Acc

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.

ACC (ACC 200)

200 mg, effervescent tablets

Acetylcysteine
ACC ACC 200are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is ACC medicine and what is it used for
• 2. Important information before taking ACC medicine
• 3. How to take ACC medicine
• 4. Possible side effects
• 5. How to store ACC medicine
• 6. Package contents and other information

1 What is ACC medicine and what is it used for
ACC effervescent tablets contain the active substance acetylcysteine - a medicine that primarily reduces the viscosity of bronchial secretions and facilitates expectoration.
ACC medicine is used as a mucolytic agent to thin bronchial secretions and facilitate their expectoration in patients with bronchitis associated with a cold.

2. Important information before taking ACC medicine

When not to take ACC medicine

if the patient is allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
Symptoms of an allergic reaction may include: itching, hives, rash, bronchospasm (shortness of breath),
accelerated heart rate and decreased blood pressure. If any of these symptoms occur, the patient should stop taking ACC medicine and consult a doctor immediately.
if the patient has active peptic ulcer disease of the stomach or duodenum;
if the patient has an acute asthmatic condition (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 medicine, the patient should discuss it with their doctor or pharmacist if:
they have had or currently have chronic bronchial asthma (as the medicine may cause bronchospasm and shortness of breath);
they have had peptic ulcer disease in the past;
they currently have or have had respiratory failure;
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, nasal discharge, itching);
they are elderly (over 65 years old).
If skin or mucous membrane changes occur during treatment, the patient should stop taking the medicine and consult a doctor immediately (see section 4).

ACC medicine and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
ACC medicine 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 thinned secretions.
Acetylcysteine (the active substance of ACC medicine) may reduce the effectiveness of some antibiotics (especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides). To avoid this, ACC medicine 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, the patient should consult their doctor.
ACC medicine 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 the patient to ensure they do not develop 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 medicine.
Large amounts of activated charcoal may reduce the effectiveness of ACC medicine.
It is not recommended to dissolve ACC medicine in solutions containing other medicines.
Effect of ACC on laboratory tests
If the patient is to undergo a blood or urine test for salicylates or a urine test for ketone bodies, they should inform their doctor and medical staff about taking ACC medicine.

ACC medicine 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 medicine can be used during pregnancy and breastfeeding only if the doctor considers it necessary.

Driving and operating machinery

The effect of ACC medicine on the ability to drive and operate machinery is not known.

ACC medicine contains lactose, sodium, and sorbitol

One effervescent tablet of ACC medicine contains a maximum of 20.0 mg of sorbitol.

ACC medicine contains lactose

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 tablet contains less than 0.01 BB (bread unit).
The medicine contains 98.9 mg of sodium (the main component of table salt) in 1 effervescent tablet.
This corresponds to 4.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take ACC medicine

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in 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 medicine 2 or 3 times a day (corresponding to 400 mg to 600 mg of acetylcysteine per day in 2 or 3 divided doses).

Children between 6 and 14 years of age

1 effervescent tablet of ACC medicine 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 medicine should not be used in children under 6 years of age.
Without a doctor's recommendation, the medicine should not be used for more than 4 to 5 days.
Method of administration
The medicine should be taken after a meal (see "ACC medicine 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.
The medicine should not be taken before bedtime due to difficult expectoration of thinned secretions during sleep. The last dose of ACC medicine 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 medicine 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 medicine

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

4. Possible side effects

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

If the patient experiences any of the following symptoms, they should stop taking ACC medicine 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
accelerated heart rate (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 (see above) up to anaphylactic shock
severe skin and mucous membrane reaction, 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 any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store ACC medicine

The medicine should be stored 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 ACC medicine after the expiry date stated on the packaging. 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. Package contents and other information

What ACC medicine contains

• The active substance of ACC medicine is acetylcysteine. 1 effervescent tablet contains 200 mg of acetylcysteine.
• The other ingredients of the medicine are: citric acid, sodium bicarbonate, sodium carbonate, mannitol, lactose, ascorbic acid, sodium citrate, sodium saccharin, blackcurrant flavor (contains sorbitol).

What ACC medicine looks like and what the package contains

ACC medicine is white, round tablets with a dividing line on one side.
The tube in the cardboard box contains 20 or 25 effervescent tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

HEXAL AG, Industriestraße 25, 83607 Holzkirchen, Germany

Manufacturer:

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Natur Produkt Zdrovit Sp. z o.o., ul. Nocznickiego 31, 01-918 Warsaw
German marketing authorization number, country of export:3003246.00.00
Parallel import authorization number:264/17
Date of leaflet approval: 26.07.2022