Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
ACC optima (ACC long), 600 mg, effervescent tablets
Acetylcysteinum
ACC optima and ACC long are different trade names for the same medicine.
Please read the entire leaflet 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 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, pharmacist, or nurse. See section 4.
If there is no improvement after 4 to 5 days, or if you feel worse, consult your doctor.

Table of Contents

What ACC optima is and what it is used for
Important information 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 aid expectoration in patients with bronchitis associated with the common cold.

2. Important information before using the medicine 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). Allergic reactions may include: itching, urticaria, rash, bronchospasm (shortness of breath), rapid heartbeat, and low blood pressure. If any of these symptoms occur, administration of ACC optima must be stopped immediately and the patient should contact a doctor.
if the patient has an active peptic ulcer 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 and sorbitol").

The medicine must 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 suffers or has suffered from chronic bronchial asthma, as the medicine may cause bronchospasm and shortness of breath. Patients with bronchial asthma must be under strict medical supervision during treatment. If bronchospasm occurs, the medicine must be discontinued immediately and medical help must be sought without delay;
the patient has a history of peptic ulcer disease, especially if taking other medicines that irritate the gastrointestinal mucosa;
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 this);
the patient has histamine intolerance (prolonged use of the medicine may lead to 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,
administration of the medicine must be stopped and the patient should immediately consult a doctor (see section 4).
Children and adolescents
Due to the content of the active substance, ACC optima must 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 must not be used in children under 2 years of age.
ACC optima with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.

Do not use ACC optima simultaneously with antitussive medicines, as they suppress the cough reflex and may hinder expectoration of the liquefied secretions caused 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 concomitantly, the doctor will monitor whether the patient develops hypotension. Headache may occur. If the patient is taking nitroglycerin or another medicine with similar action from the group of nitrates, 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 scheduled for blood or urine salicylate testing or urine ketone testing, the doctor and medical staff must be informed about the use of ACC optima.
ACC optima with food and drink
The medicine should be taken after meals. 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 baby, 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 and sorbitol
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
Sodium
The medicine contains 138.8 mg of sodium (main component of table salt) per effervescent tablet. This corresponds to 6.9% of the maximum recommended daily dietary sodium intake for adults.
Sorbitol
The medicine contains 0.12 mg of sorbitol in each effervescent tablet.

3. How to use ACC optima

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a 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 a doctor's recommendation, ACC optima should not be used for longer than 4 to 5 days.
Method of administration:
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.
Should be taken no later than 4 hours before bedtime due to difficulty in expectorating the liquefied secretions during sleep.
Avoid prolonged contact of the prepared oral solution with metals and rubber.
Accidental overdose of ACC optima
If more medicine has been taken than recommended, seek advice from a doctor or pharmacist. Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
Missed dose of ACC optima
If the medicine is taken regularly and only a short time has passed since the missed dose, it should be taken as soon as possible. If the time for the next dose is approaching, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur in a patient, discontinue use of
the medicine ACC optima and seek immediate medical assistance:

anaphylactic reaction or anaphylactoid reaction (a type of sudden allergic reaction) with symptoms such as sudden wheezing, difficulty breathing 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 in 100 people):

hypersensitivity reactions (allergic reactions)
headache
tinnitus
increased heart rate (tachycardia)
low blood pressure
nausea, vomiting, diarrhoea, abdominal pain, stomatitis
urticaria, rash, itching, angioedema
fever.

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

dyspepsia
dyspnoea, bronchospasm.

Very rare adverse reactions (may occur in less than 1 in 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 occurring with unknown frequency (frequency cannot be estimated from
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 be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine ACC optima

Keep the medicine out of sight and reach of children.
Store the tube tightly closed to protect it 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. The shelf life after first opening of the tube is 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 packaging and other information

What ACC optima contains
The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of
acetylcysteine.
The other ingredients are: ascorbic acid, citric acid, sodium hydrogen carbonate, sodium
carbonate, mannitol, lactose, sodium cyclamate, sodium saccharin, sodium citrate, raspberry
flavour “B” (containing sorbitol).
What ACC optima looks like and contents of the pack
ACC optima is a white, round tablet with a breakline on one side.
The packaging consists of a polypropylene tube with a polyethylene closure and a moisture-absorbing agent, contained in a cardboard box, containing 10 effervescent tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
Hexal AG
Industriestraße 25, 83607 Holzkirchen, Germany
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German marketing authorisation number, country of export: 13776.02.00
Parallel import authorisation number: 198/25