SOPROBEC 250 mcg/measured dose Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Soprobec, 50 micrograms/dose, inhalation aerosol, solution
3. Soprobec, 100 micrograms/dose, inhalation aerosol, solution
4. Soprobec, 200 micrograms/dose, inhalation aerosol, solution
5. Soprobec, 250 micrograms/dose, inhalation aerosol, solution
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Soprobec and what is it used for
7. Important information before using Soprobec
   1. When not to use Soprobec:
   2. Warnings and precautions
   3. Soprobec and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Soprobec contains alcohol
8. How to use Soprobec
   1. Dosage:
   2. Soprobec 50 micrograms
   3. Soprobec 100 micrograms
   4. Soprobec 200 micrograms
   5. This strength is not suitable for children.
   6. Soprobec 250 micrograms
   7. This strength is not suitable for children.
   8. Using a higher dose of Soprobec than recommended
   9. Missing a dose of Soprobec
   10. How to use
   11. Instructions for use
   12. Cleaning the inhaler
9. Possible side effects
   1. Stop using Soprobec and contact your doctor immediately if:
   2. Very common (may affect more than 1 in 10 people)
   3. Common (may affect up to 1 in 10 people)
   4. Uncommon (may affect up to 1 in 100 people)
   5. Rare (may affect up to 1 in 1,000 people)
   6. Frequency not known (frequency cannot be estimated from the available data)
   7. Reporting side effects
10. How to store Soprobec
    1. Keep the medicine out of the sight and reach of children.
11. Contents of the packaging and other information
    1. What Soprobec contains
    2. What Soprobec looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder:
    5. Manufacturer:
    6. To obtain more detailed information, contact the local representative of the marketing authorization holder:
    7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: information for the user

Soprobec, 50 micrograms/dose, inhalation aerosol, solution

Soprobec, 100 micrograms/dose, inhalation aerosol, solution

Soprobec, 200 micrograms/dose, inhalation aerosol, solution

Soprobec, 250 micrograms/dose, inhalation aerosol, solution

Beclometasone dipropionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Soprobec and what is it used for
• 2. Important information before using Soprobec
• 3. How to use Soprobec
• 4. Possible side effects
• 5. How to store Soprobec
• 6. Contents of the packaging and other information

1. What is Soprobec and what is it used for

Soprobec inhalation aerosol, solution is used for the preventionof asthma symptoms. The active substance, beclometasone dipropionate, belongs to a group of medicines called corticosteroids, which are often referred to as steroids. Steroids have anti-inflammatory effects, reducing swelling and irritation in the walls of the small airways in the lungs and making it easier to breathe.

2. Important information before using Soprobec

When not to use Soprobec:

• for the treatment of sudden asthma attacks. The medicine will not help. In this situation, a fast-acting inhalation medicine (rescue medicine) should be used, which should be carried with you at all times.

Warnings and precautions

Before starting treatment with Soprobec, discuss with your doctor, pharmacist, or nurse:

You should also discuss with your doctor, pharmacist, or nurse if the following situations apply to the patient:

• after switching from steroid tablets to an inhaled form, even if the patient feels an improvement in their airways, they may feel unwell overall, may experience a rash, eczema, nasal discharge (rhinitis), and sneezing (allergic rhinitis). Do not stopusing the inhaled medicine unless the doctor advises you to.

If the patient is using high doses of inhaled steroids for a long time and finds themselves in a stressful situation, they may need to be given a steroid medicine in the form of tablets or injections. For example, when admitted to the hospital after a serious accident, before surgery, during an acute asthma attack, or if the patient has a respiratory infection, or after another serious illness. The doctor will decide whether additional steroid treatment is necessary and advise how long to take the steroid tablets and how to reduce the dose if the patient feels better.

Soprobec and other medicines

Before starting treatment, tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

Tell your doctor if you are taking disulfiram or metronidazole, due to the possible risk of interaction, especially in sensitive individuals.

Remember to take this medicine and the inhaler with you if you need to go to the hospital.

Some medicines may enhance the effect of Soprobec, and your doctor may advise careful monitoring of your health if you are taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that Soprobec will affect your ability to drive or use machines.

Soprobec contains alcohol

This medicine contains 7.47 mg (50 micrograms and 100 micrograms strength), 8.05 mg (200 micrograms strength), and 8.62 mg (250 micrograms strength) of alcohol (ethanol) per dose, which is equivalent to 13% w/w (50 micrograms and 100 micrograms strength), 14% w/w (200 micrograms strength), and 15% w/w (250 micrograms strength). The amount of alcohol in each dose of this medicine is equivalent to less than 4 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

3. How to use Soprobec

Soprobec is available in 4 different strengths. Your doctor will determine the appropriate strength of the medicine for you. The 200 micrograms and 250 micrograms strengths are not suitable for children.

The inhaler should always be used as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The instructions for using the inhaler are provided in the section on dosage. It may take a few days for the medicine to start working, so it is essential to use it regularly.

Do not stoptreatment, even if you feel better, unless your doctor advises you to. Do notsuddenly stopusing the inhaler.

While using Soprobec, your doctor may regularly assess your asthma symptoms by performing a simple test to evaluate your lung function and ordering blood tests from time to time.

Dosage:

The initial dose will be determined by your doctor, depending on the severity of your asthma symptoms. It may be higher than the dose given below. Your doctor will prescribe the smallest dose of Soprobec that will control your symptoms.

A device known as a Volumatic inhalation chamber should always be used:

• when Soprobec is used in adults, the elderly, and adolescents aged 16 and over, and the total daily dose is 1000 micrograms or more,
• when Soprobec is used in children and adolescents under 16 years of age, who have been prescribed any dose.

Soprobec 50 micrograms

The usual initial dose is:

Adults and the elderly:

200 micrograms (4 puffs) twice a day

Children:

100 micrograms (2 puffs) twice a day

The usual maximum daily dose is:

Adults and the elderly:

800 micrograms (16 puffs)

Children:

400 micrograms (8 puffs)

The total daily dose can be divided into 2, 3, or 4 doses per day.

Soprobec 100 micrograms

The usual initial dose is:

Adults and the elderly:

200 micrograms (2 puffs) twice a day

Children:

100 micrograms (1 puff) twice a day

The usual maximum daily dose is:

Adults and the elderly:

800 micrograms (8 puffs)

Children:

400 micrograms (4 puffs)

The total daily dose can be divided into 2, 3, or 4 doses per day.

Soprobec 200 micrograms

The usual initial dose is:

Adults and the elderly:

200 micrograms (1 puff) twice a day

The usual maximum daily dose is:

800 micrograms (4 puffs)

The total daily dose can be divided into 2, 3, or 4 doses per day.

This strength is not suitable for children.

Soprobec 250 micrograms

The usual initial dose is:

Adults and the elderly:

500 micrograms (2 puffs) twice a day

The usual maximum daily dose is:

2000 micrograms (8 puffs)

The total daily dose can be divided into 2, 3, or 4 doses per day.

This strength is not suitable for children.

Using a higher dose of Soprobec than recommended

Tell your doctor as soon as possible. Your doctor may advise you to have a blood test to measure the level of cortisone in your blood, and therefore may advise you to have a blood sample taken (cortisone is a steroid hormone that occurs naturally in the body).

It is essential to use the dose as advised by your doctor. Do not increase or decrease the dose of the medicine without consulting your doctor.

Missing a dose of Soprobec

Do not take a double dose to make up for a missed dose. Take the next dose at the right time. Do not take more puffs than prescribed.

How to use

Soprobec is for inhalation use only.

Instructions for use

It is essential to know how to use the inhaler correctly. Your doctor, nurse, or pharmacist will instruct you on how to use the inhaler correctly and will regularly check that you are using it correctly. Follow the instructions carefully so that you know how when and how manypuffs of the medicine to use and how long to use the inhaler. If you have any doubts about using the inhaler or inhaling, consult your doctor, nurse, or pharmacist for help.

• 1. Remove the protective cap from the mouthpiece by holding it with your thumb and index finger, gently squeeze and pull it off as shown in the picture. Check that the mouthpiece is clean and free from debris, both inside and outside.

Checking the inhaler:If the inhaler is new or has not been used for at least 3 days, you should release one puff into the air to check that it is working.

• 2. Hold the inhaler upright as shown in the picture, holding the base of the inhaler with your thumb under the mouthpiece. Take a deep breath out without feeling uncomfortable.

• 3. Place the mouthpiece in your mouth between your teeth and seal it with your lips, without biting it.

• 4. As you start to breathe in through your mouth, press the top of the inhaler to release one puff, continuing to breathe in slowly and deeply.

• 5. Hold your breath; remove the inhaler from your mouth and take your finger off the top of the inhaler. Continue to hold your breath for a few seconds or as long as is comfortable. Breathe out slowly.
• 6. If a second puff is required, hold the inhaler upright for about half a minute before repeating steps 2 to 5.

• 7. After use, always replace the protective cap to protect the mouthpiece from dust and dirt. The cap should be pushed on firmly until it clicks into place.

Important: The steps described in points 2, 3, 4, and 5 should not be performed too quickly.

It is essential to start breathing in as slowly as possible, just before activating the inhaler. Before using the inhaler for the first time, practice these steps in front of a mirror.

If you notice a "mist" coming out of the top of the inhaler or the sides of your mouth, this means that the medicine is not getting into your lungs as it should. Take another puff, following the instructions from step 2.

If patients have weak hands or the inhaler is being used by children, it may be easier for them to hold the inhaler with both hands. Place your index fingers on the top of the inhaler and your thumbs on the bottom of the inhaler under the mouthpiece.

If you find it difficult to use the inhaler while breathing in, you may use a Volumatic inhalation chamber. Consult your doctor, pharmacist, or nurse about this device.

However, a Volumatic inhalation chamber should always be used if:

• Soprobec is used in adults, the elderly, and adolescents aged 16 and over, and the total daily dose is 1000 micrograms or more,
• Soprobec is used in children and adolescents under 16 years of age, who have been prescribed any dose.

Young children may find it difficult to use the inhaler correctly, and assistance may be necessary. In children under 5 years of age, using the inhaler with a Volumatic inhalation chamber and a face mask may be helpful. Consult your doctor, nurse, or pharmacist if you have any difficulties.

Cleaning the inhaler

It is essential to clean the inhaler at least once a week to prevent it from becoming blocked.

• Remove the metal canister from the plastic inhaler and take off the protective cap from the mouthpiece.
• Wash the plastic inhaler and the protective cap of the mouthpiece in warm water. If you use a mild detergent to clean, make sure to rinse it thoroughly before drying. Do not put the metal canister in water.
• Leave to dry in a warm place. Avoid excessive heat.
• Put the canister back and replace the protective cap of the mouthpiece.

It is essential to read the leaflet accompanying the Volumatic inhalation chamber and follow the instructions for its use and cleaning carefully.

4. Possible side effects

Like all medicines, Soprobec can cause side effects, although not everybody gets them.

Stop using Soprobec and contact your doctor immediately if:

• you experience an allergic reaction, including skin rash, urticaria, itching, or redness, or swelling of the face, eyes, lips, or throat.
• after using the medicine, you suddenly experience worsening wheezing, shortness of breath, or coughing.Stopusing Soprobec and use a fast-acting inhalation medicine (rescue medicine) immediately. Contact your doctor immediately. Your doctor will assess your asthma symptoms and may decide to change your treatment or prescribe another inhalation medicine for asthma.

The following side effects have been reported. If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor as soon as possible, but do not stoptreatment unless your doctor advises you to. To prevent side effects, your doctor will prescribe the smallest possible dose of Soprobec to control your asthma symptoms.

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

• Fungal infection (candidiasis) in the mouth and (or) throat (thrush). The occurrence of this side effect is more likely if the daily dose is greater than 400 micrograms. Thrush can be treated with antifungal medicines while you continue to use Soprobec. To prevent fungal infections in the mouth and throat, brush your teeth with a toothbrush or rinse your mouth with water after each dose of the medicine.

Common (may affect up to 1 in 10 people)

• Hoarseness or sore throat or tongue. To prevent these symptoms, use a Volumatic inhalation chamber or rinse your mouth with water after each use of the inhaler.

Uncommon (may affect up to 1 in 100 people)

• Rash, urticaria, itching, and (or) redness.

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

• Allergic reactions, including swelling of the eyelids, face, lips, and (or) throat (angioedema).
• Breathing difficulties, such as shortness of breath (feeling of shallow breathing or difficulty breathing) and (or) bronchospasm (narrowing of the airway walls with reduced airflow).
• Anaphylactic and anaphylactoid reactions (severe allergic reactions that can cause breathing difficulties or affect consciousness).
• Children and adolescents may grow more slowly, so your doctor may regularly check their growth rate. This may happen if Soprobec is used in high doses for a long time.
• Moon face (Cushing's syndrome).
• Decreased bone density (thinning and weakening of bones).
• Eyelid problems, including cataracts and glaucoma (increased pressure in the eye).
• Paradoxical bronchospasm.

Frequency not known (frequency cannot be estimated from the available data)

• Sleep problems, depression, or feelings of anxiety, restlessness, excitement, or irritability. The occurrence of these symptoms is more likely in children.
• Blurred vision.
• Headache.
• Nausea.

If you feel unwellor experience symptoms such as loss of appetite, abdominal pain, weight loss, fatigue, nausea (vomiting), feel weak, sweat, or have tremors, contact your doctor. This is especially important if you are in a stressful situation, such as surgery, an infection, an acute asthma attack, or another serious illness.

Your doctor may advise you to have blood tests from time to time to measure the level of steroids in your body.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Soprobec

Keep the medicine out of the sight and reach of children.

• Do not use Soprobec after the expiry date stated on the carton after EXP or on the inhaler label after EXP. The expiry date refers to the last day of the month stated.
• Do not freeze.
• Store in the original packaging to protect from light.
• If the inhaler is very cold, take the metal canister out of the plastic inhaler and warm it in your hands for a few minutes neverwarm it in any other way.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Warning:The canister contains a pressurized liquid. Store away from heat sources and protect from direct sunlight, do not expose to high temperatures (above 50°C), and do not puncture or burn, even after use.

6. Contents of the packaging and other information

What Soprobec contains

The active substance of the inhaled medicine is beclometasone dipropionate. Each actuated dose contains 50, 100, 200, or 250 micrograms of beclometasone dipropionate.

The other ingredients are glycerol, anhydrous ethanol, and norflurane (HFC-134a).

This medicine contains fluorinated greenhouse gases.

Soprobec, 50 micrograms:

Each inhaler contains 11.808 g of HFC-134a, which is equivalent to 0.017 tons of CO2 equivalent (GWP = 1430)

Soprobec, 100 micrograms:

Each inhaler contains 11.796 g of HFC-134a, which is equivalent to 0.017 tons of CO2 equivalent (GWP = 1430)

Soprobec, 150 micrograms:

Each inhaler contains 11.634 g of HFC-134a, which is equivalent to 0.017 tons of CO2 equivalent (GWP = 1430)

Soprobec, 200 micrograms:

Each inhaler contains 11.484 g of HFC-134a, which is equivalent to 0.016 tons of CO2 equivalent (GWP = 1430)

What Soprobec looks like and contents of the pack

Soprobec 50 micrograms/dose is an inhalation aerosol solution in an aluminum canister with a cream-colored plastic inhaler and a dark brown protective cap. Each carton contains one inhaler or two inhalers. Each canister contains 200 doses (puffs).

Soprobec 100 micrograms/dose is an inhalation aerosol solution in an aluminum canister with a gray plastic inhaler and a light pink protective cap. Each carton contains one inhaler or two inhalers. Each canister contains 200 doses (puffs).

Soprobec 200 micrograms/dose is an inhalation aerosol solution in an aluminum canister with a pink plastic inhaler and a red protective cap. Each carton contains one inhaler or two inhalers. Each canister contains 200 doses (puffs).

Soprobec 250 micrograms/dose is an inhalation aerosol solution in an aluminum canister with a burgundy-colored plastic inhaler and a gray protective cap. Each carton contains one inhaler or two inhalers. Each canister contains 200 doses (puffs).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b

140 78 Prague 4

Czech Republic

Manufacturer:

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park

Croxley Green, WD18 8YA Hertfordshire

United Kingdom

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzędz

Poland

To obtain more detailed information, contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.

ul. Osmańska 14

02-823 Warsaw

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:December 2024