IPRATROPIUM BROMIDE/SALBUTAMOL GENETIC 0.5 mg/2.5 mg SOLUTION FOR NEBULIZER INHALATION

Introduction

Package Leaflet: Information for the Patient

Ipratropium Bromide/Salbutamol Genetic 0.5 mg/2.5 mg Solution for Inhalation by Nebulizer

ipratropium bromide/salbutamol

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ipratropium Bromide/Salbutamol Genetic and what is it used for
2. What you need to know before you start using Ipratropium Bromide/Salbutamol Genetic
3. How to use Ipratropium Bromide/Salbutamol Genetic
4. Possible side effects
5. Storage of Ipratropium Bromide/Salbutamol Genetic
6. Package Contents and Further Information

1. What is Ipratropium Bromide/Salbutamol Genetic and what is it used for

This medicine is called Ipratropium Bromide/Salbutamol Genetic 0.5 mg/2.5 mg Solution for Inhalation by Nebulizer. It is used with a device called a ‘nebulizer’.

The active substances are ipratropium bromide and salbutamol. Ipratropium bromide and salbutamol belong to a group of medicines called bronchodilators, which help to improve breathing by opening up the airways.

They do this by preventing the contraction of the smooth muscle that surrounds the airways, so that they remain open.

Ipratropium bromide works by blocking the nerve signals to the muscles that surround the airways, and salbutamol works by stimulating the β2 receptors in the muscles.

Ipratropium bromide/salbutamol is used to make breathing easier in a disease known as chronic obstructive pulmonary disease or COPD in patients over 12 years of age. Ipratropium bromide/salbutamol will relieve wheezing, difficulty breathing, and chest tightness.

2. What you need to know before you start using Ipratropium Bromide/Salbutamol Genetic

Do not use Ipratropium Bromide/Salbutamol Genetic

• if you are allergic to ipratropium or salbutamol or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to similar medicines that contain atropine or medicines like atropine;
• if you have a fast heart rate (tachycardias);
• if you have cardiomegaly (enlarged heart) or a disease called hypertrophic obstructive cardiomyopathy or HOCM, where the heart walls become thickened, making it difficult for blood to flow.

Do not use it if any of the above situations apply to you.

If you are not sure, consult your doctor or pharmacist before using ipratropium bromide/salbutamol.

Warnings and Precautions

Consult your doctor before starting to use this medicine:

• if you have or think you may have an eye condition called glaucoma (increased pressure in the eyes) or any other eye condition. Your doctor may advise you to protect your eyes when using the ipratropium bromide/salbutamol ampoules;
• if you are a man and have an enlarged prostate or problems urinating;
• if you have recently had a heart attack (myocardial infarction); if you have arterial problems or pain in your legs when walking;
• if you have a history of heart disease, irregular heartbeat, or angina pectoris (please inform your doctor before starting to use this medicine);
• if you have diabetes;
• if you have an overactive thyroid gland;
• if you have cystic fibrosis;
• if you have been told you have a non-cancerous tumor in the adrenal gland called pheochromocytoma. Using the inhaler can worsen the symptoms of this condition.
• If you are pregnant, breastfeeding, or planning to become pregnant. (See section “Pregnancy and Breastfeeding”).

Tell your doctor before starting to use ipratropium bromide/salbutamol if you have any of the above conditions.

Lactic acidosis has been observed with high therapeutic doses of salbutamol, mainly in patients treated for acute bronchospasm (see sections 3 and 4). The increase in lactate levels can lead to shortness of breath and hyperventilation. Talk to your doctor immediately if you feel that the medicine is not working as usual and you need to use the nebulizer more often than your doctor has recommended.

Consult your doctor if your respiratory problems worsen or if the prescribed dose does not give the usual result. Do not increase the dose without consulting your doctor. (See section: “How to use Ipratropium Bromide/Salbutamol Genetic”).

If you use high doses of Ipratropium Bromide/Salbutamol for a long time, you should have your blood potassium levels monitored, especially if you are taking other medicines at the same time, such as steroids (corticosteroids), diuretics, or other bronchodilators like theophylline (xanthines). (See section: “Possible side effects”).

Other medicines and Ipratropium Bromide/Salbutamol Genetic

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

Certain medicines may interact with ipratropium bromide/salbutamol and worsen side effects or reduce the effect of ipratropium bromide/salbutamol. Always tell your doctor if you are taking any of the following medicines:

• diuretics (to increase urine production)
• corticosteroid tablets (medicines that reduce inflammation, such as prednisolone). These medicines increase the risk of low potassium levels;
• certain medicines for treating depression (such as “antidepressants”, which are medicines prescribed for patients with depression and anxiety). This class of medicines includes monoamine oxidase inhibitors (e.g., phenelzine) or tricyclic antidepressants (e.g., amitriptyline);
• other medicines that help you breathe, such as salbutamol and preventatives like beclometasone dipropionate. These can increase the effect of ipratropium bromide/salbutamol and increase the intensity of side effects;
• ‘anticholinergics’. These are used to treat colic pain, Parkinson's disease, problems urinating, or fecal or urinary incontinence;
• beta-blockers, i.e., medicines used to treat heart conditions, such as chest pain during exertion (called angina pectoris), irregular heartbeats (or arrhythmias), and high blood pressure (called hypertension). These include medicines like propranolol. These medicines counteract the ‘airway-opening’ effect of ipratropium bromide/salbutamol;
• medicines called ‘beta-mimetics’ such as fenoterol for respiratory problems;
• digoxin (for heart problems) can cause heart rhythm problems when given with ipratropium bromide/salbutamol;
• anesthetics can increase the tendency to experience the side effects of salbutamol on the heart. Your doctor will closely monitor you or may decide to stop treatment with ipratropium bromide/salbutamol if you are going to have surgery.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before starting to use ipratropium bromide/salbutamol.

Children and Adolescents

Ipratropium bromide/salbutamol should not be used in children under 12 years of age.

Lab Tests

If you have to provide a urine sample as part of a routine drug test in sports, tell the person taking the test that you are taking ipratropium bromide/salbutamol because it contains salbutamol, which can give a positive result in the test.

Using Ipratropium Bromide/Salbutamol Genetic with Food and Drink

Food and drink do not affect ipratropium bromide/salbutamol.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, or planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use ipratropium bromide/salbutamol if you are pregnant, planning to become pregnant, or breastfeeding unless your doctor decides that the benefit to you is greater than the risk to your child.

Driving and Using Machines

If you experience side effects such as dizziness, difficulty focusing, and blurred vision during treatment with ipratropium bromide/salbutamol, you should avoid driving or using machines.

3. How to use Ipratropium Bromide/Salbutamol Genetic

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist.

Ipratropium bromide/salbutamol is for inhalation use. The solution is for oral inhalation after nebulization.

The recommended dose for adults and children over 12 years of age is 1 ampoule, 3 to 4 times a day.

Elderly patients should take the usual adult dose.

Use in Children

Ipratropium bromide/salbutamol is not recommended for children under 12 years of age.

Ipratropium bromide/salbutamol has not been studied in patients with renal or hepatic insufficiency, so it should be used with caution in these patient populations.

Do not use more medicine than your doctor has told you. Tell your doctor if your breathing problems get worse, if the medicine does not relieve your breathing problems as well as before, or if you are using the short-acting ‘rescue’ inhaler more often than usual.

Instructions for Use

Read the instructions first before you start using the nebulizer.

• Prepare the nebulizer by following the manufacturer's instructions and your doctor's advice.
• Carefully separate one ampoule from the labeled strip by twisting and pulling. Never use an ampoule that has already been opened or if the solution for inhalation by nebulizer is discolored (image A).
• Hold the ampoule upright and open it by twisting the top (image B).
• Transfer all the contents to the nebulizer chamber by squeezing the ampoule (image C).
• Assemble the nebulizer and use it by following the manufacturer's instructions and your doctor's advice.
• After using the nebulizer, discard any solution that remains in the chamber. If there is any solution for inhalation by nebulizer left in the ampoule, it should also be discarded.
• Clean the nebulizer thoroughly by following the manufacturer's instructions. It is important to keep the nebulizer clean.

Do not dilute the solution for inhalation by nebulizer or mix it with other medicines unless your doctor tells you to.

The single-dose ampoules of ipratropium bromide/salbutamol do not contain preservatives, and it is important that the contents are used immediately after opening. You should use a new ampoule for each administration of ipratropium bromide/salbutamol with the nebulizer.

Partially used, opened, or damaged ampoules should be discarded. You should never use an ampoule that has already been opened.

It is important that you follow these instructions to avoid contaminating the solution for inhalation by nebulizer contained in the ampoules.

Do not swallow or administer this medicine by injection. Do not let the solution for inhalation by nebulizer or the vapor come into contact with your eyes. If any of the liquids or vapor accidentally get into your eyes, you may experience pain, stinging, redness, dilated pupils, blurred vision, or see colors or lights. If this happens, consult your doctor. If you have any eye problems at any other time, consult your doctor.

If you use more Ipratropium Bromide/Salbutamol Genetic than you should

If you have taken a slightly higher dose than usual, you may notice a faster heart rate (palpitations) or tremors. Other symptoms may include chest pain, changes in blood pressure, shortness of breath, restlessness, or dizziness. These effects usually disappear within a few hours. You may have low potassium levels in your blood; your doctor may want to monitor your potassium levels by doing a blood test from time to time. Tell your doctor if you are concerned about any of these symptoms or if they persist.

If you use more of this medicine than you should, tell your doctor immediately or go to the nearest hospital. If you decide to go to a doctor or hospital, you should take all your medicines, including those bought without a prescription, with you in their original packaging if possible. Also, take this package leaflet to show to the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Ipratropium Bromide/Salbutamol Genetic

If you forget to take a dose at the right time, take it as soon as you remember.

Do not take a double dose to make up for forgotten doses.

If you stop using Ipratropium Bromide/Salbutamol Genetic

Do not stop treatment with ipratropium bromide/salbutamol without consulting your doctor first.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious and require medical intervention.

Tell your doctor immediately if you notice any of the following serious adverse effects - you may need urgent medical treatment:

If your respiratory problem or wheezing worsens immediately after inhaling ipratropium bromide/salbutamol, or you have difficulty breathing and become short of breath, do not take more ipratropium bromide/salbutamol, use your short-acting relief inhaler immediately. You should stop using ipratropium bromide/salbutamol and contact your doctor as soon as possible. Your doctor may prescribe an alternative treatment for your condition.

If you think you are allergic to ipratropium bromide/salbutamol or are having an allergic reaction to the nebulizer solution (including swelling of the tongue, lips, and face), stop using ipratropium bromide/salbutamol and contact your doctor immediately.

See your doctor if you experience any of these adverse effects.

If you experience eye pain or discomfort, blurred vision, red eyes, or see halos or colored spots, you should contact your doctor immediately, as treatment for these symptoms may be necessary.

A reduction in the amount of potassium in the blood (hypokalemia) due to the salbutamol in this medicine is more likely if you are using ipratropium bromide/salbutamol with other treatments for asthma, with inhaled or oral corticosteroids (such as prednisone), or with diuretics (to increase urine elimination). Low potassium levels in the blood can cause muscle weakness, muscle contractions, or heart rhythm abnormalities. Your doctor may perform a blood test to measure your potassium levels from time to time.

The following side effect may also occur, but its frequency is not known:

A condition known as lactic acidosis that can cause stomach pain, hyperventilation, difficulty breathing, despite possible improvement in wheezing, cold hands and feet, irregular heartbeats, or thirst.

Frequency of Adverse Effects

Uncommon(may affect up to 1 in 100 people)

• Feeling nervous, trembling, or dizzy
• Dry mouth
• Cough, headache
• Feeling of discomfort (nausea)
• Throat irritation
• Increased blood pressure
• Increased heart rate or irregular heartbeats (palpitations)
• Speech problems (‘dysphonia’)
• Skin reactions

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

• Irregular heartbeat
• Regular but abnormally fast heart rate (supraventricular tachycardia)
• Chest pain (due to heart problems such as angina pectoris). Tell your doctor or pharmacist if this occurs, but do not stop taking this medicine unless they tell you to
• Blurred vision, dilated pupils, glaucoma, pain, burning, or redness of the eyes, swelling of the eyes, seeing colors or lights
• Increased sweating
• Sudden chest tightness immediately after inhaling the medicine
• Dry throat, throat swelling
• Difficulty breathing or speaking due to a brief spasm of the vocal muscles
• Diarrhea, constipation, nausea (vomiting), or other digestive system problems
• Mouth inflammation
• Cramps, weakness, and muscle pain
• Difficulty urinating
• Feeling of weakness
• Decreased blood pressure
• Mood changes

You may also have unusually low potassium levels in your blood (so-called "hypokalemia"). If this happens, your doctor will continue to check your potassium levels.

Although it is not known exactly how often this occurs, some people may experience chest pain (due to problems such as angina pectoris).

Tell your doctor as soon as possible if you develop these symptoms while being treated with ipratropium bromide/salbutamol, but do not stop using this medicine unless they tell you to.

If the liquid or vapor accidentally enters your eyes, you may feel pain, burning, or redness of the eyes, dilated pupils, blurred vision, or see colors or lights. If this happens, talk to your doctor for advice. If you have eye problems at any other time, talk to your doctor for advice.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ipratropium Bromide/Salbutamol Genetic

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton label, pouch, and ampoule after CAD. The expiration date is the last day of the month indicated.

• For single use. Use immediately after opening the ampoule for the first time. Discard immediately after the first use.
• The disposal of partially used, opened, or damaged ampoules will be carried out in accordance with local regulations.

Do not freeze.

After opening the bag, use within 7 days.

Do not use this medicine if you notice that the nebulizer solution is cloudy.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ipratropium Bromide/Salbutamol Genetic

• The active ingredients are ipratropium bromide and salbutamol. Each single-dose ampoule (2.5 ml dose) contains 0.5 mg of ipratropium bromide (as monohydrate) and 2.5 mg of salbutamol (as sulfate).
• The other excipients are sodium chloride, water for injectable preparations, and hydrochloric acid (for pH adjustment).

Appearance of the Product and Package Contents

20 or 30 single-dose ampoules of LDPE labeled, divided into strips of 5 ampoules, in a PET/Al/PE wrapper (1 strip per wrapper) and packaged in a suitable box, along with the leaflet.

Packages of 20 and 30 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder

Genetic S.p.A.

Via Giuseppe Della Monica 26

Castel San Giorgio (SALERNO)

84083 Italy

Manufacturer

Genetic S.p.A.

Contrada Canfora,

Fisciano, Salerno

84083 Italy

Local Representative

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6,

28033 Madrid,

Spain.

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

Date of the last revision of this leaflet: 04/2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)