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Treść ulotki

1. What is Acetilcisteina Hexal AG and what is it used for
2. What you need to know before taking Acetilcisteina Hexal AG
3. How to take Acetilcisteina Hexal AG
4. Possible side effects
5. How to store Acetilcisteina Hexal AG
6. Package Contents and Other Information
7. What is Acetilcisteina Hexal AG and what is it used for?
8. What you need to know before you take Acetilcisteina Hexal AG
9. How to take Acetilcisteina Hexal AG
10. Possible side effects
11. How to store Acetilcisteina Hexal AG
12. Package Contents and Other Information

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

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Read this leaflet carefully before you start taking this medicine as 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.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if you feel worse 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 you take 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 is Acetilcisteina Hexal AG and what is it used for

Acetilcisteina Hexal AG contains the active ingredient acetylcysteine, which liquefies viscous mucus
in the airways.

100 mg:
Acetilcisteina Hexal AG 100 mg effervescent tablets are used to liquefy the
mucusand facilitate coughingin cases of cold-induced bronchitis in children over 2 years of age,
adolescents and adults.

200 mg:
Acetilcisteina Hexal AG 200 mg effervescent tablets are used to liquefy the
mucusand facilitate coughingin cases of cold-induced bronchitis in children over 2 years of age,
adolescents and adults.

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

Do not take Acetilcisteina Hexal AG:

• if you are allergicto 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 age200 mg:
• if you are a child under 2 years of age
• as whole tablets in the case of children from 2 to 5 years of age

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

• skin and mucous membrane changesVery rarely, the occurrence of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, has been reported in association with the use of acetylcysteine. If new skin and mucosal changes occur, consult a doctor immediately and stop using acetylcysteine.
• bronchial asthma
• a history (or current presence) of gastric or intestinal ulcers
• Hypersensitivity to histamineIn these patients, long-term therapy should be avoided, as Acetilcisteina Hexal AG influences histamine metabolism and can cause symptoms of intolerance (such as headache, runny nose, itching).
• inability to expectorate mucus.

Children

[100 mg:]
Due to the high active ingredient content, Acetilcisteina Hexal AG is not
recommended in children under 2 years of age.

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

Other medicines and Acetilcisteina Hexal AG
Interaction studies have only been conducted in adults.
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This applies in particular to:

• Cough suppressantsThe combined use of Acetilcisteina Hexal AG with cough suppressants can cause dangerous secretory congestion due to a reduction in the cough reflex. Therefore, a particularly careful diagnosis is necessary for this combination treatment. Consult your doctor before using this combination of medicines.
• AntibioticsExperimental studies show evidence of a weakening effect of antibiotics (tetracyclines, aminoglycosides, penicillins) due to acetylcysteine. For safety reasons, antibiotics should be taken separately and at least 2 hours apart. This does not apply to medicines containing the active ingredients cefixime or loracarbef, which can be taken concurrently with acetylcysteine.
• High-dose activated charcoal
• Activated charcoal can reduce the effect of acetylcysteine
• TrinitroglycerinA medicine also known as nitroglycerin, used to widen blood vessels. Your doctor should monitor you for a possible decrease in blood pressure, which may be severe and indicated by headache.
• CarbamazepineAcetylcysteine in combination with carbamazepine may decrease the effectiveness of carbamazepine due to a decrease in plasma carbamazepine levels.

Laboratory tests
If you are to undergo a blood test for the following, inform your doctor that
you are taking Acetilcisteina Hexal AG; this medicine can affect the determination
of:

• salicylates: medicines used to treat pain, inflammation or rheumatism
• ketone bodies in the urine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Since there is no adequate experience with the use of acetylcysteine during
pregnancy and breastfeeding, you should only use Acetilcisteina Hexal AG during pregnancy and
breastfeeding if your treating doctor considers it absolutely necessary.

Driving and using machines
Acetilcisteina Hexal AG does not impair the ability to drive or operate machines.

Acetilcisteina Hexal AG contains sorbitol, lactose and sodium
If your doctor has diagnosed you with intolerance to certain sugars, contact him 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 your child) are intolerant to
certain sugars, or if you have a diagnosis of hereditary fructose intolerance (HFI), a rare
genetic disease in which patients cannot metabolize fructose, talk to your doctor
before you (or your child) take this medicine.
This medicine contains 75 mg of lactose per effervescent tablet. If your doctor has
diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains 4.2 mmol (96 mg) of sodium per effervescent tablet. This
is equivalent to 5% of the maximum recommended daily intake with the diet of an
adult.

