Soprobec

Package leaflet: 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
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Soprobec is and what it is used for

Soprobec inhalation aerosol, solution is used for the prevention of asthma symptoms. The active substance, beclometasone dipropionate, belongs to a group of medicines called corticosteroids, often referred to as steroids. Steroids have an anti-inflammatory action, reducing swelling and irritation in the walls of the small airways in the lungs, and help to make breathing easier.

2. Important information before using Soprobec

When not to use Soprobec:

• if the patient is allergic to any of the ingredients of this medicine or to any other medicine used in the treatment of asthma,
• for the treatment of sudden asthma attacks. This medicine will not help. In such a situation, a fast-acting inhaled medicine (rescue medicine) should be used, which the patient should always carry with them.

Warnings and precautions
Before starting treatment with Soprobec, discuss the following with your doctor, pharmacist, or nurse:

• if the patient has been or has ever been treated for tuberculosis,
• if the patient has had oral thrush (fungal infection in the mouth),
• if the patient must avoid alcohol for any reason.

Also discuss with your doctor, pharmacist, or nurse if any of the following situations apply to the patient:

• if the patient suspects that asthma symptoms are worsening. Breathing becomes more wheezy or more shallow than usual, the inhaled rescue medicine seems less effective, and the patient needs to use more puffs of the rescue medicine than usual, or notices no improvement after using it.
• after switching from oral steroids to inhaled steroids, even if the patient feels better in terms of breathing, they may experience general malaise, rash, skin eruptions, nasal discharge (rhinitis), or sneezing (allergic rhinitis). Do not stop using the inhaled medicine unless advised by a doctor.

If the patient has been using high doses of inhaled steroids for a prolonged period and experiences a stressful situation, it may be necessary to administer steroid treatment in the form of tablets or injections. For example, during hospitalization following a serious accident, before surgery, during an acute asthma attack, or if the patient has a respiratory tract infection or another serious illness. The doctor will decide whether additional steroid treatment is needed and will advise on how long to take oral steroids and how to reduce the dose if the patient feels better.
If the patient experiences blurred vision or any other visual disturbances, they should contact their doctor.

Soprobec and other medicines
Before starting treatment, tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Inform the doctor if the patient is taking disulfiram or metronidazole, due to the possible risk of interaction, especially in sensitive individuals.
Remember to bring this medicine and the inhaler with you if you need to go to the hospital.
Some medicines may increase the effects of Soprobec, and the doctor may recommend careful monitoring of the patient's health if such medicines are being taken (including certain HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that Soprobec will affect the ability to drive or operate machinery.

Soprobec contains alcohol
This medicine contains 7.47 mg (50 microgram and 100 microgram strength), 8.05 mg (200 microgram strength), and 8.62 mg (250 microgram strength) of alcohol (ethanol) per metered dose, equivalent to 13% w/w (50 microgram and 100 microgram strength), 14% w/w (200 microgram strength), and 15% w/w (250 microgram strength). The amount of alcohol in each metered 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 cause noticeable effects.

3. How to use Soprobec

Soprobec is available in 4 different strengths. The prescribing doctor will determine the appropriate strength for the patient. The 200 microgram and 250 microgram strengths are not suitable for children. The inhaler must always be used according to the instructions of the doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Instructions for using the inhaler are provided in the dosing section. It may take several days before the medicine starts working, so it is important to use it regularly.
Do not stop treatment, even if the patient feels better, unless otherwise advised by the doctor. Do not suddenly stop using the inhaler.
While using Soprobec, the doctor may regularly monitor asthma symptoms by performing simple lung function tests and may order blood tests.

Dosage:
The initial dose will be determined by the doctor depending on the severity of asthma symptoms. It may be higher than the dose indicated below. The doctor will prescribe the lowest dose of Soprobec that controls symptoms.
The device known as the Volumatic spacer chamber must always be used:

• when Soprobec is used in adults, elderly patients, and adolescents aged 16 years and older, and the total daily dose is 1000 micrograms or more,
• when Soprobec is used in children and adolescents aged 15 years and younger, regardless of the prescribed dose.

Soprobec 50 micrograms
Typical starting dose:
Adults and elderly patients: 200 micrograms (4 actuations) twice daily
Children: 100 micrograms (2 actuations) twice daily
Typical maximum daily dose:
Adults and elderly patients: 800 micrograms (16 actuations)
Children: 400 micrograms (8 actuations)
The total daily dose may be divided into 2, 3, or 4 doses per day.

Soprobec 100 micrograms
Typical starting dose:
Adults and elderly patients: 200 micrograms (2 actuations) twice daily
Children: 100 micrograms (1 actuation) twice daily
Typical maximum daily dose:
Adults and elderly patients: 800 micrograms (8 actuations)
Children: 400 micrograms (4 actuations)
The total daily dose may be divided into 2, 3, or 4 doses per day.

Soprobec 200 micrograms
Typical starting dose:
Adults and elderly patients: 200 micrograms (1 actuation) twice daily
Typical maximum daily dose: 800 micrograms (4 actuations)
The total daily dose may be divided into 2, 3, or 4 doses per day.
This strength is not suitable for children.

Soprobec 250 micrograms
Typical starting dose:
Adults and elderly patients: 500 micrograms (2 actuations) twice daily
Typical maximum daily dose: 2,000 micrograms (8 actuations)
The total daily dose may be divided into 2, 3, or 4 doses per day.
This strength is not suitable for children.

Taking more than the recommended dose of Soprobec
Inform your doctor as soon as possible. The doctor may recommend measuring cortisol levels in the patient's blood and may therefore request a blood sample (cortisol is a steroid hormone naturally present in the body).
It is important that the patient uses the prescribed dose as directed. Do not increase or decrease the dose without consulting your doctor.

Missed dose of Soprobec
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time. Do not use more actuations than prescribed.

Method of administration
Soprobec is for inhalation use only.

Instructions for use
It is important that the patient knows how to use the inhaler correctly. The prescribing doctor, nurse, or pharmacist will instruct the patient on proper inhaler use and will regularly check that the patient is using it correctly. Follow the instructions carefully so that the patient knows how, when, and how many actuations of the medicine to use, and for how long the inhaler must be used. If in doubt about using the inhaler or inhalation technique, consult your doctor, nurse, or pharmacist for assistance.

1. Remove the protective cap from the mouthpiece by gently squeezing it with your thumb and index finger and pulling it off as shown in the picture. Check that the mouthpiece is clean and free from dirt both inside and outside.

Checking the inhaler: If the inhaler is new or has not been used for at least 3 days, release one actuation away from yourself (into the air) to check that it is working.

2. Hold the inhaler upright as shown in the picture, supporting it with your thumb at the base of the inhaler below the mouthpiece. Breathe out slowly and comfortably.

3. Place the mouthpiece in the mouth between the teeth and close lips around it, but do not bite it.

4. Immediately after starting to breathe in through the mouth, press down on the top of the inhaler to release one actuation, continuing to breathe in steadily and deeply.

5. Hold your breath; remove the inhaler from the mouth and take your finger off the top of the inhaler. Continue to hold your breath for a few seconds or as long as possible without discomfort. Breathe out slowly.
6. If a second actuation is needed, hold the inhaler upright for about half a minute, then repeat steps 2 to 5.

7. After use, always replace the protective cap to protect the mouthpiece from dust and dirt. Press the cap firmly until it clicks into place.

Important: Do not perform steps 2, 3, 4, and 5 too quickly.
It is important to begin 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 the patient sees a "mist" escaping from the top of the inhaler or from the sides of the mouth, this means the medicine is not reaching the lungs as it should. Take another actuation, following the instructions from step 2.
If patients have weak hands or the inhaler is used by children, it may be easier to hold the inhaler with both hands. Place the index fingers of both hands on the top of the inhaler and both thumbs on the bottom of the inhaler below the mouthpiece.
If the patient has difficulty using the inhaler during inhalation, a Volumatic spacer chamber may be used. Consult your doctor, pharmacist, or nurse about this device.
However, the Volumatic spacer chamber must always be used if:

• Soprobec is used in adults, elderly patients, and adolescents aged 16 years and older, and the total daily dose is 1000 micrograms or more,
• Soprobec is used in children and adolescents aged 15 years and younger, regardless of the prescribed dose.

Young children may find it difficult to use the inhaler correctly and may need assistance. For children under 5 years of age, using the inhaler with a Volumatic spacer chamber and a face mask may be helpful. Consult your doctor, nurse, or pharmacist if the patient experiences any difficulties.

Cleaning the inhaler
It is important to clean the inhaler at least once a week to prevent blockage.

• Remove the metal canister from the plastic actuator and remove the protective cap from the mouthpiece.
• Wash the plastic actuator and the protective cap in warm water. If a mild detergent is used, rinse thoroughly before drying. Do not immerse the metal canister in water.
• Leave to dry in a warm place. Avoid excessive heat.
• Reinsert the canister and replace the protective cap on the mouthpiece.

It is important to read the leaflet provided with the Volumatic spacer chamber and follow the instructions for its use and cleaning carefully.

