Инструкция по применению BRUFIX
Содержание инструкции
BRUFIX 15 mg/2 ml solution for nebulization
EQUIVALENT MEDICINE
Ambroxol hydrochloride
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist have told you to.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your doctor or pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.
Contents of this leaflet:
- 1. What Brufix is and what it is used for
- 2. What you need to know before using Brufix
- 3. How to use Brufix
- 4. Possible side effects
- 5. How to store Brufix
- 6. Contents of the pack and other information
1. What is Brufix and what is it used for
Brufix contains ambroxol hydrochloride, a medicine that works by dissolving bronchial secretions and
facilitating their elimination.
Brufix is used in the following conditions:
Treatment of secretion disorders in acute and chronic bronchopulmonary conditions.
2. What you need to know before using Brufix
Do not take Brufix if:
Hypersensitivity to the active ingredient (ambroxol) or any of the excipients.
Severe liver and/or kidney impairment.
Pay special attention to:
Ambroxol must be administered with caution to patients with peptic ulcer.
Since excessive deep inhalation of aerosols can cause irritation-induced cough, it is important to
try to breathe and exhale normally during inhalation.
In particularly sensitive patients, it may be advisable to pre-warm the solution to be
inhaled to body temperature. For patients with bronchial asthma, it is appropriate to use a
bronchospasmolytic before inhalation.
Cases of severe skin reactions associated with the administration of ambroxol have been reported.
If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose,
eyes, genitals), stop taking Mucosolvan and consult your doctor immediately.
These reactions may be symptoms of severe skin conditions characterized by
skin peeling and severe toxic skin reaction (Stevens-Johnson syndrome and
Toxic Epidermal Necrolysis).
In addition, in the early stages of Stevens Johnson syndrome or toxic epidermal necrolysis
(TEN), patients may initially experience non-specific symptoms similar to those of
influenza, such as fever, chills, rhinitis, cough and sore throat. Due to these
misleading symptoms, symptomatic treatment with a cough and cold remedy may be initiated.
In case of mild or moderate renal insufficiency, BRUFIX can only be used after
consulting a doctor.
As with any medicine metabolized through the liver and eliminated via the kidneys, accumulation of
ambroxol metabolites generated in the liver may occur in the presence of severe renal
insufficiency (see “do not take Brufix if”).
Other medicines and Brufix:
Tell your doctor or pharmacist if you have recently taken any other medicines, including
those available without a prescription.
Following the administration of ambroxol, the concentrations of antibiotics (amoxicillin,
cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased.
No clinically relevant adverse interactions with other medicines have been observed.
Use of Brufix with food and drink:
Brufix does not interfere with food and drink.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Ambroxol hydrochloride crosses the placental barrier.
During pregnancy and breastfeeding, ambroxol should only be used after consulting
your doctor and weighing the risk/benefit ratio in your specific case.
Consult your doctor if you suspect you are pregnant or plan to become
pregnant. No clinical data are available regarding pregnancies exposed to ambroxol.
Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryo/fetal
development, delivery or postnatal development.
Despite preclinical studies and extensive clinical experience not having shown any harmful
effects after the 28th week of gestation, it is advisable to take the usual precautions
regarding the use of medicines during pregnancy. Especially during the first trimester, the use of Brufix is not
recommended.
Caution is necessary when prescribing the medicine to pregnant women.
Drugs should only be used during pregnancy if the expected benefit for the mother is considered
greater than the risk to the fetus. All medicines should be avoided, if possible, during the
first trimester of pregnancy.
The drug is secreted in breast milk. Use of ambroxol by the mother may cause
adverse effects in the infant; therefore, it is necessary to decide whether to discontinue
breastfeeding or treatment with the medicine, considering the importance of the medicine for the mother.
Driving and using machines:
There is no evidence of an effect on the ability to drive vehicles and operate machinery. No
studies have been conducted on the effects on the ability to drive and use machinery.
Brufix solution for nebulization contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
3. How to use brufix
The solution for nebulization can be administered using standard nebulizers. It can also be diluted in distilled water in a 1:1 ratio.
Adults 1 single-dose container 2 or 3 times a day.
Children over 5 years: 1 single-dose container 2 times a day. Children up to 5 years: ½
single-dose container 2 times a day.
Do not use ambroxol for prolonged treatments.
If you feel that the effect of Brufix is too strong or too weak, consult your doctor or
pharmacist.
If you take more Brufix than you should:
Data relating to ambroxol overdose are limited.
Symptoms corresponding to the described undesirable effects are expected.
In case of accidental ingestion/intake of an excessive dose of ambroxol, immediately notify your doctor or go to the nearest hospital.
If you forget to take Brufix:
Continue therapy as prescribed and do not take a double dose to make up for
any missed doses.
4. Possible side effects
Like all medicines, Brufix can have side effects, although not everybody gets them.
The side effects listed by frequency are reported, using the following convention:
Common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may
affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people), not known
(frequency cannot be estimated from the available data).
Immune system disorders
Not known: anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of
the skin, subcutaneous tissues, mucosa and submucosal tissues), itching and other hypersensitivity
reactions
Nervous system disorders
Common: Dysgeusia (e.g. taste alteration)
Rare: Headache
Respiratory, thoracic and mediastinal disorders
Common: Oral and pharyngeal hypoesthesia Rare: Rhinorrhea
Not known: Bronchial obstruction
Gastrointestinal disorders
Common: Nausea
Uncommon: Vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth
Rare: Heartburn, constipation
Not known: Dry throat
Skin and subcutaneous tissue disorders
Rare: Skin rashes, urticaria, contact dermatitis
Not known: severe skin adverse reactions (including erythema multiforme, Stevens-Johnson
syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)
Renal and urinary disorders
Rare: Dysuria
Systemic disorders and administration site conditions
Rare: Fatigue
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet,
Reporting of side effects
If 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:
hhtps://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 Brufix
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the packaging.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
6. Contents of the pack and other information
What Brufix contains
- The active ingredient is ambroxol hydrochloride.
- The excipients are sodium chloride, purified water.
Description of the appearance of Brufix and contents of the pack
Solution for nebulisation. 20 single-dose containers.
Marketing authorisation holder and manufacturer
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome - Italy
Manufacturer
COC Farmaceutici
Via Modena, 15 – S.Agata Bolognese (Bologna)

- Страна регистрации
- Форма выпускаSolution for nebulization, 0.75 %
- Код АТХR05CB06
- 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 BRUFIXФорма выпуска: Solution for nebulization, 15 MG/2 MLДействующее вещество: АмброксолПроизводитель: EPIFARMA S.R.LОтпускается без рецептаФорма выпуска: Solution for nebulization, 15 MG/2 MLДействующее вещество: АмброксолПроизводитель: TECNIGEN S.R.L.Отпускается без рецептаФорма выпуска: Coated tablet, 30 MGДействующее вещество: АмброксолПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецепту
Аналоги BRUFIX в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог BRUFIX в Испания
Аналог BRUFIX в Польша
Аналог BRUFIX в Украина
Врачи онлайн по BRUFIX
Обсудите применение BRUFIX и возможные следующие шаги — по оценке врача.
Получите рецепт на BRUFIX 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
BRUFIX не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество BRUFIX — Амброксол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
BRUFIX производится компанией S.F. GROUP 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 BRUFIX 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 BRUFIX 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 (Амброксол) включают AMBROTUS, AMBROXOL TEKNIJEN, AMBROXOLO ABK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















