Zafiron

Package leaflet: Information for the patient

ZAFIRON, 12 μg/inhalation dose, inhalation powder in hard capsules
Formoterol fumarate
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any 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 another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Zafiron is and what it is used for
2. Important information before using Zafiron
3. How to use Zafiron
4. Possible side effects
5. How to store Zafiron
6. Contents of the pack and other information

1. What Zafiron is and what it is used for

The active substance in Zafiron is formoterol fumarate. It is a bronchodilator. Its action consists of relaxing the smooth muscles of the bronchi, thus facilitating breathing. This effect occurs rapidly (within 1 to 3 minutes) and lasts for 12 hours after inhalation.
Each hard capsule contains 12 micrograms of formoterol fumarate dihydrate and is intended for use with an inhaler.
Zafiron is indicated for:

• prevention and treatment of bronchoconstriction in patients with bronchial asthma, as an add-on to inhaled glucocorticosteroid therapy;
• prevention of bronchospasm induced by inhaled allergens, cold air, or physical exertion;
• prevention and treatment of bronchoconstriction in patients with reversible or irreversible chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Zafiron improves quality of life in patients with COPD.

The bronchodilating effect lasts for 12 hours after inhalation of Zafiron. Therefore, maintenance treatment with Zafiron administered twice daily generally results in relief from bronchoconstriction associated with chronic conditions, both during the day and at night.

2. Important information before using Zafiron

When not to use Zafiron:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before using Zafiron, inform your doctor if you have ever had an allergic reaction to formoterol or any other substance.
Before starting treatment with Zafiron, discuss with your doctor:

• if the patient has heart disease, including heart rhythm disorders;
• if the patient has a rapid heartbeat;
• if the patient has severe heart failure;
• if the patient has high blood pressure;
• if the patient has diabetes;
• if the patient has hyperthyroidism;
• if the patient has an aneurysm (a bulge in an artery wall due to weakening);
• if the patient has a heart condition related to abnormal electrical impulses, known as "QT prolongation";
• if the patient has a phaeochromocytoma (a tumour of the adrenal gland that may affect blood pressure).

If your doctor has prescribed other medicines regularly for respiratory conditions, it is important to continue taking them as directed.
DO NOT STOP taking your medicine or reduce the dose without consulting your doctor, even if your health condition improves significantly.
However, if symptoms of bronchospasm (e.g. wheezing, breathlessness) do not improve or worsen, or if improvement is less pronounced or shorter-lasting than usual, contact your doctor immediately, as this may indicate worsening of the disease and a change in treatment may be necessary.
In patients with diabetes, your doctor may recommend monitoring blood glucose levels.
In patients with asthma, Zafiron must not be used as the sole controller medication for asthma. Zafiron should always be used in combination with an inhaled corticosteroid.
During treatment with Zafiron, do not use other products containing long-acting beta-adrenergic agonists such as salmeterol.
Do not use Zafiron when:

• the patient's condition is well controlled with an inhaled corticosteroid alone,
• the patient only requires an occasional short-acting beta-adrenergic agonist.

In clinical studies with Zafiron, severe asthma attacks have been observed (see section 4 "Possible side effects").
Do not initiate treatment with Zafiron or increase the dose prescribed by your doctor during an asthma attack.
Do not change or stop taking any medicines used to control or treat breathing problems, including inhaled corticosteroids.
In asthma, Zafiron must not be used to relieve sudden onset of wheezing. For treatment of acute asthma symptoms, always use a short-acting inhaled bronchodilator (e.g. salbutamol).
Treatment with Zafiron may lead to decreased potassium levels in the blood, thereby increasing the patient's susceptibility to heart rhythm disturbances. Therefore, particularly in severe asthma, your doctor may recommend monitoring blood potassium levels.
Paradoxical bronchospasm
As with other inhaled medicines, paradoxical bronchospasm may occur after using Zafiron. In such cases, discontinue the medicine immediately and contact your doctor, who may recommend alternative treatment.
Children and adolescents
Zafiron must not be used in children under 6 years of age.
Use in elderly patients
The same dose of Zafiron as in adult patients may be used in elderly patients.
Important information regarding a similar product
Zafiron belongs to a group of medicines called long-acting beta-adrenergic agonists. A large study with another long-acting beta-adrenergic agonist showed an increased risk of asthma-related death. Studies have not confirmed whether Zafiron has a similar effect. Discuss with your doctor the benefits and risks associated with treating asthma using Zafiron.
Zafiron and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Dosage adjustments or, in some cases, discontinuation of one of the medicines may be necessary. This applies to both prescription and over-the-counter medicines, and particularly:

• monoamine oxidase inhibitors (MAO inhibitors) or tricyclic antidepressants (medicines used to treat depression and mood disorders);
• sympathomimetic medicines (medicines similar to adrenaline, used to treat asthma or to reduce nasal mucosal swelling);
• antihistamines (antiallergic medicines used to prevent and treat allergic symptoms);
• steroids (medicines often used to treat asthma and other inflammatory conditions);
• diuretics (used to treat oedema due to fluid retention, heart failure, and high blood pressure);
• beta-adrenergic receptor blockers (medicines used to treat high blood pressure, heart failure, angina, anxiety, and heart rhythm disorders. Some eye drops used to treat glaucoma may contain beta-adrenergic receptor blockers);
• quinidine, disopyramide, procainamide (medicines used to treat heart rhythm disorders);
• phenothiazine derivatives (medicines used to treat psychiatric disorders such as schizophrenia, manic excitement, psychotic reactions, anxiety);
• cardiac glycosides (medicines used to treat heart failure and heart rhythm disorders);
• xanthine derivatives (medicines used to treat asthma or other chronic obstructive pulmonary diseases);
• macrolides (e.g. erythromycin, azithromycin) used to treat bacterial infections;
• general anaesthetics such as halogenated hydrocarbons (e.g. halothane). These are used for anaesthesia during surgery. Inform your doctor that you are using Zafiron if you are scheduled for surgery under general anaesthesia;
• anticholinergic medicines (e.g. ipratropium bromide) used to treat gastrointestinal disorders, urinary and genital system disorders, etc.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
Zafiron should not be used during pregnancy unless clearly prescribed by a doctor.
Your doctor will inform you about potential risks associated with using Zafiron during pregnancy.
Breastfeeding
Do not use this medicine during breastfeeding.
Driving and using machines
If dizziness or other similar adverse effects occur, do not drive or operate machinery.
Zafiron contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Zafiron.
The excipient lactose contains a small amount of milk protein, which may cause allergic reactions.

3. How to use Zafiron

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Zafiron is intended for inhalation use only. Do not swallow the capsules.
The doctor will adjust the dose individually for each patient.
Do not exceed the recommended dose.

Use in adults
Bronchial asthma
In the treatment of asthma, Zafiron should always be used as an add-on therapy together with an inhaled corticosteroid.
Maintenance treatment: inhale the contents of 1 to 2 capsules (12 to 24 micrograms) twice daily.
The maximum recommended maintenance dose is 4 capsules (48 micrograms) per day.
If necessary, the doctor may recommend taking an additional 1 to 2 capsules per day to reduce symptom severity, provided that the maximum recommended daily dose of 48 micrograms is not exceeded. If additional doses are needed frequently (e.g. more than two days per week), inform your doctor as soon as possible, as this may indicate worsening asthma. In the event of an acute asthma attack, use a short-acting bronchodilator (e.g. salbutamol).

Chronic obstructive pulmonary disease (COPD)
Maintenance treatment: inhale the contents of 1 to 2 capsules (12 to 24 micrograms) twice daily.

Prevention of bronchospasm induced by physical exertion or allergens
Inhale the contents of one capsule (12 micrograms) at least 15 minutes before physical exertion or exposure to allergens. In patients with a history of severe bronchoconstriction, 2 capsules (24 micrograms) may be required.

In asthma treatment, inhaled corticosteroids are always used.

Use in children and adolescents (over 6 years of age)
Bronchial asthma
Maintenance treatment: inhale the contents of 1 capsule (12 µg) twice daily.
The maximum recommended dose is 24 micrograms per day.
In the event of an acute asthma attack, use a short-acting bronchodilator (e.g. salbutamol).

Prevention of bronchospasm induced by physical exertion or allergens
Inhale the contents of 1 capsule (12 micrograms) approximately 15 minutes before physical exertion or exposure to allergens.

Children over 6 years of age may use Zafiron only if they are able to use the inhaler correctly (see: "Instructions for use of the inhaler") and only under adult supervision.
Zafiron is not recommended for children under 6 years of age.

Instructions for use and handling the inhaler
Remove the capsule from the blister immediately before use. Do not swallow the capsules. The powder in the capsule is intended for inhalation only, using the inhaler.

1. Remove the cap.

   

2. Firmly hold the base of the inhaler and twist the mouthpiece in the direction indicated by the arrow to open.

   

3. Place the capsule into the capsule-shaped compartment located in the base of the inhaler. Remove the capsule from the blister immediately before use.

   

4. Twist the mouthpiece back to the closed position.

   

5. Press the buttons down fully (only once), holding the inhaler in an upright position, then release the buttons.

   

NOTE: At this point, the capsule may break apart, and small pieces of gelatin may enter the mouth or throat during inhalation. Since gelatin is edible, ingestion is not harmful. The likelihood of this occurring is minimal if the capsule is pierced in the inhaler only once, storage conditions have been maintained, and the capsule is removed from the blister immediately before use.

6. Breathe out deeply.

7. Place the mouthpiece in your mouth and slightly tilt your head back. Close your lips around the mouthpiece and inhale steadily and as deeply as possible. While the capsule rotates in the inhaler chamber and the powder is dispersed, a characteristic sound (a rattling noise) should be heard. If no sound is heard, the capsule may be stuck in the compartment. In this case, open the inhaler and gently dislodge the capsule to remove it. DO NOT attempt to dislodge the capsule by repeatedly pressing the buttons.

   

8. After hearing the characteristic sound, hold your breath as long as comfortably possible, then remove the inhaler from your mouth and breathe out. Open the inhaler and check whether any powder remains in the capsule. If powder remains, repeat the steps described in points 6 to 8.

9. After use, open the inhaler, remove the empty capsule, close the mouthpiece, and replace the cap.

Cleaning the inhaler
To remove residual powder, wipe the mouthpiece and capsule compartment with a dry cloth or clean soft brush.

Accidental overdose of Zafiron
If an overdose of Zafiron has been accidentally taken, consult your doctor or pharmacist immediately.
Symptoms such as nausea and/or vomiting, muscle tremors, headache, dizziness (possible signs of high blood pressure), rapid or irregular heartbeat, drowsiness, increased blood glucose levels, or decreased blood potassium levels may indicate that the dose of Zafiron taken was too high. Contact your doctor immediately or go to the nearest hospital emergency department. The patient may require appropriate treatment.

Missed dose of Zafiron
If a dose is missed, take it as soon as possible. If it is almost time for the next scheduled dose, do not take the missed dose; instead, return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Zafiron treatment
If you have any further questions or concerns about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

In clinical trials with Zafiron, severe asthma attacks (shortness of breath, cough, wheezing and chest tightness) have been observed, which may require hospital treatment.

Immediately inform your doctor if any of the following serious adverse reactions occur:

• Bronchospasm with cough, wheezing and breathing difficulties. This reaction occurs uncommonly (in 1 to 10 out of 1,000 people),
• Allergic reactions, e.g. rash, urticaria, itching, facial swelling, throat swelling, low blood pressure and bronchospasm. This reaction occurs rarely (in 1 to 10 out of 10,000 people),
• Severe, described as tearing, chest pain (symptoms of angina), changes in ECG. This reaction occurs very rarely (less than 1 in 10,000 people),
• Muscle-related symptoms such as muscle weakness, muscle cramps and heart rhythm disturbances (these symptoms may be caused by decreased potassium levels in blood). These symptoms occur uncommonly (in 1 to 10 out of 1,000 people),
• If the patient experiences irregular heartbeat (including rapid heartbeat).

Common adverse reactions (in 1 to 10 out of 100 people):
Headache, muscle tremor, palpitations.

Uncommon adverse reactions (in 1 to 10 out of 1,000 people):
Restlessness, anxiety, nervousness, insomnia, dizziness, rapid heartbeat, throat mucosa irritation, muscle cramps, muscle pain.

Rare adverse reactions (in 1 to 10 out of 10,000 people):
Decreased potassium levels in blood, heart rhythm disturbances, extrasystoles, nausea.

Very rare adverse reactions (less than 1 in 10,000 people):
Taste disturbances, swelling of hands, ankles and feet, excessive thirst, frequent urination, fatigue (these symptoms may indicate increased blood glucose levels).

Adverse reactions with unknown frequency (cannot be estimated from available data):
Cough, rash, headache and dizziness (possible symptoms of high blood pressure).

Use of this medicine may cause increased levels of insulin, free fatty acids, glycerol and ketone bodies in blood.

Other adverse reactions may occur in some individuals during treatment with Zafiron.

If any adverse reaction worsens or if any adverse reaction not listed in this leaflet occurs, inform your doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder or its representative.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zafiron

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging.
Do not use Zafiron after the expiry date stated on the packaging after: EXP.
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 Zafiron contains

• The active substance is formoterol fumarate. Each hard capsule contains 12 micrograms (μg) of formoterol fumarate (in the form of 12.5 μg of formoterol fumarate dihydrate).
• The other ingredients are: partially micronized monohydrate lactose, micronized monohydrate lactose; the capsule shell contains gelatin.

What Zafiron looks like and contents of the pack
Zafiron is a powder for inhalation contained in capsules. The powder inside the capsule is
intended for inhalation into the lungs using an inhaler.
Zafiron is available in packs containing 60 capsules or 120 capsules, supplied with an inhaler in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów