Flegamina Acetylcysteinum effervescent tablets 10 pieces
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Description
Flegamina Acetylcysteinum effervescent tablets 10 pieces
Main features of the product
For adults and adolescents over 14 years of age
Description
Acetylcysteinum, 600 mg, effervescent tablets
Acetylcysteinum Flegamina is indicated for the thinning of mucus and facilitation of its expectoration in bronchitis caused by the common cold accompanied by persistent respiratory secretions and reduced mucus transport in adolescents over 14 years of age and adults.
OTC - Over-the-counter medication.
Acetylcysteinum Flegamina is indicated for the thinning of mucus and facilitation of its expectoration in bronchitis caused by the common cold accompanied by persistent respiratory secretions and reduced mucus transport in adolescents over 14 years of age and adults.
OTC - Over-the-counter medication.
Storage and use.
Read the leaflet before using the drug.
Refer to the leaflet for further information.
Oral administration.
Recommended dosage: adolescents over 14 years of age and adults: 1 effervescent tablet once daily. Do not take for more than 5 days. If symptoms persist or worsen, contact a doctor.
Storage: Store at ambient temperature
Packaging: box
Refer to the leaflet for further information.
Oral administration.
Recommended dosage: adolescents over 14 years of age and adults: 1 effervescent tablet once daily. Do not take for more than 5 days. If symptoms persist or worsen, contact a doctor.
Storage: Store at ambient temperature
Packaging: box
Composition
Each effervescent tablet contains 600 mg of acetylcysteine, Contains aspartame (E 951), sodium and sucrose
Manufacturer
Teva Pharmaceuticals Polska Sp. z o.o.
Manufacturer's address
Responsible party:
Teva B.V,
Swensweg 5,
2031GA Haarlem,
The Netherlands
Manufacturer:
Merckle GmbH,
Graf-Arco Str. 3,
89079 Ulm,
Germany
Safety warning
Teva B.V,
Swensweg 5,
2031GA Haarlem,
The Netherlands
Manufacturer:
Merckle GmbH,
Graf-Arco Str. 3,
89079 Ulm,
Germany
Keep the drug out of sight and reach of children.
Number of units
Number of units: 10
Lower age limit
Recommended: 14 years/years/years
General information
Read the leaflet carefully before using this medication, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 5 days, or if the patient feels worse, contact your doctor.
Table of contents of the leaflet
Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 5 days, or if the patient feels worse, contact your doctor.
Table of contents of the leaflet
1 What is the drug Acetylcysteinum Flegamina and what is it used for?
2. important information before using Acetylcysteinum Flegamina drug
3 How to use the drug Acetylcysteinum Flegamina
4 Possible side effects
5 How to store the drug Acetylcysteinum Flegamina
6. package contents and other information
Description and application
1 What is the drug Acetylcysteinum Flegamina and what is it used for?
2. important information before using Acetylcysteinum Flegamina drug
3 How to use the drug Acetylcysteinum Flegamina
4 Possible side effects
5 How to store the drug Acetylcysteinum Flegamina
6. package contents and other information
1 What is the drug Acetylcysteinum Flegamina and for what purpose it is used.
Acetylcysteinum Flegamina contains the active substance acetylcysteine, which is a drug that dilutes persistent mucus in the respiratory tract.
Acetylcysteinum Flegamina is indicated in adolescents over 14 years of age and adults for the thinning of mucus and facilitation of its expectoration in bronchitis caused by the common cold accompanied by persistent respiratory secretions and reduced mucus transport.
If, after 5 days, there is no improvement or the patient feels worse, consult a doctor.
How to use the drug
Acetylcysteinum Flegamina contains the active substance acetylcysteine, which is a drug that dilutes persistent mucus in the respiratory tract.
Acetylcysteinum Flegamina is indicated in adolescents over 14 years of age and adults for the thinning of mucus and facilitation of its expectoration in bronchitis caused by the common cold accompanied by persistent respiratory secretions and reduced mucus transport.
If, after 5 days, there is no improvement or the patient feels worse, consult a doctor.
3 How to use the drug Acetylcysteinum Flegamina
Always take this medicine exactly as described in the patient leaflet, or as directed by your doctor or pharmacist or nurse. If in doubt, ask your doctor or pharmacist or nurse.
Follow the directions below, unless a different dosage regimen has been recommended by your doctor. Follow the instructions for use, otherwise Acetylcysteinum Flegamina will not work properly.
Recommended dosage: adolescents aged 14 years and older and adults - 1 effervescent tablet once daily.
Method and time of use
Dissolve the effervescent tablet in a glass of water, and then drink the contents of the entire glass.
The drug can be taken regardless of meals.
Do not use for more than 5 days.
