Acc optima

Package leaflet: 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
Acetylcysteinum
ACC optima and ACC long are different trade names for the same medicine.
Please read the 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
your 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 you feel worse after 4 to 5 days, consult your doctor.

Contents of the leaflet

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 thin 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 is experiencing an acute asthmatic attack (exacerbation of bronchial asthma or chronic obstructive pulmonary disease);
• if the patient has galactose intolerance (see section "ACC optima contains lactose, sorbitol and sodium").

Do not use this medicine in children under 14 years of age.
Warnings and precautions
Before taking ACC optima, consult a doctor or pharmacist if:

• the patient has had or suffers from chronic bronchial asthma, as the medicine may cause bronchospasm and shortness of breath;
• the patient has previously been diagnosed with peptic ulcer disease;
• 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 this);
• 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, discontinue use of the medicine and consult a doctor immediately (see section 4).
ACC optima and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

• Do not take ACC optima simultaneously with antitussive medicines, as they suppress the cough reflex and may impair the expectoration of mucus 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 taking an antibiotic. 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 the patient develops arterial hypotension. Headache may occur. If the patient is taking nitroglycerin or another similarly acting nitrate medicine, 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 scheduled for blood or urine salicylate testing or urine ketone testing, inform the doctor and medical staff about the use of ACC optima.
ACC optima with food and drink
Take the medicine after meals. During treatment, drink an adequate amount of fluids (at least 1.5 litres daily).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
ACC optima may be used during pregnancy and breastfeeding only if the doctor considers it necessary.
Driving and operating machinery
The effect of ACC optima on the ability to drive or operate machinery is unknown.
ACC optima contains lactose, sorbitol and sodium

• Each effervescent tablet of ACC optima contains 70 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

• The medicine contains up to 40 mg of sorbitol in each effervescent tablet.
• ACC optima contains 138.8 mg of sodium (main component of table salt) in 1 effervescent tablet. This corresponds to 6.9% of the maximum recommended daily intake of sodium 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 a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 14 years of age
1 effervescent tablet of ACC optima once daily (600 mg of 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 be taken no later than 4 hours before bedtime due to difficulty in expectorating the liquefied secretion during sleep.
Prolonged contact of the prepared oral solution with metals and rubber should be avoided.
Overdose of ACC optima
In case of taking more than the recommended dose, seek advice from a doctor or pharmacist. Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
Missed dose of ACC optima
If the medicine is taken regularly and only a short time has passed since the missed dose, take it as soon as possible. If the next dose is approaching, 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 will experience them.
If any of the symptoms listed below occur in the patient, discontinue use of
the medicine ACC optima immediately and seek medical help at once:

• anaphylactic reaction or anaphylactoid reaction (a type of sudden allergic reaction) with symptoms such as sudden wheezing, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat, urticaria, itching;
• angioedema (severe allergic reaction) with swelling of the skin and (or) mucous membranes, e.g. in the area of 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 less than 1 out of 100 people):

• hypersensitivity reactions (allergic reactions)
• headache
• tinnitus
• increased heart rate (tachycardia)
• low blood pressure
• nausea, vomiting, diarrhoea, abdominal pain, stomatitis
• urticaria, rash, itching, angioedema
• fever

Rare adverse reactions (may occur in less than 1 out of 1,000 people):

• dyspepsia
• dyspnoea, bronchospasm

Very rare adverse reactions (may occur in less than 1 out of 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 and toxic epidermal necrolysis (see above)
• bleeding

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• facial swelling

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine 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 this 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What ACC optima contains

• The active substance is acetylcysteine. One effervescent tablet contains 600 mg of acetylcysteine.
• Other ingredients are: citric acid, sodium bicarbonate, sodium carbonate, mannitol, lactose, ascorbic acid, sodium saccharin, sodium cyclamate, sodium citrate, raspberry flavour “B” (containing sorbitol).

What ACC optima looks like and contents of the pack
ACC optima is white, round effervescent tablets with a breakline on one side.
The pack consists of a polypropylene tube with a polyethylene closure and a moisture-absorbing agent, placed in a cardboard box containing 10 effervescent tablets.
For more detailed 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
Parallel importer:
PharmaVitae Sp. z o.o. Sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Marketing Authorisation Number in Germany, the country of export: 13776.02.00
Parallel Import Licence Number: 354/17