FORAMED 12 mcg/inh. dose Powder

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Foramed
3. 12 µg/inhalation dose, powder for inhalation in hard capsules
   1. Read all of this leaflet carefully before using this medicine because it contains important information for you.
   2. Contents of the pack and other information:
4. What Foramed is and what it is used for
   1. Foramed is indicated for:
   2. Monitoring during treatment with Foramed
5. Important information before using Foramed
   1. When not to use Foramed:
   2. Warnings and precautions
   3. Important information
   4. Do not swallow the capsules - the capsules should be used by inhaling their contents through an inhaler.
   5. Do not use Foramed if:
   6. Paradoxical bronchospasm
   7. Children over 6 years of age and adolescents
   8. Use in elderly patients (over 65 years of age)
   9. Important information about a similar product
   10. Foramed and other medicines
   11. Pregnancy and breastfeeding
   12. Driving and using machines
   13. Foramed contains lactose
6. How to use Foramed
   1. Do not swallow the capsules - the capsules should be used by inhaling their contents through an inhaler.
   2. Dosage
   3. Adults
   4. Asthma
   5. Prevention of bronchospasm induced by physical exertion or allergens
   6. Chronic obstructive pulmonary disease
   7. Children over 6 years of age and adolescents
   8. Asthma
   9. Prevention of bronchospasm induced by physical exertion or allergens
   10. Inhaler Instructions
   11. Cleaning the inhaler
   12. Using a higher than recommended dose of Foramed
   13. Missing a dose of Foramed
7. Possible side effects
   1. You should immediately inform your doctor about the occurrence of any of the following side effects:
   2. Severe side effects:
   3. Side effects with unknown frequency:
   4. Reporting side effects
8. How to store Foramed
9. Contents of the pack and other information
   1. What Foramed contains
   2. What Foramed looks like and contents of the pack
   3. Marketing authorisation holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Foramed

12 µg/inhalation dose, powder for inhalation in hard capsules

Formoterol fumarate dihydrate

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What Foramed is and what it is used for

The active substance of Foramed is formoterol fumarate dihydrate. It is a bronchodilator. Its action is to relax the smooth muscles of the bronchi, making it easier to breathe. This effect occurs quickly (within 1-3 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.

Foramed is indicated for:

• prevention and treatment of bronchospasm in patients with asthma, as an add-on therapy to inhaled glucocorticosteroids;
• prevention of bronchospasm induced by inhalation allergens, cold air, or physical exertion;
• prevention and treatment of bronchospasm in patients with reversible and irreversible chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Formoterol improves the quality of life of patients with COPD. The bronchodilatory effect lasts for 12 hours after inhalation of Foramed. Therefore, maintenance treatment, consisting of twice-daily administration of the drug, contributes to the relief of bronchospasm associated with chronic conditions, both during the day and at night.

Monitoring during treatment with Foramed

Treatment with Foramed may cause an increase in blood sugar levels. Therefore, in patients with diabetes, it may be necessary to monitor blood sugar levels. Treatment with Foramed may cause a decrease in potassium levels in the blood, increasing the patient's susceptibility to cardiac arrhythmias. Therefore, especially in the case of severe asthma, the doctor may recommend monitoring potassium levels in the blood. If you have any questions about the operation of the Foramed medicinal product and the reasons for its prescription, you should consult a doctor.

2. Important information before using Foramed

When not to use Foramed:

• if you are allergic to formoterol fumarate dihydrate, lactose (which contains a small amount of milk protein) or any of the other ingredients of the medicine (listed in section 6).

If this applies to you, you should not take Foramed and should consult your doctor. If you think you may be allergic, you should discuss this with your doctor.

Warnings and precautions

Before starting treatment with Foramed, you should discuss this with your doctor:

• if you have heart disease, including arrhythmias;
• if you have high blood pressure;
• if you have diabetes;
• if you have hyperthyroidism;
• if you have an aneurysm (bulging of the artery wall due to its weakening);
• if you have a heart condition associated with an abnormal electrical impulse, called "QT interval prolongation";
• if you have a pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure);
• if you have tachycardia;
• if you have severe heart failure. If any of these conditions apply to you, you should inform your doctor before using Foramed.

Important information

Do not swallow the capsules - the capsules should be used by inhaling their contents through an inhaler.

If your doctor has prescribed regular use of other medicines for respiratory diseases, it is essential to continue their regular use. DO NOT STOP using the medicine or reduce its dose without consulting your doctor, even if there has been a significant improvement in your condition. If you experience shortness of breath or wheezing while using Foramed, you should continue therapy and contact your doctor as soon as possible, as a change in treatment may be necessary. In patients with diabetes, the doctor may recommend monitoring blood glucose levels. In patients with asthma, Foramed should not be used as the only medicine controlling asthma. Foramed should always be used in combination with an inhaled corticosteroid.

Do not use Foramed if:

• the patient's condition is well-controlled with an inhaled corticosteroid;
• the patient only needs a short-acting beta2-adrenergic receptor agonist from time to time.

In clinical trials with formoterol, severe asthma attacks (see section 4 "Possible side effects") have been observed. Do not start using Foramed or increase the dose prescribed by your doctor during an asthma attack. Do not change or stop using any medicines for controlling or treating breathing problems, including inhaled corticosteroids. In the case of asthma, do not use Foramed to relieve sudden wheezing. To treat sudden symptoms of asthma, you should always use a short-acting beta2-adrenergic receptor agonist (e.g., salbutamol).

Paradoxical bronchospasm

As with other inhaled medicines, after using Foramed, paradoxical bronchospasm may occur. In such cases, you should stop using the medicine immediately and contact your doctor, who may prescribe other treatment.

Children over 6 years of age and adolescents

Foramed is not recommended for use in children under 6 years of age.

Use in elderly patients (over 65 years of age)

In elderly patients, the same dose of Foramed can be used as in adult patients.

Important information about a similar product

Foramed belongs to a group of medicines called long-acting beta2-adrenergic receptor agonists. A large study with another long-acting beta2-adrenergic receptor agonist showed an increased risk of death from asthma. It has not been studied whether Foramed has a similar effect. You should discuss the benefits and risks associated with asthma treatment with Foramed with your doctor.

Foramed and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. It may be necessary to change the dosage or, in some cases, stop taking one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (medicines used to treat depression and mood changes);
• sympathomimetic medicines (medicines similar to adrenaline used to treat asthma or to reduce swelling of the nasal mucosa);
• antihistamines (anti-allergic medicines used to prevent and treat symptoms of allergic reactions);
• steroids (medicines often used to treat asthma and other inflammatory diseases);
• diuretics (used to treat swelling caused by water retention, heart failure, and high blood pressure);
• beta-adrenergic receptor blockers (medicines used to treat high blood pressure, heart failure, angina pectoris, anxiety, and arrhythmias. Some eye drops used to treat glaucoma may contain beta-adrenergic receptor blockers);
• quinidine, disopyramide, procainamide (medicines used to treat arrhythmias);
• phenothiazine derivatives (medicines used to treat mental disorders, such as schizophrenia, manic excitement, psychotic reactions, and anxiety);
• digitalis glycosides (medicines used to treat heart failure and arrhythmias);
• xanthine derivatives (medicines used to treat asthma or other chronic obstructive respiratory diseases);
• macrolides (e.g., erythromycin), used to treat bacterial infections;
• general anesthetics during surgical procedures, such as halogenated hydrocarbons (e.g., halothane). You should inform your doctor about the use of Foramed if you are scheduled to undergo surgery under general anesthesia;
• anticholinergic medicines (e.g., ipratropium bromide), used to treat gastrointestinal disorders, urogenital disorders, etc.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before using this medicine. Pregnancy Foramed should not be used during pregnancy unless clearly necessary. Your doctor will inform you about the potential risks associated with the use of Foramed during pregnancy. Breastfeeding Do not use Foramed during breastfeeding.

Driving and using machines

If you experience dizziness or other similar side effects, do not drive or operate machinery.

Foramed contains lactose

If you have been told that you have an intolerance to some sugars, e.g., lactose (a sugar found in milk), you should inform your doctor before using Foramed. Lactose contains a small amount of milk proteins, which may cause allergic reactions.

3. How to use Foramed

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Do not exceed the recommended dose.

Do not swallow the capsules - the capsules should be used by inhaling their contents through an inhaler.

Dosage

Adults

Asthma

In the treatment of asthma, Foramed should always be prescribed as an add-on therapy to an inhaled corticosteroid. Maintenance treatment: inhalation of the contents of 1 to 2 inhalation capsules (12 to 24 micrograms) twice daily. The maximum recommended maintenance dose is 4 capsules (48 micrograms) per day. If necessary, your doctor may recommend an additional 1 to 2 capsules per day to reduce the severity of symptoms, provided that the maximum recommended daily dose of 48 micrograms is not exceeded. If the need for additional doses occurs frequently (e.g., more than two days a week), you should inform your doctor as soon as possible, as this may indicate an exacerbation of asthma. In the event of a sudden asthma attack, a short-acting bronchodilator (e.g., salbutamol) should be used.

Prevention of bronchospasm induced by physical exertion or allergens

Inhalation of the contents of 1 inhalation capsule (12 micrograms) at least 15 minutes before physical exertion or exposure to an allergen. In patients with severe bronchospasm, it may be necessary to use 2 inhalation capsules (24 micrograms). In the treatment of asthma, inhaled corticosteroids are always used.

Chronic obstructive pulmonary disease

Maintenance treatment: inhalation of the contents of 1 to 2 inhalation capsules (12 to 24 micrograms) twice daily.

Children over 6 years of age and adolescents

Asthma

Maintenance treatment: inhalation of the contents of 1 inhalation capsule (12 micrograms) twice daily. The maximum recommended daily dose is 2 capsules (24 micrograms). In the event of a sudden asthma attack, a short-acting bronchodilator (e.g., salbutamol) should be used.

Prevention of bronchospasm induced by physical exertion or allergens

Inhalation of the contents of 1 inhalation capsule (12 micrograms) at least 15 minutes before physical exertion or exposure to an allergen. Children over 6 years of age can use Foramed only if they can properly use the inhaler (see "Inhaler Instructions") and only with the help of an adult. Foramed is not recommended for use in children under 6 years of age. Before starting treatment, you should read the "Inhaler Instructions".

Inhaler Instructions

The powder for inhalation in hard capsules is dosed using a powder inhaler. The powder in the capsule is intended for inhalation only. Do not swallow the capsules. The inhaler is designed to administer the powder from the number of capsules in the given package. Do not use the same inhaler for another package of the medicine. Immediately before use, remove the capsule from the blister pack. Make sure your hands are completely dry to avoid moistening the capsule.

• 1. Remove the inhaler cap.

• 2. Hold the base of the inhaler and open it by twisting the mouthpiece in the direction indicated by the arrow.

• 3. Place the powder capsule in the base chamber of the inhaler. The capsule should be removed from the blister pack immediately before use.

• 4. Close the inhaler by twisting the mouthpiece in the opposite direction of the arrow to its original position - closed.

• 5. Holding the inhaler vertically, press the inhaler buttons once, firmly.

• 6. Release the inhaler buttons. NOTE: At this point, the capsule may break, and small pieces of gelatin may enter the mouth or throat. Since gelatin is edible, its consumption is not harmful. The likelihood of such an event is minimal if the capsule is not punctured more than once, storage conditions are maintained, and the capsule is removed from the blister pack immediately before use (see point 3).
• 7. Holding the inhaler with the outlet facing your mouth, exhale slowly and deeply.

• 8. Tilt your head slightly backward, put the inhaler mouthpiece in your mouth, and seal it with your lips.

• 9. Take a quick, deep, and even breath. During inhalation, a characteristic sound should be heard. If this sound does not appear, it may indicate that the capsule is stuck in the base chamber of the inhaler. You should then open the inhaler and, by lifting the capsule, remove it from the chamber. DO NOT lift the capsule by repeatedly pressing the inhaler buttons. Then, repeat the actions described in point 9.
• 10. After hearing the characteristic sound, hold your breath for as long as possible without discomfort, then remove the inhaler from your mouth and exhale through your nose.
• 11. Open the inhaler and check if there is still powder in the capsule. If powder remains, repeat the procedure from point 7 to point 10.
• 12. After use, open the inhaler, remove the empty capsule, close the mouthpiece, and put the cap back on.

Cleaning the inhaler

The powder inhaler requires cleaning. To remove powder residues or a capsule, wipe the mouthpiece and compartment with a dry cloth or a soft brush. DO NOT use water to clean the inhaler.

Using a higher than recommended dose of Foramed

It is essential to use Foramed as directed by your doctor. If you have accidentally taken a higher dose of Foramed than recommended, you should contact your doctor or pharmacist immediately. The occurrence of nausea and/or vomiting, muscle tremors, headache, dizziness (possible symptoms of high blood pressure), rapid or irregular heartbeat, drowsiness, increased blood sugar levels, or decreased potassium levels in the blood may indicate that the dose of Foramed is too high. You should immediately inform your doctor or go to the emergency room of the nearest hospital. You may need appropriate treatment.

Missing a dose of Foramed

If you miss a dose, take the medicine as soon as possible. If it is almost time for your next scheduled dose, do not take a double dose (to make up for the missed dose) but return to your regular dosing schedule. If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In clinical trials with formoterol, severe asthma attacks (shortness of breath, cough, wheezing, and chest tightness) have been observed, which may require hospital treatment.

You should immediately inform your doctor about the occurrence of any of the following side effects:

Severe side effects:

• bronchospasm with cough, wheezing, and difficulty breathing. This effect occurs uncommonly (in 1 to 10 out of 1000 patients),
• allergic reactions, e.g., rash, urticaria, itching, swelling of the face, throat, and a decrease in blood pressure and bronchospasm. This effect occurs rarely (in 1 to 10 out of 10,000 patients),
• severe, described as tearing, chest pain (symptoms of angina pectoris), and changes in the ECG. This effect occurs very rarely (less than 1 in 10,000 patients),
• muscle symptoms, such as muscle weakness, muscle cramps, and arrhythmias (these symptoms may be caused by low potassium levels in the blood),
• if you experience an irregular heartbeat (including faster heartbeat).

Common side effects(in 1 to 10 out of 100 patients):
headache, muscle tremors, palpitations.
Uncommon side effects(in 1 to 10 out of 1000 patients):
agitation, anxiety, nervousness, insomnia, dizziness, rapid heartbeat, irritation of the throat mucosa, dryness of the oral mucosa, muscle cramps, muscle pain.
Rare side effects(in 1 to 10 out of 10,000 patients):
low potassium levels in the blood, arrhythmias, extra beats, nausea.
Very rare side effects(less than 1 in 10,000 patients):
high blood sugar levels, taste disturbances, swelling of the hands, feet, and ankles, excessive thirst, frequent urination, fatigue (these symptoms may indicate high blood sugar levels).

Side effects with unknown frequency:

cough, rash, headache, and dizziness (possible symptoms of high blood pressure). The use of the medicine may cause an increase in insulin levels in the blood, free fatty acids, glycerol, and ketone bodies.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, e-mail: [email protected]. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Foramed

Keep this medicine out of the sight and reach of children. Store in the original package, at a temperature below 25°C. Protect from light and moisture. Do not use this medicine after the expiry date stated on the blister pack or carton. The expiry date refers to the last day of the month stated. 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 Foramed contains

• The active substance of Foramed is formoterol fumarate dihydrate. One hard capsule contains 12 micrograms of formoterol fumarate dihydrate.
• The other ingredients are lactose monohydrate and gelatin.

What Foramed looks like and contents of the pack

Foramed is a powder for inhalation in hard capsules. The transparent, colorless hard capsules contain a white or cream-colored powder. The powder in the capsule is intended for inhalation into the lungs using an inhaler. Foramed capsules are packaged in OPA/Aluminum/PVC-Aluminum blisters, which, along with the inhaler and patient leaflet, are placed in a cardboard box. Foramed is available in packs containing 30, 60, 90, or 120 capsules.

Marketing authorisation holder and manufacturer

LEK-AM Pharmaceutical Company Ltd., ul. Ostrzykowizna 14 A, 05-170 Zakroczym, Poland, tel.: (22) 785 27 60, fax: (22) 785 27 60 ext. 106

Date of last revision of the leaflet: