OXODIL 320 mcg + 9 mcg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Oxodil Combo, (320 micrograms + 9 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. Adults (18 years and older)
   4. Adolescents (12 to 17 years old)
   5. For the treatment of asthma symptoms when they occur, a separate "emergency inhaler" should be used
   6. Chronic Obstructive Pulmonary Disease (COPD)
   7. Instructions for use
   8. Before using the inhaler
   9. Using the inhaler
6. Opening
7. Preparing the dose
8. Inhalation of 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 you experience any of the following symptoms, stop using Oxodil Combo and consult your doctor:
   2. and use the emergency inhaler. You should contact your doctor
   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 what the pack contains
    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, (320 micrograms + 9 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 you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 aged 12 to 17 years. It is also used to treat symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 and older.
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 breathing easier.

Asthma

For the treatment of asthma, the doctor prescribes two inhalers: Oxodil Combo and a separate inhaler for emergency use.

• Oxodil Combo is used daily. The medicine helps prevent the occurrence of asthma symptoms.
• The emergency inhaler is used when asthma symptoms occur, to facilitate breathing. Do not use Oxodil Combo, (320 micrograms + 9 micrograms)/delivered dose, as an emergency inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Oxodil Combo can also be used in adults to treat symptoms of COPD. COPD is a chronic respiratory disease in the lungs, 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 if you:

• have diabetes,
• have a lung infection,
• have high blood pressure or have ever had heart disease (including heart rhythm disorders, very fast heart rate (high pulse), narrowing of the arteries or heart failure),
• have thyroid or adrenal gland disease,
• have low potassium levels in the blood,
• have 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 taking now or have taken recently, 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 organ rejection;
• 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);
• medicines called HIV protease inhibitors (such as 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 whether they are taking these medicines, they should consult their doctor or pharmacist before using Oxodil Combo.
You should also tell your 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 - do not use Oxodil Combo unless prescribed by a doctor.
• If the patient becomes pregnant during treatment 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. 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. If you are unsure, you should consult your doctor or pharmacist.

• It is important to use Oxodil Combo every day, even if the patient does not have symptoms of asthma or COPD 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 steroid tablets for asthma or COPD, the doctor may reduce their number after starting Oxodil Combo. If the patient has been taking oral steroids for a long time, the doctor may occasionally recommend blood tests. After reducing the dose of oral steroids, the patient's condition may be poor, even if the respiratory symptoms improve. Symptoms such as a feeling of a blocked nose 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, you should contact your doctor immediately. If symptoms of allergy or arthritis occur, other medicines may need to be used. If the patient is unsure whether to continue using 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 steroid tablets 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 immediate use of other or additional treatment may be necessary.

Asthma

Oxodil Combo should be used daily. This helps prevent the occurrence of asthma symptoms.

Adults (18 years and older)

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

Adolescents (12 to 17 years old)

• The usual dose is 1 inhalation twice a day.
• After achieving symptom control, the doctor may recommend using the medicine once a day.

Oxodil Combo is not recommended for use 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 dose of the medicine should not be changed without prior consultation with the doctor.

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

"Emergency inhaler" should always be carried with youso that it can be used if needed. Do not use Oxodil Combo to treat asthma symptoms - use a separate emergency inhaler for this purpose.

Chronic Obstructive Pulmonary Disease (COPD)

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

• The usual dose is 1 inhalation 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 side chamber cover.
• Remove the foil strip from the side chamber, carefully tearing the strip along its entire length using the notched edge, as shown below in the diagram. Do not pull or jerk the strip.

• Close the side chamber cover and discard the torn foil strip.

Warning:As the inhaler is used, the side chamber will gradually fill with used foil strips. Foil strips with black lines do not contain medicine. At the end, numbered sections of the strip will appear in the chamber. Do not allow more than 2 strips to be in the side chamber, as this may cause the inhaler to clog. Gently tear the foil strip, as shown above in the diagram, and dispose of it safely.

Using the inhaler

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

1. Opening

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

2. Preparing the dose

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

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

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

3. Inhalation of the dose

• Exhale as deeply 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.
• Tightly enclose the mouthpiece with your lips.
• The patient should take a deep and forceful breath in through the mouth (not the nose) as much as possible.

• Remove the inhaler from the mouth and hold your breath for 5-10 secondsor for as long as possible without feeling uncomfortable.
• Then the patient should exhale slowly, but not in the direction of the inhaler.
• Close the protective cap over 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 must not be disassembled or cleaned, or for any other purpose!
• The parts of the inhaler must 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 the doctor. Do not increase the prescribed dose without consulting a doctor.
The most common symptoms that may occur after taking a higher than recommended dose of Oxodil Combo are: tremors, headache or rapid 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 close to the time of the next dose, the missed dose should be skipped.
• Do not take a double dose to make up for a missed dose.

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop using Oxodil Combo and consult your doctor:

immediately:

• swelling of the face, especially in the mouth area (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, stop using Oxodil Combo

and use the emergency inhaler. You should contact your doctor

immediately, as a change in treatment may be necessary. This situation is very rare (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 tremors. 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, you should consult your doctor - they may be symptoms of a lung infection:

• fever or chills
• increased production of bronchial secretions, change in their color
• increased cough or increased breathing difficulties.

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

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

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

• rash, itching
• bronchospasm (bronchial muscle spasm causing wheezing). If wheezing occurs suddenly in a patient after using Oxodil Combo, they 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
• changes in behavior, especially in children
• chest pain or tightness (angina pectoris)
• increased blood sugar 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)
• slowing of growth rate in children and adolescents
• effect on the adrenal glands (small glands located near the kidneys)
• Cushingoid features (manifested 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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.
By reporting side effects, you can help provide 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 refers to the last day of the month stated.
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. You should ask your pharmacist how to dispose of medicines that are no longer required. 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 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. Each measured dose (dose of medicine in the blister before administration) contains 346.3 micrograms of budesonide and 10.8 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (contains milk proteins).

What Oxodil Combo looks like and what the pack contains

Oxodil Combo is a red and white plastic inhaler containing the medicine, in a cardboard box.
Each inhaler contains a blister OPA/Aluminium/PVC/Aluminium 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

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. +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: