Package leaflet: Information for the patient

Acetylcysteine Hexal A/S 600 mg powder for oral solution
For adults and adolescents aged over 14 years
Equivalent medicine
Please read this leaflet carefully before 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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Acetylcysteine Hexal A/S is and what it is used for
What you need to know before taking Acetylcysteine Hexal A/S
How to take Acetylcysteine Hexal A/S
Possible side effects
How to store Acetylcysteine Hexal A/S
Contents of the pack and other information

1. What Acetylcysteine Hexal A/S is and what it is used for

Acetylcysteine Hexal A/S contains the active substance acetylcysteine, which liquefies thick mucus in the airways.
Acetylcysteine Hexal A/S 600 mg powder for oral solution is used to liquefy mucus and ease coughing in respiratory diseases associated with thick mucus in adolescents from the age of 14 and in adults.

2. What you need to know before taking Acetylcysteine Hexal A/S

Do not take Acetylcysteine Hexal A/S:

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
If you are a child under 2 years of age
If you are a child or adolescent under 14 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Acetylcysteine Hexal A/S 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 skin or mucous membrane lesions occur, consult a doctor immediately and discontinue the use of acetylcysteine.
Bronchial asthma
Current or past gastric or intestinal ulcers
Histamine hypersensitivity

In these patients, long-term therapy should be avoided, as Acetylcysteine Hexal A/S
affects histamine metabolism and may cause intolerance symptoms (such as headache, runny nose, itching).

Inability to expectorate mucus

Mixing acetylcysteine formulations with other medicines is not recommended.
Children
Acetylcysteine Hexal A/S 600 mg oral solution powder is not recommended in adolescents
under 14 years of age (due to the high content of active substance). For these patients, other
medicines with a lower active substance content are available.
Other medicines and Acetylcysteine Hexal A/S
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 acetylcysteine with cough-suppressing agents may cause dangerous secretory congestion due to reduced cough reflex. Therefore, particularly careful diagnosis is required when combining treatments. It is mandatory to consult your doctor before using this combination.
Antibiotics Experimental studies show evidence that acetylcysteine may weaken the effects 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
Glyceryl trinitrate: a medicine also known as nitroglycerin, used to dilate blood vessels. Your doctor will monitor you for possible hypotension, which may be severe and accompanied by headache.

Laboratory tests
Inform your doctor that you are taking Acetylcysteine Hexal A/S if you are scheduled for any of
the following blood tests, as 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,
please 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 A/S should be used during pregnancy and
breastfeeding only if your doctor considers it absolutely necessary.
Driving and using machines
It is not known whether Acetylcysteine Hexal A/S impairs the ability to drive or use machines.
Acetylcysteine Hexal A/S contains sucrose and sodium
This medicine contains less than 2.0 g of sucrose per sachet. Patients with rare hereditary
fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency
must not take this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to take Acetylcysteine Hexal A/S

Take this medicine exactly 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:
Adults and adolescents aged 14 years and older: one sachet once daily.
Method of administration
After a meal, dissolve Acetylcysteine Hexal A/S in at least half a glass of cold water, then fill the glass with hot, but not boiling water. Mix the solution and drink as soon as the temperature is acceptable. Caution: always add hot water to the cold water, not the other way around. The reconstituted solution must be taken immediately after preparation.
Duration of use
If symptoms worsen or do not improve after 4–5 days, consult your doctor.
Note:
The possible presence of a sulfurous odor does not indicate product deterioration, but is a characteristic of the active substance contained in this preparation.
If you take more Acetylcysteine Hexal A/S than you should
In case of overdose, gastrointestinal and intestinal irritation may occur, such as abdominal pain, nausea, vomiting, diarrhea.
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 A/S is suspected, you should inform your doctor.
If you forget to take Acetylcysteine Hexal A/S
Do not take a double dose to make up for the forgotten dose. Simply take the next dose at the usual time.
If you stop taking Acetylcysteine Hexal A/S
Do not stop taking Acetylcysteine Hexal A/S prescribed by your doctor unless instructed to do so by your doctor, as this may reduce the effectiveness of the treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Acetilcisteina Hexal A/S can cause side effects, although not everybody gets them.
The following side effects may occur:

Uncommon side effects, may affect up to 1 in 100 people
Hypersensitivity reactions indicated by:

Headache
Fever
Inflammation of the inner lining of the mouth
Ringing or buzzing in the ears
Rapid heartbeat
Decreased blood pressure
Itching, hives, skin rash
Generalized skin rash
Severe and mainly painful swelling of the deep layers of the skin, mainly in the face
Abdominal pain
Nausea, vomiting
Diarrhea

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

Shortness of breath
Bronchospasm, mainly in patients with bronchial hyperreactivity in the presence of 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 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.
Stevens-Johnson syndrome or Lyell’s syndrome: severe skin reaction (mucosal lesions only, or mucosal and skin lesions including blistering), occurring temporally after use of acetylcysteine. If skin or mucosal abnormalities develop, it is therefore advisable to immediately consult a doctor and discontinue acetylcysteine use.

Not known: frequency cannot be estimated from the available data

Facial tissue swelling due to excess fluid
Reduced platelet aggregation in the blood

Reporting of side effects
If you experience any side effect, 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 A/S

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 sachet and the outer carton after
Exp.. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The reconstituted solution must be used immediately after preparation.
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 A/S contains
The active substance is acetylcysteine.
Each sachet contains 600 mg of acetylcysteine.
The other components are sucrose, ascorbic acid (E 300), sodium saccharin, lemon flavour, honey flavour.

Description of the appearance of Acetilcisteina Hexal A/S and the contents of the pack
White, homogeneous powder with a lemon/honey odour.
The oral solution powder is packed in polyethylene-aluminium-paper sachets placed in a cardboard box.
Each sachet contains 3 g of powder.
Pack sizes: 6, 10, 20, 30, 60, 90 sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Hexal A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark
Representative for 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:
Germany: Acetylcystein HEXAL 600 mg powder for oral solution
Austria: Husten ACC Hexal akut 600 mg - powder for oral solution
Belgium: Acetylcysteïn Sandoz 600 mg powder for oral solution
Estonia: ACC
Greece: ACC 600 mg κόνις για πόσιμο διάλυμα
Italy: Acetilcisteina Hexal A/S
Lithuania: ACC 600 mg milteliai geriamajam tirpalui
Slovenia: Fluimukan 600 mg powder for oral solution with honey and lemon flavour