitors.
It is used to treat mild to moderate Alzheimer's disease symptoms, including increasing memory loss, disorientation, and behavioral changes.
As a result, people with Alzheimer's disease have increasing difficulty performing everyday activities.
Donepezil is intended for use in adults only.

2. Important Information Before Taking Donatine

When Not to Take Donatine

• If the patient is allergic to donepezil hydrochloride or to piperidine derivatives, or to any of the excipients of this medication (listed in section 6).
• 6.

Warnings and Precautions

Before starting Donatine, consult your doctor or pharmacist if you have or have had:

• stomach or duodenal ulcers,
• seizures or convulsions,
• heart problems (such as irregular or very slow heart rate, heart failure, myocardial infarction),
• a heart condition called "prolonged QT interval" or have had certain heart rhythm problems called torsades de pointes or have had a "prolonged QT interval" in the past,
• low magnesium or potassium levels in the blood
• asthma or other chronic lung disease,
• liver problems or hepatitis,
• difficulty urinating or mild kidney problems.

Women should also inform their doctor if they are pregnant or think they may be pregnant.

Children and Adolescents

Donatine is not indicated for use in children and adolescents (under 18 years of age).

Donatine and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
It is especially important to inform your doctor about taking any of the following medications:

• medications used to treat heart rhythm problems, such as amiodarone, sotalol;
• medications used to treat depression, such as citalopram, escitalopram, amitriptyline, fluoxetine;
• antipsychotic medications, such as pimozide, sertindole, ziprasidone;
• medications used to treat bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;
• antifungal medications, such as ketoconazole;
• other medications used to treat Alzheimer's disease, such as galantamine, pain relievers or medications used to treat arthritis, such as acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, such as ibuprofen or diclofenac
• anticholinergic medications, such as tolterodine
• anticonvulsant medications, such as phenytoin, carbamazepine
• medications used to treat heart problems, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• medications used for general anesthesia
• over-the-counter medications, such as herbal preparations

If you are scheduled to have surgery that requires general anesthesia, inform your doctor and anesthesiologist that you are taking Donatine, as it may affect the amount of anesthetic needed.
Donatine can be used in patients with kidney or mild to moderate liver impairment. Inform your doctor if you have kidney or liver disease.
Patient with severe liver impairment should not take Donatine.
Patient should provide their doctor or pharmacist with the name of their caregiver. The caregiver will help the patient take the medication as directed by the doctor.

Donatine with Food, Drink, and Alcohol

Food does not affect the absorption of Donatine.
Do not drink alcohol while taking Donatine, as it may affect the medication's action.

Pregnancy, Breastfeeding, and Fertility

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 medication.
Women taking Donatine should not breastfeed.

Driving and Operating Machinery

Alzheimer's disease may impair your ability to drive or operate machinery; therefore, do not perform these activities until your doctor determines it is safe.
The medication may cause drowsiness, dizziness, and muscle cramps. If these symptoms occur, do not drive or operate machinery.

Donatine Contains Lactose

This medication contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking Donatine.

3. How to Take Donatine

Always take this medication exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
Typically, treatment starts with 5 mg (one white tablet) once daily, in the evening before bedtime.
After one month, your doctor may recommend increasing the dose to 10 mg (one yellow tablet) once daily, in the evening before bedtime.
If you experience unusual dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donatine in the morning.
Take Donatine before bedtime, with a glass of water.
The dose of the tablet may be changed depending on the duration of treatment and your doctor's recommendations. The maximum recommended dose is 10 mg once daily, in the evening before bedtime.
Always follow your doctor's or pharmacist's instructions on how and when to take the medication. Do not change the dose yourself.

How Long to Take Donatine

Your doctor or pharmacist will tell you how long to continue taking the tablets. From time to time, you should consult your doctor to reassess your symptoms and treatment.

