BERNY 3 G Гранулы для приготовления раствора для приема внутрь
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Инструкция по применению BERNY
Содержание инструкции
BERNY adults 3 g granules for oral solution
Fosfomycin
Generic medicine
Read 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 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 you, because it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.
Contents of this leaflet:
- 1. What BERNY is and what it is used for
- 2. What you need to know before you take BERNY
- 3. How to take BERNY
- 4. Possible side effects
- 5. How to store BERNY
- 6. Contents of the pack and other information
1. What is BERNY and what is it used for
Fosfomycin belongs to a group of medicines called urinary antimicrobial agents.
BERNY is indicated in the prevention and treatment of acute uncomplicated lower urinary tract infections
caused by germs sensitive to fosfomycin.
2. What you need to know before you take BERNY
Do not take BERNY
if you are allergic to fosfomycin or to any of the other ingredients of this medicine (listed in
section 6);
if you have severe kidney problems;
if you have difficulty urinating;
if you are undergoing hemodialysis.
Children under 12 years of age should not take this medicine.
Warnings and precautions
Consult your doctorbefore taking BERNY and if you are in any of the following conditions:
if you have previously shown symptoms of allergic reactions to fosfomycin;
if you experience hypersensitivity reactions, including anaphylaxis or anaphylactic shock;
if you experience diarrhea, especially if severe, persistent and/or with blood; these symptoms
may indicate colitis associated with Clostridium difficile(CDAD);
if you think you are pregnant or if you are breastfeeding (see the Pregnancy and
breastfeeding section).
Other medicines and BERNY
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Concomitant administration of metoclopramide (a medicine that prevents vomiting) reduces
oral absorption of fosfomycin. Other drugs that increase gastrointestinal motility may
produce similar effects.
Concomitant administration of antacids or calcium salts may cause a reduction in
plasma and urinary concentrations of fosfomycin.
Numerous cases of increased activity of vitamin K antagonists have been reported in patients treated
with antibiotics. Risk factors include severe infection or inflammation, age and poor general health.
In these circumstances, it is difficult to determine whether the alteration of the INR is due to the infectious
disease or its treatment. However, some classes of antibiotics are more often involved and in particular:
fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins.
BERNY with food and drink
Food may delay the absorption of fosfomycin trometamol with the consequence of a reduction in
plasma peaks and urinary concentrations. Therefore, it is recommended to administer BERNY on
an empty stomach (one hour before or 2-3 hours after a meal).
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine
BERNY should be administered to pregnant or breastfeeding women only if there is a real
therapeutic need.
Driving and using machines
Dizziness may occur, this may affect your ability to drive and use machines.
Important information about some excipients:
The medicine contains sucrose: patients with intolerance to sugars must contact their
doctor before taking this medicine; use with caution in patients with diabetes or who are following a
low-calorie diet.
This medicine contains sunset yellow FCF (E110) which may cause allergic reactions.
This medicine contains saccharin.
3. How to take BERNY
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The doctor will prescribe the duration of treatment. Do not interrupt the treatment before as established by him
because in this case the expected results may not be obtained.
The contents of one sachet are dissolved in half a glass (50-75 ml) of cold water or other beverage,
stirring until completely dissolved and must be taken immediately after preparation.
It is recommended to administer BERNY on an empty stomach (see “ BERNY with food and beverages”),
preferably before bedtime after emptying the bladder.
Dosage
Adults and adolescents (12-18 years):
In acute uncomplicated infections of the lower urinary tract caused by germs sensitive to fosfomycin, the
dosage is one 3 g sachet in a single daily dose.
In the prevention of urinary tract infections in surgical interventions and transurethral diagnostic procedures,
treatment involves the administration of two 3 g doses: the first sachet is
administered 3 hours before the intervention, the second sachet is administered 24 hours after the first dose.
Generally, clinical symptoms generally disappear after 2-3 days.
The possible persistence of some local symptoms after treatment is not necessarily an expression of
therapeutic failure, but a more likely consequence of previous inflammatory processes.
Elderly and other relevant clinical conditions:
In elderly patients and in clinically more challenging cases (elderly bedridden patients, recurrent infections)
two 3 g doses may be necessary, administered 24 hours apart.
If you take more BERNY than prescribed
Experience regarding fosfomycin overdose by oral route is limited.
If you accidentally take doses of BERNY higher than those prescribed, contact your
doctor or pharmacist immediately.
In case of overdose, it is necessary to promote the urinary elimination of the active ingredient by adequate
administration of fluids.
If you forget to take BERNY
If you forget to take a dose of the medicine, do not take a double dose to compensate for
forgetfulness of the dose.
If you forget to take a dose of medicine, take it as soon as you remember; however, if the
time to take the next dose is near, omit taking the dose you forgot and
take the next dose at the prescribed time.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.
Contact your doctor as soon as possible if you experience even one of the following side effects
Common(may affect up to 1 in 10 people):
- vulvovaginitis
- headache, dizziness
- digestive problems such as diarrhea, dyspepsia (feeling of fullness with acidity), nausea Uncommon(may affect up to 1 in 1000 people):
- paresthesia (tingling)
- abdominal pain, vomiting
- rash, urticaria, itching
- fatigue Rare(may affect up to 1 in 10,000 people):
- superinfections from resistant bacteria
- reactions of the
- skin with redness, urticaria (itchy red blisters) and angioedema (swelling) and anaphylaxis (severe allergic or hypersensitivity reactions). In these cases, consult your doctor or pharmacist who can advise you on how to resolve these side effects without being forced to stop treatment with fosfomicina
- tachycardia (fast heartbeat)
- aplastic anemia (reduction in the number of red blood cells).
Other side effectshave been observed, but their frequency cannot be established from the available data; these include:
- anaphylactic reactions including anaphylactic shock and hypersensitivity
- asthma
- bronchospasm (severe difficulty breathing);
- dyspnea (breathing problems);
- antibiotic-associated colitis;
- loss of appetite;
- liver problems with a transient increase in liver enzymes (transaminases);
- angioedema
- slight increase in eosinophil and platelet counts (blood cells), slight petechial reaction (small red spots on the skin) and aplastic anemia (reduction in the number of red blood cells).
- vision disorders;
- hypotension, phlebitis (formation of blood clots in the veins);
- Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 BERNY
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the sachet. The expiry date refers to the last day of that month.
Storage conditions:
Store in the original package.
The expiry date indicated refers to the medicine in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater 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 BERNY contains
The active ingredient is fosfomycin trometamol.
Each sachet of BERNY adults 3 g granules for oral solution contains fosfomycin 3.0 g (as fosfomycin
trometamol 5.631 g)
The excipients are: sodium saccharin (E954), sucrose, calcium hydroxide (E526), orange flavour (contains:
maltodextrin, dextrose, gum arabic (E414), sunset yellow FCF (E110), butylated hydroxyanisole BHA
(E320)).
Description of the appearance of BERNY and contents of the pack
BERNY is available in sachets containing white or almost white granules to be dissolved in water or other
beverage.
The pack contains:
Adults 3 g granules for oral solution - 1 sachet of 3g
Adults 3 g granules for oral solution - 2 sachets of 3g
Marketing Authorisation Holder:
So.Se.PHARM S.r.l - Via dei Castelli Romani, 22 – 00040 Pomezia (RM) - Italy
Manufacturer
Special Product’s Line S.p.A.- Strada Paduni, 240 – 03012 Anagni (FR) - Italy
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- Страна регистрации
- Форма выпускаGranules for oral solution, 3 G
- Код АТХJ01XX01
- 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 BERNYФорма выпуска: Granules for oral solution, 3 gДействующее вещество: фосфомицинПроизводитель: PHARMACARE S.R.L.Отпускается по рецептуФорма выпуска: Granules for oral solution, 3 GДействующее вещество: фосфомицинПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецептуФорма выпуска: Granules for oral solution, 3 GДействующее вещество: фосфомицинПроизводитель: DOC GENERICI SRLОтпускается по рецепту
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Аналог BERNY в Испания
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Аналог BERNY в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
BERNY требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество BERNY — фосфомицин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
BERNY производится компанией SO.SE.PHARM S.R.L. SOCIETA' DI SERVIZIO PER L'INDUSTRIA FARMACEUTICA ED AFFINI. 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 BERNY 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 BERNY 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 (фосфомицин) включают DANIFOS, FOSFOMIKINA AUROBINDO, FOSFOMIKINA DOK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
