Donepezil Teva

Package leaflet: Information for the user

Donepezil Teva 5 mg film-coated tablets, 10 mg film-coated tablets

Donepezil hydrochloride (as monohydrate)
Equivalent medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Donepezil Teva (donepezil hydrochloride) belongs to a group of medicines known as acetylcholinesterase inhibitors. Donepezil Teva increases the levels of a substance (acetylcholine) in the part of the brain involved in memory function, thereby slowing down the breakdown of acetylcholine.
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, which cause people with Alzheimer's disease greater difficulty in carrying out normal daily activities. Donepezil Teva is indicated only for adult patients.

2. What you need to know before taking Donepezil Teva

Do not take Donepezil Teva

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

Inform your doctor if any of the conditions described below apply to you.
Warnings and precautions
Treatment with Donepezil Teva must be initiated and continuously supervised by a specialist doctor experienced in the diagnosis and treatment of Alzheimer's dementia.
Inform your doctor or pharmacist before taking Donepezil Teva if:

• you suffer or have ever suffered from stomach or duodenal ulcers
• you suffer or have ever suffered from epileptic seizures or convulsions
• you suffer or have ever suffered from heart disease (especially if you have an irregular or very slow heartbeat)
• you suffer or have ever suffered from asthma or other long-term lung diseases
• you suffer or have ever suffered from liver problems or hepatitis
• you suffer or have ever suffered from difficulty passing urine or mild kidney disorders

Also, inform your doctor if you are pregnant or suspect you may be pregnant.
Use in children and adolescents
Donepezil Teva is not recommended for children and adolescents under 18 years of age.
Other medicines and Donepezil Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This includes medicines not prescribed by your doctor that you have purchased yourself. This also applies to medicines you might take in the future, in case you continue taking Donepezil Teva. This is because these medicines may weaken or strengthen the effects of Donepezil Teva.
In particular, inform your doctor if you are taking any of the following types of medicines:

• other medicines for the treatment of Alzheimer's disease, e.g. galantamine
• painkillers or medicines for the treatment of arthritis, e.g. aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• anticholinergics, e.g. tolterodine
• antibiotics, e.g. erythromycin, rifampicin
• antifungals, e.g. ketoconazole
• antidepressants, e.g. fluoxetine
• medicines for epilepsy, e.g. phenytoin, carbamazepine
• medicines for heart conditions, e.g. quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, e.g. diazepam, succinylcholine
• general anaesthetics
• over-the-counter medicines, e.g. herbal remedies

If you are scheduled for surgery requiring general anaesthesia, inform your doctor and anaesthetist that you are taking donepezil hydrochloride, as the drug may affect the amount of anaesthetic required.

Donepezil Teva can be used in patients with kidney problems or with mild to moderate liver problems. Inform your doctor immediately if you have liver or kidney problems. Patients with severe liver disease must not take Donepezil Teva.
Inform your doctor or pharmacist about the name of the person who assists you. This person will help you take the medicine as prescribed.
If you have any doubts, consult your doctor or pharmacist before using Donepezil Teva tablets.
Donepezil Teva with food, drinks and alcohol
Donepezil Teva tablets should be taken with a glass of water. Food does not affect the action of Donepezil Teva. Do not take Donepezil Teva with alcohol, as alcohol may alter the effect of the medicine.
Pregnancy, breastfeeding and fertility
Donepezil Teva must not be taken while breastfeeding. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Alzheimer's disease may impair your ability to drive or operate machinery. Do not drive or use tools or machines unless your doctor has told you that there is no risk.
In addition, Donepezil Teva may cause fatigue, dizziness, and muscle cramps. If you experience any of these effects, do not drive or use machinery.
Donepezil Teva contains lactose monohydrate
Donepezil Teva tablets contain lactose monohydrate, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use Donepezil Teva

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
How much Donepezil Teva should you take?
The recommended starting dose is 5 mg (one white tablet) each evening. After one month, your doctor may
instruct you to take 10 mg (one yellow tablet) each evening. Swallow the Donepezil Teva tablet with a
glass of water in the evening, before going to bed. The dosage may change depending on the duration of treatment and upon
recommendation of your doctor. The maximum recommended dose is 10 mg each evening. Always
follow your doctor's or pharmacist's advice on how and when to take this medicine.
Do not change the dose on your own without consulting your doctor.
How long should you take Donepezil Teva?
Your doctor or pharmacist will advise you on how long you should continue taking the tablets.
You will need to consult your doctor from time to time to review the treatment and assess your symptoms.
If you take more Donepezil Teva than you should
DO NOT take more than one tablet per day. Contact your doctor immediately if you take more tablets
than prescribed. If you cannot contact your doctor, contact the hospital or Emergency Department. Always
bring the tablets and the packaging with you so that the doctor in hospital can see what you have taken.
Symptoms of overdose include feeling unwell, increased salivation, sweating,
slowed heartbeat, low blood pressure (dizziness or vertigo when standing),
breathing difficulties, loss of consciousness and epileptic seizures (epileptic fits) or convulsions.
If you forget to take Donepezil Teva
If you forget to take a tablet, simply take one tablet the next day at your 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, inform your doctor before taking any further
medicine.
If you stop taking Donepezil Teva
Do not stop taking the tablets unless instructed by your doctor. If you stop treatment with
Donepezil Teva, the benefits of the treatment will gradually disappear.
If you have any questions about using 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.
The following side effects have been reported in people taking donepezil hydrochloride. Contact your doctor if you experience any of these side effects while taking Donepezil Teva.

Serious side effects:
You must contact your doctor immediately if any of these serious side effects occur. Urgent medical treatment may be required.

• Liver damage, e.g. hepatitis. Symptoms of hepatitis include nausea and vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, and dark urine (may occur in up to 1 in 1,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and feeling unwell (indigestion) between the navel and the breastbone (may occur in up to 1 in 100 people).
• Bleeding in the stomach or intestines. This may result in passing black, tarry stools or bright red blood from the rectum (may occur in up to 1 in 100 people).
• Seizures or convulsions (may occur in up to 1 in 100 people).
• Fever with muscle stiffness, sweating, or reduced level of consciousness (a condition called "neuroleptic malignant syndrome") (may occur in up to 1 in 10,000 people).
• Weakness, hypotonia, or muscle pain, particularly if you also feel unwell, have a high fever, or dark urine. These symptoms could be caused by abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems (a condition known as rhabdomyolysis) (likely to occur in up to 1 in 10,000 people).

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

• Diarrhoea
• Feeling unwell or malaise
• Headache

Common side effects (may affect up to 1 in 10 people)

• Common cold
• Loss of appetite
• Hallucinations (seeing or hearing things that are not real)
• Unusual dreams and nightmares
• Agitation
• Aggressive behaviour
• Fainting
• Dizziness
• Difficulty sleeping (insomnia)
• Vomiting
• Feeling of discomfort in the stomach
• Skin rash
• Itching
• Muscle cramps
• Involuntary loss of urine
• Fatigue
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon side effects (may affect up to 1 in 100 people)

• Slowed heartbeat

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

• Tremor, stiffness, or involuntary movements, especially of the face and tongue, but also of the arms and legs

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Donepezil Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack or blister after 'EXP'.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Teva contains

• The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg or 10 mg of donepezil hydrochloride (as monohydrate).
• The other components of the tablet core are: maize starch, monohydrate lactose, microcrystalline cellulose, sodium glycolate starch (type A), colloidal anhydrous silica, magnesium stearate. The coating contains:
  5 mg film-coated tablets: monohydrate lactose, hypromellose 15 cp, titanium dioxide (E171), and macrogol 4000;
  10 mg film-coated tablets: monohydrate lactose, hypromellose 15 cp, titanium dioxide (E171), macrogol 4000, and yellow iron oxide (E172).

Description of the appearance of Donepezil Teva and contents of the pack
Donepezil Teva 5 mg film-coated tablets are white to whitish, round, biconvex tablets, engraved with “DN 5” on one side.
Donepezil Teva 10 mg film-coated tablets are yellow, round, biconvex tablets, engraved with “DN 10” on one side.
The film-coated tablets are available in packs of 7, 28, 30, 50, 56, 60, 84, 90, 98, or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturer
Teva Operations Poland Sp. z.o.o., Mogilska 80, 31-456 Krakow, Poland
Pliva Ljubljana d.o.o., Pot k sejmišču 35, 1000 Ljubljana, Slovenia
TEVA UK, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
PLIVA Hrvatska d.o.o. (Pliva Croatia Ltd), Prilaza baruna Filipovića 25, 10000 Zagreb, Croatia
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Donepezil Teva 5 mg filmomhulde tabletten
Donepezil Teva 10 mg filmomhulde tabletten
Germany: Donepezil –HCl AbZ 5 mg Filmtabletten
Donepezil –HCl AbZ 10 mg Filmtabletten
Finland: Donepezil ratiopharm
France: Donépézil TEVA 5 mg comprimé pelliculé
Donépézil TEVA 10 mg comprimé pelliculé
Ireland: Donepezil Teva 5 mg film-coated tablets
Donepezil Teva 10 mg film-coated tablets
Italy: Donepezil Teva
Portugal: Donepezilo Teva
Slovenia: Donepezil Pliva 5 mg filmsko obložene tablete
Donepezil Pliva 10 mg filmsko obložene tablete
Spain: Donepezilo Teva 5 mg comprimidos recubiertos con película EFG
Donepezilo Teva 10 mg comprimidos recubiertos con película EFG
United Kingdom: Donepezil hydrochloride 5 mg film-coated tablets
Donepezil hydrochloride 10 mg film-coated tablets