FORTEX BRONHOSOLVAN 200mg powd for oral sol x 20 sachets
Leaflet: patient information
BRONHOSOLVAN 200 mg powder for oral solution in sachet
BRONCHOSOLVAN 200 mg powder for oral solution in a sachet
Acetylcysteine
Acetylcysteine
Read all of this leaflet carefully before you start taking this medicine because 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 need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 4-5 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
- What BRONCHOSOLVAN is and what it is used for
- What you need to know before taking BRONCHOSOLVAN
- How to take BRONCHOSOLVAN
- Possible side effects
- How to store BRONCHOSOLVAN
- Package contents and additional information
- What BRONCHOSOLVAN is and what it is used for
BRONCHOSOLVAN is a drug that contains the active substance acetylcysteine and belongs to the group of mucolytics.
BRONCHOSOLVAN is used for diseases of the respiratory system associated with increased formation and difficult secretion of bronchial secretions, such as acute and chronic bronchitis (inflammation of the bronchi), bronchiectasis (permanent enlargement of the bronchi), chronic obstructive pulmonary disease (long-term lung disease, occurring with cough, secretion of a large amount of sputum and difficulty breathing), cystic fibrosis (a congenital disease accompanied by the formation of thick secretions in the lungs and other organs).
If after 4-5 days you do not feel better or your condition worsens, you should seek medical help.
- What you need to know before taking BRONCHOSOLVAN
Do not take BRONCHOSOLVAN 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 BRONCHOSOLVAN in case of:
- skin changes. The occurrence of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, has been reported very rarely in connection with the use of acetylcysteine (the active substance of BRONCHOSOLVAN). If new changes occur on the skin and mucous membranes, medical help should be sought immediately and the use of acetylcysteine should be stopped immediately;
- bronchial asthma;
- ulcers of the stomach or intestines (gastro-intestinal ulcers) in the past or at present;
- hypersensitivity to histamine. Longer duration treatment should be avoided in such patients, as acetylcysteine affects the metabolism of histamine and may cause intolerance symptoms (e.g. headache, runny nose, itching);
- inability to expectorate. The use of acetylcysteine, especially at the beginning of treatment, can lead to liquefaction and increased formation of bronchial secretions. If you have difficulty in expectorating secretions, your doctor should take appropriate measures.
BRONCHOSOLVAN should not be taken in case of liver or kidney failure to avoid additional intake of nitrogen-containing substances.
Children and adolescents
BRONCHOSOLVAN 200 mg powder for oral solution in a sachet should not be used in children under 2 years of age.
Other drugs and BRONCHOSOLVAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This applies in particular to:
- cough relievers (antitussives). The use of acetylcysteine in combination with cough suppressants can lead to a dangerous accumulation of secretions due to a reduced cough reflex. A careful diagnosis is necessary before the administration of such combined treatment. Be sure to consult your doctor before starting treatment with this combination;
- antibiotics. To avoid the influence of antibiotics on the effect of acetylcysteine, they should be taken separately, with an interval of at least two hours;
- activated carbon. Activated charcoal can reduce the effect of acetylcysteine;
- nitroglycerin. Concomitant administration of acetylcysteine with glycerol trinitrate (nitroglycerin) may increase the vasodilatory and blood-thinning effects of nitroglycerin.
BRONCHOSOLVAN with food, drink and alcohol
- This medicine should be taken after a meal.
- The action of acetylcysteine is enhanced by taking in larger amounts of fluids.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
It does not affect the ability to drive and operate machinery.
BRONCHOSOLVAN contains:
- mannitol (E 421 ). It may have a mild laxative effect;
- sodium. BRONCHOSOLVAN contains less than 1 mmol sodium (23 mg) per sachet, i.e. it can be said to be practically sodium-free.
- 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:
| Age | BRONCHOSOLVAN 200 mg powder for oral solution in a sachet |
| Adults and children over 14 years old | 1 sachet 3 times a day (equivalent to 600 mg acetylcysteine daily) |
| Children from 6 to 14 years | 1 sachet 2 times a day (equivalent to 400 mg acetylcysteine daily) |
| Children from 2 to 5 years | ½ sachet 2-3 times a day (equivalent to 200-300 mg acetylcysteine daily) |
Application method
The contents of one sachet are dissolved in a glass of warm or cold water and drunk.
- The mucolytic effect of BRONCHOSOLVAN is enhanced with more fluids.
- This medicine is taken after a meal.
Use in children and adolescents
BRONCHOSOLVAN 200 mg powder for oral solution in a sachet is used in children over 2 years of age.
If you have taken more than the required dose of BRONCHOSOLVAN
In cases of overdose, some of the following adverse gastrointestinal reactions may occur: heartburn, nausea, stomach pain, vomiting and diarrhea.
If you have taken a higher dose than stated in this leaflet, inform your doctor or pharmacist immediately.
If you forget to take BRONCHOSOLVAN
Do not take a double dose to make up for a missed dose. Continue using BRONCHOSOLVAN, observing the usual dosage.
If you have stopped taking BRONCHOSOLVAN
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions are classified by system organ class and frequency as follows: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) ), rare (≥1/10,000 to <1/1,000), very rare (≤ 1/10,000), not known (frequency cannot be estimated from the available data). The following side effects are possible:
Uncommon:
- allergic reactions (itching and urticaria), severe subcutaneous swelling (angioedema) and skin rash;
- fast heart rate (tachycardia);
- low blood pressure (hypotension);
- headache;
- ringing in the ears (tinnitus);
- stomatitis, abdominal pain, nausea, vomiting and diarrhea;
- elevated temperature.
Rare:
- shortness of breath, bronchospasm;
- indigestion (dyspepsia).
Very rare:
- severe allergic reactions that can develop including shock;
- serious skin reactions, for example, Stevens-Johnson syndrome and Lyell's syndrome;
- occurrence of bleeding (hemorrhage), partly in connection with hypersensitivity reactions.
Not known frequency:
- facial edema (accumulation of water in the face).
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the Executive Medicines Agency, 8 Damyan Gruev St., 1303 Sofia: phone +359 2 8903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
- How to store BRONCHOSOLVAN
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP and on the sachet. The expiration date corresponds to the last day of the specified month.
Do not use this medicine if you notice visible signs of product deterioration.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
- Package contents and additional information
What BRONCHOSOLVAN 200 mg powder for oral solution in a sachet contains
- The active substance is acetylcysteine 200 mg.
- Excipients are: mannitol, sodium cyclamate, orange flavor and colloidal anhydrous silica.
What BRONCHOSOLVAN looks like and contents of the pack
BRONCHOSOLVAN contains powder for oral solution in a sachet.
Each box of BRONCHOSOLVAN 200 mg powder for oral solution in a sachet contains 20 sachets together with a patient leaflet.
Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd
10 Prohladen kat St.,
Sofia 1362, Bulgaria
Date of last revision of leaflet