4. Possible adverse reactions

Like any medicine, Soprobec may cause adverse reactions, although not everyone experiences them.
You must stop using Soprobec and contact your doctor immediately if:

• the patient develops allergic reactions, including skin rash, urticaria, itching or redness of the skin, or swelling of the face, eyes, lips or throat.
• after using the medicine, the patient suddenly develops worsening of wheezing, breathlessness or coughing. You must stop using Soprobec and immediately use a fast-acting inhaled medicine (reliever medicine). Contact your doctor without delay. The doctor will assess the patient's asthma symptoms and may decide to change the treatment regimen or prescribe another inhaled medicine for asthma.

The following adverse reactions have been reported. If any adverse reactions occur in the patient, you should inform the doctor as soon as possible, but do not stop treatment unless instructed by the doctor. To prevent adverse reactions, the doctor will prescribe the lowest possible dose of Soprobec needed to control asthma symptoms.

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

• Fungal infection (candidiasis) of the mouth and/or throat (thrush). This adverse reaction is more likely when the daily dose exceeds 400 micrograms. Thrush can be treated with antifungal medicines while the patient continues to use Soprobec. To prevent fungal infection of the mouth and throat, brush teeth or thoroughly rinse the mouth with water after each dose of the medicine.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Rash, urticaria, itching and/or erythema.

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

• Allergic reactions including swelling of the eyelids, face, lips and/or throat (angioedema).
• Breathing problems such as breathlessness (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 which may cause difficulty breathing or affect consciousness).
• Children and adolescents may grow more slowly; therefore, the doctor may regularly monitor growth rate. This may occur when Soprobec is used at high doses over a prolonged period.
• Rounded facial features (moon face) (Cushing's syndrome).
• Reduced bone mineral density (thinning and weakening of bones).
• Eye disorders, including cataract and glaucoma (increased pressure in the eyeball).
• Paradoxical bronchospasm.

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

• Sleep disturbances, depression or feelings of anxiety, restlessness, nervousness, excitement or irritability. These symptoms are more likely to occur in children.
• Blurred vision.
• Headache.
• Nausea.

If the patient feels worse or develops symptoms such as loss of appetite, abdominal pain, weight loss, fatigue, nausea (feeling sick), vomiting, weakness, sweating or convulsions, contact the doctor. This is particularly important if the patient is under stress, such as during surgery, infection, acute asthma attack or another serious illness.

The doctor may recommend periodic blood tests to measure steroid levels in the patient's body.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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

Adverse reactions can also be reported to the responsible entity.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Soprobec medicine

• Keep the medicine out of the sight and reach of children.
• Do not use Soprobec after the expiry date stated on the cardboard box after: "EXP" or on the inhaler label after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
• Do not freeze.
• Store in the original packaging to protect from light.
• If the inhaler is very cold, remove the metal container from the plastic dispenser and warm it in your hands for several minutes before use. Never warm it in any other way.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Note: The container holds contents under pressure. Store away from heat sources and protect from direct sunlight. Do not expose to high temperatures (above 50°C), and do not pierce or burn the container, even when empty.

6. Contents of the pack and other information

What Soprobec contains
The active substance is beclometasone dipropionate. Each metered spray 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, equivalent to 0.017 tonnes of CO₂
(global warming potential GWP = 1430)
Soprobec 100 micrograms:
Each inhaler contains 11.796 g of HFC-134a, equivalent to 0.017 tonnes of CO₂
(global warming potential GWP = 1430)
Soprobec 150 micrograms:
Each inhaler contains 11.634 g of HFC-134a, equivalent to 0.017 tonnes of CO₂
(global warming potential GWP = 1430)
Soprobec 200 micrograms:
Each inhaler contains 11.484 g of HFC-134a, equivalent to 0.016 tonnes of CO₂
(global warming potential GWP = 1430)

What Soprobec looks like and contents of the pack
Soprobec 50 micrograms/dose is a solution for inhalation aerosol contained in an aluminium pressurised canister with a cream-coloured plastic actuator and a dark brown protective cap. Each cardboard box contains one or two inhalers. Each canister contains 200 doses (sprays).

Soprobec 100 micrograms/dose is a solution for inhalation aerosol contained in an aluminium pressurised canister with a grey plastic actuator and a light pink protective cap. Each cardboard box contains one or two inhalers. Each canister contains 200 doses (sprays).

Soprobec 200 micrograms/dose is a solution for inhalation aerosol contained in an aluminium pressurised canister with a pink plastic actuator and a red protective cap. Each cardboard box contains one or two inhalers. Each canister contains 200 doses (sprays).

Soprobec 250 micrograms/dose is a solution for inhalation aerosol contained in an aluminium pressurised canister with a burgundy plastic actuator and a grey protective cap. Each cardboard box contains one or two inhalers. Each canister contains 200 doses (sprays).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturers:
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

For further information, contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Osmańska 14
02-823 Warszawa
Poland

This medicinal product is authorised for marketing in the European Economic Area under the following names: