Leaflet: Information for the user

Ipratropio bromide/Salbutamol Cipla 0.5mg/2.5mg solution for inhalation by nebulizer

Ipratropium bromide / salbutamol

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

This medicine is called Ipratropio bromuro/Salbutamol Cipla. The active ingredients 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 they remain open. Ipratropium bromide acts by blocking nerve signals directed to the muscles surrounding the airways, and salbutamol acts by stimulating β2 receptors in the muscles.that surround the airways, and salbutamol acts by stimulating β2 receptors in the muscles.

Ipratropio bromuro/Salbutamol Ciplais used to treat respiratory problems in patients over 12years with long-term breathing difficulties (chronic obstructive pulmonary disease such as chronic bronchitis, emphysema).Ipratropio bromuro/Salbutamol Ciplawill alleviate wheezing, difficulty breathing, and chest tightness.

This medicine is used with a device called a «nebulizer», which transforms the medicine into a vapor that can be inhaled.

Do not use Ipratropium bromide/Salbutamol Cipla:

• if you are allergic to salbutamol, ipratropium bromide, atropine (including similar medications to atropine) or any of the other components of this medication (listed in section 6),
• if you have cardiomegaly (enlarged heart) or a disease called hypertrophic obstructive cardiomyopathy or HOCM,
• if you have a rapid heart rate (tachycardias),

Warnings and precautions

Consult your doctor before starting to use ipratropium/salbutamol:

• if you have or think you may have a condition called glaucoma (increased eye pressure) or any other eye condition. Your doctor may advise you to protect your eyes when using this medication.
• if you are a man and have an enlarged prostate or problems urinating.
• if you have had a recent heart attack (myocardial infarction).
• if you have arterial problems or leg pain when walking.
• if you have a history of heart disease, irregular heart rhythm or angina (please inform your doctor before starting to use this medication).
• if you have diabetes.
• if you have an overactive thyroid gland.
• if you have cystic fibrosis.
• if you have been told you have an adrenal gland tumor.
• if you have a condition called pheochromocytoma, which is a rare and non-malignant tumor. The use of the inhaler may worsen the symptoms of the same.
• if accidentally, liquid or mist enters your eyes, you may feel pain, itching or redness, dilated pupils, blurred vision, see colors or lights. If this happens, consult your doctor. If you experience eye problems at any other time, consult your doctor.

Cases of dental caries have been reported with the use of salbutamol. It is recommended, especially in children, to pay attention to proper oral hygiene and to have regular dental check-ups.

Lactic acidosis has been observed associated with high therapeutic doses of salbutamol, mainly in patients treated with acute bronchospasm (see sections 3 and 4). The increase in lactate levels may lead to respiratory failure and hyperventilation. Immediately speak with your doctor if you feel that the medication is not working as usual and you need to use the nebulizer more times than your doctor has recommended.

Consult your doctor in case of sudden worsening of your respiratory disorders or if the prescribed dose does not produce a normal result. Do not increase the dose without consulting your doctor.

If you use high doses of ipratropium/salbutamolfor a long time, monitor the amount of potassium in your blood, especially if you are taking other medications at the same time, for example: steroids (corticosteroids), medications that increase urine production (diuretics) or other medications that open the airways, such as theophylline (xanthines).

Children and adolescents

This medication should not be used in children under 12 years old.

Other medications and Ipratropium bromide/Salbutamol Cipla

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Determined medications may interact with ipratropium bromide/salbutamol and worsen the adverse effects or reduce the effect of ipratropium/salbutamol. Always inform your doctor if you are taking any of the following medications:

• Other medications that help breathe, such as salbutamol and preventives like dipropionato de beclometasona. These may increase the effect of ipratropium bromide/salbutamol and increase the intensity of the adverse effects.
• Beta-blockers, that is, medications used to treat heart conditions, such as chest pain that occurs during exercise (called angina pectoris), irregular heartbeats (or arrhythmias) and high blood pressure (called hypertension). Some of them, such as propranolol, may reduce the amount of potassium in the blood when administered at the same time as ipratropium bromide/salbutamol (beta-blockers may reduce the effect of salbutamol).
• Determined medications to treat depression («antidepressants»). In this class of medications, inhibitors of monoamine oxidase (p.eg., phenelzine) or tricyclic antidepressants (p.eg., amitriptyline) are included.
• Digoxin (for heart problems) may cause heart rhythm problems when administered with ipratropium bromide/salbutamol.
• Medications called «anticolinérgicos». They are used to treat abdominal pain, Parkinson's disease, urinary or fecal incontinence problems.
• A reduction in the amount of potassium in the blood (hypokalemia) due to salbutamol from ipratropium/salbutamolis more likely if you are using ipratropium bromide/salbutamol with other treatments for asthma, with inhaled corticosteroids or in tablets (such as prednisone), or with diuretics (to increase urine elimination). Low potassium levels in the blood may cause muscle weakness, muscle contractions or heart rhythm abnormalities. Your doctor may perform a blood test to measure the amount of potassium from time to time.
• Anesthetics may increase the likelihood of experiencing adverse effects of salbutamol on the heart. Your doctor will closely monitor you or may decide to interrupt the treatment with ipratropium/salbutamolif you are going to be operated on.

Inform the anesthesist of the medications you are taking if you are going to receive general anesthesia in the hospital.

Use of Ipratropium bromide/Salbutamol Cipla with food and drinks

Foods and drinks do not exert any influence on this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use ipratropium/salbutamolif you are pregnant, unless your doctor decides that the benefit for you is greater than the risk to your child.

This medication can be used during breastfeeding. Consult your doctor, pharmacist or nurse before using this medication during breastfeeding.

Driving and operating machines

If you experience adverse effects such as dizziness, difficulty focusing and blurred vision during treatment with ipratropium/salbutamol, you should avoid potentially hazardous tasks such as driving or operating machines.

Ipratropium bromide/Salbutamol Cipla contains sodium

This medication contains less than 1mmol (23mg) of sodium per dose, so it is considered essentially «sodium-free».

This medicationis for use by inhalation. The solution for inhalation by nebulizer is for oral inhalation after nebulization.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or nurse.

This medication should be used as needed and not on a regular basis.

If your asthma is active (for example, you have symptoms or frequent attacks, such as difficulty breathing that makes it hard to speak, eat, or sleep, cough, wheezing, chest tightness, or limited physical ability), you must immediately inform your doctor, who may start administering a medication or increase the treatment dose, such as an inhaled corticosteroid, to control your asthma.

Inform your doctor as soon as possible if your medication seems not to be working as well as usual (for example, if you need higher doses to relieve your respiratory problems or if your inhaler does not provide relief for at least 3 hours), as your asthma may be worsening and you may need a different medication.

If you use this medication more than two times a week to treat your asthma symptoms, excluding preventive use before exercise, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that may have serious complications and may put your life at risk or even be fatal. You should contact your doctor as soon as possible to review your asthma treatment.

If you use a daily anti-inflammatory medication for your lungs, e.g., an inhaled corticosteroid, it is essential to continue using it regularly, even if you feel better.

The recommended dose for adultsand children over 12yearsis 1ampoule, three to four times a day.

Elderly patients should take the usual adult dose.

Use in children

Thisipratropio/salbutamolis not recommended for use in children under 12 years.

Do not swallow or administer this medication by injection.

You will find the amount you should take and how often on the label.

Do not use a higher amount of medication than indicated by your doctor.Inform your doctor if your respiratory problems worsen, if the medication does not relieve your breathing problems as well as before, or if you are using the blue "rescue" inhaler with short-acting relief (rapid relief) more frequently than usual.

This medication should be used with a suitable nebulizer, e.g., PARI LC PLUS®, a nebulizer.Read the nebulizer usage instructions in the PARI LC PLUS® prospectus before starting inhalation.

Usage instructions

• Prepare the nebulizer following the manufacturer's instructions and your doctor's advice.
• Open the bag and remove the strip of single-dose ampoules.
• Separate a single ampoule from the strip by rotating and pulling. Never use an ampoule that has already been opened or if the inhalation solution for nebulizer is discolored (diagram A).
• Do not use it if it has already been opened or if the liquid inside is discolored.
• Hold the ampoule in a vertical position and open it by rotating the top (diagram B).
• Transfer all the contents to the nebulizer chamber by pressing the ampoule (diagram C).
• Assemble the nebulizer and use it following the manufacturer's instructions and your doctor's advice.
• If your doctor has indicated that your medication needs to be diluted, they will provide you with a sterile 0.9% sodium chloride solution. Your doctor will explain what you should do.
• After using the nebulizer, discard any remaining solution in the chamber. If there is any remaining inhalation solution for nebulizer in the ampoule, it should also be discarded.
• Clean the nebulizer thoroughly following the manufacturer's instructions.

Do not dilute the inhalation solution for nebulizer or mix it with other medications unless your doctor advises you to do so.

The single-dose ampoules of this medication do not contain preservatives, and it is essential to use the contents immediately after opening. You should use a new ampoule for each administration of ipratropio/salbutamol with the nebulizer.

Discard partially used, opened, or damaged ampoules. Never use an ampoule that has already been opened.

It is essential to follow these instructions to avoid contaminating the inhalation solution for nebulizer contained in the ampoules.

Do not ingest the inhalation solution for nebulizer or use it for injections.

Do not allow the inhalation solution for nebulizer or vapor to come into contact with your eyes. If any of the liquids or vapor accidentally enters your eyes, you may experience pain, tearing, redness, dilated pupils, blurred vision, or seeing colors or lights. If this happens, consult your doctor. If you have eye problems at any other time, consult your doctor.

Using more Ipratropio bromuro/Salbutamol Cipla than you should

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

If you use more of this medication than you should, inform your doctor immediately or go to the nearest hospital. If you decide to see a doctor or go to the hospital, bring all your medications, including those purchased without a prescription; bring them in their original packaging if possible. Also, bring this prospectus to show the doctor.

Consult your doctor or pharmacist immediately in case of overdose or accidental ingestion, or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested.

Missing a dose of Ipratropio bromuro/Salbutamol Cipla

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 compensate for the missed dose.

Stopping treatment with Ipratropio bromuro/Salbutamol Cipla

Your doctor will indicate the duration of treatment with Ipratropio/Salbutamol Cipla. Do not stop treatment with Ipratropio/Salbutamol Cipla without consulting your doctor first.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some side effects can be serious and require medical attention.

Severe side effects

• If your respiratory problem or wheezing worsens immediately after inhaling this medicine, or if you have trouble breathing and feel short of breath, do not take any more ipratropio/salbutamol; use your short-acting relief inhaler right away. You should stop using ipratropio/salbutamoland contact your doctor as soon as possible. Your doctor may prescribe an alternative treatment for your condition.

• If you think you are allergic to ipratropio/salbutamolor are having an allergic reaction to the inhalation solution for nebulizer (which includes swelling of the tongue, lips, and face), stop using this medicine and contact your doctor immediately.

Other side effects may occur with the following frequencies:

Frequent(may affect up to 1 in 10people)

• Dry mouth
• Nausea (feeling like vomiting)
• Irritation of the mouth and throat

Uncommon(may affect up to 1 in 100people)

• Headache
• Dizziness
• Nervousness
• Tremors
• Sensation of dizziness or feeling like the world is spinning (vertigo)
• Palpitations (strong heartbeat)
• Fast heartbeat
• Cough
• Irritation of the throat
• Speech difficulties
• Difficulty urinating
• Dermatological reactions

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

• Severe allergic reaction that causes difficulty breathing or dizziness
• Allergic reaction with rashes and itching
• Swelling of the face, lips, and tongue
• Decreased potassium levels
• Mental disorders
• Sweating
• Eye pain or other eye problems, such as blurred vision, mydriasis (excessive dilation of the pupil), and glaucoma (increased eye pressure)
• Irregular heartbeat
• Low blood pressure
• Heart failure
• Respiratory problems and difficulty breathing
• Swelling of the throat
• Diarrhea, constipation, vomiting, or other gastrointestinal problems
• Alteration of taste
• Tooth decay
• Muscle pain
• Weakness and cramps
• Throat dryness
• Buccal edema
• Stomatitis
• Feeling weak
• Mood changes
• Difficulty urinating

Very rare(may affect up to 1 in 10,000people)

• Increased blood pressure

Unknown frequency(the frequency cannot be estimated with the available data)

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

Although the exact frequency is unknown, some people may experience chest pain (due to conditions such as angina pectoris). Inform your doctor as soon as possible if you experience these symptoms while receiving treatment with ipratropio/salbutamol, but do not stop using this medicine unless your doctor tells you to.

You may also experience an abnormally low level of potassium in the blood («hypokalemia»). If you experience hypokalemia, your doctor will continue to monitor your potassium levels.

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the box, the blister pack, and the ampoule label after CAD. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze. Do not store above 25°C.

Single use. Use immediately after opening the ampoule for the first time. Dispose of immediately after the first use.

The disposal of partially used, opened, or damaged ampoules will be carried out in accordance with local regulations.

Store ampoules in the aluminum wrapper or in the outer packaging to protect them from light.

Do not use this medication if you observe that the inhalation solution for nebulizer is cloudy.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Ipratropio bromuro/Salbutamol Cipla

• The active principles are ipratropium bromide and salbutamol. Each single-dose ampoule (2.5 mL dose) contains 0.5 mg of ipratropium bromide (equivalent to 525 micrograms of ipratropium bromide monohydrate) and 2.5 mg of salbutamol (as sulfate).
• The other excipients are sodium chloride, water for injection, and sulfuric acid (for pH adjustment).

Appearance of the product and contents of the package

The single-dose ampoule is a polyethylene container containing 2.5 mL of transparent and colorless inhalation solution for nebulizer.

Five plastic ampoules in an aluminum wrapper with triple laminating (polyester film/aluminum foil/polyethylene film) and packaged in cardboard boxes containing 10, 20, 40, 60, 80, or 100 ampoules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Responsible manufacturer

Cipla Europe NV,De Keyserlei 58-60, Box-19, 2018, Antwerp,Belgium

or

ALTERNO LABS d.o.o., Brnciceva ulica 29, Ljubljana-Crnuce, 1231, Slovenia

Local representative

Cipla Europe NV subsidiary in Spain,

C/ Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Zerseos 0.5 mg/2.5 mg per 2.5 ml, vial

Germany:Ipratropium/Salbutamol Cipla 0.5 mg / 2.5 mg Solution for inhalation by nebulizer

Spain:Ipratropio bromuro/Salbutamol Cipla0.5mg/2.5mg solution for inhalation by nebulizer

Ireland:Zerseos 0.5 mg/2.5 mg per 2.5 mlnebuliser solution

Poland:Ipratropium/Salbutamol Cipla, (0.5 mg + 2.5 mg)/2.5 ml, solution for nebulization

Last review date of this leaflet:January 2024

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