OXODIL (160 mcg + 4.5 mcg) Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Oxodil Combo, (160 micrograms + 4.5 micrograms)/delivered dose,
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Oxodil Combo and what is it used for
   1. Asthma
   2. Chronic Obstructive Pulmonary Disease (COPD)
4. Important information before using Oxodil Combo
   1. When not to use Oxodil Combo
   2. Warnings and precautions
   3. Oxodil Combo and other medicines
   4. Pregnancy, breastfeeding and fertility
   5. Driving and using machines
   6. Oxodil Combo contains lactose
5. How to use Oxodil Combo
   1. Important information about asthma or COPD symptoms
   2. Asthma
   3. Using Oxodil Combo and an additional reliever inhaler
   4. Adults (18 years and over)
   5. Adolescents (12 to 17 years old)
   6. For the treatment of asthma symptoms when they occur, a separate "reliever inhaler" should be used
   7. Using Oxodil Combo as the only inhaler for the treatment of asthma
   8. Oxodil Combo should also be used as a "reliever inhaler" to treat asthma symptoms.
   9. Chronic Obstructive Pulmonary Disease (COPD)
   10. Instructions for use
   11. Before using the inhaler
   12. Using the inhaler
6. Opening
7. Preparing the dose
8. Inhaling the dose
   1. Cleaning
   2. Using a higher than recommended dose of Oxodil Combo
   3. Missing a dose of Oxodil Combo
9. Possible side effects
   1. If any of the following symptoms occur, the patient should stop using Oxodil Combo and consult their doctor immediately:
   2. Oxodil Combo and use a reliever inhaler. The patient should contact their doctor immediately, as a change in treatment may be necessary
   3. Other possible side effects:
   4. Common (may occur in less than 1 in 10 people)
   5. Uncommon (may occur in less than 1 in 100 people)
   6. Rare (may occur in less than 1 in 1,000 people)
   7. Very rare (may occur in less than 1 in 10,000 people)
   8. Reporting side effects
10. How to store Oxodil Combo
11. Contents of the packaging and other information
    1. What Oxodil Combo contains
    2. What Oxodil Combo looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Oxodil Combo, (160 micrograms + 4.5 micrograms)/delivered dose,

inhalation powder, divided
Budesonide + Formoterol fumarate dihydrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Oxodil Combo is an inhaler medicine used to treat:

• asthma in adults and adolescents from 12 to 17 years old.
• symptoms of chronic obstructive pulmonary disease (COPD) in adultsaged 18 and over.

Oxodil Combo contains two medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called corticosteroids. It works by reducing and preventing swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting beta2-adrenergic receptor agonists or bronchodilators. Its action is to relax the muscles in the airways. The medicine makes it easier to breathe.

Asthma

Oxodil Combo may be prescribed for the treatment of asthma in two different ways:
a)
Some people are prescribed two inhalers by their doctor to treat asthma: Oxodil Combo
and a separate reliever inhaler.

• Oxodil Combo is used every day. The medicine helps prevent asthma symptoms.
• The reliever inhaler is used when asthma symptoms occur, to make breathing easier.

b)
Some people are prescribed Oxodil Combo as the only inhaler for the treatment of
asthma.

• Oxodil Combo is used every day. The medicine helps prevent asthma symptoms.
• Oxodil Combo is also used in situations where additional doses are needed to relieve asthma symptoms and make breathing easier. These people do not need a separate reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Oxodil Combo can also be used in adults to treat symptoms of COPD. COPD is
a chronic disease characterized by persistent breathing difficulties caused by narrowing of the airways in the lungs, often with coughing and expectoration of phlegm. It is often caused by smoking.

2. Important information before using Oxodil Combo

When not to use Oxodil Combo

Warnings and precautions

Before starting to use Oxodil Combo, you should discuss it with your doctor or pharmacist,

• has diabetes,
• has a lung infection,
• has high blood pressure or has ever had heart disease (including arrhythmias, very fast heart rate (high pulse), narrowing of the arteries or heart failure),
• has thyroid or adrenal gland disease,
• has low potassium levels in the blood,
• has severe liver function disorders.

If the patient experiences blurred vision or other vision disturbances, they should contact
their doctor.

Oxodil Combo and other medicines

You should 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.
You should tell your doctor or pharmacist about the use of the following medicines:

• beta-blockers (such as atenolol or propranolol used to treat high blood pressure), including eye drops (such as timolol used to treat glaucoma);
• medicines used to treat rapid or irregular heart rhythm (such as quinidine, disopyramide, procainamide);
• medicines used to treat allergies, so-called antihistamines (such as terfenadine);
• oxytocin, a medicine used to accelerate childbirth;
• procarbazine, a medicine used to treat cancer;
• medicines such as digoxin, often used to treat heart failure;
• diuretics, so-called water pills (such as furosemide) used to treat high blood pressure;
• corticosteroids (such as prednisolone) used to treat inflammation or prevent rejection of a transplanted organ;
• xanthine derivatives (such as theophylline or aminophylline) often used to treat asthma;
• other medicines used to dilate the airways (such as salbutamol);
• medicines used to treat depression, so-called tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone;
• medicines used to treat mental illnesses, nausea or vomiting, so-called phenothiazines (such as chlorpromazine and prochlorperazine);
• medicines used to treat fungal (such as ketoconazole, itraconazole, voriconazole, posaconazole) and bacterial (such as clarithromycin, telithromycin and furazolidone) infections;
• medicines used to treat Parkinson's disease (such as levodopa);
• medicines used to treat thyroid diseases (such as levothyroxine);
• ritonavir, cobicistat (used to treat HIV infection). The effect of Oxodil Combo may be enhanced and the doctor may need to closely monitor the patient's condition.

If any of these situations apply to the patient or the patient is unsure if they are taking any of the listed medicines, they should consult their doctor or pharmacist before using Oxodil Combo.
They should also tell their doctor or pharmacist about any planned general anesthesia due to surgery or dental procedure.

Pregnancy, breastfeeding and fertility

• If the patient is pregnant or plans to have a child, they should consult their doctor before using Oxodil Combo - they should not use Oxodil Combo unless their doctor has prescribed it.
• If the patient becomes pregnant while being treated with Oxodil Combo, they should not stop using Oxodil Combo, but should contact their doctor immediately.
• If the patient is breastfeeding, they should consult their doctor before using Oxodil Combo.

Driving and using machines

Oxodil Combo has no or negligible influence on the ability to drive and use machines.

Oxodil Combo contains lactose

Oxodil Combo contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The amount of lactose in this medicine should not normally be a problem for people with lactose intolerance.
The lactose, an excipient of the medicine, contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Oxodil Combo

This medicine should always be used as directed by your doctor or pharmacist. In case of doubts, you should consult your doctor or pharmacist.

• It is important to use Oxodil Combo every day, even if the patient does not have asthma or COPD symptoms at that time.
• If the patient is using Oxodil Combo to treat asthma, the doctor will regularly check the symptoms of the disease.

If the patient is taking tablets containing corticosteroids to treat asthma or COPD, the doctor may reduce their number after starting to use Oxodil Combo. If the patient has been taking oral corticosteroids for a long time, the doctor may from time to time recommend blood tests. After reducing the dose of oral corticosteroids, the patient's condition may be poor, even despite possible improvement in respiratory symptoms. Symptoms such as nasal congestion or runny nose, weakness or joint or muscle pain and rash (rash) may occur. If any of these symptoms occur or symptoms such as headache, fatigue, nausea (nausea) or vomiting occur, the patient should contact their doctor immediately. If symptoms of allergy or arthritis occur, it may be necessary to use other medicines.
If the patient has doubts about continuing to use Oxodil Combo, they should consult their doctor.
In periods of stress (e.g. associated with chest infection or before surgery) the doctor may consider adding tablets containing corticosteroids to the usual treatment.

Important information about asthma or COPD symptoms

If the patient experiences shortness of breath or wheezing while using Oxodil Combo, they should continue to use Oxodil Combo and contact their doctor as soon as possible, as additional treatment may be necessary.
The patient should contact their doctor immediately if:

• breathing difficulties worsen or asthma symptoms wake them up often at night;
• the patient starts to feel chest tightness in the morning or the feeling of chest tightness lasts longer than usual. These symptoms may indicate inadequate control of asthma or COPD and may require immediate use of other or additional treatment.

Asthma

In the treatment of asthma, the doctor may prescribe Oxodil Combo in two different ways. The dose and duration of Oxodil Combo depend on the prescribed method of use.
a)
If the doctor has prescribed Oxodil Combo and a separate reliever inhaler, the patient should read the instructions below in the section "a) Using Oxodil Combo and an additional reliever inhaler".
b)
If the doctor has prescribed Oxodil Combo as the only inhaler for the treatment of asthma, the patient should read the instructions below in the section "b) Using Oxodil Combo as the only inhaler for the treatment of asthma".
a)

Using Oxodil Combo and an additional reliever inhaler

Oxodil Combo should be used every day. This helps prevent asthma symptoms.

Adults (18 years and over)

• The usual dose is 1 or 2 inhalations twice a day.
• The doctor may increase this dose to 4 inhalations twice a day.
• After achieving control of symptoms, the doctor may recommend using the medicine once a day.

Adolescents (12 to 17 years old)

• The usual dose is 1 or 2 inhalations twice a day.
• After achieving control of symptoms, the doctor may recommend using the medicine once a day.

Oxodil Combo should not be used in children under 12 years of age.
The doctor will help the patient properly control asthma symptoms and determine the smallest dose that will control the disease symptoms. The patient should not change the dose of the medicine without consulting their doctor first.

For the treatment of asthma symptoms when they occur, a separate "reliever inhaler" should be used

. The "reliever inhaler" should always be carried with you, so that it can be used if needed. Oxodil Combo should not be used to treat asthma symptoms - a separate reliever inhaler should be used for this purpose.
b)

Using Oxodil Combo as the only inhaler for the treatment of asthma

Oxodil Combo should be used only as directed by the doctor and only in people aged 12 and over.
Oxodil Combo should be used every day. This helps prevent asthma symptoms. The patient can use:

• 1 inhalation in the morning and 1 inhalation in the evening or
• 2 inhalations in the morning or
• 2 inhalations in the evening.

The doctor may increase this dose to 2 inhalations twice a day.

Oxodil Combo should also be used as a "reliever inhaler" to treat asthma symptoms.

• If asthma symptoms occur, the patient should take 1 inhalation and wait a few minutes.
• If there is no improvement, the patient should take another inhalation.
• The patient should not use more than 6 inhalations at a time.

The Oxodil Combo inhaler should always be carried with you, so that it can be used if needed.
Normally, the total daily dose should not exceed 8 inhalations. However, the doctor may allow the use of up to 12 inhalations per day for a certain period.
If the patient regularly needs to use 8 or more inhalations per day, they should contact their doctor or nurse. The treatment may need to be changed.
The patient should not use more than 12 inhalations per day.
If asthma symptoms occur during physical exertion, the patient should use Oxodil Combo as described above. However, the patient should not use this medicine before physical exertion to prevent asthma symptoms.

Chronic Obstructive Pulmonary Disease (COPD)

The medicine should only be used in adults (18 years and over).

• The usual dose is 2 inhalations twice a day.

In the treatment of COPD, the doctor may also prescribe other bronchodilators, such as anticholinergic medicines (such as tiotropium bromide or ipratropium).

Instructions for use

The doctor, nurse or pharmacist should demonstrate to the patient how to use the inhaler and regularly check that it is used correctly.
The inhaler contains 60 doses of the medicine in the form of powder in a rolled-up foil strip. The inhaler has a dose counter that shows how many doses are left, counting down from 60 to 0. The last 10 doses are marked on a red background.
The inhaler is not intended for refilling - after emptying the inhaler, it should be thrown away and replaced with a new one.

Before using the inhaler

• Open the transparent cover of the side chamber.
• Remove the foil strip from the side chamber by carefully tearing it off along its entire length using the notched edge, as shown below in the picture. The strip should not be pulled or jerked.

• Close the side chamber cover and discard the torn-off strip.

Note:As the inhaler is used, the side chamber gradually fills with used foil strips. The foil strips with black lines do not contain medicine. At the end, numbered sections of the strip will appear in the chamber. The side chamber should not contain more than 2 strips, as this may cause the inhaler to clog. The strip should be carefully torn off, as shown above in the picture, and disposed of safely.

Using the inhaler

The inhaler should be held in the hands as shown in the pictures.

1. Opening

• Exposing the mouthpiece by pulling down the protective cap.
• Checking the dose counter window to see how many doses of the medicine are left.

2. Preparing the dose

• Liftthe edge of the white lever. Make sure the side chamber is closed. Note: the white lever should only be used when the patient is ready to take a dose of the medicine. If the patient plays with the white lever, they will waste doses.

• Opening: pull the white lever to the stopuntil a click is heard, which will load the dose of the medicine and display its number in the dose counter.

• Closing: then carefully close the white leverso that a click is heard, and the lever returns to its original position. The inhaler is ready for immediate use.

3. Inhaling the dose

• Exhale as far as possible away from the mouthpiece. Never exhale directly into the inhaler, as this may change the size of the dose.
• Hold the inhaler with the protective cap facing downwards.
• Put the mouthpiece to your mouth and close your lips tightly around it.
• The patient should take a deep and forceful breath in through the mouth (not nose), as far as possible.

• Remove the inhaler from the mouth and hold your breath for 5-10 secondsor for as long as it is comfortable.
• Then the patient should exhale slowly, but not in the direction of the inhaler.
• Close the protective cap of the mouthpiece.
• Rinse the mouth with water, which should then be spat out. This will help prevent the development of a fungal infection in the mouth and the occurrence of hoarseness.

Cleaning

• If necessary, wipe the outer part of the mouthpiece with a clean, dry cloth.
• The inhaler should not be disassembled for cleaning or for any other purpose!
• The parts of the inhaler should not be cleaned with water or wet wipes, as moisture may change the size of the dose!
• Never insert a needle or other sharp objects into the mouthpiece or any other part of the inhaler, as this may damage it!

Using a higher than recommended dose of Oxodil Combo

It is important that the patient uses the medicine as directed by their doctor. The patient should not increase the prescribed dose without consulting their doctor.
The most common symptoms that may occur after taking a higher than recommended dose of Oxodil Combo are: tremors, headache, rapid or irregular heartbeat.

Missing a dose of Oxodil Combo

• If a dose is missed, it should be taken as soon as possible after remembering. However, if it is almost time for the next dose, the missed dose should be skipped.
• The patient should not take a double dose to make up for a missed dose.

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxodil Combo can cause side effects, although not everybody gets them.

If any of the following symptoms occur, the patient should stop using Oxodil Combo and consult their doctor immediately:

swelling of the face, especially around the mouth (swelling of the tongue and/or throat and/or difficulty swallowing) or hives with difficulty breathing (angioedema) and/or sudden feeling of fainting. These symptoms may indicate a rare allergic reaction (may occur in less than 1 in 1,000 people).

• sudden onset of wheezing or shortness of breath immediately after inhalation. If any of these symptoms occur, the patient should stop using Oxodil Combo and use their reliever inhaler

Oxodil Combo and use a reliever inhaler. The patient should contact their doctor immediately, as a change in treatment may be necessary

This situation occurs very rarely (may occur in less than 1 in 10,000 people).

Other possible side effects:

Common (may occur in less than 1 in 10 people)

• palpitations (feeling of heartbeat), muscle tremors or shakiness. If these symptoms occur, they are usually mild and disappear during continued use of Oxodil Combo.
• thrush (fungal infection) in the mouth. The risk of their development is lower if the patient rinses their mouth with water after inhalation.
• mild sore throat, cough and hoarseness
• headache
• pneumonia (lung infection) in patients with COPD

If any of the following symptoms occur while using Oxodil Combo, the patient should consult their doctor - these may be symptoms of a lung infection:

• fever or chills
• increased production of sputum, change in its color
• increased cough or difficulty breathing.

Uncommon (may occur in less than 1 in 100 people)

• feeling of anxiety, nervousness or agitation
• sleep disturbances
• dizziness
• blurred vision
• nausea (nausea)
• rapid heartbeat
• presence of bruises on the skin
• muscle cramps
• aggression
• anxiety

Rare (may occur in less than 1 in 1,000 people)

• rash, itching
• bronchospasm (bronchial muscle spasm causing wheezing). If wheezing occurs suddenly after using Oxodil Combo, the patient should stop using Oxodil Combo and consult their doctor immediately.
• low potassium levels in the blood
• irregular heartbeat

Very rare (may occur in less than 1 in 10,000 people)

• depression
• behavioral changes, especially in children
• chest pain or tightness (angina pectoris)
• increased blood sugar (glucose) levels
• changes in taste, such as unpleasant taste in the mouth
• changes in blood pressure
• weight gain, moon face, weakness, abdominal obesity (Cushing's syndrome).

Inhaled corticosteroids, especially when used for a long time in high doses, may affect the normal production of steroid hormones in the body. The symptoms include:

• changes in bone mineral density (thinning of bones)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• slowed growth rate in children and adolescents
• effect on the adrenal glands (small glands located near the kidneys)
• Cushing's syndrome (characterized by weight gain, moon face, difficulty healing wounds and thinning of the skin).
• increased susceptibility to infections and reduced ability to adapt to stressful situations. The likelihood of these symptoms is much lower when using inhaled corticosteroids than when taking corticosteroids in tablets.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their 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
Phone: +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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Oxodil Combo

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton or inhaler label after: EXP. The expiry date stated on the label means the last day of the specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Oxodil Combo contains

• The active substances of the medicine are budesonide and formoterol fumarate dihydrate. Each delivered dose (inhalation dose) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. Each measured dose (dose of medicine in the blister before administration) contains 194.7 micrograms of budesonide and 6.1 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (contains milk proteins).

What Oxodil Combo looks like and contents of the pack

Oxodil Combo is a red and white plastic inhaler containing the medicine, in a cardboard box.
Each inhaler contains a blister OPA/Aluminum/PVC/Aluminum with 60 divided doses of inhalation powder. The inhalation powder is uniform, white, almost white or light yellow.
Pack sizes: 1 or 2 inhalers (each containing 60 doses).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben, Sachsen-Anhalt
Germany
Aeropharm GmbH
Francois-Mitterand-Allee 1
07407 Rudolstadt, Thuringen
Germany

Date of last revision of the leaflet: