Acc optima

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

ACC optima(Acetylcysteine Hexal)

600 mg, effervescent tablets

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

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by your 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 if 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 taking ACC optima
• 3. How to take ACC optima
• 4. Possible side effects
• 5. How to store ACC optima
• 6. Contents of the pack 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 it easier to cough them 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 taking ACC optima

When not to take 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 allergic reaction 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 taking ACC optima and contact their doctor immediately;
• if the patient has active peptic ulcer disease;
• if the patient has acute asthma (exacerbation of bronchial asthma or chronic obstructive pulmonary disease);
• if the patient has been diagnosed with galactose intolerance (see section "ACC optima contains lactose and sodium").

This medicine should not be taken by children under 14 years of age.

Warnings and precautions

Before taking 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;
• the patient has a history of peptic ulcer disease;
• 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 entails);
• 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 taking 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 taking or have recently taken, as well as any medicines they plan to take.

• ACC optima should not be taken 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 the antibiotic .This does not apply to antibiotics such as cefixime, loracarbef, amoxicillin, doxycycline, erythromycin, tiamfenicol, 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 undergo salicylate testing in blood or urine or ketone body testing 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 taking 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 and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. One effervescent tablet of ACC optima contains 70 mg of lactose.
Information for diabetic patients:
1 tablet contains less than 0.01 BU (carbohydrate exchange unit).
ACC optima contains 139 mg of sodium (the main component of common salt) in one effervescent tablet.
This corresponds to 6.95% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take ACC optima

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of 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 taken by children under 14 years of age.
Without the doctor's recommendation, the medicine should not be taken 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 taken no later than 4 hours before bedtime due to the difficulty in expectorating thinned secretions during sleep.
Longer 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 has not been long since the missed dose was supposed to be taken, it should be taken as soon as possible. If the time for the next dose is approaching, 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 taking 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 taking 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, stomatitis
• 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)
• 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 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 or 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:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help 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.
• Do not store above 30°C. Store in the original packaging to protect from moisture.
• The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The shelf life after first opening the tube is 2 years.
• 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 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, sodium citrate, blackcurrant flavor.

What ACC optima looks like and contents of the pack

ACC optima is a white, round effervescent tablet with a dividing line on one side.
A PP tube with a PE plug in a cardboard box contains 10 effervescent tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Hexal Pharma GmbH
Stella-Klein-Löw-Weg 17
1020 Vienna
Austria

Manufacturer:

Salutas Pharma GmbH
39179 Barleben, Germany
Hermes Pharma GmbH
82515 Wolfratshausen, Germany
Hermes Pharma GmbH
9400 Wolfsberg, Austria

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
IVA Pharm Sp. z o.o.
Drawska 14/1 Street
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Austrian marketing authorization number: 1-20643
Parallel import authorization number: 7/21

Date of leaflet approval: 02.06.2023

[Information about the trademark]