Acc

Patient Information Leaflet

ACC 100 mg oral solution powder, 200 mg oral solution powder

Acetylcysteine
Generic Medicine
Please read 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor or pharmacist if you do not notice any improvement or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

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

1. What ACC 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.
ACC is indicated for the treatment of respiratory diseases characterized by increased production of thick and viscous mucus (viscous and dense hypersecretion).
If you do not feel better or feel worse after a few days of treatment, consult your doctor or pharmacist.

2. What you need to know before taking ACC

Do not take ACC

• if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a stomach or intestinal lesion (active peptic ulcer);
• if the person taking this medicine is a child under 2 years of age (see section “Children”);
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking ACC.
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. Discontinue the medicine if you experience bronchial muscle contractions (bronchospasm). Consult your doctor also if such symptoms occurred in the past;
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with ACC;
• if you habitually suffer from a stomach or intestinal condition called peptic ulcer, especially if you are concurrently taking other medicines causing stomach problems (gastrolesive drugs) together with Broncohexal.

This medicine may increase bronchial mucus volume (bronchial secretions), especially at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate bronchial secretions by coughing (expectoration), consult your doctor, who will advise you on a method to remove mucus (postural drainage or bronchoaspiration).
Very rarely, ACC may cause severe skin reactions (Stevens-Johnson syndrome and Lyell syndrome). If you notice skin or mucous membrane changes, stop treatment with this medicine and inform your doctor immediately.
If you perceive a sulfur-like odour, do not be concerned, as this does not indicate deterioration of the product but is due to acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylates and tests for ketones). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.

Children
ACC must not be administered to children under 2 years of age, as it may obstruct the bronchi and impair normal breathing.

Other medicines and ACC
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 (cough sedatives), 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 ACC;
• antibiotics taken orally for the treatment of infections. Take these medicines at least two hours apart from ACC, as their efficacy may otherwise be reduced (except for loracarbef);
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with ACC may cause low blood pressure (hypotension) and headache (cephalalgia).

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.
Take this medicine during pregnancy or breastfeeding only if strictly necessary and under direct medical supervision.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

ACC 100 mg contains 2.83 g of sucrose (sugar) per sachet and ACC 200 mg contains 2.272 g of sucrose (sugar) per sachet.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This should be taken into consideration in patients with diabetes mellitus.

3. How to take ACC

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.
Dissolve the contents of the sachet in a glass containing a small amount of water, stirring with a teaspoon.
You may also dissolve the contents of the sachet in fruit juice or cold tea.
This produces a pleasant-tasting solution that can be drunk directly from the glass or, in the case of young children over 2 years of age, administered with a teaspoon or in a feeding bottle. The solution should be taken immediately after preparation.
The recommended dose is 1 sachet of 200 mg or 2 sachets of 100 mg, 2–3 times daily.
If necessary, the frequency of administration and dose division may be adjusted, but the maximum daily dose of 600 mg must never be exceeded.
It is advisable to drink plenty of fluids during treatment and not to add any other medicines to the solution.
The duration of treatment is 5–10 days. Inform your doctor if symptoms recur or worsen.

Use in children over 2 years of age
The recommended dose is 1 sachet of 100 mg, 2 to 4 times daily, depending on age.

If you take more ACC than you should
Symptoms of overdose may include nausea, vomiting, diarrhoea, and abdominal pain.
If you take or ingest too much of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take ACC
Do not take a double dose to make up for a 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 everyone 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);
• reduction in blood pressure (hypotension);
• inflammation of the mouth (stomatitis), abdominal pain, nausea, vomiting, diarrhoea;
• skin irritations (urticaria, rash), swelling of the extremities of the face, lips, throat, mouth or tongue (angioedema), itching;
• fever.

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

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

• bronchial occlusion (bronchial obstruction);
• facial swelling (facial oedema).

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

• skin lesions (Stevens-Johnson syndrome or Lyell's syndrome). If you experience changes in the mucous membranes or skin, stop taking the medicine;
• blood disorders (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 ACC

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.
Do not store above 30°C.
Store in the original packaging and outer carton.
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 ACC 100 mg effervescent granules for oral solution contains

• The active substance is acetylcysteine: each sachet contains 100 mg of acetylcysteine.
• The other components are: sucrose, ascorbic acid, saccharin, orange flavour.

What ACC 200 mg effervescent granules for oral solution contains

• The active substance is acetylcysteine: each sachet contains 200 mg of acetylcysteine.
• The other components are: sucrose, ascorbic acid, saccharin, orange flavour.

Description of the appearance of ACC and contents of the pack
Carton containing 30 aluminium/paper/PE sachets of 3 g effervescent granules for oral solution.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milano
Italy

Manufacturer
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1,
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana 1526,
Slovenia