DONEPEZIL MYLAN GENERICS ITALIA

Package leaflet: Information for the patient

Donepezil Mylan Generics Italia 5 mg orodispersible tablets, 10 mg orodispersible 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 pass it on to others, even if their symptoms are the same as yours, as 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 Italia is and what it is used for
2. What you need to know before taking Donepezil Mylan Generics Italia
3. How to take Donepezil Mylan Generics Italia
4. Possible side effects
5. How to store Donepezil Mylan Generics Italia
6. Contents of the pack and other information

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

Donepezil Mylan Generics Italia contains the active substance donepezil hydrochloride.
Donepezil hydrochloride 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 its breakdown.
This medicine is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderate Alzheimer's disease. The symptoms include increasing memory loss, confusion, and behavioural changes. As a result, people affected by Alzheimer's find it increasingly difficult to carry out their usual daily activities.
It should be used only in adult patients.

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

Do not take Donepezil Mylan Generics Italia:

• If you are allergic to donepezil, to medicines derived from piperidine (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 Italia if
you have or have ever had any of the following conditions:

• A heart rhythm disorder (especially an irregular heartbeat, or other conditions affecting the heartbeat or rhythm of the heart).
• Stomach or duodenal ulcers (intestine)
• Difficulty in urinating
• Seizures or epileptic fits
• Stiffness, tremors, or uncontrollable movements, especially of the face and tongue, but also of the limbs (which may have occurred after taking certain medicines and are known as "extrapyramidal" or Parkinson-like effects)
• Asthma or other long-term 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 Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially if you are taking one of the following:

• Other medicines for Alzheimer's disease, such as galantamine
• Anticholinergics (which cause typical side effects of these medicines such as dry mouth, blurred vision and/or drowsiness), for example tolterodine (used for bladder problems)
• Antidepressants (e.g. fluoxetine)
• Erythromycin (an antibiotic)
• Rifampicin (for the treatment of tuberculosis)
• Antifungals, for example ketoconazole, itraconazole
• Carbamazepine or phenytoin (for controlling epilepsy)
• Medicines for heart conditions, for example quinidine, beta-blockers (e.g. propranolol and atenolol)
• Painkillers or treatments for arthritis, for example acetylsalicylic acid ("aspirin"), non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac
• Muscle relaxants, for example diazepam

If you are scheduled to undergo surgery, including dental surgery, requiring the use of an anaesthetic, inform your doctor, dentist, hospital staff, or anaesthetist that you are taking this medicine.
Donepezil Mylan Generics Italia and alcohol
Exercise particular caution regarding alcohol consumption while taking this medicine, as
alcohol may reduce the effect of donepezil hydrochloride.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Donepezil hydrochloride should not be used during pregnancy unless clearly necessary.
Women taking this medicine must not breastfeed.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, drowsiness/tiredness, or muscle cramps while being treated with this medicine.
Alzheimer's disease itself may impair your ability to drive or use machines, and you should not engage in these activities unless your doctor has told you it is safe to do so.
Donepezil Mylan Generics Italia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e.
essentially "sodium-free".

3. How to take Donepezil Mylan Generics Italia

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Inform your doctor of the name of the person who assists you. That person will help you take the medicine as prescribed.

Adults
The usual recommended starting dose is 5 mg taken once daily, usually in the evening before going to bed, for at least one month.
After one month, your doctor may increase the dose to 10 mg once daily, usually in the evening before going to bed.
The maximum daily dose is 10 mg per day.
The tablet should be placed on the tongue and allowed to disintegrate completely before swallowing, with or without water, according to the patient's preference. You may take this medicine with or without food.
Your doctor will inform you how long you should continue taking these tablets.
You should have regular check-ups with your doctor to review your treatment and assess your symptoms.

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

If you take more Donepezil Mylan Generics Italia 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 to hospital so the doctor knows what you have taken.
Symptoms of overdose include: feeling unwell, excessive salivation, sweating, slowed heartbeat, low blood pressure (mild dizziness or vertigo when standing), difficulty breathing, fainting, seizures or convulsions, and muscle weakness.

If you forget to take Donepezil Mylan Generics Italia
If you forget to take your tablet, take one tablet the following day at the usual time.
Do not take a double dose to make up for the missed dose. If you forget to take the medicine for more than one week, contact your doctor before taking it again.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately contact your doctor 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 in the stomach, liver, or intestine, or ulcers in the stomach or duodenum (intestine). If you vomit, you may see fresh blood or material resembling coffee grounds in your vomit, or you may have black, tarry stools or visible rectal bleeding (from the back passage)

• seizures.

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 the whites of the eyes (jaundice), feeling unwell, and fever;
• changes in heart rhythm or a very slow heart rate.

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

• fever with muscle stiffness, sweating, or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome");
• muscle weakness, tenderness, or pain, particularly if you also feel unwell, have high fever, or dark urine. These symptoms could be due to abnormal muscle breakdown which can be life-threatening and may lead to kidney problems (a condition called rhabdomyolysis).

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

• diarrhoea,
• feeling sick (nausea),
• headache.

Common (may affect up to 1 in 10 people):

• malaise,
• muscle cramps,
• feeling tired,
• insomnia (difficulty falling or staying asleep),
• cold 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,
• skin rash or itching,
• involuntary urination,
• pain,
• accidents (risk of falls and accidental injuries may increase).

Uncommon (may affect up to 1 in 100 people):

• slow heart rate,
• increased blood levels of a substance called creatine kinase, which is involved in metabolism and may be detected in blood tests,
• increased salivation.

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

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

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
https://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 Italia

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

6. Package contents and other information

What Donepezil Mylan Generics Italia contains

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

The other ingredients are mannitol (E421), anhydrous colloidal silica, hydroxypropylcellulose,
potassium acesulfame, glycine, sodium glycolate starch, crospovidone, microcrystalline cellulose, and magnesium stearate.
Donepezil Mylan Generics Italia 10 mg orodispersible tablets also contain yellow iron oxide (E172).

Description of the appearance of Donepezil Mylan Generics Italia and package contents
Your medicine is in the form of orodispersible tablets.
Donepezil Mylan Generics Italia 5 mg are white, round, bevel-edged tablets, engraved with “DL 5” on one side and “M” on the other.
Donepezil Mylan Generics Italia 10 mg are yellow, round, bevel-edged tablets, engraved with “DL 10” on one side and “M” on the other.
Donepezil Mylan Generics Italia is available in blister packs containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 98, 100, 120 and 180 orodispersible tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorized in the European Economic Area countries
under the following names:
Italy: Donepezil Mylan Generics Italia, 5 mg & 10 mg orodispersible tablets
Sweden: Donezil