Naos

Package leaflet: Information for the patient

Naos 1.875 mg/0.5 ml + 0.375 mg/0.5 ml

nebuliser solution (in single-dose containers)
Naos 0.375 g/100 ml + 0.075 g/100 ml
nebuliser solution (in multi-dose bottle)
Salbutamol and ipratropium bromide
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Naos is and what it is used for

Naos is a medicinal product containing two active substances for the treatment of obstructive (narrowing) bronchial diseases: salbutamol (a beta-agonist) and ipratropium bromide (an anticholinergic).
Naos is indicated for the treatment of bronchospasm (contraction of the bronchial muscles) in adult patients with chronic obstructive pulmonary disease (a condition that makes it difficult to empty air from the lungs).

2. What you need to know before using Naos

Do not use Naos:

• if you are allergic to salbutamol and/or ipratropium bromide or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to atropine or to active substances similar to atropine;
• if you have severe heart disease;
• if you have a disease of the eye called glaucoma;
• if you have prostatic hypertrophy (enlargement of the prostate);
• if you have urinary retention (difficulty of the bladder to empty urine);
• if you have intestinal obstruction (blockage of the passage of intestinal contents).

Warnings and precautions
Talk to your doctor or pharmacist before using Naos if:

• you have obstruction of the blood vessels supplying the heart (coronary artery disease);
• you have an irregular heartbeat;
• you have high blood pressure (hypertension);
• you suffer from a thyroid disease caused by overactivity of the thyroid (hyperthyroidism);
• you have phaeochromocytoma, a tumour that produces chemicals causing increased blood pressure and rapid heartbeat;
• you suffer from diabetes (a disease characterized by high levels of glucose in the blood due to reduced insulin production by the pancreas);
• you suffer from cystic fibrosis. Treatment with Naos may increase the risk of gastrointestinal disorders. Contact your doctor if you experience chest pain, severe breathing difficulties with increased wheezing or shortness of breath, visual disturbances such as eye pain, blurred vision, coloured images, pupil dilation, or if you notice a worsening of your health condition, especially if:
  • you suffer from ischaemic heart disease (a heart condition occurring due to reduced blood flow caused by narrowing of the coronary arteries),
  • you suffer from tachyarrhythmia (irregular and rapid heartbeat),
  • you have severe heart failure (inability of the heart to pump sufficient blood to meet the body's needs).

Treatment with Naos may cause a decrease in potassium levels in the blood (hypokalaemia), which can be severe; therefore, your doctor will prescribe periodic monitoring.
A condition known as lactic acidosis has been reported in association with high therapeutic doses of salbutamol, mainly in patients treated for acute bronchospasm (see sections 3 and 4). Increased plasma lactate levels may lead to shortness of breath and hyperventilation, even though your wheezing improves. If you feel that the medicine is no longer effective and you need to use the nebulizer more often than recommended by your doctor, contact your doctor immediately.
Immediate hypersensitivity reactions may occur during treatment, rarely including urticaria, angioedema, paradoxical bronchospasm (sudden involuntary contraction of the bronchi and difficulty breathing), and anaphylaxis.
Be careful not to spray the solution into your eyes, especially if you have glaucoma (an eye disease caused by increased intraocular pressure). When ipratropium bromide (one of the active substances in Naos) has come into contact with the eye, isolated cases of ocular complications have been reported (such as mydriasis, blurred vision, visual halos or coloured images, increased intraocular pressure, angle-closure glaucoma, eye pain).
Children and adolescents
Naos is not indicated in children and adolescents (under 18 years of age).
For those engaged in sports activities
Using this medicine without a medical need constitutes doping and may result in a positive anti-doping test.
Other medicines and Naos
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are being treated with:

• beta-blockers, such as propranolol (medicines used for heart diseases and to lower blood pressure);
• xanthine derivatives, e.g. theophylline and aminophylline (medicines that relax bronchial muscles);
• corticosteroids (medicines used to treat inflammatory conditions);
• diuretics (medicines that lower blood pressure);
• antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors);
• anticholinergic medicines;
• digoxin – a medicine used to treat heart failure;
• if you are scheduled for surgery. Some anaesthetics may affect the actions of Naos. If you are undergoing surgery, inform your doctor, dentist, or anaesthetist that you are being treated with Naos.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Your doctor will prescribe Naos only if clearly necessary.
Driving and using machines
During treatment, dizziness, difficulty focusing vision, pupil dilation (mydriasis), and blurred vision may occur. If this happens, avoid driving or operating machinery.
Naos (multi-dose vial) contains para-hydroxybenzoates (parabens)
The solution in the multi-dose vial contains ethyl-para-hydroxybenzoate and methyl-para-hydroxybenzoate as preservatives, which may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm (narrowing of the airways and difficulty breathing).

3. How to use Naos

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Inhalation using electric nebulizers, for outpatient or home use:
Dilute 5 drops with 2 ml of distilled water or sterile physiological solution: nebulization duration 10–15 minutes, repeat 2–3 times daily.

