Aceflucil

Patient Information Leaflet

Aceflucil, 600 mg, effervescent tablets
Acetylcysteinum
Please read all of this leaflet carefully before taking this medicine, as it contains important
information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any 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, you should contact your doctor.

Leaflet Contents:

1. What Aceflucil is and what it is used for
2. What you need to know 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 Aceflucil is and what it is used for

Aceflucil contains the active substance acetylcysteine, which liquefies thick mucus in the
respiratory tract.
Aceflucil 600 mg effervescent tablets are used to liquefy secretions and facilitate expectoration in cases of colds in adults.

2. Important information before using Aceflucil

When not to use Aceflucil:

• If the patient is allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
• This medicine must not be used in children under 2 years of age.
• Children and pregnant women with phenylketonuria (phenylketonuria is a certain congenital metabolic disorder) should not use this medicine.

Warnings and precautions
Before using Aceflucil, discuss with a doctor or pharmacist if the patient has:

• Bronchial asthma If the patient suffers from bronchial asthma, Aceflucil should be used under strict medical supervision, as it may cause airway constriction (bronchospasm). If such symptoms occur, acetylcysteine must be discontinued immediately.

• Stomach or intestinal ulcers, either currently or in the past If the patient has or has had peptic ulcer disease, because Aceflucil may irritate the gastric mucosa. This is particularly important if the patient is taking other medicines known to irritate the gastric mucosa.

• Skin and mucous membrane lesions Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported with the use of acetylcysteine. If new skin or mucous membrane lesions appear, medical advice should be sought immediately and acetylcysteine discontinued.

• As thick mucus becomes more fluid, its volume may increase, especially at the beginning of treatment. If the patient is unable to effectively expectorate this fluid mucus, they must consult a doctor so that appropriate measures can be taken to remove the mucus.

• Histamine intolerance In such patients, prolonged treatment should be avoided, as Aceflucil affects histamine metabolism and may lead to intolerance symptoms (e.g. headache, rhinitis, itching).

• Inability to expectorate mucus Mucolytic agents may obstruct the airways of children under 2 years of age due to the characteristics of their respiratory tract and limited ability to expectorate sputum. Therefore, mucolytic agents should not be used in children under 2 years of age.

Aceflucil with other medicines
Tell 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 take.
This particularly includes:

• Cough suppressants Concurrent use of Aceflucil with cough suppressants may result in: dangerous accumulation of secretions due to reduced cough reflex. Such combination therapy requires particularly careful assessment. It is essential to consult a doctor before using this combination.
• Antibiotics Experimental studies indicate reduced efficacy of antibiotics (tetracyclines, aminoglycosides, penicillins) when used concurrently 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 may be taken simultaneously with acetylcysteine.
• Activated charcoal
• Glyceryl trinitrate: a medicine also known as nitroglycerin, used to dilate blood vessels The doctor will monitor for blood pressure reduction, which may be severe and may manifest as headache.
• Carbamazepine When used concomitantly with carbamazepine, the effect of carbamazepine may be reduced due to decreased plasma concentration.

Laboratory tests
Inform the doctor about taking Aceflucil if testing is required in the following cases, as it may affect test results:

• Salicylates: medicines used to treat pain, inflammatory conditions or rheumatism
• Ketone bodies in urine

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.
Pregnancy
As there are insufficient data on the use of acetylcysteine in pregnant women, Aceflucil should be used during pregnancy only if the physician considers it absolutely necessary.
Breastfeeding
There are no data on the passage of acetylcysteine into human milk. Therefore, Aceflucil may be used during breastfeeding only if the physician considers it absolutely necessary.
Driving and operating machinery
The effect of Aceflucil on the ability to drive and operate machinery is unknown.
Aceflucil contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the 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 improper excretion.
Aceflucil contains sodium
This medicine contains 65.714 mg of sodium (the main component of table salt) in each effervescent tablet.
This corresponds to 3.29% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Aceflucil

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose, unless otherwise advised by a doctor, is:
Adults aged 18 years and over: 1 effervescent tablet once daily.
Method of administration
Dissolve the effervescent tablet in half a glass of water and drink the solution immediately.
For patients who have difficulty expectorating mucus (elderly and weakened patients), it is recommended to take the effervescent tablet in the morning.
Duration of treatment
Do not use this medicine for longer than 14 days without consulting a doctor.
If symptoms worsen or do not improve within 4 to 5 days, consult a doctor.
Overdose of Aceflucil
In case of overdose, symptoms of gastrointestinal irritation may occur, such as abdominal pain, nausea, vomiting, and diarrhoea.
Severe adverse effects or signs of poisoning have not been observed so far, even following significant overdose. If an overdose of Aceflucil is suspected, inform a doctor immediately.
Missed dose of Aceflucil
Do not take a double dose to make up for a missed dose. Take the next dose at the usual scheduled time.
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 they do not occur in everyone.
You must stop taking Aceflucil and contact your doctor if symptoms of an allergic reaction or severe skin reaction occur.

Not common (may occur in fewer than 1 in 100 people)

• Allergic reactions

Very rare (may occur in fewer than 1 in 10,000 people)

• Severe allergic reactions up to and including anaphylactic shock
• Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis

Other possible adverse reactions may occur with the following frequency:
Not common (may occur in fewer than 1 in 100 people)

• headache
• fever
• inflammation of the mucous membrane of the mouth
• abdominal pain
• nausea, vomiting
• diarrhoea
• ringing or buzzing in the ears
• rapid heartbeat
• low blood pressure
• itching, hives, skin rash
• generalized rash
• predominantly painful, pronounced swelling of the deep skin layers, mainly of the face

Rare (may occur in fewer than 1 in 1,000 people)

• shortness of breath
• bronchospasm – mainly in patients with hyperreactive respiratory tract, especially in the presence of bronchial asthma
• indigestion

Very rare (may occur in fewer than 1 in 10,000 people)

• haemorrhage

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

• facial swelling due to fluid accumulation
• reduced platelet aggregation

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 soft blister pack and carton
after: EXP. The expiry date refers to the last day of the stated month.
Store below 30℃.
Keep in the original packaging to protect from light.
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 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 hydrogen carbonate, crospovidone (type B), lactose monohydrate, orange flavour (contains flavouring preparations, flavouring substances, natural flavouring substances, maltodextrin, gum arabic (E 414), butylated hydroxyanisole (E 320)), peppermint flavour (contains flavouring preparations, natural flavouring substances, maltodextrin, gum arabic (E 414)), aspartame (E 951), leucine.

What Aceflucil looks like and contents of the pack
Effervescent tablets.
Aceflucil 600 mg effervescent tablets:
White, flat, bevelled round tablets.
Aceflucil 600 mg effervescent tablets are available in soft blisters made of composite foil (Paper/Aluminium/PE), packed in a cardboard box.
Pack sizes:
Soft blister: 10 effervescent tablets

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 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 medicinal product is authorised in the European Economic Area countries 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