BECLOMETASONE 50 MICROGRAMS Pressurized solution for inhalation

Зміст інструкції

1. BECLOMETASONE DOC generici 50 micrograms per actuation solution
2. BECLOMETASONE DOC generici 100 micrograms per actuation solution
3. BECLOMETASONE DOC generici 200 micrograms per actuation solution
   1. What is BECLOMETASONE DOC GENERICI and what is it used for?
   2. - What you need to know before using BECLOMETASONE DOC GENERICI
   3. How to use BECLOMETASONE DOC generics
   4. Possible side effects
   5. How to store BECLOMETASONE DOC generics
   6. Package Contents and Other Information

BECLOMETASONE DOC generici 50 micrograms per actuation solution

pressurized for inhalation

BECLOMETASONE DOC generici 100 micrograms per actuation solution

pressurized for inhalation

BECLOMETASONE DOC generici 200 micrograms per actuation solution

pressurized for inhalation
BECLOMETASONE DOC generici250 micrograms per actuation solution
pressurized for inhalation
beclometasone dipropionate
Equivalent Medicinal Product

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could 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:

• What BECLOMETASONE DOC GENERICI is and what it is used for
• What you need to know before you use BECLOMETASONE DOC GENERICI
• How to use BECLOMETASONE DOC GENERICI
• Possible side effects
• How to store BECLOMETASONE DOC GENERICI
• Contents of the pack and other information

1. What is BECLOMETASONE DOC GENERICI and what is it used for?

BECLOMETASONE DOC GENERICI pressurized solution for inhalation is used to
prevent the symptoms of asthma. The active ingredient, beclometasone dipropionate, belongs to the group
of corticosteroids, often simply called steroids. Steroids have an
anti-inflammatory action that reduces swelling and inflammation in the walls of the airways,
thus relieving breathing problems.

2. - What you need to know before using BECLOMETASONE DOC GENERICI

Do not use BECLOMETASONE DOC GENERICI if:
you are allergic to any of the ingredients of this medicine or to other medicines
used to treat asthma.
or you need to treat a sudden asthma attack. Use a quick-acting
inhaler for this purpose and always carry it with you.

Warnings and precautions
Take special care and talk to your doctor, pharmacist or nurse before using
BECLOMETASONE DOC generici in any of the following cases:
you are currently, or have ever been, treated for tuberculosis (TB).
you have recently had thrush (a fungal infection) in your mouth.
you take or have taken alcohol for any reason.
your asthma gets worse or does not improve or you have more difficulty breathing and need to
use the inhaler as needed more frequently or this does not improve your
symptoms.
Your doctor may need to increase the dose of cortisone or prescribe a course of
cortisone tablets or change the treatment altogether. If you have a chest infection, your doctor may
prescribe a course of antibiotics.
When switching from systemic therapy to inhaled therapy, despite initial improvement,
you may not feel well and develop a rash, eczema, runny nose and sneezing
(rhinitis). Do not stopinhaled treatment unless your doctor tells you to.
If you have been treated for a long time with high doses of corticosteroids by inhalation, you may need a
supplementary course of cortisone tablets during periods of stress. For example, during hospitalization after a serious accident, before surgery, during an acute asthma attack or in case
of a chest infection or other serious illnesses. The doctor will assess whether further
treatment with corticosteroids is necessary and will advise you on the duration of oral therapy, with cortisone tablets,
and how to reduce them gradually as your symptoms improve.
See your doctor if you experience blurred vision or other visual disturbances.

Other medicines and BECLOMETASONE DOC generici
Before starting treatment, tell your doctor if you are taking, or have recently taken other
medicines, or may take medicines, including those obtained without a prescription.
Tell your doctor if you are taking disulfiram or metronidazole, as there is a potential risk of
interaction in particularly sensitive patients.
If you have to go to hospital, remember to bring your medicines and inhalers with you.
Some medicines can increase the effects of BECLOMETASONE DOC generici and your doctor
may want to monitor you carefully if you are taking these medicines (including some medicines
for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding:
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, consult
your doctor or pharmacist before taking this medicine .
Driving and using machines
BECLOMETASONE DOC generici does not affect the ability to drive vehicles and operate
machinery.

