Beclocomb

Leaflet accompanying the packaging: information for the user

Beclocomb, (100 micrograms + 6 micrograms)/dose measured,

inhalation aerosol, solution
Beclometasone dipropionate + 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, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Beclocomb and what is it used for

Beclocomb is a solution in an inhalation aerosol, containing two active substances that are inhaled through the mouth and go directly to the lungs.
The medicine contains two active substances: beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory effect by reducing swelling and irritation of the lungs.
Formoterol fumarate dihydrate belongs to a group of long-acting bronchodilator medicines, which relax the muscles in the airways and make breathing easier.
Together, these two active substances make breathing easier by relieving symptoms such as:
shortness of breath, wheezing, and cough in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.
Asthma
Beclocomb is indicated for the regular treatment of asthma in adult patients, in whom:

• asthma symptoms are not adequately controlled with inhaled corticosteroids and a short-acting bronchodilator used as needed, or
• asthma symptoms have been adequately controlled with both inhaled corticosteroids and long-acting bronchodilators.

COPD
Beclocomb may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic respiratory disease in the lungs, mainly caused by smoking.

2. Important information before using Beclocomb

When not to use Beclocomb:

Warnings and precautions

Before starting to use Beclocomb, you should discuss with your doctor, pharmacist, or nurse:

for any reason.

Before using Beclocomb, you should always inform your doctor if any of the above warnings apply to you.

Before using an inhaled medicine, you should consult a doctor, pharmacist, or nurse if you have any current or past health problems or allergies, or if you are unsure whether Beclocomb can be used.
Treatment with beta-agonists, such as formoterol in Beclocomb, may cause a sudden decrease in blood potassium levels (hypokalemia).
Particular caution is required in patients with severe asthma,as oxygen deficiency in the blood, as well as the use of other medicines with Beclocomb, such as: medicines used to treat heart disease or high blood pressure, called diuretics, or other medicines used to treat asthma, may increase the decrease in blood potassium levels. For this reason, the doctor may recommend checking potassium levels in the blood from time to time.
If the patient is taking high doses of inhaled corticosteroids for a long time, they may be more likely to require corticosteroid administration during stress. Stressful situations may include: hospitalization after an accident, serious injury, or pending surgery. In such situations, the attending physician will decide on possible increased corticosteroid doses or may recommend other steroids in the form of tablets or injections.
If hospitalization is necessary, the patient should remember to bring all their medicines and inhalers, including Beclocomb, as well as over-the-counter medicines, if possible, in their original packaging.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
Children and adolescents
Beclocomb should not be used in children and adolescents under 18 years of age until more data is available.
Beclocomb and other medicines
The patient should tell their doctor about all the medicines they are currently taking or have recently taken, including over-the-counter medicines.
Some medicines may enhance the effect of Beclocomb, and the doctor may want to carefully monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).
Do not use beta-adrenergic blockers with Beclocomb. Beta-blockers, such as atenolol, propranolol, and sotalol, are used to treat many conditions, including high blood pressure and heart disease, such as irregular heartbeat and heart failure; timolol is used to treat glaucoma. If beta-blockers are used, the effect of formoterol may be reduced or formoterol may not work at all. On the other hand, the use of other beta-adrenergic medicines (medicines that work in the same way as formoterol) may enhance the effect of formoterol.

Concomitant use of Beclocomb with:

• medicines used to treat irregular heartbeat (quinidine, disopyramide, procainamide), medicines used to treat allergies (antihistamines), medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), tricyclic antidepressants (e.g., amitriptyline and imipramine), phenothiazines, may cause certain changes in the electrocardiogram (ECG, heart activity record) and may increase the risk of heart rhythm disorders (ventricular arrhythmias);
• medicines used to treat Parkinson's disease (L-DOPA), used to treat hypothyroidism (L-thyroxine), medicines containing oxytocin (which cause uterine contractions), and alcohol, may reduce the heart's tolerance to beta-agonists, such as formoterol;
• monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine, used to treat mental disorders, may cause an increase in blood pressure;
• medicines used to treat heart disease (digoxin), may cause a decrease in blood potassium levels, which can increase the risk of heart rhythm disorders;
• other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics, may cause a decrease in blood potassium levels;
• certain anesthetics, may increase the risk of heart rhythm disorders.

Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Beclocomb during pregnancy. Beclocomb should not be used if the patient is pregnant, suspects they may be pregnant, or plans to have a child, or if the patient is breastfeeding, unless the doctor decides otherwise.
Driving and using machines
It is unlikely that Beclocomb will affect the ability to drive and use machines. However, if the patient experiences side effects such as dizziness and/or tremors, it may affect the ability to drive and use machines.
Beclocomb contains alcohol
Beclocomb contains 7 mg of alcohol (ethanol) in each inhalation from the inhaler. The amount of alcohol in this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
A small amount of alcohol in this medicine will not have noticeable effects.

3. How to use Beclocomb

Beclocomb is intended for inhalation use. Beclocomb should be inhaled through the mouth into the lungs.

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. Information on how many inhalations to take and how often to take them can be found in the leaflet.

Dosage

Asthma

The doctor will regularly check if the patient is taking the optimal dose of Beclocomb. The doctor will determine the smallest dose that provides the best control of asthma symptoms.
The doctor may prescribe Beclocomb in two different ways:
a)
Beclocomb should be used daily to treat asthma, along with another inhaled medicine that provides quick relief in case of sudden worsening of asthma symptoms,
such as shortness of breath, wheezing, and cough,
Adults and the elderly:
The recommended dose is one or two inhalations twice a day. The maximum daily dose is 4 inhalations.
Remember: You should always have a quick-acting inhaled medicine for relief on hand to treat worsening asthma symptoms or sudden asthma attacks.
b)
Beclocomb should be used daily to treat asthma, as well as to provide quick relief in case of sudden worsening of asthma symptoms,
such as shortness of breath, wheezing, and cough.
Adults and the elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening.
You should also use Beclocomb as a quick-acting inhaled medicine to provide relief in case of sudden worsening of asthma symptoms.
If asthma symptoms occur, use one inhalation and wait a few minutes.
If there is no improvement, use another inhalation.

Do not use more than 6 relief inhalations in 24 hours.

The maximum daily dose of Beclocomb as the only inhaled medicine for asthma is 8 inhalations.

If the patient needs to take more inhalations to control asthma symptoms, they should consult their doctor. A change in treatment may be necessary.

Use in children and adolescents under 18 years of age:

This medicine should NOTbe used in children and adolescents under 18 years of age.

Chronic obstructive pulmonary disease (COPD) Adults and the elderly:

The recommended dose is two inhalations in the morning and two inhalations in the evening.
Special patient groups:
There is no need to adjust the dosage in elderly patients. There is no information on the use of Beclocomb in patients with impaired liver or kidney function.

The dose of beclometasone dipropionate in Beclocomb, which is effective in treating asthma, may be lower than the dose contained in other inhaled medicines containing beclometasone dipropionate. If the patient has previously used another inhaled medicine

containing beclometasone dipropionate, the doctor will recommend the appropriate dose of Beclocomb.

Do not increase the dose.

If you feel that the effect of the medicine is insufficient, you should always consult your doctor before increasing the dose.

In case of worsening breathing difficulties:

If shortness of breath or wheezing worsens(breathing with a noticeable whistling sound) immediately after inhaling the medicine, you should immediately STOP using Beclocomband use a quick-acting inhaled bronchodilatorto relieve shortness of breath and wheezing. You should contact your doctor immediately.
See also section 4. "Possible side effects".

In case of worsening asthma symptoms:

If the symptoms worsen or become difficult to control (e.g., if you need to use another inhaled medicine or Beclocomb as a relief medicine more often) or if the inhaled relief medicine or Beclocomb does not relieve the symptoms, you should immediately inform your doctor. This may indicate a worsening of asthma, and the doctor may decide to change the dosage of Beclocomb or use another treatment.
In case of any further doubts about using this medicine, you should consult your doctor or pharmacist.

Method of administration:

This medicine is in a pressurized container, in a plastic casing with a mouthpiece. The front of the inhaler has a dose counter, which shows how many doses of the medicine are left. Each time the inhaler is pressed, a dose of the medicine is released. The inhaler has a built-in dose counter, which accurately counts each press and displays it in increments of 20.

• 1. Remove the protective cap from the mouthpiece.
• 2. Hold the container upright with the mouthpiece facing downwards.
• 3. Point the mouthpiece away from you.
• 4.a. If the inhaler is being used for the first time, press the container firmly 3 times to release a spray, each time the container is pressed.
• 4.b. If the inhaler has not been used for 14 days or more, press the container firmly to release one spray.

• 5. Check the dose counter. If the inhaler test is being performed for the first time, the counter should show 120.

How to use the inhaler

If possible, you should stand or sit upright while inhaling. Before inhaling, check the dose counter: any number between "1" and "120" means that there are still doses left. If the dose counter shows "0", it means that there are no more doses - you should discard the inhaler and get a new one.

1
2
3
4
5

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust or other contaminants.
• 2. Exhale slowly and deeply.
• 3. Hold the container upright, with the base facing upwards, and then place the mouthpiece between your lips. Do not bite it.
• 4. Take a slow, deep breath in through your mouth. As soon as you start breathing in, press the top of the inhaler firmly to release one spray of the medicine.
• 5. Hold your breath for as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

If you need to take another dose of the medicine, hold the inhaler upright for about half a minute, then repeat the steps described in points 2 to 5.
Important:The actions described in points 2 to 5 should not be performed too quickly.
After use, replace the protective cap and check the dose counter.

When to replace the inhaler

You should have a new inhaler ready when the counter shows 20, and the dose counter color changes from white to red. You should stop using the inhaler when the counter shows 0, as any sprays left in the device may not be enough to deliver a full dose.

If a "mist" is seen coming out of the top of the inhaler or from the sides of the mouth, it means that Beclocomb is not getting into the lungs as it should. You should take another spray, following the instructions, starting from point 2.

People with a weak grip will find it easier to hold the inhaler with both hands: they should then place both index fingers on the top of the inhaler and both thumbs on the bottom.
To reduce the risk of fungal infection of the mouth and throat, after each inhalation, you should rinse your mouth or throat with water, or brush your teeth.
If you feel that the effect of Beclocomb is too strong or too weak, you should consult your doctor or pharmacist.
If you have difficulty using the inhaler during inhalation, you can use a spacer (AeroChamber Plus). You should ask your doctor, pharmacist, or nurse about this device. It is essential to carefully read the leaflet that comes with the spacer and follow the instructions for use and cleaning.

Cleaning the inhaler

The inhaler should be cleaned once a week. During cleaning, do not remove the container from the plastic casing, and do not use water or other liquids to clean the inhaler.
Cleaning the inhaler:

• 1. Remove the protective cap from the mouthpiece by pulling it off the inhaler.
• 2. Wipe the mouthpiece and dose counter with a clean, dry cloth or tissue from the inside and outside.
• 3. Replace the protective cap on the mouthpiece.

Using a higher dose of Beclocomb than recommended:

• Using a higher dose of formoterol than recommended may cause the following symptoms: nausea, vomiting, rapid heartbeat, palpitations, heart rhythm disorders, changes in the electrocardiogram (heart activity record), headache, tremors, drowsiness, excessive acid in the blood, decreased blood potassium levels, increased blood glucose levels. The doctor may recommend a blood test to check potassium and glucose levels.
• Using too high a dose of beclometasone dipropionate may cause short-term adrenal gland disorders, which resolve on their own within a few days. The doctor may recommend a blood test to check cortisol levels in the blood.

If you experience any of these symptoms, you should inform your doctor.

Missing a dose of Beclocomb:

You should take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose, only take the next dose at the usual planned time. Do not take a double dose.

Stopping Beclocomb:

You should not reduce the dose or stop using the medicine.
Even if you feel better, you should not stop using Beclocomb or reduce the dose. You should discuss this with your doctor. It is very important to take the medicine regularly, even if the symptoms of the disease have disappeared.

4. Possible side effects

Like all medicines, Beclocomb can cause side effects, although not everybody gets them.
Severe side effects
As with other inhaled medicines, there is a risk of worsening shortness of breath and wheezing immediately after taking Beclocomb, known as paradoxical bronchospasm. You should immediately STOP using Beclocomband use a quick-acting inhaled bronchodilatorto relieve shortness of breath and wheezing. You should contact your doctor immediately.
You should immediately inform your doctorif you experience any allergic reactions, such as: skin allergies, itching, skin rash, skin redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other side effects
Other possible side effects are listed below, depending on their frequency.

• Fungal infections (of the mouth and throat);
• headache;
• hoarseness;
• sore throat;
• pneumonia (lung infection) in patients with COPD: you should tell your doctor if any of the following symptoms occur while using Beclocomb; they may be symptoms of a lung infection:
• fever or chills;
• increased production of mucus, change in mucus color;
• worsening cough or increased breathing difficulties.

Uncommon(occurring in less than 1 in 100 people):

• decrease in white blood cell count,
• increase in platelet count,
• decrease in blood potassium levels,
• increase in blood sugar levels,
• increase in insulin, free fatty acids, and ketones in the blood,
• rash or hives.
• cough and cough with expectoration,
• nausea,
• taste disturbances,
• mouth burning,
• dry mouth,
• difficulty swallowing,
• indigestion,
• stomach upset,
• diarrhea,
• muscle pain and muscle cramps,
• flushing,
• increased sweating,
• increased blood flow to some tissues in the body,
• changes in some blood components:
• abnormal rapid heartbeat and heart rhythm disorders,
• changes in the electrocardiogram (ECG),
• asthma attack,
• tremors,
• restlessness,
• dizziness,
• palpitations,
• flu-like symptoms,
• vaginal fungal infections,
• sinusitis,
• ear infection,
• throat irritation,
• nasal mucositis,

The following side effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease:

• decrease in cortisol levels in the blood, which is caused by the effect of corticosteroids on the adrenal glands;
• irregular heartbeat.

Rare(occurring in less than 1 in 1000 people):

• feeling of pressure in the chest;
• heart rhythm disorders;
• increased or decreased blood pressure;
• kidney inflammation;
• swelling of the skin and mucous membranes, lasting for several days.

Very rare(occurring in less than 1 in 10,000 people):

• shortness of breath;
• worsening of asthma;
• decrease in platelet count;
• swelling of the hands and feet.

Long-term use of inhaled corticosteroids in high doses may

cause systemic side effects in very rare cases. These include:

• adrenal gland disorders (adrenal gland suppression),
• increased eye pressure (glaucoma),
• cataracts
• growth retardation in children and adolescents
• decrease in bone density (osteoporosis).

Unknown (frequency cannot be estimated from available data):

• sleep problems, depression, or feelings of anxiety, restlessness, nervousness, overexcitement, or irritability. These events are more likely to occur in children;
• blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
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:
Jerozolimskie Avenue 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 Beclocomb

The medicine should be stored out of sight and reach of children.
The single packaging contains one container with 120 doses.
The medicine should not be used after 3 months from the date of dispensing from the pharmacy and should not be used after the expiry date stated on the carton and label after EXP.
The expiry date refers to the last day of the stated month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation LOT indicates the batch number.
Before use:

The inhaler should be stored in the refrigerator (at a temperature of 2-8°C) in an upright position for a maximum of 18 months.
After first use:

The inhaler should not be stored at a temperature above 25°C.
The inhaler should not be stored for more than 3 months.
Do not use the inhaler after this period and never use it after the expiry date stated on the carton and label.
If the inhaler is cooled, before using the medicine, you should warm it in your hands for a few minutes. You should never use other methods to heat the container.
Important:The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container.
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 needed. This will help protect the environment.

6. Contents of the packaging and other information

What Beclocomb contains:

• The active substances of the medicine are: beclometasone dipropionate and formoterol fumarate dihydrate. Each measured dose from the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose through the mouthpiece, containing 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• The other ingredients are: norflurane (HFC 134a), anhydrous ethanol, maleic acid, and water for injection.

What Beclocomb looks like and what the packaging contains

Each packaging contains one container, which delivers 120 doses (inhalations).
Beclocomb is an inhalation solution under pressure, placed in an aluminum container coated with fluoropolymer (FCP), closed with a metering valve, in a cardboard box. The container is placed in a white plastic dose counter with a pink protective cap. The dose counter has a built-in counter that accurately counts each press and displays it every 20 presses.

Marketing authorization holder:

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Importer:

Oy Medfiles Ltd
Volttikatu 5 and 8
70700 Kuopio
Finland
Hormosan Pharma GmbH
Hanauer Landstraße 139 - 143
60314 Frankfurt am Main
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Slovakia: Beclometasone/Formoterol Polpharma
Czech Republic: Beclometasone/Formoterol Polpharma
Germany: BECLOCOMB 100 micrograms/6 micrograms per spray, solution for inhalation
Poland: Beclocomb

Date of last revision of the leaflet: