BISOLMONUS 600 mg Эффервесцентная Таблетка
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Инструкция по применению BISOLMONUS
Содержание инструкции
Bisolmonus 600 mg effervescent tablets
Acetylcysteine
Generic medicine
Read this leaflet carefully before taking this medicine because
it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you to.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not feel better or if your symptoms get worse after 8-10 days.
Contents of this leaflet:
- 1. What Bisolmonus is and what it is used for
- 2. What you need to know before you take Bisolmonus
- 3. How to take Bisolmonus
- 4. Possible side effects
- 5. How to store Bisolmonus
- 6. Contents of the pack and other information
1. What is Bisolmonus and what is it used for
Acetylcysteine breaks down and liquefies dense mucus, making it watery and easy to
expectorate. Acetylcysteine is indicated in adults for the treatment of respiratory diseases in which it is necessary to reduce the viscosity of bronchial secretions
to facilitate expectoration, especially during periods of acute bronchitis.
Consult your doctor if you do not feel better or if you feel worse after 8-10 days.
2. What you need to know before taking Bisolmonus
Do not take Bisolmonus
- if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
- Children under 2 years of age should not use this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bisolmonus.
If you suffer from asthma or have experienced episodes of bronchospasm (narrowing/cramps
of the airways) in the past, Bisolmonus must be taken with particular caution as treatment
with Bisolmonus could worsen this condition. In this case, consult a doctor immediately.
If you suffer from a stomach ulcer or have suffered from one in the past, it is advisable to take
particular care, as Bisolmonus can irritate the stomach wall,
especially if you are using other medicines that irritate the stomach wall.
Very rare cases of severe hypersensitivity reactions with fever (high), red signs on the skin, joint pain and/or eye inflammation (Stevens-Johnson syndrome) and
acute hypersensitivity reactions associated with fever and blisters on the skin or peeling
of the skin (Lyell's syndrome) have been reported, which may be associated with the use of acetylcysteine. If
you experience new changes in the skin or mucous membranes, consult a doctor immediately
and stop taking Bisolmonus.
If you are unable to expel fluid mucus effectively (e.g. elderly or frail patients
with impaired cough reflex). Especially at the beginning of treatment, you should
take particular care, as the secretion of mucus may increase in volume as
it becomes more fluid.
When you open the package, you may notice a slight sulfurous odor (rotten egg odor). This is a
property of the active ingredient and is normal. It does not indicate any abnormality in the medicine.
Children and adolescents
Bisolmonus can block the airways in children under 2 years of age, as their
ability to expel mucus is limited. For this reason, Bisolmonus should not be used
in children under 2 years of age.
Bisolmonus is not suitable for children and adolescents.
Other medicines and Bisolmonus
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
If you are using other medicines, do not dissolve them together with Bisolmonus.
If you need to use other medicines to fight or prevent infections (antibiotics), it is
advisable to take them two hours before or after Bisolmonus.
Bisolmonus may increase the blood pressure lowering effect of
nitroglycerin (a medicine used to treat a strong and painful sensation in the chest, called
angina pectoris). Caution is required.
If you are using activated charcoal (a medicine for traveler's diarrhea), the effect of
Bisolmonus may be reduced.
Acetylcysteine can bind to metal salts such as gold, iron and potassium salts, and reduce their
effect in the body. Do not take these salts together with Bisolmonus or maintain an
interval between administrations.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Data on the use of acetylcysteine in pregnant women are limited. Use
acetylcysteine during pregnancy only if your doctor considers it necessary.
Breastfeeding
It is not known whether acetylcysteine is excreted in breast milk. If you are breastfeeding, ask
your doctor for advice before using acetylcysteine.
Fertility
Based on available data, there are no indications of possible effects of the use
of acetylcysteine on fertility.
Driving and using machines
Bisolmonus does not, or negligibly, alter the ability to drive vehicles or operate
machinery.
Bisolmonus contains sodium, lactose and sorbitol
This medicine contains 6.03 mmol (or 138.8 mg) of sodium per dose. This must be
taken into consideration in patients who are on a low sodium diet.
This medicine contains lactose and sorbitol. If your doctor has told you that you suffer from
intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take this medicine
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
Take one 600 mg effervescent tablet once a day.
Use in children
Bisolmonus should not be administered to children under 2 years of age and is not
recommended in children and adolescents.
Dissolve the effervescent tablet in half a glass of water. Drink
the solution immediately. The score line is to facilitate breaking
the tablet, so that it dissolves more easily.
Do not take this medicine for more than 8-10 days without consulting a doctor.
If you take more Bisolmonus than you should
If you have taken an excessive amount of Bisolmonus, seek immediate medical
attention or contact your pharmacist. You may experience nausea, vomiting and diarrhoea.
If you forget to take Bisolmonus
If you have forgotten to take an effervescent tablet and it is almost time to take
the next dose, skip the forgotten effervescent tablet and continue as indicated
in the “How to take this medicine” section. Do not take a double dose to
make up for the forgotten tablet.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following very serious side effects, stop using Bisolmonus immediately
and contact your doctor, or go immediately to the emergency room of a nearby hospital. These side
effects are very rare (may affect up to 1 in 10,000 people):
- Shock (rapid drop in blood pressure, paleness, restlessness, weak pulse, clammy skin, decreased
level of consciousness) due to a sudden widening of blood vessels due to severe hypersensitivity to
specific substances (anaphylactic shock). - Sudden accumulation of fluid in the skin and mucous membranes (e.g. throat or tongue) with
difficulty breathing and/or sensation of itching and rash,
often due to an allergic reaction (angioedema).
Contact your doctor if you experience any of the following side effects. These side effects are part
of a hypersensitivity reaction to the active ingredient of this medicine and are uncommon (may affect
up to 1 in 100 people):
- Tightness due to cramps in the muscles of the airways (bronchospasm)
- Difficulty breathing, shortness of breath or chest tightness (dyspnea)
Other side effects
Uncommon (may affect up to 1 in 100 people):
- Hypersensitivity reactions such as increased heart rate (tachycardia), sensation of itching, rash with
severe itching and appearance of spots (urticaria) - Headache
- Ringing in the ears (tinnitus)
- Inflammation of the mucous membrane in the mouth (stomatitis)
- Stomach pain (abdominal pain)
- Nausea, vomiting
- Diarrhea
- Fever (pyrexia)
- Decreased blood pressure
Rare (may affect up to 1 in 1,000)
- Impairment of digestion with heartburn (dyspepsia)
Very rare (may affect up to 1 in 10,000)
- Bleeding
Frequency not known (frequency cannot be estimated based on available data)
- Facial swelling
If you develop gastric or intestinal ulcers, or if you have suffered from them in the past, acetylcysteine
may have an unfavorable effect on the gastrointestinal mucosa.
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 www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Bisolmonus
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Package in laminated aluminum foil
Does not require any special storage conditions or temperature.
Polypropylene tubes with polyethylene caps, containing a desiccant
Do not store at temperatures above 30°C.
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. Package Contents and Other Information
What Bisolmonus contains
- The active ingredient is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
- The other components are citric acid, anhydrous, ascorbic acid, sodium citrate, sodium cyclamate, sodium saccharin, mannitol, sodium bicarbonate, sodium carbonate, anhydrous, lactose, anhydrous, magnesium stearate and lemon flavour (composed of: natural lemon oil, lemon oil natural/identical to natural, mannitol (E421), maltodextrin, gluconolactone (E575), sorbitol (E420), silica, colloidal anhydrous (E551)).
Description of the appearance of Bisolmonus and package contents
Bisolmonus are white, round tablets, with a smooth surface, an incision line on
one side and a diameter of 20 mm.
Each effervescent tablet is individually sealed in an aluminium foil packaged
in a foldable box, or the unsealed tablets are packaged in a tube of
polypropylene plastic with polyethylene caps with desiccant containing molecular sieve.
Pack sizes:
Boxes of 10 and 20 tablets.
Polypropylene tubes with 10, 20 and 25 tablets.
Not all pack sizes may be marketed.
When opening the package, you may sometimes notice a slight smell of sulphur. This is normal and
harmless.
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/b
20158 Milano
Italy
Manufacturer
Hermes Pharma GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany
This medicinal product is authorised in the Member States of the EEA with the following
names:
Netherlands: Bisolaclar
Finland: Bisolaclar
Italy: Bisolmonus
Norway: Bisolaclar
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- Страна регистрации
- Форма выпускаEffervescent tablet, 600 MG
- Код АТХR05CB01
- 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 BISOLMONUSФорма выпуска: Injectable solution, 300 MG/3 MLДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается по рецептуФорма выпуска: Powder for oral solution, 100 MGДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается без рецептаФорма выпуска: Oral solution powder, 600 MGДействующее вещество: АцетилцистеинПроизводитель: HEXAL A/SОтпускается по рецепту
Аналоги BISOLMONUS в других странах
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Аналог BISOLMONUS в Испания
Аналог BISOLMONUS в Польша
Аналог BISOLMONUS в Украина
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Часто задаваемые вопросы
BISOLMONUS не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество BISOLMONUS — Ацетилцистеин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
BISOLMONUS производится компанией OPELLA HEALTHCARE ITALY 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 BISOLMONUS 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 BISOLMONUS 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 (Ацетилцистеин) включают AKK FLUIDIFIKANTE E ANTIDOTO, AKK, AKKFLUBUST. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