BECLOMETASONE DOC generici contains alcohol:
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per
actuation (spray).
For those who play sports, the use of medicines containing ethyl alcohol may result in a positive
doping test in relation to the concentration limits of alcohol indicated by some sports federations .

For athletes:the use of the drug without therapeutic necessity constitutes doping and
may still result in a positive doping test.

3. How to use BECLOMETASONE DOC generics

BECLOMETASONE DOC generics is available in 4 different dosages. Your doctor will decide which dosage you need. BECLOMETASONE DOC GENERICI 200
micrograms and BECLOMETASONE DOC GENERICI 250 micrograms are not suitable for
children.
Always use the inhaler exactly as your doctor or pharmacist has instructed.
Consult your doctor or pharmacist if you have any doubts. The instructions for using the inhaler are
provided in the “Instructions for use” section. It takes a few days for the therapy to take
effect. It is very important to use it regularly.

Do not stoptreatment even if your symptoms improve unless your doctor advises you to.
Do not stopinhaled treatment abruptly.
While using BECLOMETASONE DOC generics, your doctor will monitor you
carefully by performing simple breathing tests and periodic blood tests.

Dosage:
Your doctor will decide the initial dose based on the severity of the disease. This may be
higher than the doses indicated below.
Initially, your doctor will prescribe the minimum dose of BECLOMETASONE DOC generics to
control your symptoms.
The spacer device called Volumatic must always be used in the following cases:

• adults, elderly patients and adolescents aged 16 years or older who take daily doses of BECLOMETASONE DOC generics equal to or greater than 1000 mcg,
• children and adolescents aged 15 years or younger regardless of the dosage.

BECLOMETASONE DOC generics 50 micrograms
The initial dose is:
Adults and elderly patients: 200 micrograms (4 puffs) twice a day
Children: 100 micrograms (2 puffs) twice a day
The maximum daily dose is:
Adults and elderly patients: 800 micrograms (16 puffs)
Children: 400 micrograms (8 puffs)
The maximum daily dose can be divided into 2, 3 or 4 inhalations per day.

BECLOMETASONE DOC generics 100 micrograms
The initial dose is:
Adults and elderly patients: 200 micrograms (2 puffs) twice a day
Children: 100 micrograms (1 puff) twice a day
The maximum daily dose is:
Adults and elderly patients: 800 micrograms (8 puffs)
Children: 400 micrograms (4 puffs)
The maximum daily dose can be divided into 2, 3 or 4 inhalations per day.

BECLOMETASONE DOC generics 200 micrograms
The initial dose is:
Adults and elderly patients: 200 micrograms (1 puff) twice a day
The maximum daily dose is:
Adults and elderly patients: 200 micrograms (1 puff) twice a day
The maximum daily dose should not exceed 800 micrograms (4 puffs)
The maximum daily dose can be divided into 2, 3 or 4 inhalations per day.

This dosage is not recommended for children
BECLOMETASONE DOC generics 250micrograms
The initial dose is:
Adults and elderly patients: 500 micrograms (2 puffs) twice a day
The maximum daily dose should not exceed 2000 micrograms (8 puffs)
The maximum daily dose can be divided into 2, 3 or 4 inhalations per day.

This dosage is not recommended for children
If you use more BECLOMETASONE DOC generics than you should
Tell your doctor as soon as possible. Your doctor may want to check your cortisol levels in your blood and,
therefore, a blood sample may need to be taken (cortisol is a steroid hormone that
is naturally found in the body).
It is important to take the dose recommended by your doctor. Do not change the dosage without consulting
your doctor.

If you forget to use BECLOMETASONE DOC generics
Do not take a double dose to make up for a missed dose. Take the next
dose as normal. Do not take more inhalations than prescribed.

