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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ipratropium bromide/Salbutamol Cipla 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should 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 side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ipratropium bromide/Salbutamol Cipla is and what it is used for

2. What you need to know before using Ipratropium bromide/Salbutamol Cipla

3. How to use Ipratropium bromide/Salbutamol Cipla

4. Possible side effects

5. How to store Ipratropium bromide/Salbutamol Cipla

6. Contents of the pack and other information

1. What Ipratropium bromide/salbutamol Cipla is and what it is used for

This medicine is called Ipratropium bromide/Salbutamol Cipla. 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 to the muscles around the airways, while salbutamol works by stimulating the β2 receptors in these muscles.

Ipratropium bromide/Salbutamol Cipla is used to treat breathing problems in patients over 12 years of age who have long-term breathing difficulties (chronic obstructive pulmonary disease such as chronic bronchitis, emphysema). Ipratropium bromide/Salbutamol Cipla will relieve wheezing, shortness of breath, and chest tightness.

This medicine is used with a device called a "nebulizer", which turns the medicine into a mist so that you can breathe it in.

2. What you need to know before using Ipratropium bromide/salbutamol Cipla

Do not use Ipratropium bromide/Salbutamol Cipla:

• if you are allergic to salbutamol, ipratropium bromide, atropine (including drugs similar to atropine), or to any of the other ingredients of this medicine (listed in section 6),
• if you have cardiomegaly (enlarged heart) or a condition called hypertrophic obstructive cardiomyopathy or HOCM,
• if you have a fast heart rate (tachycardias),

Warnings and precautions

Talk to your doctor before starting to use ipratropium/salbutamol:

• 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 this medicine.
• if you are a man and have an enlarged prostate or have difficulty urinating.
• 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 told you have a tumour in the adrenal gland.
• if you have a disorder called phaeochromocytoma, which is a rare, non-malignant tumour. Using the inhaler may worsen its symptoms.
• if liquid or mist accidentally gets into your eyes, you may experience pain, itching, redness, dilated pupils, blurred vision, or see colours 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 adequate oral hygiene and to have regular dental check-ups.

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

Contact 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.

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

Children and adolescents

This medicine must not be used in children under 12 years of age.

Other medicines and Ipratropium bromide/Salbutamol Cipla

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 and increase adverse effects or reduce the effect of ipratropium/salbutamol. Always inform your doctor if you are taking any of the following medicines:

• 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 adverse effects.
• Beta-blockers, i.e., medicines often used to treat heart conditions such as chest pain during exertion (called angina pectoris), irregular heartbeats (or arrhythmias), and high blood pressure (called hypertension). Some of these, such as propranolol, may reduce blood potassium levels when administered together with ipratropium bromide/salbutamol (beta-blockers may reduce the effect of salbutamol).
• Certain medicines used to treat depression (‘antidepressants’). This class includes monoamine oxidase inhibitors (e.g., phenelzine) or tricyclic antidepressants (e.g., amitriptyline).
• Digoxin (for heart problems) may cause heart rhythm problems when taken together with ipratropium bromide/salbutamol.
• Medicines called ‘anticholinergics’. These are used to treat colicky pain, Parkinson’s disease, urinary problems, or urinary or faecal incontinence.
• A reduction in blood potassium levels (hypokalaemia) due to salbutamol in ipratropium/salbutamol is more likely if you are using ipratropium/salbutamol together with other asthma treatments, with inhaled or tablet corticosteroids (such as prednisone), or with diuretics (to increase urine elimination). Low blood potassium levels may cause muscle weakness, muscle cramps, or heart rhythm abnormalities. Your doctor may occasionally perform a blood test to measure your potassium levels.
• Anaesthetics may increase the likelihood of salbutamol’s adverse effects on the heart. Your doctor will monitor you closely or may decide to stop treatment with ipratropium/salbutamol if you are undergoing surgery.

If you are to receive general anaesthesia in hospital, inform the anaesthetist about all medicines you are taking.

Use of Ipratropium bromide/Salbutamol Cipla with food and drink

Food and drink do not affect this medicine.

Pregnancy and breastfeeding

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

Do not use ipratropium/salbutamol if you are pregnant unless your doctor decides that the benefit to you outweighs the risk to your unborn child.

This medicine may be used during breastfeeding. Consult your doctor, pharmacist, or nurse before using this medicine while breastfeeding.

Driving and using machines

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

Ipratropium bromide/Salbutamol Cipla contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, therefore it is considered essentially “sodium-free”.

3. How to use Ipratropium bromide/Salbutamol Cipla

This medicine is for inhalation use. The solution for nebulisation is for oral inhalation after nebulisation.

Always follow exactly the instructions given by your doctor for using this medicine. If you are unsure, consult your doctor or nurse.

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

If your asthma is active (for example, you have frequent symptoms or attacks, such as difficulty breathing that interferes with speaking, eating, or sleeping, coughing, wheezing, chest tightness, or limited physical capacity), inform your doctor immediately. Your doctor may start you on a new medicine or increase the dose of your current treatment, such as an inhaled corticosteroid, to control your asthma.

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

If you use this medicine more than twice 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 can lead to serious complications and may be life-threatening or even fatal. You should contact your doctor as soon as possible to review your asthma treatment.

If you are taking a daily anti-inflammatory medicine for your lungs, e.g., an “inhaled corticosteroid”, it is important that you continue to use it regularly, even if you feel well.

The recommended dose for adults and children over 12 years of age is 1 ampoule, three to four times daily.

Elderly patients should take the usual adult dose.

Use in children

Do not use this ipratropium/salbutamol in children under 12 years of age.

Do not swallow or inject this medicine.

The label will indicate the amount you should take and how often.

Do not use more medicine than prescribed 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.

This medicine must be used with a suitable nebuliser, e.g., PARI LC PLUS® pneumatic nebuliser. Carefully read the nebuliser instructions for use provided in the PARI LC PLUS® package leaflet before starting inhalation.

Instructions for use

• Prepare the nebuliser according to the manufacturer's instructions and your doctor's advice.
• Open the pouch and remove the strip of single-dose ampoules.
• Carefully separate one ampoule from the labelled strip by twisting and pulling. Never use an ampoule that has already been opened or if the solution for nebulisation is discoloured (diagram A).
• Do not use if it has already been opened or if the liquid inside is discoloured.
• Hold the ampoule upright and open it by twisting off the top (diagram B).
• Transfer the entire contents into the nebuliser chamber by squeezing the ampoule (diagram C).
• Assemble the nebuliser and use it according to the manufacturer's instructions and your doctor's directions.
• If your doctor has instructed you to dilute your medicine, you will be given a sterile 0.9% sodium chloride solution. Your doctor will explain what you need to do.
• After using the nebuliser, discard any remaining solution in the chamber. If any solution for nebulisation remains in the ampoule, it should also be discarded.
• Clean the nebuliser thoroughly according to the manufacturer's instructions.

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

The single-dose ampoules of this medicine do not contain preservatives, and therefore it is important that the contents are used immediately after opening. A new ampoule must be used for each administration of ipratropium/salbutamol via the nebuliser.

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

It is important that you follow these instructions to avoid contamination of the nebuliser solution contained in the ampoules.

Do not swallow the nebuliser solution or use it for injections.

Do not allow the nebuliser solution or vapour to come into contact with the eyes. If any of the liquid or vapour accidentally enters the eyes, they may become painful, stinging, red, or you may experience dilated pupils, blurred vision, or see colours or lights. If this occurs, consult your doctor. If you experience eye problems at any other time, consult your doctor.

If you use more Ipratropium bromide/Salbutamol Cipla 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. It is possible that the amount of potassium in your blood may decrease; your doctor may wish 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 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, you must bring all your medicines with you, including those obtained 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 Ipratropium bromide/Salbutamol Cipla

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 forgotten doses.

If you stop using Ipratropium bromide/Salbutamol Cipla

Your doctor will advise you on how long to take Ipratropium/Salbutamol Cipla. Do not stop treatment with Ipratropium/Salbutamol Cipla 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 experiences them. Some adverse effects may be serious and require medical intervention.

Serious adverse effects

• If your breathing problem or wheezing worsens immediately after inhaling this medicine, or if you have difficulty breathing and become short of breath, do not take any more ipratropium/salbutamol; use your short-acting reliever inhaler immediately. You must stop using ipratropium/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/salbutamol or are experiencing an allergic reaction to the nebulizer inhalation solution (including swelling of the tongue, lips, and face), stop using this medicine and contact your doctor immediately.

Other adverse effects may occur with the following frequencies:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Headache
• Dizziness
• Nervousness
• Tremor
• Sensation of dizziness or spinning (vertigo)
• Palpitations (strong heartbeat)
• Rapid heartbeat
• Cough
• Throat irritation
• Speech disorders
• Difficulty urinating
• Skin reactions

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

• Severe allergic reaction causing difficulty breathing or dizziness
• Allergic reaction with hives 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 pressure in the eyes)
• Irregular heartbeat
• Decreased blood pressure
• Heart failure
• Breathing problems and difficulty breathing
• Swelling of the throat
• Diarrhea, constipation, vomiting, or other digestive problems
• Taste disturbances
• Dental caries
• Muscle pain
• Weakness and cramps
• Dry throat
• Oral edema
• Stomatitis
• Feeling weak
• Mood changes
• Difficulty urinating

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

• Increased blood pressure

Frequency not known (frequency cannot be estimated from the available data)

A condition known as lactic acidosis, which may cause stomach pain, hyperventilation, breathing difficulties (despite possible improvement in wheezing), cold hands and feet, 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 ipratropium/salbutamol, but do not stop using this medicine unless instructed by your doctor.

You may also develop an unusually low level of potassium in the blood («hypokalaemia»). If you develop hypokalaemia, your doctor will continue monitoring your potassium levels.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 Cipla

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 label after EXP. The expiry date refers to the last day of the month indicated.

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

For single use only. Use immediately after first opening of the ampoule. Discard immediately after first use.

Disposal of partially used, opened, or damaged ampoules must be carried out in accordance with local regulations.

Store ampoules in their aluminium foil sachet or outer packaging to protect them from light.

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

Medicines should not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ipratropium bromide/Salbutamol Cipla

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

Appearance of the medicinal product and contents of the pack

The single-dose container is a polyethylene ampoule containing 2.5 mL of a clear, colourless solution for inhalation by nebuliser.

Five plastic ampoules in an aluminium triple-laminated foil wrapper (polyester film/aluminium foil/polyethylene film), packed in cardboard boxes containing 10, 20, 40, 60, 80 or 100 ampoules.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp, Belgium

Manufacturer

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp, Belgium

ALTERNO LABS d.o.o.,

Brnciceva ulica 29, Ljubljana-Crnuce,

1231, Slovenia

Local representative

Cipla Europe NV, Spanish branch,

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

This medicinal product is authorised in the European Economic Area member states under the following names:

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

Germany: Ipratropium/Salbutamol Cipla 0.5 mg / 2.5 mg Lösung für eine Vernebler

Spain: Ipratropio bromuro/Salbutamol Cipla 0.5 mg/2.5 mg solución para inhalación por nebulizador

Ireland: Zerseos 0.5 mg/2.5 mg per 2.5 ml nebuliser solution

Poland: Ipratropium/Salbutamol Cipla, (0.5 mg + 2.5 mg)/2.5 ml, roztwór do nebulizacji

Date of the latest review of this leaflet: January 2024

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