Acetylcysteine PensA

Package leaflet: information for the patient

ACETYLCYSTEINE PENSA 600 mg effervescent tablets

Acetylcysteine
Generic 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

This medicinal product 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 PENSA 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);
• a genetic disease known as cystic fibrosis or mucoviscidosis;
• permanent bronchial dilations (bronchiectasis).

This medicine is used as an antidote particularly for:

• accidental or intentional poisoning with paracetamol (an analgesic medicine);
• urinary tract disorders impairing normal urine flow (uropathy) caused by medicines such as ifosfamide and cyclophosphamide (chemotherapeutic agents).

2. What you need to know before taking ACETYLCYSTEINE PENSA

Do not use ACETYLCYSTEINE PENSA

• if you are allergic to acetylcysteine 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”);
• if the patient is a child under 2 years of age, except when used as an antidote (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACETYLCYSTEINE PENSA.
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 taking the medicine if bronchial muscle contractions occur (bronchospasm).
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with ACETYLCYSTEINE PENSA that may cause stomach problems (gastrotoxic drugs).

This medicine may liquefy bronchial mucus (bronchial secretions) and increase its volume,
especially at the beginning of treatment. If this occurs and you are unable to expel the mucus by coughing
(expectoration), consult your doctor, who will recommend specific treatments 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 the active substance acetylcysteine.
Laboratory tests: acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and ketone tests). Inform your doctor that you are
taking this medicine before undergoing these tests.
Children
ACETYLCYSTEINE PENSA must not be administered to children under 2 years of age
because the ability to expel mucus is limited in this age group (due to the physiological characteristics of the respiratory tract), which may lead to bronchial obstruction and impaired breathing.
The only exception is for antidotal treatment (See section “What ACETYLCYSTEINE PENSA is and what it is used for”). In this case, your doctor will assess whether its use is appropriate.
Other medicines and ACETYLCYSTEINE PENSA
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 to eliminate intestinal gas (meteorism), as it may reduce the effectiveness of ACETYLCYSTEINE PENSA;
• antibiotics taken orally for the treatment of infections. Take these medicines at least two hours apart from ACETYLCYSTEINE PENSA;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with ACETYLCYSTEINE PENSA may cause low blood pressure (hypotension) and headache (cephalalgia). In this case, your doctor will monitor you closely.

Do not mix other medicines with the ACETYLCYSTEINE PENSA solution.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, this medicine will be prescribed to you by your doctor only
if strictly necessary and under direct medical supervision.
Driving and using machines
It is unknown whether ACETYLCYSTEINE PENSA may affect the ability to drive or use machinery.
ACETYLCYSTEINE PENSA effervescent tablets contain lactose, sodium and sorbitol
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains 116.21 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to 5.81% of the maximum recommended daily dietary intake for an adult.
This medicine contains 0.52 mg of sorbitol per effervescent tablet.

3. How to take ACETILCISTEINA PENSA

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 effervescent tablet daily, preferably in the evening or as
prescribed by the doctor.
The duration of treatment is 5 to 10 days for acute conditions.
For chronic conditions, i.e. long-lasting conditions, the doctor may extend the treatment duration 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, within 10 hours of paracetamol intake. Subsequently, the dose is 70 mg of acetylcysteine
per kg of body weight every 4 hours for 1–3 days.
Treatment of uropathy due to ifosfamide and cyclophosphamide:
The recommended dose is 4 g of acetylcysteine per day, divided into 4 doses of 1 g each, in patients
undergoing a chemotherapy cycle with ifosfamide and cyclophosphamide at a dose of 1,200 mg/m² of body
surface area per day for 5 days every 28 days. Acetylcysteine should be administered on the days of
chemotherapy treatment.
Dissolve one tablet in half a glass of water, stirring if necessary with a teaspoon.
If you take more ACETILCISTEINA PENSA than you should
Cases of overdose have not been reported.
Symptoms of overdose may include nausea, vomiting and diarrhoea.
In case of accidental ingestion/overdose of this medicine, inform your doctor immediately or go to the nearest
hospital.
If you forget to take ACETILCISTEINA PENSA
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 everybody gets 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 (pruritus);
• fever;
• low blood pressure.

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

• bronchial muscle contractions (bronchospasm);
• difficulty breathing (dyspnoea);
• digestive discomfort (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)

• blockage of the bronchi (bronchial obstruction);
• 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 this 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 PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The shelf life after first opening the tube is 18 months (record the date of first opening in the designated space on the carton).
Do not dispose of medicines 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 PENSA contains

• The active substance is acetylcysteine: 1 effervescent tablet contains 600 mg of acetylcysteine.
• The other components are: anhydrous citric acid, ascorbic acid, disodium hydrogen citrate dihydrate, sodium cyclamate, sodium saccharin, mannitol, sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous lactose, lemon flavour “AU” (code 132).

Description of the appearance of ACETILCISTEINA PENSA and package contents
Pack containing a bottle with 10, 20 or 30 effervescent tablets.
Pack containing 20 or 30 effervescent tablets in laminated aluminium sheet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milano
Manufacturer
Hermes Arzneimittel GmbH, Hans-Urmiller-Ring 52, 82515 Wolfratshausen, Germany