Blixie

PATIENT LEAFLET: INFORMATION FOR THE USER

Blixie 5 mg film-coated tablets, 10 mg film-coated tablets

Donepezil hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you take 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

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

1. WHAT BIXIE IS AND WHAT IT IS USED FOR

Blixie (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down its breakdown.
It is used for the treatment of symptoms of dementia in patients diagnosed with mild to moderate Alzheimer's disease. Symptoms include increasing memory loss, confusion, and mood changes. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out normal daily activities.
This medicine is intended for use in adult patients only.

2. WHAT YOU SHOULD KNOW BEFORE TAKING BLIXIE

Do not take Blixie:

• if you are allergic to donepezil hydrochloride, to 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 Blixie.
Talk to your doctor or pharmacist if you have or have had:

• a stomach or intestinal ulcer;
• epileptic seizures or convulsions;
• a heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction);
• a heart disorder called “prolonged QT interval” or a history of certain heart rhythm abnormalities known as torsade de pointes, or if anyone in your family has a “prolonged QT interval”;
• low levels of magnesium or potassium in the blood;
• asthma or another long-term lung disease;
• liver problems or hepatitis;
• difficulty urinating or mild kidney disease.

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.
Other medicines and Blixie
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines prescribed by your doctor as well as those you have purchased without a prescription. This also applies to any medicines you may take in the future while continuing to take Blixie.
Inform your doctor especially if you are being treated with any of the following medicines:

• medicines for heart rhythm disorders (e.g. amiodarone, sotalol);
• 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);
• antifungal medicines, e.g. ketoconazole;
• other medicines for Alzheimer’s disease, such as galantamine;
• painkillers or medicines for the treatment of arthritis, e.g. acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac;
• anticholinergic medicines, e.g. tolterodine;
• anticonvulsant medicines, e.g. phenytoin or carbamazepine;
• heart medicines, such as quinidine, beta-blockers (propranolol and atenolol);
• muscle relaxants, e.g. diazepam or succinylcholine;
• general anaesthetics;
• over-the-counter medicines, e.g. herbal remedies.

If you have scheduled surgery requiring a general anaesthetic, you must inform your doctor and anaesthetist that you are taking Blixie, as this medicine may affect the amount of anaesthetic required.
Inform your doctor if you have kidney or liver disease. Patients with severe liver disease should not take Blixie. Blixie may be used in patients with mild to moderate kidney or liver disease.
Tell your doctor or pharmacist the name of the person who cares for you. This person will help you take the medicine as prescribed by your doctor.
Blixie with food, drinks and alcohol
Food does not affect the action of Blixie.
Blixie should not be taken with alcohol, as alcohol may alter its effects.
Pregnancy and breastfeeding
Blixie must not be used during breastfeeding.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Blixie should not be used during pregnancy unless clearly necessary.
Driving and using machines
Alzheimer’s disease may impair your ability to drive or use machines. You should not perform these activities unless your doctor tells you that it is safe to do so. In addition, donepezil may cause tiredness, dizziness, and muscle cramps. If you experience any of these effects, you should not drive or use machines.
Blixie contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE BLIXIE

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Blixie should you take?
Treatment is usually started by taking 5 mg (one white tablet) each evening. After one month,
your doctor may prescribe 10 mg (one yellow tablet) each evening.
Swallow the Blixie tablet with a drink or water before going to bed.
Your tablet dosage may change, depending on how long you have been taking the
medicine and on your doctor's recommendation. The maximum recommended dose is 10 mg each evening.
Always follow your doctor’s or pharmacist’s advice on how and when to take the medicine. Do not
change the dose on your own initiative without consulting your doctor.
How long should you take Blixie?
Your doctor or pharmacist will tell you how long you should take the tablets. It is necessary to visit
your doctor periodically to review the treatment and assess your symptoms.
If you stop taking Blixie
Do not stop taking the tablets unless your doctor advises you to do so. If
you stop treatment with Blixie, the benefits of treatment will gradually disappear.
If you take more Blixie 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 are unable to contact your doctor, go immediately to the nearest Emergency Room.
Always take the tablets and the packaging with you to the hospital so that the doctor knows what you have
taken.
Symptoms of overdose include feeling unwell, salivation, sweating,
slowing of the heartbeat, drop in blood pressure (dizziness or lightheadedness when standing),
difficulty breathing, loss of consciousness, epileptic seizures (seizures), or convulsions.
If you forget to take Blixie
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 have forgotten to take your medicine for more than one week, consult your doctor before taking
any further medicine.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported in people taking donepezil.
Contact your doctor if you experience any of these reactions while taking Blixie.

Serious adverse reactions
Seek immediate medical advice if you notice any of the serious adverse reactions listed below.
You may require urgent medical treatment.

• Weakness, muscle weakness or muscle pain, especially if you also feel unwell, have high fever or dark urine. These symptoms may be caused by abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems (a condition known as rhabdomyolysis). (may affect up to 1 in 10,000 people)
• Liver damage, for example hepatitis. Symptoms of hepatitis include feeling or being sick, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), dark urine (may affect up to 1 in 1,000 people).
• Stomach or intestinal ulcers. Symptoms of stomach ulcer include pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This may result in black stools or visible rectal bleeding (may affect up to 1 in 100 people).
• Epileptic seizures or convulsions (may affect up to 1 in 100 people).
• Fever with muscle stiffness, sweating or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).

Very common adverse reactions (may affect more than 1 in 10 people)

• Diarrhoea.
• Headache.

Common adverse reactions (may affect up to 1 in 100 people)

• Muscle cramps.
• Fatigue.
• Difficulty sleeping (insomnia).
• Common cold.
• Hallucinations (seeing or hearing things that are not really there).
• Unusual dreams, including nightmares.
• Agitation.
• Aggressive behaviour.
• Fainting.
• Dizziness.
• Feeling of stomach discomfort.
• Skin rash.
• Itching.
• Urinary incontinence.
• Pain.
• Accidents (patients may be more prone to falls or accidental injuries).

Uncommon adverse reactions (may affect up to 1 in 1,000 people)

• Slow heartbeat.
• Excessive salivation.

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

• Stiffness, agitation or uncontrolled movements, especially of the face and tongue, but also of the arms and legs.

Frequency not known:

• Changes in heart activity that can be seen on an electrocardiogram (ECG), known as "prolonged QT interval". Rapid and irregular heartbeat and fainting, which may be symptoms of a life-threatening condition called torsade de pointes.

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

5. HOW TO STORE BLIXIE

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 after "Exp.". The expiry date refers to the last day of that month.
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. PACK CONTENTS AND OTHER INFORMATION

What Blixie contains
The active substance is donepezil hydrochloride.
Blixie is available in two strengths: 5 mg tablets containing 5 mg of donepezil hydrochloride and
10 mg tablets containing 10 mg of donepezil hydrochloride.
The other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose, maize starch,
hydroxypropylcellulose and magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), talc, macrogol 400 and yellow iron oxide (E172) (only for the 10 mg strength).

Description of the appearance of Blixie and pack contents
Blixie 5 mg tablets are film-coated, white, round, biconvex tablets.
Blixie 10 mg tablets are film-coated, yellow, round, biconvex tablets.
Blixie film-coated tablets are supplied in blisters containing 28 film-coated tablets.

Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy.
Sole Distributor: Ecupharma Srl, via Mazzini 20 - 20123 Milano.

Manufacturers
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra
Portugal.