Інструкція із застосування BISOLVON
Зміст інструкції
BISOLVON 4 mg/2 ml injectable solution
bromexine hydrochloride
Read this leaflet carefully before using 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 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, as it may be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Bisolvon is and what it is used for
- 2. What you need to know before you use Bisolvon
- 3. How to use Bisolvon
- 4. Possible side effects
- 5. How to store Bisolvon
- 6. Contents of the pack and other information
1. What is Bisolvon and what is it used for
Bisolvon contains bromhexine hydrochloride, a mucolytic that liquefies mucus in the respiratory tract
facilitating its elimination.
Bisolvon is indicated for the treatment of acute (newly occurring) and chronic
respiratory diseases accompanied by cough with phlegm in adults.
2. What you need to know before using Bisolvon
Do not use Bisolvon
- if you are allergic to bromhexine or any of the other ingredients of this medicine (listed in section 6);
- if you are breastfeeding (see section 2. “Pregnancy, breastfeeding and fertility”).
Warnings and precautions
Talk to your doctor or pharmacist before using Bisolvon:
- if you suffer from a respiratory disease that occurs and worsens within a relatively short period of time (acute respiratory conditions). Consult your doctor if your symptoms do not improve or worsen during therapy;
- if you are pregnant (see section 2. “Pregnancy, breastfeeding and fertility”). Children The use of the medicine is reserved for adults. Cases of severe skin reactions associated with the administration of bromhexine hydrochloride have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Bisolvon and consult your doctor immediately. These reactions may be symptoms of serious skin diseases characterized by skin peeling and severe toxic skin reaction (Stevens Johnson Syndrome and Toxic Epidermal Necrolysis). Most of these may be due to pre-existing serious illnesses or the concurrent use of other drugs. In addition, in the early stages of Stevens Johnson Syndrome or toxic epidermal necrolysis (TEN), you may experience non-specific symptoms similar to those of the flu, such as fever, chills,
runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, it is possible that you will undertake
symptomatic treatment with a cough and cold therapy.
Treatment with Bisolvon involves an increase in bronchial secretion (this promotes
expectoration).
Use Bisolvon for short periods.
Other medicines and Bisolvon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pregnancy, breastfeeding and fertility
If you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before using
this medicine.
Pregnancy
- As a precaution, it is preferable to avoidusing Bisolvon if you are pregnant (see section 2. “Warnings and precautions”). Breastfeeding
- Do notuse Bisolvon during breastfeeding (see section 2. “Do not use Bisolvon”). Fertility
- Based on preclinical experience, there is no indication of possible effects on fertility following the use of bromhexine.
Driving and using machines
No studies have been conducted on the effects of bromhexine hydrochloride on the ability to drive vehicles and
operate machinery.
3. How to use Bisolvon
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Dosage
Adults
The recommended dose is 4 mg (corresponding to 1 vial of injectable solution) to be administered by
intramuscular or slow intravenous route 2-3 times a day.
Children
Bisolvon should not be used in children.
Method of administration
Bisolvon can be administered by intramuscular route (injected into a muscle) and by intravenous route (directly
into a vein as is or diluted with Ringer's solution or physiological solution (0.9% sodium chloride).
For instructions on diluting the medicine before administration, the period of validity and the
precautions for storage after dilution, see “The following information is intended
exclusively for healthcare professionals”.
- 1.
If you use more Bisolvon than you should
In case of accidental intake of an excessive dose of Bisolvon, immediately inform your doctor or
go to the nearest hospital.
If you forget to use Bisolvon
Do not use a double dose to make up for a missed dose.
If you stop using Bisolvon
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur following the use of Bisolvon:
uncommon (may affect up to 1 in 100 people)
- nausea, vomiting, diarrhoea and upper abdominal pain; rare (may affect up to 1 in 1,000)
- hypersensitivity reactions, rash (skin eruption), urticaria (appearance of red spots on the skin); not known (frequency cannot be estimated from available data)
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and pruritus,
- severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis),
- narrowing of the bronchi making breathing difficult (bronchospasm).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. 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 to provide more information on the safety of
this medicine.
5. How to store Bisolvon
This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.
6. Package contents and other information
What Bisolvon contains
- the active ingredient is bromhexine hydrochloride (one vial contains 4 mg of bromhexine hydrochloride);
- the other ingredients are: tartaric acid, glucose, water for injections.
Description of the appearance of Bisolvon and package contents
Injectable solution in a pack of 5 glass vials of 2 ml.
Marketing authorisation holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano (Italy)
Manufacturer
Sanofi S.r.l.
Via Valcanello, 4
03012 Anagni (FR
The following information is intended for healthcare professionals only:
Breakable ampoules (no ampoule cutter required).
This medicine must not be mixed with other medicines except for the following dilution solutions:
Ringer's solution and sodium chloride 0.9% solution.
Dilution in Ringer's solution
Ringer's solution in glass containers at concentrations between 0.008 mg/ml (1 vial in 500 ml) and
0.08 mg/ml (1 vial in 50 ml).
Dilution in sodium chloride 0.9% solution
Sodium Chloride 0.9% solution in polyethylene bags: concentration 0.008 mg/ml (1 vial in 500 ml);
concentration 0.08 mg/ml (1 vial in 50 ml) and concentration 0.048 mg/ml (3 vials in 250 ml).
Shelf life and storage precautions after dilution for intravenous use
Dilution in Ringer's solution contained in glass containers at concentrations between 0.008 mg/ml
(1 vial in 500 ml) and 0.08 mg/ml (1 vial in 50 ml): 24 hours at 25°C.
Dilution in sodium chloride 0.9% solution contained in polyethylene bags at a concentration of 0.008 mg/ml (1 vial
in 500 ml): 6 hours at 25°C; at a concentration of 0.08 mg/ml (1 vial in 50 ml): administer immediately
after preparation of the diluted solution; at a concentration of 0.048 mg/ml (3 vials in 250 ml): 24 hours at
25°C.


- Країна реєстрації
- Лікарська формаOral solution, 2 MG/ML
- Код АТХR05CB02
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до BISOLVONЛікарська форма: Syrup, 4 MG/5 MLДіюча речовина: bromhexineВиробник: TOWA PHARMACEUTICAL S.P.A.Рецепт не потрібенЛікарська форма: Syrup, 4 MG/5 MLДіюча речовина: bromhexineВиробник: AESCULAPIUS FARMACEUTICI SRLРецепт не потрібенЛікарська форма: Syrup, 4 MG/5 MLДіюча речовина: bromhexineВиробник: COOPER CONSUMER HEALTH B.V.Рецепт не потрібен
Аналоги BISOLVON в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог BISOLVON у Іспанія
Аналог BISOLVON у Польща
Аналог BISOLVON у Україна
Лікарі онлайн щодо BISOLVON
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на BISOLVON онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
BISOLVON не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у BISOLVON — bromhexine. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
BISOLVON виробляється компанією OPELLA HEALTHCARE ITALY S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування BISOLVON з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати BISOLVON у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (bromhexine) включають BROMEXINA PENSA, FLUTOXIL, FROBEN TOSSE GRASSA. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