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 your child) are intolerant to
certain sugars, or if you have a diagnosis of hereditary fructose intolerance (HFI), a rare
genetic disease in which patients cannot metabolize fructose, talk to your doctor
before you (or your child) take this medicine.
This medicine contains 70 mg of lactose per effervescent tablet. If your doctor has
diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.
One tablet contains 4.3 mmol (99 mg) of sodium per effervescent tablet. This
is equivalent to 5% of the maximum recommended daily intake with the diet of an
adult

3. How to take Acetilcisteina Hexal AG

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

100 mg:

200 mg:

Method of administration
Dissolve the effervescent tablet in a glass of water and drink the entire contents of the glass immediately
after a meal.
Dissolving Acetilcisteina Hexal AG with other medicines is not recommended.

200 mg:
The effervescent tablet can be divided into two equal doses.

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

If you take more Acetilcisteina Hexal AG than you should
In case of overdose, irritation in the gastrointestinal tract may occur, such as
abdominal pain, nausea, vomiting, diarrhea.
Serious adverse effects or symptoms of intoxication have not been observed so far, even
in the case of massive overdose. However, if you suspect an overdose with
Acetilcisteina Hexal AG, it is necessary to inform your doctor.

If you forget to take Acetilcisteina Hexal AG
Do not take a double dose to make up for a missed dose. Simply take the next dose at the usual time.
If you have any doubts 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 everyone gets them.

• Two serious side effects are severe skin reactions such as Stevens-Johnson syndrome (painful red or purplish rash that spreads and leads to blistering) and/or Lyell's syndrome (skin and mucous membrane damage including blistering). These have been reported in temporal association with the use of acetylcysteine. In most of these reported cases, at least one additional medicine that could potentially intensify the described mucocutaneous effects was taken simultaneously. If skin or mucous membrane abnormalities develop, consult a doctor immediately and stop using acetylcysteine.

In addition, the following side effects may occur:

Uncommon side effects, may affect up to 1 in 100 people

• allergic reactions (skin rashes 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 can be life-threatening.
• headache
• fever
• inflammation of the lining of the mouth
• abdominal pain
• nausea, vomiting
• diarrhoea
• ringing or buzzing in the ears (tinnitus)
• fast heartbeat
• low blood pressure

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

• Shortness of breath
• Bronchospasm, predominantly in patients with bronchial hyperreactivity in the presence of bronchial asthma
• Indigestion. The main symptom is generally pain or discomfort in the upper abdomen (stomach)

Very rare, may affect up to 1 user in 10,000

• 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-Johnsons syndrome or Lyell's syndrome: severe skin reaction (skin and mucous membrane damage including blistering) in temporal association with the use of acetylcysteine. If skin or mucous membrane abnormalities develop, you should therefore consult a doctor immediately and stop using acetylcysteine,

Not known: the frequency cannot be estimated based on the available data

• swelling of the facial tissues, caused by excess fluid

Numerous studies have shown a reduction in platelet aggregation (aggregation of certain blood components) during the use of acetylcysteine. The clinical significance of this is not yet clear.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 Acetilcisteina 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 pack and on the tube or
sachet, after Exp. The expiry date refers to the last day of the month.

100 mg, 200 mg:
Tube: do not store at a temperature above 25°C.
Keep the tube tightly closed to protect the medicine from moisture.
Sachets: do not store at a temperature above 30°C.
Do not dispose of any medicine in 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 ingredient is acetylcysteine.
Each effervescent tablet contains 100 mg of acetylcysteine.
Each effervescent tablet contains 200 mg of acetylcysteine.
The other ingredients are anhydrous citric acid, sodium hydrogen carbonate, sodium carbonate
anhydrous, mannitol, anhydrous lactose, ascorbic acid, sodium citrate, sodium saccharin, aroma
of blackberry “B” (contains vanillin, maltodextrin, mannitol (E 421), gluconolactone (E 575),
sorbitol (E 420), magnesium carbonate (E 504 II), colloidal anhydrous silica (E 551)).

Description of the appearance of Acetilcisteina Hexal AG and package contents

100 mg:
Round, white, smooth tablets with a blackberry aroma.

200 mg:
Round, white, smooth tablets, with a fracture line on one side and a blackberry aroma.
The effervescent tablets are packaged in polypropylene tubes closed with a polyethylene cap equipped with a desiccant (molecular sieve) or are packaged in
PAP/Al/PE sachets and inserted into a cardboard box.
Package sizes:
Tube: 20 effervescent tablets
Sachets: 20, 40, 50, 80, 100 effervescent tablets
Not all package sizes may be marketed.

Marketing Authorisation Holder
HEXAL AG
Industriestrasse25, 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 designations:
100 mg :

GermanyAcetylcystein HEXAL 100 mg Brausetabletten

BulgariaAЦЦ 100 MG ЕФЕРВЕСЦЕНТНИ ТАБЛЕТКИ

ItalyAcetilcisteina Hexal AG

RomaniaACC 100 mg comprimate efervescente
200 mg

BelgiumAcetylcysteïn Sandoz 200 mg bruistabletten

BulgariaAЦЦ 200 MG ЕФЕРВЕСЦЕНТНИ ТАБЛЕТКИ

GermanyAcetylcystein HEXAL 200 mg Brausetabletten

ItalyAcetilcisteina Hexal AG

RomaniaACC 200 mg comprimate efervescente

Acetilcisteina Hexal AG 600 mg effervescent tablets
For adults and adolescents over 14 years of age
acetylcysteine
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Acetilcisteina Hexal AG contains the active ingredient acetylcysteine, which liquefies viscous mucus in the airways.
Acetilcisteina Hexal AG is used to thin mucusand facilitate coughingin cases of
cold-induced bronchitis in adolescents over 14 years of age and in adults.

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

Do not take Acetilcisteina Hexal AG:

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

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

• skin and mucous membrane alterationsVery rarely, the occurrence of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, has been reported in association with the use of acetylcysteine. If new skin and mucosal alterations occur, consult a doctor without delay and stop using acetylcysteine.
• bronchial asthma
• a history (or current presence) of gastric or intestinal ulcers
• Hypersensitivity to histamineIn these patients, long-term therapy should be avoided, as Acetilcisteina Hexal AG influences histamine metabolism and may cause symptoms of intolerance (such as headache, runny nose, itching).
• inability to expectorate mucus.

Children
Due to the high active ingredient content, Acetilcisteina Hexal AG is not
recommended for children and adolescents under 14 years of age. Other pharmaceutical forms, with a lower active ingredient content, are available for these patients.

Other medicines and Acetilcisteina Hexal AG
Interaction studies have only been conducted in adults.
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This applies in particular to:

• Cough sedativesThe combined use of Acetilcisteina Hexal AG with cough sedatives may cause a dangerous secretory congestion due to a reduction in the cough reflex. A particularly accurate diagnosis is therefore necessary for this combination treatment. Consult your doctor before using this combination of medicines.
• AntibioticsExperimental studies show evidence of a weakening effect of antibiotics (tetracyclines, aminoglycosides, penicillins) due to acetylcysteine. For safety reasons, antibiotics should be taken separately and at least 2 hours apart. This does not apply to medicines containing the active ingredients cefixime or loracarbef, which can be taken concurrently with acetylcysteine.
• High-dose activated charcoalActivated charcoal may reduce the effect of acetylcysteine
• Trinitroglycerin:A medicine also known as nitroglycerin, used to widen blood vessels. Your doctor should monitor you for a possible reduction in blood pressure, which may be severe and indicated by headache.
• CarbamazepineAcetylcysteine in combination with carbamazepine may decrease the effectiveness of carbamazepine due to a decrease in plasma carbamazepine levels.

Laboratory tests
If you are to undergo a blood test for the following, tell your doctor that
you are taking Acetilcisteina Hexal AG; this medicine may affect the determination
of:

• salicylates: medicines used to treat pain, inflammation or rheumatism
• ketone bodies in the urine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Since there is no adequate experience with the use of acetylcysteine during
pregnancy and breastfeeding, you should only use Acetilcisteina Hexal AG during pregnancy and
breastfeeding if your treating 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 you as having intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains 6.03 mmol (139mg) of sodium per effervescent tablet.
This is equivalent to 7% of the recommended daily intake of sodium with the diet
of an adult.

