Package leaflet: information for the patient

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

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

Table of 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 contains 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 secretions and facilitate 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, stop using ACC immediately and contact a doctor.
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 your doctor or pharmacist if:

the patient has suffered from or currently suffers from 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, stop using the medicine immediately and seek medical help without delay;
the patient has had peptic ulcer disease in the past; especially if other medicines irritating the gastrointestinal mucosa are used concomitantly;
the patient currently has or has had respiratory insufficiency in the past;
the patient has difficulty expectorating (respiratory physiotherapy may be necessary – your doctor will provide information on this);
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 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 must not be used in children under 2 years of age.
ACC with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.

Do not use ACC simultaneously with antitussive medicines, as they suppress the cough reflex and may impair expectoration of the liquefied secretions caused 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 the antibiotic. This does not apply to antibiotics such as cefixime, loracarbef, amoxicillin, doxycycline, erythromycin, thiamphenicol and cefuroxime. In case of doubt, consult your 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 nitrate medicine, 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 testing, inform the doctor and medical staff about taking ACC.
ACC with food and drink
Take the medicine after meals. During treatment, drink an adequate amount of fluids (at least 1.5 l daily).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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, he or she should consult a doctor before taking the medicine.
Sodium
The medicine contains 98.8 mg of sodium (main component of table salt) in each effervescent tablet. This corresponds to 4.94% of the maximum recommended daily dietary sodium intake for adults.
Sorbitol
Patients with hereditary fructose intolerance should not take this medicine.
Information for diabetic patients:
1 tablet contains less than 0.01 carbohydrate exchange unit (CEU).

3. How to use ACC

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor 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.
Method of administration
ACC should be taken after meals (see "ACC 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 take before bedtime due to difficulty in expectorating the liquefied mucus 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.
If you take more ACC than recommended
If you take too much medicine, consult a doctor or pharmacist immediately. Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
If you forget to take ACC
If you are taking the medicine regularly and only a short time has passed since 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 missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the symptoms listed below occur in the patient, discontinue use of
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, breathing difficulties or dizziness, eyelid swelling, 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, oral inflammation
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 or pharmacist. 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, phone: +48 22 4921301, fax: +48 22 4921309, 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 the sight and reach of children.
Do not store above 25°C.
Store in the original packaging, protected from light and moisture.
Keep the tube tightly closed.
Do not use the ACC medicine after the expiry date stated on the packaging. 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What ACC contains

The active substance is acetylcysteine. One effervescent tablet contains 200 mg of acetylcysteine.
The other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, ascorbic acid, sodium saccharin, sodium citrate, lactose, mannitol, raspberry flavour (containing, among others, maltodextrin, mannitol (E 421) and sorbitol (E 420)).

What ACC looks like and contents of the pack
ACC is a white, round tablet with a break line on one side.
The medicinal product comes in a polypropylene tube with a polyethylene cap, packed in a cardboard box containing 20 effervescent tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Sandoz d.d.
Verovškova 57
SI-1000 Ljubljana, Slovenia
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Latvia, country of export: 00-0515
Parallel import licence number: 90/26