Ipratropium + Fenoterol Farmak

Leaflet attached to the packaging: information for the user

Ipratropium + Fenoterol Farmak, (0.5 mg + 1.25 mg)/4 ml, solution for nebulization
Ipratropium bromide+ Fenoterol hydrobromide

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ipratropium + Fenoterol Farmak and what is it used for
• 2. Important information before using Ipratropium + Fenoterol Farmak
• 3. How to use Ipratropium + Fenoterol Farmak
• 4. Possible side effects
• 5. How to store Ipratropium + Fenoterol Farmak
• 6. Contents of the packaging and other information

1. What is Ipratropium + Fenoterol Farmak and what is it used for

The active substances of Ipratropium + Fenoterol Farmak are ipratropium bromide and fenoterol hydrobromide, which relax the muscles of the airways and expand the bronchi.
This medicine is used to treat bronchial spasms associated with asthma or chronic obstructive pulmonary disease (COPD) in adults and adolescents over 12 years of age. COPD is a chronic lung disease that causes shortness of breath and coughing.

2. Important information before using Ipratropium + Fenoterol Farmak

When not to use Ipratropium + Fenoterol Farmak

• if the patient is allergic to ipratropium bromide, fenoterol hydrobromide, other atropine-like substances, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a rapid heart rate or irregular heart rhythm (tachyarrhythmia) or a heart muscle disease characterized by narrowing of the left ventricular outflow tract (obstructive hypertrophic cardiomyopathy).

Warnings and precautions

Before starting treatment with Ipratropium + Fenoterol Farmak, you should discuss it with your doctor or pharmacist if:

• the patient has poorly controlled diabetes;
• the patient has recently had a heart attack;
• the patient has heart or blood vessel disorders;
• the patient has an overactive thyroid gland (hyperthyroidism);
• the patient has been diagnosed with a adrenal gland tumor (pheochromocytoma);
• the patient has urinary tract obstruction [e.g. if the patient has been diagnosed with an enlarged prostate (prostatic hyperplasia) or narrowing of the neck of the bladder];
• the patient has cystic fibrosis;
• the patient has glaucoma (increased intraocular pressure).

In case of acute, rapidly worsening shortness of breath, the patient should immediately contact their doctor.
In rare cases, after using Ipratropium + Fenoterol Farmak, immediate hypersensitivity reactions may occur, such as: hives, facial, skin, and mucous membrane swelling, including swelling of the mouth and throat, rash, bronchospasm, and severe, life-threatening allergic reactions (anaphylactic).
Similarly, as with other inhaled medicines, Ipratropium + Fenoterol Farmak may cause a life-threatening cough attack resembling an asthma attack (called paradoxical bronchospasm). In case of paradoxical bronchospasm, the use of Ipratropium + Fenoterol Farmak should be stopped immediately and alternative therapy should be initiated. Therefore, you should contact your doctor immediately.
If the patient experiences eye pain, blurred vision, or vision disturbances, such as seeing halos (rings) or colored images with eye redness, they should consult their doctor immediately – these symptoms require special treatment.
When using Ipratropium + Fenoterol Farmak, you should be particularly careful not to get the sprayed medicine into your eyes. If you use a mask, you should fit it carefully and protect your eyes. If the sprayed medicine accidentally gets into your eyes, you should rinse them immediately with cold water.
Using high doses of beta-2-adrenergic agonists, such as those contained in Ipratropium + Fenoterol Farmak, may cause a significant decrease in blood potassium levels (hypokalemia).
If the treatment does not produce the desired effect after administering the prescribed dose, you should contact your doctor immediately. The treatment should be adjusted to the individual needs of the patient.

Ipratropium + Fenoterol Farmak and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The long-term concurrent use of Ipratropium + Fenoterol Farmak with other anticholinergic medicines (used to treat nervous system, respiratory, or gastrointestinal diseases) has not been studied. Therefore, it is not recommended to use Ipratropium + Fenoterol Farmak with these medicines for a long time.
The following medicines may cause or worsen heart rhythm disorders:

• quinidine, disopyramide, procainamide (medicines used to treat heart rhythm disorders);
• phenothiazines (sedatives);
• antihistamines (used to treat allergies);
• tricyclic antidepressants (used to treat depression);
• levodopa (used in Parkinson's disease);
• thyroxine (used in hypothyroidism, thyroid disease);
• theophylline (used in asthma treatment);
• oxytocin (used to induce uterine contractions to help start or continue labor).

The following medicines may enhance the side effects of Ipratropium + Fenoterol Farmak:

• sympathomimetics (medicines used to treat heart, nervous system, or respiratory diseases);
• other anticholinergic medicines (medicines used to treat nervous system, respiratory, or gastrointestinal diseases);
• certain anesthetics (halogenated hydrocarbons): do not use Ipratropium + Fenoterol Farmak less than 12 hours before anesthesia.

The following medicines may affect the action of Ipratropium + Fenoterol Farmak:

• beta-adrenergic blockers (medicines used to treat high blood pressure), including eye drops (used to treat glaucoma): may reduce or neutralize the effect of Ipratropium + Fenoterol Farmak. Do not use them at the same time as Ipratropium + Fenoterol Farmak;
• certain antidepressants (monoamine oxidase inhibitors or tricyclic antidepressants): may enhance the effect of Ipratropium + Fenoterol Farmak.

The following medicines may increase the potassium deficiency (hypokalemia) associated with the use of Ipratropium + Fenoterol Farmak:

• xanthines (medicines that expand the bronchi);
• corticosteroid-like medicines (used to treat inflammatory conditions);
• diuretics (medicines that increase urine production). If necessary, the doctor may recommend monitoring blood potassium levels.

There may be special problems with this medicine:

• cisapride (used in gastrointestinal motility disorders): its effect may be weakened when used concurrently with Ipratropium + Fenoterol Farmak.

Using Ipratropium + Fenoterol Farmak with alcohol

It is not recommended to consume alcohol while using Ipratropium + Fenoterol Farmak. This may affect the cardiovascular system.

Pregnancy, breastfeeding, and fertility

You should avoid using Ipratropium + Fenoterol Farmak during pregnancy and breastfeeding.
No studies have been conducted on the effect of this medicine on human fertility.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

If you experience blurred vision, dizziness, or tremors while using Ipratropium + Fenoterol Farmak, you should not drive or operate machinery.

Ipratropium + Fenoterol Farmak contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 4 ml polyethylene container, i.e. the medicine is considered "sodium-free".

3. How to use Ipratropium + Fenoterol Farmak

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.

Recommended dose:

The doctor will determine the initial dose of the medicine. Depending on the patient's response to treatment, the doctor will adjust the recommended dosage of the medicine. Exceeding the recommended dose may be dangerous.

Adults

When starting treatment and during treatment, patients should be under the doctor's supervision, e.g. in a hospital setting.

• In case of critical bronchospasm: inhalation of one dose (contents of one single-dose container).
• In particularly severe cases: if significant improvement in breathing is not achieved within 5 minutes after inhalation of one dose, a second dose may be inhaled to relieve symptoms.

Use in children and adolescents

• Adolescents over 12 years of age: see the recommendations for adults.
• Children under 12 years of age: not recommended.

You should not increase the prescribed dose of the medicine without consulting your doctor.You should consult your doctor if breathing problems worsen significantly or if the prescribed dose does not produce the expected effect.

Method of administration

The solution for nebulization should be administered by inhalation using a nebulizer. Do not take orally.
The contents of each container are ready to use and do not require dilution. After opening the container, the contents should be used immediately.

• 1. Prepare the nebulizer for use according to the manufacturer's instructions and the doctor's recommendations.
• 2. For each inhalation, use a new single-dose container. Never use a container that has been open for several hours or is damaged.
• 3. Open the single-dose container by twisting the neck. Hold the container upright to avoid contaminating the contents. The container should be opened just before use.
• 4. Pour the entire contents of the container into the nebulizer chamber, unless the doctor recommends otherwise.
• 5. Use the nebulizer according to the doctor's instructions. Make sure the solution does not get into your eyes. If this happens, eye pain and blurred vision may occur.
• 6. After each nebulization, discard the partially used container and pour out the remaining solution.
• 7. After each inhalation, wash the nebulizer according to the manufacturer's instructions.

Using a higher dose of Ipratropium + Fenoterol Farmak than recommended

• In case of using a higher dose of Ipratropium + Fenoterol Farmak than recommended or accidental ingestion, you should contact your doctor or pharmacist immediately.
• Symptoms of overdose may include irregular or rapid heart rhythm, angina pectoris, facial flushing, muscle tremors. The doctor will decide on the appropriate treatment.

Missing a dose of Ipratropium + Fenoterol Farmak

You should not take a double dose to make up for a missed dose.

Stopping the use of Ipratropium + Fenoterol Farmak

Before stopping the use of Ipratropium + Fenoterol Farmak, you should consult your doctor.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of any of the following side effects, you should contact your doctor as soon as possible:

• chest pain. Although the exact frequency is unknown, some people may occasionally experience chest pain (due to conditions such as angina pectoris or reduced blood flow to the heart muscle). If such symptoms occur while using Ipratropium + Fenoterol Farmak, you should inform your doctor as soon as possible, but do not stop using the medicine unless the doctor recommends it.
• vision disturbances (after getting the medicine into the eyes), such as blurred vision, eye pain, dilated pupils, increased intraocular pressure, eye redness, seeing halos (rings) or colored images, or swelling of the eye surface (corneal edema). These may be symptoms of glaucoma (an eye disease caused by increased intraocular pressure). See also section 2, "Warnings and precautions".

Other side effects:

• Common (may occur in less than 1 in 10 people)
• cough
• Uncommon (may occur in less than 1 in 100 people)
• rapid heart rate (tachycardia), palpitations, accelerated pulse
• decreased diastolic blood pressure
• pharyngitis
• speech difficulties (dysphonia - voice disorders)
• dizziness
• headache
• nervousness
• muscle tremors
• dry mouth
• nausea, vomiting
• Rare (may occur in less than 1 in 1000 people)
• irregular heart rhythm (atrial fibrillation)
• high blood pressure
• dry throat, inflammation of the oral mucosa or tongue
• gastrointestinal disorders (diarrhea, constipation)
• weakness and loss of energy
• muscle pain, weakness, or cramps
• inability to fully empty the bladder (urinary retention)
• swelling of the throat or mouth
• allergic reactions, including tongue, throat, lip, or facial swelling (angioedema)
• skin rashes, hives, itching
• excessive sweating
• hypersensitivity, anaphylactic reactions (severe allergic reactions)
• low blood potassium levels
• psychiatric disorders, agitation
• bronchospasm or laryngospasm
• throat irritation
• Unknown (frequency cannot be estimated from available data)
• hyperactivity

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ipratropium + Fenoterol Farmak

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month stated.
There are no special storage temperature recommendations for this medicine.
After opening the medicinal foil pouch, unused single-dose containers should be stored in the same pouch.
After opening the single-dose container, the medicine should be used immediately.
After use, the remaining solution should be discarded immediately.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ipratropium + Fenoterol Farmak contains

• The active substances of the medicine are ipratropium bromide and fenoterol hydrobromide. Each single-dose container with a capacity of 4 ml contains ipratropium bromide in an amount equivalent to 0.5 mg of anhydrous ipratropium bromide, which corresponds to 0.125 mg/ml, and 1.25 mg of fenoterol hydrobromide, which corresponds to 0.3125 mg/ml.
• The other ingredients are: sodium chloride; hydrochloric acid, diluted (to adjust pH); water for injections.

What Ipratropium + Fenoterol Farmak looks like and what the pack contains

Ipratropium + Fenoterol Farmak is a clear, colorless liquid in single-dose polyethylene containers.
Ipratropium + Fenoterol Farmak is available in single-dose containers with a capacity of 4 ml, made of LDPE. Strips of five containers are packaged in a medicinal foil pouch. 2 or 4 medicinal foil pouches are packaged in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
phone: +48 22 822 93 06
e-mail: [email protected]

Importer

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Date of last revision of the leaflet:May 2025