Инструкция по применению XSYSTO
Содержание инструкции
XSYSTO 400 mg film-coated tablets
Pivmecillinam hydrochloride
Read this leaflet carefully before 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. See section 4.
Contents of this leaflet:
- 1. What XSYSTO is and what it is used for
- 2. What you need to know before you take XSYSTO
- 3. How to take XSYSTO
- 4. Possible side effects
- 5. How to store XSYSTO
- 6. Contents of the pack and other information
1. What is XSYSTO and what is it used for
XSYSTO belongs to a group of medicines called penicillins. It is a type of antibiotic. XSYSTO
works by killing germs (bacteria) that cause infections.
XSYSTO is used to treat bladder infections (cystitis) in adults
2. What you need to know before you take XSYSTO
Your doctor may have prescribed a use or dosage different from those reported in this leaflet. Always follow
your doctor's instructions.
Do not take XSYSTO:
- If you are allergic (hypersensitive) to pivmecillinam or any of the ingredients of this medicine (listed in section 6).
- If you are allergic (hypersensitive) to other antibiotics. These include penicillin or cephalosporins.
- In case of narrowing of the esophagus.
- If you suffer from a condition that can lead to a reduction in your body of a substance called carnitine. These conditions include carnitine transporter disorder, methylmalonic aciduria and propionic acidemia.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking XSYSTO. The tablets must be
taken with at least half a glass of liquid to avoid getting stuck in the esophagus.
Tell your doctor before starting treatment:
- If you have porphyria
- If you have recently taken XSYSTO, as prolonged use may reduce the amount of carnitine in the body
During treatment:
- If you suddenly experience diarrhea while taking XSYSTO, tell your doctor immediately. This may occur in case of intestinal inflammation (colitis).
- Taking pivmecillinam shortly before delivery may alter newborn screening for the detection of inherited metabolic disorders and provide a false positive result. A "false positive" means that the analysis incorrectly indicates the presence of the disorder in the newborn. There is no risk to the newborn, but it is important to inform your doctor if you have taken XSYSTO shortly before delivery.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age because the potential
benefits may not outweigh the risks.
Other medicines and XSYSTO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Tell your doctor or pharmacist if you are using any of the following medicines:
- Probenecid (for the treatment of gout). May increase the effect of XSYSTO
- Methotrexate (for the treatment of rheumatism and tumors). The elimination of methotrexate from the body may be slower when taken with XSYSTO
- Valproate or valproic acid (for the treatment of epilepsy). This increases the risk of carnitine deficiency in the body when taken with XSYSTO
- Other anti-inflammatory drugs (e.g. tetracyclines, erythromycin, other beta-lactam antibiotics). This may affect the effect of XSYSTO
XSYSTO with food and drink
You can take this medicine during or immediately after meals. You must take XSYSTO with
at least half a glass of water. It is important to take the medicine with plenty of liquid and with
anticipation before going to bed. This will avoid problems with the esophagus.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy
XSYSTO can be taken during pregnancy.
Some cases of false positive results in newborn screening simulating the presence of
a metabolic disorder called isovaleric acidemia have been reported. Taking pivmecillinam shortly before
delivery may alter newborn screening for the detection of inherited metabolic disorders and provide a
false positive result. A "false positive" means that the analysis incorrectly indicates the presence of
the disorder in the newborn. There is no risk to the newborn, but it is important to inform your doctor if you have
taken XSYSTO shortly before delivery.
Breastfeeding
XSYSTO can be taken during breastfeeding.
Fertility
No clinical studies on fertility have been conducted.
Driving and using machines
XSYSTO does not alter or negligibly alters the ability to drive vehicles or use machines.
3. How to take XSYSTO
Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor, pharmacist or nurse. You must take the medicine at regular intervals throughout the day. If you need to take it three times a day, take it at breakfast, lunch and dinner. XSYSTO must be taken with at least half a glass of liquid. Your doctor will tell you how long you need to take the XSYSTO tablets.
The recommended dose is 400 mg 3 times a day.
Elderly: no dose adjustment is necessary.
