Acc

Package Leaflet: Information for the Patient

ACC, 200 mg, Tablets

Acetylcysteine

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

This medicine should always be taken exactly as described in the package 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 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 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
ACC tablets 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 to facilitate expectoration of bronchial secretions 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).
Signs of hypersensitivity may include: itching, hives, rash, bronchospasm (shortness of breath), tachycardia, and decreased blood pressure. If any of these symptoms occur, the patient should stop taking ACC and consult a doctor immediately.
if the patient has active peptic ulcer disease.
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, 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 of age).
If skin or mucous membrane changes occur during treatment with ACC, the patient should stop taking the medicine and consult a doctor immediately (see section 4).

ACC 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 should not be taken at the same time as cough suppressants, as they may weaken the cough reflex and make expectoration of the thinned secretion more difficult.
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 an antibiotic. This does not apply to antibiotics such as cefixime, loracarbef, amoxicillin, doxycycline, erythromycin, tiamphenicol, 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 blood or urine test for salicylates or a urine test for ketone bodies, 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 and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".
Information for diabetics:
1 tablet contains less than 0.01 WW (carbohydrate exchange units).

3. How to take ACC

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The usual dosage is:
Adults and adolescents over 14 years of age
1 ACC tablet 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 ACC tablet 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 used 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 can be swallowed whole without chewing, washed down with a sufficient amount of fluid, or dissolved in half a glass of water and taken immediately after dissolution.
Do not take before bedtime due to difficulty in expectorating thinned secretions during sleep. The last dose of ACC should be taken no later than 4 hours before bedtime.
Tablets should not be dissolved in solutions containing other medicines.
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 overdose, 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 skip the missed dose and take the next dose 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 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 sudden allergic reaction) with symptoms such as sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat, hives, itching;
angioedema (severe allergic reaction) with swelling of the skin and/or mucous membranes, e.g., in the face, limbs, joints;
development of changes in the skin and mucous membranes, 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
tachycardia (rapid heart rate)
decreased blood pressure
nausea, vomiting, diarrhea, abdominal pain, stomatitis
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 reactions, 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 any side effects 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store ACC

The medicine should be stored out of sight and reach of children.
Store in a temperature not exceeding 25°C.
Do not use this medicine 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 tablet contains 200 mg of acetylcysteine.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, corn starch, citric acid, sodium cyclamate, sodium saccharin, magnesium stearate, lemon flavor.

What ACC looks like and contents of the pack

Blister packs in a cardboard box containing 20 tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
To obtain more detailed information, the patient should 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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