NAOS 0.375 g/100 ml + 0.075 g/100 ml Раствор для небулайзера

Содержание инструкции

1. Naos 1.875 mg/0.5 ml + 0.375 mg/0.5 ml
   1. What is Naos and what is it 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

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

solution for nebulisation (in single-dose containers)
Naos 0.375 g/100 ml + 0.075 g/100 ml
solution for nebulisation (in multi-dose bottle)
Salbutamol and ipratropium bromide
Generic medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even 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 you use 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 is Naos and what is it for

Naos is a medicine consisting of an association of two active ingredients for the therapy of
obstructive (narrowing) diseases of the bronchi: salbutamol (beta-agonist) and ipratropium
bromide (anticholinergic).
Naos is indicated for the treatment of bronchospasm (contraction of the bronchial muscles) in
adult patients with chronic obstructive bronchopneumopathy (a disease 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 active substances similar to atropine;
• if you suffer from severe heart disease;
• if you suffer from an eye disease called glaucoma;
• if you suffer from prostatic hypertrophy (enlargement of the prostate);
• if you suffer from urinary retention (difficulty of the bladder to empty urine);
• if you suffer from intestinal obstruction (stopping of the passage of contents in the intestine).

Warnings and precautions
Consult your doctor or pharmacist before using Naos, if:

• you have an obstruction of the vessels that carry blood to the heart (coronary artery disease);
• you have an irregular heartbeat;
• you have high blood pressure (hypertension);
• you suffer from a thyroid disease caused by its increased activity (hyperthyroidism);
• you are affected by pheochromocytoma, a tumor that produces chemicals that cause an increase in pressure and an acceleration of the heartbeat;
• you suffer from diabetes (a disease characterized by high levels of glucose in the blood due to reduced production of insulin by the pancreas);
• you suffer from cystic fibrosis. Treatment with Naos may predispose you more to gastrointestinal disorders. Contact your doctor if you experience chest pain, severe difficulty breathing with increased wheezing or shortness of breath, visual disturbances such as eye pain, blurred vision, colored images, dilation of the pupil, or if you perceive a worsening of your health conditions if:
• you suffer from ischemic heart disease (a heart condition that occurs following a reduction in blood flow due to narrowing of the coronary arteries),
• you suffer from tachyarrhythmia (irregular and accelerated heartbeat),
• you have severe heart failure (inability of the heart to pump the adequate amount of blood necessary for the needs of the body).

Therapy with Naos may determine a decrease in potassium in the blood (hypokalemia), even
severe, therefore the doctor will prescribe you periodic checks.
A condition known as lactic acidosis has been reported in association with high doses
therapeutic of salbutamol, mainly in patients treated for acute bronchospasm
(see paragraphs 3 and 4). Increased plasma lactate levels can lead to shortness of breath
and hyperventilation, even if your wheezing improves. If you think the
medicine is no longer effective and that it is necessary to use the nebulizer more than the
doctor has recommended, contact your doctor immediately.
During treatment, immediate hypersensitivity reactions may occur with the appearance
in rare cases of urticaria, angioedema, paradoxical bronchospasm (sudden contraction
involuntary of the bronchi and difficulty breathing) and anaphylaxis.
Be careful not to spray the solution into your eyes, especially if you suffer from glaucoma
(an eye condition caused by increased intraocular pressure); when ipratropium
bromide (one of the active ingredients of Naos) has come into contact with the eye, it has been
reported cases of eye complications (such as mydriasis, blurred vision, visual halos or
colored 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 athletes
The use of the medicine without therapeutic necessity constitutes doping and may determine
anyway positivity to doping tests.

Other medicines and Naos
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Tell your doctor if you are taking:

• beta-blockers, such as propranolol (medicines used for heart disease and to lower blood pressure);
• xanthine derivatives, e.g. theophylline and aminophylline (medicines that relax the bronchial muscles);
• corticosteroids (medicines used for the treatment of inflammatory states);
• diuretics (medicines that lower blood pressure);
• antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors);
• anticholinergic medicines;
• digoxin - a medicine used for the treatment of heart failure;
• if you are going to undergo surgery. Some anesthetics may affect the effects of Naos. If you are going to undergo surgery, inform your doctor, dentist or anesthesiologist that you are being treated with Naos.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
The doctor will prescribe Naos only if absolutely necessary.

Driving and operating machinery
During treatment, dizziness, disturbances in focusing
of the image, dilation of the pupil (mydriasis), blurred vision may occur. If this happens
avoid driving or operating machinery.

Naos (multi-dose bottle) contains para-hydroxybenzoates (parabens)
The solution in the multi-dose bottle contains as preservatives ethyl-para-hydroxybenzoate and
methyl-para-hydroxybenzoate which may cause allergic reactions (even delayed) and,
exceptionally, bronchospasm (narrowing of the bronchi and difficulty breathing).

3. How to use Naos

Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Inhalation with electric nebulizers, for outpatient or home use:
Dilute 5 drops with 2 ml of distilled water or sterile saline solution: duration
of nebulization 10 - 15 minutes, to be repeated 2 - 3 times a day.
Inhalation with electric respirators (Intermittent Positive Pressure Breathing) for hospital
use:
Dilute 2 drops with 1 ml of distilled water or with sterile saline solution: 6
inspirations.
Alternatively, dilute 2 drops with 5 ml of distilled water or with sterile saline
solution: inhalation duration 2 minutes.
Or
Dilute 1 drop with 5 ml of distilled water or with sterile saline solution: inhalation duration 10 minutes.

Use in children and adolescents
Naos is not indicated 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, the opening of which requires a non-instinctive, but rational movement. To open the bottle, apply
simultaneous pressure on the dropper ring and a counterclockwise twist. To close the bottle, screw the ring clockwise, as usual.

If you take more Naos than you should
In case of ingestion/administration of an excessive dose of Naos, contact your doctor or the nearest
hospital.
In case of overdose, 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 a missed dose.

If you stop taking Naos
Do not stop using this medicine without consulting your doctor.
If you have any doubts about the use of this medicine, ask 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

• Onset of chest pain
• Severe breathing difficulties
• Eye pain with blurred vision, pupil dilation Immediately contact your doctor if you experience any of these symptoms and stop therapy.

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

• headache, tension, dizziness (sensation of movement or rotation), drowsiness, muscle tremors, agitation, psychomotor hyperactivity,
• dry mouth, nausea, irritation of the mouth and throat, intestinal motility disorders (diarrhea, constipation and vomiting), stomatitis,
• hypersensitivity, anaphylaxis and angioedema,
• accommodation disorders of vision (blurred vision), pupil dilation (mydriasis), eye pain, dilation of superficial eye vessels (conjunctival hyperemia), glaucoma, increased eye pressure.
• peripheral vasodilation (red and warm skin) for high dosages.

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

• cardiac arrhythmias (irregular heartbeat) including atrial fibrillation, supraventricular tachycardia and extrasystole,
• myocardial ischemia (reduced oxygenation of the heart),
• angina (chest pain).

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• irritability,
• hypokalemia (decreased potassium in the blood),
• paradoxical bronchospasm (constriction of the bronchi) and hyperventilation (increased number of breaths immediately after inhalation),
• cough, dysphonia, throat irritation, throat dryness,
• 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 can cause stomach pain, hyperventilation, shortness of breath despite your wheezing improving, cold feet and hands, irregular heartbeat or thirst.

undesirable.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging. The expiry date
refers to the last day of that month. The expiry date refers to the
product in intact packaging, correctly stored.
Store at a temperature not exceeding 25°C.
The contents of the single-dose container must be used immediately after opening.
If this is not used completely, discard the container with the remaining
solution.
After opening the aluminium wrapper containing the single-dose containers, these
must be used within 7 days, after which period discard any remaining single-dose
containers.
The contents of the multi-dose vial can be used for up to 28 days from the first opening
of the vial, after which period, discard any remaining contents.

6. Contents of the pack and other information

What Naos contains
The active ingredients 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.
One single-dose container of 0.5 ml is equivalent 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 contains 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 contents of the pack
Naos is presented as a solution for nebulisation. The solution may be of
straw-yellow colour.

• Pack of 30 single-dose containers of 0.5 ml.
• Multi-dose bottle of 15 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A., Via San Giuseppe Cottolengo 15 – 20143 Milano

Manufacturer
Genetic S.p.A., Contrada Canfora – 84084 Fisciano (SA)