This medicine fluidizes the secretions and stimulates expectoration. Due to its antioxidant nature, it carries out a protective action on the respiratory tract against the toxic phenomena arising from the release of oxidant substances of different origins.
Acetilcisteína Liboran is prescribed as a mucolytic adjuvant of the antibacterial treatment of respiratory infections, in the presence of bronchitis hypersecretion.

DO NOT TAKE ACETILCISTEÍNA LIBORAN
• If you’re allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a gastroduodenal ulcer.
• If you are taking nitroglycerin (a medicine used on the treatment of angina pectoris).

WARNINGS AND PRECAUTIONS
If any of the following situations applies to you or if you have any doubt about the medicine, talk to your doctor or pharmacist before taking Acetilcisteína Liboran.
• If you suffer from asthma or have trouble breathing.
• If you suffer from severe respiratory failure.
• If your health status is currently weak (you may suffer from a diminutive coughing reflex, risking the obstruction of the respiratory tract as a consequence of the secretions increase).
• If you usually suffer from gastroduodenal disorders (stomach and small intestine). The mucolytics are able to destroy the stomach’s mucous barrier, therefore, they shall be used with care on individuals prone to gastroduodenal ulcers.
• If you are pregnant or planning to have a baby, or breast-feeding.

CHILDREN AND ADOLESCENTS
Acetilcisteína Liboran should not be taken by children under 12 years of age.

OTHER MEDICINES AND ACETILCISTEÍNA LIBORAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Acetylcysteine may interact with:
• Nitroglycerin: the association of acetylcysteine and nitroglycerin causes hypotension (blood pressure decrease) and headache induced by nitroglycerin.
• Cough medicine and secretion driers.
• Gold salts: the administration of acetylcysteine with medicines which contain gold salts, calcium or iron, should be carried out at different times, due to a possible interaction.
• Antibiotics of the cephalosporin group: acetylcysteine may also interact with these medicine, therefore, its administration should be carried out at different times.
Acetilcisteína Liboran doesn’t interacts with antibiotics, such as amoxicillin, erythromycin, doxycycline or bacampicillin, nor with the association of amoxicillin + clavulanic acid.

ACETILCISTEÍNA LIBORAN WITH FOOD AND DRINKS
No restrictions to the use of Acetilcisteína Liboran with food and drinks are known.

PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Even though it hasn’t been proved that acetylcysteine has a teratogenic action, its careful administration during your pregnancy is recommended.
It also has not been proved that acetylcysteine dissolves on breast milk, therefore, its careful administration during breast-feeding is recommended.

DRIVING AND USING MACHINES
No effects of this medicine on the capability of driving or using machines were observed.

ACETILCISTEÍNA LIBORAN CONTAINS LACTOSE AND SODIUM
This medicine contains lactose. If you have been informed by your doctor that you are intolerant to certain sugars, contact them before taking this medicine.
This medicine contains 138.86 mg of sodium (main component of cooking/table salt) in each tablet. This is equivalent to 7% of the recommended maximum daily dietary intake of sodium for an adult. This information should be considered on patients with a controlled sodium intake.

Always take this medicine exactly as described in this leaflet or accordingly to your doctor or pharmacist’s indications. Talk to your doctor or pharmacist if you have any doubts.

ACETILCISTEÍNA LIBORAN IS AIMED FOR ORAL ADMINISTRATION

Dissolve the tablet on a glass of water or other liquid. Wait until it completely dissolves and ingest it immediately. Use a glass or plastic cup (never use cups made of rubber or metal).

The presence of a slight sulfurous smell is normal, as it is common on acetylcysteine.

This medicine causes a decrease of the mucus viscosity, as well as its elimination, through the coughing reflex. Therefore, an increase of expectoration and coughing at the beginning of the treatment is to be expected.

IF YOU TAKE MORE ACETILCISTEÍNA LIBORAN THAN YOU SHOULD
If you take more acetylcysteine than you should, symptoms just like the ones described on section 4 may appear. In those cases, you should interrupt the treatment and immediately consult a doctor.
In the case of overdose or accidental ingestion, consult the Poison Control Center (808 250 143), indicating the medicine and the ingested quantity.

IF YOU FORGET TO TAKE ACETILCISTEÍNA LIBORAN
If you miss a dose, it shall be taken as soon as possible, continuing the treatment as prescribed. Nevertheless, if it is close to the next dose, it is better not to take the missed dose and take the next one at the scheduled time. Never take a double dose to compensate the dose you forgot to take.

If you have any doubts on the use of this medicine, talk to your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Occasionally, digestive alterations (nausea, vomiting and diarrhea) may occur.
On rare occasions, hyper sensibility reactions (allergy), such as hives and bronchospasm, may occur.
We recommend special attention to asthmatic patients due to the risk of bronchoconstriction.
In these cases, you should interrupt the treatment and consult a doctor.

REPORTING OF SIDE EFFECTS
If you get any side effects, including possible side effects not included on this leaflet, talk to your doctor or pharmacist. You can also report side effects directly to the INFARMED, I.P. (consult the contacts below. By reporting side effects, you are helping to provide more data on the safety of this medicine.
Internet site: http://www.infarmed.pt/web/infarmed/submissaoram (preferably) or through the following contacts:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisboa
Tel: +351 21 798 73 73
Medicines line: 800 222 444 (free of charge)
Email: farmacovigilancia@infarmed.pt

WHAT ACETILCISTEÍNA LIBORAN CONTAINS
The active substance is acetylcysteine, each effervescent tablet contains 600 mg of acetylcysteine.
The other components (excipients) are: anhydrous citric acid, ascorbic acid, dehydrated sodium citrate, sodium cyclamate, sodium saccharine (E954), mannitol, sodium bicarbonate, sodium carbonate, lactose, lemon aroma and purified water.

WHAT ACETILCISTEÍNA LIBORAN LOOKS LIKE AND THE CONTENTS OF THE PACK
Acetilcisteína Liboran is presented as round white effervescent tablets, with a groove on one of its sides, packaged on a polypropylene tablet’s container (tube) with a non-screwed clasp and polyethylene lid, containing substances that absorb humidity (aluminosilicate and silica gel) or on a thermowell aluminum tape, on packages which contain 10, 20 or 25 tablets. It is possible that not all presentations are sold.

MARKETING AUTHORIZATION HOLDER
toLife - Produtos Farmacêuticos, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal

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

Detailed and updated information on this medicine is available through the scan of the 2D code included on the package with a smartphone. The same information is also available on the following URL: https://www.tolifeotc.com/liboran.

This leaflet was last revised on July 2019.