Azimil

Package leaflet: Information for the user

Azimil 15 mg/2 ml nebuliser and oral solution, 15 mg/5 ml single-dose syrup, 15 mg/5 ml multidose bottle syrup

Ambroxol hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of time.

Contents of this leaflet:

1. What Azimil is and what it is used for
2. What you need to know before taking Azimil
3. How to take Azimil
4. Possible side effects
5. How to store Azimil
6. Contents of the pack and other information

1. What Azimil is and what it is used for

Azimil contains ambroxol, an active substance belonging to a group of medicines called mucolytics, which works by making mucus more fluid and therefore easier to eliminate from the respiratory tract (bronchi and lungs).
Azimil is used in patients with acute and chronic respiratory tract diseases characterized by thick and viscous mucus.

2. What you need to know before taking Azimil

Do not take Azimil if:

• you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• you have severe liver and/or kidney disease.

Do not use Azimil in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Azimil if:

• you have stomach lesions (peptic ulcer);
• you have mild or moderate impairment of kidney function;
• you are in the first three months of pregnancy or if you are breastfeeding.

PAY ATTENTION:
Serious skin reactions have been reported with the use of Ambroxol.

• If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Azimil and contact your doctor immediately.
• If you experience coughing during inhalation, try to breathe in and out normally. If you are particularly sensitive, you may pre-warm the solution to body temperature.
• If you suffer from asthma, it is recommended that you take your usual asthma medications (bronchial spasmolytics) before inhaling Azimil with a nebulizer. This will help prevent possible breathing difficulties.

Children
Do not use Azimil in children under 2 years of age, as mucolytic agents may cause obstruction of the airways (bronchi).
Other medicines and Azimil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking Azimil, inform your doctor if you are taking antibiotics used to treat bacterial infections (e.g. amoxicillin, cefuroxime, and erythromycin).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In particular, during the first three months of pregnancy and during breastfeeding, Azimil should be used only if clearly necessary and under direct medical supervision.
Driving and using machines
Azimil does not affect the ability to drive or operate machinery.
Azimil syrup contains maltitol and hydroxybenzoates
Azimil syrup in single-dose containers and multidose bottles contains maltitol.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Azimil syrup in multidose bottles contains parahydroxybenzoates.
Parahydroxybenzoates may cause allergic reactions (including delayed reactions).
Azimil nebulizing and oral solution
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically 'sodium-free'.

3. How to take Azimil

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Solution for nebulization and oral use
Each single-dose container contains 2 ml and has a mark at the 1 ml volume (half dose).

Solution for nebulization:
Adults
1 single-dose container, twice daily.

Children
Children aged 2 to 5 years: half or 1 single-dose container, 1–2 times daily.
Children over 5 years: 1 single-dose container, twice daily.

Method of administration
This medicine must be nebulized (converted into very fine droplets) using an “aerosol device” equipped with mouth and/or nasal administration accessories.
Take the medicine by breathing normally through the mouth and/or nose.
To take a half dose, use the volume marking on the container. The prescribed dose may also be diluted by adding an equal volume of distilled water (1:1 ratio) to the solution in the nebulizer chamber.
Breathing too deeply may cause coughing; to reduce this risk, try to inhale and exhale normally during nebulization. It may be helpful to warm the vial containing the medicine to body temperature before nebulizing.

Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in your symptoms.

Oral solution:
Adults
2–4 ml (1–2 single-dose containers) three times daily.

Children
Children aged 2 to 5 years: 1 ml (half a single-dose container) 2–3 times daily.
Children over 5 years: 1–2 ml (half to one single-dose container), 2–3 times daily.

Method of administration
Dilute the solution in a small amount of water, tea, milk, or fruit juice.
The medicine should be taken with meals.

Oral syrup:
Adults
The initial dose is 10 ml of syrup (or two single-dose containers) three times daily, unless otherwise directed by the doctor; subsequently, 5 ml (or one single-dose container) three times daily.

Children
Children aged 2 to 5 years: the dose is 2.5 ml (or half a single-dose container) of syrup, 2–3 times daily, unless otherwise directed by the doctor.
Children over 5 years: the dose is 5 ml (or one single-dose container) of syrup, three times daily, unless otherwise directed by the doctor.

The bottle packaging includes a dosing cup with markings at 2.5 ml, 5 ml, and 10 ml volumes.

If using a half dose, reseal the single-dose container by pressing the cap closed and store it in the refrigerator (2–8 °C) for no more than 12 hours.

Do not exceed the recommended doses.
Do not use for prolonged treatments. If there is no noticeable improvement after a short treatment period, consult your doctor.

If you take more Azimil than you should
The risk of experiencing adverse effects increases. In case of accidental ingestion or intake of an excessive dose of Azimil, contact your doctor immediately or go to the nearest hospital.

If you forget to take Azimil
Do not take a double dose to make up for the missed dose.

If you stop taking Azimil
If you have any doubts about using Azimil, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Azimil immediately and contact your doctor if you experience any of the following symptoms: itching, skin rash (urticaria, cutaneous rash), swelling (angioedema) of the face, eyes, lips and/or throat with breathing difficulties, due to allergy (hypersensitivity).
Inform your doctor if you notice:
Common side effects (may affect up to 1 in 10 people):

• altered or reduced sense of taste (dysgeusia);
• decreased sensitivity (hypoesthesia) of the mouth and pharynx (oral cavity);
• nausea.

Uncommon side effects (may affect up to 1 in 100 people):

• vomiting;
• diarrhoea;
• difficulty digesting (dyspepsia);
• abdominal pain;
• dry mouth.

Rare side effects (may affect up to 1 in 1,000 people):

• headache;
• hypersensitivity reactions;
• rash, urticaria.

Side effects with unknown frequency: (frequency cannot be estimated from the available data)

• obstruction of the airways (bronchi); dry throat; anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and itching;
• severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis).

Reporting of side effects
If you experience any side effect, 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 the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azimil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
After opening the aluminium pouch containing the single-dose containers of syrup and solution for nebulisation and oral use, the medicine must be used within three months; after this period, any unused medicine must be discarded. When using a half dose, the container must be stored at 2°C–8°C (in the refrigerator) for a maximum of 12 hours; after this period, any remaining medicine must be discarded.
After the first opening of the syrup bottle, the medicine must be used within one month; after this period, any remaining medicine must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Azimil contains
The active substance is: Ambroxol.
Azimil 15 mg/2 ml nebulizer and oral solution.

• One single-dose container contains 15 mg of ambroxol hydrochloride.
• The other components are: Sodium chloride, Water for injections.

Azimil 15 mg/5 ml syrup in single-dose container.

• One single-dose container contains 15 mg of ambroxol hydrochloride.
• The other components are: Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Water for injections.

Azimil 15 mg/5 ml multidose syrup – 200 ml bottle.

• 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
• The other components are: Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Water for injections.

Description of the appearance of Azimil and package contents
Azimil Nebulizer and Oral Solution:
Carton pack containing 15 or 30 single-dose containers of 2 ml, divided into strips of 5 containers; each strip is enclosed in an aluminum pouch.
Azimil Syrup in single-dose container:
Carton pack containing 20 single-dose containers of 5 ml. The single-dose containers are divided into strips of 5; each strip is enclosed in an aluminum pouch.
Azimil Syrup in multidose bottle:
200 ml bottle.

Marketing Authorization Holder
GENETIC S.p.A., Via G. Della Monica 26, Castel San Giorgio (SA)
Manufacturer
GENETIC S.p.A., Contrada Canfora, Fisciano (SA)
This leaflet was last updated on: