Naxim

Patient Information Leaflet: Information for the User

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

Ambroxol hydrochloride
Read this entire 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 you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of time.

Contents of this leaflet:

1. What Naxim is and what it is used for
2. What you need to know before taking Naxim
3. How to take Naxim
4. Possible side effects
5. How to store Naxim
6. Package contents and other information

1. What Naxim is and what it is used for

Naxim 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).
Naxim is used in patients with acute and chronic respiratory diseases characterized by thick and viscous mucus.

2. What you need to know before taking Naxim

Do not take Naxim 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 Naxim in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Naxim if:

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

PAY ATTENTION:
Serious skin reactions have been reported with ambroxol administration.

• If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Naxim 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 to take your usual asthma medications (bronchial spasmolytics) before inhaling Naxim with a nebulizer. This will help prevent possible breathing difficulties.

Children
Do not use Naxim in children under 2 years of age, as mucolytics may cause obstruction of the airways (bronchi).
Other medicines and Naxim
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking Naxim, 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 to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
In particular, during the first three months of pregnancy and during breastfeeding, Naxim should be used only if clearly necessary and under direct medical supervision.
Driving and using machines
Naxim does not affect the ability to drive or operate machinery.
Naxim syrup contains maltitol and hydroxybenzoates
Naxim syrup in single-dose containers and multidose bottles contains maltitol.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Naxim syrup in multidose bottles contains parahydroxybenzoates.
Parahydroxybenzoates may cause allergic reactions (including delayed reactions).
Naxim 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 Naxim

Take this medicine exactly as stated in this leaflet or as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Nebuliser and oral solution

Each single-dose container contains 2 ml and has a marking at the 1 ml volume (half dose).

Nebuliser solution:

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 nebulised (converted into very fine droplets) using an “aerosol device” equipped with oral and/or nasal administration accessories.
Take the medicine by breathing normally through the mouth and/or nose. To administer half a dose, use the 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 nebuliser chamber.
Breathing too deeply may cause coughing; to reduce this risk, try to inhale and exhale normally during nebulisation. It may be helpful to warm the container with the medicine to body temperature before nebulisation.

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

Oral solution:

Adults
2–4 ml (1–2 single-dose containers), 3 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 1 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) 3 times daily, unless otherwise directed by the doctor; subsequently, 5 ml (or one single-dose container) 3 times daily.

Children

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

The medicine should be taken with meals.

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

If using half a dose, close the single-dose container by pressing the cap firmly 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 period of treatment, consult your doctor.

If you take more Naxim than you should
The risk of experiencing adverse effects increases. In case of accidental ingestion or overdose of Naxim, inform your doctor immediately or go to the nearest hospital.

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

If you stop taking Naxim
If you have any doubts about using Naxim, 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 Naxim immediately and contact your doctor if you experience any of the following:
itching, skin rash (urticaria, skin 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;
• indigestion (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 respiratory tract (bronchi); dry throat; anaphylactic reactions including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and pruritus;
• serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis).

Reporting of side effects
If you get any side effect, including ones 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 Naxim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 should 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 should be used within one month; after this period, any remaining medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Naxim contains
The active substance is: Ambroxol.
Naxim 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.

Naxim 15 mg/5 ml oral solution 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.

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

• 5 ml of syrup contain 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 Naxim and pack contents
Naxim Nebulizer and oral solution:
Carton containing 15 or 30 single-dose containers of 2 ml, divided into strips of 5 containers; each strip is enclosed in an aluminium foil pouch.
Naxim Oral solution in single-dose containers:
Carton containing 20 single-dose containers of 5 ml. The single-dose containers are divided into strips of 5; each strip is enclosed in an aluminium foil pouch.
Naxim Multidose syrup:
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)
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