Donepezil Mylan Generics

Patient Information Leaflet

Donepezil Mylan Generics 5 mg film-coated tablets, 10 mg film-coated tablets

donepezil hydrochloride
Generic Medicine
Read this entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Donepezil Mylan Generics is and what it is used for
2. What you need to know before taking Donepezil Mylan Generics
3. How to take Donepezil Mylan Generics
4. Possible side effects
5. How to store Donepezil Mylan Generics
6. Contents of the pack and other information

1. What Donepezil Mylan Generics is and what it is used for

Donepezil Mylan Generics contains the active substance donepezil hydrochloride, which belongs
to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride
increases the levels in the brain of a substance (acetylcholine) involved in memory function, by slowing down the breakdown of this substance.
It is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderate Alzheimer's disease.
The symptoms of the disease include increasing memory loss, confusion and changes in behaviour. As a result, people affected by Alzheimer's disease find it increasingly difficult to carry out their usual daily activities.
It should only be used in adult patients.

2. What you need to know before taking Donepezil Mylan Generics

Do not take Donepezil Mylan Generics

• If you are allergic to donepezil, to piperidine derivatives (your doctor or pharmacist can advise you on this), 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 Donepezil Mylan Generics if you have or have ever had any of the following conditions:

• A heart disorder (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
• A problem with your heart rate or rhythm (for example, sick sinus syndrome or other conditions affecting your heart rate or rhythm). Donepezil Mylan Generics can slow your heart rate.
• A heart condition called "prolonged QT interval" or a history of certain heart rhythm abnormalities known as torsade de pointes, or if someone in your family has a "prolonged QT interval"
• Low levels of magnesium or potassium in your blood
• Stomach or duodenal (intestinal) ulcer
• Difficulty in urination
• Seizures or epileptic fits: Donepezil Mylan Generics may cause seizures or epileptic fits. Your doctor will monitor your symptoms.
• Stiffness, tremors, or uncontrolled movements, especially of the face and tongue, but also of the limbs (which may have occurred after taking certain medicines and are reported as "extrapyramidal" or "Parkinson-like" effects)
• Asthma or other chronic lung problems
• Liver problems

Children and adolescents
Children and adolescents under 18 years of age must not take this medicine.
Other medicines and Donepezil Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. In particular, inform your doctor or pharmacist if you are taking any of the following:

• Other medicines for Alzheimer's disease, e.g. galantamine
• Medicines for depression (e.g. citalopram, escitalopram, amitriptyline, fluoxetine)
• Medicines for psychosis (e.g. pimozide, sertindole, ziprasidone)
• Medicines for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin)
• Rifampicin (for the treatment of tuberculosis)
• Antifungal medicines, e.g. ketoconazole or itraconazole
• Carbamazepine or phenytoin (for controlling epilepsy)
• Medicines for heart conditions, e.g. quinidine, beta-blockers (e.g. propranolol, atenolol)
• Medicines for heart rhythm disorders (e.g. amiodarone, sotalol, quinidine)
• Painkillers or treatments for arthritis, e.g. acetylsalicylic acid (aspirin), non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac
• Anticholinergics (medicines that typically cause dry mouth, blurred vision, and/or drowsiness), e.g. tolterodine (used for bladder problems)

If you are due to undergo surgery, including dental procedures, requiring an anaesthetic, inform your doctor, dentist, hospital staff, or anaesthetist that you are taking this medicine.
Donepezil Mylan Generics and alcohol
Be especially careful about consuming alcohol while taking this medicine, as alcohol may reduce the effect of donepezil.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, do not take this medicine without first discussing it with your doctor. Donepezil Mylan Generics must not be used during pregnancy unless clearly necessary.
Donepezil Mylan Generics must not be used during breastfeeding.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, drowsiness, or muscle cramps while taking this medicine. Alzheimer's disease itself may impair your ability to drive or use machines. Do not engage in these activities unless your doctor has specifically told you it is safe to do so.
Donepezil Mylan Generics contains lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Donepezil Mylan Generics

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.
Tell your doctor the name of the person who assists you. That person will help you take the medicine as prescribed.

Adults
The recommended starting dose is 5 mg of Donepezil Mylan Generics taken once daily for at least one month. Your doctor may then increase the dose to 10 mg of Donepezil Mylan Generics once daily. The maximum recommended daily dose is 10 mg. If you experience an increase in side effects while taking 10 mg daily, talk to your doctor or pharmacist.

Use in patients with hepatic and renal disease
In adults with mild to moderate liver disease, your doctor may decide to adjust the dose. Dose adjustment is not required if you have kidney problems.

Method of administration
Take Donepezil Mylan Generics by mouth with a glass of water in the evening before going to bed.
Your doctor will tell you how long you should continue taking these tablets.
You should see your doctor regularly to review your treatment and assess your symptoms. You may take this medicine before or after meals.

If you take more Donepezil Mylan Generics than you should
Do not take more than one tablet per day. Contact your doctor or the nearest hospital emergency department immediately if you have taken more tablets than prescribed. Take the pack and any remaining tablets with you so that the doctor at the hospital can see what you have taken.

If you have taken more Donepezil Mylan Generics than you should, you may experience symptoms such as nausea, vomiting, salivation, sweating, slowing of heart rate (bradycardia), low blood pressure (dizziness and vertigo when standing up), breathing difficulties, loss of consciousness, seizures (convulsions). In addition, you may experience increased muscle weakness, which could be life-threatening if the muscles involved include those used for breathing.

If you forget to take Donepezil Mylan Generics
If you forget to take your tablet, take one tablet the next day at the usual time. Never take a double dose to make up for a forgotten tablet.
If you forget to take the medicine for more than one week, contact your doctor before taking the medicine again.

If you stop taking Donepezil Mylan Generics
When treatment is stopped, the beneficial effects of Donepezil Mylan Generics will gradually decrease.
Do not stop taking the tablets without first talking to your doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Contact your doctor immediately or go to the nearest hospital Emergency Department
if you experience any of the following serious side effects:

Uncommon (may affect up to 1 in 100 people)

• Bleeding from the stomach, intestine, or ulcers in the stomach or duodenum. If you vomit, you may notice fresh blood or material resembling coffee grounds in your vomit, or you may have black, tarry stools or fresh blood from the rectum.
• Seizures or convulsions.

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

• Liver problems including hepatitis (inflammation of the liver). You may notice dark urine, pale stools, yellowing of the skin or whites of the eyes (jaundice), nausea, and fever.
• Changes in heart rhythm, such as changes in heartbeat rhythm or "missed" beats. These symptoms may be signs of problems with the electrical signal in the heart.

Very rare (may affect up to 1 in 10,000 people)

• Fever with muscle stiffness, sweating, or reduced level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome");
• Muscle weakness, stiffness, or pain, particularly if you also feel unwell, have a high temperature, or dark urine. These may be caused by abnormal muscle breakdown, which can be potentially fatal and cause kidney problems (a condition called rhabdomyolysis).

Not known (frequency cannot be estimated from available data):

• Rapid and irregular heartbeat, fainting, which could be symptoms of a life-threatening condition called torsade de pointes.

Other side effects include:
Very common (may affect more than 1 in 10 people)

• Diarrhea,
• Feeling unwell,
• Headache.

Common (may affect up to 1 in 10 people)

• Vomiting,
• Muscle cramps,
• Feeling tired,
• Insomnia (difficulty falling asleep),
• Cold-like symptoms,
• Anorexia (loss of appetite),
• Hallucinations (seeing or hearing things that are not real),
• Unusual dreams including nightmares,
• Agitation,
• Aggressive behaviour,
• Fainting,
• Dizziness,
• Abdominal pain or discomfort,
• Rash and itching,
• Inability to control urination,
• Pain,
• Accidents (patients may be more prone to falls and accidental injuries).

Uncommon (may affect up to 1 in 100 people)

• Slowing of the heartbeat,
• Increased blood levels of a substance called creatine kinase, which is involved in metabolism (this may be observed in blood tests),
• Increased salivation.

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

• Extrapyramidal symptoms including involuntary movements, tremor and rigidity, motor restlessness, muscle contractions, and changes in respiratory and heart rate.

Not known (frequency cannot be estimated from available data):

• Changes in heart activity that can be seen on an electrocardiogram (ECG), known as "prolonged QT interval".

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Donepezil Mylan Generics

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and on the blister/ bottle after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Donepezil Mylan Generics contains

• The active substance is donepezil hydrochloride.
• Donepezil Mylan Generics 5 mg film-coated tablets: each tablet contains 5 mg of donepezil hydrochloride (equivalent to 4.56 mg of donepezil).
• Donepezil Mylan Generics 10 mg film-coated tablets: each tablet contains 10 mg of donepezil hydrochloride (equivalent to 9.12 mg of donepezil).

The other ingredients are:
Tablet core: monohydrate lactose (see section 2 “Donepezil Mylan Generics contains lactose”), maize starch, hydroxypropylcellulose, microcrystalline cellulose and magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171) and macrogol.

Description of the appearance of Donepezil Mylan Generics and pack contents

Your medicine is in the form of film-coated tablets.
Donepezil Mylan Generics 5 mg film-coated tablets: white, round, film-coated tablets, marked with “DL” above “5” on one side and “G” on the other.
Donepezil Mylan Generics 10 mg film-coated tablets: white, round, film-coated tablets, marked with “DL” above “10” on one side and “G” on the other.

Donepezil Mylan Generics 5 mg film-coated tablets are available in blisters containing 7, 10, 28, 30, 56, 60, 84, 98 or 100 film-coated tablets, calendar packs of 28 or 98, and single-dose blisters of 50 x 1.
Donepezil Mylan Generics 5 mg film-coated tablets are also available in bottles containing 100 or 250 film-coated tablets.
Donepezil Mylan Generics 10 mg film-coated tablets are available in blisters containing 10, 28, 30, 56, 60, 84, 98 or 100 film-coated tablets, calendar packs of 28 or 98, and single-dose blisters of 50 x 1.
Donepezil Mylan Generics 10 mg film-coated tablets are also available in bottles containing 100 or 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano

Manufacturers
McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., Mylan utca 1, Komárom, 2900 (Hungary)

This medicinal product has been authorised in other European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria: “Donepezil HCL“Arcana” 5 mg - Filmtabletten”, “Donepezil HCL“Arcana” 10 mg - Filmtabletten”
France: “DONEPEZIL MYLAN 5 mg, comprimé pelliculé”, “DONEPEZIL MYLAN 10 mg, comprimé pelliculé”
Greece: “DONEPEZIL/MYLAN”
United Kingdom (Northern Ireland): “Donepezil Hydrochloride 5mg Film-coated Tablets”, “Donepezil Hydrochloride 10mg Film-coated Tablets”
Ireland: “Aripil 5mg Film-coated Tablets”, “Aripil 10mg Film-coated Tablets”
Poland: Pamigen
Portugal: DONEPEZILO MYLAN
Czech Republic: “Donepezil Mylan 5 mg”, “Donepezil Mylan 10 mg”
Spain: “DONEPEZILO Viatris 5 mg comprimidos recubiertos con película EFG”, “DONEPEZILO Viatris 10 mg comprimidos recubiertos con película EFG”
Sweden: “Donepezil Mylan”