Patient Information Leaflet

SALBUTAMOL AND IPRATROPIUM BROMIDE EG

3.75 mg/ml + 0.75 mg/ml nebuliser solution
Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SALBUTAMOLO E IPRATROPIO BROMURO EG is and what it is used for

SALBUTAMOLO E IPRATROPIO BROMURO EG is a medicine containing a combination of two active substances for the treatment of obstructive (narrowing) airway diseases: salbutamol (a beta-agonist) and ipratropium bromide (an anticholinergic).
SALBUTAMOLO E IPRATROPIO BROMURO EG 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).

2. What you need to know before using SALBUTAMOL AND IPRATROPIUM BROMIDE EG

Do not use SALBUTAMOL AND IPRATROPIUM BROMIDE EG

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 glaucoma (increased internal eye pressure);
if you have prostatic hypertrophy (enlarged prostate);
if you have urinary retention or intestinal obstruction.

Warnings and precautions
Talk to your doctor or pharmacist before using SALBUTAMOL AND IPRATROPIUM BROMIDE EG if:

you have blockage 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 increased blood pressure and rapid heartbeat;
you have diabetes (a condition characterized by high blood glucose levels due to reduced insulin production by the pancreas);
you have cystic fibrosis. Treatment with SALBUTAMOL AND IPRATROPIUM BROMIDE EG may increase the risk of gastrointestinal disturbances.

Contact your doctor if you experience chest pain, severe breathing difficulties with worsening 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, 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 have 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 SALBUTAMOL AND IPRATROPIUM BROMIDE EG may lead to decreased potassium levels in the blood (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, primarily in patients treated for acute bronchospasm (see sections 3 and 4). Increased plasma lactate levels may cause 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.
Immediate hypersensitivity reactions may occur during treatment, rarely including urticaria, angioedema, paradoxical bronchospasm (sudden involuntary bronchial constriction and breathing difficulty), and anaphylaxis.
Be careful not to spray the solution into the eyes, especially if you have glaucoma (an eye condition caused by increased intraocular pressure); isolated cases of ocular complications (such as mydriasis, blurred vision, halos or coloured images, increased ocular pressure, closed-angle glaucoma, eye pain) have been reported when ipratropium bromide (one of the active substances in SALBUTAMOL AND IPRATROPIUM BROMIDE EG) has come into contact with the eye.

Use in children and adolescents
SALBUTAMOL AND IPRATROPIUM BROMIDE EG is not indicated in children and adolescents (under 18 years of age).
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and SALBUTAMOL AND IPRATROPIUM BROMIDE EG
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, for example 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 SALBUTAMOL AND IPRATROPIUM BROMIDE EG. If you are undergoing surgery,

inform your doctor, dentist or anaesthetist that you are being treated with SALBUTAMOL AND IPRATROPIUM BROMIDE EG.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Your doctor will prescribe SALBUTAMOL AND IPRATROPIUM BROMIDE EG 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.

SALBUTAMOL AND IPRATROPIUM BROMIDE EG contains parahydroxybenzoates
Parahydroxybenzoates may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.

3. How to use SALBUTAMOL AND IPRATROPIUM BROMIDE EG

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Dosage
The recommended dose is 5 drops diluted in 2 ml of sterile physiological solution in the nebulizer, 2–3 times a
day.
The maximum daily dose is 15 drops.
Do not exceed the recommended maximum dose.
Method of administration
Dilute with sterile physiological solution in the nebulizer.
Duration of treatment
The duration of nebulization is 10–15 minutes.
The maximum dose and duration of treatment are determined by the doctor according to your clinical condition.
Instructions for use
To open the vial, press and turn the dropper cap counterclockwise simultaneously. To close the vial, screw the cap clockwise.
Use in children and adolescents
SALBUTAMOL AND IPRATROPIUM BROMIDE EG is not indicated for use in children and adolescents (under 18 years of age).
If you take more SALBUTAMOL AND IPRATROPIUM BROMIDE EG than you should
If you accidentally ingest or use an excessive dose of SALBUTAMOL AND IPRATROPIUM BROMIDE
EG, contact your doctor immediately or go to the nearest hospital emergency department.
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 SALBUTAMOL AND IPRATROPIUM BROMIDE EG
Take the missed dose as soon as you remember, unless it is almost time for the next dose. In that case, continue taking SALBUTAMOL AND IPRATROPIUM BROMIDE EG at your usual time and at the dose prescribed by your doctor. Do not take a double dose to make up for a forgotten dose.
If you stop treatment with SALBUTAMOL AND IPRATROPIUM BROMIDE EG
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 everyone experiences 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, intestinal 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 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 and extrasystolic tachycardia;
Myocardial ischemia (reduced oxygen supply to the heart);
Angina (chest pain).

Side effects with unknown frequency (frequency cannot be estimated based on 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;
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 discomfort, 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 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 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 SALBUTAMOL AND IPRATROPIUM BROMIDE EG

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 after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
After 10 months from first opening of the vial, the medicine must be discarded, even if not completely used.
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 SALBUTAMOL AND IPRATROPIUM BROMIDE EG contains

The active substances are salbutamol (as salbutamol sulphate) and ipratropium bromide. 1 ml of solution contains 3.75 mg of salbutamol and 0.75 mg of ipratropium bromide.
The other components are ethyl parahydroxybenzoate, methyl parahydroxybenzoate, purified water.

Description of the appearance of SALBUTAMOL AND IPRATROPIUM BROMIDE EG and contents of the
package
Colourless or pale yellow solution for nebulisation, in a 15 ml multidose vial.
Marketing Authorisation Holder
EG S.p.A., Via Pavia 6 – 20136 Milan
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)