Ambroxol Fludoran 6 mg/ml Syrup is an expectorant for oral use.

Ambroxol Fludoran may be used to treat the following conditions:

• Mucolytic adjuvant to antibacterial treatment for respiratory infections, in the presence of bronchial hypersecretion.

Do not take Ambroxol Fludoran:
• if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you are ill with a gastroduodenal ulcer.

WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse before taking Ambroxol Fludoran.

In patients with bronchial motility disorders associated with an excessive accumulation of secretions (e.g. malignant ciliary syndrome) Ambroxol Fludoran 6 mg/ml Syrup should only be used with caution due to a potential effect of congestion of secretion.

In patients with kidney impairment or severe liver disease, Ambroxol Fludoran 6 mg/ml Syrup should only be used with special caution (i.e. long interval between administrations or dose reductions).

Mucolytic use means a reduction in mucus viscosity and removal, through both the ciliary activity of the epithelium and the coughing reflex, and therefore an increase in secretion flux with spitting and coughing is to be expected.

As mucolytics have the capacity to destroy the gastric mucus barrier, they must be used with caution in individuals with a history of peptic ulcer.

An equally careful administration to asthmatic patients is advised.

Do not use the syrup if it becomes cloudy.

There have been reports of severe skin reactions associated with the administration of ambroxol. If you develop a skin rash (including mucous membrane lesions, such as in your mouth, throat, nose, eyes, genital organs), stop using Ambroxol Fludoran and contact your doctor immediately.

Ambroxol Fludoran 6 mg/ml Syrup does not contain alcohol (ethanol) and it is also suitable for diabetics.

OTHER MEDICINES AND AMBROXOL FLUDORAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Simultaneous administration of Ambroxol Fludoran 6 mg/ml Syrup with cough medicines can cause a dangerous congestion of secretions due to the changes in the coughing reflex, therefore an early diagnosis must be made before using this medicinal combination.
Concomitant administration of ambroxol with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) leads to a greater concentration of antibiotic in the lung tissue.

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.
During pregnancy, in particular in the first three months and while breast-feeding, Ambroxol Fludoran 6 mg/ml Syrup should only be used after the benefits have been carefully weighed against the risks, as there is not enough experience with use of Fludoran 6 mg/ml in human beings.

DRIVING AND USING MACHINES
No effect of this medicine on the ability to drive vehicles or use machines is listed.

AMBROXOL FLUDORAN 6 MG/ML SYRUP CONTAINS GLYCEROL, METHYL P-HYDROXYBENZOATE (E218), PROPYL P-HYDROXYBENZOATE (E216) AND SORBITOL (E420)
This medicine contains Glycerine (or glycerol): it may be harmful in large doses. It may cause headache, stomach upset and diarrhoea.
This medicine contains methyl p-hydroxybenzoate (E218) and propyl p-hydroxybenzoate (E216). It can cause allergic reactions (possibly delayed), and bronchospasm less commonly.
This medicine contains liquid sorbitol (crystallisable) (E420). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as described in this leaflet or according to the instructions of your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
Administer orally.

Ambroxol Fludoran must be taken at mealtimes.

IF YOU TAKE MORE AMBROXOL FLUDORAN THAN YOU SHOULD
Symptoms of overdose: To date, no cases of overdose in human beings have been reported. Ambroxol is well tolerated after parenteral administration in doses up to 5 mg/kg of body weight daily. The condition of acute intoxication with extreme overdose in the trial animal is characterised by an increase in salivary secretion, nausea, vomiting and drop in blood pressure. In cases of extreme accidental or intentional overdose, there may be a local irritating effect in the throat or epigastric pains, nausea, vomiting and diarrhoea.
Therapy for overdose: An initial appropriate measure is to induce vomiting and drink fluids (tea, water). Extremely large amounts of ambroxol hydrochloride may have to be removed from the stomach (by gastric lavage performed 1 to 2 hours after the overdose) and cardiovascular function monitored.
If an overdose occurs, you should consult a doctor or the Poison Information Centre (Tel: 808 250 143).

IF YOU FORGET TO TAKE AMBROXOL FLUDORAN
Do not take a double dose to make up for a forgotten dose.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, gastric complaints may occur (e.g. nausea and epigastric pain), as well as allergic reactions (e.g., erythema, oedema of the face, dyspnoea, fever and shivers), hypersensitivity reaction, skin rash and hives.
In addition, rare cases of dryness of the mouth and respiratory airways, drooling, runny nose, constipation and painful urination were reported following administration of ambroxol.
A case of allergic contact dermatitis was also described.

Unknown: the frequency cannot be calculated from the available data
• Anaphylactic reactions including anaphylactic shock, angioedema (rapidly appearing rash on skin, on subcutaneous tissues, on mucosa or submucosa) and itching.
• Serious 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to INFARMED, I.P. through the contacts below. By reporting side effects, you can help provide more information on the safety of this medicine.
INFARMED, I.P.
Drug Risk Management Directorate
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisboa
Tel: +351 21 798 73 73
Medication Line: 800 222 444 (free)
Fax: +351 21 798 73 97
Website: http://www.infarmed.pt/web/infarmed/submissaoram
E-mail: farmacovigilancia@infarmed.pt

WHAT AMBROXOL FLUDORAN CONTAINS
The active substance is ambroxol, in the form of ambroxol hydrochloride. Each ml of Ambroxol Fludoran 6 mg/ml Syrup contains 6 mg of ambroxol hydrochloride.
The other components (excipients) are: liquid sorbitol (crystallisable) (E420), methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), glycerol, raspberry essence, peppermint essential oil, citric acid anhydrous and purified water.

WHAT AMBROXOL FLUDORAN LOOKS LIKE AND CONTENTS OF THE PACK
Ambroxol Fludoran 6 mg/ml Syrup comes in the form of clear, colourless syrup with the aroma and flavour of peppermint, packaged in an amber glass bottle, with a plastic cap and measuring cup.
Packaging with 100 ml, 120 ml, 125 ml and 200 ml bottles of syrup. Not all pack sizes may be marketed.

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

MANUFACTURER
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias – Alto do Colaride
2735-213 Cacém
Portugal

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

This leaflet was last revised in April 2020.