Acc optima

Leaflet attached to the packaging: patient information

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 ACC longare 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 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 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 packaging 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 facilitate the expectoration of bronchial secretions in patients with bronchitis associated with a cold.

2. Important information before using ACC optima

When not to use ACC optima

• if the patient is allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergy may include: itching, hives, rash, bronchospasm (shortness of breath), rapid heartbeat, and low blood pressure. If any of these symptoms occur, the patient should stop using ACC optima and contact their doctor immediately.
• if the patient has an active stomach or duodenal ulcer;
• if the patient has an acute asthmatic condition (exacerbation of bronchial asthma or chronic obstructive pulmonary disease); if the patient has been diagnosed with galactose intolerance (see "ACC optima contains lactose, sorbitol, and sodium").

The 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 or has had bronchial asthma, as the medicine may cause bronchospasm and shortness of breath in them;
• the patient has a history of stomach ulcers;
• the patient currently has or has had respiratory failure;
• the patient has a problem with expectoration (physiotherapy may be necessary - 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, nasal discharge, itching);
• the patient is elderly (over 65 years of age).

If the patient experiences skin or mucous membrane changes while using the medicine, they should stop taking it and consult their doctor immediately (see section 4).

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 use.

• 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 expectorate the secretions thinned by ACC optima.
• 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 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 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 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 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 about 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 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 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, sorbitol, and sodium

• An 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 effervescent tablet contains less than 0.01 BU (carbohydrate exchange unit).

• The medicine contains a maximum of 40 mg of sorbitol in each effervescent tablet.
• ACC optima contains 138.8 mg of sodium (the main component of table salt) in 1 effervescent tablet, which corresponds to 6.9% of the maximum recommended daily intake of sodium in the diet for adults.

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, ACC optima 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 expectorating thinned secretions during sleep.
The patient should avoid prolonged contact between the prepared oral solution and metals or rubber.

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, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should take it at the usual time. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about using 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 sudden allergic reaction) with symptoms such as sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat, hives, itching;
• angioedema (a 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 mucositis
• 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)
• a 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they 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
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, it is possible to 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 stated on the packaging is the last day of the given month.
The shelf life after opening the tube is 2 years, but no longer than the expiry date of the medicine.

• 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 packaging 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, sodium cyclamate, sodium citrate, blackcurrant flavor "B" (contains sorbitol).

What ACC optima looks like and what the packaging contains

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

PharmaVitae Sp. z o.o. Sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND JOINT-STOCK COMPANY, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
German marketing authorization number:13776.02.00
Parallel import authorization number:354/17
Date of leaflet approval: 17.10.2022