Package leaflet: Information for the user

ACC mini, 100 mg, effervescent tablets
Acetylcysteine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement after 4 to 5 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet:

What ACC mini is and what it is used for
Important information before taking ACC mini
How to take ACC mini
Possible side effects
How to store ACC mini
Contents of the pack and other information

1. What ACC mini is and what it is used for
ACC mini effervescent tablets contain the active substance acetylcysteine – a medicine which primarily reduces the viscosity of bronchial secretions and facilitates expectoration.
ACC mini is used short-term as a mucolytic agent to thin respiratory secretions and assist in their expectoration in patients with symptoms of upper respiratory tract infections.

2. Important information before taking ACC mini

When not to take ACC mini
Do not take this medicine if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
Allergic reactions may include: itching, urticaria, rash, bronchospasm (shortness of breath), rapid heartbeat, and low blood pressure. If any of these symptoms occur, stop taking ACC mini immediately and contact your doctor.
Do not take this medicine if you have active peptic ulcer disease of the stomach or duodenum.
Do not take this medicine if you are experiencing an acute asthmatic attack (exacerbation of bronchial asthma or chronic obstructive pulmonary disease).
This medicine must not be used in children under 3 years of age.

Warnings and precautions
Before taking ACC mini, consult your doctor or pharmacist if:

you have suffered or suffer from chronic bronchial asthma (because the medicine may cause bronchospasm and shortness of breath). Patients with bronchial asthma must be under strict medical supervision during treatment. If bronchospasm occurs, stop taking the medicine immediately and seek medical help without delay;
you have previously been diagnosed with peptic ulcer disease, especially if you are also taking other medicines that irritate the gastrointestinal mucosa;
you currently have or have previously had respiratory insufficiency;
you have difficulty expectorating (respiratory physiotherapy may be necessary – your doctor will provide information on this);
you have histamine intolerance (long-term use of the medicine may lead to symptoms of intolerance such as headache, nasal discharge, itching);
you are elderly (over 65 years of age).
If skin or mucous membrane reactions occur during treatment, stop taking the medicine and consult your doctor immediately (see section 4).

Children and adolescents
Due to its active ingredient, ACC mini must not be used in children under 3 years of age.
Mucolytic agents (which liquefy respiratory secretions and reduce their viscosity) may cause narrowing (obstruction) or blockage of the airways in children under 2 years of age due to the physiological characteristics of the respiratory tract and limited ability to expectorate in this age group. Therefore, mucolytic agents should not be used in children under 2 years of age.

Other medicines and ACC mini
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take ACC mini simultaneously with cough suppressants (antitussives), as they suppress the cough reflex and may hinder the expectoration of secretions thinned by ACC mini.
Acetylcysteine (the active substance in ACC mini) may reduce the effectiveness of certain antibiotics (especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides). To avoid this, take ACC mini at least 2 hours after taking an antibiotic. This does not apply to the following antibiotics: cefixime, loracarbef, amoxicillin, doxycycline, erythromycin, thiamphenicol, and cefuroxime. If in doubt, consult your doctor.
ACC mini may enhance the effect of nitroglycerin and other nitrates (medicines used in cardiovascular diseases and ischemic heart disease). When these medicines are used together, your doctor will monitor you for signs of hypotension. Headache may occur. If you are taking nitroglycerin or another nitrate with similar action, consult your doctor before taking ACC mini.
Large amounts of activated charcoal may reduce the effectiveness of ACC mini.
It is not recommended to dissolve ACC mini in solutions containing other medicines.

Effect of ACC mini on laboratory tests
If you are scheduled for blood or urine salicylate tests or urine ketone tests, inform your doctor and medical staff that you are taking ACC mini.

ACC mini with food and drink
Take this medicine after meals. During treatment, drink an adequate amount of fluids (at least 1.5 litres daily).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
ACC mini may be used during pregnancy and breastfeeding only if your doctor considers it necessary.

Driving and operating machinery
The effect of ACC mini on the ability to drive and operate machinery is unknown.