In case of reduced kidney or liver function, no dose adjustment is necessary.
If you take more XSYSTO than you should:
Inform your doctor immediately. It may be necessary to stop using the medicine. You may feel unwell, have a feeling of discomfort or stomach problems.
If you forget to take XSYSTO
If you forget to take the medicine, take it as soon as you remember. Always take it with half a glass of water or other liquid. Then take the next dose at the usual time.
If you stop taking XSYSTO
It is very important that you take the amount of medicine prescribed by your doctor. You must complete the treatment with the medicine even if you feel better. This is necessary to prevent you from feeling unwell again.
If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
More serious side effects:
Uncommon: may affect up to 1 in 100 people.
- Sudden skin rash, swelling of the face and/or throat, difficulty breathing or fainting due to hypersensitivity (anaphylactic reaction). Seek immediate medical help as you mayneed urgent medical attention.
- Severe and persistent diarrhoea with traces of blood, with stomach pain and fever (pseudomembranous colitis). Seek immediate medical help as you may needurgent medical attention.
- Bleeding from the skin and mucous membranes and bruising on the skin due to changes in the blood (low platelet count) (thrombocytopenia). Contact your doctor.
Other side effects:
Common: may affect up to 1 in 10 people
- Vaginal fungal infections
- Diarrhoea
- Feeling unwell (nausea)
Uncommon: may affect up to 1 in 100 people
- Headache
- Dizziness
- Feeling unwell (vomiting)
- Stomach pain
- Ulcers of the mouth or esophagus, inflammation of the esophagus
- Liver function disorders
- Changes in blood or liver values
- Muscle weakness or loss of muscle tone. Fatigue or lack of energy. A deficiency of carnitine in the body can cause these symptoms.
- Hives
- Itching
- Fatigue
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at 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 XSYSTO
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 after SCAD. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What XSYSTO contains
- The active ingredient is pivmecillinam hydrochloride. One film-coated tablet of XSYSTO 400 mg contains 400 mg of pivmecillinam hydrochloride
- The other ingredients are hydroxypropylcellulose, hypromellose 6 cps, magnesium stearate, microcrystalline cellulose, simeticone emulsion 30%, synthetic paraffin.
Description of XSYSTO and contents of the pack
XSYSTO is a white, film-coated capsule-shaped tablet, measuring 8 x 17 mm.
Packs:
9, 10, 15 and 20 tablets in a blister.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
Manufacturer:
Recipharm Strängnäs AB, Mariefredsvägen 35, S-645 41 Strängnäs, Sweden
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium: Selexid 400 mg Tablets
Denmark: Pivmecillinamhydrochlorid Karo Pharma
Netherlands: Selexid 400 mg Film-coated tablets
Ireland: Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets
Italy: XSYSTO
Luxembourg: Selexid 400 mg Film-coated tablets
Poland: X-SYSTO 400 mg Coated Tablets
Spain: Selexid 400 mg Film-coated tablets
Germany: X-SYSTO 400 mg Film-coated tablets
- Страна регистрации
- Форма выпускаFilm-coated tablet, 400 MG
- Код АТХJ01CA08
- 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 XSYSTOФорма выпуска: Orodispersible tablet, 1 GДействующее вещество: АмоксициллинОтпускается по рецептуФорма выпуска: Coated tablet, 1 GДействующее вещество: АмоксициллинПроизводитель: S.F. GROUP S.R.L.Отпускается по рецептуФорма выпуска: Soluble tablet, 1GДействующее вещество: АмоксициллинПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецепту
Аналоги XSYSTO в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог XSYSTO в Испания
Аналог XSYSTO в Польша
Врачи онлайн по XSYSTO
Обсудите применение XSYSTO и возможные следующие шаги — по оценке врача.
Получите рецепт на XSYSTO 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
XSYSTO требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество XSYSTO — pivmecillinam. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
XSYSTO производится компанией KARO HEALTHCARE AB. 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 XSYSTO 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 XSYSTO 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 (pivmecillinam) включают AMOSOL, AMOX, AMOXIKILLINA ABK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















