Package leaflet: Information for the user

INASAL 3.75 mg/ml + 0.75 mg/ml NEBULISATION SOLUTION

SALBUTAMOL AND IPRATROPIUM BROMIDE
“EQUIVALENT MEDICINE”
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What INASAL is and what it is used for
What you need to know before using INASAL
How to use INASAL
Possible side effects
How to store INASAL
Contents of the pack and other information

1. What INASAL is and what it is used for

INASAL is a medicine containing a combination of two active substances for the treatment of obstructive (narrowing) diseases of the bronchi: salbutamol (a beta-agonist) and ipratropium bromide (an anticholinergic).
INASAL is indicated for the treatment of bronchospasm (contraction of the bronchial muscles) in adult patients with chronic obstructive pulmonary disease (a disease that makes it difficult to empty air from the lungs).
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using INASAL

Do not use INASAL

if you are allergic to salbutamol 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;
in case of heart disease;
in case of glaucoma (increased pressure inside the eye);
in case of prostatic hyperplasia (enlarged prostate);
in case of urinary retention syndromes or intestinal obstruction.

Warnings and precautions
Talk to your doctor or pharmacist before taking INASAL 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 disorder caused by overactivity of the gland (hyperthyroidism);
you have phaeochromocytoma, a tumour that produces chemicals causing high blood pressure and rapid heartbeat;
you suffer from diabetes (a condition characterised by high blood glucose levels due to reduced insulin production by the pancreas);
you suffer from cystic fibrosis. Treatment with INASAL may increase the risk of gastrointestinal disturbances.

Contact your doctor if you experience chest pain, severe breathing difficulties with increased wheezing or shortness of breath, or visual disturbances such as eye pain, blurred vision, coloured images, pupil dilation, or if you notice a worsening of your health condition when:

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 suffer from severe heart failure (inability of the heart to pump sufficient blood to meet the body's needs).

Treatment with INASAL may cause a decrease in blood potassium levels (hypokalaemia), even 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 if your wheezing improves. If you think the medicine is no longer effective and you need to use the nebuliser more often than recommended by your doctor, contact your doctor immediately.
Hypersensitivity reactions may occur during treatment, including, rarely, urticaria, angioedema, paradoxical bronchospasm (sudden involuntary contraction of the bronchi and difficulty breathing), and anaphylaxis.
Take care not to spray the solution into the eyes, especially if you have glaucoma (an eye condition caused by increased intraocular pressure); when ipratropium bromide (one of the active substances in INASAL) has come into contact with the eye, isolated cases of ocular complications (such as mydriasis, blurred vision, halos or coloured images, increased intraocular pressure, closed-angle glaucoma, eye pain) have been reported.

Children and adolescents
INASAL is not indicated in children and adolescents (under 18 years of age).

Other medicines and INASAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Inform your doctor if you are being treated with:

beta-blockers, such as propranolol (medicines used for heart conditions 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 INASAL. If you are undergoing surgery, inform your doctor, dentist, or anaesthetist that you are being treated with INASAL.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Your doctor will prescribe INASAL only if clearly necessary.

Driving and using machines
Dizziness, blurred vision, pupil dilation (mydriasis), and difficulty focusing may occur during treatment. If this happens, avoid driving or operating machinery.

INASAL contains parahydroxybenzoates. These may cause allergic reactions (including delayed reactions) and, rarely, bronchospasm.

“For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.”

3. How to use INASAL

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

Use with nebulizers Adults For inhalation with 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, to be repeated 2–3 times daily.

For inhalation with electric respirators (Intermittent Positive Pressure Breathing), for
hospital use
It is possible to dilute 2 drops with 1 ml of distilled water or sterile physiological solution: 6
inspirations;
alternatively, dilute 2 drops with 5 ml: inhalation duration 2 minutes;
or dilute 1 drop with 5 ml: inhalation duration 10 minutes.
Use in children and adolescents
Inasal is not indicated for use in children and adolescents (under 18 years of age).
Instructions for use
To prevent the bottle from being easily opened, a dropper has been used that requires a non-instinctive, rational action to open.
To open the bottle, simultaneously apply pressure on the dropper ring and turn it counterclockwise. To close the bottle, screw the ring clockwise, as usual.
If you use more INASAL than you should
In case of accidental ingestion/overdose of INASAL, 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 INASAL
Do not take a double dose to make up for the missed dose.
If you stop using INASAL
Do not stop using this medicine without consulting your doctor.
If you have any questions about the use of 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 → Contact your doctor immediately if you experience any of these symptoms 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 (diarrhoea, 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 hyperaemia), glaucoma, increased intraocular 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 tachycardia and extrasystoles
Myocardial ischaemia (reduced oxygen supply to the heart)
Angina (chest pain)

Unknown frequency side effects – (frequency cannot be estimated from available data):

Irritability
Hypokalaemia (reduced potassium levels in the blood)
Bronchospasm (bronchial constriction), paradoxical bronchospasm and hyperventilation (increased respiratory rate immediately after inhalation)
Cough, dysphonia, throat irritation, sore throat, dry throat
Increase in systolic blood pressure / decrease in 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, breathlessness despite improvement in wheezing, cold hands and feet, irregular heartbeat or thirst

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects via 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 INASAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
DO NOT STORE ABOVE 25°C
The contents of the multidose bottle may be used for up to 10 months after first opening the bottle; after this period, any remaining solution must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What INASAL contains

The active substances are: Salbutamol and Ipratropium bromide. 100 ml of solution contain: 0.375 g of salbutamol (as Salbutamol Sulfate 0.450 g) and 0.075 g of ipratropium bromide. One drop contains: 187.5 micrograms of salbutamol and 37.5 micrograms of ipratropium bromide.
The other components are: Ethyl p-hydroxybenzoate, methyl p-hydroxybenzoate, purified water.

Description of the appearance of INASAL and contents of the pack
Nebuliser solution. Multi-dose bottle of 15 ml.
INASAL solution may be pale yellow in colour.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
KONPHARMA S.r.l. – Via Pietro della Valle, 1 – 00193 Rome - Italy
Manufacturer
Special Product’s Line S.p.A. –
Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) Italy