Package leaflet: Information for the patient

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

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 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 facilitate their expectoration in patients with bronchitis associated with the common cold.

2. Important information before taking ACC

When not to take ACC

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 immediately and contact your doctor.
if you have active peptic ulcer disease of the stomach or duodenum;
if you have acute asthmatic attack (exacerbation of bronchial asthma or chronic obstructive pulmonary disease).

Do not use this medicine in children under 6 years of age.
Warnings and precautions
Before taking ACC, discuss with your doctor or pharmacist if:

you have had or currently have bronchial asthma (as the medicine may cause bronchospasm and shortness of breath). Patients with bronchial asthma must be under close medical supervision during treatment. If bronchospasm occurs, stop taking the medicine immediately and seek medical help;
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 changes occur during treatment, stop taking the medicine and contact your doctor immediately (see section 4).
Children and adolescents
Due to the content of the active substance, ACC should not be used in children under 6 years of age.
Mucolytic agents (which liquefy respiratory secretions and reduce their viscosity) may cause airway obstruction or blockage 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 agents should not be used in children under 2 years of age.
ACC with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Do not take ACC together with antitussive medicines, as they suppress the cough reflex and may hinder the 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 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 together, your doctor will monitor whether you develop hypotension. Headache may occur. If you are taking nitroglycerin or another nitrate medicine, consult your doctor 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 you are scheduled for blood or urine salicylate tests or urine ketone tests, inform your doctor and medical staff that you are taking ACC.
ACC with food and drink
Take the 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 have a baby, consult your doctor or pharmacist before taking this medicine.
ACC may be used during pregnancy and breastfeeding only if your 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, sorbitol (E 420) 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
Each effervescent tablet contains 99 mg of sodium (main component of table salt).
This corresponds to 5% of the maximum recommended daily dietary sodium intake for adults.
Sorbitol (E 420)
The medicine contains less than 20 mg of sorbitol per effervescent tablet.
Glucose (component of maltodextrine)
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Information for diabetic patients:
1 tablet contains less than 0.01 carbohydrate exchange unit (CEU).

3. How to use the medicine ACC

This medicine should always be taken exactly as described in the patient leaflet or as advised 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
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.
Without a doctor's recommendation, ACC should not be used for longer than 4 to 5 days.
Method of administration
The medicine 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 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 you take too much medicine, consult your doctor or pharmacist immediately.
Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
If you miss a dose of ACC
If you are taking the medicine regularly and it is not long since the missed dose was due, 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 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 will experience them.
If any of the symptoms listed below occur in a patient, discontinue use of
the medicine ACC 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;
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 out of 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 out of 1,000 people):

dyspepsia
dyspnoea, bronchospasm.

Very rare adverse reactions (may occur in less than 1 out of 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 occurring 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 also 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
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 30°C.
Store in the original packaging to protect from light.
Keep the tube tightly closed to protect from moisture.
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. Package contents and other information

What ACC contains

The active substance is acetylcysteine. Each effervescent tablet contains 200 mg of acetylcysteine.
Other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, mannitol (E 421), lactose, sodium citrate, sodium saccharin, "B" raspberry flavour (containing vanillin, maltodextrin, mannitol (E 421), glucono delta-lactone, sorbitol (E 420), magnesium hydroxy carbonate, colloidal anhydrous silica, and wild berry and raspberry flavours).

What ACC looks like and contents of the pack
ACC is a white, round tablet with a break line on one side.
The pack is a polypropylene tube with a polyethylene stopper and a desiccant, contained in a cardboard box, containing 25 effervescent tablets.
For further information, please contact the responsible entity or parallel importer.
Responsible entity in Norway, country of export:
Sandoz A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Norway, country of export: 05-3462
Parallel import licence number: 408/24