Acc

Package Leaflet: Information for the Patient

Warning!

The leaflet must be kept. Information on the immediate packaging in a foreign language.

ACC (ACC 200)

200 mg, effervescent tablets

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

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

This medicine should always be taken 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 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 effervescent 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 thin and loosen mucus and other secretions in the airways, making it easier to cough up, in patients with bronchitis associated with a cold.

2. Important information before taking ACC

When not to take ACC

The medicine should not be taken by children under 6 years of age.

Warnings and precautions

Before taking ACC, the patient should discuss it with their doctor or pharmacist if:

• the patient has or has had bronchial asthma (as the medicine may cause bronchospasm and shortness of breath in them);
• the patient has had a peptic ulcer in the past;
• the patient currently has or has had respiratory failure;
• the patient has a problem with expectoration (physiotherapy may be necessary - the doctor will provide information on what it involves);
• the patient has been diagnosed with histamine intolerance (long-term use of the medicine may cause 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, 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 it more difficult to expectorate the thinned secretions.
• 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 blood or urine salicylate test or a urine ketone body test, 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, sorbitol, and sodium

The medicine contains lactose.
If the patient has previously 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 BB (bread unit).
The medicine contains up to 20.0 mg of sorbitol in 1 effervescent tablet.
The medicine contains 98.9 mg of sodium (the main component of common 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

This medicine should always be taken 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 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 taken by 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 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 more than the recommended dose of ACC

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 the next dose 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 the use of 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;
• 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
• rapid heartbeat (tachycardia)
• 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)
• a 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 the 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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, it is possible 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.
• Do not store above 25°C. The tube should be kept tightly closed to protect from moisture.
• Do not use ACC after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. 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: citric acid, sodium bicarbonate, sodium carbonate, ascorbic acid, sodium saccharin, sodium citrate, blackcurrant flavor, lactose, mannitol.

What ACC looks like and contents of the pack

ACC is a white, round effervescent tablet with a dividing line on one side.
A polypropylene tube with a polyethylene cap with a desiccant, in a 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
D-39179 Barleben
Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 3003246.00.00

Parallel import authorization number: 233/12 Date of leaflet approval: 21.04.2022

[Information about the trademark]