Acc

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

ACC(Acetylcysteine Sandoz)

200 mg, effervescent tablets

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

You should carefully read the contents of the leaflet before taking the medicine, 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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 packaging and other information

1 What is ACC and what is it used for
The effervescent tablets of 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 to thin and loosen mucus 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 had or currently has chronic bronchial asthma (since the medicine may cause bronchospasm and shortness of breath in them). The patient with bronchial asthma must be under close medical supervision during treatment. If bronchospasm occurs, the patient should stop taking the medicine and seek medical help immediately;
• the patient has had peptic ulcer disease in the past; especially if they are also taking other medicines that irritate the mucous membranes of the gastrointestinal tract;
• the patient currently has or has had respiratory failure;
• the patient has difficulty expectorating (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, runny nose, 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 their doctor immediately (see section 4).

Children and adolescents

Due to the active substance content, ACC should not be taken by children under 6 years of age.
Mucolytic agents (which thin and loosen mucus in the airways) 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 taken by children under 2 years of age.

ACC and other medicines

The patient should tell 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 harder to expectorate the mucus thinned 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 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 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 low blood pressure. 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 have a blood or urine test for salicylates or a urine test for ketone bodies, they should inform their doctor and medical staff that they are 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, 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 taken 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 (E 420), 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 99 mg of sodium (the main component of common salt) per effervescent tablet.
This corresponds to 5% of the maximum recommended daily intake of sodium in the diet for adults.

Sorbitol (E 420)

The medicine contains less than 20 mg of sorbitol per 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 the patient leaflet or as directed by the 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 (which corresponds 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 (which corresponds 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 the difficulty in expectorating thinned mucus 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 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 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)
• low blood pressure
• nausea, vomiting, diarrhea, abdominal pain, oral inflammation
• hives, rash, itching, angioedema
• fever.

Rare side effects (may occur in less than 1 in 1,000 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 tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store ACC

The medicine should be stored out of sight and reach of children.
It should not be stored at a temperature above 30°C.
It should be stored in the original packaging to protect it from light.
The tube should be kept tightly closed to protect it from moisture.
ACC should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the specified 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 packaging 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 hydrogen carbonate, sodium carbonate, mannitol (E 421), lactose, ascorbic acid, sodium citrate, sodium saccharin, blackcurrant flavor "B" (contains vanillin, maltodextrin, mannitol (E 421), gluconolactone, sorbitol (E 420), magnesium hydroxide carbonate, colloidal silica, and flavors of wild berries and blackcurrant).

What ACC looks like and what the packaging contains

ACC is white, round, and has a dividing line on one side.
A polypropylene tube with a polyethylene cap and a desiccant, in a cardboard box, contains 25 effervescent tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Norway, the 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.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Norway, the country of export: 05-3462
Parallel import authorization number: 408/24

Date of leaflet approval: 21.11.2024

[Information about the trademark]