Bronchosolvan 200 mg

• General information
• Ingredients

• Package leaflet: Information for the patient

  BRONHOSOLVAN 200 mg powder for oral solution in sachet

  Acetylcysteine

  Read all of this leaflet carefully before you start 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 have told you.

  - Keep this leaflet. You may need to read it again.

  - Ask your pharmacist if you need more information or advice.

  - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  - You should seek medical attention if you do not feel better or if you feel worse after 4-5 days.

   

  What is in this leaflet

  1. What BRONHOSOLVAN is and what it is used for

  2. What you need to know before you take BRONHOSOLVAN

  3. How to take BRONHOSOLVAN

  4. Possible side effects

  5. How to store BRONHOSOLVAN

  6. Contents of the pack and other information

   

  1. What BRONHOSOLVAN is and what it is used for

  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).

  You should seek medical attention if you do not feel better or if you feel worse after 4-5 days.

   

  2. What you need to know before you take BRONHOSOLVAN

  Do not take BRONHOSOLVAN if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).

  Warnings and precautions

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

  • skin changes. The occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome has very rarely been reported in connection with the use of acetylcysteine (the active substance of BRONHOSOLVAN). If skin and mucosal changes newly occur, medical advice should be sought without delay and use of acetylcysteine be terminated;
  • bronchial asthma;
  • a history of stomach or bowel  ulcers (gastrointestinal ulcers) or currently  have them;
  • a hypersensitivity to histamine. Longer-term therapy should be avoided in these patients, since acetylcysteine influences the histamine metabolism and may lead to symptoms of intolerance (e.g. headache, running nose, itching).
  • an inability to cough up mucous. The use of acetylcysteine, especially at the beginning of treatment, may lead to liquefaction and increased bronchial secretion. If you have difficulty swapping, your doctor should take appropriate measures.

  BRONHOSOLVAN should not be taken in case of hepatic or renal insufficiency to avoid the additional intake of substances containing nitrogen.

  Children and adolescents

  BRONHOSOLVAN 200 mg powder for oral solution in sachetshould not be taken by children under 2 years.

  Other medicines and BRONHOSOLVAN

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially for:

  • cough relievers (anti-cough agents). The use of acetylcysteine in combination with cough relievers can lead to dangerous accumulation of secretion due to reduced cough reflex. Prior to administering such combination therapy, careful diagnosis is required. You should consult your doctor before starting treatment with this combination;
  • antibiotics. To avoid antibiotics being affected by the effect of acetylcysteine, they should be taken separately with an interval of at least two hours;
  • active charcoal. Activated  charcoal may reduce the effect of acetylcysteine;
  • nitroglycerin. Concomitant administration of acetylcysteine with glycerol trinitrate (nitroglycerin) may increase the vasodilating and blood-damaging effects of nitroglycerin.

   

  BRONHOSOLVAN with food, drink and alcohol

  This medicine should be taken after eating.

  The effect of acetylcysteine is enhanced by the larger amounts of fluid.

  Pregnancy, breast-feeding and fertility

  If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

  your doctor or pharmacist for advice before taking this medicine.

  Driving and using machines

  It does not affect your ability to drive or operate machinery.

  BRONHOSOLVAN contains:

  • mannitol (E 421). There may be a slight laxative effect;
  • sodium. BRONHOSOLVAN contains less than 1 mmol of sodium (23 mg) per sachet, ie. it can be said that practically does not contain sodium.

  3. How to take BRONHOSOLVAN

  Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  The recommended dose is:

  Age	BRONHOSOLVAN 200 mg powder for oral solution in sachet
  Adults and children over 14 years	1 sachet three times a day (corresponds to 600 mg daily Acetylcysteine)
  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)

  Method of administration

  The contents of a sachet dissolve in a cup of hot or cold water and drink it. The mucolytic effect of BRONHOSOLVAN is enhanced by the intake of more fluids. This medicine is taken after eating.

  Use in children and adolescents

  BRONHOSOLVAN 200 mg powder for oral solution in sachetshould be taken by children over 2 years.

  If you take use more BRONHOSOLVAN 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 BRONHOSOLVAN

  Do not take a double dose to make up for a forgotten dose. Continue using BRONHOSOLVAN by following the usual dosage.

  If you stop taking BRONHOSOLVAN

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

  4. Possible side effects

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

  Possible side effects 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:
  • allergic reactions (pruritus and urticaria), severe underlying swelling (angioneurotic edema) and skin rash;
  • accelerated heart rhythm (tachycardia);
  • decrease in blood pressure (hypotension);
  • headache;
  • tinnitus (tinnitus);
  • stomatitis, abdominal pain, nausea, vomiting and diarrhea;
  • high temperature.
  
  Rare:
  • shortness of breath, bronchospasm;
  • a disorder of digestion (dyspepsia).
  
  Very rare:
  • severe allergic reactions that can develop, including shock;
  • serious skin reactions, such as Stevens-Johnson syndrome and Lyell syndrome;
  • bleeding (bleeding), in part in connection with hypersensitivity reactions.
  
  Not known:
  • facial swelling (build-up of water in the face).

  Reporting of side effects

  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Bulgarian Drug Agency, Address: 8, Damyan Gruev Str. 1303 Sofia; Country Bulgaria; Phone: +359 2 890 34 17, уебсайт: www.bda.bg; Email: bda@bda.bg. By reporting side effects you can help provide more information on the safety of this medicine.

  5. How to store BRONHOSOLVAN

  Keep this medicine out of the sight and reach of children.

  Do not use this medicine after the expiry date which is stated on the carton box after the “Expiry date” 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 deterioration.

  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

  to throw away medicines you no longer use. These measures will help protect the environment.

  6. Contents of the pack and other information

  What BRONHOSOLVAN 200 mg powder for oral solution in sachet contains

  - The active substance is acetylcysteine 200 mg.

  - The excipients are: mannitol, sodium cyclamate, orange flavor and colloidal anhydrous silica.

  What BRONHOSOLVAN looks like and contents of the pack

  BRONXOSOLVAN contains powder for oral solution in a sachet.
  Each box BRONXOSOLVAN 200 mg powder for oral solution in sachet contains 20 sachets together with a Package leaflet: Information for the patient.

  Marketing Authorisation Holder and Manufacturer

  Fortex Nutraceuticals Ltd.

  10, Prohladen kat Street, 

  1362 Sofia, Bulgaria

  The leaflet was last revised in April 2018.

   

• What BRONHOSOLVAN 200 mg powder for oral solution in sachet contains

  - The active substance is acetylcysteine 200 mg.

  - The excipients are: mannitol, sodium cyclamate, orange flavor and colloidal anhydrous silica.

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