Ipratropium + fenoterol farmak

Package leaflet: Information for the user

Ipratropium + Fenoterol Farmak, (0.5 mg + 1.25 mg)/4 ml, solution for nebulization
Ipratropii bromidum + Fenoteroli hydrobromidum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ipratropium + Fenoterol Farmak is and what it is 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 pack and other information

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

The active substances in Ipratropium + Fenoterol Farmak are ipratropium bromide and fenoterol hydrobromide, which relax the muscles of the airways and dilate the bronchi.
This medicine is used in the treatment of bronchospasm associated with asthma or chronic obstructive pulmonary disease (COPD) in adults and adolescents above 12 years of age. COPD is a chronic lung disease causing shortness of breath and cough.

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 rapid heart rate or irregular heartbeat (tachyarrhythmia), or a heart muscle disease involving narrowing of the outflow tract of the left ventricle (obstructive hypertrophic cardiomyopathy).

Warnings and precautions
Before starting treatment with Ipratropium + Fenoterol Farmak, consult a 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 overactive thyroid (hyperthyroidism);
• the patient has been diagnosed with a tumour of the adrenal gland (pheochromocytoma);
• the patient has urinary tract obstruction [e.g. if the patient has been diagnosed with enlargement of the prostate gland (benign prostatic hyperplasia) or narrowing of the bladder neck];
• the patient has cystic fibrosis;
• the patient has glaucoma (increased intraocular pressure).

In case of acute, rapidly worsening breathlessness, the patient should contact a doctor immediately.
Rarely, immediate hypersensitivity reactions may occur after using Ipratropium + Fenoterol Farmak, such as: urticaria, facial swelling, skin and mucous membrane swelling including the mucous membranes of the mouth and throat, rash, airway constriction, and severe, life-threatening allergic (anaphylactic) reactions.
As with other inhaled medicines, Ipratropium + Fenoterol Farmak may cause a potentially life-threatening cough attack resembling an asthma attack (called paradoxical bronchospasm). If paradoxical bronchospasm occurs, the use of Ipratropium + Fenoterol Farmak should be stopped immediately and alternative therapy initiated. Therefore, contact a doctor immediately.
If the patient experiences eye pain, blurred vision or visual disturbances such as seeing halos (coloured rings) or coloured images, together with redness of the eyes, immediate medical advice should be sought – these symptoms require specific treatment.
Special care should be taken during administration of Ipratropium + Fenoterol Farmak to avoid spraying the medicine into the eyes. If a mask is used, it should be properly fitted and the eyes protected. If the medicine accidentally gets into the eyes, they should be rinsed immediately with cold water.
The use of high doses of beta-2 adrenergic agonists, such as those contained in Ipratropium + Fenoterol Farmak, may cause a significant decrease in blood potassium levels (hypokalaemia).
If treatment does not produce the desired effect after the recommended dose is administered, contact a doctor immediately. Treatment should be adjusted to the individual needs of the patient.

Ipratropium + Fenoterol Farmak and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used by the patient.
Long-term concomitant use of Ipratropium + Fenoterol Farmak with other anticholinergic medicines (used in the treatment of nervous, respiratory, or gastrointestinal disorders) has not been studied. Therefore, long-term use of Ipratropium + Fenoterol Farmak together with these medicines is not recommended.
The following medicines may cause or worsen heart rhythm disturbances:

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

The following medicines may worsen the adverse effects of Ipratropium + Fenoterol Farmak:

• sympathomimetics (medicines used in the treatment of heart, nervous or respiratory disorders);
• other anticholinergic medicines (medicines used in nervous, respiratory or gastrointestinal disorders);
• certain anaesthetics (halogenated hydrocarbons): do not use Ipratropium + Fenoterol Farmak less than 12 hours before anaesthesia.

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

• beta-blockers (medicines used to treat high blood pressure), including eye drops (used in the treatment of glaucoma): may reduce or neutralize the effect of Ipratropium + Fenoterol Farmak. They should not be used simultaneously with Ipratropium + Fenoterol Farmak;
• certain antidepressants (monoamine oxidase inhibitors or tricyclic antidepressants): may enhance the effect of Ipratropium + Fenoterol Farmak.

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

• xanthines (medicines that dilate the airways);
• corticosteroid-like medicines (used in the treatment of inflammatory conditions);
• diuretics (medicines that increase urine production). If necessary, the doctor may recommend monitoring blood potassium levels.

Special problems may occur with this medicine:

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

Alcohol consumption with Ipratropium + Fenoterol Farmak
Alcohol consumption is not recommended during treatment with Ipratropium + Fenoterol Farmak. It may affect the cardiovascular system.

Pregnancy, breastfeeding and fertility
Ipratropium + Fenoterol Farmak should be avoided during pregnancy and breastfeeding. Studies on the effect of this medicine on human fertility have not been conducted.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
If the patient experiences blurred vision, dizziness or tremor during treatment with Ipratropium + Fenoterol Farmak, driving vehicles or operating machinery should be avoided.

Ipratropium + Fenoterol Farmak contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 4 ml polyethylene container, meaning the medicine is considered "sodium-free".

3. How to use Ipratropium + Fenoterol Farmak

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
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. Exceeding the recommended dose may be dangerous.
Adults
During initiation of treatment and throughout therapy, patients should be under medical supervision,
e.g. in a hospital setting.

• In case of acute bronchospasm: inhalation of one dose (contents of 1 single-dose container).
• In particularly severe cases: if no significant improvement in breathing occurs within 5 minutes after inhalation of one dose, a second dose may be administered by inhalation to relieve symptoms.

Use in children and adolescents

• Adolescents over 12 years of age: see adult dosing recommendations.
• Children under 12 years of age: use is not recommended.

Do not increase the prescribed dose of the medicine without consulting a doctor. Consult a doctor if breathing problems worsen significantly or if the prescribed dose does not produce the expected effect.
Method of administration
The solution for nebulization must be administered by inhalation using a nebulizer. Do not take
orally.
The contents of each container are ready for 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. Use a new single-dose container for each inhalation. Never use a container that has been open for several hours or has been damaged.
3. Open the single-dose container by twisting off the cap. Hold the container upright to avoid contaminating the contents. Open the container immediately before use.
4. Pour the entire contents of the container into the nebulizer chamber, unless otherwise instructed by the doctor.
5. Use the nebulizer according to the doctor's instructions. Ensure that the solution does not enter the eyes. If this occurs, eye pain and blurred vision may result.
6. After each nebulization, discard the partially used container and any remaining solution.
7. After each inhalation, clean the nebulizer according to the manufacturer's instructions.

Use of a higher than recommended dose of Ipratropium + Fenoterol Farmak

• If a higher than recommended dose of Ipratropium + Fenoterol Farmak is used or if the solution is accidentally swallowed, contact a doctor or pharmacist immediately.
• Symptoms of overdose may include irregular or rapid heartbeat, chest pain, facial flushing, and muscle tremors. The doctor will decide on appropriate treatment.

Missed dose of Ipratropium + Fenoterol Farmak
Do not use a double dose to make up for a missed dose.
Stopping Ipratropium + Fenoterol Farmak
Always consult a doctor before stopping treatment with Ipratropium + Fenoterol Farmak.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the side effects listed below occur, 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 (ischaemia) to the heart (myocardium)). If such symptoms occur while using Ipratropium + Fenoterol Farmak, you should inform your doctor immediately, but do not stop using the medicine unless your doctor advises otherwise.
• Vision disturbances (after the medicine gets into the eye), such as blurred vision, eye pain, dilated pupils, increased intraocular pressure, eye redness, seeing halos (rings) around lights, or swelling of the eye surface (corneal swelling). 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 affect less than 1 in 10 people)
  • Cough
• Uncommon (may affect less than 1 in 100 people)
  • Fast heartbeat (tachycardia), palpitations, increased pulse
  • Decreased diastolic blood pressure
  • Sore throat
  • Difficulty speaking (dysphonia – voice disturbances)
  • Dizziness
  • Headache
  • Nervousness
  • Muscle tremor
  • Dry mouth
  • Nausea, vomiting
• Rare (may affect less than 1 in 1000 people)
  • Irregular heart rhythm (atrial fibrillation)
  • High blood pressure
  • Dry throat, inflammation of the mucous membranes of the mouth or tongue
  • Gastrointestinal disorders (diarrhoea, constipation)
  • Weakness and loss of energy
  • Muscle pain, weakness, or muscle cramps
  • Inability to completely empty the bladder (urinary retention)
  • Swelling of the throat or mouth
  • Allergic reactions, including swelling of the tongue, throat, lips, or face (angioedema)
  • Skin rash, urticaria, itching
  • Excessive sweating
  • Hypersensitivity, anaphylactic reactions (severe allergic reactions)
  • Low potassium levels in the blood
  • Psychiatric disorders, restlessness
  • Bronchospasm or laryngospasm
  • Throat irritation
• Unknown frequency (cannot be estimated from available data)
  • Hyperactivity

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 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, more information on the safety of this medicine can be collected.

5. How to store Ipratropium + Fenoterol Farmak

Keep this medicine out of the 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 stated month.
There are no special storage temperature requirements for this medicine.
After first opening the medicinal foil pouch, any unused single-dose containers should be stored in the same medicinal pouch.
After first opening a single-dose container, the medicine should be used immediately.
After use, any remaining solution should be discarded immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ipratropium + Fenoterol Farmak contains

• The active substances are ipratropium bromide and fenoterol hydrobromide. Each single-dose container with a volume of 4 ml contains ipratropium bromide equivalent to 0.5 mg of anhydrous ipratropium bromide, corresponding to 0.125 mg/ml, and 1.25 mg of fenoterol hydrobromide, corresponding to 0.3125 mg/ml.
• Other components: sodium chloride; hydrochloric acid, diluted (for pH adjustment); water for injections.

What Ipratropium + Fenoterol Farmak looks like and contents of the pack
Ipratropium + Fenoterol Farmak is a clear, colourless liquid contained in single-dose containers made of polyethylene.
Ipratropium + Fenoterol Farmak is available in single-dose containers with a volume of 4 ml made of LDPE. Strips of five containers are packed in a medicinal foil pouch made of laminated aluminium foil. Each carton contains 2 or 4 medicinal pouches.
Pack sizes: 10 or 20 single-dose containers.
Not all pack sizes may be marketed.

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

Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw