Acetylcysteine Alter

Patient Information Leaflet

ACETILCISTEINA ALTER 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 they have the same symptoms as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ACETILCISTEINA ALTER contains the active substance N-acetylcysteine, which belongs to a group of medicines called mucolytics, used to help eliminate mucus from the respiratory tract, and to a group of medicines called antidotes, used to counteract the toxic effects of certain substances.
ACETILCISTEINA ALTER 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);
• Lung alveolar disease (pulmonary emphysema);
• Cystic fibrosis (mucoviscidosis);
• Bronchial dilatations (bronchiectasis).

ACETILCISTEINA ALTER is used as an antidote particularly in cases of:

• Accidental or intentional poisoning with paracetamol, an anti-inflammatory medicine;
• Urinary tract disorders (uropathy) caused by chemotherapeutic drugs such as ifosfamide and cyclophosphamide.

2. What you need to know before taking ACETILCISTEINA ALTER

Do not take ACETILCISTEINA ALTER

• 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 ALTER. 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 ALTER 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 ALTER;
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are concurrently taking other medicines that may cause stomach problems (gastrolesive drugs) together with ACETILCISTEINA ALTER. This medicine may increase the volume of bronchial mucus (bronchial secretions), particularly at the beginning of treatment. Therefore, if this occurs and you are unable to clear bronchial secretions by coughing (expectoration), consult your doctor, who will recommend a method to remove the mucus (postural drainage or bronchoaspiration). If you notice a sulphur-like odour, 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 ALTER
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 ALTER;
• antibiotics taken orally (except loracarbef) used to treat infections. Take these medicines at least two hours apart from ACETILCISTEINA ALTER;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with ACETILCISTEINA ALTER 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, suspect 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 while breastfeeding only if strictly necessary and under direct medical supervision.

Driving and using machines
ACETILCISTEINA ALTER does not affect the ability to drive or use machinery.

ACETILCISTEINA ALTER contains sodium
This medicine contains 194 mg of sodium (the main component of table salt) per dose.
This is equivalent to 9.7% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to take ACETILCISTEINA ALTER

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 adjust the frequency and dose of administration, but without exceeding the
maximum daily dose of 600 mg.
The duration of treatment ranges from 5 to 10 days; in chronic forms, your doctor will evaluate whether to continue the 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, given 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 daily, 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 ALTER
Dissolve one tablet in a glass containing a small amount of water, stirring if necessary with a teaspoon. Do not mix other medicines with the ACETILCISTEINA ALTER solution.

If you take more ACETILCISTEINA ALTER 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 more than the recommended dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take ACETILCISTEINA ALTER
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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;
• urticaria, skin rash;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema);
• itching (pruritus);
• fever (pyrexia);
• low blood pressure.

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

• bronchial muscle contractions (bronchospasm);
• difficulty breathing (dyspnoea);
• digestive problems (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 been reported. 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 may 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 ALTER

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.
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 ALTER contains

• The active substance is N-acetylcysteine: 1 effervescent tablet contains 600 mg of N-acetylcysteine.
• The other components are: anhydrous citric acid (E 330), maltodextrin, sodium hydrogen carbonate E 500 ii), orange flavour, leucine (E 641), sodium saccharin (E 954 ii).

Description of the appearance of ACETILCISTEINA ALTER and pack contents
ACETILCISTEINA ALTER 600 mg effervescent tablets, white, round, flat, with an average diameter of 25 mm.
Polypropylene bottle with polyethylene cap, supplied with desiccant: 15 effervescent tablets. The carton contains two bottles of 15 tablets each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LABORATORI ALTER S.R.L.
VIA EGADI, 7
20144 MILAN
Italy

Manufacturer:
E-Pharma Trento S.p.A.
Via Provina 2
38123 – Trento
Italy