Beclometasone and formoterol Elpen

Patient Information Leaflet

Beclometasone and Formoterol Elpen 100 micrograms/6 micrograms per dose

pressurised solution for inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it may be harmful to them.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Beclometasone and Formoterolo Elpen is and what it is used for

Beclometasone and Formoterolo Elpen is a pressurised solution for inhalation containing two active substances which are inhaled through the mouth and released directly into the lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which exert an anti-inflammatory action by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles of the airways and help you breathe more easily.
Together, these two active substances make breathing easier, providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma or COPD, and also help to prevent asthma symptoms.

Asthma
Beclometasone and Formoterolo Elpen is indicated for regular treatment of asthma in adults when:

• asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators used "as needed", or
• asthma responds well to treatment with both inhaled corticosteroids and long-acting bronchodilators.

COPD
Beclometasone and Formoterolo Elpen may also be used for the treatment of symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic lung airway disease mainly caused by cigarette smoking.

2. What you should know before using Beclometasone and Formoterolo Elpen

Do not take Beclometasone and Formoterolo Elpen

• If you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Beclometasone and Formoterolo Elpen if you have any of the following conditions:

• heart problems, such as angina (chest pain), recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around the heart (coronary heart disease), heart valve disease or other known heart abnormalities, or if you suffer from a condition known as obstructive hypertrophic cardiomyopathy (also known as HOCM, a condition in which the heart muscle is abnormal).
• narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you know you have an aneurysm (an abnormal dilation of the walls of blood vessels).
• heart rhythm disorders such as rapid or irregular heartbeat, rapid pulse, palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• overactive thyroid gland.
• low levels of potassium in the blood.
• liver or kidney disease.
• diabetes (inhaling high doses of formoterol may increase blood glucose levels and therefore additional tests may be needed to monitor blood sugar levels when starting this inhaler and periodically during treatment).
• a tumour of the adrenal gland (known as phaeochromocytoma).
• if you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop treatment with Beclometasone and Formoterolo Elpen at least 12 hours before anaesthesia.
• if you currently have, have previously had, or are being treated for tuberculosis (TB), or if you have a known viral or fungal infection of the chest.
• if you need to avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before using
Beclometasone and Formoterolo Elpen.
If you have or have ever had any medical problems or allergies, or if you are unsure whether you can use
Beclometasone and Formoterolo Elpen, contact your doctor, a nurse experienced in asthma management, or a
pharmacist before using the inhaler.
Treatment with a beta-2 agonist, such as formoterol contained in Beclometasone and Formoterolo Elpen, may cause a sudden decrease in serum potassium levels (hypokalaemia).
If you have severe asthma, you should exercise particular caution. This is due to low oxygen levels in the blood and to some other treatments that may be taken together with Beclometasone and Formoterolo Elpen, such as medicines for heart conditions or high blood pressure known as diuretics, or other medicines used to treat asthma, which may worsen the reduction in potassium levels. For this reason, your doctor may wish to monitor your blood potassium levels periodically.
If you take high doses of inhaled corticosteroids for prolonged periods, you may require additional corticosteroids during periods of stress. Stressful situations may include hospitalisation following an accident, serious injury, or prior to surgery. In such cases, your treating doctor may decide whether an increase in corticosteroid dose is necessary and may prescribe steroid tablets or injections.
If you are admitted to hospital, remember to bring all your medicines and inhalers, including Beclometasone and Formoterolo Elpen, and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Beclometasone and Formoterolo Elpen must not be used in children and adolescents under 18 years of age until further data are available.
Other medicines and Beclometasone and Formoterolo Elpen
Inform your doctor if you are taking or have recently taken any other medicines, including those not requiring a prescription.
Some medicines may increase the effects of Beclometasone and Formoterolo Elpen, and your doctor may wish to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
Do not take beta-blockers with this medicine. If beta-blockers (including eye drops) must be used, the effect of formoterol may be reduced or formoterol may not work at all. On the other hand, concomitant use of other beta-adrenergic medicines (medicines with the same mechanism of action as formoterol) may increase the effect of formoterol.
Taking Beclometasone and Formoterolo Elpen together with:

