FLUTOXIL 4 мг/5 мл Сироп
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Инструкция по применению FLUTOXIL
BEFORE USE
READ ALL INFORMATION CAREFULLY
This is a self-medication medicine that you can use to treat mild and transient disorders
easily recognizable and resolvable without resorting to the help of a doctor.
It can therefore be purchased without a prescription but must be used correctly to ensure its effectiveness and reduce its
undesirable effects.
- for more information and advice, contact your pharmacist.
- consult your doctor if the disorder does not resolve after a short period of treatment.
MEDICINE NAME
FLUTOXIL 4 mg/5 ml syrup
bromhexine
WHAT IT IS
FLUTOXIL syrup is a mucolytic: it fluidifies the deposits of viscous mucus in the respiratory tract and thus
facilitates its elimination.
WHY IT IS USED
FLUTOXIL syrup is used for the treatment of secretion disorders (for example, the presence of cough and
phlegm) in acute and chronic respiratory conditions.
WHEN IT MUST NOT BE USED
Hypersensitivity to the active substance or to any of the excipients.
The drug is contraindicated in children under the age of 2 years.
Breastfeeding (see What to do during pregnancy and breastfeeding).
In case of hereditary conditions that may be compatible with one of the excipients (see the paragraph
“Important information”).
PRECAUTIONS FOR USE
Treatment with FLUTOXIL syrup involves an increase in bronchial secretion (this promotes
expectoration).
Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult
your doctor.
Cases of severe skin reactions associated with the administration of bromhexine have been reported. If you develop
a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Flutoxil and
seek immediate medical attention.
These reactions may be symptoms of serious skin diseases such as Stevens-Johnson syndrome and
Toxic Lyell's syndrome. Most of these may be explained by the severity of underlying diseases or
by other drugs taken at the same time.
WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT OF THE MEDICINE
No interactions with other medicines have been reported.
If you are using other medicines, ask your doctor or pharmacist for advice.
IMPORTANT INFORMATION
Mucolytics can cause bronchial obstruction in children under 2 years of age.
In fact, the drainage capacity of bronchial mucus is limited in this age group, due to the
physiological characteristics of the respiratory tract.
They should therefore not be used in children under 2 years of age.
When it can only be used after consulting a doctor
There are no absolute contraindications, but in patients with gastroduodenal ulcer it is advisable to use it after
consulting a doctor. Pregnancy (see What to do during pregnancy and breastfeeding).
It is advisable to consult a doctor also in cases where such disorders have manifested in the past.
What to do during pregnancy and breastfeeding
During pregnancy, FLUTOXIL should only be used after consulting a doctor and assessing with him the
risk/benefit ratio in your case.
FLUTOXIL should not be used during breastfeeding.
Consult your doctor if you suspect you are pregnant or wish to plan a pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Bromhexine hydrochloride does not affect the ability to drive vehicles and vigilance in the use of machinery.
Important information about some excipients of FLUTOXIL
The medicine contains sorbitol: if your doctor has diagnosed you with intolerance to certain sugars, contact him
before taking this medicine. The product may cause moderate laxative effects. The caloric value
of sorbitol is 2.6 kcal/g.
The product contains 3.7 vol % of ethanol. One dose may contain up to 0.3 g of ethanol per dose
equivalent to 7.4 ml of beer and 3 ml of wine per dose. It may be harmful to alcoholics. To be kept
in consideration in pregnant or breastfeeding women, children and groups at high risk such as
people affected by liver or epilepsy diseases.
For those who play sports, the use of medicines containing ethyl alcohol may determine positivity to doping tests
in relation to the concentration limits of alcohol indicated by some sports federations.
HOW TO USE THIS MEDICINE
How much
The following dosages are recommended unless otherwise prescribed by your doctor.
Adults: 1-2 teaspoons (5-10 ml) 3 times a day.
In adults, at the beginning of treatment, it may be necessary to increase the total daily dose up to 48
mg (60 ml) divided into three times.
Children over 2 years of age: 1/2 – 1 teaspoon (2.5 – 5 ml) 3 times a day (= 12 mg per day).
