Acc optima

Package Leaflet: Information for the Patient

ACC optima, 600 mg, Effervescent Tablets

Acetylcysteine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Package 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 package 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 taking ACC optima

When not to take ACC optima

if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: itching, hives, rash, bronchospasm (shortness of breath), rapid heartbeat, and low blood pressure. If any of these symptoms occur, stop taking ACC optima and contact your doctor immediately; if you have active peptic ulcer disease of the stomach or duodenum; if you have acute asthma (exacerbation of bronchial asthma or chronic obstructive pulmonary disease); if you have been diagnosed with galactose intolerance (see section "ACC optima contains lactose, sodium, sorbitol, and glucose (a component of maltodextrin)"). The medicine should not be taken by children under 14 years of age.

Warnings and precautions

Before taking ACC optima, discuss with your doctor or pharmacist if: you have had or currently have chronic bronchial asthma, as the medicine may cause bronchospasm and shortness of breath in you. Patients with bronchial asthma must be under close medical supervision during treatment. If bronchospasm occurs, stop taking the medicine and seek medical help immediately; you have had peptic ulcer disease in the past, especially if you are taking other medicines that irritate the mucous membranes of the gastrointestinal tract; you currently have or have had respiratory failure; you have a problem with expectoration (you may need to use so-called respiratory physiotherapy - your doctor will provide information on what it involves); you have been diagnosed with histamine intolerance (long-term use of the medicine may cause symptoms of intolerance, such as headache, nasal discharge, itching); you are elderly (over 65 years old). If you experience skin or mucous membrane changes while taking the medicine, stop taking it and consult your doctor immediately (see section 4).

Children and adolescents

Due to the content of the active substance, ACC optima should not be taken by children under 14 years of age. Mucolytic agents (which thin bronchial secretions and reduce their viscosity) can cause airway obstruction or blockage in children under 2 years of age due to the physiological characteristics of the airways and limited expectoration ability in this age group. Therefore, mucolytic agents should not be taken by children under 2 years of age.

ACC optima and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Do not take ACC optima at the same time as cough suppressants, as they may weaken the cough reflex and make it difficult to expectorate the thinned secretions. 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, take ACC optima 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, consult your 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, your doctor will monitor whether you develop low blood pressure. Headache is possible. If you are taking nitroglycerin or another similarly acting medicine from the nitrate group, consult your 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 you are to have a salicylate test in blood or urine or a ketone body test in urine, inform your doctor and medical staff that you are taking ACC optima.

ACC optima with food and drink

Take the medicine after a meal. During treatment, drink a sufficient amount of fluids (at least 1.5 liters per day).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. ACC optima can be taken during pregnancy and breastfeeding only if your 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, sodium, sorbitol, and glucose (a component of maltodextrin)

Lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Sodium

The medicine 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.

Sorbitol

The medicinal product contains 0.12 mg of sorbitol (E 420) in each effervescent tablet.

Glucose (a component of maltodextrin)

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine. Information for diabetics: 1 effervescent tablet contains less than 0.01 BU (bread unit).

3. How to take ACC optima

Always take this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Adults and adolescents over 14 years of age1 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, do not take ACC optima for more than 4 to 5 days. Method of administration: Take the medicine after a meal (see "ACC optima with food and drink"). Dissolve the effervescent tablet in half a glass of water and drink immediately after dissolution. Do not dissolve the effervescent tablet in solutions containing other medicines. Take no later than 4 hours before bedtime due to difficult expectoration of thinned secretions during sleep. Avoid prolonged contact of the prepared oral solution with metals and rubber.

Taking a higher dose of ACC optima than recommended

If you have taken a higher dose of the medicine than recommended, consult your doctor or pharmacist. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur.

Missing a dose of ACC optima

If you are taking the medicine regularly and it is almost time for the next dose, take the missed dose as soon as possible. If it is already close to the time for the next dose, take it at the usual time. Do not take a double dose to make up for the missed dose. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ACC optima can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking ACC optima and seek medical help immediately:

anaphylactic reaction or anaphylactoid reaction (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, or 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): allergic reactions headache tinnitus rapid heartbeat low blood pressure nausea, vomiting, diarrhea, abdominal pain, oral thrush 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 anaphylactoid reaction, up to anaphylactic shock (see above) 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 you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACC optima

Keep the medicine out of the sight and reach of children. Do not store above 30°C. Keep the tube tightly closed to protect from moisture. Do not take the medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. Medicines should 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 package and other information

What ACC optima contains

• The active substance is acetylcysteine. One effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, mannitol (E 420), lactose, anhydrous, ascorbic acid, sodium saccharin, sodium cyclamate, sodium citrate dihydrate, blackcurrant flavor "B" (contains, among others, maltodextrin, propylene glycol (E 1520), mannitol (E 421), and sorbitol (E 420)).
• 1520), mannitol (E 421) and sorbitol (E 420).

What ACC optima looks like and contents of the package

ACC optima is a white, round tablet with a dividing line on one side. A polypropylene tube in a cardboard box contains 10 effervescent tablets. A soft plastic/aluminum blister in a cardboard box contains 10 effervescent tablets.

Marketing authorization holder

Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany Hermes Pharma GmbH Hans-Urmiller-Ring 52 82515 Wolfratshausen Germany For more detailed information, please contact: Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Date of last revision of the package leaflet:
{Logo Sandoz}