Beclometasone and formoterol Doc Generici

Package leaflet: Information for the user

BECLOMETASONE AND FORMOTEROL DOC Generici

200 micrograms/6 micrograms/dose, pressurised solution for inhalation
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

What is in this leaflet

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

1. What BECLOMETASONE AND FORMOTEROL DOC Generici is and what it is used for

BECLOMETASONE AND FORMOTEROL DOC Generici is a pressurized 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, which belongs to a group of medicines called corticosteroids,
has an anti-inflammatory action that reduces swelling and irritation in the lungs.
Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators,
relaxes the muscles of the airways and helps you breathe more easily.
These two active substances together make breathing easier. They also help prevent asthma symptoms
such as shortness of breath, wheezing and coughing.
BECLOMETASONE AND FORMOTEROL DOC Generici is used for the treatment of asthma in adults.
If you have been prescribed BECLOMETASONE AND FORMOTEROL DOC Generici, 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 corticosteroids and long-acting bronchodilators.

2. What you need to know before taking BECLOMETASONE AND FORMOTEROL DOC Generics

Generics
Do not use BECLOMETASONE AND FORMOTEROL DOC Generics:
if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of the
other components of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using BECLOMETASONE AND FORMOTEROL DOC
Generics if you have any of the following conditions:

• heart problems, such as angina (chest pain), heart failure, narrowed arteries, heart valve problems, or other known heart abnormalities;
• high blood pressure or if you know you have an aneurysm (an abnormal widening of blood vessel walls);
• 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;
• overactivity of the thyroid gland;
• low levels of potassium in the blood;
• any liver or kidney problems;
• diabetes (if you inhale high doses of formoterol, blood glucose levels may increase. Additional blood tests to monitor blood sugar levels may therefore be needed when you start using this medicine and periodically during treatment);
• tumour of the adrenal gland (called phaeochromocytoma);
• if you are due to undergo anaesthesia. Depending on the type of anaesthetic, you may need to stop treatment with BECLOMETASONE AND FORMOTEROL DOC Generics at least 12 hours before anaesthesia;
• if you are taking, or have taken, medicines to treat tuberculosis (TB), or if you have known viral or fungal infections in the chest;
• if you should avoid alcohol for any reason.

If you fall into any of the categories listed above, always inform your doctor before using
BECLOMETASONE AND FORMOTEROL DOC Generics.
If you have or have had any medical problems or allergies, or if you are unsure whether you can use
BECLOMETASONE AND FORMOTEROL DOC Generics, consult your doctor, an asthma nurse specialist,
or pharmacist before using this medicine.
Your doctor may decide to periodically monitor your blood potassium levels, especially if your asthma
is severe. Like many bronchodilators, BECLOMETASONE AND FORMOTEROL DOC Generics may
cause a sudden drop in serum potassium levels (hypokalaemia). This occurs because reduced oxygen
levels in the blood associated with other treatments taken alongside this medicine can worsen the
decrease in potassium levels.
If you are taking high doses of inhaled corticosteroids for long periods of time, you may require
additional corticosteroids during times of stress. Stressful situations may include hospitalisation due
to an accident, serious injury, or the period before surgery. In such cases, your doctor may decide
whether or not to increase your corticosteroid dose and may prescribe steroid tablets or injectable
steroids.
If you need to be admitted to hospital, remember to bring all your medicines and inhalers with you,
including this medicine, 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
BECLOMETASONE AND FORMOTEROL DOC Generics must not be used in children and adolescents
under 18 years of age.

Other medicines and BECLOMETASONE AND FORMOTEROL DOC Generics
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Inform your doctor, pharmacist, or nurse 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 alter the effect of other medicines. In addition, other medicines may affect the action of
BECLOMETASONE AND FORMOTEROL DOC Generics.
In particular, consult 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 these (including certain HIV treatments: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure, or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or blocked.
• Beta-adrenergic medicines (medicines with effects similar to formoterol) may increase the effects of formoterol.
• Medicines used to treat heart rhythm disorders (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 for the treatment of Parkinson’s disease (L-dopa).
• Medicines for treating an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines for treating mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties like furazolidone and procarbazine.
• Medicines for treating heart conditions (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics ("water tablets").

Also inform your doctor if you plan to use a general anaesthetic for surgery or dental procedures.

Pregnancy, breastfeeding, and fertility
There are no clinical data available on the use of BECLOMETASONE AND FORMOTEROL DOC
Generics during pregnancy.
BECLOMETASONE AND FORMOTEROL DOC Generics must not be used if you are pregnant, think
you may be pregnant, are planning a pregnancy, or are breastfeeding, unless your doctor has told you
that you may do so.

Driving and using machines
It is unlikely that BECLOMETASONE AND FORMOTEROL DOC Generics will affect your ability to
drive or operate machinery.

BECLOMETASONE AND FORMOTEROL DOC Generics contains alcohol
This medicine contains 9 mg of alcohol (ethanol) per dose, equivalent to 0.25 mg/kg for a two-dose
inhalation. The amount in two doses of this medicine is less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

For athletes:
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping
test.
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3. How to use BECLOMETASONE AND FORMOTEROL DOC Generici

BECLOMETASONE AND FORMOTEROL DOC Generici is for inhalation use.
BECLOMETASONE AND FORMOTEROL DOC Generici must be inhaled through the
mouth into the lungs.
Always use this medicine exactly as your doctor or pharmacist has instructed you. 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 DOC Generici. Your doctor will prescribe the lowest dose that provides optimal control of your symptoms.
Dosage:
Adults and elderly
The recommended dose is 2 inhalations twice daily.
The maximum daily dose is 4 inhalations.
Remember: You must always carry your fast-acting rescue inhaler with you to use “as needed” in case of worsening asthma symptoms or an acute asthma attack.
Patients at risk:
Dose adjustment is not required if you are elderly. 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.
BECLOMETASONE AND FORMOTEROL DOC Generici is effective in the treatment of asthma
with a beclometasone dipropionate dosage that may be lower than that of other inhaled products
containing this substance. If you previously used a different inhaled medicine containing
beclometasone dipropionate, your doctor will prescribe the exact dose of BECLOMETASONE
AND FORMOTEROL DOC Generici appropriate for your asthma treatment.
Do not increase the dose
If you feel the medicine is not working well enough, always consult your doctor before increasing the dose.
If asthma worsens
If your symptoms worsen or become difficult to control (for example, if you are using your “as needed” inhaler more frequently), or if your “as needed” inhaler fails to relieve symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may decide to adjust your dose of BECLOMETASONE AND FORMOTEROL DOC Generici or prescribe an alternative treatment.
Method of administration
BECLOMETASONE AND FORMOTEROL DOC Generici is for inhalation use
This medicine is contained in a pressurized canister inserted into a plastic inhaler device with a mouthpiece. On the front of the inhaler there is a dose counter indicating the number of doses remaining. Each time the canister is pressed, a dose of medicine is released. With each actuation, the indicator emits a “click”; this sound confirms the correct functioning of the indicator. The actuator is equipped with an integrated dose indicator that accurately counts each actuation and displays the remaining doses every 20 sprays. The dose counter shows the approximate number of doses (sprays) remaining in the container. The dose counter window displays the number of remaining inhalations in intervals of 20 doses (e.g., 120, 100, 80, etc.). When
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20 doses remain, the display shows the number 20 against a half-red, half-white background, indicating that the container is nearly empty.
After 120 actuations, the display shows 0 against a red background.
The indicator will stop moving from “0” and will no longer emit a “click”.
Checking the inhaler function
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or more, check the inhaler as described below to ensure it is working properly.

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler in an upright position with the mouthpiece pointing downwards.
3. Keep the mouthpiece away from yourself.
   4.a. If using the inhaler for the first time, press the canister firmly 3 times to release a dose each time the canister is pressed.
   4.b. If the inhaler has not been used for 14 days or more, press the canister firmly once to release a dose.
4. Check the dose counter. If using the inhaler for the first time, the number 120 should appear in the dose counter window.

How to use the inhaler
Whenever possible, remain standing or sit upright during inhalation.
Check the dose counter before inhalation: any number between "1" and "120" indicates that doses remain. If the indicator shows "0", no doses remain – dispose of the inhaler and use a new one.

1 2 3 4 5

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt, or any foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the inhaler upright, with the body of the actuator facing upwards, and place the mouthpiece between your lips, sealing your lips firmly around it. 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 your index fingers on the top of the inhaler and both thumbs on the base of the inhaler.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler.

If another dose is required, keep the inhaler in an upright position for about half a minute and repeat steps 2 to 5.
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Important: Do not perform steps 2 to 5 too quickly.
After use, replace the protective cap and check the dose counter.
To reduce the risk of developing a fungal infection in the mouth and throat, rinse your mouth, gargle with water, or brush your teeth each time you use the inhaler.
When to replace the inhaler
You should obtain a new pack of medicine when the dose counter shows 20 and the background color of the dose indicator changes from white to half-red and half-white: this indicates that the inhaler is nearly empty. Stop using the inhaler when the indicator shows 0 on a red background, as any remaining doses in the device may not deliver a complete dose; therefore, you must start using a new inhaler.
If you see a “mist” escaping from the inhaler or from the sides of your mouth, this means
BECLOMETASONE AND FORMOTEROL DOC Generici did not reach your lungs as intended.
Release another dose by following the instructions and repeating steps 2 to 5.
If you think the effect of BECLOMETASONE AND FORMOTEROL DOC Generici is too strong or too weak, inform your doctor or pharmacist.
If you have difficulty using the inhaler while starting to inhale, you may use the spacer device AeroChamber Plus. 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 on how to use and clean it.
Cleaning
The inhaler should be cleaned 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 away from the inhaler.
2. Wipe the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
3. Replace the protective cap on the mouthpiece.

If you use more BECLOMETASONE AND FORMOTEROL DOC Generici than you should:

• Taking too much formoterol may cause the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, 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 potassium and glucose levels.
• Taking an excessive amount 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 blood cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to take BECLOMETASONE AND FORMOTEROL DOC Generici:
Take it 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 scheduled time. Do not take a double dose to make up for a
missed dose.
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If you stop treatment with BECLOMETASONE AND FORMOTEROL DOC Generici:
Even if you feel better, do not stop taking BECLOMETASONE AND FORMOTEROL DOC
Generici or reduce the dose without consulting your doctor. If you wish to do so, speak to your doctor. It is very important that you use BECLOMETASONE AND FORMOTEROL DOC Generici regularly, even when you have no symptoms.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BECLOMETASONE AND FORMOTEROL DOC Generics can 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 BECLOMETASONE AND FORMOTEROL DOC
Generics; this condition is known as paradoxical bronchospasm. If this occurs, you must
STOP using BECLOMETASONE AND FORMOTEROL DOC Generics 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 hypersensitivity reactions, such as
skin allergies, skin itching, 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 in order of 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 rapid heartbeat, and heart rhythm disturbances
• changes in 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 altered taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pains and cramps
• redness of the face and throat
• increased blood flow to certain body tissues
• excessive sweating

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• tremor
• restlessness
• dizziness
• urticaria (hives)
• changes in certain blood components:
• reduced number of white blood cells
• increased number of platelets in the blood
• reduced levels of potassium in the blood
• increased blood sugar levels
• increased levels of insulin, free fatty acids, and ketones in the blood

The following side effects have been reported with “uncommon” frequency 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 coughing, worsening breathing problems
• reduced levels of cortisol in the blood: this is caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeat

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

• chest tightness
• missed heartbeat (caused by premature ventricular contractions)
• decreased blood pressure
• kidney inflammation
• persistent swelling of the skin and mucous membranes lasting several days

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

• shortness of breath
• worsening of asthma
• decreased number of platelets in the blood
• swelling of the hands and feet

Long-term use of high-dose inhaled corticosteroids may, very rarely, lead to systemic effects, including:

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

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

• sleep disorders
• depression or anxiety (feeling of worry)
• nervousness
• feeling of hyperexcitability or irritability.

These events are more likely to occur in children, but the frequency is unknown.

• 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.
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5. How to store BECLOMETASONE AND FORMOTEROL DOC Generics

Keep this medicine out of the sight and reach of children.
Single pack containing a container with 120 actuations.
Do not use this medicine more than 3 months after the date you purchased it from the pharmacy, and never use it after the expiry date stated on the carton and label. The expiry date refers to the last day of that month.
Before first use: store the inhaler in the 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.
If the inhaler has been exposed to very low temperatures, warm it with your hands for several minutes before use. Never heat it using artificial means.
Warning: The container contains pressurized liquid. Do not expose it 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 BECLOMETASONE AND FORMOTEROL DOC Generici contains

• The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate. Each metered valve actuation contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an amount delivered from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• The excipients are: norflurane (HFC 134-a), ethanol, maleic acid and water for injections.

Description of the appearance of BECLOMETASONE AND FORMOTEROL DOC Generici and
contents of the pack
Each pack contains:
1 pressurized container (a canister delivering 120 actuations)
2 pressurized containers (two canisters delivering 120 actuations each)
Not all pack sizes may be marketed.
BECLOMETASONE AND FORMOTEROL DOC Generici is a pressurized solution contained in
an aluminium container treated with fluorocarbon polymerization (FCP), closed with a metering valve. The container is inserted into a white plastic inhaler with a green plastic dust-cap. The inhaler is equipped with an integrated dose indicator, which accurately counts each actuation and displays the remaining doses every 20 actuations.
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
Germany: Luforbec 200 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Italy: BECLOMETASONE E FORMOTEROLO DOC Generici
Marketing Authorization Holder:
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DOC Generici Srl - Via Turati 40, 20121 Milano – Italy
Oy Medfiles Ltd,
Volttikatu 5 e 8,
70700 Kuopio,
Finland
Hormosan Pharma GmbH
Hanauer Landstraße 139 - 143
60314 Frankfurt am Main,
Germany
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