Leaflet:information for theuser

COMBIPRASAL 0.5 mg/2.5 mg

solution for inhalation by nebulizer

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

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

1. What isCOMBIPRASALand what it is used for

2. What you need to know before starting to useCOMBIPRASAL

3. How to use COMBIPRASAL

4. Possible side effects

5. Storage of COMBIPRASAL

6. Contents of the pack and additional information

This medication is presented in single-dose ampoules containing a transparent and colourless solution for inhalation via nebulizer. Combiprasal contains 0.5 mg of ipratropium bromide (as monohydrate) and 2.5 mg of salbutamol (as sulfate).

COMBIPRASAL belongs to a group of medications called bronchodilators that help open the airways of the lungs so that you can breathe more easily.

It is indicated for the treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients who require more than one bronchodilator.

Do not use COMBIPRASAL

• If you are allergic (hypersensitive) to ipratropium bromide, salbutamol sulfate, atropine, or any of the other components of Combiprasal.
• If you have a heart disease called hypertrophic obstructive cardiomyopathy (this occurs when the heart does not work properly due to inflammation of the heart muscles).
• If you have a rapid and irregular heart rhythm (known as tachyarrhythmia).

Warnings and precautions

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 shortness of breath and hyperventilation.

Talk to your doctor immediately 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.

Be especially careful with COMBIPRASAL

Inform your doctor before starting treatment with this medication:

-If you have a history of heart disease, irregular heart rhythm, or angina pectoris

• If you are pregnant, intend to become pregnant, or are breastfeeding.
• Immediate allergic reactions may appear, such as urticaria, angioedema, skin rash, cough, wheezing, and difficulty breathing (bronchospasm) and swelling of the mouth and throat (oropharyngeal edema).
• When acute respiratory difficulty worsens rapidly, you should consult your doctor immediately.
• If you have diabetes.
• If you have an overactive thyroid gland.
• If you have a condition called pheochromocytoma, which is a tumor that produces chemicals that can cause fatigue, high blood pressure, and a faster heart rate.
• If you have cystic fibrosis, as you may be more prone to gastrointestinal motility disorders.
• If you have a predisposition to glaucoma angle closure. You should avoid the solution coming into contact with your eyes. This can cause eye pain or discomfort, transient blurred vision, halos, or colored images, along with eye redness. If any of these symptoms appear, discontinue treatment and consult a doctor immediately.
• If you have benign prostatic hyperplasia (enlargement of the prostate).
• If you have a condition that makes it difficult to urinate.

Use of other medications

Inform your doctor or pharmacist if you are takingor have recently takenother medications, including those purchased without a prescription.

Some medications may interact with Combiprasal. It is essential to inform your doctor if you are taking any of the following medications:

• Xanthine-derived medications, such as theophylline.
• Medications containing beta-blockers, such as propranolol or timolol, as they may reduce the effectiveness of this medication.
• Diuretics, such as furosemide or indapamide.
• Digoxin, used in the treatment of heart failure.
• Other medications that help you breathe more easily, such as terbutaline.
• Medications containing anticholinergics (used to treat asthma, irritable bowel syndrome, Parkinson's disease, and incontinence).
• Certain medications for depression (known as monoamine oxidase inhibitors and tricyclic antidepressants).
• Anesthetic medications, such as halothane.

Pregnancy and lactation

Consult your doctor or pharmacist before taking any medication.

Combiprasal is not recommended for use during pregnancy or lactation. If necessary, your doctor will assess the convenience of using it.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. However, do not drive or operate machinery until you know how you tolerate the medication.

Use in athletes

Inform athletes that this medication contains salbutamol, which may establish a positive analytical result for doping control.

Follow exactly the administration instructions forCombiprasalas indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Combiprasal 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 Combiprasalmore 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 can 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.

Your doctor may instruct you to use your nebulizer regularly, daily, or only when you have difficulty breathing.

Adults including elderly and children over 12 years:The recommended dose is 1 single-dose vial, 3 or 4 times a day. In severe cases, your doctor may increase the dose to 1 single-dose vial, 4 times a day.

There is no experience with the use of this medication in children under 12 years.

If you do not experience significant improvement or if your condition worsens, you should consult your doctor.

Instructions for correct administration of the preparation:

Your medication is for inhalation using a nebulizer or ventilator, so do not inject or swallow it.

1.Prepare your nebulizer following the manufacturer's and your doctor's instructions. Make sure the nebulizer device is clean.

2.Take a plastic strip with ampoules from the box, open it, and take one of the ampoules (Fig. 1). Leave the rest of the ampoules on the strip and return it to the box.

3.Take the ampoule and open it by turning the top part (Fig. 2).

4.Unless your doctor gives you other instructions, add the entire liquid from the plastic ampoule to the solution container of the nebulizer.

5.Use the nebulizeraccording to your doctor's instructions. Discard theempty plastic ampoule.

6.After using the nebulizer, clean it according to the manufacturer's instructions.

If you estimate that the action ofCombiprasalis too strong or weak, inform your doctor or pharmacist.

If you use more COMBIPRASAL than you should:

If you use more than you should, you may experience alterations in heart rhythm, palpitations, tremors, increased or decreased blood pressure, changes in pulse, angina pectoris, hot flashes, dry mouth, and visual accommodation disorders.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered. Contact your doctor or the nearest Emergency Hospital Service. Bring this leaflet or a vial of this medication with you, so that the doctor treating you knows what you are taking.

If you forgot to use COMBIPRASAL

If you forgot to useCombiprasal,use the next dose when due or before if you start breathing with difficulty.

Do not take a double dose to compensate for the missed doses.

Like all medications,Combiprasalcan cause side effects, although not everyone will experience them.

The following side effects have been reported:

Frequent (affect 1 in 10 people)

• Nervousness
• Headache (cephalalgia)
• Cough
• Dry mouth

Infrequent (affect fewer than 1 in 100 people)

• Dizziness
• Tremor
• Hoarseness
• Cardiac rhythm disturbances (tachycardia, palpitations, arrhythmia)
• Throat irritation
• Nausea
• Urinary retention

Rare (affect fewer than 1 in 1000 people)

• Allergic reactions (hypersensitivity)
• Decreased potassium levels in the blood (hypokalemia)
• Psychological disturbances
• Increased intraocular pressure
• Narrow-angle glaucoma
• Eye pain
• Pupil dilation (mydriasis)
• Paradoxical bronchospasm
• Vomiting
• Gastrointestinal motility disorders
• Skin reaction and increased sweating
• Muscle pain and weakness
• Muscle cramps
• Increased or decreased blood pressure

The following side effects may also occur, but their frequency is unknown:

• Some people may occasionally experience chest pain (due to heart problems such as angina pectoris). Inform your doctor if you develop these symptoms while being treated with COMBIPRASAL, but do not stop taking this medication unless your doctor tells you to.
• A condition known as lactic acidosis that can cause stomach pain, hyperventilation, respiratory difficulty, despite possible improvement in your wheezing, cold feet and hands, irregular heartbeat, or thirst.

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not store at a temperature above25ºC.

Store in the outer packaging to protect it from light.

The ampoules must be opened immediately before use and any remaining solution should be discarded.

Expiration Date:

Do not useCombiprasalafter the expiration date that appears on the packaging after Cad.: The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.This will help toprotectthe environment.

Composition of Combiprasal:

• The active principles are ipratropium bromide and salbutamol
• The other components (excipients) are: sodium chloride, hydrochloric acid, and water for injections.

Each ampoule of 2.5 ml of Combiprasal contains 0.5 mg of ipratropium bromide (equivalent to 0.52 mg of ipratropium bromide monohydrate) and 2.5 mg of salbutamol (equivalent to 3 mg of salbutamol sulfate).

Appearance of the product and contents of the package:

Combiprasal is presented in strips of 10 ampoules containing a transparent and colorless solution inside an aluminum foil pouch.

Each box contains 20 ampoules.

Holder of the marketing authorization:

Laboratorio ALDO-UNIÓN, S.L.

Baronessa de Maldà, 73

08950 Esplugues de Llobregat

Barcelona (Spain)

Responsible for manufacturing:

Laboratoire Unither

Espace Industriel Nord

151 rue André Durouchez-CS 28028

80084 AMIENS Cedex 2

France

This prospectus was approved in February 2018.

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