Taking more than the recommended dose of the drug Acetylcysteinum Flegamina
Overdose may lead to gastrointestinal irritation (e.g. abdominal pain, nausea, vomiting, diarrhea). To date, no serious adverse reactions that are signs of poisoning have been observed, even after a significant overdose of acetylcysteine tablets. If you suspect an overdose of Acetylcysteinum Flegamina, inform your doctor.
Omission of taking Acetylcysteinum Flegamina drug.
Do not use a double dose to make up for a missed tablet. Continue taking the drug as described in the instructions for use.
If you have any further doubts about the use of this drug, ask your doctor or pharmacist.
How to store the drug
Always take this medicine exactly as described in the patient leaflet, or as directed by your doctor or pharmacist or nurse. If in doubt, ask your doctor or pharmacist or nurse.
Follow the directions below, unless a different dosage regimen has been recommended by your doctor. Follow the instructions for use, otherwise Acetylcysteinum Flegamina will not work properly.
Recommended dosage: adolescents aged 14 years and older and adults - 1 effervescent tablet once daily.
Method and time of use
Dissolve the effervescent tablet in a glass of water, and then drink the contents of the entire glass.
The drug can be taken regardless of meals.
Do not use for more than 5 days.
Taking more than the recommended dose of the drug Acetylcysteinum Flegamina
Overdose may lead to gastrointestinal irritation (e.g. abdominal pain, nausea, vomiting, diarrhea). To date, no serious adverse reactions that are signs of poisoning have been observed, even after a significant overdose of acetylcysteine tablets. If you suspect an overdose of Acetylcysteinum Flegamina, inform your doctor.
Omission of taking Acetylcysteinum Flegamina drug.
Do not use a double dose to make up for a missed tablet. Continue taking the drug as described in the instructions for use.
If you have any further doubts about the use of this drug, ask your doctor or pharmacist.
5 How to store the drug Acetylcysteinum Flegamina.
Store the drug out of sight and reach of children.
Do not use this medicine after the expiration date placed on the container and box after: "Expiration date (EXP)" or "EXP". Expiration date means the last day of the month stated.
Storage conditions
Do not store at temperatures above 25°C.
Keep the container tightly closed to protect it from moisture.
Shelf life after the first opening of the container: 12 months.
Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Such treatment will help protect the environment.
Possible side effects
Store the drug out of sight and reach of children.
Do not use this medicine after the expiration date placed on the container and box after: "Expiration date (EXP)" or "EXP". Expiration date means the last day of the month stated.
Storage conditions
Do not store at temperatures above 25°C.
Keep the container tightly closed to protect it from moisture.
Shelf life after the first opening of the container: 12 months.
Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Such treatment will help protect the environment.
4 Possible side effects
Like any drug, this medication may cause side effects, although not everyone will experience them.
If you experience any of the following very rare (may occur less than 1 in 10,000 people) symptoms, discontinue Acetylcysteinum Flegamina and seek medical help immediately:
- severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome associated with temporary acetylcysteine intake. Symptoms include a rash, trouble swallowing or breathing, swelling of the lips, face, throat or tongue.
The following side effects may occur:
Uncommon (may occur less than 1 in 100 people):
- hypersensitivity reactions
- headache
- ringing in the ears (tinnitus)
- accelerated heartbeat
- vomiting, diarrhea, oral mucositis, abdominal pain, nausea
- allergic reactions: urticarial blisters, itching, rash, swelling of the skin and mucous membranes
- fever
- low blood pressure
Rare (may occur less than 1 in 1000 people):
- dyspnea, bronchospasm - mainly in patients with hyperreactive bronchial system in bronchial asthma
- heartburn
Very rarely (may occur less than 1 in 10,000 people):
- hypersensitivity reactions up to shock
- hemorrhage
Frequency unknown (frequency cannot be determined from available data):
- accumulation of water in the face (facial edema)
Immediately seek medical advice and immediately discontinue Acetylcysteinum Flegamina if new skin and mucous membrane lesions appear.
Do not continue treatment with Acetylcysteinum Flegamina.
Various studies have confirmed a reduction in aggregation (clumping of certain blood components) of platelets during the administration of acetylcysteine. The clinical significance of this effect is still unclear.
Remedies
Stop taking Acetylcysteineum Flegamina at the first sign of a hypersensitivity reaction (see above). In this case, contact your doctor.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.
Package contents and other information
Like any drug, this medication may cause side effects, although not everyone will experience them.
If you experience any of the following very rare (may occur less than 1 in 10,000 people) symptoms, discontinue Acetylcysteinum Flegamina and seek medical help immediately:
- severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome associated with temporary acetylcysteine intake. Symptoms include a rash, trouble swallowing or breathing, swelling of the lips, face, throat or tongue.
