Ipratropium bromide/salbutamol Genetic 0.5 mg/2.5 mg solution for inhalation by nebulizer

Package leaflet: Information for the user

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 all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Bromuro de ipratropio/Salbutamol Genetic is and what it is used for
2. What you need to know before using Bromuro de ipratropio/Salbutamol Genetic
3. How to use Bromuro de ipratropio/Salbutamol Genetic
4. Possible side effects
5. How to store Bromuro de ipratropio/Salbutamol Genetic
6. Contents of the pack and other information

1. What Bromuro de ipratropio/Salbutamol Genetic is and what it is used for

This medicine is called Bromuro de ipratropio/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 improve breathing by opening the airways.

They do this by preventing the contraction of the smooth muscles surrounding the airways, so that the airways remain open.

Ipratropium bromide works by blocking nerve signals directed to the muscles surrounding the airways, while salbutamol works by stimulating β2 receptors in these muscles.

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

2. What you need to know before using Bromuro de ipratropio/Salbutamol Genetic

Do not use Bromuro de ipratropio/Salbutamol Genetic

• if you are allergic to ipratropium or salbutamol, or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to similar medicines containing atropine or medicines like atropine;
• if you have a fast heartbeat (tachycardias);
• if you have cardiomegaly (enlarged heart) or a condition called hypertrophic obstructive cardiomyopathy (HOCM), in which the heart walls thicken, making blood flow more difficult.

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

If you are unsure, consult your doctor or pharmacist before using ipratropium bromide/salbutamol.

Warnings and precautions

Talk to your doctor before starting to use this medicine:

• if you have or think you may have a condition affecting the eyes called glaucoma (increased pressure in the eyes), or any other eye condition. Your doctor may advise you to protect your eyes when using ipratropium bromide/salbutamol ampoules;
• if you are a man and have prostate enlargement or problems with urination;
• if you have recently had a heart attack (myocardial infarction); if you have arterial problems or leg pain when walking;
• if you have a history of heart disease, irregular heartbeat, or angina (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 diagnosed with a tumour of the adrenal gland (non-malignant) called a phaeochromocytoma. Using the inhaler may worsen its symptoms;
• if you are pregnant, planning to become pregnant, or breastfeeding. (See section “Pregnancy and Breastfeeding”).

Inform 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, particularly in patients being treated for acute bronchospasm (see sections 3 and 4). Increased lactate levels may lead to shortness of breath and hyperventilation. Speak to your doctor immediately if you feel the medicine is not working as it usually does and you need to use the nebuliser more often than your doctor has recommended.

Consult your doctor if your breathing problems worsen suddenly or if the prescribed dose does not produce the expected effect. Do not increase the dose without consulting your doctor. (See section: “How to use Bromuro de ipratropio/Salbutamol Genetic”).

If you use high doses of ipratropium bromide/salbutamol for a long time, your blood potassium levels should be monitored, especially if you are taking other medicines at the same time, such as: steroids (corticosteroids), medicines that increase urine production (diuretics), or other medicines that open the airways, such as theophylline (xanthines). (See section: “Possible side effects”).

Other medicines and Bromuro de ipratropio/Salbutamol Genetic

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

Certain medicines may interact with ipratropium bromide/salbutamol, worsening side effects or reducing the effect of ipratropium bromide/salbutamol. Always inform your doctor if you are taking any of the following medicines:

• diuretics (to increase urine elimination);
• steroid tablets (medicines that reduce inflammation such as prednisolone). These medicines increase the risk of low potassium levels;
• certain medicines used to treat depression (such as “antidepressants”, prescribed for patients with depression and anxiety). This includes monoamine oxidase inhibitors (e.g., phenelzine) or tricyclic antidepressants (e.g., amitriptyline);
• other medicines that help you breathe, such as salbutamol, and preventers like beclometasone dipropionate. These may increase the effect of ipratropium bromide/salbutamol and intensify side effects;
• ‘anticholinergics’. These are used to treat colicky pain, Parkinson’s disease, urinary problems, or urinary or faecal incontinence;
• beta-blockers, i.e., medicines often used to treat heart conditions such as chest pain during exertion (called angina), irregular heartbeats (or arrhythmias), and high blood pressure (called hypertension). Examples include 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) may cause heart rhythm problems when given together with ipratropium bromide/salbutamol;
• anaesthetics may increase the likelihood of experiencing salbutamol’s adverse effects on the heart. Your doctor will monitor you closely, or your doctor, dentist, or anaesthetist may decide to stop treatment with ipratropium bromide/salbutamol if you are undergoing surgery.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before starting to use ipratropium bromide/salbutamol.

Children and adolescents

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

Laboratory tests

If you need to provide a urine sample as part of a routine doping control in sports, tell the person conducting the test that you are taking ipratropium bromide/salbutamol, as it contains salbutamol, which may result in a positive test.

Use of Bromuro de ipratropio/Salbutamol Genetic with food and drink

Food and drink have no effect on ipratropium bromide/salbutamol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 outweighs the risk to your baby.

Driving and using machines

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

3. How to use Bromuro de ipratropio/Salbutamol Genetic

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, ask your doctor or pharmacist.

Bromuro de ipratropio/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 one ampoule three to four times daily.

Elderly patients should take the usual adult dose.

Use in children

Bromuro de ipratropio/salbutamol is not recommended for children under 12 years of age.

Bromuro de ipratropio/salbutamol has not been studied in patients with renal or hepatic impairment, and should therefore be used with caution in these patient populations.

