Acc

Leaflet accompanying the packaging: patient information

ACC, 200 mg, effervescent tablets

Acetylcysteine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is ACC and what is it used for
• 2. Important information 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 is ACC and what is it used for
Effervescent tablets ACC contain the active substance acetylcysteine - a medicine that primarily
reduces the viscosity of bronchial secretions and facilitates expectoration.
ACC is used as a mucolytic agent for the treatment of respiratory tract disorders and to facilitate
expectoration in patients with bronchitis associated with a cold.

2. Important information before taking ACC

When not to take ACC

if the patient is hypersensitive to acetylcysteine or to any of the other ingredients of this
medicine (listed in section 6).
Symptoms of hypersensitivity may include: itching, hives, rash, bronchospasm (shortness of breath),
rapid heartbeat and decreased blood pressure. If any of these symptoms occur, the patient should
immediately stop taking ACC and consult a doctor.
if the patient has active peptic ulcer disease of the stomach or duodenum;
if the patient has acute asthma (exacerbation of bronchial asthma or chronic obstructive pulmonary
disease).
The medicine should not be used in children under 6 years of age.

Warnings and precautions

Before taking ACC, the patient should discuss it with their doctor or pharmacist if:
they have had or currently have chronic bronchial asthma (since the medicine may cause
bronchospasm and shortness of breath in them). Patients with bronchial asthma must be under close
medical supervision during treatment. If bronchospasm occurs, the patient should immediately stop
taking the medicine and seek medical help;
they have had peptic ulcer disease in the past; especially if they are taking other medicines that
irritate the mucous membranes of the gastrointestinal tract;
they currently have or have had respiratory failure in the past;
they have a problem with expectoration (physiotherapy may be necessary - the doctor will provide
information on what it entails);
they have been diagnosed with histamine intolerance (long-term use of the medicine may cause
symptoms of intolerance, such as headache, runny nose, itching);
they are elderly (over 65 years of age).
If skin or mucous membrane changes occur during treatment, the patient should stop taking the
medicine and consult a doctor immediately (see section 4).

Children and adolescents

Due to the active substance content, ACC should not be used in children under 6 years of age.
Mucolytic agents (which thin out secretions in the respiratory tract and reduce their viscosity)
may cause airway obstruction or blockage in children under 2 years of age due to the physiological
characteristics of their airways and limited ability to expectorate in this age group. Therefore,
mucolytic agents should not be used in children under 2 years of age.

ACC and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking,
have recently taken, or plan to take.
ACC should not be taken at the same time as cough suppressants, as they may weaken the cough
reflex and make it difficult to expectorate the secretions thinned out by ACC.
Acetylcysteine (the active substance of ACC) may reduce the effectiveness of some antibiotics
(especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides). To avoid
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, the patient should consult their doctor.
ACC may enhance the effect of nitroglycerin and other nitrates (medicines used in cardiovascular
diseases and coronary heart disease). During concurrent use of these medicines, 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 nitrate group, they should consult their
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 the patient is to undergo a test for salicylates in blood or urine or ketone bodies in urine, they
should inform their doctor and medical staff about taking ACC.

ACC with food and drink

The medicine should be taken after a meal. During treatment, the patient should drink a sufficient
amount of fluids (at least 1.5 liters per day).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child,
they should consult their doctor or pharmacist before taking this medicine.
ACC can be used during pregnancy and breastfeeding only if the doctor considers it necessary.

Driving and using machines

The effect of ACC on the ability to drive and use machines is not known.

ACC contains lactose, sodium, sorbitol, and glucose (a component of maltodextrin).

Lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor
before taking the medicine.

Sodium

The medicine contains 98.9 mg of sodium (the main component of common salt) in each effervescent
tablet.
This corresponds to 4.95% of the maximum recommended daily intake of sodium in the diet for
adults.

Sorbitol (E 420)

The medicinal product contains 0.06 mg of sorbitol in each effervescent tablet.

Glucose (a component of maltodextrin)

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor
before taking the medicine.
Information for diabetic patients:
1 effervescent tablet contains less than 0.01 BU (bread unit).

3. How to take ACC

This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Usually, the following dosage is used:
Adults and adolescents over 14 years of age
1 effervescent tablet of ACC 2 or 3 times a day (corresponding to 400 mg to 600 mg of acetylcysteine
per day in 2 or 3 divided doses).
Children from 6 to 14 years of age
1 effervescent tablet of ACC 2 times a day (corresponding to 400 mg of acetylcysteine per day in 2
divided doses). If 300 mg of acetylcysteine per day is necessary, ACC mini should be used.
ACC should not be used in children under 6 years of age.
Without a doctor's recommendation, ACC should not be taken for more than 4 to 5 days.
Method of administration
The medicine should be taken after a meal (see "ACC with food and drink"). The tablet should be
dissolved in half a glass of water and taken immediately after dissolution.
The effervescent tablet should not be dissolved in solutions containing other medicines.
It should not be taken before bedtime due to difficult expectoration of thinned-out secretions during
sleep. The last dose of ACC should be taken no later than 4 hours before bedtime.
After dissolving the tablet, the patient should avoid prolonged contact of the prepared liquid with
metals and rubber.

Taking a higher dose of ACC than recommended

In case of taking too much medicine, the patient should consult their doctor or pharmacist.
It is possible to experience gastrointestinal symptoms such as nausea, vomiting, and diarrhea.

Missing a dose of ACC

If the medicine is taken regularly and it is almost time for the next dose, the missed dose should be
taken as soon as possible. If it is almost time for the next dose, the patient should take it at the usual
time. A double dose should not be taken to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or
pharmacist.

4. Possible side effects

Like all medicines, ACC can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, they should stop taking ACC and seek
medical help immediately:

anaphylactic reaction or a reaction similar to anaphylaxis (a type of severe allergic reaction) with
symptoms such as sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face,
lips, or throat, hives, itching;
angioedema (a severe allergic reaction) with swelling of the skin and (or) mucous membranes, e.g.,
in the face, limbs, joints;
skin and mucous membrane changes, which may be accompanied by fever and joint pain;
bronchospasm (sudden shortness of breath).
Uncommon side effects (may occur in less than 1 in 100 people):
hypersensitivity reactions (allergic reactions)
headache
tinnitus
rapid heartbeat (tachycardia)
decreased blood pressure
nausea, vomiting, diarrhea, abdominal pain, oral inflammation
hives, rash, itching, angioedema
fever
Rare side effects (may occur in less than 1 in 1000 people):
indigestion
shortness of breath, bronchospasm
Very rare side effects (may occur in less than 1 in 10,000 people):
anaphylactic reaction or a reaction similar to anaphylaxis, up to anaphylactic shock (see above)
severe skin and mucous membrane changes, which may indicate Stevens-Johnson syndrome and toxic
epidermal necrolysis (see above)
bleeding
Side effects with unknown frequency (frequency cannot be estimated from available data):
facial swelling
Reporting side effects
If the patient experiences any side effects, including those not listed in the leaflet, they should
inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of
Pharmacovigilance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store ACC

The medicine should be stored out of sight and reach of children.
Tube: Store in a temperature below 25°C.
Store the tube tightly closed to protect it from moisture.
Soft blister: Store in a temperature below 30°C.
Do not use ACC after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their
pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ACC contains

• The active substance of ACC is acetylcysteine. 1 effervescent tablet contains 200 mg of acetylcysteine.
• The other ingredients of the medicine are: anhydrous citric acid, sodium bicarbonate, anhydrous sodium
  carbonate, mannitol (E 421), lactose, anhydrous, ascorbic acid, sodium citrate, sodium saccharin, blackcurrant
  flavor "B" (contains, among others, maltodextrin, propylene glycol (E 1520), mannitol (E 421), and sorbitol (E
  420)).

What ACC looks like and what the pack contains

ACC is white, round tablets with a dividing line on one side.
A polypropylene tube in a cardboard box contains 20 effervescent tablets.
A soft blister pack, paper/aluminum, in a cardboard box contains 20 individually packaged effervescent
tablets.
Not all pack sizes may be marketed.

Marketing authorization 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 more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

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