Acc Optima Active

Package Leaflet: Information for the Patient

ACC Optima Active, 600 mg, Oral Powder in Sachet

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 the package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.
• The medicine ACC Optima Active should not be taken without a doctor's recommendation for more than 14 days.
• 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 Package Leaflet

• 1. What is ACC Optima Active and what is it used for
• 2. Important information before taking ACC Optima Active
• 3. How to take ACC Optima Active
• 4. Possible side effects
• 5. How to store ACC Optima Active
• 6. Contents of the pack and other information

1. What is ACC Optima Active and what is it used for

ACC Optima Active contains the active substance acetylcysteine, which thins the thick mucus in the airways.
ACC Optima Active is used to thin mucus and make it easier to cough up
in patients with respiratory diseases that produce thick mucus.
The medicine should only be taken by adults.

2. Important information before taking ACC Optima Active

When not to take ACC Optima Active

if the patient is allergicto acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
The medicine should not be taken by children under 2 years of age.

Warnings and precautions

Before taking ACC Optima Active, the patient should discuss it with their doctor or pharmacist if they:
have skin lesions
During treatment with acetylcysteine, very rare severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been reported. If new skin lesions or mucous membrane lesions occur, the patient should stop taking the medicine and seek medical attention immediately.
have bronchial asthma
currently have or have had stomach or intestinal ulcers;
are allergic to histamine
The patient should avoid taking ACC Optima Active for a longer period, as the medicine affects histamine metabolism and may cause intolerance symptoms (e.g., headache, vasomotor rhinitis, itching).
do not tolerate fructose, as the medicine contains sorbitol
have phenylketonuria, as the medicine contains a component that is a source of phenylalanine
have problems with coughing up mucus
Taking ACC Optima Active, especially at the beginning of treatment, may cause thinning and increased production of bronchial mucus. If the patient is unable to cough up the mucus, the doctor will take appropriate action.
ACC Optima Active should not be taken by patients with liver or kidney failure to avoid additional administration of nitrogen compounds to the body.

Children and adolescents

In children under 2 years of age, mucolytics (medicines that thin and liquefy mucus in the airways) may cause airway narrowing due to the characteristics and function of the airways in this age group and limited ability to cough up mucus. Therefore, mucolytics should not be taken by children under 2 years of age.
ACC Optima Active is not intended for use in children and adolescents. For these patients, the medicine is available in other pharmaceutical forms.

ACC Optima Active 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. This is especially important for the following medicines:
cough suppressants
Taking ACC Optima Active and cough suppressants at the same time may cause dangerous accumulation of mucus due to reduced cough reflex. The use of these medicines requires careful diagnosis of the type of cough. Before taking such a combination of medicines, the patient should consult their doctor.
antibiotics
To avoid the effect of antibiotics on the efficacy of acetylcysteine, the patient should wait at least 2 hours between taking the two medicines. This does not apply to medicines whose active substance is cefixime or loracarbef. Due to the lack of interaction, these medicines can be taken at the same time as acetylcysteine.
activated charcoal
Activated charcoal may reduce the effect of acetylcysteine.
glyceryl trinitrate (nitroglycerin)
When taking glyceryl trinitrate and acetylcysteine at the same time, the dilation of blood vessels and reduction of platelet activity are enhanced. The doctor will monitor whether the patient experiences a decrease in blood pressure (which may be significant), which may be indicated by a headache.

Lab tests

If the patient is to undergo the listed tests, they should inform their doctor about taking ACC Optima Active, as it may affect the test results:

• salicylates: medicines used to treat pain, inflammation, or rheumatism,
• ketone bodies in urine.

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.

Pregnancy

Due to insufficient experience with the use of acetylcysteine in pregnant women, ACC Optima Active can be taken during pregnancy only if the doctor considers it absolutely necessary.

Breastfeeding

There is no available data on the penetration of acetylcysteine into breast milk, so ACC Optima Active can be taken during breastfeeding only if the doctor considers it absolutely necessary.

Driving and using machines

It is not known whether ACC Optima Active affects the ability to drive or use machines, or if this effect is insignificant.

ACC Optima Active contains aspartame, sorbitol, and sodium

This medicine contains 0.5 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.
This medicine contains up to 527 mg of sorbitol in each sachet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take ACC Optima Active

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is taken only by adults.
If the doctor has not recommended otherwise, the recommended dose is 1 sachet once a day.

Method of administration

The oral powder contained in one sachet of ACC Optima Active should be poured directly onto the tongue. The powder stimulates saliva production, making it easy to swallow.
Note: the oral powder should not be chewed before swallowing.
Water is not necessary to swallow the powder.
It is not recommended to dissolve ACC Optima Active with other medicines.
Note:
A possible sulfur smell does not indicate changes in the medicinal product but is characteristic of the active substance of this product.
Patient with advanced age and weakened patients
Patients with weakened cough reflex (patients with advanced age and weakened patients) should take the medicine preferably in the morning.

Duration of treatment

• ACC Optima Active should not be taken for more than 14 days without a doctor's recommendation.
• If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Taking a higher dose of ACC Optima Active than recommended

Overdose of the medicine may cause stomach and intestinal irritation with symptoms such as abdominal pain, nausea, vomiting, diarrhea.
So far, no severe side effects or symptoms of poisoning have been observed, even after significant overdose. However, if an overdose of ACC Optima Active is suspected, the patient should consult their doctor.

Missing a dose of ACC Optima Active

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.
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 Active can cause side effects, although not everybody gets them.
If the patient experiences symptoms of an allergic reaction or a severe skin reaction, they should stop takingACC Optima Active and seek medical attention immediately.
Uncommonside effects (may occur in less than 1 in 100 people):
allergic reactions (itching and hives, severe swelling of the subcutaneous tissue [angioedema] and skin rash)
rapid heartbeat (tachycardia)
low blood pressure (hypotension)
headache
ringing in the ears (tinnitus)
inflammation of the mucous membrane of the mouth (stomatitis)
abdominal pain, nausea, vomiting, and diarrhea
fever
Rareside effects (may occur in less than 1 in 1000 people):
shortness of breath, bronchospasm (mainly in patients with hyperreactive airways in bronchial asthma)
digestive disorders (dyspepsia)
Very rareside effects (may occur in less than 1 in 10,000 people):
severe allergic reactions, up to anaphylactic shock
severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome*
bleeding (hemorrhage), partly related to hypersensitivity reactions
Side effects with unknown frequency(frequency cannot be estimated from the available data):
water accumulation in the face (facial edema)
reduced platelet aggregation
* Very rare severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in temporal association with the use of acetylcysteine. In most of these cases, the patient was taking at least one other medicine that could have exacerbated the disorders affecting the mucous membranes and skin.
If skin or mucous membrane lesions occur, the patient should stop taking acetylcysteine and seek medical attention immediately.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store ACC Optima Active

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the sachet and the carton after "EXP". The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste containers. 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 Active contains

• The active substance of the medicine is acetylcysteine. Each sachet contains 600 mg of acetylcysteine.
• The other ingredients are: tripalmitin, polysorbate 65, sorbitol (E 420), xylitol (E 967), citric acid, sodium dihydrogen citrate, magnesium citrate, sodium carmellose, aspartame (E 951), talc, blackberry flavor "Blackberry B" [contains vanillin, maltodextrin, gluconolactone (E 575), sorbitol (E 420), colloidal silica (E 551), mannitol (E 421), magnesium hydroxycarbonate (E 504 II)], magnesium stearate.

What ACC Optima Active looks like and contents of the pack

ACC Optima Active is a white or slightly yellowish powder with easily crumbling granules (if present), with a blackberry flavor and a possible slight sulfur smell.
The medicine is packaged in sachets made of aluminum/paper foil and placed in a cardboard box.
Each sachet contains 1.6 g of powder.
Pack size: 10 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Hermes Pharma Ges.m.b.H
Schwimmschulweg 1a
9400 Wolfsberg
Austria

For more information about the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Date of last revision of the package leaflet: 11/2024
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