The following side effects may occur:
Uncommon (may occur less than 1 in 100 people):
- hypersensitivity reactions
- headache
- ringing in the ears (tinnitus)
- accelerated heartbeat
- vomiting, diarrhea, oral mucositis, abdominal pain, nausea
- allergic reactions: urticarial blisters, itching, rash, swelling of the skin and mucous membranes
- fever
- low blood pressure
Rare (may occur less than 1 in 1000 people):
- dyspnea, bronchospasm - mainly in patients with hyperreactive bronchial system in bronchial asthma
- heartburn
Very rarely (may occur less than 1 in 10,000 people):
- hypersensitivity reactions up to shock
- hemorrhage
Frequency unknown (frequency cannot be determined from available data):
- accumulation of water in the face (facial edema)
Immediately seek medical advice and immediately discontinue Acetylcysteinum Flegamina if new skin and mucous membrane lesions appear.
Do not continue treatment with Acetylcysteinum Flegamina.
Various studies have confirmed a reduction in aggregation (clumping of certain blood components) of platelets during the administration of acetylcysteine. The clinical significance of this effect is still unclear.
Remedies
Stop taking Acetylcysteineum Flegamina at the first sign of a hypersensitivity reaction (see above). In this case, contact your doctor.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.
6 Contents of the package and other information
What does the drug Acetylcysteinum Flegamina contain?
- The active substance of the drug is: acetylcysteine.
1 effervescent tablet contains 600 mg of acetylcysteine.
- Other ingredients of the drug are:
Citric acid, sodium bicarbonate, adipic acid, povidone K-25, aspartame (E 951), lemon flavor (contains maltodextrin, sucrose, gumarabic (E 414), triacetin (E 1518), alpha-tocopherol (E 307)).
What the drug Acetylcysteinum Flegamina looks like and what it contains in the package.
White to yellowish, round, effervescent tablets, flat and smooth on both sides, with a lemon fragrance.
The effervescent tablets are packaged in polypropylene tubes with a white polyethylene stopper containing a moisture absorbing agent (60% molecular sieve and 40% silica gel).
Acetylcysteinum Flegamina is available in packs of 10 effervescent tablets.
Important before use
What does the drug Acetylcysteinum Flegamina contain?
- The active substance of the drug is: acetylcysteine.
1 effervescent tablet contains 600 mg of acetylcysteine.
- Other ingredients of the drug are:
Citric acid, sodium bicarbonate, adipic acid, povidone K-25, aspartame (E 951), lemon flavor (contains maltodextrin, sucrose, gumarabic (E 414), triacetin (E 1518), alpha-tocopherol (E 307)).
What the drug Acetylcysteinum Flegamina looks like and what it contains in the package.
White to yellowish, round, effervescent tablets, flat and smooth on both sides, with a lemon fragrance.
The effervescent tablets are packaged in polypropylene tubes with a white polyethylene stopper containing a moisture absorbing agent (60% molecular sieve and 40% silica gel).
Acetylcysteinum Flegamina is available in packs of 10 effervescent tablets.
2 Information important before using Acetylcysteinum Flegamina.
When not to use the drug Acetylcysteinum Flegamina:
- if the patient is allergic to acetylcysteine or any of the other components of this drug (listed in section 6).
Due to the significant content of the active substance, the drug Acetylcysteinum Flegamina must not be used in children under 14 years of age. For this group of patients, medicines of adequate strength are available.
Warnings and precautions
Discuss with your doctor or pharmacist before taking Acetylcysteinum Flegamina.
- There are very rare reports of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome associated with the temporary intake of acetylcysteine.
If new skin and mucosal lesions appear, seek immediate medical attention and discontinue acetylcysteine.
- Caution should be exercised in patients with bronchial asthma or in patients with a history of gastric or duodenal ulcers, especially during the concomitant use of other drugs with irritating effects on the gastrointestinal mucosa.
- Caution should be exercised in patients with histamine intolerance. Long-term use in these patients should be avoided, as Acetylcysteinum Flegamina affects histamine metabolism and may lead to symptoms of intolerance (e.g. headache, nasal discharge, itching).
- The use of Acetylcysteinum Phlegamin, especially at the beginning of treatment, may cause mucus liquefaction, thus leading to an increase in the volume of bronchial secretions. If the patient is unable to expectorate sufficiently, the doctor will apply appropriate treatment.
Acetylcysteinum Flegamina and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take. This applies to all medications, including those purchased without a prescription.
Tell your doctor or pharmacist if you are taking any of the following medications:
- Drugs used to treat cough (cough suppressants), as they can cause dangerous accumulation of secretions due to disruption of the cough reflex.
- Activated charcoal, used to treat poisoning.
- Drugs used to treat bacterial infections (antibiotics), e.g. tetracycline, aminoglycosides, penicillins. For safety reasons, antibiotics should be taken separately, at intervals of at least two hours.
- Drugs used to treat attacks of angina pain; chest, neck and arm pressure (e.g., nitroglycerin).
