Tuxiflud

Italy
Brand name Tuxiflud
Form syrup
Active substance / Dosage
AMBROXOL HYDROCHLORIDE
Prescription type Non-prescription – not available over the counter
ATC code
R05CB06
Registration number 035128
Manufacturer DYMALIFE PHARMACEUTICAL S.R.L.

Tuxiflud 3 mg/ml Syrup – 150 ml Bottle
Tuxiflud 0.75% Nebulizing Solution
40 ml Bottle
Tuxiflud 15 mg/2 ml Nebulizing Solution
15 Single-dose Containers
Tuxiflud 15 mg/2 ml Nebulizing Solution – 6 Vials 2 ml
Equivalent medicine

COMPOSITION
Tuxiflud 3 mg/ml Syrup – 150 ml Bottle
100 ml of syrup contain: Active substance: Ambroxol hydrochloride 300 mg.
Excipients: Sucrose; Methyl p-hydroxybenzoate; Propyl p-hydroxybenzoate; Cherry flavor; Purified water.

Tuxiflud 0.75% Nebulizing Solution – 40 ml Bottle
100 ml of solution contain: Active substance: Ambroxol hydrochloride 750 mg.
Excipients: Citric acid monohydrate; Disodium hydrogen phosphate dihydrate; Sodium chloride; Benzalkonium chloride; Purified water.

Tuxiflud 15 mg/2 ml Nebulizing Solution – 15 Single-dose Containers 2 ml
100 ml of 0.75% solution contain: Active substance: Ambroxol hydrochloride 750 mg.
Excipients: Sodium chloride, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Purified water.
Each single-dose container contains 15 mg of ambroxol hydrochloride.

Tuxiflud 15 mg/2 ml Nebulizing Solution – 6 Vials 2 ml
Each vial contains: Active substance: Ambroxol hydrochloride 15 mg.
Excipients: Citric acid; Disodium phosphate; Sodium chloride; Water for injections.

PHARMACEUTICAL FORM AND CONTENT
Tuxiflud 3 mg/ml Syrup:
Box containing one 150 ml bottle (0.3% concentration), for oral use.

Tuxiflud 0.75% Nebulizing Solution:
Box containing one 40 ml bottle.

Tuxiflud 15 mg/2 ml Nebulizing Solution:
Box containing 15 single-dose containers of 2 ml of 0.75% solution for aerosol therapy.

Tuxiflud 15 mg/2 ml Nebulizing Solution:
Box containing 6 vials of 2 ml.

THERAPEUTIC CATEGORY
Mucolytic.

MARKETING AUTHORIZATION HOLDER
DYMALIFE PHARMACEUTICAL S.r.l.
Via Bagnulo, 95 – 80063 - Piano di Sorrento – Italy

MANUFACTURERS AND FINAL CONTROLLERS
Tuxiflud 3 mg/ml Syrup
Pharmaceutical Workshop FRANCIA FARMACEUTICI Industria Farmaco Biologica S.r.l.
Via dei Pestagalli, 7 - Milan
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
Via Licino, 11 - 22036 Erba - (CO).

Tuxiflud 0.75% Nebulizing Solution – 40 ml Bottle
Special Product's Line S.p.A. Via Campobello, 15 - Pomezia (Rome)

Tuxiflud 15 mg/2 ml Nebulizing Solution – 15 vials

  1. IBSA Farmaceutici Italia S.r.l. - Via Martiri di Cefalonia, 2 - 26900 LODI
  2. Special Product's Line S.p.A. Via Campobello, 15 - Pomezia (Rome)

Tuxiflud 15 mg/2 ml Nebulizing Solution – Single-dose containers
Pharmaceutical Workshop COC Farmaceutici S.r.l. - S. Agata Bolognese (BO)

THERAPEUTIC INDICATIONS
Treatment of secretory disorders in acute and chronic bronchopulmonary conditions.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Severe hepatic and/or renal impairment.
Tuxiflud “3 mg/ml Syrup” is contraindicated in children under 2 years of age.

PRECAUTIONS FOR USE
Mucolytics may cause bronchial obstruction in children under 2 years of age. Indeed, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory tract. Therefore, they should not be used in children under 2 years of age (for the syrup).

Tuxiflud should be administered with caution in patients with peptic ulcer.

Tuxiflud 0.75% nebulizing solution in 40 ml bottle contains benzalkonium chloride as a preservative. Especially when using the medicine for prolonged periods, benzalkonium chloride may cause swelling of the nasal mucosa. If such a reaction is suspected (persistent nasal congestion), a nasal medicine without BAC should be used, if possible. If BAC-free nasal medicines are not available, another pharmaceutical form should be considered. Furthermore, benzalkonium chloride may cause bronchospasm.

INTERACTIONS
Tuxiflud generally does not interfere with other medicines.

SPECIAL WARNINGS
Serious skin reactions associated with ambroxol administration have been reported.
If a skin rash occurs (including mucosal lesions such as in the mouth, throat, nose, eyes, genitals), stop taking ambroxol and contact your doctor immediately.

Tuxiflud in the 15 mg/2 ml nebulizing solution (15 single-dose containers) and 3 mg/ml syrup contains: methyl parahydroxybenzoate and propyl parahydroxybenzoate: mild irritants for skin, eyes, and mucous membranes. They may increase the risk of jaundice in newborns.

Pregnancy and breastfeeding
During pregnancy and breastfeeding, ambroxol should be used only after consulting a doctor and evaluating the risk/benefit ratio in your individual case.
Consult your doctor if you suspect you are pregnant or plan to become pregnant.

There are no clinical data available on ambroxol use during pregnancy.
Animal studies do not indicate direct or indirect adverse effects on pregnancy, embryonic/fetal development, birth, or postnatal development. However, caution is required when prescribing this medicine to pregnant women. During pregnancy, medicines should be used only if the expected benefit to the mother outweighs the potential risk to the fetus. All medicines should be avoided, if possible, during the first trimester of pregnancy. The drug is excreted in breast milk.

Ambroxol use by the mother may cause adverse effects in the infant; therefore, a decision must be made whether to discontinue breastfeeding or the treatment, taking into account the importance of the medicine for the mother.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION

Nebulizing Solution
Adults and children over 5 years: 2–3 ml of solution 1–2 times daily.
Children under 5 years: 2 ml of solution 1–2 times daily.

Since deep inhalation of aerosol may trigger coughing, normal breathing is recommended during inhalation. It is advisable to warm the solution to body temperature before inhalation.

In patients with bronchial asthma, it is recommended to administer the usual bronchodilator before inhalation.

The nebulizing solution can be administered using standard aerosol therapy devices. It may also be diluted with distilled water in a 1:1 ratio.

Instructions for use of single-dose containers
To use the single-dose container, follow these steps:

  1. Separate one container from the strip.
  2. Open the single-dose container by twisting the tab.
  3. Apply moderate pressure on the container walls to dispense the prescribed amount of medicine.
  4. If using half the dose, the container can be reclosed by flipping and pressing the cap. The remaining amount should be used within 24 hours.

Nebulizing Solution
Adults and children over 5 years: 2–3 ml of solution 1–2 times daily.
Children under 5 years: 2 ml of solution 1–2 times daily.

Since deep inhalation of aerosol may trigger coughing, normal breathing is recommended during inhalation. It is advisable to warm the solution to body temperature before inhalation.

In patients with bronchial asthma, it is recommended to administer the usual bronchodilator before inhalation.

The nebulizing solution can be administered using standard aerosol therapy devices. It may also be diluted with distilled water in a 1:1 ratio.

Syrup
Adults: 10 ml (30 mg) three times daily.
Children aged 2 to 5 years: 2.5 ml (7.5 mg) three times daily.
Children over 5 years: 5 ml (15 mg) three times daily.

It is recommended to take the syrup after meals.

Inhalation Vials
Adults: 2–3 vials daily.
Children up to 5 years: 1–2 vials daily.
Children over 5 years: 2–3 vials daily.

Instructions for use: Pre-scored vials, no file required.

Do not use ambroxol for prolonged treatments.

OVERDOSE
Data on ambroxol overdose are limited.
Symptoms corresponding to the described adverse effects are expected.
In case of accidental ingestion/overdose of ambroxol, contact your doctor immediately or go to the nearest hospital.

ADVERSE EFFECTS
Rarely: fatigue, dry mouth, rhinorrhea, 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 1,000 people:
Hypersensitivity reactions
Rash, urticaria

Not known: frequency cannot be estimated from available data
Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus.
Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute exanthematous pustulosis).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report adverse effects directly via http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse effects, you help provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Check the expiry date on the packaging.
The expiry date refers to the product stored unopened and correctly stored.
Caution: do not use the medicine after this date.

KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN.

Date of revision of the leaflet: