FORTEX BRONHOSOLVAN / Bronchosolvan cough powder 200 mg x 20 sachets
Patient information leaflet
BRONHOSOLVAN 200 mg powder for oral solution in sachet
BRONCHOSOLVAN 200 mg powder for oral solution in 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, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better after 4-5 days or your condition worsens, you should seek medical attention.
What this leaflet contains
- What is BRONCHOSOLVAN and what is it used for?
- What you need to know before you take BRONCHOSOLVAN
- How to take BRONHOSOLVAN
- Possible side effects
- How to store BRONHOSOLVAN
- Package contents and additional information
- What is BRONCHOSOLVAN and what is it used for?
BRONCHOSOLVAN is a medicine 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 difficulty in the discharge of bronchial secretions, such as acute and chronic bronchitis (inflammation of the bronchi), bronchiectasis (permanent dilation of the bronchi), chronic obstructive pulmonary disease (long-term lung disease characterized by cough, secretion of large amounts of sputum and difficulty breathing), cystic fibrosis (a congenital disease accompanied by the formation of thick secretions in the lungs and other organs).
If you do not feel better after 4-5 days or your condition worsens, you should seek medical attention.
- What you need to know before you take 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 (gastrointestinal ulcers) in the past or now;
- Hypersensitivity to histamine. Longer-term treatment should be avoided in such patients, as acetylcysteine affects histamine metabolism and may cause symptoms of intolerance (e.g. headache, runny nose, itching);
- inability to expectorate. The use of acetylcysteine, especially at the beginning of treatment, may lead to liquefaction and increased formation of bronchial secretions. If you have difficulty 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 sachets should not be used in children under 2 years of age.
Other medicines 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 suppressants (anticupactives). The use of acetylcysteine in combination with cough suppressants may lead to a dangerous build-up of phlegm due to a reduced cough reflex. Careful diagnosis is necessary before using such a combination treatment. It is essential to consult your doctor before starting treatment with this combination;
- Antibiotics. To avoid antibiotics interfering with the effect of acetylcysteine, they should be taken separately, with an interval of at least two hours;
- Activated charcoal. Activated charcoal may reduce the effect of acetylcysteine;
- Nitroglycerin. Concomitant administration of acetylcysteine with glycerol trinitrate (nitroglycerin) may lead to an increase in the vasodilator and blood-thinning effects of nitroglycerin.
BRONHOSOLVAN with food, drinks and alcohol
- This medicine should be taken after meals.
- The effect of acetylcysteine is enhanced by the intake of larger amounts of fluids.
Pregnancy, breastfeeding 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
Does not affect the ability to drive and use machines.
BRONCHOSOLVAN contains:
- Mannitol (E 421 ). May have a mild laxative effect;
- sodium. BRONCHOSOLVAN contains less than 1 mmol sodium (23 mg) per sachet, i.e. it can be said that it contains practically no sodium.
- How to take BRONHOSOLVAN
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 sachet |
| Adults and children over 14 years old | 1 sachet 3 times daily (equivalent to 600 mg acetylcysteine daily) |
| Children from 6 to 14 years old | 1 sachet 2 times daily (equivalent to 400 mg acetylcysteine daily) |
| Children from 2 to 5 years old | ½ sachet 2-3 times daily (equivalent to 200-300 mg of acetylcysteine daily) |
Method of administration
The contents of one sachet are dissolved in a glass of warm or cold water and drunk.
- The mucolytic effect of BRONCHOSOLVAN is enhanced by drinking more fluids.
- This medicine is taken after meals.
Use in children and adolescents
BRONCHOSOLVAN 200 mg powder for oral solution in sachet is used in children over 2 years of age.
If you take more BRONCHOSOLVAN than you should
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 BRONHOSOLVAN
Do not take a double dose to make up for a forgotten dose. Continue taking BRONCHOSOLVAN at your usual dosage.
If you stop taking BRONCHOSOLVAN
If you have any further questions on 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 adverse reactions are possible:
Uncommon:
- allergic reactions (itching and hives), severe swelling under the skin (angioedema) and skin rash;
- rapid heart rate (tachycardia);
- low blood pressure (hypotension);
- headache;
- ringing in the ears (tinnitus);
- stomatitis, abdominal pain, nausea, vomiting and diarrhea;
- fever.
Rare:
- shortness of breath, bronchospasm;
- indigestion (dyspepsia).
Very rare:
- severe allergic reactions, which may develop into shock;
- serious skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome;
- occurrence of bleeding (hemorrhage), partly in connection with hypersensitivity reactions.
Unknown frequency:
- facial edema (water accumulation in the face).
Reporting side effects
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia: tel. +359 2 8903417, website: www.bda.bg. By reporting side effects, you can help to obtain more information on the safety of this medicine.
- How to store BRONHOSOLVAN
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 expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of product deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
- Package contents and additional information
What BRONHOSOLVAN 200 mg powder for oral solution in sachet contains
- The active substance is acetylcysteine 200 mg.
- Excipients are: mannitol, sodium cyclamate, orange flavor and colloidal anhydrous silicon dioxide.
What BRONHOSOLVAN looks like and what the pack contains
BRONCHOSOLVAN contains powder for oral solution in a sachet.
Each box of BRONCHOSOLVAN 200 mg powder for oral solution in sachet contains 20 sachets together with a patient leaflet.
Marketing Authorisation Holder and Manufacturer
Fortex Nutraceuticals Ltd.
10 Prohladen Kat Street,
Sofia 1362, Bulgaria
Date the leaflet was last revised