Do not use more medicine than the amount indicated by your doctor. Inform your doctor if your breathing problems worsen, if the medicine does not relieve your breathing difficulties as effectively as before, or if you are using your short-acting "rescue" blue inhaler more frequently than usual.

Instructions for use

Read the instructions first before starting to use the nebulizer.

• Prepare the nebulizer according to 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 nebulized inhalation solution is discolored (image A).
• Hold the ampoule upright and open it by twisting off the top (image B).
• Transfer the entire contents into the nebulizer chamber by squeezing the ampoule (image C).
• Assemble the nebulizer and use it according to the manufacturer's instructions and your doctor's guidance.
• After using the nebulizer, discard any remaining solution in the chamber. If any nebulized inhalation solution remains in the ampoule, it should also be discarded.
• Clean the nebulizer thoroughly according to the manufacturer's instructions. It is important to keep the nebulizer clean.

Do not dilute the nebulized inhalation solution or mix it with other medicines unless instructed by your doctor.

The single-dose ampoules of bromuro de ipratropio/salbutamol do not contain preservatives, and therefore it is important that the contents are used immediately after opening. A new ampoule should be used for each administration of bromuro de ipratropio/salbutamol with the nebulizer.

Partially used, opened, or damaged ampoules must be discarded. Never use an ampoule that has already been opened.

It is important to follow these instructions to avoid contamination of the nebulized inhalation solution contained in the ampoules.

Do not swallow or administer this medicine by injection. Do not allow the nebulized inhalation solution or vapor to come into contact with the eyes. If the liquid or vapor accidentally enters your eyes, you may experience eye pain, stinging, redness, dilated pupils, blurred vision, or see colors or lights. If this occurs, consult your doctor. If you experience eye problems at any other time, consult your doctor.

If you use more Bromuro de ipratropio/Salbutamol Genetic than you should

If you have taken a slightly higher dose than usual, you may notice a faster heartbeat (palpitations) or tremors. Other symptoms may include chest pain, changes in blood pressure, flushing, restlessness, or dizziness. These effects usually disappear within a few hours. Potassium levels in your blood may decrease; your doctor may wish to monitor your potassium levels with periodic blood tests. Inform your doctor if you are concerned about any of these symptoms or if they persist.

If you have used more of this medicine than you should, inform your doctor immediately or go to the nearest hospital. If you decide to see a doctor or go to hospital, take all your medicines with you, including those purchased without a prescription; bring them in their original packaging if possible. Also bring this leaflet to show to the doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Bromuro de ipratropio/Salbutamol Genetic

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

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

If you stop using Bromuro de ipratropio/Salbutamol Genetic

Do not stop treatment with bromuro de ipratropio/salbutamol without first consulting your doctor.

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 everyone will experience them.

Some adverse effects may 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 breathing problem or wheezing worsens immediately after inhaling ipratropium bromide/salbutamol, or you experience difficulty breathing and shortness of breath, do not take any more ipratropium bromide/salbutamol. Use your short-acting reliever inhaler immediately. You must stop using ipratropium bromide/salbutamol and contact your doctor as soon as possible. Your doctor may prescribe you 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 for inhalation (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 must contact your doctor immediately, as treatment for these symptoms may be necessary.

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

The following side effect may also occur, but its frequency is unknown:

A condition known as lactic acidosis, which may cause stomach pain, hyperventilation, breathing difficulties despite improvement in wheezing, cold hands and feet, irregular heartbeat, or thirst.

Frequency rates of adverse effects

Uncommon (may affect up to 1 in 100 people)

• Feeling nervous, shaky, or dizzy
• Dry mouth
• Cough, headache
• Feeling unwell (nausea)
• Throat irritation
• Increased blood pressure
• Increased heart rate or irregular heartbeat (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). Inform your doctor or pharmacist if this occurs, but do not stop taking this medicine unless instructed to do so
• Blurred vision, dilated pupils, glaucoma, eye pain, stinging or redness of the eyes, eye swelling, seeing colors or lights
• Increased sweating
• Unexpected tightness in the chest immediately after inhaling the medicine
• Dry throat, throat swelling
• Difficulty breathing or speaking due to brief spasm of the vocal muscles
• Diarrhea, constipation, nausea (vomiting), or other digestive system problems
• Mouth inflammation
• Muscle cramps, weakness, and pain
• Difficulty urinating
• Feeling weak
• Drop in blood pressure
• Mood changes

You may also have unusually low levels of potassium in the blood (known as "hypokalaemia"). If this occurs, your doctor will continue monitoring your potassium levels.

Although the exact frequency is unknown, some people may experience chest pain (due to conditions such as angina).

Inform 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 instructed to do so.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton, sachet, and ampoule after EXP. The expiry date refers to the last day of the month indicated.

• For single use only. Use immediately after first opening the ampoule. Discard immediately after first use.
• Disposal of partially used, opened, or damaged ampoules must be carried out in accordance with local regulations.

Do not freeze.

After opening the pouch, use within 7 days.

Do not use this medicine if the nebulizer solution appears cloudy.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Ipratropium bromide/Salbutamol Genetic

• The active substances 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 injections, and hydrochloric acid (for pH adjustment).

Appearance of the medicinal product and contents of the pack

20 or 30 single-dose LDPE ampoules, labelled, divided into strips of 5 ampoules, in PET/Al/PE pouches (1 strip per pouch), packed in a carton with the package leaflet.

Pack sizes of 20 and 30 vials.

Only some pack 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: 04/2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)