3. How to take Acetilcisteina Hexal AG

Take this medicine following exactly as indicated 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 your doctor, is:

Method of use
Dissolve the effervescent tablet in a glass of water and drink the entire contents of the glass immediately
after a meal.
It is not recommended to dissolve Acetilcisteina Hexal AG with other medicines.
The effervescent tablet can be divided into two equal doses.

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

If you take more Acetilcisteina Hexal AG than you should
In case of overdose, irritation may occur in the gastrointestinal tract, such as
abdominal pain, nausea, vomiting, diarrhea.
So far, no serious adverse effects or symptoms of intoxication have been observed, even
in the case of massive overdose. However, if you suspect an overdose with
Acetilcisteina Hexal AG, you must inform your doctor.

If you forget to take Acetilcisteina Hexal AG
Do not take a double dose to make up for a missed dose. Simply take the next dose at the usual time.
If you have any doubts about using this medicine, ask 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 (painful red or purple rash that spreads and leads to blistering) and/or Lyell's syndrome (skin and mucous membrane lesions including blistering). 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 intensify the described mucocutaneous effects was taken simultaneously. If skin or mucous membrane abnormalities develop, consult a doctor immediately and stop using acetylcysteine.

In addition, the following side effects may occur:

Uncommon side effects, may affect 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. Swelling of the face, lips and tongue can be life-threatening.
• headache
• fever
• inflammation of the inner lining of the mouth
• abdominal pain
• nausea, vomiting
• diarrhoea
• ringing or buzzing in the ears (tinnitus)
• fast heartbeat
• low blood pressure

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

• Shortness of breath
• Bronchospasm, predominantly in patients with bronchial hyperreactivity in the presence of bronchial asthma
• Indigestion. The main symptom is generally pain or discomfort in the upper part of the abdomen

Very rare, may affect up to 1 in 10,000 people

• Bleeding
• Sudden skin 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 (skin and mucous membrane lesions including blistering) in temporal association with the use of acetylcysteine. If skin or mucous membrane abnormalities develop, a doctor should therefore be consulted immediately and the use of acetylcysteine should be stopped.

Not known: frequency cannot be estimated based on available data

• swelling of the facial tissues, caused by excess fluid

Numerous studies have shown a decrease in platelet aggregation
(aggregation of certain blood components) during the use of acetylcysteine. The clinical
significance of this is not yet clear.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 Acetilcisteina 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 package and on the tube or
sachet, after Scad.. 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 particular storage temperature
Do not dispose of any medicine in 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 Acetylcysteine Hexal AG contains
The active ingredient is acetylcysteine.
Each effervescent tablet contains 600 mg of acetylcysteine.
The other components are anhydrous citric acid, sodium hydrogen carbonate, sodium carbonate
anhydrous, mannitol, anhydrous lactose, ascorbic acid, sodium cyclamate, saccharin
sodium citrate, blackberry aroma “B” (contains vanillin, maltodextrin, mannitol (E
421), gluconolactone (E 575), sorbitol (E 420), magnesium carbonate (E 504 II), colloidal anhydrous silica (E 551),).

Description of the appearance of Acetylcysteine Hexal AG and package contents
Round, white, smooth tablets, with a fracture line on one side and a blackberry aroma.

• The effervescent tablets are packaged in polypropylene tubes closed with a polyethylene cap equipped with a desiccant (silica gel and molecular sieve) or are packaged in PAP/AL/PE sachets and inserted into a cardboard box. Package sizes: Tube: 10, 20, 30, 60 effervescent tablets Sachets: 10, 20, 30, 50, 60 effervescent tablets

Not all package sizes may be marketed.

Marketing Authorisation Holder
HEXAL AG
Industriestrasse25, 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 with the
following denominations:
BelgiumAcetylcysteine Sandoz 600 mg effervescent tablets

BulgariaAЦЦ 600 MG ЕФЕРВЕСЦЕНТНИ ТАБЛЕТКИ

GermanyAcetylcystein HEXAL 600 mg effervescent tablets

GreeceACC 600 mg effervescent tablets

ItaliaAcetilcisteina Hexal AG

RomaniaACC 600 mg effervescent tablets