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Package leaflet: Information for the patient

Acetylcysteine Hexal AG 100 mg effervescent tablets
For adults, adolescents and children over 2 years of age
Acetylcysteine Hexal AG 200 mg effervescent tablets
For adults, adolescents and children over 2 years of age
acetylcysteine
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

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 has told you to do.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, ask your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4-5 days.

Contents of this leaflet:

1. What Acetylcysteine Hexal AG is and what it is used for
2. What you need to know before taking Acetylcysteine Hexal AG
3. How to take Acetylcysteine Hexal AG
4. Possible side effects
5. How to store Acetylcysteine Hexal AG
6. Contents of the pack and other information

1. What Acetylcysteine Hexal AG is and what it is used for

Acetylcysteine Hexal AG contains the active substance acetylcysteine, which liquefies thick mucus in the airways.
100 mg:
Acetylcysteine Hexal AG 100 mg effervescent tablets are used to fluidify mucus and ease coughing in cold-induced bronchitis in children over 2 years of age, adolescents and adults.
200 mg:
Acetylcysteine Hexal AG 200 mg effervescent tablets are used to fluidify mucus and ease coughing in cold-induced bronchitis in children over 2 years of age, adolescents and adults.

2. What you need to know before taking Acetylcysteine Hexal AG

Do not take Acetylcysteine Hexal AG:

• if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6) 100 mg:
• if you are a child under 2 years of age 200 mg:
• if you are a child under 2 years of age
• as whole tablets in children aged between 2 and 5 years

Warnings and precautions
Talk to your doctor or pharmacist before taking Acetylcysteine Hexal AG if you have:

• skin and mucous membrane disorders Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported in association with the use of acetylcysteine. If new skin or mucosal lesions appear, consult a doctor immediately and discontinue use of acetylcysteine.
• bronchial asthma
• history (or current presence) of gastric or intestinal ulcers
• histamine hypersensitivity In these patients, long-term therapy should be avoided, as Acetylcysteine Hexal AG affects histamine metabolism and may cause intolerance symptoms (such as headache, runny nose, itching).
• inability to expectorate mucus.

Children
[100 mg:]
Due to the high content of active ingredient, Acetylcysteine Hexal AG is not recommended in children under 2 years of age.
[200 mg:]
Due to the high amount of active ingredient, Acetylcysteine Hexal AG is not recommended in children under 2 years of age, and whole tablets of Acetylcysteine Hexal AG are not recommended in children under 6 years of age.

Other medicines and Acetylcysteine Hexal AG
Interaction studies have been conducted only in adults.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important for:

• Cough suppressants The combined use of Acetylcysteine Hexal AG with cough suppressants may cause dangerous secretory congestion due to reduced cough reflex. Therefore, particularly careful diagnosis is required when using this combination. Consult your doctor before using these medicines together.
• Antibiotics Experimental studies show evidence that acetylcysteine may weaken the effect of certain antibiotics (tetracyclines, aminoglycosides, penicillins). For safety reasons, antibiotics should be taken separately, at least 2 hours apart from acetylcysteine. This does not apply to medicines containing the active ingredients cefixime or loracarbef, which may be taken concurrently with acetylcysteine.
• Activated charcoal at high doses
• Activated charcoal may reduce the effect of acetylcysteine.
• Glycerol trinitrate A medicine also known as nitroglycerin, used to dilate blood vessels. Your doctor should monitor you for possible reduction in blood pressure, which may be severe and accompanied by headache.
• Carbamazepine Acetylcysteine in combination with carbamazepine may reduce the effectiveness of carbamazepine due to decreased plasma levels of carbamazepine.

Laboratory tests
If you are scheduled for blood tests for any of the following, inform your doctor that you are taking Acetylcysteine Hexal AG; this medicine may affect the measurement of:

• salicylates: medicines used to treat pain, inflammation, or rheumatism
• urinary ketone bodies.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Since adequate experience with the use of acetylcysteine during pregnancy and breastfeeding is lacking, Acetylcysteine Hexal AG should be used during pregnancy and breastfeeding only if your doctor considers it absolutely necessary.

