Oxis turbuhaler

Package leaflet: Information for the patient

Oxis Turbuhaler
4.5 micrograms/dose, powder for inhalation
Formoterol fumarate dihydrate
Please read all of this leaflet carefully before you start using this medicine, as it contains
important information for you.

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

Leaflet contents:

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

1. What Oxis Turbuhaler is and what it is used for

Formoterol, the active substance in Oxis Turbuhaler, is a selective β₂-adrenergic agonist.
It works by relaxing the smooth muscles of the bronchi, thereby making breathing easier.
When you inhale through the mouthpiece of the inhaler, the medicine reaches your lungs.
The effect of the medicine begins within 1 to 3 minutes after inhalation and lasts up to 12 hours.
Oxis Turbuhaler is indicated for maintenance treatment, in combination with inhaled
glucocorticosteroids, of bronchial obstruction symptoms and for prevention of exercise-induced
symptoms in patients with asthma, when treatment with glucocorticosteroids alone is insufficient.
Oxis Turbuhaler is also indicated for the treatment of bronchial obstruction symptoms
in patients with chronic obstructive pulmonary disease (COPD).

2. Important information before using Oxis Turbuhaler

When not to use Oxis Turbuhaler

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

Warnings and precautions
Oxis Turbuhaler is not intended for initiating asthma treatment, as it is insufficient for this purpose.
Oxis Turbuhaler should not be started during acute, severe asthma exacerbation or during worsening of an existing exacerbation. Asthma exacerbations and serious adverse effects related to asthma may occur during treatment.
If there is no improvement in symptoms after starting treatment or if an exacerbation occurs, continue taking the medicine and contact the doctor who prescribed it.
Inform your doctor about any concerning reactions that occurred in the past after using formoterol or lactose, or after taking other medicines. In certain cases, Oxis Turbuhaler should be used with particular caution. Inform your doctor especially about heart diseases, diabetes, thyroid disorders (hyperthyroidism), pheochromocytoma, arterial hypertension, aneurysm, and decreased serum potassium levels.
If bronchospasm occurs after using the medicine, discontinue its use immediately and contact your doctor.
Oxis Turbuhaler should be used in asthma treatment concomitantly with glucocorticosteroids.
Continue glucocorticosteroid treatment after starting Oxis Turbuhaler, even if symptoms improve. In case of an acute asthma attack, an additional dose of Oxis Turbuhaler may be used. However, if it becomes necessary to use additional doses of Oxis Turbuhaler more frequently than usual to relieve breathing difficulties, contact your doctor immediately. In such cases, additional treatment may be required.
In patients with diabetes, the doctor may recommend monitoring blood glucose levels during the initial period of treatment.
In patients with severe asthma who are taking other medicines, the doctor may recommend monitoring serum potassium levels.
Strictly follow the instructions of your treating doctor and do not change them without prior consultation.

Children
Oxis Turbuhaler should not be used in children under 6 years of age due to insufficient data on use in this age group.

Oxis Turbuhaler and other medicines
Other medicines taken concomitantly may influence the effect of Oxis Turbuhaler.
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take, including those available without a prescription.
Especially inform your doctor if the patient is taking any of the following medicines:

• xanthine derivatives (e.g. theophylline, aminophylline) – medicines used in the treatment of asthma or other chronic obstructive pulmonary diseases,
• steroids (medicines used in the treatment of asthma and other inflammatory diseases),
• diuretics (e.g. furosemide),
• quinidine, disopyramide, or procainamide (medicines used in cardiac arrhythmias),
• phenothiazines (e.g. chlorpromazine), used in the treatment of psychiatric disorders,
• antihistamines (e.g. terfenadine),
• monoamine oxidase inhibitors (MAOIs), used, among others, in the treatment of depression,
• levodopa (used in Parkinson's disease),
• levothyroxine (used in hypothyroidism),
• oxytocin (used to induce uterine contractions),
• tricyclic antidepressants (used in the treatment of depression),
• beta-adrenergic blocking agents (such as atenolol or propranolol, used in high blood pressure), including eye drops (e.g. timolol used in glaucoma),
• anticholinergic medicines (such as tiotropium or ipratropium bromide) may enhance the bronchodilating effect of Oxis Turbuhaler. Inform your doctor about using the medicine if the patient is undergoing general anesthesia or dental procedures.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
If a woman using Oxis Turbuhaler becomes pregnant, she should inform her doctor as soon as possible.
It is not known whether formoterol passes into human breast milk; therefore, Oxis Turbuhaler should not be used by breastfeeding mothers.

Driving and operating machinery
The use of Oxis Turbuhaler does not affect the ability to drive or operate machinery.

Oxis Turbuhaler contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
One delivered dose of Oxis Turbuhaler 4.5 micrograms/dose contains 895.5 micrograms of monohydrated lactose, which is usually not clinically significant in patients with lactose intolerance.
Monohydrated lactose contains small amounts of milk proteins. These may cause allergic reactions.

3. How to use Oxis Turbuhaler

Always use Oxis Turbuhaler exactly as directed by your doctor. If you are unsure, consult your doctor.
The dosage of Oxis Turbuhaler is individually determined.
Asthma
Oxis Turbuhaler may be used in patients with asthma once or twice daily (maintenance doses) or on an as-needed basis to relieve breathing difficulties.
Adults over 18 years of age
As-needed use
1 inhalation or 2 inhalations to relieve breathing difficulties.
Maintenance dose
1 inhalation or 2 inhalations once or twice daily. In some patients, it may be necessary to use 4 inhalations once or twice daily.
Prevention of exercise-induced bronchospasm
2 inhalations before exercise.
The maximum daily maintenance dose should not exceed 8 inhalations; however, up to 12 inhalations per day may be used if needed.
The maximum single dose is 6 inhalations.
Children aged 6 years and older
As-needed use
1 inhalation or 2 inhalations to relieve breathing difficulties.
Maintenance dose
2 inhalations once or twice daily.
Prevention of exercise-induced bronchospasm
1 inhalation or 2 inhalations before exercise.
The maximum daily maintenance dose should not exceed 4 inhalations; however, up to 8 inhalations per day may be used if needed.
The maximum single dose is 2 inhalations.
Your doctor will monitor your asthma and adjust the dose of Oxis Turbuhaler accordingly, gradually reducing it to the lowest effective dose that controls asthma.
Do not change the dose of the medicine without first consulting your doctor.
Chronic obstructive pulmonary disease (COPD)
Adults over 18 years of age
Maintenance dose
2 inhalations once or twice daily.
The maximum daily maintenance dose should not exceed 4 inhalations.
Patients using Oxis Turbuhaler to relieve symptoms may, if necessary, use additional doses (inhalations) beyond those used for maintenance treatment.
The maximum total daily maintenance dose is 8 inhalations (including regularly used doses).
The maximum single dose is 4 inhalations.
Special patient groups
Dosage adjustment is not required in elderly patients or in patients with hepatic or renal impairment when the usual recommended doses are used.
Note:
The need to use additional doses (inhalations) more than twice a week, beyond those used for maintenance treatment, indicates inadequate disease control.
In such a case, contact your doctor as soon as possible.
Before starting to use the medicine, read the “Instructions for use of Oxis Turbuhaler” provided below.
Due to the very small amount of fine medicinal substance in each dose, you may not taste the medicine after inhalation. However, if you follow the “Instructions for use of Oxis Turbuhaler”, you can be certain that the prescribed dose has been inhaled. Each dose contains a minimal amount of non-medicinal carrier substance.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Instructions for use of Oxis Turbuhaler
Preparing the Oxis Turbuhaler inhaler for first use
Before the first use of a new Oxis Turbuhaler inhaler, prepare it as follows:

• Unscrew and remove the inhaler cap. During unscrewing, you may hear a characteristic rattling sound. This is caused by the moisture-absorbing agent moving inside the inhaler.
• Hold the Oxis Turbuhaler inhaler vertically with the turquoise dial facing downwards.
• Turn the turquoise dial fully in one direction, then turn it fully in the opposite direction (the starting direction of turning the dial does not matter). You will hear a characteristic click sound.
• Only before the first use, repeat this action by turning the turquoise dial in both directions.
• The Oxis Turbuhaler inhaler is now ready for use.

Using the inhaler
To perform an inhalation, always follow the instructions below.

1. Unscrew and remove the inhaler cap. You may hear a characteristic rattling sound during unscrewing.
2. Hold the Turbuhaler inhaler vertically with the turquoise dial facing downwards.
3. Do not hold the inhaler by the mouthpiece when loading the dose. To load a dose of medicine, turn the turquoise dial fully in one direction, then fully in the opposite direction (the starting direction does not matter). You will hear a characteristic click sound. The Turbuhaler inhaler is now loaded and ready for use. Only load the dose immediately before use.

4. Move the Turbuhaler inhaler away from your mouth and then exhale. Do not exhale through the inhaler mouthpiece.
5. Gently place the inhaler mouthpiece between your teeth. Close your lips around the mouthpiece and inhale slowly, deeply, and steadily through your mouth. Do not chew or bite the mouthpiece. Do not use a damaged inhaler or an inhaler without a mouthpiece.

6. Remove the inhaler mouthpiece from your mouth before exhaling. Then exhale. The amount of medicine in a single inhalation dose is very small, so you may not taste the medicine after inhalation. However, if you follow the instructions correctly, you can be certain that the dose has been inhaled and the medicine has reached your lungs.
7. If a second inhalation is prescribed, repeat the steps described in points 2 to 6.
8. After using the inhaler, replace the cap and close it tightly.
9. Do not remove the mouthpiece, as it is attached to the Turbuhaler inhaler and cannot be detached. The mouthpiece may be rotated, but avoid unnecessary turning. Do not use a Turbuhaler inhaler that is damaged or if the mouthpiece is not properly attached.

As with all inhalers, caregivers should ensure that children prescribed Oxis Turbuhaler use the correct inhalation technique as described above.
Cleaning the Turbuhaler inhaler
Wipe the outer surface of the mouthpiece weekly with a dry cloth. Do not use water or other liquids to clean the inhaler.
When to start using a new inhaler

• The dose counter window shows how many doses (inhalations) remain in the Turbuhaler inhaler; it starts at 60, as a full inhaler contains 60 doses.

• The dose counter is marked every 10 inhalations, so the counter does not change after each single dose.
• The appearance of a red mark at the edge of the dose counter window indicates that approximately 20 doses remain. During the last 10 doses, the background of the dose counter window turns red. When the number 0 on a red background is centered in the dose counter window, it means you should start using a new Turbuhaler inhaler.

Note:

• After the inhaler is empty, the dial will still turn and produce a characteristic click sound.
• The sound heard when shaking the Turbuhaler inhaler is produced by the moisture-absorbing agent, not by the medicine. Therefore, you cannot assess the remaining content of the Turbuhaler inhaler by the sound it makes when shaken.
• If more than one dose is accidentally loaded, the patient will still receive only one dose of medicine. However, all loaded doses will be counted in the dose counter.

Use of a higher than recommended dose of Oxis Turbuhaler
Overdose may cause the following symptoms: muscle tremors, headache, rapid heartbeat, dizziness, drowsiness.
If you have taken more than the recommended dose, contact your doctor immediately or go to a hospital.
Missed dose of Oxis Turbuhaler
Oxis Turbuhaler powder for inhalation should be used exactly as prescribed by your doctor, and only the prescribed number of doses should be taken. Do not take a double dose to make up for a missed dose.
Stopping treatment with Oxis Turbuhaler
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
As with other inhaled medicines, paradoxical bronchospasm may very rarely occur (in fewer than 1 in
10,000 patients). If bronchospasm occurs after using the medicine, discontinue use immediately
and consult your doctor without delay.

Adverse effects occurring frequently (in 1 to 10 out of 100 patients treated):

• headache,
• tremor,
• dizziness,
• nausea,
• muscle cramps.

Adverse effects occurring uncommonly (in 1 to 10 out of 1,000 patients treated):

• hypersensitivity reactions (e.g. bronchospasm, rash, urticaria, pruritus),
• decreased serum potassium concentration,
• increased serum glucose concentration,
• rapid heartbeat,
• palpitations,
• cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, and extrasystoles),
• changes in blood pressure,
• symptoms of angina (pain and feeling of pressure in the chest),
• sleep disturbances,
• taste disturbances.

Adverse effects occurring rarely (in 1 to 10 out of 10,000 patients treated):

• restlessness,
• motor hyperactivity.

Adverse effects occurring very rarely (in fewer than 1 out of 10,000 patients treated):

• abnormalities in ECG readings.

During treatment with β2-mimetics, increased levels of insulin, free fatty acids, glycerol, and ketone bodies in blood may occur.
Other adverse effects may occur in some individuals during treatment with Oxis Turbuhaler.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects may also be reported to the marketing authorization holder.

5. How to store Oxis Turbuhaler

Keep the medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
The inhaler should be stored with the cap tightly closed.
Do not use Oxis Turbuhaler after the expiry date stated on the carton and
the Turbuhaler label.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help
protect the environment.

6. Contents of the pack and other information

What Oxis Turbuhaler contains

• The active substance is formoterol. One delivered dose contains 4.5 micrograms of formoterol fumarate dihydrate.
• Another ingredient of the medicine is lactose monohydrate (which contains milk proteins). See section 2 of the leaflet: Oxis Turbuhaler contains lactose.

What Oxis Turbuhaler looks like and contents of the pack
The carton contains one inhaler with 60 doses of medicine.
Each inhaler is additionally labelled:
“60 DOSES FORMOTEROL 4,5 \μ g/DOSE
LOT/LOTE ZM 1234
EXP/CAD MM-YYYY”,
which means:
“60 DOSES FORMOTEROL 4.5 \μ g/DOSE
BATCH NUMBER ZM 1234
EXPIRY DATE: MM-YYYY”

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
AstraZeneca AB
S-151 85 Sodertalje
Sweden

Manufacturer
AstraZeneca AB
Forskargatan 18
SE-151 36 Södertälje
Sweden

For more detailed information, please contact the representative of the Marketing Authorisation Holder:
AstraZeneca Pharma Poland Sp. z o.o.
Postępu 14 Street
02-676 Warsaw
Phone: +48 22 245 73 00
Fax: +48 22 485 30 07