Inhalation using electric respirators (Intermittent Positive Pressure Breathing), for hospital use:
Dilute 2 drops with 1 ml of distilled water or sterile physiological solution: 6 inspirations.
Alternatively, dilute 2 drops with 5 ml of distilled water or sterile physiological solution: inhalation duration 2 minutes.
Or
Dilute 1 drop with 5 ml of distilled water or sterile physiological solution: inhalation duration 10 minutes.

Use in children and adolescents
Naos is not indicated for use in children and adolescents (under 18 years of age).

Instructions for use

Single-dose containers
To open the single-dose container, twist the cap.

Multi-dose bottle
To prevent the bottle from being easily opened, a dropper has been used that requires a non-instinctive, but rational, action to open. To open the bottle, simultaneously press down on the dropper ring and turn it counterclockwise. To close the bottle, screw the ring back on clockwise, as usual.

If you take more Naos than you should
If you ingest or take an excessive dose of Naos, contact your doctor or go to the nearest hospital immediately.
In case of overdose, symptoms such as tremors, increased heart rate, increased respiratory rate (tachypnea), and metabolic acidosis (alteration of blood acidity) may occur.

If you forget to take Naos
Do not take a double dose to make up for the forgotten dose.

If you stop using Naos
Do not stop using this medicine without first consulting your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you should pay attention to:

• Chest pain
• Severe breathing difficulties
• Eye pain with blurred vision, pupil dilation

If you experience any of these symptoms, contact your doctor immediately and stop treatment.

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

• Headache, tension, dizziness (sensation of movement or spinning), drowsiness, muscle tremors, agitation, psychomotor hyperactivity,
• Dry mouth, nausea, irritation of the mouth and throat, gastrointestinal motility disorders (diarrhea, constipation, and vomiting), stomatitis,
• Hypersensitivity, anaphylaxis and angioedema,
• Visual accommodation disorders (blurred vision), pupil dilation (mydriasis), eye pain, dilation of superficial ocular blood vessels (conjunctival hyperemia), glaucoma, increased eye pressure.
• Peripheral vasodilation (red, warm skin) at high doses.

Very rare side effects (may affect up to 1 in 10,000 people)

• Cardiac arrhythmias (irregular heartbeat), including atrial fibrillation, supraventricular and extrasystolic tachycardia,
• Myocardial ischemia (reduced oxygen supply to the heart),
• Angina (chest pain).

Side effects not known (frequency cannot be estimated from available data):

• Irritability,
• Hypokalaemia (reduced potassium levels in the blood),
• Paradoxical bronchospasm (bronchial constriction) and hyperventilation (increased respiratory rate immediately after inhalation),
• Cough, dysphonia, throat irritation, sore throat,
• Increased systolic blood pressure/decreased diastolic blood pressure,
• Asthenia,
• Urticaria, pruritus, excessive sweating (hyperhidrosis),
• Muscle pain, cramps, muscle weakness,
• Urinary retention,
• A condition known as lactic acidosis which may cause stomach ache, hyperventilation, shortness of breath despite improvement in wheezing, cold hands and feet, irregular heartbeat or thirst.

Following the instructions contained in this leaflet reduces the risk of side effects.
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/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Naos

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers
to the last day of that month. The expiry date applies to the product in its original, unopened
packaging, correctly stored.
Store below 25°C.
The contents of the single-dose container must be used immediately after opening.
If not completely used, discard the container together with any remaining solution.
After opening the aluminium pouch containing the single-dose containers, these must be used within 7 days; after this period, discard any unused single-dose containers.
The contents of the multidose bottle may be used within 28 days after first opening of the bottle; after this period, discard any remaining solution.

6. Package contents and other information

What Naos contains
The active substances are: salbutamol and ipratropium bromide.

• Single-dose containers

Each single-dose container contains 1.875 mg of salbutamol (2.25 mg as salbutamol
sulfate) and 0.375 mg of ipratropium bromide.
The other component is: water for injections.
A single-dose container of 0.5 ml corresponds to 10 drops. One drop (0.05 ml) contains:
187.5 micrograms of salbutamol and 37.5 micrograms of ipratropium bromide.

• Multi-dose bottle

100 ml of solution contain 0.375 g of salbutamol (0.450 g as salbutamol
sulfate) and 0.075 g of ipratropium bromide.
The other components are: ethyl parahydroxybenzoate, methyl parahydroxybenzoate, water
for injections.
Description of the appearance of Naos and pack contents
Naos is a solution for nebulization. The solution may be pale yellow in colour.

• Carton pack containing 30 single-dose containers of 0.5 ml.
• Multi-dose bottle of 15 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A., Via San Giuseppe Cottolengo 15 – 20143 Milan
Manufacturer
Genetic S.p.A., Contrada Canfora – 84084 Fisciano (SA)