Donatine

Package leaflet: Information for the patient

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

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

Contents of the leaflet:

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

1. What Donatine is and what it is used for

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used for the symptomatic treatment of mild to moderate dementia in Alzheimer's disease. Symptoms include increasing memory loss, disorientation, and changes in behaviour. As a result, people with Alzheimer's disease experience increasing difficulty performing everyday tasks.
Donepezil is intended for use in adults only.

2. Important information before taking Donatine

Do not take Donatine if:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Donatine if you have or have ever had:

• Peptic ulcer of the stomach or duodenum,
• Seizures or epilepsy,
• Heart problems (such as irregular or very slow heartbeat, heart failure, myocardial infarction),
• A heart condition known as "prolonged QT interval", or if you have previously been diagnosed with a certain type of arrhythmia called torsade de pointes, or if you have a family history of "prolonged QT interval",
• Low levels of magnesium or potassium in the blood,
• Asthma or other chronic lung disease,
• Liver dysfunction or hepatitis,
• Difficulty in passing urine or mild kidney function impairment.

You should also inform your doctor if you are pregnant or think you may be pregnant.

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

Donatine with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your doctor if you are taking 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;
• Antipsychotic medicines, e.g. pimozide, sertindole, ziprasidone;
• Medicines used for bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;
• Antifungal medicines, e.g. ketoconazole;
• Other medicines used to treat Alzheimer's disease, e.g. galantamine, painkillers or medicines used to treat joint inflammation, e.g. acetylsalicylic acid, non-steroidal anti-inflammatory drugs such as ibuprofen or diclofenac;
• Anticholinergic medicines, e.g. tolterodine;
• Antiepileptic medicines, e.g. phenytoin, carbamazepine;
• Medicines used for heart conditions, e.g. quinidine, beta-blockers (propranolol and atenolol);
• Muscle relaxants, e.g. diazepam, succinylcholine;
• Medicines used for general anaesthesia;
• Over-the-counter medicines, e.g. herbal remedies.

If you are scheduled for surgery requiring general anaesthesia, you must inform your doctor and anaesthesiologist that you are taking Donatine. This medicine may affect the amount of anaesthetic drugs required.

Donatine may be used in patients with kidney disease or mild to moderate liver impairment. Inform your doctor if you have any kidney or liver problems.
Patients with severe liver impairment should not take Donatine.
You should provide your doctor or pharmacist with the name and contact details of your caregiver. The caregiver will help ensure that you take the medicine as prescribed.

Donatine with food, drink and alcohol
Meals do not affect the absorption of Donatine.
You should not drink alcohol while taking Donatine, as alcohol may affect the action of the medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Women taking Donatine should not breastfeed.

Driving and using machines
Alzheimer's disease may impair your ability to drive or operate machinery; therefore, do not perform these activities unless your doctor has confirmed it is safe.
This medicine may cause fatigue, dizziness, and muscle cramps. If these symptoms occur, do not drive or operate machinery.

Donatine contains lactose
This medicine contains lactose. If you have been advised by your doctor that you have an intolerance to certain sugars, consult your doctor before taking Donatine.

3. How to use Donatine

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The usual starting dose is 5 mg (one white tablet) taken once daily,
in the evening before bedtime.
After one month, your doctor may recommend increasing the dose to 10 mg (one yellow tablet) taken once daily,
in the evening before bedtime.
If unusual dreams, nightmares or difficulty falling asleep occur (see
section 4), your doctor may advise you to take Donatine in the morning.
Donatine should be taken before bedtime, with a glass of water.
The strength of the tablet taken may be adjusted depending on the duration of treatment and your doctor's instructions. The maximum recommended dose is 10 mg once daily, taken in the evening before bedtime.
Always follow your doctor’s or pharmacist’s instructions regarding how and when to take this medicine. Do not change the dose on your own.

How long should Donatine be taken?
Your doctor or pharmacist will advise you on how long to continue taking the tablets. Periodic reassessment of symptoms and treatment progress should be carried out by consulting your doctor.

Taking more Donatine than recommended
If you take more than the recommended dose, contact your doctor immediately or go to the nearest hospital. Always bring the medicine and its packaging with you so the doctor knows which medicine has been taken.
Symptoms of overdose may include: nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure (a feeling of emptiness in the head or dizziness when standing up), breathing difficulties, collapse, and seizures or convulsions.

If you miss a dose of Donatine
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for the missed tablet.
If you have missed taking the medicine for longer than one week, consult your doctor before resuming treatment.

Stopping Donatine
Do not stop taking this medicine unless advised by your doctor. After stopping treatment, the beneficial effects of Donatine will gradually decrease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported in patients treated with Donatine.
If any of the following adverse reactions occur during treatment with Donatine,
you should contact your doctor immediately.
Serious adverse reactions:
Inform your doctor if any of the listed adverse reactions occur. Immediate medical intervention may be necessary.

• Gastric or duodenal ulcers. Symptoms of gastric ulcers include stomach pain and discomfort (dyspepsia) 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 result in passing black, tarry stools or visible blood passing from the anus (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, e.g. hepatitis (inflammation of the liver). Symptoms of hepatitis include: nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (these symptoms may occur in less than 1 in 1000 people).
• Fever accompanied by muscle rigidity, sweating, or reduced level of consciousness (a condition known as neuroleptic malignant syndrome) (these symptoms may occur in less than 1 in 1000 people).
• Muscle weakness, tenderness or pain, particularly if the patient also feels unwell, has fever and dark urine. These may be symptoms of a condition called rhabdomyolysis, in which muscle breakdown occurs. This is a life-threatening condition that may also lead to kidney dysfunction (these symptoms may occur in less than 1 in 10,000 people).
• Rapid or irregular heartbeat, fainting – these may be symptoms of a potentially life-threatening condition called torsade de pointes (frequency cannot be estimated from available data).

Other adverse reactions
Very common: occurs in more than 1 in 10 people:

• Diarrhea
• Nausea and vomiting
• Headache

Common: occurs in up to 1 in 10 people:

• Muscle cramps
• Fatigue
• Insomnia (difficulty falling asleep)
• Colds
• Loss of appetite
• Hallucinations (seeing or hearing things that are not real)
• Unusual dreams (including nightmares)
• Restlessness
• Aggressive behaviour
• Fainting
• Dizziness
• Dyspepsia
• Vomiting
• Rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: occurs in up to 1 in 100 people:

• Slow heart rate
• Excessive salivation
• Slight increase in blood creatine kinase (CK) activity

Rare: occurs in up to 1 in 1000 people:

• Muscle stiffness or uncontrolled muscle movements, particularly in the face and tongue, but also in limbs
• Heart rhythm disorders

Frequency unknown (cannot be estimated from available data):

• Changes in heart function seen on ECG, known as "QT interval prolongation";
• Increased libido, hypersexuality
• Pisa syndrome (characterized by involuntary muscle contractions causing abnormal twisting of the body and head to one side).

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

5. How to store Donatine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister (EXP). The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system 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 Donatine contains
The active substance is donepezil hydrochloride. Each coated tablet contains donepezil hydrochloride monohydrate equivalent to 5 mg / 10 mg of donepezil hydrochloride.
The other ingredients are:
Tablet core: lactose monohydrate, maize starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose, magnesium stearate.
Coating composition:
For 5 mg tablets: hypromellose (E464), titanium dioxide (E171), polyethylene glycol 400, talc (E553b).
For 10 mg tablets: hypromellose (E464), titanium dioxide (E171), polyethylene glycol 400, talc (E553b), yellow iron oxide (E172).

What Donatine looks like and contents of the pack
Donatine is available as 5 mg and 10 mg tablets.
5 mg coated tablets: white or almost white, round, approximately 7.14 mm in diameter, biconvex with bevelled edges, embossed with "5" on one side and smooth on the other.
10 mg coated tablets: yellow, round, approximately 8.73 mm in diameter, biconvex with bevelled edges, embossed with "10" on one side and smooth on the other.
Donatine tablets are available in cardboard boxes containing blister packs made of PVC/aluminium foil in pack sizes 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 Authorisation Holder and Importer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland

Importer
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice, Poland

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: