Aceflucil

Package Leaflet: Information for the User

Aceflucil, 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 for the patient or as directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet:

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

1. What is Aceflucil and what is it used for

Aceflucil contains the active substance acetylcysteine and thins the thick mucus in the airways.
Aceflucil, 600 mg, effervescent tablets are used to thinsecretions and make them
easier to cough upin case of a cold in adults.

2. Important information before taking Aceflucil

When not to take Aceflucil:

• If you are allergicto acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
• Do not give this medicine to children under 2 years of age.
• Children and pregnant women with phenylketonuria (a rare genetic disorder) should not take this medicine.

Warnings and precautions

Before taking Aceflucil, discuss it with your doctor or pharmacist if you have:

• bronchial asthmaIf you have bronchial asthma, Aceflucil should be taken under close medical supervision, as it may cause bronchospasm. If you experience such symptoms, stop taking acetylcysteine immediately.
• stomach or intestinal ulcersin the past or present If you have or have had stomach ulcers, as Aceflucil may irritate the stomach lining. In particular, if you are taking other medicines known to

irritate the stomach lining.

• skin and mucous membrane changesVery rare cases of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been reported with acetylcysteine. If new skin or mucous membrane changes appear, seek medical advice immediately and stop taking acetylcysteine.
• As the thick mucus becomes more fluid, its volume increases, especially at the beginning of treatment. If you are unable to cough up this fluid mucus effectively, consult your doctor to take appropriate measures to remove the mucus.
• Histamine hypersensitivityIn these patients, avoid prolonged treatment, as Aceflucil affects histamine metabolism and may lead to intolerance symptoms (e.g., headache, runny nose, itching).
• Inability to cough up mucusMucolytic agents may block the airways in children under 2 years of age due to their airway characteristics and limited ability to cough up mucus. Therefore, mucolytic agents should not be used in children under 2 years of age.

Aceflucil and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take.
This is especially important for:

• cough suppressantsTaking Aceflucil with cough suppressants may cause: dangerous accumulation of secretions due to reduced cough reflex. In the case of this combination, a very careful diagnosis is required. It is necessary to consult a doctor before using such a combination.
• antibioticsExperimental studies indicate a weakening of the effect of antibiotics (tetracyclines, aminoglycosides, penicillins) due to concurrent use with acetylcysteine. For safety reasons, Aceflucil and antibiotics should be taken separately, with an interval of at least 2 hours. This does not apply to medicines containing active substances such as cefixime or loracarbef, which can be taken simultaneously with acetylcysteine.
• activated charcoal
• nitroglycerin:a medicine also known as glyceryl trinitrate, used to dilate blood vessels Your doctor will monitor the decrease in blood pressure, which may be severe and may cause headaches.
• carbamazepineWhen taken with carbamazepine, the effect of carbamazepine may be weakened due to reduced serum concentration.

Lab tests

Inform your doctor about taking Aceflucil if a test is required, as it may affect the test result:

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

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.

Pregnancy

Since there are insufficient data on the use of acetylcysteine in pregnant women, Aceflucil may be used during pregnancy only if your doctor considers it absolutely necessary.

Breastfeeding

There are no data on the penetration of acetylcysteine into breast milk. Therefore, Aceflucil may be used during breastfeeding only if your doctor considers it absolutely necessary.

Driving and using machines

The effect of Aceflucil on the ability to drive and use machines is not known.

Aceflucil contains lactose monohydrate

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

Aceflucil contains aspartame

Each effervescent tablet contains 15 mg of aspartame.
Aspartame (E 951) 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 improper excretion.

Aceflucil contains sodium

This medicine contains 65.714 mg of sodium (the main component of common salt) in each effervescent tablet.
This corresponds to 3.29% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Aceflucil

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
The recommended dose, unless your doctor has prescribed otherwise, is:
Adults from 18 years: 1 effervescent tablet once a day

Method of administration

Dissolve the effervescent tablet in half a glass of water and drink the solution immediately.
Patients who have difficulty coughing up mucus (elderly and weakened patients) are advised to take the effervescent tablet in the morning.

Duration of treatment

Do not take this medicine for more than 14 days without consulting a doctor.
If symptoms worsen or do not improve after 4 to 5 days, consult a doctor.

Taking more than the recommended dose of Aceflucil

In case of overdose, symptoms of stomach and intestinal irritation, such as abdominal pain, nausea, vomiting, diarrhea, may occur.
Severe side effects or symptoms of poisoning have not been observed so far, even in the case of significant overdose. If you suspect an overdose of Aceflucil, inform your doctor.

Missing a dose of Aceflucil

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Aceflucil and contact a doctorif you experience symptoms of an allergic reaction or severe skin reaction.
Uncommon(may affect up to 1 in 100 people)

• allergic reactions

Rare(may affect up to 1 in 10,000 people)

• severe allergic reactions, including anaphylaxis
• severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis

Other possible side effects may occur with the following frequency:
Uncommon(may affect up to 1 in 100 people)

• headache
• fever
• mouth ulcers
• abdominal pain
• nausea, vomiting
• diarrhea
• ringing or buzzing in the ears
• rapid heartbeat
• low blood pressure
• itching, hives, skin rash
• widespread rash
• usually painful, severe swelling of the deep layers of the skin, mainly on the face

Rare(may affect up to 1 in 1,000 people)

• shortness of breath
• bronchospasm - mainly in patients with hyperreactive airway disease, in the presence of bronchial asthma
• indigestion

Very rare(may affect up to 1 in 10,000 people)

• bleeding

Frequency not known(frequency cannot be estimated from the available data)

• facial swelling due to excess fluid
• decreased platelet aggregation

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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 Aceflucil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after: EXP. The expiry date refers to the last day of the month stated.
Store in a temperature below 30°C.
Store in the original package to protect from light.
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 pack and other information

What Aceflucil contains

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: ascorbic acid, citric acid, sodium bicarbonate, crospovidone (type B), lactose monohydrate, orange flavor (contains flavoring preparations, flavorings, natural flavorings, maltodextrin, arabic gum (E 414), butylated hydroxyanisole (E 320)), peppermint flavor (contains flavoring preparations, natural flavorings, maltodextrin, arabic gum (E 414)), aspartame (E 951), leucine.

What Aceflucil looks like and contents of the pack

Effervescent tablets.
Aceflucil, 600 mg, effervescent tablets:
White, flat, beveled, round tablets.
Aceflucil, 600 mg, effervescent tablets are available in soft blister packs (paper/Aluminum/PE) in a cardboard box.
Pack sizes:
Soft blister pack: 10 effervescent tablets

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Acetylcysteine AB 600 mg bruistabletten / comprimés effervescents / Brausetabletten
Italy:
Acetilcisteina Aurobindo
Netherlands:
Acetylcysteine Auro 600mg, bruistabletten
Poland:
Aceflucil
Portugal:
Acetilcisteína Generis
Spain:
Acetilcisteína Aurovitas 600mg comprimidos efervescentes EFG
Date of last revision of the leaflet: