Acetylcysteine Liboran 600 mg effervescent tablets are indicated for the treatment of breathing difficulties caused by too much mucus in the lungs and airways, or by the mucus being too thick and viscous to be easily coughed up.

DO NOT TAKE ACETYLCYSTEINE LIBORAN
• If you are allergic (hypersensitive) to acetylcysteine or any of the other components of this medicinal product (listed in Section 6).
• If you suffer from gastroduodenal ulcer.
• If you are receiving nitroglycerin.

WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking ACETYLCYSTEINE Liboran.
• If you are asthmatic or have attacks of breathlessness (see section 4).
• If you suffer from severe respiratory insufficiency.
• If you are lacking strength or energy. In this case, you may have a reduced cough reflex or not have enough strength to cough, resulting in failure to cough up phlegm that has become less viscous and which needs to be expelled. Increased sputum and coughing are to be expected at the start of treatment.
• If you suffer from gastroduodenal (stomach, gut) problems. As mucolytics have the capacity to destroy the gastric mucus barrier, they must be used with caution in individuals who are susceptible to gastroduodenal ulcers.
• If you have histamine intolerance.
• If you are following a controlled sodium diet, as the product contains 138.86 mg sodium per effervescent tablet.

CHILDREN AND ADOLESCENTS
Do not use in children under the age of 2 years. Mucolytics may induce respiratory obstruction in children under 2 years of age. Due to the physiological characteristics of the airways in this age group, the ability to expel phlegm may be limited.
Acetylcysteine Liboran should not be taken by children under 12 years of age.

OTHER MEDICINES AND ACETYLCYSTEINE LIBORAN
Tell your doctor or pharmacist if you are taking, have recently taken or might come to take any other medicines.

Acetylcysteine may interfere with:
• Nitroglycerin. The combination of acetylcysteine and nitroglycerin causes significant hypotension and nitroglycerin-induced headache.
• Antitussives and secretion dryer, because they have an effect contrary to that of Acetylcysteine Liboran. In this case, do not combine the two medications.
• Acetylcysteine may decrease the amount of antibiotic that is absorbed. When oral administration of antibiotics is required, it is recommended that administration be performed at a 2-hour interval from acetylcysteine administration.
• Carbamazepine. The combination of acetylcysteine and carbamazepine (a medicine for epilepsy) may reduce the therapeutic effect of carbamazepine.
• Dissolution of acetylcysteine with other medicinal products is not recommended.

ACETYLCYSTEINE LIBORAN WITH FOOD AND DRINK
There are no known problems concerning the administration of Acetylcysteine Liboran and food or drink, so it can be taken with any meal.

PREGNANCY AND BREASTFEEDING
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Although acetylcysteine has not been shown to have teratogenic action, as a precautionary measure it is recommended that Acetylcysteine Liboran not be used during pregnancy. It is also unknown whether acetylcysteine passes into breast milk. A possible risk to the newborn/infant should not be excluded. It may be necessary to decide whether to discontinue breast-feeding or to discontinue/abstain from treatment with Acetylcysteine Liboran, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.

DRIVING AND OPERATING MACHINERY
No effects on the ability to drive and use machines have been observed.

ACETYLCYSTEINE LIBORAN CONTAINS LACTOSE AND SODIUM
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 138.86 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 7% of the maximum daily intake of sodium recommended in the diet for an adult.
A slight smell of sulfur is normal because this is typical of acetylcysteine.

Always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist.
Acetylcysteine Liboran can be taken with or without meals.

ROUTE OF ADMINISTRATION
Dissolve the effervescent tablet in half a glass of water or other liquid, and wait until it dissolves completely. Swallow immediately. Use a vessel made from glass or plastic (never use with rubber or metal).

IF YOU TAKE MORE ACETYLCYSTEINE LIBORAN THAN YOU SHOULD
Acetylcysteine has been used in humans in doses up to 500 mg/kg/day without causing undesirable effects and therefore overdose poisoning can be excluded. If effects are produced similar to those described in "4. Possible undesirable effects", you should contact your doctor or pharmacist.

IF YOU FORGET TO TAKE ACETYLCYSTEINE LIBORAN
As soon as you remember that you have forgotten to take Acetylcysteine Liboran, take the missed dose. However, if the time for the next dose is close, do not take the missed dose and stick to the schedule initially planned. Do not take a double dose to make up for a missed dose.

IF YOU STOP TAKING ACETYLCYSTEINE LIBORAN
Acetylcysteine Liboran may be discontinued at any time.

If you have any further questions about taking this medicine, speak to your doctor or pharmacist.

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.

Digestive disturbances (nausea, vomiting, diarrhoea or abdominal pain), headache and hypersensitivity reactions such as urticaria and tachycardia have been infrequently reported. Rarely, bronchospasm and gastric dyspepsia may occur. Special attention should be paid to asthmatic patients due to the risk of an asthma attack (bronchoconstriction). In such cases treatment should be stopped and a doctor consulted.

REPORTING UNDESIRABLE EFFECTS
If you suffer with any undesirable effects, talk to your doctor or pharmacist. This includes any possible undesirable effects not listed in this leaflet. You can also report undesirable effects directly to INFARMED, I.P. using the contact information indicated below. By reporting undesirable effects, you will help provide more information on the safety of this medicine.

Website: http://www.infarmed.pt/web/infarmed/submissaoram (preferably) or at the following addresses:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Tel: +351 21 798 73 73
Medicines line: 800 222 444 (freephone)
Email: farmacovigilancia@infarmed.pt

WHAT ACETYLCYSTEINE LIBORAN CONTAINS

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg acetylcysteine.
• The other ingredients are: citric acid anhydrous, ascorbic acid, sodium citrate dihydrate, sodium cyclamate, saccharin sodium (E954), mannitol, sodium bicarbonate, sodium carbonate, lactose, lemon flavour and purified water.

WHAT ACETYLCYSTEINE LIBORAN LOOKS LIKE AND THE CONTENTS OF THE PACK
Acetylcysteine Liboran is presented in the form of round white effervescent tablets with a score line on one side, packaged in a polypropylene tablet container (tube) with a non-screw-on cap and a polyethylene stopper, containing moisture absorbing substances (aluminosilicate and silica gel) or in aluminium heat-welded tape, in cartons containing 10, 20 or 25 tablets.

Not all packet sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER

MARKETING AUTHORISATION HOLDER
Towa Pharmaceutical, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal

MANUFACTURER
Hermes Pharma GmbH
Hans-Urmiller-Ring 52, 82515 Wolfratshausen
Germany

Detailed and up-to-date information on this medicine is available by scanning the 2D code printed on the packet with a smartphone. The same information is also available at the following URL: https://www.tolifeotc.com/liboran.

This leaflet was last revised in March 2025.