Donectil odt

Package leaflet: Information for the user

Donectil ODT, 10 mg, orodispersible tablets
Donepezili hydrochloridum
Please read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Donectil ODT is and what it is used for

Donectil ODT contains donepezil hydrochloride as the active substance, which belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat symptoms of dementia (impairment of reasoning) in people diagnosed with mild to moderate Alzheimer's disease. It is intended for use in adult patients only.

2. Important information before using Donectil ODT

When not to use Donectil ODT

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

Warnings and precautions
Before starting treatment with Donectil ODT, discuss with your doctor or pharmacist if:

• the patient has ever been diagnosed with gastric or duodenal ulcers
• the patient has ever experienced epileptic seizures or convulsions
• the patient has or has had heart conditions (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
• the patient has or has had a heart condition known as "prolonged QT interval" or previously diagnosed certain rhythm disorders called torsade de pointes, or has a history of "prolonged QT interval"
• the patient has or has had low blood levels of magnesium or potassium
• the patient has bronchial asthma (shortness of breath) or another chronic lung disease
• the patient has ever been diagnosed with hepatitis or other liver diseases
• the patient has difficulty urinating or has been diagnosed with mild kidney disease

Donectil ODT may be used in patients with kidney disease or in patients with mild to moderate liver disease. Inform your doctor about any kidney or liver disease before starting treatment. Patients with severe liver disease should not take Donectil ODT.

Donectil ODT and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

Always inform your doctor or pharmacist if any of the following medicines are taken together with Donectil ODT:

• other medicines for Alzheimer's disease, e.g. galantamine
• medicines used to treat heart rhythm disorders, e.g. amiodarone, sotalol
• medicines used to treat depression, e.g. citalopram, escitalopram, amitriptyline, fluoxetine
• medicines used to treat psychosis, e.g. pimozide, sertindole, ziprasidone
• medicines used to treat bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, e.g. ketoconazole
• painkillers or medicines used to treat joint inflammation, e.g. acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• anticholinergic medicines, e.g. tolterodine
• muscle relaxants, e.g. diazepam, succinylcholine
• anticonvulsant medicines, e.g. phenytoin, carbamazepine
• medicines used for heart conditions, e.g. quinidine, beta-blockers (propranolol and atenolol)
• medicines used in general anaesthesia
• over-the-counter medicines, e.g. herbal remedies

If a surgical procedure requiring general anaesthesia (general anaesthetic) is planned, the patient must inform the doctor and anaesthetist about taking Donectil ODT. This medicine may affect the amount of anaesthetic required.

Donectil ODT with food, drink and alcohol
After the Donectil ODT tablet dissolves on the tongue, it should be swallowed with a glass of water. Food does not affect the action of the medicine. During treatment with Donectil ODT, alcohol consumption should be limited, as alcohol may reduce the blood concentration of donepezil.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Donectil ODT should not be used during breastfeeding.

Driving and operating machinery
Do not drive, as Alzheimer's disease may impair the ability to do so, or operate mechanical equipment. Do not engage in these activities unless your doctor decides it is safe.
Do not use any devices or operate machinery, as this medicine may cause fatigue, dizziness, and muscle cramps. If these symptoms occur, do not drive or operate mechanical equipment.

Donectil ODT contains lactose and aspartame
Donectil ODT contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Donectil ODT contains aspartame (E 951), a source of phenylalanine. It may be harmful to patients with phenylketonuria.

