PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
ACC (ACC 200)
200 mg, effervescent tablets
Acetylcysteinum
ACC and ACC 200 are different trade names of the same medicinal product.
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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

Contents of the leaflet

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

1. What ACC is and what it is used for

ACC effervescent tablets contain the active substance acetylcysteine — a medicine which primarily reduces the viscosity of bronchial secretions and facilitates expectoration.
ACC is used as a mucolytic agent to thin respiratory tract secretions and aid their expectoration in patients with bronchitis associated with the common cold.

2. Important information before using ACC

When not to use ACC

if the patient is allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6). Symptoms of allergy may include: itching, urticaria, rash, bronchospasm (shortness of breath), rapid heartbeat, and low blood pressure. If any of these symptoms occur, administration of ACC must be stopped immediately and the patient should contact a doctor without delay.
if the patient has active peptic ulcer disease of the stomach or duodenum;
if the patient is in an acute asthmatic state (exacerbation of bronchial asthma or chronic obstructive pulmonary disease).

ACC must not be used in children under 6 years of age.
Warnings and precautions
Before using ACC, discuss with a doctor or pharmacist if:

the patient has had or currently suffers from chronic bronchial asthma (as the medicine may cause bronchospasm and shortness of breath). A patient with bronchial asthma must be under strict medical supervision during treatment. If bronchospasm occurs, discontinue the medicine immediately and seek medical help without delay;
the patient has a history of peptic ulcer disease, especially when other medicines irritating the gastrointestinal mucosa are used concomitantly;
the patient currently has or has previously had respiratory insufficiency;
the patient has difficulty expectorating (respiratory physiotherapy may be necessary – the doctor will provide information on what this involves);
the patient has histamine intolerance (prolonged use of the medicine may lead to symptoms of intolerance such as headache, nasal discharge, itching);
the patient is elderly (over 65 years of age).

If skin or mucous membrane changes occur during treatment,
discontinue taking the medicine and consult a doctor immediately (see section 4).
Children and adolescents
Due to the content of the active substance, ACC must not be used in children under
6 years of age.
Mucolytic medicines (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 physiological characteristics of the respiratory tract and limited ability to expectorate in this age group. Therefore, mucolytic medicines should not be used in children under 2 years of age.
ACC with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use.

Do not use ACC simultaneously with antitussive medicines, as they suppress the cough reflex and may hinder expectoration of secretions liquefied by ACC.
Acetylcysteine (the active substance in ACC) may reduce the effectiveness of certain antibiotics (especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides). To prevent this, ACC should be taken 2 hours after taking an antibiotic. This does not apply to antibiotics such as cefixime, loracarbef, amoxicillin, doxycycline, erythromycin, thiamphenicol, and cefuroxime. In case of doubt, consult a doctor.
ACC may enhance the effect of nitroglycerin and other nitrates (medicines used in cardiovascular diseases and ischemic heart disease). When these medicines are used concomitantly, the doctor will monitor whether the patient develops hypotension. Headache may occur. If the patient is taking nitroglycerin or another similarly acting medicine from the group of nitrates, medical advice should be sought before taking ACC.
Large amounts of activated charcoal may reduce the effectiveness of ACC.
It is not recommended to dissolve ACC in solutions containing other medicines.

Effect of ACC on laboratory tests
If the patient is to undergo blood or urine salicylate testing or urine ketone body testing, inform the doctor and medical staff about taking ACC.
ACC with food and drink
The medicine should be taken after meals. During treatment, an adequate amount of fluids should be consumed (at least 1.5 L daily).
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
ACC may be used during pregnancy and breastfeeding only if the doctor considers it necessary.
Driving and operating machinery
The effect of ACC on the ability to drive or operate machinery is unknown.
ACC contains lactose, sodium, and sorbitol
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.
Sodium
The medicine contains 98.9 mg of sodium (the main component of table salt) in each effervescent tablet.
This corresponds to 4.9% of the maximum recommended daily intake of sodium in the diet for adults.
Sorbitol
The medicinal product contains up to 20 mg of sorbitol in each effervescent tablet.

3. How to use the medicine ACC

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The usual dosage is as follows:
Adults and adolescents over 14 years of age
1 effervescent tablet of ACC twice or three times daily (corresponding to 400 mg to 600 mg
of acetylcysteine per day in 2 or 3 divided doses).
Children aged 6 to 14 years
1 effervescent tablet of ACC twice daily (corresponding to 400 mg of acetylcysteine per day in 2
divided doses). If a daily dose of 300 mg of acetylcysteine is required, use ACC mini.
ACC should not be used in children under 6 years of age.
Do not use ACC for longer than 4 to 5 days without medical advice.
Administration instructions
The medicine should be taken after meals (see "ACC with food and drink").
Dissolve the tablet in half a glass of water and drink immediately after dissolving.
Do not dissolve the effervescent tablet in solutions containing other medicines.
Do not use before going to sleep due to difficulty in expectorating the liquefied secretions during
sleep. The last dose of ACC should be taken no later than 4 hours before bedtime.
After dissolving the tablet, avoid prolonged contact of the prepared solution with metals and
rubber.
Taking more ACC than recommended
If too much medicine is taken, seek advice from a doctor or pharmacist.
Gastrointestinal symptoms such as nausea, vomiting and diarrhoea may occur.
Missing a dose of ACC
If the medicine is taken regularly and only a short time has passed since the missed dose was due,
take it as soon as possible. If the next dose is approaching, take it at the usual time. Do not take a
double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur in a patient, stop using the
medicine ACC and seek immediate medical assistance:

anaphylactic reaction or anaphylactoid reaction (a type of sudden allergic reaction) with symptoms such as sudden wheezing, difficulty breathing or dizziness, eyelid, facial, lip or throat swelling, urticaria, itching;
angioedema (severe allergic reaction) with swelling of the skin and/or mucous membranes, e.g. in the face, limbs, joints;
development of skin and mucous membrane lesions, possibly accompanied by fever and joint pain;
bronchospasm (sudden shortness of breath).

Uncommon adverse reactions (may occur in less 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 less than 1 in 1,000 people):

dyspepsia
dyspnoea, bronchospasm

Very rare adverse reactions (may occur in less 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 adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine ACC

Keep the medicine out of sight and reach of children.
Do not store above 25°C. Keep the tube tightly closed to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of information on the tube:
Ch.-B./verwendbar bis siehe Röhrchenboden – Batch number and expiry date are embossed on the bottom of the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What ACC contains

The active substance is acetylcysteine. Each effervescent tablet contains 200 mg of acetylcysteine.
The other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, mannitol, lactose, ascorbic acid, sodium citrate, sodium saccharin, raspberry flavour.

What ACC looks like and contents of the pack
ACC is a white, round effervescent tablet with a break line on one side.
The packaging consists of a polypropylene tube with a polyethylene cap and a moisture-absorbing agent, contained in a cardboard box with either 20 or 25 effervescent tablets.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Germany, country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany
Manufacturers:
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
9400 Wolfsberg
Austria
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
German Marketing Authorisation Number (country of export): 3003246.00.00
Parallel Import Authorisation Number: 267/22