Iprixon Neb

Leaflet accompanying the packaging: patient information

Iprixon Neb, (0.5 mg + 2.5 mg)/2.5 ml, solution for nebulization
Ipratropium bromide + Salbutamol
You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Iprixon Neb and what is it used for
• 2. Important information before using Iprixon Neb
• 3. How to use Iprixon Neb
• 4. Possible side effects
• 5. How to store Iprixon Neb
• 6. Contents of the packaging and other information

1.

What is Iprixon Neb and what is it used for
The name of the medicine is Iprixon Neb. The active substances of the medicine are ipratropium bromide and salbutamol. Ipratropium bromide and salbutamol belong to a group of medicines called bronchodilators, which make breathing easier by widening the airways.
This happens because they prevent the contraction of smooth muscle in the airways, keeping them open.
Ipratropium bromide works by blocking nerve signals to the muscles surrounding the airways, while salbutamol works by stimulating beta receptors in these muscles.
Iprixon Neb is used to treat breathing problems in people with chronic obstructive pulmonary disease (COPD).
Iprixon Neb is also used as a bronchodilator to treat symptoms of obstructive airway diseases: asthma and chronic bronchitis with or without emphysema.
Iprixon Neb reduces wheezing, shortness of breath, and chest tightness.

2. Important information before using Iprixon Neb

When not to use Iprixon Neb:

• if the patient is allergic (hypersensitive) to ipratropium bromide, salbutamol, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to similar medicines containing atropine, including atropine-like medicines;
• if the patient has an irregular heartbeat, including a very fast heartbeat (called tachyarrhythmia);
• if the patient has an enlarged heart or a condition called hypertrophic cardiomyopathy with outflow obstruction or HOCM (Hypertrophic Obstructive Cardiomyopathy), a condition where part of the heart muscle becomes thickened, causing the outflow of blood to be obstructed;
• if the patient is pregnant or breastfeeding, or thinks they may be pregnant. If in doubt, the patient should consult a doctor or pharmacist before taking Iprixon Neb.

Warnings and precautions:

With the use of salbutamol in high therapeutic doses, a condition called lactic acidosis has occurred, mainly in patients being treated for acute bronchospasm (see sections 3 and 4).
An increase in lactic acid levels can lead to shortness of breath and hyperventilation, even if there is an improvement in wheezing.
If the patient feels that the medicine is not working as well as usual and needs to use the nebulizer more often than prescribed by the doctor, they should contact their doctor immediately.
Before starting treatment with Iprixon Neb, the patient should discuss the following with their doctor or pharmacist:

• if the patient has or suspects they have glaucoma (increased pressure in the eye) or any other eye problems. The doctor may recommend eye protection while using Iprixon Neb ampoules;
• if the patient has an enlarged prostate or problems with urination;
• if the patient has recently had a heart attack; if the patient has heart disease or has leg pain when walking;
• if the patient has ever had heart problems; irregular heartbeat or angina pectoris (the patient should inform their doctor before starting treatment with this medicine);
• if the patient has diabetes;
• if the patient has an overactive thyroid gland;
• if the patient has cystic fibrosis;
• if the patient has a non-cancerous tumor of the adrenal gland called pheochromocytoma. The use of inhalation medication may worsen symptoms. Before using Iprixon Neb, the patient should inform their doctor if they have any of the above conditions.

Iprixon Neb and other medicines:

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may interact with Iprixon Neb and may increase the risk of side effects or reduce the effectiveness of Iprixon Neb.
The patient should always inform their doctor if they are taking any of the following medicines:

• diuretics (water pills) and steroids in tablet form (medicines used to reduce inflammation in the body, such as prednisolone). These medicines may increase the risk of low potassium levels;
• certain medicines used to treat depression (antidepressants, such as phenelzine) or tricyclic antidepressants (such as amitriptyline);
• other medicines used to treat asthma, including inhalers and tablets used to treat asthma, including bronchodilators like salbutamol, or anti-inflammatory medicines like beclomethasone dipropionate. They may increase the effect of Iprixon Neb and increase the risk of side effects;
• anticholinergic medicines, which may be used to treat colic, Parkinson's disease, urinary problems, or incontinence.
• beta-blockers, i.e., medicines usually used to treat heart conditions, such as exertional chest pain (angina pectoris), irregular heartbeat, or arrhythmias, and high blood pressure (hypertension). These include medicines such as propranolol. These medicines counteract the bronchodilatory effect of Iprixon Neb.

and

• beta2-mimetics, such as fenoterol, used in breathing disorders.
• digoxin (used in heart conditions) given at the same time as Iprixon Neb may cause arrhythmias;
• anesthetics may increase the sensitivity of the heart to the effect of salbutamol - the patient will be closely monitored. The doctor may also decide to discontinue Iprixon Neb if the patient is having surgery.

If the patient is unsure whether any of the above situations apply to them, they should consult their doctor or pharmacist before using Iprixon Neb.

Procedures

Certain volatile substances used during surgical procedures (anesthetics) may affect the action of this medicine.
If the patient is going to have surgery, they should make sure to inform their doctor, dentist, or anesthesiologist that they are using Iprixon Neb.

Doping tests

If the patient is going to provide a urine sample for doping tests, they should inform the person conducting the test that they are taking Iprixon Neb, as the medicine contains salbutamol, which may result in a positive test result.

Iprixon Neb with food and drink

Food and drink do not affect the action of Iprixon Neb.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Iprixon Neb should not be used in pregnant or breastfeeding women unless the doctor decides that the benefits to the mother outweigh the risks to the baby.

Driving and using machines

While using Iprixon Neb, the patient may experience dizziness, difficulty concentrating, or blurred vision.
In such cases, the patient should not drive or operate machinery.

3. How to use Iprixon Neb

This medicine should always be used as directed by the doctor.
If in doubt, the patient should consult their doctor or pharmacist.
Iprixon Neb is intended for inhalation use.
The solution is intended for inhalation through the mouth after nebulization.
The recommended dose of the medicine for adults and children over 12 years old is the contents of one ampoule three or four times a day.
Elderly patients should take the usual adult dose.
Iprixon Neb is not recommended for use in children under 12 years old.
Never use a higher dose of the medicine than recommended by the doctor. If breathing difficulties worsen or the medicine does not provide sufficient relief from breathing difficulties, or if it is necessary to use a short-acting bronchodilator inhaler more often than usual, the patient should inform their doctor.

• Prepare the nebulizer for use according to the manufacturer's instructions and the doctor's recommendations.
• Carefully separate the Iprixon Neb ampoule from the labeled blister pack by twisting and pulling. Never use an ampoule that has been previously opened or if the solution has changed color (Figure A).
• Hold the ampoule upright and twist the top (Figure B).
• Squeeze the contents into the nebulizer chamber (Figure C).
• Follow the manufacturer's instructions and the doctor's recommendations for assembling and using the nebulizer.
• After using the nebulizer, remove any remaining solution from the chamber. The solution remaining in the ampoule should also be discarded.
• Clean the nebulizer thoroughly according to the manufacturer's instructions. It is essential to keep the nebulizer clean.

Do not dilute the solution or mix it with other medicines unless the doctor recommends otherwise.
The single-dose ampoules of Iprixon Neb do not contain preservatives, so it is essential to use the medicine immediately after opening the ampoule.
Each time Iprixon Neb is used in the nebulizer, a new ampoule should be used.
Partially used, opened, or damaged ampoules should be discarded. Never use a previously opened ampoule.
It is essential to follow the above recommendations to avoid contaminating the nebulizer solution in the ampoule.
Do not swallow the solution or use it for injections. Be careful not to get the solution or aerosol into the eyes.
If the solution or aerosol accidentally gets into the eyes, it may cause eye pain, stinging, or redness, pupil dilation, blurred vision, or seeing colored or light spots.
In such cases, the patient should consult their doctor. If the patient experiences any eye problems during treatment, they should consult their doctor.

Using a higher dose of Iprixon Neb than recommended

If a slightly higher dose than recommended is used, the patient may experience a rapid heartbeat (palpitations) or muscle tremors.
Other symptoms may occur, including chest pain, changes in blood pressure, flushing, anxiety, or dizziness.
These symptoms usually resolve within a few hours.
The patient may also experience a decrease in potassium levels in the blood (hypokalemia), so the doctor may recommend regular blood tests to check potassium levels.
If the patient is concerned about any of these symptoms or if they persist, they should inform their doctor.
If a higher dose of the medicine is used, the patient should immediately inform their doctor or go to the nearest hospital.
If a hospital visit is necessary, the patient should take all their medicines, including those available without a prescription, with them to the hospital, if possible, in their original packaging.
The patient should also take this leaflet to show it to their doctor.

Missing a dose of Iprixon Neb

If the patient misses a dose at the scheduled time, they should take it as soon as possible.
Do not take two doses of the medicine at the same time.

Stopping treatment with Iprixon Neb

Do not stop using Iprixon Neb without first discussing it with the doctor.
If the patient has any further doubts about using the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Iprixon Neb can cause side effects, although not everybody gets them.
Some side effects may be serious and require medical attention.

If the patient notices any of the following serious side effects, they should immediately inform their doctor – the patient may need urgent medical attention:

If, immediately after inhaling the Iprixon Neb solution, the patient's asthma symptoms or wheezing worsen, or if breathing becomes difficult and the patient experiences shortness of breath, they should stop taking Iprixon Neb and immediately use a short-acting, inhaled bronchodilator.
The patient should stop using Iprixon Neb and immediately contact their doctor.
The doctor may recommend a different treatment for the condition.
If the patient thinks they are allergic to the Iprixon Neb solution or suspects they may have an allergic reaction (e.g., skin rash, itching, hives) to the solution, they should immediately stop using Iprixon Neb and contact their doctor.
If any of the above side effects occur, the patient should immediately consult their doctor.
The patient may also experience the following side effects, but the frequency of their occurrence is unknown:
A condition called lactic acidosis, which can cause stomach pain, hyperventilation, shortness of breath, even if there is an improvement in wheezing, cold hands and feet, irregular heartbeat, or a feeling of thirst.
If the patient experiences eye pain or discomfort, blurred vision, or redness of the eyes, they should immediately contact their doctor, as treatment may be necessary.
The patient may also experience a decrease in potassium levels in the blood (hypokalemia) due to the effect of salbutamol, a component of Iprixon Neb, which can cause muscle weakness, tremors, or heart rhythm disturbances.
This is more likely to occur if the patient is taking Iprixon Neb with other medicines used to treat asthma, inhaled steroids, or steroid tablets, or if they are taking diuretics.
The doctor may recommend regular blood tests to check potassium levels.

Frequency of side effects

Uncommon(occurring in less than 1 in 100 people)

• Feeling nervous, trembling, or dizzy
• Dry mouth
• Cough, headache
• Nausea
• Irritation of the throat
• High blood pressure
• Irregular or very fast heartbeat (palpitations)
• Difficulty speaking (dysphonia)
• Skin reactions

Rare(occurring in less than 1 in 1,000 people)

• Irregular heartbeat
• Regular but abnormally fast heartbeat (supraventricular tachycardia)
• Chest pain (caused by heart problems, such as angina pectoris). If such symptoms occur, the patient should inform their doctor as soon as possible, but should not stop using the medicine unless the doctor recommends otherwise.
• Blurred vision, pupil dilation, glaucoma, pain, stinging, or redness of the eyes, swelling around the eyes, seeing colored or light spots
• Excessive sweating
• Feeling of chest tightness immediately after inhaling the medicine
• Feeling of dryness in the throat, swelling of the throat
• Difficulty breathing or speaking due to contraction of the vocal cord muscles
• Diarrhea, constipation, vomiting, or other gastrointestinal disorders
• Oral thrush
• Muscle cramps, weakness, and pain
• Difficulty urinating
• Feeling of weakness
• Low blood pressure
• Mood swings

The patient may also experience an abnormally low level of potassium in the blood (hypokalemia).
In such cases, the doctor will regularly check the patient's potassium levels.
Some patients may experience chest pain (due to conditions such as angina pectoris), although it is not known how often this occurs.
If such symptoms occur while using Iprixon Neb, the patient should inform their doctor as soon as possible, but should not stop using the medicine unless the doctor recommends otherwise.
If the solution or aerosol accidentally gets into the eyes, it may cause eye pain, stinging, or redness, pupil dilation, blurred vision, or seeing colored or light spots.
In such cases, the patient should consult their doctor. If the patient experiences any eye problems during treatment, they should consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Iprixon Neb

The medicine should be stored out of 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 the month.
Do not freeze.
After opening the protective bag, the medicine should be used within 7 days.
Do not use the medicine if the solution is discolored or cloudy.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What Iprixon Neb contains

Each 2.5 ml Iprixon Neb ampoule contains:

• active substances: 0.5 mg ipratropium bromide and 2.5 mg salbutamol (as salbutamol sulfate).
• other ingredients: sodium chloride, water for injection, and hydrochloric acid 1N (to adjust pH).

What Iprixon Neb looks like and contents of the pack

Each Iprixon Neb ampoule contains a clear solution.
Ampoules made of LDPE (Steri-Neb), packaged in 5s in PET/Aluminum/PE bags, in a cardboard box.
The box contains 20 or 30 ampoules (Steri-Neb) of 2.5 ml solution.
Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Phone: 22 732 77 00

Manufacturer:

Genetic S.p.A,
Nucleo Industriale, Contrada Canfora,
84084 Fisciano (SA),
Italy
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicine is authorized for marketing in the Member States of the European Economic Area under the following names:

Portugal
Iprixon
Poland
Iprixon Neb

Date of last revision of the leaflet:

June 2025