BECLOMETASONE 100 MICROGRAMS/6 MICROGRAMS Roztwór ciśnieniowy do inhalacji

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1. BECLOMETASONE E FORMOTEROLO DOC Generici
   1. What is BECLOMETASONE AND FORMOTEROL DOC Generici and what is it used for
   2. What you need to know before taking BECLOMETASONE E FORMOTEROLO DOC
   3. How to use BECLOMETASONE AND FORMOTEROL DOC Generici
   4. Possible side effects
   5. How to store BECLOMETASONE E FORMOTEROLO DOC Generici
   6. Package Contents and Other Information

BECLOMETASONE E FORMOTEROLO DOC Generici

200 micrograms/6 micrograms/actuation, pressurized solution for inhalation
Generic equivalent medicine

Read this leaflet carefully before taking 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

BECLOMETASONE AND FORMOTEROL DOC Generici is a pressurized inhalation solution
containing two active ingredients that are inhaled through the mouth and are released directly into the
lungs.
The two active ingredients are:
Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids,
has an anti-inflammatory action capable of reducing 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 ingredients together make breathing easier. They also help prevent the symptoms
of asthma such as shortness of breath, wheezing and cough.

BECLOMETASONE AND FORMOTEROL DOC Generici is used for the treatment of asthma
in adults.
If BECLOMETASONE AND FORMOTEROL DOC Generici has been prescribed to you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and fast-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 E FORMOTEROLO DOC

Generics
Do not use BECLOMETASONE E FORMOTEROLO DOC Generics:
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 E FORMOTEROLO DOC Generics if you have any of the following conditions:

• heart problems, such as angina (heart pain, chest pain), heart failure, narrowing of the arteries, problems with heart valves or other known heart abnormalities;
• high blood pressure or if you know you have an aneurysm (an abnormal dilation of the blood vessel walls);
• heart rhythm disorders such as a fast or irregular heartbeat, accelerated pulse rate or palpitations, or if you have been told that your heart tracing is abnormal;
• overactive 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. It may therefore be necessary to perform further blood tests to check your blood sugar levels when you start using this medicine and periodically during the duration of treatment);
• tumour of the adrenal gland (called pheochromocytoma);
• if you are going to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop treatment with BECLOMETASONE E FORMOTEROLO DOC Generics at least 12 hours before the anaesthetic;
• 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 need to avoid drinking alcohol for any reason.

If you fall into any of the above cases, always inform your doctor before using BECLOMETASONE E FORMOTEROLO DOC Generics.
If you have or have had any medical problem or allergies or if you are not sure you can use BECLOMETASONE E FORMOTEROLO DOC Generics, talk to your doctor, experienced asthma nurse or pharmacist before using this medicine.
Your doctor may decide to measure your potassium levels in your blood periodically, especially if your asthma is severe. Like many bronchodilators, BECLOMETASONE E FORMOTEROLO DOC Generics can cause a sudden drop in serum potassium levels (hypokalaemia). This happens because a reduction in oxygen in the blood associated with some other treatments taken together with this medicine can worsen the reduction in potassium levels.

If you take high doses of inhaled corticosteroids for long periods of time, you may have a greater need for corticosteroids in stressful situations. Stressful situations can include being admitted to hospital following an accident, suffering serious injuries or the period before surgery. In such cases, the doctor may decide whether or not to increase your dose of corticosteroids and to prescribe steroid tablets or steroid injections.
If you need to be hospitalized, remember to bring all your medicines and inhalers with you, including this medicine and any over-the-counter medicines or tablets, in their original packaging, if possible.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
BECLOMETASONE E FORMOTEROLO DOC Generics should not be used in children and adolescents under 18 years of age.

Other medicines and BECLOMETASONE E FORMOTEROLO DOC Generics
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Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines including over-the-counter medicines. This is necessary because this medicine can alter the action of other medicines. Also, other medicines can have effects on the activity of BECLOMETASONE E FORMOTEROLO DOC Generics.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

• Some medicines can increase the effects of this medicine and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: 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 cancelled.
• Beta-adrenergic medicines (medicines with similar activity to that of formoterol) can increase the effects of formoterol.
• Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide, procainamide).
• Medicines used in the treatment of 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 the treatment of an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contraction).
• Medicines for the treatment of mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine.
• Medicines for the treatment of heart diseases (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline or steroids).
• Diuretics (water tablets).

Also tell your doctor if you intend to use a general anaesthetic for an operation or dental procedure.

Pregnancy, breastfeeding and fertility
There are no clinical data on the use of BECLOMETASONE E FORMOTEROLO DOC Generics during pregnancy.
BECLOMETASONE E FORMOTEROLO DOC Generics should not be used if you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, unless your doctor has told you that you can do so.

Driving and operating machinery
It is unlikely that BECLOMETASONE E FORMOTEROLO DOC Generics will affect your ability to drive vehicles or operate machinery.

BECLOMETASONE E FORMOTEROLO DOC Genericscontains alcohol
This medicine contains 9 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.25 mg/kg per dose of two actuations. The amount in two actuations of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will have no noticeable effects.

For athletes:
The use of the medicine without therapeutic need constitutes doping and may still result in positive doping tests.
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3. How to use BECLOMETASONE AND FORMOTEROL DOC Generici

BECLOMETASONE AND FORMOTEROL DOC Generici is for inhalation.
BECLOMETASONE AND FORMOTEROL DOC Generici must be inhaled through the
mouth into the lungs.
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will monitor you regularly to make sure 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.

Dose:
Adults and the elderly
The recommended dose is 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: You should always carry with you the reliever inhaler to use “as
needed” to treat a worsening of asthma symptoms or a sudden asthma attack.
Patients at risk:
You do not need to change the dose if you are elderly. No information is available 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 should 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
inhalation products containing this substance. If you have previously used a different
inhalation medicine based on beclometasone dipropionate, your doctor will prescribe you the
exact dose of BECLOMETASONE AND FORMOTEROL DOC Generici to take to treat
asthma.
Do not increase the dose
If you feel that the medicine is not very effective, always consult your doctor before
increasing the dosage.

If your asthma worsens
If your symptoms worsen or are difficult to control (for example, if you use 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 BECLOMETASONE AND FORMOTEROL DOC Generici or
prescribe you alternative treatment.

How to administer
BECLOMETASONE AND FORMOTEROL DOC Generici is for inhalation
This medicine is contained in a pressurized canister inserted into a plastic inhaler
with a mouthpiece. On the front of the inhaler there is a dose counter, which indicates the number of doses
remaining. Each time you press on the canister, a dose of medicine is delivered. With each
actuation the indicator emits a “click”; this sound is the acoustic feedback that indicates the correct
functioning of the indicator. The dispenser is equipped with an integrated dose indicator that counts
accurately each actuation and displays every 20 actuations. The dose indicator shows the approximate number
of actuations (sprays) remaining in the container. The dose counter window displays the
number of remaining inhalations at intervals of 20 doses (e.g., 120, 100, 80, etc.). When
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20 doses remain, the display shows the number 20 on a half-red and half-white background,
indicating that the container is almost empty.
After 120 actuations, the display shows the number 0 on a red background.
The indicator will stop moving from “0” and will stop emitting the “click”.

Checking the inhaler’s operation
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or
more, you must check the inhaler as described below to ensure it is working correctly.

• 1. Remove the protective cap from the mouthpiece
• 2. Hold the inhaler in a vertical position with the mouthpiece facing down
• 3. Point the mouthpiece away from yourself
• 4.a. If you are using the inhaler for the first time, press the container firmly 3 times to release a dose each time you press the container.
• 4.b If the inhaler has not been used for 14 days or more, press the container firmly once to release a dose.
• 5. Check the dose counter. If you are using the inhaler for the first time, the number 120 should appear in the dose counter window.

How to use the inhaler
When possible, remain standing or sitting in an upright position during inhalation.
Check the dose counter before inhalation: any number between "1" and "120" indicates that there are still
doses. If the indicator shows "0" there are no doses remaining - dispose of the inhaler and get a
new one.

1 2 3 4 5

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust and dirt or any other foreign object.
• 2. Exhale as slowly and deeply as possible.
• 3. Hold the inhaler vertically, with the body of the dispenser facing upwards, and then place the mouthpiece between your tightly closed lips. Do not bite the mouthpiece.
• 4. Inhale slowly and deeply through your mouth and, immediately after starting to inhale, press firmly on the top of the inhaler to release a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: position 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 and at the end remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler.

If another actuation is necessary, keep the inhaler in a vertical 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, close with the protective cap and check the dose counter.
To reduce the risk of 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 need to get a new package of medicine when the dose counter indicates the number 20 and
the color of the background on the dose indicator changes from white to white and red: this indicates that
the inhaler is almost empty. Stop using the inhaler when the indicator shows 0 on a red background, as any actuations remaining in the device may not be sufficient to
deliver a complete dose, so you need to start using the new inhaler.

If you see a “mist” escaping from the inhaler or from the sides of your mouth, it means that
BECLOMETASONE AND FORMOTEROL DOC Generici has not reached your lungs as
it should have. Deliver another dose following the instructions by repeating the operations from point
If you think that the effect of BECLOMETASONE AND FORMOTEROL DOC Generici is too strong or
insufficient, tell your doctor or pharmacist.
If you have difficulty using the inhaler while starting to inhale, you can use the AeroChamber Plus spacer device. Ask your doctor, pharmacist or
nurse for information about this device.
follow the instructions on how to use it and how to clean it carefully.

Cleaning
The inhaler should be cleaned once a week. During cleaning, do not remove the container
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. Clean the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
• 3. Reposition the protective cap on the mouthpiece.

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

• taking too much formoterol can have the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, irregular heartbeat, changes in the electrocardiogram (heart tracing), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high glucose levels in the blood. Your doctor may want to perform some blood tests to check the levels of potassium and glucose in the blood.
• taking an excessive amount of beclometasone dipropionate can lead to temporary disorders of the adrenal glands. These problems will resolve spontaneously within a few days, however your doctor may decide to check the levels of cortisol in the blood.

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 the 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 the
forgotten 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. If you want to do so, consult your doctor. It is very important that you use
BECLOMETASONE AND FORMOTEROL DOC Generici regularly even in the absence of
symptoms.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, BECLOMETASONE E FORMOTEROLO DOC Generici can cause side effects
although not everybody gets them.
As with other inhaled treatments, there is a risk of worsening of shortness of breath and
wheezing, immediately after using BECLOMETASONE E FORMOTEROLO
DOC Generici; this condition is known as paradoxical bronchospasm. If this happens, you must

STOP using BECLOMETASONE E FORMOTEROLO DOC
Generici immediately and use your reliever inhaler straight awayto treat the symptoms of shortness
of breath and wheezing. You should contact your doctor immediately.

Tell your doctor immediatelyif you experience any hypersensitivity reactionsuch as
skin allergies, skin itching, skin rash, redness of the skin, swelling of the skin or
mucous membranes especially of the eyes, face, lips and throat.
Other 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 fast heartbeat and heart rhythm disturbances
• changes in the electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• inflammation of the sinuses
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• taste disturbances or alteration
• burning of the lips
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhoea
• muscle pain and cramps
• redness of the face and throat
• increased blood flow to some tissues in the body
• excessive sweating

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• tremor
• restlessness
• dizziness
• urticaria
• alteration of some blood components:
• reduction in the number of white blood cells
• increase in the number of platelets in the blood
• reduction in potassium levels in the blood
• increase in blood sugar levels
• increase in 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:

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

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

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

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

The use of high doses of inhaled corticosteroids for long periods of time can, in very rare cases, cause
systemic effects, including:

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

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

• sleep disturbances
• depression or anxiety (feeling worried)
• nervousness
• feeling of over-excitement or irritability.

These events are more likely to happen in children, but the frequency is not known.

• Blurred vision

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 E FORMOTEROLO DOC Generici

Keep this medicine out of the sight and reach of children.
Single pack containing a container with 120 doses.
Do not use this medicine beyond 3 months from the date you purchased it from the pharmacy and do not use it after
the expiry date which is reported on the box and on the label. The expiry date refers to
the last day of that month.
Before use: store the inhaler in a refrigerator (at 2-8°C) in an upright position for a maximum of
18 months.
After first use: do not store the inhaler at a temperature above 25°C.
If the inhaler has been exposed to very low temperatures, warm it with your hands for a few minutes before
use. Never heat it with artificial means.

Warning: The container contains liquid under pressure. Do not expose it to temperatures above
50°C. Do not puncture the canister.
Do not dispose of any medicine in 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 E FORMOTEROLO DOC Generici contains

• The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate. Each actuation of the metered-dose valve contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a dose released 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 E FORMOTEROLO DOC Generici and
package contents
Each pack contains:
1 pressurised container (one canister providing 120 actuations)
2 pressurised containers (two canisters providing 120 actuations each)
Not all pack sizes may be marketed.
BECLOMETASONE E FORMOTEROLO DOC Generici is a pressurised solution contained in
an aluminium container treated with fluorocarbon polymer coating (FCP) closed with a
metered-dose valve. The container is inserted into a white plastic inhaler with a green plastic dust cap. The inhaler is equipped with an integrated dose counter, which accurately counts each actuation and displays the remaining doses in increments of 20 actuations.

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany: Luforbec 200 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Italy: BECLOMETASONE E FORMOTEROLO DOC Generici

Marketing Authorisation 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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