Acc optima

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

ACC optima(ACC long)

600 mg, effervescent tablets

Acetylcysteine
ACC optima and ACC long are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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 optima and what is it used for
• 2. Important information before using ACC optima
• 3. How to use ACC optima
• 4. Possible side effects
• 5. How to store ACC optima
• 6. Contents of the package and other information

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

ACC optima contains the active substance acetylcysteine. Acetylcysteine reduces the viscosity of bronchial secretions and makes them easier to cough up.
ACC optima is used as a mucolytic agent to thin bronchial secretions and make them easier to cough up in patients with bronchitis associated with a cold.

2. Important information before using ACC optima

When not to use ACC optima

This medicine should not be used in children under 14 years of age.

Warnings and precautions

Before using ACC optima, the patient should discuss it with their doctor or pharmacist if:

• the patient has had or currently has chronic bronchial asthma, as the medicine may cause bronchospasm and shortness of breath in them. Patients with bronchial asthma must be under close medical supervision during treatment. If bronchospasm occurs, the use of the medicine should be stopped immediately and medical help sought;
• the patient has had peptic ulcer disease in the past, especially if they are also taking other medicines that irritate the mucous membranes of the digestive tract;
• the patient currently has or has had respiratory failure in the past;
• the patient has a problem with coughing up (may require the use of so-called respiratory physiotherapy - the doctor will provide information on what it involves);
• the patient has been diagnosed with histamine intolerance (long-term use of the medicine may cause symptoms of intolerance, such as headache, runny nose, itching);
• the patient is elderly (over 65 years of age).

If skin or mucous membrane changes occur during the use of the medicine, the patient should stop taking it and consult a doctor immediately (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 agents (thinning bronchial secretions and reducing their viscosity) may cause bronchial obstruction or blockage in children under 2 years of age due to the physiological characteristics of the airways and limited ability to cough up in this age group. Therefore, mucolytic agents should not be used in children under 2 years of age.

ACC optima and other medicines

The patient should tell 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 optima should not be used at the same time as cough suppressants, as they may weaken the cough reflex and make it harder to cough up the thinned secretions.
• Acetylcysteine (the active substance of ACC optima) may reduce the effectiveness of some antibiotics (especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides). To avoid 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, the patient should consult their doctor.
• ACC optima 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 low blood pressure. 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 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 have a salicylate test in blood or urine or a ketone body test in urine, they should inform their doctor and medical staff that they are taking ACC optima.

ACC optima 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 a woman is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
ACC optima can be used during pregnancy and breastfeeding only if the doctor considers it necessary.

Driving and using machines

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

ACC optima contains lactose, sodium, and sorbitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

• The effervescent tablet of ACC optima contains 70 mg of lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

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

• ACC optima contains 139 mg of sodium per dose, which should be taken into account in patients with impaired renal function and in patients on a low-sodium diet (low-sodium or salt-free diet).
• ACC optima contains a maximum of 40.0 mg of sorbitol per dose.

3. How to use ACC optima

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adults and adolescents over 14 years of age

1 effervescent tablet of ACC optima once a day (600 mg of acetylcysteine per day).
ACC optima should not be used in children under 14 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 optima with food and drink").
The effervescent tablet should be dissolved in half a glass of water and taken immediately after dissolution.
The effervescent tablet should not be dissolved in solutions containing other medicines.
It should be used no later than 4 hours before bedtime due to the difficulty in coughing up thinned secretions during sleep.
Prolonged contact between the prepared oral solution and metals or rubber should be avoided.

Taking a higher dose of ACC optima than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur.

Missing a dose of ACC optima

If the medicine is taken regularly and it is not long since the missed dose was due to be taken, it should be taken as soon as possible. If it is almost time for the next dose, it should be taken 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 the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following symptoms, they should stop using ACC optima 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
• rapid heartbeat (tachycardia)
• low blood pressure
• nausea, vomiting, diarrhea, abdominal pain, oral inflammation
• hives, rash, itching, angioedema
• fever

Rare side effects (may occur in less than 1 in 1000 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 reaction, 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 side effects occur, including any side effects not listed in the leaflet, the patient should tell 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store ACC optima

• The medicine should be stored out of sight and reach of children.
• The tube should be kept tightly closed to protect it from moisture.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. After the first opening - 2 years.
• Translation of the information on the tube: Ch.-B./verwendbar bis siehe Röhrchenboden - The batch number and expiry date are embossed on the bottom of the tube.
• 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 package and other information

What ACC optima contains

• The active substance of ACC optima is acetylcysteine. 1 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, blackcurrant flavor "B".

What ACC optima looks like and what the package contains

ACC optima is a white, round effervescent tablet with a dividing line on one side.
The polypropylene tube with a polyethylene closure and a desiccant, in a cardboard box, contains 10 effervescent tablets.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization 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.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Marketing authorization number in Germany, the country of export: 13776.02.00
Parallel import authorization number: 326/19

Date of leaflet approval: 19.08.2024

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