ACC 20 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. ACC classic, 20 mg/ml, Oral Solution
   1. Read the Leaflet Carefully Before Using the Medication, as it Contains
   2. Table of Contents of the Leaflet:
3. What ACC classic is and what it is used for
4. Important information before taking ACC classic
   1. When not to take ACC classic
   2. Warnings and precautions
   3. Children and adolescents
   4. ACC classic and other medications
   5. ACC classic with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. ACC classic contains sodium, sodium benzoate, methyl parahydroxybenzoate, benzyl alcohol, and propylene glycol
   9. Sodium
   10. Sodium benzoate (E 211)
   11. Methyl parahydroxybenzoate (E 218)
   12. Benzyl alcohol
   13. Propylene glycol (E 1520)
5. How to take ACC classic
   1. If your doctor has not advised otherwise, the usual dose is:
   2. Note: After the first opening of the bottle, the medication can be stored for a maximum of 11 days at a temperature below 25°C.
   3. Taking a higher dose of ACC classic than recommended
   4. Missing a dose of ACC classic
6. Possible side effects
   1. If you experience any of the following symptoms, you should stop taking ACC classic and seek medical help immediately:
7. How to store ACC classic
8. Contents of the pack and other information
   1. What ACC classic contains
   2. What ACC classic looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

ACC classic, 20 mg/ml, Oral Solution

Acetylcysteine

Read the Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient leaflet or as advised 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 more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What ACC classic is and what it is used for
• 2. Important information before taking ACC classic
• 3. How to take ACC classic
• 4. Possible side effects
• 5. How to store ACC classic
• 6. Contents of the pack and other information

1. What ACC classic is and what it is used for

ACC classic contains the active substance acetylcysteine - a medication that primarily reduces the viscosity of bronchial secretions and facilitates expectoration.
ACC classic is used short-term as a mucolytic agent for the treatment of respiratory tract disorders and to facilitate expectoration in patients with symptoms of upper respiratory tract infections.

2. Important information before taking ACC classic

When not to take ACC classic

• if you are allergic to acetylcysteine, methyl parahydroxybenzoate, or any of the other ingredients of ACC classic (listed in section 6). Symptoms of an allergic reaction may include: itching, hives, rash, bronchospasm (shortness of breath), rapid heartbeat, and decreased blood pressure. If you experience any of these symptoms, you should stop taking ACC classic and contact your doctor immediately. if you have active peptic ulcer disease. if you have acute asthma (exacerbation of bronchial asthma or chronic obstructive pulmonary disease).

The medication should not be used in children under 3 years of age.

Warnings and precautions

Before taking ACC classic, you should discuss it with your doctor or pharmacist if:
you have had or have bronchial asthma (since the medication may cause bronchospasm and shortness of breath in you). Patients with bronchial asthma must be under close medical supervision during treatment. If bronchospasm occurs, you should stop taking the medication immediately and seek medical help;
you have had peptic ulcer disease in the past, especially if you are also taking other medications that irritate the mucous membranes of the gastrointestinal tract;
you currently have or have had respiratory failure;
you have a problem with expectoration (you may need to use so-called respiratory physiotherapy - your doctor will provide information on what it involves);
you have been diagnosed with histamine intolerance (long-term use of the medication may cause symptoms of intolerance, such as headache, runny nose, itching);
you are elderly (over 65 years old).
If you experience skin or mucous membrane changes during treatment, you should stop taking the medication and seek medical help immediately (see section 4).

Children and adolescents

Due to the content of the active substance, ACC classic should not be used in children under 3 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 the respiratory tract and limited ability to expectorate in this age group. Therefore, mucolytic agents should not be used in children under 2 years of age.

ACC classic and other medications

You should tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take.
ACC classic should not be used at the same time as cough suppressants, as they may weaken the cough reflex and make expectoration of the thinned-out secretions more difficult.
Acetylcysteine (the active substance of ACC classic) may reduce the effectiveness of some antibiotics (especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides). To avoid this, ACC classic 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. If in doubt, you should consult your doctor.
ACC classic may enhance the effect of nitroglycerin and other nitrates (medications used in cardiovascular diseases and coronary heart disease). During concurrent use of these medications, your doctor will monitor whether you develop hypotension. Headache is possible. If you are taking nitroglycerin or another similarly acting medication from the nitrate group, you should consult your doctor before taking ACC classic.
Large amounts of activated charcoal may reduce the effectiveness of ACC classic.
It is not recommended to mix ACC classic with solutions containing other medications.
Effect of ACC classic on laboratory tests
If you are to undergo a test for salicylates in blood or urine or ketone bodies in urine, you should inform your doctor and medical staff that you are taking ACC classic.

ACC classic with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medication.
The medication contains benzyl alcohol (see subsection "Benzyl alcohol").
ACC classic can be used during pregnancy and breastfeeding only if your doctor considers it necessary.

