Patient Information Leaflet

ACETILCISTEINA DOC 600 mg effervescent tablets

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, 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:

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

1. What ACETILCISTEINA DOC is and what it is used for

This medicine contains the active substance acetilcisteina, which belongs to a group of
medicines called expectorants - mucolytics, used to facilitate the removal of mucus from the
respiratory tract. It is also an antidote in cases of paracetamol overdose and counteracts the
effects on the urinary tract caused by certain medicines.
ACETILCISTEINA DOC is indicated for the treatment of respiratory diseases
characterized 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);
dilation and destruction of the pulmonary alveoli (pulmonary emphysema);
cystic fibrosis (mucoviscidosis);
bronchiectasis.

This medicine is also used to counteract the toxic effects of certain substances
(antidotal treatment), particularly in:

accidental or intentional paracetamol poisoning (an anti-inflammatory medicine);
urinary tract abnormalities impairing normal urine flow (uropathy) caused by medicines such as ifosfamide and cyclophosphamide (chemotherapeutic agents).

2. What you should know before taking ACETILCISTEINA DOC

Do not take ACETILCISTEINA DOC

if you are allergic to acetylcysteine, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACETILCISTEINA DOC.
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 the medicine if bronchial muscle contractions occur (bronchospasm);
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 DOC that cause stomach problems (gastrolesive drugs);
if you are histamine-intolerant, allergic reactions (hypersensitivity) may occur during treatment with ACETILCISTEINA DOC.

This medicine may make bronchial mucus (bronchial secretions) more fluid and increase its volume, especially at the beginning of treatment. Therefore, if this occurs and you are unable to clear the bronchial secretions by coughing (expectorate), consult your doctor, who will advise you on 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 degradation of the medicine but is due to the active substance acetylcysteine contained in the medicine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and tests to detect ketones).
Inform your doctor that you are taking this medicine before undergoing any laboratory tests.
Children and adolescents
ACETILCISTEINA DOC 600 mg effervescent tablets are not recommended for children and adolescents (due to the high content of active substance). Other pharmaceutical forms with a lower active substance content are available for these patients.
Other medicines and ACETILCISTEINA DOC
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 due to reduced cough reflex.

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 to eliminate intestinal gas (meteorism), as it may reduce the effectiveness of ACETILCISTEINA DOC;
antibiotics, medicines used to treat infections taken by mouth (except loracarbef). It is recommended to take these medicines at least two hours apart from ACETILCISTEINA DOC;
nitroglycerin, used for certain heart conditions. Concomitant use of this medicine and ACETILCISTEINA DOC may cause a drop in blood pressure (hypotension), even severe, and headache (cephalalgia). If simultaneous administration of nitroglycerin and acetylcysteine is necessary, your doctor will monitor you for possible hypotension and headache.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine during pregnancy or breastfeeding only if your doctor considers it absolutely necessary.
Driving and using machines
There are no data indicating that the effects of this medicine affect the ability to drive or operate machinery.
ACETILCISTEINA DOC effervescent tablets contain sodium
This medicine contains 194 mg of sodium (a main component of table salt) per tablet. This corresponds to 9.7% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to take ACETYLCYSTEINE DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Instructions for use
Dissolve one tablet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
Take the medicine immediately after preparing the solution and after meals.
Do not mix other medicines into the solution.
It is advisable to drink fluids during treatment.

Treatment of respiratory tract diseases:
The recommended dose of ACETYLCYSTEINE DOC effervescent tablets is 1 tablet (600 mg) per day, preferably in the evening.
Your doctor may advise you to adjust the frequency of administration or to divide the dose, but without exceeding the maximum daily dose of 600 mg.
Treatment duration is 5 to 10 days for acute conditions; for chronic conditions, treatment may continue, at the physician's discretion, for several months.

Treatment of accidental or intentional paracetamol poisoning:
The recommended initial dose is 140 mg of acetylcysteine per kg of body weight, administered as soon as possible and within 10 hours of paracetamol ingestion.
Subsequently, the dose is 70 mg of acetylcysteine per kg of body weight every 4 hours for 1–3 days.

Treatment of urinary tract pathology (uropathy) caused by chemotherapy (with iso- and cyclophosphamide):
Follow your doctor’s prescription.
Generally, the recommended dose is 4 g of acetylcysteine per day, divided into 4 doses of 1 g each, to be taken during the 5 days of chemotherapy treatment.

If you take more ACETYLCYSTEINE DOC than you should
Cases of overdose have not been reported. Symptoms of overdose may include nausea, vomiting, and diarrhea.
If you have taken too much of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take ACETYLCYSTEINE DOC
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;
skin irritations (urticaria, rash);
swelling due to fluid accumulation in the deeper layers of the skin (angioedema), most commonly affecting the eyes, lips, tongue, throat, genitals, hands and feet, which may cause difficulty in breathing and/or swallowing (angioedema);
itching (pruritus);
fever (pyrexia);
low blood pressure.

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

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

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

severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
bleeding from blood vessels (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 signs of an allergic reaction or a severe skin reaction with skin lesions and mucosal changes, stop taking ACETILCISTEINA DOC and consult your doctor immediately.
You should also consult your doctor if you experience prolonged bleeding time (reduced coagulation due to decreased platelet aggregation).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ACETILCISTEINA DOC 600 mg effervescent tablets contain

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

Description of the appearance of ACETILCISTEINA DOC and contents of the pack
ACETILCISTEINA DOC 600 mg effervescent tablets: carton pack containing 20 or 30 effervescent tablets.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano
Manufacturer
E-Pharma Trento S.p.A., Frazione Ravina, Via Provina, 2, 38123 Trento (TN)