Taking More Than the Recommended Dose of Donatine

If you have taken more than the recommended dose of the medication, immediately inform your doctor or go to the nearest hospital. Always take the tablets and packaging with you, so the doctor knows what medication you have taken.
Symptoms of overdose may include: nausea (vomiting), vomiting, salivation, sweating, slow heart rate, low blood pressure (feeling of emptiness in the head or dizziness when standing up), breathing difficulties, collapse, and seizures or convulsions.

Missing a Dose of Donatine

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.
If you have missed taking the medication for more than a week, consult your doctor before restarting treatment.

Stopping Donatine Treatment

Do not stop taking the medication unless your doctor tells you to. After stopping treatment, the beneficial effects of Donatine will gradually decrease.
If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Donatine can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Donatine.

If You Experience Any of the Following Side Effects While Taking Donatine, Consult Your Doctor.

Severe Side Effects:

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

• stomach or duodenal ulcers. Symptoms of stomach ulcers include stomach pain and discomfort (indigestion) felt in the area between the navel and the breastbone (these symptoms may occur in less than 1 in 100 people).
• bleeding from the stomach or intestines. This may cause black, tarry stools or visible blood in the stool (these symptoms may occur in less than 1 in 100 people).
• seizures or convulsions (these symptoms may occur in less than 1 in 100 people).
• liver damage, such as hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark urine (these symptoms may occur in less than 1 in 1000 people).
• fever with stiff muscles, sweating, or decreased consciousness (a condition called neuroleptic malignant syndrome) (these symptoms may occur in less than 1 in 1000 people).
• muscle weakness, tenderness, or pain, especially if you feel unwell, have a fever, and dark urine. These may be symptoms of a condition called rhabdomyolysis, which can lead to kidney problems (these symptoms may occur in less than 1 in 10000 people)
• fast, irregular heartbeat, fainting, which may be symptoms of a condition called torsades de pointes, which can be life-threatening (frequency cannot be estimated from the available data).

Other Side Effects

Very Common: Occur in More Than 1 in 10 People:

• diarrhea
• nausea and vomiting
• headache

Common: Occur in Less Than 1 in 10 People:

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

Uncommon: Occur in Less Than 1 in 100 People:

• slow heart rate
• excessive salivation
• mild increase in muscle enzyme levels in the blood

Rare: Occur in Less Than 1 in 1000 People:

• stiffness or uncontrolled movements of the muscles, especially of the face and tongue, but also of the limbs
• heart rhythm problems

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
• Tower of Pisa syndrome (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, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Donatine

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister pack (EXP). The expiry date refers to the last day of the month.
There are no special storage instructions for this medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Donatine Contains

The active substance of Donatine is donepezil hydrochloride. Each film-coated tablet contains donepezil hydrochloride equivalent to 5 mg / 10 mg of donepezil hydrochloride.
The other ingredients are:
Core:lactose monohydrate, corn starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate.

Coating:

For 5 mg tablets: Hypromellose (E464), titanium dioxide (E171), macrogol 400, talc (E553b)
For 10 mg tablets: Hypromellose (E464), titanium dioxide (E171), macrogol 400, talc (E553b), yellow iron oxide (E172).

What Donatine Looks Like and Package Contents

Donatine is available in 5 mg and 10 mg film-coated tablets.
5 mg film-coated tablets: are white or almost white, round with a diameter of approximately 7.14 mm, biconvex with beveled edges and engraved with "5" on one side and smooth on the other.
10 mg film-coated tablets: are yellow, round with a diameter of approximately 8.73 mm, biconvex with beveled edges and engraved with "10" on one side and smooth on the other.
Donatine tablets are available in cardboard boxes with blisters of PVC/Aluminum in packs of 7, 10, 28, 30, 50, 56, 60, 84, 98, and 120 tablets or in HDPE bottles containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Importer

Marketing Authorization Holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański

Importer

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice

This Medication is Authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) Under the Following Names:

Date of Last Revision of the Leaflet:November 2023