The syrup can be given to diabetics and children, it does not contain fructose or sucrose.
Do not exceed the recommended doses.
When and for how long
It is recommended to take the medicine after meals. Consult your doctor if the disorder occurs
repeatedly or if you have noticed any recent change in its characteristics.
Caution: use only for short periods of treatment.
How
Administer orally.
WHAT TO DO IF YOU HAVE TAKEN TOO MUCH MEDICINE
Cases of overdose have never been reported. In case of overdose, symptomatic treatment is necessary.
In case of accidental ingestion of an excessive dose of FLUTOXIL, immediately notify your doctor or
go to the nearest hospital.
If you have any doubts about the use of FLUTOXIL, consult your doctor or pharmacist.
SIDE EFFECTS
Like all medicines, FLUTOXILcan cause side effects, although not everyone experiences them.
The following side effects may occur following the use of Flutoxil:
Rare(may affect up to 1 in 1,000 people)
- hypersensitivity reactions;
- rash, urticaria. Not known(frequency cannot be estimated on the basis of available data)
- Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching;
- Severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized pustulosis);
- bronchospasm.
In such cases, discontinue treatment.
Cases of diarrhea, nausea, vomiting and cases of other mild gastrointestinal disorders have been reported.
Bronchial obstruction with unknown frequency.
These side effects are generally transient. When they occur, however, it is advisable to consult
your doctor or pharmacist.
Following the instructions contained in the leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of
this medicine.
EXPIRY AND STORAGE
See the expiry date indicated on the packaging.
The expiry date indicated refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date indicated on the packaging.
After the first opening of the bottle, the product must be consumed within 9 months, if the product is
stored at a temperature below 25°C; after this period, the excess product must be discarded.
It is important to always have the information on the medicine available, therefore keep both the box
Keep the medicine out of reach and sight of children.
COMPOSITION
5 ml of syrup contain:
Active ingredient: bromhexine hydrochloride 4 mg (equivalent to bromhexine 3.65 mg)
(1 teaspoon, equal to 5 ml, contains: bromhexine hydrochloride 4 mg).
Excipients: tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, sorbitolliquid, ethanol(96%),
all fruits flavor, sodium hydroxide, purified water.
HOW IT IS PRESENTED
FLUTOXIL is available in syrup form. The contents of the package are 250 ml.
MARKETING AUTHORISATION HOLDER
Aesculapius Farmaceutici S.r.l. – Via Cozzaglio, 24 – 25125 Brescia
PRODUCER AND FINAL CONTROLLER
ABC FARMACEUTICI S.P.A. – Canton Moretti, 29 – 10090 San Bernardo d’Ivrea (TO)
REVIEW OF THE LEAFLET BY THE ITALIAN DRUG AGENCY
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- Страна регистрации
- Форма выпускаSyrup, 4 MG/5 ML
- Код АТХR05CB02
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги FLUTOXILФорма выпуска: Oral solution, 2 MG/MLДействующее вещество: bromhexineПроизводитель: OPELLA HEALTHCARE ITALY S.R.L.Отпускается без рецептаФорма выпуска: Syrup, 4 MG/5 MLДействующее вещество: bromhexineПроизводитель: TOWA PHARMACEUTICAL S.P.A.Отпускается без рецептаФорма выпуска: Syrup, 4 MG/5 MLДействующее вещество: bromhexineПроизводитель: COOPER CONSUMER HEALTH B.V.Отпускается без рецепта
Аналоги FLUTOXIL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог FLUTOXIL в Испания
Аналог FLUTOXIL в Польша
Аналог FLUTOXIL в Украина
Врачи онлайн по FLUTOXIL
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
FLUTOXIL не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество FLUTOXIL — bromhexine. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
FLUTOXIL производится компанией AESCULAPIUS FARMACEUTICI SRL. 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 FLUTOXIL 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 FLUTOXIL 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 (bromhexine) включают BISOLVON, BROMEXINA PENSA, FROBEN TOSSE GRASSA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
