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  Bronchosolvan 600mg

10 sachets
Препоръчителната доза е: Възрастни и деца над 14 години – 1 саше 1 път дневно (съответства на 600 mg ацетилцистеин дневно)
GENERAL INFORMATION

LEAFLET: INFORMATION FOR THE USER

 

Bronhosolvan 200 / Bronhosolvan 600
200 mg / 600 mg powder for oral solution

Acetylcysteine

 

Read the leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However, to get the best results from the treatment, you should carefully follow the instructions for use of Bronhosolvan 200/ Bronhosolvan 600.

  • Keep this leaflet. You may need to read it again.
  • If you need further information or advice, ask your pharmacist.
  • You must contact a doctor if your symptoms worsen or do not improve after 4-5 days.
  • If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

 In this leaflet:

  1. What Bronhosolvan 200 / Bronhosolvan 600 is and what it is used for
  2. What do you need to know before taking Bronhosolvan 200 / Bronhosolvan 600
  3. How to take Bronhosolvan 200 / Bronhosolvan 600
  4. Possible side effects
  5. How to store Bronhosolvan 200 / Bronhosolvan 600
  6. Contents of the package and further information

  

  1. What Bronhosolvan 200 / Bronhosolvan 600 is and what it is used for

Bronhosolvan 200 / Bronhosolvan 600 is a medicinal product containing the active substance acetylcysteine. It is used in cases of liquefaction and facilitating expectoration of bronchial secretions in acute and chronic diseases of the bronchi and lungs trachea, bronchitis, pneumonia, cystic fibrosis associated with increased formation and difficulties passing bronchial secretions.

  1. What do you need to know before taking Bronhosolvan 200 / Bronhosolvan 600

 Do not take Bronhosolvan 200 / Bronhosolvan 600:

  •  if you are hypersensitive or allergic to the active substance acetylcysteine ​​or any of the other ingredients.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Bronhosolvan 200 / Bronhosolvan 600.

This is important because some states are more likely to get side effects (see also section 4):

  • if you suffer from asthma
  • if you have histamine intolerance
  • if you have or have had a stomach or duodenal ulcer

Children

Bronhosolvan 200 is not suitable for children under 2 years.
Bronhosolvan 600 is not suitable for children under 14 years.

Other medicines and Bronhosolvan 200 / Bronhosolvan 600

Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. This applies in particular to:

  • medicines that suppress the cough

The combined administration of Bronhosolvan 200 / Bronhosolvan 600 and medicines that suppress cough may lead to retention of the bronchial secretions, due to the suppression of the cough reflex.

  • medicines for treating bacterial infections (antibiotics)

Oral administration of antibiotics should be performed separately from the intake of Bronhosolvan 200 / Bronhosolvan 600 at intervals of at least 2 hours.

  • Nitroglycerin

Coadministration of Bronhosolvan 200 / Bronhosolvan 600 with glycerol trinitrate (nitroglycerin) may lead to increased blood thinning and vasodilating effects of nitroglycerin.

Pregnancy, lactation and fertility
There are no adequate data from the use of acetylcysteine ​​during pregnancy or breastfeeding. You can take Bronhosolvan 200 / Bronhosolvan 600 in these periods only if your doctor considers it absolutely necessary.

Driving and using machines
There is no evidence of impairment of concentration and reaction time when driving or operating machinery, while taking acetylcysteine.

  1. How to take Bronhosolvan 200 / Bronhosolvan 600

Always take this medicine exactly as described in this leaflet or as you have been told by your doctor or pharmacist. If you’re not sure, ask your doctor or pharmacist.

Method of administration
Dissolve the content of one sachet in a glass of warm or cold water and drink it.

Bronhosolvan 200 / Bronhosolvan 600 is recommended to be taken after meals.

The mucolytic effect of Bronhosolvan 200 / Bronhosolvan 600 increases when taking more fluids.

The usual dose is:

Bronhosolvan 200
200 mg of Acetylcysteine
Bronhosolvan 600
600 mg of Acetylcysteine
Adults and children over 14 years 1 sachet three times a day
(corresponds to 600 mg daily Acetylcysteine)
1 sachet 1 a day
(corresponding to 600 mg Acetylcysteine ​​daily)
Children 6 to 14 years 1 sachet 2 times daily
(corresponding to 400 mg Acetylcysteine ​​daily)
Children 2 to 5 years ½ sachet 2-3 times daily
(corresponding to 200-300 mg daily Acetylcysteine)

 

Duration of treatment
Bronhosolvan 200 / Bronhosolvan 600 should not be taken more than 4-5 days without consulting a doctor. The duration of the treatment depends on the type and severity of the disease and must be determined by the attending physician.

If you take more dose of Bronhosolvan 200 / Bronhosolvan 600
If you have taken intentionally or accidentally a higher dose of that in this leaflet, tell your doctor or pharmacist.

In case of overdose it can occur any of the following gastrointestinal adverse reactions: heartburn, nausea, stomach pain, vomiting and diarrhea.

If you have forgotten to take Bronhosolvan 200 / Bronhosolvan 600
If you have forgotten to take Bronhosolvan 200 / Bronhosolvan 600 or you have taken a smaller dose, you should not take a double dose to make up. Continue the use of Bronhosolvan 200 / Bronhosolvan 600 observing the usual dosage.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, Bronhosolvan 200 / Bronhosolvan 600 can cause side effects, although not everybody gets them.

Stop taking Bronhosolvan 200 / Bronhosolvan 600 and consult a doctor immediately if you experience signs of an allergic reaction or any other serious reaction.

Possible side effects are the following:

Very common (may affect more than 1 in 10 people)

Uncommonly were observed headache, inflammation of the oral mucosa and tinnitus.

Rare (may affect more than 1 in 1000 people)

In rare cases may occur gastrointestinal complaints such as heartburn, nausea, vomiting and diarrhea; allergic reactions – itching, urticaria (hives), skin rashes. In rare cases may also occur shortness of breath, rapid heart rate and lowering blood pressure, headache, pyrexia (fever). Rarely the intake of acetylcysteine ​​may cause bleeding, partly as a result of hypersensitivity reactions.

Very rare (may affect more than 1 in 10 000)

Very rarely were reported cases of allergic reactions (including itching, hives, rashes, shortness of breath (especially in patients with asthma)), increased heart rate and lowering blood pressure. Bronchospasm (airway narrowing) was observed very rarely, predominantly in patients with bronchial asthma.

Adverse event reporting

If you get any side effects, contact your doctor or pharmacist. This includes any possible side effects, not listed in this leaflet.

You can also report adverse events directly through the national system for reporting directly to the Bulgarian Drug Agency, Damyan Gruev Str., No 8, 1303 Sofia, tel. +359 2 8903417, website www.bda.bg.

Reporting adverse reactions, you can do your bit to obtain more information on the safety of this medicine.

  1. How to store Bronhosolvan 200 / Bronhosolvan 600

Keep out of reach of children.

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Keep at temperatures below 25 ° C.

Do not dispose of this medicine in wastewater or household waste.

Ask your pharmacist how to dispose of medicines of no longer use. These measures will help to protect the environment.

  1. Contents of the package and further information

What are the contents of  Bronhosolvan 200 / Bronhosolvan 600

The active substance in one sachet is: acetylcysteine ​​200 mg / 600 mg

Other ingredients (excipients) include: mannitol, sodium cyclamate, silicon dioxide, flavor orange (Bronhosolvan 200) / lemon (Bronhosolvan 600).

What Bronhosolvan 200 / Bronhosolvan 600 looks like and contents of the pack

Bronhosolvan 200 / Bronhosolvan 600 contains powder for oral solution in sachet.

The contents of the sachet are almost white mixture of dust and dry agglomerates.

Each box contains 20 sachets / 200 Bronhosolvan / or 10 sachets / Bronhosolvan 600 / and the package leaflet.

Marketing Authorisation Holder and Manufacturer
Fortex Nutraceutical Ltd.
Prohladen kat str., 10
Sofia 1362, Bulgaria

Date of last revision of the leaflet
August 2015

Package Leaflet: Patient Information

BRONHOSOLVAN 600 mg powder for oral solution in a sachet
БРОНХОСОЛВАН 600 mg прах за перорален разтвор в саше

Ацетилцистеин
Acetylcysteine

Read all of this leaflet carefully before you start taking 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 has told you.

  • Keep this leaflet. You may have to read it again.
  • If you need more information or advice, ask your pharmacist.
  • Ако получите някакви нежелани реакции, уведомете Вашия лекар или фармацевт. Това включва и всички възможни нежелани реакции, неописани в тази листовка. Вижте точка 4.
  • If after 4-5 days you do not feel better or your condition gets worse, you should seek medical attention.

 What this leaflet contains

  1. What BRONCHOSOLVAN is and what it is used for
  2. What you need to know before you take BRONCHOSOLVAN
  3. How to take Bronchosolvan
  4. Possible side effects
  5. How to store BRONCHOSOLVAN
  6. Packaging content and additional information

 

  1. What BRONCHOSOLVAN is and what it is used for

BRONCHOSOLVAN is a medicine that contains the active substance acetylcysteine and belongs to the group of mucolytics.

BRONCHOSOLVAN is used in respiratory diseases associated with increased formation and difficulty in the release of bronchial secretions such as acute and chronic bronchitis (bronchitis), bronchiectasis (chronic bronchitis), chronic obstructive pulmonary disease (long-term lung disease, coughing, large amounts of sputum and difficulty in breathing), cystic fibrosis (congenital disease accompanied by thick secretion in the lungs and other organs).

If after 4-5 days you do not feel better or your condition gets worse, you should seek medical attention.

  1. What you need to know before you take BRONCHOSOLVAN

Не приемайте БРОНХОСОЛВАН, ако сте алергични към ацетилцистеин или към някоя от останалите съставки на това лекарство (изброени в точка 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking BRONCHOSOLVAN in case of:

  • промени в кожата. Възникването на тежки кожни реакции, като синдром на Стивънс-Джонсън и синдром на Лайел, се съобщава много рядко във връзка с употребата на ацетилцистеин (активното вещество на БРОНХОСОЛВАН). Ако възникнат нови промени по кожата и лигавиците трябва веднага да се потърси медицинска помощ и незабавно да се спре употребата на ацетилцистеин;
  • бронхиална астма;
  • язви на стомаха или червата (стомашно-чревни язви) в миналото или понастоящем;
  • свръхчувствителност към хистамин. Трябва да се избягва лечение с по-голяма продължителност при такива пациенти, тъй като ацетилцистеин повлиява метаболизма на хистамин и може да предизвика симптоми на непоносимост (например главоболие, хрема, сърбеж);
  • неспособност за отхрачване. Употребата на ацетилцистеин, особено в началото на лечението, може да доведе до втечняване и повишено образуване на бронхиален секрет. Ако сте затруднени в отхрачването на секрета, Вашият лекар трябва да вземе съответните мерки.

BRONCHOSOLVAN should not be used in case of hepatic or renal insufficiency to avoid additional intake of substances containing nitrogen.

Children and adolescents

БРОНХОСОЛВАН 600 mg прах за перорален разтвор в саше не трябва да се използва при деца под 14–годишна възраст.

Other medicines and BRONCHOSOLVAN

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This applies especially to:

  • средства за облекчаване на кашлицата (противокашлични средства). Употребата на ацетилцистеин в комбинация със средства за облекчаване на кашлицата може да доведе до опасно натрупване на секрет поради намален кашличен рефлекс. Преди прилагане на такова комбинирано лечение е необходимо внимателно диагностициране. Задължително се консултирайте с Вашия лекар, преди да започнете лечение с тази комбинация;
  • антибиотици. За да се избегне повлияване от страна на антибиотиците на ефекта на ацетилцистеин, те трябва да се приемат отделно, с интервал от поне два часа;
  • активен въглен. Активният въглен може да намали ефекта на ацетилцистеин;
  • нитроглицерин. Едновременното приложение на ацетилцистеин с глицерол тринитрат (нитроглицерин) може да доведе до засилване на съдоразширяващите и кръворазреждащи ефекти на нитроглицерина.

BRONCHOSOLVAN with food, beverages and alcohol

  • This medicine should be taken after a meal.
  • The effect of acetylcysteine is enhanced by the intake of larger amounts of fluid.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It does not affect the ability to drive and use machines.

BRONCHOSLOVAN contains:

  • манитол (Е 421). Може да има слабо изразено слабително действие;
  • натрий. БРОНХОСОЛВАН съдържа по-малко от 1 mmol натрий (23 mg) на саше т.е. може да се каже, че практически не съдържа натрий.
  1. How to take Bronchosolvan

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

 The recommended dose is:

 Възраст БРОНХОСОЛВАН 600 mg прах за перорален разтвор в саше
Възрастни и деца над 14 години 1 саше 1 път дневно
(съответства на 600 mg ацетилцистеин дневно)

Application method
The contents of a sachet dissolve in a cup of hot or cold water and is drunk.

  • The mucolytic effect of BRONCHO aSOLVAN is enhanced by the intake of more fluids.
  • This medicine is taken after a meal.

Use in children and adolescents
БРОНХОСОЛВАН 600 mg прах за перорален разтвор в саше се използва при деца над 14 години.

If you take more Bronchosolvan than you should
In cases of overdose, some of the following undesirable gastrointestinal reactions may occur: stomach acid, nausea, stomach pain, vomiting and diarrhea.

If you take a higher dose than the one mentioned in this leaflet, tell your doctor or pharmacist immediately.

If you forget to take BRONCHOSOLVAN
Do not take a double dose to make up for the missed dose. Continue using BRONCHOSOLVAN by following the usual dosage.

If you stop taking BRONCHOSOLVAN
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Adverse reactions are classified by system organ class and frequency in the following way: very common (≥1 / 10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100 ), rare (≥1 / 10,000 to <1 / 1,000), very rare (≤ 1 / 10,000), not known (can not be estimated from the available data). The following side effects are possible:

Uncommon:

  • алергични реакции (сърбеж и образуване на уртикария), тежко подкожно подуване (ангионевротичен оток) и кожен обрив;
  • ускорен сърдечен ритъм (тахикардия);
  • понижение на кръвното налягане (хипотония);
  • главоболие;
  • шум в ушите (тинитус);
  • стоматит, коремна болка, гадене, повръщане и диария;
  • повишена температура.

Rare:

  • задух, бронхоспазъм;
  • нарушение на храносмилането (диспепсия).

Very rare:

  • тежки алергични реакции, които могат да се развият включително до шок;
  • сериозни кожни реакции, например синдром на Стивънс-Джонсън и синдром на Лайел;
  • възникване на кървене (кръвоизлив), отчасти във връзка с реакции на свръхчувствителност.

Not known:

  • оток на лицето (натрупване на вода в лицето).

Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Drug Agency, 8 Damian Gruev Str., 1303 Sofia, tel. +359 2 8903417, website: www.bda.bg. As you report side effects, you can contribute to getting more information about the safety of this medicine.

  1. How to store BRONCHOSOLVAN

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP and on the sachet. The expiry date refers to the last day of that month.

Do not use this medicine if you notice visible signs of product quality impairment.

Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

  1. Packaging content and additional information

 Какво съдържа БРОНХОСОЛВАН 600 mg прах за перорален разтвор в саше

  • Активното вещество е ацетилцистеин 600 mg.
  • Помощни вещества са: манитол, натриев цикламат, аромат лимон и колоиден безводен силициев диоксид.

What BRONCHOSOLVAN looks like and what the package contains
BRONCHOSOLVAN contains powder for oral solution in a sachet.

Всяка кутия БРОНХОСОЛВАН 600 mg прах за перорален разтвор в саше съдържа 10 сашета заедно с листовка за пациента.

Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd.
10 Prohladen kut street,
Sofia 1362, Bulgaria

Date of the last review of the package leaflet
Април 2018

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