Driving and using machines
Acetylcysteine Hexal AG does not affect the ability to drive or operate machinery.

Acetylcysteine Hexal AG contains sorbitol, lactose, and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

100 mg:
This medicine contains up to 20 mg of sorbitol per effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
This medicine contains 75 mg of lactose per effervescent tablet. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains 4.2 mmol (96 mg) of sodium per effervescent tablet. This corresponds to 5% of the maximum daily intake of sodium recommended in the adult diet.

200 mg:
This medicine contains up to 20 mg of sorbitol per effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
This medicine contains 70 mg of lactose per effervescent tablet. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
One tablet contains 4.3 mmol (99 mg) of sodium per effervescent tablet. This corresponds to 5% of the maximum daily intake of sodium recommended in the adult diet.

3. How to take Acetylcysteine Hexal AG

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose, unless otherwise prescribed by the doctor, is:
100 mg:

200 mg:

Instructions for use
Dissolve the effervescent tablet in a glass of water and drink the entire contents of the glass after a meal.
It is not recommended to dissolve Acetylcysteine Hexal AG together with other medicines.
200 mg:
The effervescent tablet may be divided into two equal doses.
Duration of treatment
If symptoms worsen or do not improve after 4–5 days, you must consult your doctor.
Inform your doctor or pharmacist if you feel that the effect of Acetylcysteine Hexal AG is too strong or too weak.
If you take more Acetylcysteine Hexal AG than you should
In case of overdose, gastrointestinal and intestinal irritation may occur, such as abdominal pain, nausea, vomiting and diarrhoea.
To date, no severe adverse effects or signs of poisoning have been observed, even in cases of massive overdose. However, if an overdose of Acetylcysteine Hexal AG is suspected, you must inform your doctor.
If you forget to take Acetylcysteine Hexal AG
Do not take a double dose to make up for the forgotten dose. Simply take the next dose at the usual time.
If you have any questions about 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.

• Two serious side effects are severe skin reactions such as Stevens-Johnson syndrome (a painful red or purplish rash that spreads and leads to blistering) and/or Lyell's syndrome (lesions of the mucosa only, or lesions of both mucosa and skin including blister formation). These have been reported in temporal association with the use of acetylcysteine. In most of these reported cases, at least one additional drug that could potentially enhance the described mucocutaneous effects was taken concomitantly. If skin or mucosal abnormalities develop, consult a doctor immediately and discontinue the use of acetylcysteine.

Additionally, the following side effects may occur:
Uncommon side effects – may affect up to 1 in 100 people

• Allergic reactions (skin rash and swelling, itching, urticaria, shortness of breath, rapid heartbeat, and low blood pressure). These may be serious. Contact your doctor. Cases of swelling of the face, lips, and tongue may be life-threatening.
• Headache
• Fever
• Inflammation of the inner lining of the mouth
• Abdominal pain
• Nausea, vomiting
• Diarrhea
• Ringing or buzzing in the ears (tinnitus)
• Increased heart rate
• Decreased blood pressure

Rare – may affect up to 1 in 1,000 people

• Shortness of breath
• Bronchospasm, mainly in patients with bronchial hyperreactivity such as in bronchial asthma
• Indigestion. The main symptom is usually pain or discomfort in the upper part of the stomach (abdomen)

Very rare – may affect up to 1 in 10,000 users

• Bleeding
• Sudden rash, difficulty breathing, and fainting (within minutes or hours) due to hypersensitivity (severe allergic reaction including anaphylactic shock). This may be life-threatening.
• Drowsiness
• Stevens-Johnson syndrome or Lyell's syndrome: severe skin reaction (lesions of the mucosa only, or lesions of both mucosa and skin including blister formation) in temporal association with the use of acetylcysteine. Therefore, if skin or mucosal abnormalities develop, consult a doctor immediately and discontinue the use of acetylcysteine.

Not known – frequency cannot be established from available data

• Swelling of facial tissues due to fluid accumulation

Numerous studies have shown a reduction in platelet aggregation (clumping of certain blood components) during the use of acetylcysteine. The clinical significance of this is not yet clear.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acetylcysteine Hexal AG

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 and on the tube or
on the sachet, after Exp. The expiry date refers to the last day of the month.
100 mg, 200 mg:
Tube: do not store above 25°C.
Keep the tube tightly closed to protect the medicine from moisture.
Sachets: do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Acetilcisteina Hexal AG contains
The active substance is acetylcysteine.
Each effervescent tablet contains 100 mg of acetylcysteine.
Each effervescent tablet contains 200 mg of acetylcysteine.
The other components are anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, mannitol, anhydrous lactose, ascorbic acid, sodium citrate, sodium saccharin, blackberry flavour “B” (containing vanillin, maltodextrin, mannitol (E 421), glucono delta-lactone (E 575), sorbitol (E 420), magnesium carbonate (E 504 II), anhydrous colloidal silica (E 551)).

Description of the appearance of Acetilcisteina Hexal AG and contents of the pack
100 mg:
Round, white, smooth effervescent tablets with blackberry flavour.
200 mg:
Round, white, smooth effervescent tablets with a break line on one side and blackberry flavour.
The effervescent tablets are packed in polypropylene tubes closed with a polyethylene cap containing a desiccant (molecular sieve), or in sachets made of PAP/Al/PE and placed in a cardboard box.
Pack sizes:
Tube: 20 effervescent tablets
Sachets: 20, 40, 50, 80, 100 effervescent tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
HEXAL AG
Industriestrasse 25, D-83607 Holzkirchen, Germany
Representative in Italy:
Sandoz S.p.A.
L.go U. Boccioni 1, 21040 Origgio (VA)

Responsible manufacturer for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
100 mg:
Germany Acetylcystein HEXAL 100 mg Brausetabletten
Bulgaria AЦЦ 100 MG ЕФЕРВЕСЦЕНТНИ ТАБЛЕТКИ
Italy Acetilcisteina Hexal AG
Romania ACC 100 mg comprimate efervescente

200 mg:
Belgium Acetylcysteïn Sandoz 200 mg bruistabletten
Bulgaria AЦЦ 200 MG ЕФЕРВЕСЦЕНТНИ ТАБЛЕТКИ
Germany Acetylcystein HEXAL 200 mg Brausetabletten
Italy Acetilcisteina Hexal AG
Romania ACC 200 mg comprimate efervescente

Package leaflet: Information for the patient

Acetylcysteine Hexal AG 600 mg effervescent tablets
For adults and adolescents over 14 years of age
Acetylcysteine
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Acetylcysteine Hexal AG is and what it is used for
2. What you need to know before taking Acetylcysteine Hexal AG
3. How to take Acetylcysteine Hexal AG
4. Possible side effects
5. How to store Acetylcysteine Hexal AG
6. Contents of the pack and other information

1. What Acetilcisteina Hexal AG is and what it is used for

Acetilcisteina Hexal AG contains the active substance acetylcysteine, which liquefies thick mucus in the airways.
Acetilcisteina Hexal AG is used to fluidify mucus and facilitate coughing in cold-induced bronchitis in adolescents over 14 years of age and adults.

2. What you need to know before taking Acetilcisteina Hexal AG

Do not take Acetilcisteina Hexal AG:

• if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6)
• if you are a child/adolescent under 14 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Acetilcisteina Hexal AG if you have:

• skin and mucous membrane disorders Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported in association with the use of acetylcysteine. If new skin or mucosal lesions appear, consult a doctor immediately and discontinue use of acetylcysteine.
• bronchial asthma
• history (or current presence) of gastric or intestinal ulcers
• histamine hypersensitivity In these patients, long-term treatment should be avoided, as Acetilcisteina Hexal AG affects histamine metabolism and may cause intolerance symptoms (such as headache, runny nose, itching).
• inability to expectorate mucus.

Children
Due to the high content of active substance, Acetilcisteina Hexal AG is not recommended in children and adolescents under 14 years of age. For these patients, other pharmaceutical forms with a lower content of active substance are available.
Other medicines and Acetilcisteina Hexal AG
Interaction studies have been conducted only in adults.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important for:

• Cough suppressants The combined use of Acetilcisteina Hexal AG with cough suppressants may cause dangerous secretory congestion due to reduced cough reflex. Therefore, particularly careful diagnosis is required when combining these treatments. Consult your doctor before using this combination of medicines.
• Antibiotics Experimental studies show evidence that acetylcysteine may weaken the effect of certain antibiotics (tetracyclines, aminoglycosides, penicillins). For safety reasons, antibiotics should be taken separately, at least 2 hours apart from acetylcysteine. This does not apply to medicines containing the active substances cefixime or loracarbef, which may be taken concurrently with acetylcysteine.
• Activated charcoal at high doses Activated charcoal may reduce the effect of acetylcysteine.
• Glyceryl trinitrate: A medicine also known as nitroglycerin, used to dilate blood vessels. Your doctor should monitor you for possible hypotension, which may be severe and manifest as headache.
• Carbamazepine Acetylcysteine in combination with carbamazepine may reduce the effectiveness of carbamazepine due to decreased plasma levels of carbamazepine.

Laboratory tests
If you are scheduled for a blood test for any of the following, inform your doctor that you are taking Acetilcisteina Hexal AG; this medicine may affect the measurement of:

• salicylates: medicines used to treat pain, inflammation or rheumatism
• urinary ketone bodies.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Since adequate experience with the use of acetylcysteine during pregnancy and breastfeeding is not available, Acetilcisteina Hexal AG should be used during pregnancy and breastfeeding only if your doctor considers it absolutely necessary.
Driving and using machines
Acetilcisteina Hexal AG does not impair the ability to drive or operate machinery.
Acetilcisteina Hexal AG contains sorbitol, lactose and sodium
This medicine contains up to 40 mg of sorbitol per effervescent tablet.
This medicine contains 70 mg of lactose per effervescent tablet. If your doctor has diagnosed intolerance to certain sugars, contact them before taking this medicine.
This medicine contains 6.03 mmol (139 mg) of sodium per effervescent tablet.
This corresponds to 7% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to take Acetilcisteina Hexal AG

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose, unless otherwise prescribed by the doctor, is:

Instructions for use
Dissolve the effervescent tablet in a glass of water and drink the entire contents of the glass after a meal.
It is not recommended to dissolve Acetylcysteine Hexal AG together with other medicines.
The effervescent tablet may be divided into two equal doses.

Duration of treatment
If symptoms worsen or do not improve after 4–5 days, consult your doctor.
Inform your doctor or pharmacist if you feel that the effect of Acetylcysteine Hexal AG is too strong or too weak.

If you take more Acetylcysteine Hexal AG than you should
In case of overdose, gastrointestinal and intestinal irritation may occur, such as abdominal pain, nausea, vomiting, and diarrhoea.
To date, no severe adverse effects or symptoms of poisoning have been observed, even in cases of massive overdose. However, if an overdose with Acetylcysteine Hexal AG is suspected, you must inform your doctor.

If you forget to take Acetylcysteine Hexal AG
Do not take a double dose to make up for the missed dose. Simply take the next dose at your usual time.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• Two serious side effects are severe skin reactions such as Stevens-Johnson syndrome (a painful red or purplish rash that spreads and leads to blistering) and/or Lyell's syndrome (mucosal lesions only, or both mucosal and skin lesions including blister formation). These have been reported in temporal association with the use of acetylcysteine. In most of these reported cases, at least one additional drug that could potentially exacerbate the described mucocutaneous effects was taken concomitantly. If you develop abnormalities of the skin or mucous membranes, consult a doctor immediately and discontinue the use of acetylcysteine.

Additionally, the following side effects may occur:
Uncommon side effects, affecting up to 1 in 100 people

• Allergic reactions (skin rash and swelling, itching, hives, shortness of breath, rapid heartbeat, and low blood pressure). These can be serious. Contact your doctor. Cases of swelling of the face, lips, and tongue may be life-threatening.
• Headache
• Fever
• Inflammation of the inner lining of the mouth
• Abdominal pain
• Nausea, vomiting
• Diarrhea
• Ringing or buzzing in the ears (tinnitus)
• Increased heart rate
• Low blood pressure

Rare, affecting up to 1 in 1,000 people

• Shortness of breath
• Bronchospasm, mainly in patients with bronchial hyperreactivity such as bronchial asthma
• Indigestion. The main symptom is usually pain or discomfort in the upper part of the stomach (abdomen)

Very rare, affecting up to 1 in 10,000 people

• Bleeding
• Sudden rash, difficulty breathing, and fainting (within minutes or hours) due to hypersensitivity (severe allergic reaction including anaphylactic shock). This can be life-threatening.
• Drowsiness
• Stevens-Johnson syndrome or Lyell's syndrome: severe skin reaction (mucosal lesions only, or both mucosal and skin lesions including blister formation) in temporal association with acetylcysteine use. Therefore, if abnormalities of the skin or mucous membranes develop, consult a doctor immediately and discontinue the use of acetylcysteine.

Not known: frequency cannot be estimated from the available data

• Swelling of facial tissues caused by fluid accumulation

Numerous studies have shown a reduction in platelet aggregation (clumping of certain blood components) during the use of acetylcysteine. The clinical significance of this is not yet clear.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acetylcysteine Hexal AG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the tube or
sachet, after Exp.. The expiry date refers to the last day of the month.
Tube: Keep the container tightly closed to protect the medicine from moisture.
Sachets: This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Acetilcisteina Hexal AG contains
The active substance is acetylcysteine.
Each effervescent tablet contains 600 mg of acetylcysteine.
The other ingredients are anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, mannitol, anhydrous lactose, ascorbic acid, sodium cyclamate, sodium saccharin, sodium citrate, blackberry flavour “B” (containing vanillin, maltodextrin, mannitol (E 421), glucono delta-lactone (E 575), sorbitol (E 420), magnesium carbonate (E 504 II), colloidal anhydrous silica (E 551)).

Description of the appearance of Acetilcisteina Hexal AG and the contents of the pack
White, round, smooth effervescent tablets with a break line on one side and a blackberry flavour.

• The effervescent tablets are packed in polypropylene tubes closed with a polyethylene cap containing a desiccant (silica gel and molecular sieve), or packed in pouches made of PAP/AL/PE and placed in a cardboard box.
  Pack sizes:
  Tubes: 10, 20, 30, 60 effervescent tablets
  Pouches: 10, 20, 30, 50, 60 effervescent tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
HEXAL AG
Industriestrasse 25, D-83607 Holzkirchen, Germany
Representative for Italy:
Sandoz S.p.A.
L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturer responsible for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium Acetylcysteïn Sandoz 600 mg effervescent tablets
Bulgaria AЦЦ 600 MG ЕФЕРВЕСЦЕНТНИ ТАБЛЕТКИ
Germany Acetylcystein HEXAL 600 mg Brausetabletten
Greece ACC 600 mg αναβράζοντα δισκία
Italy Acetilcisteina Hexal AG
Romania ACC 600 mg effervescent tablets