Beclocomb

Package leaflet: Information for the user

Beclocomb, (100 micrograms + 6 micrograms)/metered dose,
inhalation aerosol, solution
Beclometasone dipropionate + Formoterol fumarate dihydrate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. 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, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

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

1. What Beclocomb is and what it is used for

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

Asthma
Beclocomb is indicated for regular treatment of asthma in adult patients in whom:

• asthma symptoms are not adequately controlled by inhaled corticosteroids and an as-needed short-acting bronchodilator, or
• adequate control of asthma symptoms has been achieved with both inhaled corticosteroids and long-acting bronchodilators.

COPD
Beclocomb may also be used in the treatment of symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic lung disease of the airways, mainly caused by smoking.

2. Important information before using Beclocomb

When not to use Beclocomb:

• if the patient is allergic or suspects allergy to either of the active substances in Beclocomb, or if allergic to other medicines or inhalation products used in asthma treatment, or to any of the other ingredients of Beclocomb (listed in section 6: "Contents of the pack and other information"), consult a doctor.

Warnings and precautions
Before starting Beclocomb, discuss with your doctor, pharmacist, or nurse:

• if the patient has heart conditions such as: angina (chest pain), recent heart attack (myocardial infarction), heart failure, coronary artery narrowing (coronary heart disease), heart valve disorders, or any other heart disease, or a condition known as obstructive hypertrophic cardiomyopathy (characterized by abnormal heart muscle structure);
• if the patient has arterial narrowing (also called arteriosclerosis or atherosclerosis); if the patient has high blood pressure or a diagnosed aneurysm (abnormal blood vessel wall dilation);
• if the patient has heart rhythm disorders, such as rapid or irregular heartbeat, increased pulse rate, or palpitations, or if there is any history of abnormal heart rhythm;
• if the patient has hyperthyroidism;
• if the patient has low blood potassium levels;
• if the patient has liver or kidney disease;
• if the patient has diabetes (inhaled high doses of formoterol may increase blood glucose levels, so additional blood tests to monitor blood sugar levels may be required before starting treatment and periodically during therapy);
• if the patient has a tumour of the adrenal gland (pheochromocytoma);
• if the patient is scheduled for general anaesthesia. Depending on the type of anaesthesia, it may be necessary to discontinue Beclocomb at least 12 hours before anaesthesia;
• if the patient is currently or has previously been treated for pulmonary tuberculosis, or if the patient has a viral or fungal chest infection;
• if the patient must avoid alcohol consumption for any reason.

Always inform your doctor before using Beclocomb if any of the above warnings apply to you.
Before using this inhalation medicine, consult your doctor, pharmacist, or nurse if you currently have or have ever had any health problems or allergies, or if you have any doubts about whether Beclocomb can be used.
Treatment with beta-agonists such as formoterol contained in Beclocomb may cause a sudden decrease in serum potassium levels (hypokalaemia).
Extreme caution is required in patients with severe asthma, as hypoxia (low blood oxygen) and concomitant use of other medicines together with Beclocomb—such as drugs used to treat heart conditions or high blood pressure called diuretics, or other asthma medications—may worsen the reduction in blood potassium levels. For this reason, your doctor may periodically recommend blood tests to monitor potassium levels.
If the patient has been using high doses of inhaled corticosteroids for a prolonged period, they may require additional corticosteroid therapy during periods of stress. Stress situations may include hospitalization after an accident, serious injury, or prior to surgery. In such cases, the treating physician will decide whether corticosteroid dosage should be increased or whether other steroids in tablet or injectable form should be prescribed.
If hospitalization is required, the patient should remember to bring all their medicines and inhalers, including Beclocomb, as well as any over-the-counter medicines, preferably in their original packaging.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children and adolescents
Beclocomb should not be used in children and adolescents under 18 years of age until further data are available.

Beclocomb with other medicines
Inform your doctor about all medicines currently or recently taken, including those obtained without a prescription.
Some medicines may intensify the effect of Beclocomb, and your doctor may wish to closely monitor your condition when taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Do not use beta-blockers together with Beclocomb. Beta-blockers such as atenolol, propranolol, and sotalol are used to treat various conditions, including high blood pressure and heart conditions such as arrhythmia and heart failure; timolol is used in glaucoma treatment. If beta-blockers are necessary, including beta-blocker eye drops, the effect of formoterol may be reduced or formoterol may not work at all. Conversely, concomitant use of other beta-adrenergic drugs (medicines acting similarly to formoterol) may enhance the effect of formoterol.
Concomitant use of Beclocomb with:

• medicines used to treat irregular heart rhythm (quinidine, disopyramide, procainamide), antihistamines (used for allergies), medicines used to treat depression or psychiatric 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). These may also increase the risk of cardiac arrhythmias (ventricular arrhythmias);
• medicines used to treat Parkinson's disease (L-DOPA), hypothyroidism (L-thyroxine), medicines containing oxytocin (which induce uterine contractions), and alcohol, may reduce cardiac tolerance to beta-agonists such as formoterol;
• monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine, used in the treatment of psychiatric disorders, may cause increased blood pressure;
• medicines used to treat heart conditions (digoxin), may cause decreased blood potassium levels, potentially increasing susceptibility to cardiac arrhythmias;
• other asthma medications (theophylline, aminophylline, or steroids) and diuretics, may cause decreased blood potassium levels;
• certain anaesthetic agents, may increase the risk of cardiac arrhythmias.

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 she may be pregnant, plans to become pregnant, or is breastfeeding, unless otherwise directed by a doctor.

Driving and operating machinery
It is unlikely that Beclocomb will affect the ability to drive or operate machinery. However, if the patient experiences adverse effects such as dizziness and/or tremor, this may impair the ability to drive or operate machinery.

Beclocomb contains alcohol
Beclocomb contains 7 mg of alcohol (ethanol) in each inhalation dose from the inhaler. The amount of alcohol in this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Beclocomb

Beclocomb is for inhalation use only. Beclocomb should be inhaled through the mouth into the lungs.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. The number of puffs to take and how often to take them is given in the leaflet.

Dosage
Asthma
Your doctor will regularly check whether you are taking the optimal dose of Beclocomb. The doctor will determine the lowest dose that provides the best control of asthma symptoms.
Your doctor may prescribe Beclocomb in two different ways:

a) Beclocomb should be taken daily to treat asthma, together with another reliever inhaler medicine used in case of sudden worsening of asthma symptoms, such as asthma attack, wheezing and coughing.
Adults and elderly patients:
The recommended dose is one or two puffs twice daily. The maximum daily dose is 4 puffs.
Always remember: Keep a fast-acting reliever inhaler with you at all times to treat sudden worsening of asthma symptoms or acute asthma attacks.

b) Beclocomb should be taken daily to treat asthma, and also used as a reliever in case of sudden worsening of asthma symptoms, such as asthma attack, wheezing and coughing.
Adults and elderly patients:
The recommended dose is one puff in the morning and one puff in the evening.
You should also use Beclocomb as a reliever inhaler in case of sudden asthma symptoms.
If asthma symptoms occur, take one puff and wait a few minutes.
If there is no improvement, take another puff.
Do not use more than 6 reliever puffs in 24 hours.
The maximum daily dose of Beclocomb, when used as the sole inhaled medicine for asthma treatment, is 8 puffs.
If you need to use more puffs to control your asthma symptoms, you should consult your doctor. A change in treatment may be necessary.

Use in children and adolescents under 18 years of age:
This medicine must not be used in children and adolescents under 18 years of age.

Chronic obstructive pulmonary disease (COPD)
Adults and elderly patients:
The recommended dose is two puffs in the morning and two puffs in the evening.

Special patient groups:
No dose adjustment is necessary in elderly patients. There is no information available on the use of Beclocomb in patients with hepatic or renal impairment.

The dose of beclometasone dipropionate contained in Beclocomb that is effective in the treatment of asthma may be lower than the dose contained in other inhaled medicines containing beclometasone dipropionate. If you have previously used another inhaled medicine containing beclometasone dipropionate, your doctor will advise you on the appropriate dose of Beclocomb.
Do not increase the dose.
If you feel the effect of the medicine is too weak, always consult your doctor before increasing the dose.

In case of worsening breathing difficulties:
If breathing becomes more difficult or wheezing (audible whistling sound during breathing) worsens immediately after inhalation, stop using Beclocomb immediately and use a fast-acting reliever inhaler. Seek immediate advice from your doctor, who will assess your symptoms and, if necessary, recommend alternative treatment.
See also section 4. "Possible side effects".

In case of worsening asthma symptoms:
If asthma symptoms worsen or become difficult to control (e.g. if you need to use your reliever inhaler or Beclocomb as a reliever more frequently), or if your reliever inhaler or Beclocomb does not relieve symptoms, contact your doctor immediately. This may indicate worsening asthma. Your doctor may decide to change the Beclocomb dose or initiate alternative treatment.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

Method of administration:
This medicine is contained in a pressurized canister housed in a plastic casing with a mouthpiece.
At the front of the inhaler there is a dose counter showing the number of doses remaining. Each time the inhaler is pressed, a dose of medicine is released. The dispenser is equipped with an integrated dose counter that accurately counts each actuation and displays it in increments of 20.
The dose counter shows the approximate number of actuations (puffs) remaining in the canister. The counter window displays the number of puffs left in the inhaler in increments of twenty (e.g. 120, 100, 80, etc.). When 20 puffs remain, the display will show the number 20 on a half-red, half-white background, indicating that the canister is nearing the end of its use.
After 120 actuations, the display will show 0 on a red background. The counter will stop moving at "0".

Inhaler test
Before first use, or if the inhaler has not been used for 14 days or more, perform an inhaler test to ensure it is working properly.

1. Remove the protective cap from the mouthpiece.
2. Hold the canister upright with the mouthpiece pointing downwards.
3. Point the mouthpiece away from yourself.
   4.a. If the inhaler is being used for the first time, press the canister firmly 3 times to release a puff each time it is pressed.
   4.b. If the inhaler has not been used for 14 days or more, press the canister firmly once to release one puff.
4. Check the dose counter. If this is the first time the inhaler test is performed, the counter should display 120.

How to use the inhaler
If possible, stand or sit upright during inhalation. Before starting inhalation, check the dose counter: any number between "1" and "120" means that doses remain. If the dose counter shows "0", no doses remain – discard the inhaler and obtain 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 from dust or other debris.
2. Breathe out as deeply and slowly as possible.
3. Hold the canister upright with the base pointing upwards, then place the mouthpiece between your lips. Do not bite down on it.
4. Breathe in deeply and slowly through your mouth. Just after starting to inhale, press firmly on the top of the inhaler to release one puff of medicine.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

If another dose is to be taken, keep the inhaler upright for about half a minute, then repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, replace the protective cap and check the dose counter.

When to replace the inhaler
Have a new inhaler ready when the counter shows 20 and the background color of the dose counter changes from white to red. Stop using the inhaler when the counter shows 0, as any remaining puffs may not deliver a full dose.

If a "mist" is seen escaping from the top of the inhaler or from the sides of the mouth, this means that Beclocomb is not reaching the lungs as it should. Take another puff, following the instructions starting from step 2.

People with weak grip may find it easier to hold the inhaler with both hands: place both index fingers on top of the inhaler and both thumbs on the base.

To reduce the risk of developing fungal infection of the mouth or throat, rinse your mouth or throat with water, or brush your teeth, immediately after each inhalation.

If you feel the effect of Beclocomb is too strong or too weak, consult your doctor or pharmacist.

If you have difficulty using the inhaler during inhalation, you may use a spacer device (AeroChamber Plus). Ask your doctor, pharmacist or nurse for this device. It is important to read the instructions provided with the AeroChamber Plus spacer carefully and follow the usage and cleaning instructions.

Cleaning the inhaler
Clean the inhaler once a week. During cleaning, do not remove the canister from the plastic casing and do not use water or other liquids to clean the inhaler.

Cleaning the inhaler:

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

Use of more than the recommended dose of Beclocomb:

• Taking more than the recommended dose of formoterol may cause the following symptoms: nausea, vomiting, faster heartbeat, palpitations, heart rhythm disturbances, changes in electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low blood potassium levels, increased blood glucose levels. Your doctor may recommend a blood test to check potassium and glucose levels.
• Taking too high a dose of beclometasone dipropionate may cause temporary adrenal gland dysfunction, which resolves spontaneously within a few days. Your doctor may recommend a blood test to check serum cortisol levels.

If any of these symptoms occur, inform your doctor.

Missed dose of Beclocomb:
Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose; instead, take the next dose at the usual scheduled time. Do not take a double dose.

Stopping Beclocomb treatment:
Do not reduce the dose or stop using Beclocomb.
Even if you feel better, do not stop using Beclocomb or reduce the dose without first talking to your doctor. It is very important to take the medicine regularly, even when symptoms have subsided.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects
As with other inhaled medicines, there is a risk of worsening breathlessness and wheezing immediately after taking Beclocomb, known as paradoxical bronchospasm. In such cases, Beclocomb must be stopped IMMEDIATELY and a fast-acting inhaled bronchodilator should be used to relieve symptoms of breathlessness and wheezing. Contact your doctor immediately.

You must inform your doctor immediately if any hypersensitivity reactions occur, such as: skin allergies, skin itching, skin rash, redness of the skin, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.

Other adverse effects
Other possible adverse effects are listed below according to their frequency of occurrence.

Common (occur in fewer than 1 in 10 people):

• Fungal infections (of the mouth and throat);
• Headache;
• Hoarseness;
• Sore throat;
• Pneumonia (lung infection) in patients with COPD: inform your doctor if any of the following symptoms occur during treatment with Beclocomb; these may be symptoms of lung infection:
  • Fever or chills;
  • Increased mucus production, change in mucus colour;
  • Worsening cough or increased difficulty breathing.

Uncommon (occur in fewer than 1 in 100 people):

• Unusual rapid heartbeat – cough and coughing • decreased heart rate and heart rhythm disturbances, with sputum production, - nausea, • increased number of
• Changes – taste disturbances, platelet count, in electrocardiogram (ECG), - burning sensation of lips, • decreased potassium levels in blood,
• Asthma attack, - dry mouth, • increased blood sugar levels,
• Tremor, - difficulty swallowing, • increased insulin levels,
• Dizziness, - indigestion,
• Palpitations, - stomach upset,
• Influenza-like symptoms, - diarrhoea,
• Fungal infection of the vagina, - facial flushing,
• Sinusitis, - increased sweating,
• Ear infection, - increased blood flow to certain tissues in the body,
• Irritation of the throat, - changes in certain blood components:
• Inflammation of the nasal mucosa,

The following adverse effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):

• Decreased blood cortisol levels, caused by the effect of corticosteroids on the adrenal glands;
• Irregular heartbeat.

Rare (occur in fewer than 1 in 1,000 people):

• Feeling of chest tightness;
• Heart rhythm disturbances;
• Increased or decreased blood pressure;
• Kidney inflammation;
• Skin and mucous membrane swelling lasting for several days.

Very rare (occur in fewer than 1 in 10,000 people):

• Breathlessness;
• Worsening of asthma;
• Decreased platelet count;
• Swelling of hands and feet.

Long-term, high-dose inhaled corticosteroid therapy may very rarely lead to systemic effects. These include:

• Adrenal gland dysfunction (suppression of adrenal function);
• Increased intraocular pressure (glaucoma);
• Cataract;
• Growth retardation in children and adolescents;
• Decreased bone mineral density (osteoporosis).

Unknown (frequency cannot be estimated from available data):

• Sleep problems, depression, or feelings of worry, anxiety, restlessness, over-excitement, or irritability. These events are more likely in children;
• Blurred vision.

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

5. How to store Beclocomb

Keep the medicine out of sight and reach of children.
The single package contains one container with 120 doses.
Do not use the medicine after 3 months from the date of dispensing from the pharmacy, and do not use the medicine 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 marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation LOT indicates the batch number.

Before use:
Store the inhaler in a refrigerator (at 2–8°C) in an upright position for up to 18 months.

After first use:
Do not store the inhaler at temperatures above 25°C.
Do not store the inhaler for longer than 3 months.
Do not use the inhaler after this period, and never use it after the expiry date indicated on the carton and label.

If the inhaler has become cold, warm it in your hands for several minutes before using the medicine. Never use other methods to warm the container.

Important: The container contains pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the container.

Medicines must 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 packaging and other information

What Beclocomb contains:

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

What Beclocomb looks like and contents of the pack
Each pack contains one canister delivering 120 doses (sprays).
Beclocomb is a pressurized inhalation solution contained in a fluorocarbon polymer-coated aluminum canister (FCP) fitted with a metering valve, packed in a cardboard box. The canister is placed in a white plastic actuator with a pink protective cap. The actuator is equipped with an integrated dose counter that accurately counts down each actuation and displays every 20th actuation.

Marketing Authorisation Holder:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 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 medicinal product is authorized for sale in the European Economic Area under the following names:
Slovakia: Beclometasone/Formoterol Polpharma
Czech Republic: Beclometasone/Formoterol Polpharma
Germany: BECLOCOMB 100 Microgram/6 Microgram per Spray Pressurized Inhalation, Solution
Poland: Beclocomb