ACC mini contains lactose, sodium, sorbitol, and glucose (component of maltodextrin).
Lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Sodium
This medicine contains 96 mg of sodium (main component of table salt) per effervescent tablet. This corresponds to 4.8% of the maximum recommended daily intake of sodium in the adult diet. If taking 5 or more effervescent tablets daily for a prolonged period, patients, especially those monitoring sodium intake, should consult their doctor or pharmacist.
Sorbitol
The medicinal product contains 0.06 mg of sorbitol (E 420) per effervescent tablet.
Glucose (component of maltodextrin)
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use ACC mini

This medicine should always be taken exactly as described in this patient leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dosage is as follows:
Adults and adolescents over 14 years of age
2 effervescent tablets of ACC mini twice or three times daily (corresponding to 400 mg to 600 mg of acetylcysteine per day in 2 or 3 divided doses).
Children aged 7 to 14 years
1 effervescent tablet of ACC mini four times daily or 2 effervescent tablets of ACC mini twice daily (corresponding to 400 mg of acetylcysteine per day in 2 or 4 divided doses).
Children aged 3 to 6 years
1 effervescent tablet of ACC mini two or three times daily (200 mg to 300 mg of acetylcysteine per day in 2 or 3 divided doses).
ACC mini must not be used in children under 3 years of age.
Without medical advice, ACC mini should not be used for longer than 4 to 5 days.

Instructions for use
The medicine should be taken after meals (see "ACC mini with food and drink"). The tablet should be dissolved in half a glass of water and taken immediately after dissolving.
Do not dissolve the effervescent tablet in solutions containing other medicines.
Do not use before bedtime due to difficulty in expectorating the liquefied secretions during sleep. The last dose of ACC mini should be taken no later than 4 hours before bedtime.
After dissolving the tablet, prolonged contact of the prepared solution with metals and rubber should be avoided.

If you take more ACC mini than recommended
If you take too much of this medicine, consult your doctor or pharmacist immediately.
Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.

If you forget to take ACC mini
If you are taking the medicine regularly and realize shortly after the missed dose, take it as soon as possible. If it is almost time for the next dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the symptoms listed below occur in the patient, discontinue use of
the medicine ACC mini and seek immediate medical help:
anaphylactic reaction or anaphylactoid reaction (a type of sudden allergic reaction)
with symptoms such as sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat, urticaria, itching;
angioedema (severe allergic reaction) with swelling of the skin and (or) mucous membranes, e.g. in the face, limbs, joints;
skin and mucous membrane lesions, which may be accompanied by fever and joint pain;
bronchospasm (sudden shortness of breath).

Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
hypersensitivity reactions (allergic reactions)
headache
tinnitus
rapid heartbeat (tachycardia)
low blood pressure
nausea, vomiting, diarrhoea, abdominal pain, stomatitis
urticaria, rash, itching, angioedema
fever

Rare adverse reactions (may occur in fewer than 1 in 1,000 people):
dyspepsia
dyspnoea, bronchospasm

Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):
anaphylactic reaction or anaphylactoid reaction up to anaphylactic shock (see above)
severe reaction affecting the skin and mucous membranes, which may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis (see above)
bleeding

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
facial swelling

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine ACC mini

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use the medicine ACC mini after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What ACC mini contains

The active substance is acetylcysteine. Each effervescent tablet contains 100 mg of acetylcysteine.
The other ingredients are: anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, mannitol (E 421), anhydrous lactose, ascorbic acid, disodium citrate dihydrate, sodium saccharin dihydrate, raspberry flavour “B” (containing, among others, maltodextrin, propylene glycol (E 1520), mannitol (E 421) and sorbitol (E 420)).

What ACC mini looks like and contents of the pack
Polypropylene tube closed with an LDPE stopper containing a desiccant,
in a cardboard box containing 20 effervescent tablets.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Hermes Pharma GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany
Hermes Pharma Ges.m.b.H.
Schwimmschulweg 1a
A-9400 Wolfsberg
Austria
For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00