Oxodil pph

Package leaflet: information for the patient

Oxodil PPH, 12 micrograms, inhalation powder in hard capsule
Formoteroli fumaras dihydricus
Please read carefully all the information in this leaflet before using this 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Oxodil PPH is and what it is used for

Oxodil PPH contains a bronchodilator substance that facilitates breathing (a selective
β-adrenergic receptor agonist).
Oxodil PPH is a medicine used for the long-term treatment of moderate to severe chronic
bronchial asthma in patients requiring regular treatment with a bronchodilator in combination with long-term anti-inflammatory therapy. Glucocorticosteroids should be used regularly.
Oxodil PPH is also indicated for the relief of bronchospasm symptoms (shortness of breath due to narrowing of the airways) in patients with chronic obstructive pulmonary disease.
Oxodil PPH capsules are intended for inhalation use only.

2. Important information before using Oxodil PPH

When not to use Oxodil PPH:

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

Warnings and precautions
Before starting treatment with Oxodil PPH, discuss this with your doctor or pharmacist.

• Oxodil PPH is not identical to other inhaled medicines containing formoterol. Do not switch from another inhaled medicine containing formoterol to Oxodil PPH without consulting your doctor.

• Oxodil PPH should only be used when long-term regular treatment with a bronchodilator is required. Oxodil PPH is not an alternative to short-acting β-adrenergic receptor agonists for acute asthma attacks. For treatment of sudden asthma symptoms, use a short-acting β-adrenergic receptor agonist.

• Do not exceed the maximum daily dose.

• The need for frequent use of the medicine to prevent exercise-induced bronchospasm (in addition to appropriate maintenance therapy) may indicate inadequate asthma control and requires a change in asthma management by a specialist doctor.

Anti-inflammatory treatment
Patients with asthma requiring regular use of β-adrenergic receptor agonists should also receive appropriate doses of inhaled or oral corticosteroids regularly. Patients should continue anti-inflammatory treatment after starting formoterol, even if symptoms improve after beginning treatment with Oxodil PPH. If symptoms persist or if the dose of Oxodil PPH needs to be increased to achieve symptom control, this usually indicates worsening of the disease. In such cases, the doctor should reassess the asthma treatment regimen.

Concomitant diseases
The following conditions require close medical supervision and may necessitate dosage adjustments:

• If the patient has heart disease associated with cardiac rhythm disorders (tachycardia, serious conduction disturbances), valvular heart disease (subvalvular aortic stenosis of unknown origin), thickening of the heart muscle (hypertrophic cardiomyopathy with outflow tract obstruction), or certain ECG changes (prolonged QT interval, QTc >0.44 sec).
• If the patient has severe heart disease, especially following a recent myocardial infarction, coronary artery disease, or severe weakening of the heart muscle (heart failure).
• If the patient has severe hyperthyroidism (thyrotoxicosis).
• If the patient has blood vessel narrowing (occlusive vascular disease), particularly atherosclerosis, high blood pressure (hypertension), or pathological dilation of blood vessel walls (aneurysms).
• If the patient has difficult-to-treat diabetes; since β-adrenergic receptor agonists such as Oxodil PPH may increase blood glucose levels, blood glucose should be monitored more closely with additional tests.
• In case of certain adrenal gland disorders (e.g. phaeochromocytoma). This also applies to conditions that occurred in the past.

Hypokalaemia
Severe hypokalaemia (reduced potassium levels in blood) may occur during treatment with β-adrenergic receptor agonists. Particular caution is advised in patients with severe asthma, as hypoxia increases the risk of hypokalaemia. In such cases, the doctor may recommend monitoring serum potassium levels.
As with other inhaled medicines, paradoxical bronchospasm (sudden worsening of breathing difficulties after inhalation) may rarely occur. If this happens, the medicine should be discontinued immediately and alternative treatment initiated.

Anti-doping tests
Use of Oxodil PPH may result in a positive anti-doping test.

Oxodil PPH and other medicines
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.

• When used concomitantly with certain medicines used for cardiac arrhythmias (quinidine, disopyramide, procainamide), heart failure (medicines containing cardiac glycosides), malaria (quinidine), allergies (terfenadine, astemizole, mizolastine), or schizophrenia (phenothiazine derivatives) or depression (tricyclic antidepressants), adverse effects such as cardiac arrhythmias and/or specific ECG changes (prolonged QT interval) may occur.

• Concomitant use of medicines used for cardiac arrhythmias or asthma (β-adrenergic receptor agonists, catecholamines, anticholinergics, and corticosteroids) may increase the adverse effects of Oxodil PPH.

• Concurrent use of Oxodil PPH and xanthine derivatives such as theophylline (asthma medicine), other asthma medicines (steroids), or diuretics may enhance the hypokalaemic effect. In patients receiving cardiac glycosides, hypokalaemia may increase the risk of cardiac arrhythmias.

• Oxodil PPH may be used together with certain medicines used to treat depression (monoamine oxidase inhibitors or tricyclic antidepressants), provided caution is exercised.

• With certain general anaesthetics (halogenated anaesthetic agents such as halothane, methoxyflurane, or enflurane), patients treated with Oxodil PPH should be aware of a possible increased risk of severe cardiac arrhythmias.

• Anticholinergic medicines may enhance the bronchodilating effect of Oxodil PPH.

• β-adrenergic receptor blockers (medicines used for hypertension, heart disease, hyperthyroidism, migraine, or high intraocular pressure) may reduce or block the effect of Oxodil PPH. In general, patients with asthma should not use non-selective (systemic) β-blockers (including eye drops), unless there are strong reasons for their use. β-blockers may provoke asthma attacks.

Please remember that this information may also apply to medicines that have been recently used.

Children and adolescents:
Due to insufficient data on safety and efficacy, Oxodil PPH should not be used in children and adolescents under 18 years of age.

Elderly patients:
In general, dosage adjustment is not required in elderly patients. However, elderly patients more frequently have other medical conditions and may be taking additional medicines (see sections: "Concomitant diseases", "Oxodil PPH and other medicines", and "Possible side effects").

Oxodil PPH with food and drink
Oxodil PPH can be used regardless of meal times.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy unless clearly recommended by a doctor.
Do not use this medicine during breastfeeding unless clearly recommended by a doctor.

Driving and using machines
Oxodil PPH has no effect or negligible effect on the ability to drive and operate machinery.

Oxodil PPH contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
However, the amount of lactose in this medicine (less than 500 micrograms per dose) is generally not problematic for patients with lactose intolerance.

3. How to use Oxodil PPH

This medicine should always be used exactly as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
If you feel breathless or hear wheezing while using Oxodil PPH, continue using the medicine but contact
your doctor as soon as possible, as additional treatment may be required.
If asthma is well controlled, your doctor may consider gradually reducing the dose of Oxodil PPH.
For inhalation use only.
The active substance in Oxodil PPH is delivered to the airways during inhalation.
Proper use of Oxodil PPH is crucial for successful treatment.
Important: Wash your hands thoroughly and dry them completely before using Oxodil PPH.
Neither the capsule nor the powder inside must come into contact with moisture.

Instructions for using the Oxodil PPH inhaler
Remove the capsule from its container immediately before use. A capsule left in the inhaler for up to three days remains stable.

1. Remove the protective cap from the inhaler.

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

3. Place the capsule into the compartment in the base of the inhaler.

4. Twist the mouthpiece back to the closed position.
5. Hold the inhaler vertically and press down firmly ONCE ONLY on the red buttons on the side of the device until fully depressed. Release the buttons.

Warning: At this point, the capsule may break! Small fragments of hypromellose may be inhaled into the mouth and throat during inhalation. Since hypromellose is edible, ingestion is not harmful. The likelihood of this occurring is minimal if the capsule is pierced only once, storage conditions are maintained, and the capsule is removed from its container only immediately before inhalation.

6.a) Breathe out deeply as quickly as possible (do not do this through the inhaler).
6.b) Place the mouthpiece in your mouth and seal your lips tightly around it. Tilt your head slightly backward and inhale quickly and deeply. While the capsule rotates in the inhaler chamber and the powder disperses, a characteristic sound should be heard. If this sound does not occur, it means the capsule is stuck in the compartment. In this case, open the inhaler and remove the capsule from the compartment. Do not attempt to dislodge the capsule by repeatedly pressing the buttons.

6.c) After hearing the characteristic sound, hold your breath as long as possible. Remove the inhaler from your mouth before breathing out slowly. Then resume normal breathing. After use, check whether the inhalation was performed correctly. To do this, open the inhaler and check whether any powder remains in the capsule. If powder remains, repeat the steps described in points (6a) to (6c).

After inhalation
Open the inhaler, remove the empty capsule, return the mouthpiece to its original position, and replace the protective cap.

Cleaning the inhaler
Clean the inhaler with a dry cloth to remove any residual powder. Open the capsule compartment and completely remove any remaining powder. Also clean the mouthpiece. A clean, soft brush may also be used for cleaning.

Warning:
Oxodil PPH capsules must only be used with the provided inhaler. Under no circumstances should other inhalers be used.
The inhaler provided for Oxodil PPH must not be used to inhale any other medicines.

Recommended dose:
Adults, including elderly patients:

• Asthma

  • Long-term use: 1 inhalation once or twice daily. In some patients, 2 inhalations once or twice daily may be required.
  • Prevention of exercise-induced bronchospasm:
    1 inhalation before exercise.
    The daily dose should not exceed 4 inhalations.
    Do not use more than 2 inhalations at a time.

• Chronic obstructive pulmonary disease (COPD)

  • Long-term use: 1 inhalation once or twice daily.
    The regular daily dose should not exceed 2 inhalations.
    If needed to relieve symptoms, additional inhalations may be used beyond the regular dose, up to a maximum daily dose of 4 inhalation capsules (including regularly used doses).
    Do not use more than 2 inhalations at a time.

Special patient groups
Dose adjustment is not required in patients with renal or hepatic impairment.
When switching from another inhaled formoterol product to Oxodil PPH, dose adjustment may be necessary.
Using more than 2 doses per day more often than two days per week indicates that current treatment is inadequate. In such cases, the doctor will consider changing the treatment approach.
Using doses higher than recommended does not provide additional benefit but increases the risk of adverse effects, including severe ones.
If you feel that the effect of Oxodil PPH is too strong or too weak, consult your doctor.

Overdose of Oxodil PPH
Symptoms of overdose are similar to adverse reactions but may occur suddenly and be more severe.
Symptoms of overdose include:
Nausea, vomiting, headache, palpitations, rapid or irregular heartbeat, muscle tremors (especially in the hands), dizziness, restlessness, difficulty sleeping, and chest pain.
If such symptoms occur, contact your doctor immediately. The patient may require appropriate treatment.

Missed dose of Oxodil PPH
Do not take a double dose to make up for a missed dose.
Making up a missed dose is usually not necessary, but if the patient's condition requires it, the dose may be taken. The interval to the next regularly scheduled dose should be at least 6 hours.

Stopping treatment with Oxodil PPH
Inform your doctor of any interruption or discontinuation of treatment, including the reason (e.g., due to adverse effects, etc.).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following convention has been used to describe the frequency of occurrence:
Very common: affects more than 1 in 10 people;
Common: affects 1 to 10 in 100 people;
Uncommon: affects 1 to 10 in 1,000 people;
Rare: affects 1 to 10 in 10,000 people;
Very rare: affects fewer than 1 in 10,000 people;
Not known: frequency cannot be estimated from the available data.
The most commonly reported adverse reactions during treatment with β-adrenergic receptor agonists, such as tremor and palpitations, appear to be mild and tend to resolve within a few days of treatment.
No very common adverse reactions have been reported.

Lactose contains small amounts of milk proteins and therefore may cause allergic reactions.
You should inform your doctor if any adverse reactions occur. If necessary, your doctor will have to adjust the dose of the medicine. Do not change the doses without consulting your doctor. If severe adverse reactions occur, discontinue use of Oxodil PPH immediately and inform your doctor.

Reporting adverse reactions
If any undesirable symptoms occur, including any adverse reactions not listed in this leaflet, you should 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
Tel.: + 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Oxodil PPH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton box and inhaler. The expiry date refers to the last day of the stated month.
The abbreviation EXP indicates the expiry date, and the abbreviation Lot indicates the batch number.
Store below 25°C.
Keep in the original packaging to protect from moisture.
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 Oxodil PPH contains

• The active substance is formoterol fumarate dihydrate. Each hard capsule contains 12 micrograms of formoterol fumarate dihydrate. Each delivered dose contains 9 micrograms of formoterol fumarate dihydrate.
• The other ingredients are: anhydrous lactose, monohydrate lactose, hypromellose.

What Oxodil PPH looks like and contents of the pack
An HDPE bottle closed with a polypropylene cap containing a desiccant to absorb moisture. A plastic inhaler is supplied with the pack.
Oxodil PPH is available in packs containing 60, 120, 180 and 240 hard capsules for inhalation powder and one inhaler.

Marketing Authorisation Holder:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer:
SMB TECHNOLOGY SA
39, Rue du Parc Industriel
B-6900 Marche-en-Famenne
Belgium
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Other sources of information
Detailed instructions for use of the inhaler are available by scanning with a smartphone the QR code located in the leaflet below. The same information is also available at the website: www.instrukcjeoxodil.pl
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