ACC OPTIMA

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
ACC optima (ACC LONG)
600 mg, effervescent tablets
Acetylcysteinum
ACC optima and ACC LONG are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 4 to 5 days, consult your doctor.

Table of Contents

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

When not to use ACC optima

• if the patient is allergic to acetylcysteine or to any of the other ingredients of this medicine (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, administration of ACC optima must be stopped immediately and the patient should contact a doctor.
• if the patient has active peptic ulcer disease of the stomach or duodenum;
• if the patient has acute asthmatic attack (exacerbation of bronchial asthma or chronic obstructive pulmonary disease);
• if the patient has galactose intolerance (see section "ACC optima contains lactose and sodium").

ACC optima 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 suffers or has suffered from chronic bronchial asthma, as the medicine may cause bronchospasm and shortness of breath;
• the patient has had peptic ulcer disease in the past;
• the patient currently has or has had respiratory insufficiency in the past;
• the patient has difficulty expectorating (respiratory physiotherapy may be necessary – the doctor will provide information on how it is performed);
• the patient has histamine intolerance (prolonged use of the medicine may lead to 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 should stop taking the medicine and seek immediate medical advice (see section 4).
ACC optima and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.

• Do not use ACC optima simultaneously with antitussive medicines, 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 antibiotic administration. 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 nitroglycerin and other nitrates (medicines used in cardiovascular diseases and ischemic heart disease). When these medicines are used concomitantly, the doctor will monitor whether arterial hypotension develops. Headache may occur. If the patient is taking nitroglycerin or another medicine with similar action from the nitrate group, 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 medicines.

Effect of ACC optima on laboratory tests
If the patient is to undergo blood or urine salicylate testing or urine ketone testing, the doctor and medical staff should be informed about the use of ACC optima.
ACC optima with food and drink
The medicine should be taken after meals. During treatment, an adequate amount of fluids should be consumed (at least 1.5 litres daily).
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
ACC optima may be used during pregnancy and breastfeeding only if considered necessary by the doctor.
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
Each effervescent tablet of ACC optima contains 70 mg of lactose and sorbitol. If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking the medicine.
Information for diabetic patients:
1 tablet contains less than 0.01 carbohydrate exchange unit (CEU).
The medicine contains 139 mg of sodium (main component of table salt) per effervescent tablet. This corresponds to 6.95% of the maximum recommended daily sodium intake in the adult diet.

3. How to use ACC optima

This medicine should always be taken exactly as described in the patient 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 dissolving.
Do not dissolve the effervescent tablet in solutions containing other medicines.
Should not be taken later than 4 hours before bedtime due to difficulty in expectorating the liquefied secretion during sleep.
Avoid prolonged contact of the prepared oral solution with metals and rubber.
Taking more ACC optima than recommended
If you take more ACC optima than recommended, consult your doctor or pharmacist immediately. Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
Missing a dose of ACC optima
If you are taking the medicine regularly and realize shortly after the missed dose that you forgot it, 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 experiences them.
If any of the symptoms listed below occur in the patient, stop using the
ACC optima medicine 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, eyelid, facial, lip or throat swelling, 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 fewer 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 fewer than 1 in 1000 people):

• dyspepsia
• dyspnoea, bronchospasm

Very rare adverse reactions (may occur in fewer 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 symptoms occur, including any adverse symptoms not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to 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.
• Shelf life after first opening of the tube: 2 years, but not beyond the expiry date of the medicine.
• 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 pack and other information

What ACC optima contains

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, mannitol, lactose, ascorbic acid (vitamin C), sodium saccharin dihydrate, sodium cyclamate, sodium citrate, raspberry flavour (contains sorbitol).

What ACC optima looks like and contents of the pack
ACC optima is white, round effervescent tablets with a score line on one side.
The tube in the cardboard box contains 10 effervescent tablets.
For further 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
Hermes Arzneimittel Holding GmbH
Georg-Kalb-Str. 5 - 8
82049 Pullach i. Isartal
Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Germany, the country of export: 13776.02.00
Parallel Import Licence Number: 66/18