PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
ACC optima (ACC long)
600 mg, effervescent tablets
Acetylcysteinum
ACC optima and ACC long are different brand names for the same medicine.
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
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 side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 4 to 5 days, you should contact your doctor.

Contents of the leaflet

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 liquefy respiratory secretions and facilitate their expectoration in patients with bronchitis associated with the common cold.

2. Important information before using the medicinal product ACC optima

When not to use ACC optima

if the patient is allergic to acetylcysteine or to any of the other ingredients of this medicinal product (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, use of ACC optima must be stopped immediately and medical advice must be sought.
if the patient has active peptic ulcer disease of the stomach or duodenum;
if the patient is experiencing an acute asthmatic attack (exacerbation of bronchial asthma or chronic obstructive pulmonary disease);
if the patient has been diagnosed with lactose intolerance (see section "ACC optima contains lactose, sodium and sorbitol").

The medicinal product 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 has suffered from or currently suffers from bronchial asthma, as the medicinal product may cause bronchospasm and shortness of breath. Patients with bronchial asthma must be under close medical supervision during treatment. If bronchospasm occurs, the use of the medicinal product must be stopped immediately and medical help must be sought urgently;
the patient has previously been diagnosed with peptic ulcer disease, especially if other medicines irritating the gastrointestinal mucosa are used concomitantly;
the patient currently has or has previously had respiratory insufficiency;
the patient has difficulty expectorating (respiratory physiotherapy may be necessary – your doctor will provide information on what this involves);
the patient has been diagnosed with histamine intolerance (prolonged use of the medicinal product 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 must stop taking the medicinal product and seek immediate medical advice (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 medicinal products (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 medicinal products must not be used in children under 2 years of age.
ACC optima and other medicinal products
Inform your doctor or pharmacist about all medicinal products currently taken or recently taken, as well as any medicinal products the patient intends to use.

Do not use ACC optima simultaneously with antitussive medicinal products, 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 an 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 glyceryl trinitrate and other nitrates (medicinal products used in cardiovascular diseases and ischaemic heart disease). During concomitant use of these medicinal products, the doctor will monitor whether the patient develops hypotension. Headache may occur. If the patient is taking glyceryl trinitrate or another nitrate with similar action, 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 medicinal products.

Effect of ACC optima on laboratory tests
If the patient is to undergo blood or urine salicylate testing or urine ketone body testing, inform the doctor and medical staff about the use of ACC optima.
ACC optima with food and drink
The medicinal product 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 woman 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 medicinal product.
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
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicinal product.

Each effervescent tablet of ACC optima contains 70 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicinal product.

Information for diabetic patients:
1 tablet contains less than 0.01 carbohydrate exchange unit (CEU).

ACC optima contains 139 mg of sodium per dose, which should be taken into account in patients with impaired renal function and in patients controlling sodium intake in their diet (low-sodium or salt-free diet).
ACC optima contains up to 40.0 mg of sorbitol per dose.

3. How to use ACC optima

This medicine should always be taken exactly as described in this patient information leaflet or as directed 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 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.
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.
Avoid taking the medicine 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, consult 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 it is not long since the missed dose was due, 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 missed dose.
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 any of the symptoms listed below occur in a patient, 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, 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
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 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 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 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.
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. After first opening – 2 years.
Translation of information on the tube: Ch.-B./verwendbar bis siehe Röhrchenboden – Batch number and expiry date are embossed on the bottom of the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package 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, lactose, ascorbic acid, sodium saccharin dihydrate, sodium cyclamate, sodium citrate, raspberry flavour “B”.

What ACC optima looks like and contents of the pack
ACC optima is a white, round tablet with a break line on one side.
The product comes in a polypropylene tube with a polyethylene closure and a moisture-absorbing agent, packed 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:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
Number of marketing authorisation in Germany, the country of export: 13776.02.00
Number of parallel import authorisation: 326/19