Driving and using machines

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

ACC classic contains sodium, sodium benzoate, methyl parahydroxybenzoate, benzyl alcohol, and propylene glycol

Sodium

The medication contains 4.8 mg of sodium (the main component of common salt) per 1 ml of oral solution.
This corresponds to 0.24% of the maximum recommended daily intake of sodium in the diet for adults.

Sodium benzoate (E 211)

The medication contains 1.95 mg of sodium benzoate per 1 ml of oral solution.

Methyl parahydroxybenzoate (E 218)

The medication contains a preservative (methyl parahydroxybenzoate). It may cause allergic reactions (possible late reactions, i.e., symptoms of allergy may occur even after several hours or days).

Benzyl alcohol

The medication contains less than 0.1 mg of benzyl alcohol (a component of cherry flavor) per 1 ml of oral solution.
Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to small children is associated with a risk of severe side effects, including respiratory disorders (so-called "gasping syndrome"). Pregnant or breastfeeding women should consult their doctor before using the medication, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult their doctor before using the medication, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Propylene glycol (E 1520)

The medication contains 1.33 mg of propylene glycol (E 1520) (a component of cherry flavor) per 1 ml of oral solution.

3. How to take ACC classic

This medication should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
ACC classic can be administered orally using the measuring cup (5 ml) or measuring spoon (10 ml) attached to the packaging.

If your doctor has not advised otherwise, the usual dose is:

Children from 3 to 6 years old
5 ml of solution two or three times a day (200 mg to 300 mg of acetylcysteine per day in 2 or 3 divided doses).
Children from 7 to 14 years old
10 ml of solution two times a day (400 mg of acetylcysteine per day in 2 divided doses).
Do not exceed the dose of 4 measuring cups (or 2 measuring spoons) per day.
Adults and adolescents over 14 years old
10 ml of solution two or three times a day (400 mg to 600 mg of acetylcysteine per day in 2 or 3 divided doses).
ACC classic should not be used in children under 3 years of age.
Without a doctor's recommendation, the medication should not be used for more than 4 to 5 days.
Method of administration
The medication should be taken after a meal.
Do not mix ACC classic with solutions containing other medications.
Do not take before bedtime due to difficult expectoration of thinned-out secretions during sleep. The last dose of ACC classic should be taken no later than 4 hours before bedtime.

• 1. Open the child-resistant bottle by pressing the cap with your hand and turning it to the left.
• 2. Insert the attached perforated connector into the neck of the bottle. If it is not possible to insert the connector all the way, you can put on the protective cap and turn it. The connector connects the measuring cup to the bottle and should be left in the bottle neck.
• 3. Press the plunger of the measuring cup firmly into the bottle until it stops.
• 4. Carefully turn the bottle upside down, pull the plunger of the measuring cup, and draw the prescribed amount of solution (in milliliters) into it. If air bubbles are visible in the solution, the contents of the measuring cup should be returned to the bottle and the measuring cup should be filled slowly again. If the prescribed amount of solution is more than 5 ml, the measuring cup should be filled again.
• 5. Turn the bottle back and remove the measuring cup from the perforated connector.
• 6. The contents of the measuring cup can be administered directly to the child or poured into a spoon before administration. When taking the medication from the measuring cup, the child should be in a sitting position. The measuring cup is best emptied slowly, directing its end towards the inner side of the cheek.
• 7. Close the bottle tightly after use.

The measuring cup should be rinsed with water after administration by repeatedly drawing and releasing water.
Long-term contact between the oral solution ACC classic and metals or rubber should be avoided.

Note: After the first opening of the bottle, the medication can be stored for a maximum of 11 days at a temperature below 25°C.

Taking a higher dose of ACC classic than recommended

In case of taking too much medication, you should consult your doctor or pharmacist.
It is possible to experience gastrointestinal symptoms, such as nausea, vomiting, and diarrhea.

Missing a dose of ACC classic

If the medication is taken regularly and it has not been long since the missed dose was supposed to be taken, it should be taken as soon as possible. If the time for the next dose is approaching, it should be taken at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further doubts about using this medication, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, you should stop taking ACC classic 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 (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, stomatitis
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)
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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store ACC classic

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and label after: EXP.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
The shelf life of the medication after the first opening of the bottle is 11 days when stored below 25°C.
Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ACC classic contains

• The active substance is acetylcysteine. 1 ml of oral solution contains 20 mg of acetylcysteine.
• The other ingredients of the medication are: caramel color, methyl parahydroxybenzoate (E 218), sodium benzoate (E 211), sodium edetate, sodium hydroxide (10% aqueous solution), sodium saccharin, purified water, cherry flavor (contains, among others, benzyl alcohol and propylene glycol (E 1520)).

What ACC classic looks like and what the pack contains

ACC classic is a clear, slightly viscous solution with a cherry flavor.
The medication is available in orange glass bottles with a polypropylene cap and a tear-off seal, in a cardboard box, containing 100 or 200 ml of oral solution.
A polypropylene measuring cup (for measuring 2.5, 5, and 10 ml) or a polypropylene measuring spoon with a plunger made of HDPE (for measuring 5 ml of medication) is attached to the packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, GermanySandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

{Logo Sandoz}