• medicines for abnormal heart rhythm (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines used to treat symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines may cause certain changes in the electrocardiogram (ECG). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).
• medicines for Parkinson’s disease (L-dopa), for the treatment of hypothyroidism (L-thyroxine), medicines containing oxytocin (which causes uterine contractions), and alcohol may reduce cardiac tolerance to beta-2 agonists such as formoterol.
• monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine, used in the treatment of mental disorders, may cause an increase in blood pressure.
• medicines for heart conditions (digoxin) may cause a decrease in potassium levels in the blood. This may increase the likelihood of heart rhythm abnormalities.
• other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics may cause a decrease in potassium levels in the blood.
• some anaesthetics may increase the risk of abnormal heart rhythm.

Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Beclometasone and Formoterolo Elpen during pregnancy.
Beclometasone and Formoterolo Elpen must not be used if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, unless advised by your doctor.
Driving and using machines
It is unlikely that Beclometasone and Formoterolo Elpen will affect your ability to drive or operate machinery.
Beclometasone and Formoterolo Elpen contains alcohol
Beclometasone and Formoterolo Elpen contains 7 mg of alcohol (ethanol) per dose, equivalent to 0.20 mg/kg for a two-dose administration. The amount in two doses of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
This small amount of alcohol in the medicine will have no noticeable effects.
Caution for athletes: the product contains substances prohibited for doping. Use differing from the therapeutic indications, dosage regimen, or route of administration specified is prohibited.

3. How to use Beclometasone and Formoterol Elpen

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Asthma
Your doctor will monitor you regularly to ensure you are taking the optimal dose of
Beclometasone and Formoterol Elpen. The doctor will adjust the treatment to the lowest dose that provides
adequate control of your symptoms.
Beclometasone and Formoterol Elpen may be prescribed by your doctor in two different ways:
a) daily use of Beclometasone and Formoterol Elpen for asthma treatment, together with another “rescue” inhaler to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and cough.
b) daily use of Beclometasone and Formoterol Elpen for asthma treatment, plus additional use of Beclometasone and Formoterol Elpen to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and cough.
a) Use of Beclometasone and Formoterol Elpen together with another rescue inhaler:
Adults and elderly
The recommended dose is one or two inhalations twice daily.
The maximum daily dosage is four inhalations.
Remember: you must always carry your fast-acting “rescue” inhaler with you to treat worsening asthma symptoms or sudden asthma attacks.
b) Use of Beclometasone and Formoterol Elpen as the sole inhaler for asthma:
Adults and elderly
The recommended dose is one inhalation in the morning and one in the evening.
You must also use Beclometasone and Formoterol Elpen as a “rescue” inhaler to treat sudden asthma symptoms.
If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.
Do not exceed 6 “rescue” inhalations per day.
The maximum daily dose of Beclometasone and Formoterol Elpen is 8 inhalations.
If you feel you need more inhalations per day to control your asthma symptoms,
contact your doctor for advice. Your treatment may need to be changed.
Use in children and adolescents under 18 years of age
Children and adolescents under 18 years of age must NOT use this medicine.
Chronic obstructive pulmonary disease (COPD)
Adults and elderly
The recommended dose is two inhalations in the morning and two in the evening.
Patients at risk
Elderly patients do not need to adjust the dose. There is no available information on the use of Beclometasone and Formoterol Elpen in patients with liver or kidney problems.
Beclometasone and Formoterol Elpen is effective in the treatment of asthma at a dosage of
beclometasone dipropionate that may be lower than that of other inhalers containing
beclometasone dipropionate. If you previously used a different beclometasone dipropionate inhaler, your doctor will advise you on the exact dose of Beclometasone and Formoterol Elpen to take for asthma.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the dosage.
If you use more Beclometasone and Formoterol Elpen than you should:

