Инструкция по применению BLIXIE
Содержание инструкции
Blixie 5 mg film-coated tablets, 10 mg film-coated tablets
Donepezil hydrochloride
Generic medicine
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even 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 you take 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 IS BLIXIE AND WHAT IS IT 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 people diagnosed with mild to moderately severe
Alzheimer's disease. Symptoms include increasing memory loss, confusion, and mood changes.
As a result of this, patients suffering from Alzheimer's disease find it increasingly difficult to perform
normal daily activities.
The use of this medicine is reserved for adult patients only.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BLIXIE
Do not take Blixie:
- if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Blixie.
Tell your doctor or pharmacist if you have or have had:
- a stomach or intestinal ulcer;;
- epilepsy or convulsions;
- a heart problem (such as irregular or very slow heartbeat, heart failure, myocardial infarction);
- a heart condition called “prolonged QT interval” or a history of certain abnormalities of the
heart rhythm called torsades de pointes, or if someone 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 also if you are pregnant or suspect you might be.
Other medicines and Blixie
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines that your doctor has not prescribed but that
you have bought yourself from a pharmacy. This also applies to medicines you may take in the future
if you continue to take Blixie.
.
Tell 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);
- medicines against fungal infections, e.g. Ketoconazole;
- other medicines for Alzheimer's disease, such as galantamine;
- painkillers or medicines for the treatment of arthritis, for example acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium;
- anticholinergic drugs, e.g. Tolterodine;
- anticonvulsant medicines, e.g. phenytoin or carbamazepine;
- medicines for the heart, such as quinidine, beta-blockers (propanolol and atenolol);
- muscle relaxants, e.g. diazepam or succinylcholine;
- general anesthetics;
- medicines bought without a prescription, e.g. herbal medicines.
If you have planned an operation that requires a general anesthetic, you must inform your doctor and
the anesthesiologist that you are taking Blixie because this medicine may affect the amount of
anesthetic needed.
Tell your doctor if you have kidney or liver disease. Patients with severe liver disease should not
take Blixie. It can be used in patients with mild to moderate kidney or liver disease. .
Tell your doctor or pharmacist the name of the person who takes care of you. This will help them to take
the medicine according to the doctor's prescription. .
Blixie with food, drinks andalcohol
Food does not affect the effect of Blixie.
Blixie should not be taken with alcohol because alcohol can alter its effects. .
Pregnancyand breastfeeding
Blixie should not be used during breastfeeding.
If you are pregnant, suspect you might be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine. Blixie should not be
used during pregnancy unless it is clearly necessary.
Driving and operating machinery
Alzheimer's disease can impair your ability to drive or operate machinery. You should not
perform these activities unless your doctor tells you that you can do so safely. In addition, donepezil
can cause fatigue, dizziness and muscle cramps. If you experience any of these effects, you should not
drive or operate machinery.
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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
How much Blixie should you take?
Generally, therapy is started by taking 5 mg (one white tablet) every evening. After one month, your
doctor may prescribe you to take 10 mg (one yellow tablet) every evening.
Swallow the Blixie tablet with a drink or water before going to bed.
The dosage of the tablet you take may change, depending on how long you have been taking the
medicine and as recommended by your doctor. The maximum recommended dose is 10 mg every evening.
Always follow the advice of your doctor or pharmacist on how and when to take the medicine. Do not
change the dose on your own initiative without consulting your doctor.
For how long should you take Blixie?
Your doctor or pharmacist will tell you how long you should take the tablets. It is necessary to go
to your doctor periodically to review the treatment and evaluate your symptoms.
If you stop taking Blixie
Do not stop taking the tablets unless your doctor advises you to do so. If
you stop the treatment with Blixie, the benefits of the treatment will gradually disappear.
If you take more Blixie than you should
Do not take more than one tablet a day. Contact your doctor immediately if you take more tablets
than you should. If you are unable to contact your doctor, go immediately to the nearest Emergency Room.
Always bring the tablets and packaging with you to the hospital so that the doctor knows what
you have ingested.
Symptoms of overdose include feeling unwell, salivation, sweating,
slowing of the heartbeat, drop in blood pressure (dizziness or vertigo when standing up),
difficulty breathing, loss of consciousness, seizures (epileptic attacks) or convulsions.
If you forget to take Blixie
If you forget to take a tablet, simply take one tablet the next day
at the usual time. Do not take a double dose to make up for a missed dose.
If you forget to take your medicine for more than a week, consult your doctor before taking
any other medicine.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported by people taking donepezil.
Contact your doctor if you experience any of these effects while taking Blixie.
Serious side effects
You should contact your doctor immediately if you notice these serious side effects mentioned.
You may need urgent medical treatment.
- Weakness, hypotonia or muscle pain, especially if, at the same time, you feel unwell, have a high fever or dark urine. These symptoms may be caused by abnormal muscle breakdown which can be life-threatening and can cause kidney problems (a condition called rhabdomyolysis). (may affect up to 1 in 10,000 people)
- Liver damage, for example hepatitis. The symptoms of hepatitis are feeling sick or being ill, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, dark urine (may affect up to 1 in 1000 people).
- Stomach or intestinal ulcers. Symptoms of a stomach ulcer are pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people).
- Bleeding in the stomach or intestines. This can cause black stools or visible blood from the rectum (may affect up to 1 in 100 people).
- 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 side effects (may affect more than 1 in 10 people)
- Diarrhoea.
- Headache.
Common side effects (may affect up to 1 in 10 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 discomfort in the stomach.
- Skin rash.
- Itching.
- Urinary incontinence.
- Pain.
- Accidents (patients may be more prone to falls or accidental injuries).
Uncommon side effects (may affect up to 1 in 100 people)
- Slowed heartbeat.
- Increased salivation
Rare side effects (may affect up to 1 in 1000 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 observed with an electrocardiogram (ECG) called “QT prolongation”. Fast and irregular heartbeat and fainting, which can be symptoms of a life-threatening condition called torsades de pointes.
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 BLIXIE
Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date that is reported on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Blixie contains
The active ingredient is donepezil hydrochloride.
Blixie is available in two dosages: 5 mg tablet containing 5 mg of donepezil hydrochloride and
5 mg tablet containing 10 mg of donepezil hydrochloride.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, corn starch,
hydroxypropylcellulose and magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), talc, macrogol 400 and iron oxide
yellow (E172) (only for the 10 mg dosage).
Description of the appearance of Blixie and contents of the pack
Blixie 5 mg tablets are film-coated tablets, white in colour, round and biconvex.
Blixie 10 mg tablets are film-coated tablets, yellow in colour, round and biconvex.
Blixie film-coated tablets are supplied in blisters containing 28 film-coated tablets.
Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy.
Distributor for sales: 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.
- Страна регистрации
- Форма выпускаFilm-coated tablet, 5MG
- Код АТХN06DA02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги BLIXIEФорма выпуска: Film-coated tablet, 5 MGДействующее вещество: ДонепезилПроизводитель: ALMUS S.R.L.Отпускается по рецептуФорма выпуска: Film-coated tablet, 5 MGДействующее вещество: ДонепезилПроизводитель: LABORATORI ALTER S.R.L.Отпускается по рецептуФорма выпуска: Film-coated tablet, 5 MGДействующее вещество: ДонепезилПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецепту
Аналоги BLIXIE в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог BLIXIE в Испания
Аналог BLIXIE в Польша
Аналог BLIXIE в Украина
Врачи онлайн по BLIXIE
Обсудите применение BLIXIE и возможные следующие шаги — по оценке врача.
Получите рецепт на BLIXIE онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
BLIXIE требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество BLIXIE — Донепезил. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
BLIXIE производится компанией TECNIGEN S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения BLIXIE с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить BLIXIE в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Донепезил) включают DONEPETSIL ALMUS, DONEPETSIL ALTER, DONEPETSIL AUROBINDO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















