Bibecfo

Patient Information Leaflet: Information for the User

BIBECFO 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What BIBECFO is and what it is used for

BIBECFO 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.
BIBECFO is used to treat asthma in adults.
If you have been prescribed BIBECFO, it is likely that:

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

2. What you need to know before using BIBECFO

Do not take BIBECFO

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using BIBECFO if you:

• have heart problems, such as angina (chest pain, heart pain), heart failure, narrowed heart arteries, valvular heart disease, or any other known heart abnormalities.
• have high blood pressure (hypertension) or if you know you have an aneurysm (an abnormal widening of blood vessel walls).
• have heart rhythm disorders such as rapid or irregular heartbeat, increased pulse rate, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• have an overactive thyroid gland.
• have low potassium levels in your blood.
• have any liver or kidney problems.
• have diabetes (if you inhale high doses of formoterol, blood glucose levels may increase, so additional tests may be needed to monitor your blood sugar levels when you start using this inhaler and occasionally throughout treatment).
• have a tumour of the adrenal gland (called phaeochromocytoma).
• need to undergo anaesthesia. Depending on the type of anaesthetic, you may need to stop treatment with BIBECFO at least 12 hours before anaesthesia.
• have had or currently have tuberculosis (TB), or if you have a known viral or fungal chest infection.
• must avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before using BIBECFO.
If you have or have ever had any medical conditions or allergies, or if you are unsure whether you can use
BIBECFO, contact your doctor, a nurse experienced in asthma management, or a pharmacist before using the inhaler.
Your doctor may decide to periodically check your blood potassium levels, especially if your asthma is severe. Like many bronchodilators, BIBECFO may cause a sudden drop in plasma potassium levels (hypokalaemia). This occurs because low oxygen levels in the blood, combined with other treatments that may be taken alongside this medicine, can worsen the reduction in potassium levels.
If you have used high doses of inhaled corticosteroids for long periods, you may require additional corticosteroids during times of stress. Stressful situations may include hospitalisation following an accident, suffering a serious injury, or before surgery. In such cases, your treating doctor may decide whether you need an increased dose of corticosteroids and may prescribe steroid tablets or an injection.
If you need to go to hospital, remember to bring all your medicines and inhalers with you, including BIBECFO, as well as 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
BIBECFO must not be used in children and adolescents under 18 years of age until further data are available.

Other medicines and BIBECFO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is important because this medicine may affect the action of other medicines. Conversely, other medicines may affect the action of BIBECFO.
In particular, talk to your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• Some medicines may increase the effects of this medicine, and your doctor may wish to monitor you closely if you are taking them (including certain HIV treatments: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, hypertension, 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 drugs (medicines that work similarly to formoterol) may increase the effects of formoter combust.
• Medicines used to treat abnormal heart rhythms (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.
• 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 drugs with similar properties like 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 scheduled to undergo general anaesthesia for surgery or a dental procedure.

Pregnancy and breastfeeding
There are no clinical data on the use of BIBECFO during pregnancy.
BIBECFO 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 BIBECFO will affect your ability to drive or operate machinery.

BIBECFO contains alcohol
This medicine contains 9 mg of alcohol (ethanol) per dose (inhalation). The amount of alcohol in 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 those engaged in sports: Using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use BIBECFO

BIBECFO is for inhalation use. BIBECFO must be inhaled through the mouth into the lungs.
Always use this medicine exactly as prescribed 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 receiving the optimal dose
of BIBECFO. Your doctor will adjust your treatment to the lowest dose that provides adequate
control of your symptoms.

Dosage:
Adults and elderly:
The recommended dose is two inhalations twice daily.
The maximum daily dosage is 4 inhalations.

Remember: Always carry your "reliever" inhaler with rapid action to use in case of
worsening asthma symptoms or sudden asthma attack.

Patients at risk:
Dosage adjustment is not required in elderly patients. There is no available information on the use of
this medicine 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 use this medicine.

BIBECFO is effective in the treatment of asthma with a beclometasone dipropionate dosage
that may be lower than that of other inhalers containing this substance. If you previously used
a different beclometasone dipropionate inhaler, your doctor will advise you on the exact dose
of this medicine to take for asthma treatment.

Do not increase the dose
If you feel the medicine is not working well enough, always consult your doctor before
increasing the dosage.

If your asthma worsens:
If your symptoms worsen or become difficult to control (for example, if you are using your
"reliever" inhaler more frequently), or if your "reliever" inhaler does not improve your
symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may
decide to change your dose of BIBECFO or prescribe an alternative treatment.

Method of administration
BIBECFO is for inhalation use.
This medicine is contained in a pressurized canister inserted into a plastic casing equipped with a mouthpiece. On the back of the inhaler there is a dose counter indicating how many doses remain. Each time you press the canister, a dose of medicine is released and the dose counter decreases by one. Be careful not to drop the inhaler, as this may cause the counter to decrease by one dose.

Checking that the inhaler is working properly
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or more,
you must check that the inhaler is working correctly.

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

How to use the inhaler
Whenever possible, stand or sit upright during inhalation.
Before starting inhalation, check the dose counter: any number between "1" and "120"
indicates that doses remain. If the dose counter shows "0", no doses remain—dispose of the inhaler and use 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 facing upwards, 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 puff. 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 required, keep the inhaler in an upright 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.
Replace the inhaler when the dose counter indicates the number 20. Stop using the inhaler when the dose counter shows 0, as the remaining number of puffs in the device may not be sufficient to deliver a complete dose.

If you see a "mist" escaping from the top of the inhaler or from the sides of your mouth,
this means BIBECFO has not reached your lungs as intended. Perform another puff,
following the instructions and repeating steps 2 to 5.

To reduce the risk of developing a fungal infection in the mouth or throat, rinse your mouth, gargle with water, or brush your teeth after using the inhaler.

If you feel that the effect of BIBECFO is too strong or not strong enough, inform your doctor or pharmacist.

If you have difficulty coordinating 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 to 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 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. Clean 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 BIBECFO 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 blood glucose levels.
• Excessive intake of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These problems will resolve spontaneously within a few days; however, 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 BIBECFO:
Do not take a double dose to make up for the missed dose. Take the dose 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.

If you stop using BIBECFO:
Do not reduce the dose or stop taking the medicine. Even if you feel better, do not stop using BIBECFO or reduce the dose without consulting your doctor. It is very important that you use this medicine regularly, even when you have no symptoms.
If you have any doubts about how to use this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, BIBECFO may cause side effects, although not everyone experiences them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using this medicine, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using BIBECFO immediately and use your fast-acting "rescue" 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 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 disorders
• some changes in the electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• sinus inflammation
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• taste abnormalities or disturbances
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• redness of the face and throat
• increased blood flow in certain parts of the body
• excessive sweating
• tremor
• restlessness
• dizziness
• urticaria (hives)
• changes in certain blood components: reduction in white blood cell count, increase in blood platelet count, reduction in blood potassium levels, increase in blood sugar levels, increase in 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):

• Lung infection; inform your doctor if you notice any of the following symptoms: increased sputum (phlegm) production, change in sputum colour, fever, increased cough, worsening breathing problems
• 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):

• chest tightness
• sensation of missed heartbeat
• decrease in 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):

• worsening of asthma
• breathlessness
• decrease in blood platelet count
• swelling of hands and feet

Long-term use of high-dose inhaled corticosteroids may very rarely cause systemic effects. These include:

• adrenal gland function disorders (adrenal suppression)
• increased intraocular pressure (glaucoma)
• cataract
• growth retardation (slowed growth in children and adolescents)
• reduced bone mineral density (bone thinning)

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

• sleep disorders
• depression or anxiety
• nervousness
• hyperexcitability or irritability

These effects occur mainly in children.

• 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 BIBECFO

• Keep this medicine out of the sight and reach of children.
• Before dispensing: store the inhaler in the refrigerator (at 2–8°C).
• After dispensing (after receiving this medicine from the pharmacist): Do not use this medicine for more than 3 months after the pharmacy purchase date, 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. Do not store the inhaler above 25°C. If the inhaler has been exposed to low temperatures, warm it with your hands for a few minutes before use. Never warm the inhaler using artificial methods. Warning: The canister contains pressurized liquid. 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What BIBECFO 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 an inhaled dose delivered from the mouthpiece of 169.2 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• This medicinal product contains fluorinated greenhouse gases. Each inhaler contains 10.24 g of HFC-134a (norflurane), equivalent to 0.015 tonnes of CO₂-equivalent (global warming potential = 1430).
• The excipients are: anhydrous ethanol and hydrochloric acid.

Description of the appearance of BIBECFO and contents of the pack
BIBECFO is contained in a 19 ml aluminium pressurised canister closed with a metering valve, inserted into a plastic polypropylene actuator incorporating a dose counter and a mouthpiece, and fitted with a plastic protective cap.
Pack sizes:
1 pressurised container providing 120 actuations, or
2 pressurised containers providing 120 actuations each.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium

Manufacturer:
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium
S&D Pharma CZ, spol. s r.o.
Theodor 28
273 08 Pchery (Pharmos a.s. facility)
Czech Republic

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Beclometasone/Formoterol Cipla 200 micrograms per spray pressurised inhalation solution
Bulgaria BIBECFO 200/6 micrograms per actuation pressurised inhalation solution
Czech Republic Beklometason/Formoterol Cipla
Germany Beclometasone/Formoterol Cipla 200 micrograms/6 micrograms per spray pressurised inhalation solution
Spain Bibecfo 200 micrograms/6 micrograms per actuation solution for pressurised inhalation
France BÉCLOMÉTASONE/FORMOTÉROL CIPLA 200/6 micrograms/dose, solution for pressurised inhalation
Italy BIBECFO 200 micrograms/6 micrograms per actuation pressurised solution for inhalation
Norway Beclometasone dipropionate/Formoterol Cipla
Romania Beclometasone/Formoterol Cipla 200/6 micrograms per dose pressurised inhalation solution
Sweden Brofobec
Slovakia BIBECFO 200/6 micrograms per inhalation inhalation solution in pressurised container