• Taking more formoterol than recommended may cause the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high blood glucose levels. Your doctor may wish to perform blood tests to monitor your potassium and glucose levels.
• Excessive intake of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These will improve within a few days, but your doctor may need to monitor your blood cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to take Beclometasone and Formoterol Elpen:
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose; instead, take the next dose at the correct time. Do not take a double dose.
If you stop treatment with Beclometasone and Formoterol Elpen:
Do not reduce the dose or stop using the medicine.
Even if you feel better, do not stop using Beclometasone and Formoterol Elpen or reduce the dose without first discussing it with your doctor. It is very important that you take Beclometasone and Formoterol Elpen regularly, even when you have no symptoms.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.
If your breathing worsens:
If you experience worsening shortness of breath or wheezing (breathing with an audible whistling sound) immediately after inhaling the medicine, stop using the Beclometasone and Formoterol Elpen inhaler immediately and use your fast-acting “rescue” inhaler right away. Contact your doctor immediately. Your doctor will assess your symptoms and, if necessary, may decide to start a different treatment. See also section 4. Possible side effects.
If your asthma worsens:
If your symptoms worsen or are difficult to control (e.g., if you are using your “rescue” inhaler or Beclometasone and Formoterol Elpen as a “rescue” inhaler more frequently), or if your “rescue” inhaler or Beclometasone and Formoterol Elpen does not improve your symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may need to increase your dose of Beclometasone and Formoterol Elpen or prescribe an alternative treatment.
Method of administration
Beclometasone and Formoterol Elpen is for inhalation use only.
This medicine is contained in a pressurized canister inserted into a plastic holder with a mouthpiece.
On the back of the inhaler there is a dose counter (or dose indicator) showing how many doses (or inhalations) remain. Each time you press the canister, one dose of medicine is released and the counter decreases by one (or the dose indicator rotates slightly. The number of remaining inhalations is displayed in intervals of 20). Be careful not to drop the inhaler, as this could inadvertently activate the dose counter.
Checking the inhaler function
Before using the inhaler for the first time, or if you have not used it for 14 days or more, you must check that the inhaler is working properly.

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler vertically with the mouthpiece pointing downwards.
3. Turn the mouthpiece away from you and press firmly on the canister to release one inhalation.
4. Check the dose counter (or dose indicator). If using the inhaler for the first time, the counter (or indicator) should display 120 or 180.

How to use the inhaler
Whenever possible, stand or sit upright when inhaling.
Before starting inhalation, check the dose counter (or dose indicator): any number between “1” and “120” or “180” indicates that doses remain. If the counter (or indicator) shows “0”, no doses remain—dispose of the inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean, free of dust, dirt, or any foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically, with the body of the inhaler upright, and place your lips around the mouthpiece. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through your mouth, and immediately after starting to inhale, press firmly on the top of the inhaler to release one dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place both index fingers on the top of the inhaler and both thumbs on the bottom.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe into the inhaler.

If another inhalation is needed, keep the inhaler in the vertical position for about half a minute and 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 (or dose indicator).
To reduce the risk of developing a fungal infection in the mouth or throat, rinse your mouth or gargle with water or brush your teeth each time you use the inhaler.
Obtain a new inhaler when the dose counter (or dose indicator) shows 20. Stop using the inhaler when the dose counter shows 0, as the remaining amount of medicine in the device may not be sufficient to deliver a full dose, and start using a new inhaler.
If you see a “mist” escaping from the top of the inhaler or from the sides of your mouth, this means that Beclometasone and Formoterol Elpen is not reaching your lungs as intended. Perform another dose following the instructions, repeating steps 2 to 5.
If you think the effect of Beclometasone and Formoterol Elpen is too strong or not strong enough, inform your doctor or pharmacist.
If you find it difficult to coordinate inhaler use with the start of inhalation, you may use the AeroChamber Plus™ spacer device. Ask your doctor, pharmacist, or nurse for information about this device.
It is important that you read the instruction leaflet provided with the AeroChamber Plus™ spacer device and carefully follow the instructions for its use and cleaning.
Cleaning
You must clean the inhaler once a week.
During cleaning, do not remove the canister from the holder and do not use water or other liquids to clean the inhaler.
To clean the inhaler:

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using Beclometasone and Formoterolo Elpen, a condition known as paradoxical bronchospasm. If this occurs, you MUST STOP using Beclometasone and Formoterolo Elpen IMMEDIATELY and use your "rescue" fast-acting inhaler right away to treat symptoms of breathlessness and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if you experience any signs of hypersensitivity reactions such as skin allergies, skin itching, skin rash, skin redness, or swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other possible side effects are listed below, classified by their frequency.

Common: may affect up to 1 in 10 people

• Fungal infections (of mouth and throat), headache, hoarseness, sore throat.
• Pneumonia in patients with COPD: inform your doctor if you experience any of the following symptoms while taking Beclometasone and Formoterolo Elpen, as they may indicate a lung infection:
  • fever or chills
  • increased mucus production or change in mucus colour
  • increased coughing or worsening breathing difficulties

Uncommon: may affect up to 1 in 100 people

• Palpitations, abnormally fast heartbeat, and heart rhythm disturbances, some changes in the electrocardiogram (ECG)
• Flu-like symptoms
• Vaginal fungal infections
• Sinusitis
• Rhinitis
• Ear inflammation
• Sore throat
• Cough and productive cough
• Asthma attack
• Nausea
• Taste disturbances or altered taste
• Lip burning, dry mouth
• Difficulty swallowing
• Indigestion
• Stomach discomfort
• Diarrhoea
• Muscle pain and muscle cramps
• Facial flushing
• Increased blood flow in certain body tissues
• Excessive sweating
• Tremor
• Restlessness
• Dizziness
• Hives or skin rash
• Changes in certain blood components:
  • reduced number of white blood cells
  • increased number of blood platelets
  • reduced blood potassium levels
  • increased blood sugar levels
  • increased levels of insulin, free fatty acids, and ketones in the blood

The following side effects have also been reported as "uncommon" in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Reduced blood cortisol levels; this is caused by the effect of corticosteroids on the adrenal glands.
• Irregular heartbeat.

Rare: may affect up to 1 in 1,000 people

• Sensation of chest tightness, feeling of missed heartbeat (caused by premature contraction of the heart ventricles), increased or decreased blood pressure, kidney inflammation, persistent swelling of the skin and mucous membranes lasting for several days

Very rare: may affect up to 1 in 10,000 people

• Shortness of breath, worsening of asthma, decreased number of blood platelets, swelling of hands and feet

Not known (frequency cannot be estimated from the available data):

• Blurred vision

Prolonged use of high-dose inhaled corticosteroids over long periods may, in very rare cases, lead to systemic effects:

• These include: adrenal gland function disorders (adrenal suppression), reduced bone mineral density (thinning of the bones), growth retardation in children and adolescents, increased intraocular pressure (glaucoma), cataract.
• Sleep disorders, depression or feelings of anxiety, restlessness, nervousness, hyperexcitability, or irritability: these events are more likely to occur in children, but the frequency is unknown.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Beclometasone and Formoterol Elpen

Keep this medicine out of the sight and reach of children.
For the pharmacist:
Store in the refrigerator (at 2-8°C) for up to 18 months.
For patients:
Do not use this medicine for more than 3 months after the date of purchase at the pharmacy, and never use it after the expiry date stated on the packaging and label after Exp.
The expiry date refers to the last day of that month.
Store the inhaler at a temperature below 25°C.
If the inhaler has been exposed to intense cold, warm it with your hands for a few minutes before use. Never warm it using artificial methods.
Warning: the canister contains liquid under pressure. Do not expose the canister to temperatures above 50°C. Do not pierce the canister.
Do not dispose of any medicine 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 Pack and Other Information

What Beclometasone and Formoterolo Elpen 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 an amount delivered from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
The other components are: norflurane (HFA 134a), anhydrous ethanol, hydrochloric acid.

Description of the Appearance of Beclometasone and Formoterolo Elpen and Contents of the Pack
Beclometasone and Formoterolo Elpen is a pressurized solution contained in a 19 ml aluminum pressurized container closed with a metering valve and inserted into a white plastic inhaler device incorporating a dose counter (pack of 120 actuations) or a dose indicator (pack of 180 actuations) with a blue plastic protective cap.
This medicine contains fluorinated greenhouse gases.
For 120 actuations: Each inhaler contains 8.07 g of 1,1,1,2-tetrafluoroethane, equivalent to 0.0115 tonnes of CO₂ (global warming potential = 1430).
For 180 actuations: Each inhaler contains 11.40 g of 1,1,1,2-tetrafluoroethane, equivalent to 0.0163 tonnes of CO₂ (global warming potential = 1430).
Each pack contains:
1 pressurized container (delivering 120 actuations)
2 pressurized containers (each delivering 120 actuations)
3 pressurized containers (each delivering 120 actuations)
1 pressurized container (delivering 180 actuations).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Elpen Pharmaceutical Co. Inc.
Marathonos Avenue 95
Pikermi, Attiki 190 09
Greece

Manufacturer
Elpen Pharmaceutical Co. Inc.
Keratea Industrial Park
Zapani, Block 1048
Keratea, Attiki 190 01
Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:
Sweden Brelung
Cyprus Brelung 100/6 mcg ανά ψεκασμό, διάλυμα για εισπνοή υπό πίεση
Germany Beclometason/Formoterol ELPEN 100 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Greece Brelung
Italy Beclometasone e formoterolo ELPEN

Patient information leaflet

Beclometasone and Formoterol Elpen 200 micrograms/6 micrograms per dose

Pressurised solution for inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent medicine
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Beclometasone and Formoterol Elpen is and what it is used for

Beclometasone and Formoterol Elpen is a pressurised solution for inhalation containing two active substances which are inhaled through the mouth and released directly into the lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which exert an anti-inflammatory action by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles of the airways and help you breathe more easily.
These two active substances help you breathe more easily. They also help prevent asthma symptoms such as shortness of breath, wheezing and coughing.
Beclometasone and Formoterol Elpen is used to treat asthma in adults.
If you have been prescribed Beclometasone and Formoterol Elpen, it is likely that:

• Your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed”, or
• Your asthma responds well to treatment with both inhaled corticosteroids and long-acting bronchodilators.

2. What you need to know before using Beclometasone and Formoterolo Elpen

Do not take Beclometasone and Formoterolo Elpen

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Beclometasone and Formoterolo Elpen if you have any of the following conditions:

• heart problems, such as angina (chest pain, heart discomfort), heart failure, narrowed arteries, heart valve disease, or other known heart abnormalities.
• high blood pressure or if you have an aneurysm (an abnormal bulging of blood vessel walls).
• heart rhythm disorders such as rapid or irregular heartbeat, fast pulse rate, palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• an overactive thyroid gland.
• low levels of potassium in the blood.
• liver or kidney disease.
• diabetes (inhaling high doses of formoterol may increase blood glucose levels. When starting this medicine and periodically during treatment, additional tests may be needed to monitor your blood sugar levels).
• a tumour of the adrenal gland (known as phaeochromocytoma).
• need to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop treatment with Beclometasone and Formoterolo Elpen for at least 12 hours before the procedure.
• if you are or have previously been treated for tuberculosis (TB), or if you have a known viral or fungal infection of the chest.
• if you need to avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before using
Beclometasone and Formoterolo Elpen.
If you have or have had any medical problems or allergies, or if you are unsure whether you can use
Beclometasone and Formoterolo Elpen, consult your doctor, a nurse experienced in asthma management, or a pharmacist before using the inhaler.
Your doctor may want to monitor your blood potassium levels from time to time,
especially if your asthma is severe. Like many bronchodilators, Beclometasone and Formoterolo Elpen
can cause a sudden drop in serum potassium levels (hypokalaemia). This may result from low oxygen levels in the blood, combined with some other treatments that may be taken together with Beclometasone and Formoterolo Elpen, which can worsen the reduction in potassium levels.
If you are taking high doses of inhaled corticosteroids for prolonged periods, you may require additional corticosteroids during times of stress. Stressful situations may include hospital admission following an accident, a serious injury, or prior to surgery. In such cases, your treating doctor may decide whether corticosteroid doses need to be increased and may prescribe steroid tablets or injections.
If you need to go to hospital, remember to bring all your medicines and inhalers, including Beclometasone and Formoterolo Elpen, and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Beclometasone and Formoterolo Elpen must not be used in children and adolescents under 18 years of age.

Other medicines and Beclometasone and Formoterolo Elpen
Inform your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is important because Beclometasone and Formoterolo Elpen may alter the effects of other medicines. Likewise, other medicines may affect the action of Beclometasone and Formoterolo Elpen.
In particular, consult your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• certain medicines may increase the effects of Beclometasone and Formoterolo Elpen, and your doctor may wish to monitor you closely if you are taking these (including some HIV treatments: ritonavir, cobicistat).
• beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure, and glaucoma (increased pressure in the eyes). If beta-blockers must be used, including eye drops, the effect of formoterol may be reduced or formoterol may not work at all.
• beta-adrenergic medicines (medicines that work similarly to formoterol) may increase the effects of formoterol.
• medicines used to treat abnormal heart rhythm (quinidine, disopyramide, procainamide).
• medicines used to treat allergic reactions (antihistamines).
• medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarbazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.
• medicines used to treat Parkinson’s disease (L-dopa).
• medicines used to treat hypothyroidism (L-thyroxine).
• medicines containing oxytocin (which causes uterine contractions).
• medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine.
• medicines used to treat heart disease (digoxin).
• other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• diuretics (water tablets).

Also inform your doctor or pharmacist if you are planning to undergo general anaesthesia for surgery or a dental procedure.

Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Beclometasone and Formoterolo Elpen during pregnancy.
Beclometasone and Formoterolo Elpen must not be used if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, unless specifically advised by your doctor.

Driving and using machines
It is unlikely that Beclometasone and Formoterolo Elpen will affect your ability to drive or operate machinery.

Beclometasone and Formoterolo Elpen contains alcohol
Beclometasone and Formoterolo Elpen contains 9 mg of alcohol (ethanol) per dose, equivalent to 0.25 mg/kg for a two-dose administration. The amount in two doses of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
This small amount of alcohol in the medicine will not have any noticeable effects.

For athletes: using the medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to use Beclometasone and Formoterol Elpen

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will monitor you regularly to ensure you are taking the optimal dose of
Beclometasone and Formoterol Elpen. The doctor will adjust your treatment to the lowest dose that provides
optimal control of your symptoms.
Dosage:
Adults and elderly
The recommended dose is two actuations twice daily.
The maximum daily dosage is 4 actuations.
Remember: You should always carry your fast-acting inhaler with you “as needed” to treat worsening asthma symptoms or sudden asthma attacks.
Patients at risk:
Dose adjustment is not required if you are elderly. There is no available information on the use of
Beclometasone and Formoterol Elpen in patients with liver or kidney problems.
Use in children and adolescents under 18 years of age
Children and adolescents under 18 years of age MUST NOT take this medicine.
Beclometasone and Formoterol Elpen is effective in the treatment of asthma with a dosage of
beclometasone dipropionate that may be lower than that of other inhalers containing
beclometasone dipropionate. If you previously used a different beclometasone dipropionate
inhaler, your doctor will advise you on the exact dose of Beclometasone and Formoterol Elpen
to take for your asthma.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the
dosage.
If asthma worsens:
If your symptoms worsen or become difficult to control (e.g. if you are using your “as needed” inhaler more frequently), or if your “as needed” inhaler does not improve your symptoms, contact
your doctor immediately. Asthma may worsen and your doctor may need to increase your dose of
Beclometasone and Formoterol Elpen or prescribe an alternative treatment.
Method of administration
Beclometasone and Formoterol Elpen is for inhalation use only.
This medicine is contained in a pressurized canister inserted into a plastic housing fitted with a mouthpiece. On the back of the inhaler there is a dose counter (or dose indicator) showing how many doses (or actuations) remain. Each time you press the canister, a dose of medicine is released and the counter therefore decreases by one number (or the dose indicator rotates slightly.
The number of remaining actuations is displayed in intervals of 20). Be careful not to drop
the inhaler, as this could inadvertently activate the dose counter. Checking that the inhaler is working
Before using the inhaler for the first time, or if you have not used it for 14 days or more, you must
check that it is working properly.

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler upright with the mouthpiece pointing downwards.
3. Turn the mouthpiece away from you and firmly press down on the canister to release one puff.
4. Check the dose counter (or dose indicator). If using the inhaler for the first time, the counter (or indicator) should display the number 120 or 180.

How to use the inhaler
Whenever possible, remain standing or sit upright during inhalation.
Before starting inhalation, check the dose counter (or indicator): any number between “1” and
“120” or “180” indicates that doses remain. If the counter (or indicator) shows “0”, no doses remain – dispose of the inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt, or any foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically, with the body of the inhaler facing upwards, and place your lips around the mouthpiece. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through your mouth and, just as you begin to inhale, firmly press down on the top of the inhaler to release one dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place both index fingers on the top of the inhaler and both thumbs on the bottom.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe into the inhaler.

If you need to perform another inhalation, hold the inhaler upright for about half a
minute and repeat steps 2 to 5.
Important: Do not carry out steps 2 to 5 too quickly.
After use, replace the protective cap and check the dose counter (or indicator).
To reduce the risk of developing a fungal infection in the mouth or throat, rinse your
mouth with water, gargle, or brush your teeth each time you use the inhaler.
You should obtain a new inhaler when the dose counter (or indicator) shows the number 20. Stop
using the inhaler when the dose counter shows “0”, as the remaining number of actuations in the
device may not be sufficient to deliver a complete dose, and start using a new inhaler.
If you see a “mist” escaping from the top of the inhaler or from the sides of your mouth, this means
Beclometasone and Formoterol Elpen is not reaching your lungs as it should. Perform another
inhalation by following the instructions, repeating steps 2 to 5.
If you think the effect of Beclometasone and Formoterol Elpen is too strong or not strong enough, inform your
doctor or pharmacist.
If you find it difficult to operate the inhaler while starting to inhale, you may use the
AeroChamber Plus™ spacer device. Ask your doctor, pharmacist, or nurse for information about this device.
It is important that you read the instruction leaflet provided with the AeroChamber Plus™ spacer device and carefully follow the instructions for its use and cleaning.
Cleaning
You should clean your inhaler once a week.
During cleaning, do not remove the canister from the inhaler and do not use water or other liquids to clean
the inhaler.
To clean the inhaler:

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

If you use more Beclometasone and Formoterol Elpen than you should:

• Taking more formoterol than recommended may cause the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high blood glucose levels. Your doctor may wish to perform blood tests to monitor your potassium and glucose levels.
• Excessive intake of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These problems will resolve spontaneously within a few days, but your doctor may decide to monitor your blood cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to take Beclometasone and Formoterol Elpen:
Take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose, but take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop treatment with Beclometasone and Formoterol Elpen:
Even if you feel better, do not stop taking Beclometasone and Formoterol Elpen or reduce the dose.
If you intend to do so, discuss it with your doctor. It is very important that you take Beclometasone and
Formoterol Elpen regularly, even when you have no symptoms.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using Beclometasone and Formoterolo Elpen, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using Beclometasone and Formoterolo Elpen immediately and use your "rescue" fast-acting inhaler right away to treat symptoms of breathlessness and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if you experience any hypersensitivity reactions such as skin allergies, skin itching, skin rash, skin redness, or swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.

Other possible side effects are listed below by frequency.

Common: may affect up to 1 in 10 people

• Fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat

Uncommon: may affect up to 1 in 100 people

• Palpitations, unusually fast heartbeat, and heart rhythm disturbances
• Some changes in the electrocardiogram (ECG)
• Increased blood pressure
• Influenza-like symptoms
• Sinusitis
• Rhinitis
• Ear inflammation
• Throat irritation
• Cough and productive cough
• Asthma attack
• Vaginal fungal infections
• Nausea
• Taste abnormalities or alterations
• Lip burning
• Dry mouth
• Difficulty swallowing
• Indigestion
• Stomach disturbances
• Diarrhea
• Muscle pains and cramps
• Facial and throat redness
• Increased blood flow in certain parts of the body
• Excessive sweating
• Tremor
• Restlessness
• Dizziness
• Urticaria (hives)
• Changes in certain blood components:
  • Decrease in the number of white blood cells
  • Increase in the number of blood platelets
  • Decrease in blood potassium levels
  • Increase in blood sugar levels
  • Increase in blood insulin, free fatty acids, and ketones

The following side effects have also been reported as "uncommon" in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Lung infection; inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, increased cough, worsening breathing problems
• Decreased blood cortisol levels; this is caused by the effect of corticosteroids on the adrenal glands
• Irregular heartbeat

Rare: may affect up to 1 in 1,000 people

• Chest tightness
• Sensation of missed heartbeat (caused by premature contraction of the heart ventricles)
• Decreased blood pressure
• Kidney inflammation
• Persistent swelling of the skin and mucous membranes lasting for several days

Very rare: may affect up to 1 in 10,000 people

• Shortness of breath
• Worsening of asthma
• Decrease in the number of blood platelets
• Swelling of hands and feet

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

• Adrenal gland function disorders (adrenal suppression)
• Reduced bone mineral density (bone thinning)
• Growth retardation in children and adolescents
• Increased intraocular pressure (glaucoma)
• Cataract

Not known (frequency cannot be estimated from the available data):

• Sleep disorders
• Depression or anxiety
• Nervousness
• Hyperexcitability or irritability: these events are more likely to occur in children, but their frequency is not known
• Blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Beclometasone and Formoterol Elpen

Keep this medicine out of the sight and reach of children.
For the pharmacist:
Store in the refrigerator (at 2-8°C) for up to 18 months.
For patients:
Do not use this medicine for more than 3 months after the date of purchase from the pharmacy, and never use it after the expiry date stated on the packaging and label following "Exp."
The expiry date refers to the last day of that month.
Store the inhaler at a temperature below 25°C.
If the inhaler has been exposed to intense cold, warm it with your hands for several minutes before use.
Never warm the inhaler by artificial means.
Caution: the canister contains liquid under pressure. Do not expose the canister to temperatures above 50°C. Do not pierce the canister.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterolo Elpen contains
The active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Each inhalation/dose delivered from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a dose delivered from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
The other components are: norflurane (HFA 134-a), anhydrous ethanol, hydrochloric acid.

Description of the appearance of Beclometasone and Formoterolo Elpen and contents of the pack
Beclometasone and Formoterolo Elpen is a pressurized solution contained in a 19 ml aluminum pressurized container closed with a metering valve, fitted into a white plastic inhaler device incorporating a dose counter (pack of 120 actuations) or a dose indicator (pack of 180 actuations), with a dark blue plastic protective cap.
This medicine contains fluorinated greenhouse gases.
For 120 actuations: Each inhaler contains 10.23 g of 1,1,1,2-tetrafluoroethane, equivalent to 0.0148 tonnes of CO₂ equivalent (global warming potential = 1430).
For 180 actuations: Each inhaler contains 13.99 g of 1,1,1,2-tetrafluoroethane, equivalent to 0.0204 tonnes of CO₂ equivalent (global warming potential = 1430).
Each pack contains:
1 pressurized container (delivering 120 actuations)
2 pressurized containers (each delivering 120 actuations)
3 pressurized containers (each delivering 120 actuations)
1 pressurized container (delivering 180 actuations).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Elpen Pharmaceutical Co. Inc.
Marathonos Avenue 95
Pikermi, Attiki 190 09
Greece

Manufacturer
Elpen Pharmaceutical Co. Inc.
Keratea Industrial Park
Zapani, Block 1048
Keratea, Attiki 190 01
Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:
Sweden Brelung
Cyprus Brelung 100/6 mcg ανά ψεκασμό, διάλυμα για εισπνοή υπό πίεση
Germany Beclometason/Formoterol ELPEN 100 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Greece Brelung
Italy Beclometasone e formoterolo ELPEN