Beclometasone Doc Generici

Italy
Brand name Beclometasone Doc Generici
Form solution, inhalation
Active substance / Dosage
BECLOMETASONE DIPROPIONATE
Prescription type Prescription only
ATC code
R03BA01
Registration number 048102
Manufacturer DOC GENERICI SRL

Table of Contents

PACKAGE LEAFLET: Information for the user

BECLOMETASONE DOC generici 50 micrograms per dose solution

pressurised inhalation
BECLOMETASONE DOC generici 100 micrograms per dose solution
pressurised inhalation
BECLOMETASONE DOC generici 200 micrograms per dose solution
pressurised inhalation
BECLOMETASONE DOC generici 250 micrograms per dose solution
pressurised inhalation
beclometasone dipropionate
Generic 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 may be harmful.
  • If you experience any side effect, including 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 using 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 BECLOMETASONE DOC GENERICI is and what it is used for

BECLOMETASONE DOC GENERICI pressurised solution for inhalation is used to
prevent asthma symptoms. The active substance, beclometasone dipropionate, belongs to the group
of corticosteroids, often simply referred to as steroids. Steroids have an anti-inflammatory action that reduces swelling and inflammation in the walls of the airways, thereby relieving breathing difficulties.

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

Do not use BECLOMETASONE DOC GENERICS if:

  • you are allergic to any of the ingredients of this medicine or to other medicines used to treat asthma.
  • you need to treat a sudden asthma attack. Use a fast-acting inhaler for this purpose and always carry it with you.

Warnings and precautions
Exercise particular caution and consult your doctor, pharmacist, or nurse before using BECLOMETASONE DOC GENERICS if any of the following apply to you:

  • you are currently being treated or have previously been treated for tuberculosis (TB).
  • you have recently had oral thrush (a fungal infection in the mouth).
  • you consume or have consumed alcohol for any reason.
  • your asthma worsens or does not improve, or you experience increased breathing difficulties and need to use your rescue inhaler more frequently, or if it fails to relieve your symptoms.

Your doctor may need to increase your corticosteroid dose, prescribe a course of oral corticosteroid tablets, or change your 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 might feel unwell and develop a skin rash, eczema, runny nose, or sneezing (rhinitis). Do not stop your inhaled treatment unless your doctor tells you to do so.

If you have been treated for a long time with high doses of inhaled corticosteroids, you may require an additional course of oral corticosteroid tablets during periods of stress. For example, during hospitalization after a serious accident, before surgery, during an acute asthma attack, or if you have a chest infection or other serious illness. Your doctor will assess whether additional corticosteroid treatment is needed, advise you on the duration of oral therapy with corticosteroid tablets, and how to gradually reduce the dose as your symptoms improve.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and BECLOMETASONE DOC GENERICS
Before starting treatment, inform your doctor if you are currently taking, have recently taken, or might take other medicines, including those obtained without a prescription.

Inform your doctor if you are taking disulfiram or metronidazole, as there is a potential risk of interaction in particularly sensitive patients.

If you go to hospital, remember to bring your medicines and inhalers with you.

Some medicines may increase the effects of BECLOMETASONE DOC GENERICS, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
BECLOMETASONE DOC GENERICS does not affect your ability to drive or operate machinery.

BECLOMETASONE DOC GENERICS contains alcohol:
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose (spray).

For individuals engaged in sports activities, the use of medicines containing ethyl alcohol may lead to a positive result in anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.

For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test regardless.

3. How to use BECLOMETASONE DOC generici

BECLOMETASONE DOC generici is available in 4 different strengths. Your doctor will decide which strength you need. BECLOMETASONE DOC GENERICI 200 micrograms and BECLOMETASONE DOC GENERICI 250 micrograms are not suitable for children.
Always use the inhaler exactly as directed by your doctor or pharmacist.
Consult your doctor or pharmacist if you have any doubts. Instructions for using the inhaler are provided in the section “Instructions for use”. It may take several days for the treatment to take effect. It is very important to use it regularly.
Do not stop the treatment even if your symptoms improve, unless your doctor advises you to do so. Do not stop the inhaled treatment abruptly.
While using BECLOMETASONE DOC generici, your doctor will monitor you closely by performing simple breathing tests and periodic blood tests.

Dosage:
Your doctor will determine the initial dose based on the severity of your condition. This may be higher than the doses listed below.
Initially, your doctor will prescribe the lowest effective dose of BECLOMETASONE DOC generici needed to control your symptoms.

The spacer device called Volumatic must always be used in the following cases:

  • adults, elderly, and adolescents aged 16 years and older who are taking daily doses of BECLOMETASONE DOC generici equal to or greater than 1000 mcg,
  • children and adolescents aged 15 years and younger, regardless of the prescribed dose.

BECLOMETASONE DOC generici 50 micrograms
Initial dose:
Adults and elderly: 200 micrograms (4 sprays) twice daily
Children: 100 micrograms (2 sprays) twice daily
Maximum daily dose:
Adults and elderly: 800 micrograms (16 sprays)
Children: 400 micrograms (8 sprays)
The maximum daily dose may be divided into 2, 3, or 4 inhalations per day.

BECLOMETASONE DOC generici 100 micrograms
Initial dose:
Adults and elderly: 200 micrograms (2 sprays) twice daily
Children: 100 micrograms (1 spray) twice daily
Maximum daily dose:
Adults and elderly: 800 micrograms (8 sprays)
Children: 400 micrograms (4 sprays)
The maximum daily dose may be divided into 2, 3, or 4 inhalations per day.

BECLOMETASONE DOC generici 200 micrograms
Initial dose:
Adults and elderly: 200 micrograms (1 spray) twice daily
Maximum daily dose:
Adults and elderly: 800 micrograms (4 sprays)
The maximum daily dose must not exceed 800 micrograms (4 sprays).
The maximum daily dose may be divided into 2, 3, or 4 inhalations per day.
This strength is not recommended for children.

BECLOMETASONE DOC generici 250 micrograms
Initial dose:
Adults and elderly: 500 micrograms (2 sprays) twice daily
Maximum daily dose must not exceed 2000 micrograms (8 sprays).
The maximum daily dose may be divided into 2, 3, or 4 inhalations per day.
This strength is not recommended for children.

If you use more BECLOMETASONE DOC generici than you should
Inform your doctor as soon as possible. Your doctor may wish to check your blood cortisol levels, and a blood sample may therefore be required (cortisol is a steroid hormone naturally present in the body).
It is important to take the dose prescribed by your doctor. Do not change the dose without consulting your doctor.

If you forget to use BECLOMETASONE DOC generici
Do not take a double dose to make up for the missed dose. Take the next dose as scheduled. Do not perform 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 properly and will check that you are using it correctly. It is essential to follow the instructions carefully to understand how, when, how much, and how often you should use the medicine. These instructions are provided in this patient information leaflet under the section “Instructions for use”. If you are unsure what to do or experience difficulties with inhalation, consult your doctor, nurse, or pharmacist.

  1. Remove the protective cap from the mouthpiece by gripping it between your thumb and index finger and pulling it off gently outward (as shown). Always check that the inhaler is clean and free from foreign objects.
Two hands separate a rectangular component from the base of a cylindrical medical device indicated by a directional arrow

Inhaler test: If the inhaler is new or has not been used for more than three days, spray one dose into the air to ensure it is working properly.

  1. Hold the inhaler upright as shown in the figure, with your thumb placed on the base, below the mouthpiece. Breathe out fully.
Side profile of a face inhaling air from a handheld inhaler with an arrow indicating the airflow direction
  1. Place the mouthpiece in your mouth between your teeth, close your lips around it, without biting.
Line drawing of a human profile holding a vertical medical device near the nose and mouth for administration
  1. Immediately after starting to inhale slowly and deeply through your mouth, press down on the top of the inhaler to release one dose.
Illustration of a person using an inhaler by placing it in front of the mouth while pressing down to release a cloud of medication

  1. Hold your breath; keep the inhaler in your mouth, holding it with your finger on top. Hold your breath for a few seconds or as long as possible. Then breathe out slowly.

  2. If you wish to take another inhalation, keep the inhaler upright and wait about half a minute before repeating steps 2 to 5.

Black and white drawing of a human profile holding an inhaler near the mouth and nose for administration
  1. After use, always cover the mouthpiece with the cap to prevent dust and fluff from accumulating. Close firmly until you hear a click.
Two hands separate a rectangular component from the base of a medical device following the direction of a gray arrow

Important: Do not rush steps 2, 3, 4, and 5.
It is important to breathe as slowly as possible before using the inhaler. Practice the first few times in front of a mirror.
If you see a "mist" around the top of the inhaler or around the sides of your mouth, the beclomethasone is not reaching your lungs properly. In this case, repeat the inhalation, carefully following the instructions from step 2 onwards.
People with weak hand grip or children may hold the inhaler with both hands. Place both index fingers on top of the inhaler and both thumbs underneath the base, below the mouthpiece.
If you have difficulty operating the inhaler during inhalation, you may use the Volumatic spacer device. Ask your doctor or pharmacist for assistance.
However, the Volumatic spacer device must always be used if:

  • you are an adult, elderly person, or adolescent aged over 16 years taking daily doses of BECLOMETASONE DOC generici of 1,000 micrograms or more;
  • BECLOMETASONE DOC generici is used in children and adolescents aged 15 years or younger, regardless of the prescribed dose.

Young children may have difficulty using the inhaler correctly and will need help.
Using the inhaler with the Volumatic spacer device and a face mask may assist children under 5 years of age. Inform your doctor, nurse, or pharmacist if you experience difficulties.

Cleaning:
It is important to clean the inhaler at least once a week to prevent it from malfunctioning.

  • Remove the metal canister from the plastic inhaler casing and remove the mouthpiece cap.
  • Rinse the plastic casing and mouthpiece cap under warm water. If using a mild liquid detergent, rinse thoroughly with clean water before drying. Do not immerse the metal canister in water.
  • Allow to dry completely in a warm place. Avoid excessive heat.
  • Replace the mouthpiece cap.

It is important to also read the instruction leaflet provided with the Volumatic spacer device and carefully follow the instructions for its correct use and thorough cleaning.

4. Possible side effects

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

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

The following side effects have been reported. Inform your doctor as soon as possible if you experience any
of these side effects, but do not stop treatment unless instructed to do so. Your doctor will try to prevent these side effects by prescribing BECLOMETASONE DOC
generics at the lowest possible dose needed to control asthma symptoms.
Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

  • Hoarseness (dysphonia) or sore throat. To prevent this, use a 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)

  • Allergic reactions presenting as swelling of the eyelids, face, lips, and/or throat (angioedema).
  • Respiratory disorders such as dyspnea (shortness of breath or breathing difficulty) and/or bronchospasm (narrowing of the bronchial walls resulting in reduced inspiration).
  • Anaphylactic or anaphylactoid reactions (severe allergic reactions that may cause difficulty breathing or altered consciousness).
  • Children and adolescents may experience slowed growth; regular monitoring of height by the doctor may be necessary. This is particularly likely after prolonged treatment with high doses of BECLOMETASONE DOC generics.
  • Rounded face ("moon face") (Cushing's syndrome).
  • Decreased bone mineral density (thinning and weakening of bones).
  • Eye problems including cataract formation and glaucoma (increased intraocular pressure).
  • Sleep disturbances, depression, feelings of anxiety, restlessness, nervousness, excitement, or irritability. These 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 experience illness or develop symptoms such as loss of appetite, abdominal pain, weight loss, fatigue, nausea, vomiting (feeling unwell), fainting, sweating, or possible seizures (fits), consult your doctor. This is particularly important during periods of stress such as surgery, infections, acute asthma attacks, or other serious illnesses.
Your doctor may periodically perform blood tests to monitor steroid levels in your body.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 generici

  • Keep this medicine out of the sight and reach of children.
  • Do not use BECLOMETASONE DOC generici after the expiry date stated on the package. The expiry date refers to the last day of that month.
  • Protect from freezing and direct sunlight.
  • If the inhaler becomes very cold, remove the metal canister from the plastic holder and warm it in the hands for a few minutes before use. Never use anything 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 protect the environment.

Warning: The container contains a pressurised liquid. Keep away from heat sources and
direct sunlight. Do not expose to high temperatures (above 50 °C). Do not pierce or burn
(incinerate) the container, even if it is empty.

6. Package contents and other information

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

Description of the appearance of BECLOMETASONE DOC generici and contents of the pack
50 mcg:
BECLOMETASONE DOC generici is a pressurized inhalation solution contained in an aluminium canister with a cream-coloured plastic actuator and a dark brown dust-protective cap. Each container contains 200 actuations.

100 mcg:
BECLOMETASONE DOC generici is a pressurized inhalation solution contained in an aluminium canister with a grey plastic actuator and a light pink dust-protective cap. Each container contains 200 actuations.

200 mcg:
BECLOMETASONE DOC generici is a pressurized inhalation solution contained in an aluminium canister with a light brown plastic actuator and a cream-coloured dust-protective cap. Each container contains 200 actuations.

250 mcg:
BECLOMETASONE DOC generici is a pressurized inhalation solution contained in an aluminium canister with a burgundy plastic actuator and a grey dust-protective 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, Italy.

Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire
WD18 8YA, United Kingdom

Volumatic is a registered trademark of the GlaxoSmithKline group.