3. How to use Donectil ODT

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your
doctor or pharmacist.
The recommended dose is 5 mg once daily, in the evening before bedtime. After one month, your doctor
may recommend increasing the dose to 10 mg once daily, in the evening before bedtime. The maximum
recommended daily dose is 10 mg.
Donectil ODT should be taken orally, in the evening before bedtime. If the patient experiences unusual
dreams, nightmares, or difficulty sleeping (see section 4), the doctor may recommend taking Donectil
ODT in the morning instead.
Place the tablet on the tongue and wait until it dissolves before swallowing. After that, you may drink
water or not, depending on personal preference.
The dose of this medicine may be adjusted depending on the duration of treatment and your doctor's
recommendations. Always follow your doctor's or pharmacist's instructions regarding how to take this
medicine. Do not change the dose without consulting your doctor. Your doctor or pharmacist will advise
you on how long to take the medicine. Periodic check-ups with your doctor are necessary to assess the
effectiveness of treatment and the symptoms of the disease.
Taking more Donectil ODT than recommended
Do not take more than one tablet per day. If you take more than the recommended dose, symptoms such
as nausea, vomiting, salivation, sweating, slowed heart rate, low blood pressure (dizziness upon
standing), breathing difficulties, collapse, and seizures may occur.
Contact your doctor immediately or go to the nearest hospital. Always bring the medicine in its
original packaging so the doctor knows which medicine has been taken.
Missing a dose of Donectil ODT
If you miss a dose, take one tablet the next day at your usual time. If you have not taken the medicine
for more than one week, contact your doctor before restarting treatment. Do not take a double dose to
make up for a missed dose.
Stopping Donectil ODT
Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Patients taking Donectil ODT have reported the following adverse reactions:

Severe adverse reactions:
Inform your doctor immediately if the patient experiences any of the following severe adverse reactions, as immediate medical attention may be required.

Uncommon: may affect up to 1 in 100 people
Peptic ulcers (gastric and duodenal ulcers). Symptoms of ulcers include: abdominal pain and discomfort (dyspepsia) felt between the navel and the breastbone.
Gastrointestinal bleeding. This may cause passage of black, tarry stools or visible rectal bleeding.
Seizures or convulsions.

Rare: may affect up to 1 in 1,000 people
Liver damage, such as hepatitis. Symptoms of hepatitis include: nausea or vomiting, malaise, loss of appetite, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine.

Very rare: may affect up to 1 in 10,000 people
Fever with muscle rigidity, sweating, and reduced level of consciousness (a complication known as neuroleptic malignant syndrome).
Muscle weakness, tenderness, or pain, especially when occurring together with malaise, high fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney dysfunction (a condition called rhabdomyolysis).

Frequency not known:
Changes in heart function seen on ECG, known as "QT interval prolongation."
Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.
If any of these symptoms occur during treatment with Donectil ODT, they should be reported to a doctor.

Other adverse reactions:

Very common: may affect more than 1 in 10 people

• Diarrhea
• Nausea
• Headache

Common: may affect up to 1 in 10 people

• Common cold
• Injuries (patients may be more prone to falls and accidental injuries)
• Loss of appetite
• Vomiting
• Abdominal discomfort
• Hallucinations (seeing or hearing things that are not really there)
• Unusual dreams, including nightmares
• Rash
• Itching
• Agitation
• Aggressive behaviour
• Muscle cramps
• Fainting
• Urinary incontinence
• Dizziness
• Fatigue
• Insomnia (difficulty falling asleep)
• Pain

Uncommon: may affect up to 1 in 100 people

• Slow heart rate (bradycardia)
• Slight increase in serum creatine kinase levels

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

• Sinoatrial block, atrioventricular block
• Muscle rigidity or uncontrolled movements, especially of the face and tongue, but also of the limbs

Frequency not known:

• Increased libido, hypersexuality
• Leaning Tower of Pisa sign (involuntary muscle contraction causing abnormal twisting of the body and head to one side)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Donectil ODT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
There are no special requirements for storage of this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Donectil ODT contains
The active substance in Donectil ODT is donepezil hydrochloride.
Each tablet contains 10 mg of donepezil hydrochloride.
Other ingredients are:
Povidone, microcrystalline cellulose, spray-dried lactose monohydrate, anhydrous sodium citrate,
aspartame (E 951), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate,
hydrochloric acid for pH adjustment.

What Donectil ODT looks like and contents of the pack
Round, flat tablets with bevelled edges, white to cream in colour, embossed with the number "10" on one side and smooth on the other, containing 10 mg of donepezil hydrochloride.
Packaging:
PVC/Aclar/Aluminium and Aluminium/Aluminium blisters containing 7, 10 or 14 tablets,
in a cardboard box.
Pack sizes:
30, 60 orally disintegrating tablets.
Not all pack types may be marketed.

Marketing Authorisation Holder
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer
Genepharm S.A.
18 km Marathonos Avenue
153 51 Pallini Attikis
Greece
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice