Acetylcysteine Doc Generici

Package leaflet: Information for the patient

ACETYLCYSTEINE DOC Generics 600 mg powder for oral solution

Equivalent Medicinal Product
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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

This medicinal product contains the active substance acetylcysteine, which belongs to a group of medicines called expectorants – mucolytics, used to facilitate the elimination 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 Generici is indicated for the treatment of respiratory tract 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 (a medicinal product with anti-inflammatory properties);
• urinary tract abnormalities impairing normal urine flow (uropathy) caused by medicines such as ifosfamide and cyclophosphamide (chemotherapeutic agents).

2. What you need to know before taking ACETILCISTEINA DOC Generici

Do not take ACETILCISTEINA DOC Generici

• if you are allergic to N-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 Generici.
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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 discontinue use if bronchial muscle contractions occur (bronchospasm);
• if you currently have or have previously had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with ACETILCISTEINA DOC Generici that may cause stomach problems (gastrolesive drugs);
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with ACETILCISTEINA DOC Generici. This medicine may make bronchial secretions more fluid and increase their volume, especially at the beginning of treatment. Therefore, if this occurs and you are unable to clear bronchial secretions by coughing (expectorate), consult your doctor, who will advise you on an appropriate method to remove 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 ingredient, acetylcysteine, contained in the product.
Laboratory tests
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 any laboratory tests.
Children and adolescents
ACETILCISTEINA DOC Generici 600 mg oral solution powder is not recommended for children and adolescents.
Other medicines and ACETILCISTEINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is advised not to mix other drugs with the ACETILCISTEINA DOC Generici solution.
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 intestinal gas (meteorism), as it may reduce the effectiveness of ACETILCISTEINA DOC Generici;
• antibiotics or other medicines used to treat infections taken orally (except loracarbef). It is recommended to take these medicines at least two hours apart from ACETILCISTEINA DOC Generici;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine and ACETILCISTEINA DOC Generici may cause a drop in blood pressure (hypotension), even severe, and headache (cephalalgia). If it is necessary to take nitroglycerin and acetylcysteine simultaneously, your doctor will monitor you for possible hypotension and headache.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
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Take this medicine during pregnancy or while breastfeeding only if your doctor considers it absolutely necessary.
Driving and using machines
There is no information indicating that this medicine affects the ability to drive or operate machinery.
ACETILCISTEINA DOC Generici oral solution powder contains sorbitol, aspartame, and
sunset yellow FCF
This medicine contains 2170 mg of sorbitol per dose (sachet). Sorbitol is a source of fructose. If your doctor has diagnosed you with intolerance to certain sugars or with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, speak with your doctor before taking this medicine.
This medicine contains 78 mg of aspartame per dose (sachet). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation due to the body's inability to eliminate it properly.
This medicine contains sunset yellow FCF (E110). It may cause allergic reactions.

3. How to take ACETILCISTEINA DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Instructions for use of ACETILCISTEINA DOC Generici powder for oral solution: dissolve the
contents of one sachet in a glass containing some water, stirring if necessary with a
teaspoon.
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 ACETILCISTEINA DOC Generici powder for oral solution is 1 sachet per
day (preferably in the evening).
Any adjustments in dosage may involve changes in the frequency of administration or splitting the dose, but must remain within the maximum daily dose of 600 mg.
The duration of treatment 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 ingestion of the toxic agent (e.g. paracetamol).
Subsequently, administer 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 ifosfamide or
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, taken during the 5 days of chemotherapy treatment.
If you take more ACETILCISTEINA DOC Generici than you should
Cases of overdose have not been reported. Symptoms of overdose may include nausea, vomiting, and diarrhoea. If you have taken or ingested an excessive amount of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take ACETILCISTEINA DOC Generici
Do not take a double dose to make up for the missed dose.
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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 (cephalaea);
• 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 eyes, lips, tongue, throat, genitals, hands and feet, which may cause difficulty in breathing and/or swallowing (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 (oedema)

In very rare cases, severe skin reactions have been reported (Stevens-Johnson syndrome or Lyell’s syndrome). If you experience signs of an allergic reaction or a severe skin reaction with skin lesions and mucosal changes, stop taking ACETILCISTEINA DOC Generici and contact your doctor immediately.
You should also contact 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, 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.
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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 required. This will help protect the environment.

6. Package contents and other information

What ACETILCISTEINA DOC Generici 600 mg oral solution powder contains

• The active substance is acetylcysteine: each sachet contains 600 mg of acetylcysteine.
• The other components are: sorbitol, aspartame, lemon flavour, sunset yellow FCF (E110).

Description of the appearance of ACETILCISTEINA DOC Generici and package contents
ACETILCISTEINA DOC Generici 600 mg powder for oral solution: carton pack containing 10 or 30
sachets.
Marketing Authorization Holder
DOC Generici SRL, VIA TURATI 40, 20121 MILANO
Manufacturer
Lamp San Prospero Spa, Via della Pace 25/A, 41030 San Prospero (MO)
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