Patient Information Leaflet: Information for the User

ACETILCISTEINA ZENTIVA LAB 600 mg effervescent tablets

N-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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ACETILCISTEINA ZENTIVA LAB is and what it is used for
What you need to know before taking ACETILCISTEINA ZENTIVA LAB
How to take ACETILCISTEINA ZENTIVA LAB
Possible side effects
How to store ACETILCISTEINA ZENTIVA LAB
Contents of the pack and other information

1. What ACETILCISTEINA ZENTIVA LAB is and what it is used for

ACETILCISTEINA ZENTIVA LAB contains the active substance acetylcysteine, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract, and to a group of medicines called antidotes, used to counteract the toxic effects of certain substances.
ACETILCISTEINA ZENTIVA LAB is indicated for the treatment of respiratory diseases characterised by increased production of thick and viscous mucus (dense and viscous hypersecretion), such as:

inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
lung alveolar disease (pulmonary emphysema);
cystic fibrosis (mucoviscidosis);
bronchiectasis.

ACETILCISTEINA ZENTIVA LAB is used as an antidote particularly for:

accidental or intentional poisoning with paracetamol, an anti-inflammatory medicine;
urinary tract disorders (uropathy) caused by chemotherapeutic medicines such as ifosfamide and cyclophosphamide.

2. What you need to know before taking ACETILCISTEINA ZENTIVA LAB

Do not take ACETILCISTEINA ZENTIVA LAB:

if you are allergic to N-acetylcysteine or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding unless after careful evaluation by your doctor (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACETILCISTEINA ZENTIVA LAB.
Take this medicine with caution and always under medical supervision in the following cases:

if you suffer from a bronchial inflammatory disease called bronchial asthma. Immediately stop taking ACETILCISTEINA ZENTIVA LAB if you experience bronchial muscle contraction (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
if you are histamine intolerant; allergic reactions (hypersensitivity) may occur during treatment with ACETILCISTEINA ZENTIVA LAB;
if you currently have or have previously had a stomach or intestinal condition called peptic ulcer, especially if you are taking other medicines together with ACETILCISTEINA ZENTIVA LAB that may cause stomach problems (gastrotoxic drugs). This medicine may increase the volume of bronchial mucus (bronchial secretions), especially at the beginning of treatment. Therefore, if this occurs and you are unable to expel the bronchial secretions by coughing (expectorate), consult your doctor, who will recommend a method to remove the mucus (postural drainage or bronchoaspiration). If you notice a sulfur-like odor, do not be concerned, as this does not indicate deterioration of the product but is due to N-acetylcysteine. Laboratory tests: N-acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and tests for ketones). Inform your doctor that you are taking this medicine before undergoing such tests.

Other medicines and ACETILCISTEINA ZENTIVA LAB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking:

cough suppressants (antitussives), as they may lead to mucus accumulation in the bronchi. Take this medicine with caution and consult your doctor if you are taking any of the following medicines:
activated charcoal, used to treat digestive disorders or intestinal gas (meteorism), as it may reduce the effectiveness of ACETILCISTEINA ZENTIVA LAB;
medicines used to treat infections (antibiotics) taken orally (except loracarbef). Take these medicines at least two hours apart from ACETILCISTEINA ZENTIVA LAB;
nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with ACETILCISTEINA ZENTIVA LAB may cause low blood pressure (hypotension) and headache (cephalalgia). In such cases, your doctor will monitor you closely.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine during pregnancy or breastfeeding only if strictly necessary and under direct medical supervision.

Driving and using machines
ACETILCISTEINA ZENTIVA LAB does not affect the ability to drive or operate machinery.

ACETILCISTEINA ZENTIVA LAB contains sodium
This medicine contains 194 mg of sodium (a main component of table salt) per tablet. This corresponds to 9.7% of the maximum recommended daily dietary intake for an adult.

3. How to take ACETILCISTEINA ZENTIVA LAB

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Treatment of respiratory tract diseases
The recommended dose is 1 tablet (600 mg) daily, preferably in the evening. Your doctor may
advise you to modify the frequency and dose of administration, but without exceeding the maximum
daily dosage of 600 mg.
The duration of treatment for acute conditions ranges from 5 to 10 days; for chronic conditions, your doctor will
assess whether to continue treatment for several months.
Treatment of accidental or intentional paracetamol poisoning
The recommended initial dose is 140 mg of N-acetylcysteine per kg of body weight, administered
as soon as possible, within 10 hours of paracetamol ingestion. Subsequently, the dose is 70 mg of N-acetylcysteine
per kg of body weight every 4 hours for 1–3 days.
Treatment of urinary tract disorders (uropathy) caused by chemotherapeutic medicines such as ifosfamide and cyclophosphamide
The recommended dose is 4 g of N-acetylcysteine per day, divided into 4 doses of 1 g, in patients
undergoing a chemotherapy cycle with ifosfamide and cyclophosphamide for 5 days every 28 days.
Instructions for use of ACETILCISTEINA ZENTIVA LAB
Dissolve one tablet in a glass of water, stirring if necessary with a teaspoon, and
drink the solution immediately without letting it stand. Do not mix other medicines with the Acetilcisteina EPharma Trento solution.
If you take more ACETILCISTEINA ZENTIVA LAB than you should
No cases of overdose have been reported. Symptoms of overdose may include nausea,
vomiting, and diarrhea.
In case of ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take ACETILCISTEINA ZENTIVA LAB
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

allergic reactions (hypersensitivity);
headache (cephalalgia);
ringing in the ears (tinnitus);
increased heart rate (tachycardia);
vomiting;
diarrhoea;
inflammation of the mouth (stomatitis);
abdominal pain;
nausea;
hives, skin rash;
swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
itching;
fever (pyrexia);
low blood pressure.

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

bronchial muscle contractions (bronchospasm);
difficulty breathing (dyspnoea);
digestive difficulties (dyspepsia).

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

severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
bleeding (haemorrhage).

Not known (frequency cannot be estimated from the available data)

facial swelling (facial oedema).

In very rare cases, severe skin reactions (Stevens-Johnson syndrome or Lyell’s syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking the medicine and consult your doctor.
You should also consult your doctor if you experience prolonged bleeding time (reduced platelet aggregation).
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 ACETILCISTEINA ZENTIVA LAB

Keep this medicine out of the sight and reach of children.
Keep the tube tightly closed to protect the medicine from light and moisture.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the cardboard box after EXP. The expiry date refers to the last day of that month.
After first opening the tube, store the medicine at a temperature below 25°C for a period of 3 months.
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 ZENTIVA LAB contains

The active substance is acetylcysteine: one effervescent tablet contains 600 mg of acetylcysteine.
The other components are: citric acid, maltodextrins, sodium bicarbonate, orange flavour, leucine, sodium saccharin.

Description of the appearance of ACETILCISTEINA ZENTIVA LAB and package contents
ACETILCISTEINA ZENTIVA LAB 600 mg is available as effervescent tablets
packaged in bottles containing 15 tablets each.
The package contains 30 tablets, supplied in 2 bottles of 15 tablets each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: ZENTIVA ITALIA S.R.L.
VIALE LUIGI BODIO, 37/B, 20158 MILAN
Manufacturer: E-Pharma Trento S.p.A., via Provina 2, 38123 Trento (TN).