Changes in laboratory test results
Acetylcysteine may affect salicylate determinations.
Acetylcysteine may affect the results of determination of ketone bodies in urine.
It is not recommended to dissolve Acetylcysteinum Flegamina with other drugs.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.
Pregnancy
Since there is insufficient experience with the use of acetylcysteine in pregnant women, Acetylcysteinum Flegamina should be used during pregnancy only if the attending physician deems it absolutely necessary.
Breastfeeding
There are no data on the secretion of acetylcysteine into human milk.
For this reason, Acetylcysteinum Flegamina should be used during breastfeeding only if the attending physician deems it absolutely necessary.
Driving and operating machinery
There is no evidence that acetylcysteine would have any effect on the ability to drive or operate machinery.
Acetylcysteinum Phlegamine contains sodium.
This medication contains 150 mg of sodium (the main component of table salt) in each effervescent tablet. This is equivalent to 7.65% of the maximum recommended daily dietary sodium intake in adults. This should be taken into account in patients controlling dietary sodium.
Acetylcysteinum Flegamina contains aspartame.
This drug contains 20 mg of aspartame in each effervescent tablet.
Aspartame is a source of phenylalanine. It can be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its abnormal excretion.
Acetylcysteinum Phlegamine contains sucrose and glucose (a component of maltodextrin).
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the drug.
Product identification
When not to use the drug Acetylcysteinum Flegamina:
- if the patient is allergic to acetylcysteine or any of the other components of this drug (listed in section 6).
Due to the significant content of the active substance, the drug Acetylcysteinum Flegamina must not be used in children under 14 years of age. For this group of patients, medicines of adequate strength are available.
Warnings and precautions
Discuss with your doctor or pharmacist before taking Acetylcysteinum Flegamina.
- There are very rare reports of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome associated with the temporary intake of acetylcysteine.
If new skin and mucosal lesions appear, seek immediate medical attention and discontinue acetylcysteine.
- Caution should be exercised in patients with bronchial asthma or in patients with a history of gastric or duodenal ulcers, especially during the concomitant use of other drugs with irritating effects on the gastrointestinal mucosa.
- Caution should be exercised in patients with histamine intolerance. Long-term use in these patients should be avoided, as Acetylcysteinum Flegamina affects histamine metabolism and may lead to symptoms of intolerance (e.g. headache, nasal discharge, itching).
- The use of Acetylcysteinum Phlegamin, especially at the beginning of treatment, may cause mucus liquefaction, thus leading to an increase in the volume of bronchial secretions. If the patient is unable to expectorate sufficiently, the doctor will apply appropriate treatment.
Acetylcysteinum Flegamina and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take. This applies to all medications, including those purchased without a prescription.
Tell your doctor or pharmacist if you are taking any of the following medications:
- Drugs used to treat cough (cough suppressants), as they can cause dangerous accumulation of secretions due to disruption of the cough reflex.
- Activated charcoal, used to treat poisoning.
- Drugs used to treat bacterial infections (antibiotics), e.g. tetracycline, aminoglycosides, penicillins. For safety reasons, antibiotics should be taken separately, at intervals of at least two hours.
- Drugs used to treat attacks of angina pain; chest, neck and arm pressure (e.g., nitroglycerin).
Changes in laboratory test results
Acetylcysteine may affect salicylate determinations.
Acetylcysteine may affect the results of determination of ketone bodies in urine.
It is not recommended to dissolve Acetylcysteinum Flegamina with other drugs.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.
Pregnancy
Since there is insufficient experience with the use of acetylcysteine in pregnant women, Acetylcysteinum Flegamina should be used during pregnancy only if the attending physician deems it absolutely necessary.
Breastfeeding
There are no data on the secretion of acetylcysteine into human milk.
For this reason, Acetylcysteinum Flegamina should be used during breastfeeding only if the attending physician deems it absolutely necessary.
Driving and operating machinery
There is no evidence that acetylcysteine would have any effect on the ability to drive or operate machinery.
Acetylcysteinum Phlegamine contains sodium.
This medication contains 150 mg of sodium (the main component of table salt) in each effervescent tablet. This is equivalent to 7.65% of the maximum recommended daily dietary sodium intake in adults. This should be taken into account in patients controlling dietary sodium.
Acetylcysteinum Flegamina contains aspartame.
This drug contains 20 mg of aspartame in each effervescent tablet.
Aspartame is a source of phenylalanine. It can be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its abnormal excretion.
Acetylcysteinum Phlegamine contains sucrose and glucose (a component of maltodextrin).
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the drug.
Acetylcysteinum Flegamina, 600 mg, effervescent tablets
acetylcysteinum
For adults and adolescents over 14 years of age
acetylcysteinum
For adults and adolescents over 14 years of age
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