Acetylcysteine Coop

Package leaflet: Information for the patient

ACETYLCYSTEINE COOP 200 mg effervescent granules for oral solution

Acetylcysteine

Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

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

This medicine contains the active substance acetylcysteine, which belongs to a group of
medicines called expectorants - mucolytics, used to help eliminate mucus from the
respiratory tract.
ACETILCISTEINA COOP is indicated for the treatment of respiratory tract diseases
characterized by increased production of thick and viscous mucus (dense and viscous hypersecretion).
Consult your doctor if you do not improve or feel worse after 10 days.

2. What you need to know before taking ACETYLCYSTEINE COOP

Do not take ACETYLCYSTEINE COOP

• 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”);
• if the person taking this medicine is a child under 12 years of age.

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

• if you suffer from a chronic inflammatory bronchial disease called bronchial asthma. Discontinue taking the medicine if you experience dyspnea (difficulty breathing) after taking it, due to 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 ACETYLCYSTEINE COOP;
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with ACETYLCYSTEINE COOP 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 clear
the 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 sulfur-like odor, do not be concerned, as this does not indicate deterioration of the product,
but is due to acetylcysteine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses
(colorimetric assay for salicylate measurement and tests for ketones). Inform
your doctor that you are taking this medicine before undergoing any tests.
Do not mix the ACETYLCYSTEINE COOP solution with other medicines.
Other medicines and ACETYLCYSTEINE COOP
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 ACETYLCYSTEINE COOP;
• antibiotics taken orally (except loracarbef), used to treat infections. Take these medicines at least two hours apart from ACETYLCYSTEINE COOP;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with ACETYLCYSTEINE COOP may cause low blood pressure (hypotension) and headache (cephalalgia).

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.
If you are pregnant or breastfeeding, take this medicine only if strictly necessary and under direct medical supervision.
Driving and using machines
ACETYLCYSTEINE COOP does not affect the ability to drive or operate machinery.
ACETYLCYSTEINE COOP contains sucrose, sunset yellow (E 110), and lactose
This medicine contains sucrose. It may be harmful to teeth. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains 2.24 g of sucrose per sachet, which should be taken into account in patients with diabetes mellitus, especially when taking multiple sachets per day.
This medicine contains sunset yellow (E110), a dye that may cause allergic reactions.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take ACETILCISTEINA COOP

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use
Dissolve the contents of the sachet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
Take the medicine immediately after preparing the solution.
The recommended dose of ACETILCISTEINA COOP for adults is 1 sachet of 200 mg, 2–3 times daily.
The duration of treatment is 5 to 10 days for acute conditions. In chronic conditions, your doctor may extend the treatment up to 1 or more months.
This medicine is intended for adults and children over 12 years of age.
If you take more ACETILCISTEINA COOP than you should
Symptoms of overdose may include nausea, vomiting and diarrhoea.
If you have taken or ingested too much of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take ACETILCISTEINA COOP
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 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;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema), itching;
• fever (pyrexia);
• decrease in blood pressure.

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

• bronchial muscle spasms (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)

• swelling (oedema) of the face.

Contact your doctor if you experience any of the following side effects:

• blood disorders (reduced platelet aggregation);
• skin lesions (Stevens-Johnson syndrome or Lyell’s syndrome). If you notice changes in the mucous membranes or skin, stop taking the medicine.

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 the following 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 ACETYLCYSTEINE COOP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last
day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines 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 COOP 200 mg effervescent granules for oral solution contains

• The active substance is acetylcysteine: each sachet contains 200 mg of acetylcysteine.
• The other components are: granular orange juice, orange flavour (containing lactose), saccharin, sunset yellow (E 110), sucrose.

Description of the appearance of ACETILCISTEINA COOP and contents of the pack
Carton containing 30 sachets of 3 g.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Mipharm S.p.A. – Via Bernardo Quaranta, 12 - Milan