Acc optima

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

ACC optima (Acetylcysteine Hexal 600 mg), 600 mg, effervescent tablets

Acetylcysteine
ACC optima and Acetylcysteine Hexal 600 mg 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, pharmacist, or nurse.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 4 to 5 days, 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 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 thin bronchial secretions and make them easier to cough up in patients with bronchitis associated with a cold.

2. Important information before taking ACC optima

When not to take ACC optima

The 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 difficulty 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 the patient experiences skin or mucous membrane changes while taking the medicine, they should stop taking it and seek medical attention 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 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 cough up the thinned secretions.
• Acetylcysteine (the active substance in 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. If in doubt, the patient should consult their doctor.
• ACC optima may enhance the effect of nitroglycerin and other nitrates (medicines used to treat cardiovascular diseases and coronary heart disease). When taking these medicines together, the doctor will monitor the patient to ensure they do not develop low blood pressure. Headache may occur. If the patient is taking nitroglycerin or another similar medicine, 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 plenty 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 contact their doctor before taking the medicine.
Information for diabetic patients:
1 effervescent tablet contains less than 0.01 BU (bread unit).
The medicine contains 139 mg of sodium (the main component of common salt) per 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. 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 taken by children under 14 years of age.
Without a doctor's recommendation, ACC optima 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 coughing up thinned secretions during sleep.
Contact between the prepared oral solution and metals or rubber should be avoided.

Taking a higher dose of ACC optima than recommended

If a higher dose of the medicine is taken 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 almost time for the next dose, the missed dose should be taken as soon as possible. If it is already close to the time for the next dose, the patient should take the next dose at the usual time. A double dose should not be taken to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they 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 attention 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 (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)
• severe skin and mucous membrane changes, 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 inform 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store ACC optima

• The medicine should be stored out of sight and reach of children.
• It should not be stored at a temperature above 30°C. It should be stored in the original packaging to protect it 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 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 of the medicine are: ascorbic acid, citric acid, sodium bicarbonate, sodium carbonate, mannitol, lactose, sodium cyclamate, sodium saccharin, sodium citrate, blackcurrant flavor.

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 PP tube with a PE cap 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 Austria, the country of export:

Hexal Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Vienna, Austria

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian export license number: 1-20643

Parallel import license number: 100/08

Date of leaflet approval: 20.09.2023

[Information about the trademark]