TUXIFLUD*SCIR 15MG/5ML

Tuxiflud 3 mg/ml Syrup - 150 ml bottle
Tuxiflud 0.75% Nebuliser Solution - 40 ml bottle
Tuxiflud 15 mg/2 ml Nebuliser Solution - 15 single-dose containers
Tuxiflud 15 mg/2 ml nebuliser solution - 6 x 2 ml ampoules
Equivalent medicine

What it is and what it is used for
Treatment of secretion disorders in acute and chronic bronchopulmonary conditions.

What you need to know before taking the medicine
Hypersensitivity to the active substance or to any of the excipients.
Severe liver and/or kidney impairment.
Tuxiflud “3 mg/ml Syrup” is contraindicated in children under 2 years of age.

Warnings and precautions
Mucolytics can cause bronchial obstruction in children under 2 years of age. This is because the ability to drain bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children under 2 years of age (for the syrup).

Tuxiflud should be administered with caution in patients with peptic ulcers.
Tuxiflud 0.75% nebuliser solution in a 40 ml bottle contains benzalkonium chloride as a preservative. Especially when the medicine is used for long periods, benzalkonium chloride can cause swelling of the nasal mucosa. If such a reaction (persistent nasal congestion) is suspected, a nasal medicine without BAC should be used if possible. If such nasal medicines without BAC are not available, another pharmaceutical form should be considered. Furthermore, benzalkonium chloride can cause bronchospasm.

Cases of severe skin reactions associated with Ambroxol administration have been reported.
If you develop a skin rash (including lesions of mucous membranes such as the mouth, throat, nose, eyes, genitals), stop taking Ambroxol and contact your doctor immediately.

Tuxiflud in the 15 mg/2ml nebuliser solution 15 single-dose containers and 3 mg/ml syrup packs contain: methyl parahydroxybenzoate and propyl parahydroxybenzoate: mild irritants to skin, eyes and mucous membranes. They may increase the risk of jaundice in newborns.

Pregnancy and breastfeeding
During pregnancy and breastfeeding, ambroxol should only be used after consulting your doctor and evaluating the risk/benefit ratio in your case.
Consult your doctor if you suspect you are pregnant or wish to plan a pregnancy.
There are no clinical data on exposed pregnancies for ambroxol.
Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic/foetal development, birth or post-natal development. Caution should be exercised when prescribing the medicine to pregnant women. During pregnancy, medicines should only be used if the expected benefit to the mother is considered greater than the risk to the foetus. All medicines should be avoided, if possible, during the first trimester of pregnancy. The medicine is secreted into breast milk.
The use of ambroxol by the mother can cause undesirable effects in the infant; therefore, it is necessary to decide whether to stop breastfeeding or treatment with the medicine, taking into consideration the importance of the medicine for the mother.

Possible side effects
Rarely: tiredness, dry mouth, rhinorrhoea, dysuria, headache, gastrointestinal disorders (heartburn, dyspepsia, constipation, nausea and vomiting), contact dermatitis or other allergic reactions (especially skin rashes).

Rare: may affect up to 1 in 1000 people:
Hypersensitivity reactions
Rash, urticaria

Not known: frequency cannot be defined based on available data

Anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching.

Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.