Oxodil combo

Package leaflet: Information for the user

Oxodil Combo, (320 micrograms + 9 micrograms)/delivered dose,
inhalation powder, pre-dispensed
Budesonide + Formoterol fumarate dihydrate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

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

Leaflet contents

1. What Oxodil Combo is and what it is 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 pack and other information

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

Oxodil Combo is a medicine in an inhaler used for the treatment of asthma in adults and adolescents aged 12 to 17 years. It is also used for the treatment of symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years 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 inflammation and swelling in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting beta2-adrenergic agonists or bronchodilators. It works by relaxing the muscles in the airways. The medicine makes breathing easier.

Asthma
For the treatment of asthma, your doctor will prescribe two inhaler medicines: Oxodil Combo and a separate reliever medicine.

• Oxodil Combo should be used every day. This medicine helps prevent asthma symptoms from occurring.
• The reliever inhaler should be used when asthma symptoms occur, to help breathing. Do not use Oxodil Combo, (320 micrograms + 9 micrograms)/delivered dose, as a reliever inhaler.

Chronic obstructive pulmonary disease (COPD)
Oxodil Combo may also be used in adults for the treatment of COPD symptoms. COPD is a chronic lung disease affecting the airways, often caused by smoking.

2. Important information before using Oxodil Combo

When not to use Oxodil Combo

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

Warnings and precautions
Before starting treatment with Oxodil Combo, discuss with your doctor or pharmacist if the patient:

• has diabetes,
• has a lung infection,
• has high blood pressure or has ever had heart disease (including heart rhythm disorders, very fast heart rate (high pulse), narrowed arteries, or heart failure),
• has thyroid or adrenal gland disease,
• has low blood potassium levels,
• has severe liver dysfunction.

If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
Oxodil Combo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• β-blocking agents (such as atenolol or propranolol used to treat high blood pressure), including eye drops (such as timolol used in the treatment of glaucoma);
• medicines used to treat rapid or irregular heart rhythm (such as quinidine, disopyramide, procainamide);
• antihistamines (medicines used to treat allergies, such as terfenadine);
• oxytocin, a medicine used to induce labour;
• procarbazine, a medicine used to treat cancer;
• medicines such as digoxin, commonly used in the treatment of heart failure;
• diuretics (so-called water tablets, such as furosemide) used to treat high blood pressure;
• corticosteroids (such as prednisolone) used to treat inflammatory conditions or to prevent rejection of transplanted organs;
• xanthine derivatives (such as theophylline or aminophylline) commonly used in the treatment of asthma;
• other medicines used to dilate the airways (such as salbutamol);
• antidepressants, including tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone;
• medicines used to treat psychiatric disorders, nausea or vomiting, known as phenothiazines (such as chlorpromazine and prochlorperazine);
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, voriconazole, posaconazole) and bacterial infections (such as clarithromycin, telithromycin, and furazolidone);
• medicines used to treat Parkinson's disease (such as levodopa);
• medicines used to treat thyroid disorders (such as levothyroxine);
• medicines known as HIV protease inhibitors (such as ritonavir, cobicistat), used in the treatment of HIV infection. The effect of Oxodil Combo may be increased, and the doctor may closely monitor the patient's condition.

If any of these situations apply to the patient, or if the patient is unsure whether they are taking any of the listed medicines, they should consult their doctor or pharmacist before using Oxodil Combo.
Also inform your doctor or pharmacist if general anaesthesia is planned due to surgery or a dental procedure.
Pregnancy, breastfeeding and fertility

• If the patient is pregnant or planning to become pregnant, she should consult her doctor before using Oxodil Combo – do not use Oxodil Combo unless advised by a doctor.
• If the patient becomes pregnant while being treated with Oxodil Combo, she should not stop using Oxodil Combo but should contact her doctor immediately.
• If the patient is breastfeeding, she should consult her doctor before using Oxodil Combo.

Driving and operating machinery
Oxodil Combo has no effect or negligible effect on the ability to drive vehicles or operate tools or machinery.
Oxodil Combo contains lactose
Oxodil Combo contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine. The amount of lactose in this medicine should not usually cause problems for people with lactose intolerance. Lactose, an excipient of this 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 a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

• It is important to use Oxodil Combo every day, even if the patient does not currently have asthma or COPD symptoms.
• If the patient is using Oxodil Combo for asthma treatment, the doctor will regularly monitor disease symptoms.

If the patient is taking steroid-containing tablets for asthma or COPD treatment, the doctor may
reduce their dose after starting Oxodil Combo. If the patient has been taking oral steroids for a prolonged period, the doctor may occasionally recommend blood tests. After reducing the dose of oral steroids, the patient may feel unwell, even if respiratory symptoms improve. Symptoms may include nasal congestion or runny nose,
weakness or joint or muscle pain, and rash (skin eruption). If any of these symptoms occur, or if headache, fatigue, nausea, or
vomiting occur, contact the doctor immediately. If allergic symptoms or joint inflammation occur,
additional medications may be required. If the patient is uncertain whether to continue using Oxodil Combo,
they should consult their doctor.
During periods of stress (e.g., chest infection or prior to surgery), the doctor may consider adding steroid-containing tablets to the usual treatment regimen.
Important information about asthma or COPD symptoms
If the patient experiences shortness of breath or wheezing while using Oxodil Combo,
they should continue using Oxodil Combo and contact their doctor as soon as possible, as additional
treatment may be necessary.
Contact the doctor immediately if:

• breathing difficulties worsen or asthma symptoms frequently wake the patient at night;
• the patient begins to experience chest tightness in the morning or chest tightness lasts longer than usual.

These symptoms may indicate inadequate control of asthma or COPD and may require
immediate initiation of different or additional treatment.
Asthma
Oxodil Combo should be used daily. This helps prevent asthma symptoms from occurring.
Adults (aged 18 years and above)

• The usual dose is 1 inhalation twice daily.
• The doctor may increase the dose to 2 inhalations twice daily.
• Once symptoms are under control, the doctor may recommend using the medicine once daily.

Adolescents (aged 12 to 17 years)

• The usual dose is 1 inhalation twice daily.
• Once symptoms are under control, the doctor may recommend using the medicine once daily.

Oxodil Combo is not recommended for children under 12 years of age.
The doctor will help the patient properly manage asthma symptoms and determine the lowest effective dose
that controls the disease. Do not change the dose without first consulting the doctor.
For treating asthma symptoms as they occur, a separate “reliever inhaler” should be used.
The “reliever inhaler” should always be carried so it can be used when needed. Do not use Oxodil Combo to treat asthma symptoms—use a separate reliever inhaler for this purpose.
Chronic obstructive pulmonary disease (COPD)
The medicine should only be used in adults (aged 18 years and above).

• The usual dose is 1 inhalation twice daily. For COPD treatment, the doctor may also prescribe other bronchodilators, such as anticholinergics (e.g., 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 being used correctly.
The inhaler contains 60 doses of medicine in powder form on a foil strip inside a sealed chamber. The inhaler has a dose counter that displays the number of doses remaining, counting down from 60 to 0. The last 10 doses are indicated against a red background.
The inhaler is not refillable—once empty, it should be discarded and replaced with a new one.

Before using the inhaler

• Open the transparent side chamber cover.
• Remove the foil strip from the side chamber by carefully peeling it off along its entire length using the serrated edge, as shown in the illustration below. Do not pull or jerk the strip.

• Close the side chamber cover and dispose of the removed foil strip.

Note: As the inhaler is used, the side chamber gradually fills with used foil strips. Foil strips with black marks do not contain medicine. At the end, numbered segments of the strip will appear. Do not allow more than 2 strips to accumulate in the side chamber, as this may block the inhaler. Gently peel off the foil strip as shown in the illustration above and remove it safely.
Using the inhaler
Hold the inhaler in the hands as shown in the illustrations.
1. Opening

• Uncover the mouthpiece by pulling down the protective cap.
• Check the dose counter window to see how many doses remain.

2. Preparing the dose

• Lift the white lever. Ensure the side chamber is closed. Note: The white lever should only be used when the patient is ready to take the dose. Playing with the white lever will waste doses.

• Opening: Pull the white lever fully until a click is heard, which loads the dose and displays its number in the dose counter.

• Closing: Then fully close the white lever until a click is heard and the lever returns to its original position. The inhaler is now ready for immediate use.

3. Inhaling the dose

• Breathe out as deeply as possible away from the mouthpiece. Never breathe out directly into the inhaler, as this may alter the dose size.
• Hold the inhaler with the protective cap pointing downward.
• Close lips tightly around the mouthpiece.
• The patient should inhale as deeply and forcefully as possible through the mouth (not the nose).

• Remove the inhaler from the mouth and hold breath for 5–10 seconds, or as long as possible without discomfort.
• Then, the patient should breathe out slowly, but not toward the inhalator.
• Close the protective cap over the mouthpiece.
• Rinse the mouth with water and spit it out. This helps prevent the development of oral fungal infection and hoarseness.

Cleaning

• If necessary, wipe the outer part of the mouthpiece with a clean, dry cloth.
• Do not disassemble the inhaler for cleaning or any other purpose!
• Do not clean any parts of the inhaler with water or wet wipes, as moisture may alter the dose size!
• Never insert needles or other sharp objects into the mouthpiece or any other part of the inhaler, as this may damage it!

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

• If a dose is missed, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If there are any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop using Oxodil Combo immediately and consult a doctor:

• facial swelling, especially around the mouth (swelling of the tongue and/or throat and/or difficulty swallowing) or urticaria with breathing difficulties (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 breathlessness immediately after inhalation. If any of these symptoms occur, stop using Oxodil Combo immediately and use a reliever inhaler. Seek medical advice 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 adverse reactions:
Common (may occur in less than 1 in 10 people)

• palpitations (awareness of heartbeat), muscle twitching or tremor. If these symptoms occur, they are usually mild and diminish during continued use of Oxodil Combo.
• oral thrush (fungal infection in the mouth). The risk of developing this is reduced if the patient rinses the 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, consult a doctor – these may be signs of lung infection:

• fever or chills
• increased production of bronchial secretions, change in their colour
• worsening cough or increased difficulty breathing.

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

• aggression
• anxiety
• feelings of restlessness, nervousness, or agitation
• sleep disturbances
• dizziness
• 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 (constriction of muscles in the airways causing wheezing). If wheezing occurs suddenly after using Oxodil Combo, discontinue use of Oxodil Combo and contact a doctor immediately.
• low blood potassium levels
• irregular heartbeat

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

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

Inhaled corticosteroids, especially when used long-term at high doses, may affect the normal production of steroid hormones in the body. Symptoms include:

• changes in bone mineral density (bone thinning)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• slowed growth rate in children and adolescents
• effects on the adrenal glands (small glands located near the kidneys)
• cushingoid features (including weight gain, moon-shaped face, poor wound healing, and thinning of the skin)
• increased susceptibility to infections and reduced ability to cope with stressful situations. The likelihood of these symptoms is considerably lower with inhaled corticosteroids than with oral corticosteroid tablets.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Oxodil Combo

Keep this medicine out of the 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 label of the inhaler following: EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Oxodil Combo contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each delivered dose (inhaled dose) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. Each metered dose (dose 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 contents of the pack
Oxodil Combo is a red and white plastic inhaler containing the medicine, in a cardboard box.
Each inhaler contains an OPA/Aluminum/PVC/Aluminum blister with 60 divided doses of powder for inhalation. The powder for inhalation is homogeneous, white, almost white or light yellow.
Pack sizes: 1 or 2 inhalers (each with 60 doses).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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, Saxony-Anhalt
Germany
Aeropharm GmbH
Francois-Mitterand-Allee 1
07407 Rudolstadt, Thuringia
Germany