PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
ACC optima (Acetylcystein Hexal)
600 mg, effervescent tablets
Acetylcysteinum
ACC optima and Acetylcystein Hexal are different trade names for the same medicine.
Please read the following information carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 4 to 5 days, consult your doctor.

Table of contents of the leaflet:

What ACC optima is and what it is used for
What you need to know before taking ACC optima
How to take ACC optima
Possible side effects
How to store ACC optima
Contents of the pack and other information

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

ACC optima contains the active substance acetylcysteine. Acetylcysteine reduces the viscosity
of bronchial secretions and facilitates expectoration.
ACC optima is used as a mucolytic agent to thin respiratory secretions and assist in their
expectoration in patients with bronchitis associated with the common cold.

2. Important information before using ACC optima

When not to use ACC optima

if the patient is allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6); symptoms of allergy may include: itching, urticaria, rash, bronchospasm (shortness of breath), rapid heartbeat and low blood pressure. If any of these symptoms occur, the use of ACC optima must be stopped immediately and the patient should contact a doctor;
if the patient has active peptic ulcer disease of the stomach or duodenum;
if the patient is experiencing an acute asthmatic episode (exacerbation of bronchial asthma or chronic obstructive pulmonary disease);
if the patient has been diagnosed with galactose intolerance (see section "ACC optima contains lactose, sodium, sorbitol and glucose (component of maltodextrin)"). The medicine should not be used in children under 14 years of age.

Warnings and precautions
Before using ACC optima, consult a doctor or pharmacist if:

the patient has suffered from or currently suffers from bronchial asthma, as the medicine may cause bronchospasm and shortness of breath. A patient with bronchial asthma must be under strict medical supervision during treatment. If bronchospasm occurs, the use of the medicine must be stopped immediately and immediate medical help sought;
the patient has previously been diagnosed with peptic ulcer disease, especially if taking other medicines that irritate the gastrointestinal mucosa at the same time;
the patient currently has or has previously had respiratory insufficiency;
the patient has difficulty expectorating (respiratory physiotherapy may be necessary – the doctor will provide information on what this 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 seek immediate medical advice (see section 4).
Children and adolescents
Due to the content of the active substance, ACC optima should not be used in children under 14 years of age.
Mucolytic medicines (which liquefy respiratory secretions and reduce their viscosity) may cause narrowing (obstruction) or blockage of the airways in children under 2 years of age due to physiological characteristics of the respiratory tract and limited ability to expectorate in this age group. Therefore, mucolytic medicines should not be used in children under 2 years of age.
ACC optima with other medicines
Inform your doctor or pharmacist about any medicines currently taken, recently taken or planned to be taken.

ACC optima should not be used simultaneously with antitussive medicines, as they suppress the cough reflex and may hinder the expectoration of secretions liquefied by ACC optima.
Acetylcysteine (the active substance in ACC optima) may reduce the effectiveness of certain antibiotics (especially semi-synthetic penicillins, tetracyclines, cephalosporins and aminoglycosides). To prevent this, ACC optima 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, consult a doctor.
ACC optima may enhance the effect of nitroglycerin and other nitrates (medicines used in cardiovascular diseases and ischemic heart disease). When these medicines are used together, 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, medical advice should be sought before taking ACC optima.
Large amounts of activated charcoal may reduce the effectiveness of ACC optima.
It is not recommended to dissolve ACC optima in solutions containing other medicines.

Effect of ACC optima on laboratory tests
If the patient is to undergo blood or urine salicylate testing or urine ketone testing, inform the doctor and medical staff about taking ACC optima.
ACC optima with food and drink
The medicine should be taken after a meal. During treatment, an adequate amount of fluids should be consumed (at least 1.5 litres daily).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
ACC optima may be used during pregnancy and breastfeeding only if the doctor considers it necessary.
Driving and operating machinery
The effect of ACC optima on the ability to drive or operate machinery is unknown.
ACC optima contains lactose, sodium, sorbitol and glucose (component of maltodextrin)
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking the medicine.
Sodium
The medicine contains 139 mg of sodium (main component of table salt) per effervescent tablet. This corresponds to 6.95% of the maximum recommended daily intake of sodium in the adult diet.
Sorbitol
The medicine contains 0.12 mg of sorbitol (E 420) per effervescent tablet.
Glucose (component of maltodextrin)
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking the medicine.
Information for diabetic patients:
1 tablet contains less than 0.01 carbohydrate exchange unit (CEU).

3. How to use ACC optima

This medicine should always be taken exactly as described in this patient leaflet or as advised by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents over 14 years of age
1 effervescent tablet of ACC optima once daily (600 mg of acetylcysteine per day).
ACC optima should not be used in children under 14 years of age.
Without medical advice, ACC optima should not be used for longer than 4 to 5 days.
Instructions for use:
The medicine should be taken after a meal (see "ACC optima with food and drink").
The effervescent tablet should be dissolved in half a glass of water and taken immediately after dissolution.
Do not dissolve the effervescent tablet in solutions containing other medicines.
Take no later than 4 hours before bedtime due to difficulty in expectorating the liquefied mucus during sleep.
Avoid prolonged contact of the prepared oral solution with metals and rubber.
If you take more ACC optima than you should
If you take more than the recommended dose, seek advice from your doctor or pharmacist immediately.
Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
If you forget to take ACC optima
If you are taking the medicine regularly and remember the missed dose shortly after the scheduled time,
take it as soon as possible. If it is almost time for the next dose, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten one.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the symptoms listed below, stop using the
medicine ACC optima and seek immediate medical help:

anaphylactic reaction or anaphylactoid reaction (a type of sudden allergic reaction) with symptoms such as sudden wheezing, breathing difficulties or dizziness, swelling of the eyelids, face, lips or throat, urticaria, itching;
angioedema (severe allergic reaction) with swelling of the skin and/or mucous membranes, e.g. in the face, limbs, joints;
development of skin and mucous membrane lesions, possibly accompanied by fever and joint pain;
bronchospasm (sudden shortness of breath).

Uncommon adverse reactions (may occur in less than 1 out of 100 people):

hypersensitivity reactions (allergic reactions)
headache
tinnitus
rapid heartbeat (tachycardia)
low blood pressure
nausea, vomiting, diarrhoea, abdominal pain, stomatitis
urticaria, rash, itching, angioedema
fever

Rare adverse reactions (may occur in less than 1 out of 1,000 people):

dyspepsia
dyspnoea, bronchospasm

Very rare adverse reactions (may occur in less than 1 out of 10,000 people):

anaphylactic reaction or anaphylactoid reaction up to anaphylactic shock (see above)
severe reaction affecting the skin and mucous membranes, which may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis (see above)
haemorrhage

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

facial swelling

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ACC optima

Keep the medicine out of sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month. Shelf life after first opening of the tube – 2 years.
Medicines must not be disposed of via wastewater or household waste. Ask your 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 optima contains

The active substance is acetylcysteine. One effervescent tablet contains 600 mg of acetylcysteine.
The other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, mannitol (E 421), lactose, ascorbic acid, sodium saccharin, sodium cyclamate, trisodium citrate, raspberry flavour.

What ACC optima looks like and contents of the pack
ACC optima is a white, round effervescent tablet with a break line on one side.
The pack consists of a PP tube with a PE cap, contained in a cardboard box, containing 10 effervescent tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Austria, the country of export:
Hexal Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Vienna
Austria
Manufacturer:
Salutas Pharma GmbH
39179 Barleben, Germany
Hermes Pharma GmbH
82515 Wolfrathshausen, Germany
Hermes Pharma GmbH
9400 Wolfsberg, Austria
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged by:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation number in Austria, the country of export: 1-20643
Parallel Import licence number: 7/21