Instructions for use:
It is important to know how to use the inhaler correctly. Your doctor, nurse or
pharmacist will show you how to use the inhaler correctly and will check your correct
use. It is important to follow the instructions carefully, to know how, whenand in what
quantity and how often you should use the medicine. The instructions are provided in
if you experience problems with inhalation, contact your doctor, nurse or pharmacist.

• 1. Remove the protective cap from the mouthpiece, hold it between your thumb and index finger, and remove it with a slight outward movement (as shown). Always check that the actuator is clean and free of foreign objects.

Testing the inhaler:if the inhaler is new or has not been used for more than three days, spray a dose
into the air to make sure it works .

• 2. Hold the inhaler in an upright position as shown in the figure, with your thumb on the base, under the mouthpiece. Exhale as much as possible.

• 3. Place the mouthpiece in your mouth between your teeth, closing your lips, without biting.

• 4. Immediately after starting to inhale deeply through your mouth, press on the top of the inhaler until a dose is released

• 5. Hold your breath; keep the inhaler in your mouth holding it at the top with your finger. Hold your breath for a few seconds or as long as possible. Exhale slowly.
• 6. If you want to take another inhalation, hold the inhaler in an upright position and wait about half a minute before repeating steps 2 to 5.

• 7. After use, always close the mouthpiece with the cap to prevent dust and lint from accumulating. Reclose firmly until you hear a click.

Important: do not rush through steps 2, 3, 4 and 5.
It is important to breathe as slowly as possible before using the inhaler. The first few times, practice
in front of a mirror.

If you see "mist" around the top of the inhaler or on the sides of your mouth, the beclometasone
will not pass into your lungs as it should. In this case, repeat the inhalation, carefully following
the instructions from step 2 onwards.
People with a weak grip or children may hold the inhaler with both hands. Place
both index fingers on the top of the inhaler and both thumbs on the bottom under the mouthpiece.

If you have difficulty getting the inhaler to work during inhalation, you can use the
Volumatic spacer device. Ask your doctor or pharmacist for help.
However, the Volumatic spacer device should always be used if:

• you are an adult, an elderly patient and an adolescent over 16 years of age who takes daily doses of BECLOMETASONE DOC generics of 1,000 micrograms;
• BECLOMETASONE DOC generics is used in children and adolescents aged 15 years or younger, regardless of the prescribed dose.

Small children may have difficulty using the inhaler correctly and will need help.
Using the inhaler with the Volumatic spacer device with a face mask can help
children under 5 years of age. Tell your doctor, nurse or pharmacist if you have
difficulty.
Cleaning:
It is important to clean the inhaler at least once a week to prevent it from malfunctioning.

• Remove the metal container from the plastic casing of the inhaler and remove the cap from the mouthpiece.
• Rinse the plastic casing and mouthpiece cap in warm water. If you use a mild liquid detergent, rinse thoroughly with clean water before drying. Do not immerse the metal container in water.
• Let it dry completely in a warm place. Avoid excessive heat.
• Reattach the mouthpiece cap.

follow the instructions carefully for correct use and thorough cleaning of Volumatic.

4. Possible side effects

Like all medicines, BECLOMETASONE DOC generics can cause side effects, although
not everyone gets them.
Stop taking BECLOMETASONE DOC generics immediately and contact
your doctor immediately if:

• you experience allergic reactions including skin rashes, hives, itching or redness or swelling of the face, eyes, lips and throat.
• you notice, immediately after using the inhaler, an increase in wheezing, shortness of breath and cough; stop using BECLOMETASONE DOC generics and use a fast-acting inhaled emergency medicine immediately. Contact your doctor immediately. Your doctor may change your treatment and prescribe a different inhaler to treat asthma.

The following side effects have been reported. Tell your doctor as soon as possibleif you suffer from any
of these side effects but do not stop treatmentunless you are told to do so. Your doctor will try to prevent these effects by prescribing BECLOMETASONE DOC
generics at the lowest possible dose to control your asthma symptoms.

Very common (may affect more than 1 in 10 people)

• Oral candidiasis of the mouth and/or throat (thrush). This is more likely to occur if the daily dose taken is greater than 400 micrograms. Thrush can be treated with antifungal medicines while continuing to use BECLOMETASONE DOC generics. To prevent thrush, wash your teeth or rinse your mouth thoroughly with water after each treatment.

Common (may affect up to 1 in 10 people)

• Hoarse voice (raucousness) or sore throat. To prevent this, use the spacer device

Volumatic and rinse your mouth with water immediately after inhalation.

Uncommon (may affect up to 1 in 100 people)

• Skin rash, hives, itching and/or erythema .

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

• Allergies, which manifest with swelling of eyelids, face, lips and/or throat (angioedema).
• Breathing difficulties such as dyspnea (shortness of breath or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with reduced inspiration).
• Anaphylactic or anaphylactoid reactions (severe allergic reactions that can make breathing difficult or alter consciousness).
• Children and adolescents may experience slowing of growth; regular monitoring of height by the doctor may be necessary. This occurs particularly after treatment with BECLOMETASONE DOC generics at high doses for prolonged periods of time.
• Rounded face (full moon) (Cushing's syndrome).
• A decrease in bone mineral density (thinning and weakening of the bones).
• Eye problems including cataract formation and glaucoma (increased eye pressure).
• Sleep disturbances, depression or feeling worried, restless, nervous, excited or irritable. These effects are more likely to occur in children.
• Paradoxical bronchospasm.

Frequency not known:

• Depression or aggression. These effects are more likely to occur in children.
• Blurred vision

If you feel unwell or develop symptoms such as loss of appetite, abdominal pain, weight loss,
fatigue, nausea, vomiting (feeling sick), fainting, sweating and possible convulsions
(seizures), consult your doctor. This is particularly important in cases of stress such as surgeries,
infections, acute asthma attacks or other serious illnesses.
Your doctor may periodically perform blood tests to monitor steroid levels in the body.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at:
https://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 DOC generics

• Keep this medicine out of the sight and reach of children.
• Do not use BECLOMETASONE DOC generics after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
• Protect from frost and direct sunlight.
• If the inhaler becomes very cold, remove the metal canister from the plastic casing and warm it between your handsfor a few minutes before use. Do not use everanything else to warm it.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Warning:the container contains a liquid under pressure. Keep away from sources of heat and
direct sunlight, do not expose to high temperatures (above 50 ° C). Do not puncture or burn
(incinerate) the container even if empty.

6. Package Contents and Other Information

What BECLOMETASONE DOC generics contains
The active ingredient of the medicine is beclometasone dipropionate. Each actuation contains 50, 100, 200
or 250 mcg of beclometasone dipropionate.
The other ingredients are glycerol, ethanol and norflurane (HFA-134a).

Description of the appearance of BECLOMETASONE DOC generics and package contents
50 mcg:
BECLOMETASONE DOC generics is a pressurized inhalation solution contained in an
aluminum canister with a cream-colored plastic actuator and a dark brown dust protection cap. Each container contains 200 actuations.

100mcg:
BECLOMETASONE DOC generics is a pressurized inhalation solution contained in an
aluminum canister with a gray plastic actuator and a light pink dust protection cap. Each container contains 200 actuations.

200mcg:
BECLOMETASONE DOC generics is a pressurized inhalation solution contained in an
aluminum canister with a light brown plastic actuator and a cream-colored dust protection
cap. Each container contains 200 actuations.

250mcg:
BECLOMETASONE DOC generics is a pressurized inhalation solution contained in an
aluminum canister with a burgundy plastic actuator and a gray dust protection cap. Each container contains 200 actuations.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. Via F. Turati n.40 - 20121 - Milano.

Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire
WD18 8YA, United Kingdom
Volumatic is a registered trademark of GlaxoSmithKline Group.