Acc mini

Package Leaflet: Information for the Patient

ACC mini, 100 mg, Powder for Oral Solution

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 those not listed in the leaflet, they should inform their doctor or pharmacist. 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 mini and what is it used for
• 2. Important information before taking ACC mini
• 3. How to take ACC mini
• 4. Possible side effects
• 5. How to store ACC mini
• 6. Contents of the pack and other information

1 What is ACC mini and what is it used for
The powder for oral solution ACC mini contains the active substance acetylcysteine - a medicine that primarily reduces the viscosity of bronchial secretions and facilitates expectoration.
ACC mini is used for a short period 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 mini

When not to take ACC mini

if the patient is hypersensitive to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
Symptoms of hypersensitivity may include: itching, hives, rash, bronchospasm (shortness of breath), tachycardia, and hypotension. If any of these symptoms occur, the patient should stop taking ACC mini and consult a doctor immediately.
if the patient has active peptic ulcer disease.
if the patient has acute asthma (exacerbation of bronchial asthma or chronic obstructive pulmonary disease).
if the patient has been diagnosed with fructose intolerance (see section "ACC mini contains sucrose").
The medicine should not be used in children under 3 years of age.

Warnings and precautions

Before taking ACC mini, the patient should discuss it with their doctor or pharmacist if:
they have had or currently have 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 difficulty expectorating (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, the patient should stop taking the medicine and consult a doctor immediately (see section 4).

ACC mini 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 mini 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 secretions thinned by ACC mini.
Acetylcysteine (the active substance of ACC mini) may reduce the effectiveness of some antibiotics (especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides). To avoid this, ACC mini 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 mini 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 mini.
Large amounts of activated charcoal may reduce the effectiveness of ACC mini.
It is not recommended to dissolve ACC mini in solutions containing other medicines.
Effect of ACC mini on laboratory tests
If the patient is to undergo a test for salicylates in blood or urine or ketone bodies in urine, they should inform their doctor and medical staff about taking ACC mini.

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

Driving and using machines

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

ACC mini contains sucrose

The medicine contains sucrose, which includes fructose and glucose. 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 sachet (3 g of powder) contains 0.24 BU (bread unit).

3. How to take ACC mini

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The usual dosage is:
Adults and adolescents over 14 years of age
The contents of 2 sachets of ACC mini 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 7 to 14 years of age
The contents of 1 sachet of ACC mini 4 times a day or the contents of 2 sachets of ACC mini 2 times a day (corresponding to 400 mg of acetylcysteine per day in 2 or 4 divided doses).
Children from 3 to 6 years of age
1 sachet of ACC mini 2 or 3 times a day (200 mg to 300 mg of acetylcysteine per day in 2 or 3 divided doses).
ACC mini should not be used in children under 3 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 mini with food and drink"). The contents of the sachet should be dissolved in a cold liquid (water, juice, tea, etc.) and taken immediately after dissolution.
The contents of the sachet should not be dissolved in solutions containing other medicines.
The medicine should not be taken before bedtime due to difficulty in expectorating thinned secretions during sleep. The last dose of ACC mini should be taken no later than 4 hours before bedtime.
Prolonged contact between the prepared oral solution and metals or rubber should be avoided.

Taking a higher dose of ACC mini than recommended

In case of taking too much medicine, the patient should consult their doctor or pharmacist.
Gastrointestinal symptoms such as nausea, vomiting, diarrhea, abdominal pain, and stomatitis may occur.

Missing a dose of ACC mini

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 already close to the 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 taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following symptoms, they should stop taking ACC mini 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 (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
tachycardia
hypotension
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 the available data):
facial swelling
Reporting side effects
If the patient experiences any side effects, including those not listed in the leaflet, they should inform 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store ACC mini

The medicine should be stored out of sight and reach of children.
Store in a temperature below 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 mini contains

• The active substance of ACC mini is acetylcysteine. 1 sachet (3 g of powder) contains 100 mg of acetylcysteine.
• The other ingredients of the medicine are: sucrose, ascorbic acid, saccharin, orange flavor.

What ACC mini looks like and what the pack contains

ACC mini is a white to yellowish powder with partial agglomeration.
The pack contains 20 sachets of 3 g each.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
For more detailed information, please 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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