Package Insert: Information for the Patient

Soprobec 50 micrograms/inhalation solution for inhalation in a pressurized container

Beclometasone, dipropionate

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1.What Soprobec is and for what it is used

2.What you need to know before starting to use Soprobec

3.How to use Soprobec

4.Possible adverse effects

5.Storage of Soprobec

6.Contents of the container and additional informationl.

Soprobec inhalation solution in a pressurized container is used to help prevent symptoms of asthma. The active ingredient, dipropionate beclometasone,preventthe symptoms of asthma. The active ingredient, dipropionate beclometasone,belongs to a group of medicines known as corticosteroids, sometimes also called simply steroids. Steroids have an anti-inflammatory action, reducing swelling and irritation of the walls of the small airways through which air passes in the lungs and thus facilitate breathing.

Do not use Soprobec:

• if you are allergic to beclomethasone dipropionate or any of the components of this medication (listed in section 6) or any other medication used to treat asthma.
• to treat a sudden attack of breathing difficulty. It will not help. Use a quick-acting inhaler for this purpose and carry it with you at all times.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Soprobec:

• if you have or have been treated for tuberculosis.
• if you have had mouth ulcers.
• you should avoid consuming alcohol for any reason.

Also consult your doctor, pharmacist, or nurse:

• if your asthma seems to be getting worse. You may be more breathless and short of breath than usual, your rescue inhaler seems to be less effective, you need more puffs than usual from your rescue inhaler, or you do not seem to be improving.
• when you are transferred from a treatment with oral steroids to an inhaler, you will find that, even if your chest is improving, you feel unwell, develop a rash, itching, or nasal discharge and sneezing (rhinitis).Do not interruptyour treatment with your inhaler unless your doctor tells you to.

If you have been treated with high doses for a long period of time with inhaled steroids, you may need oral steroid treatment or possibly an intramuscular steroid injection at times of stress. For example, during hospital admission after a serious accident, before surgery, during a severe asthma attack, or if you have a chest infection or other serious illness. Your doctor will consider whether you need supplementary steroid treatment and will inform you of how long you need to continue taking oral steroids and how to reduce them as you improve.

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

Other medications and Soprobec

Before starting treatment, inform your doctor if you are taking or have recently taken or may need to take any other medication, 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 individuals.

Remember to carry these medications and your inhalers with you if you visit the hospital.

Some medications may increase the effects of Soprobec, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Soprobechas no known effects on driving and operating machinery.

Soprobec contains alcohol

This medication contains 7.47 mg of alcohol (ethanol) in each inhalation, which is equivalent to a 13%. The amount of alcohol in each inhalation is equivalent to less than 4 ml of beer or 2 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

Soprobec is available in 4 different doses. Your doctor will decide the dose you need. Soprobec 200 micrograms/inhalation and Soprobec 250 micrograms/inhalation are not indicated for children.and Soprobec 250 micrograms/inhalation are not indicated for children.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The inhaler instructions are given after the dosage section. The inhaler takes a few days to work. It is very important that you use it regularly.

Do not interruptthe treatment even if you feel better unless your doctor tells you to. Do not stop using the inhaler suddenly.Do not interruptthe use of the inhaler suddenly.

During your treatment with Soprobec, your doctor will evaluate your asthma regularly through simple breathing tests and may need to perform occasional blood tests.

Dosage:

The initial dose will depend on the severity of your asthma and will be decided by your doctor. It may be higher than those described below. Your doctor will prescribe the lowest dose of Soprobec that controls your symptoms.

The Volumatic™ spacer inhalation chamber must always be used when:

• Adults, elderly patients, and adolescents over 16 years inhale total daily doses of Soprobec equal to or greater than 1,000 micrograms.
• When Soprobec is used in children and adolescents under 15 years at any prescribed dose.

Soprobec 50 micrograms/inhalation

The standard initial dose is:

Adults and elderly patients:200 micrograms (4 puffs) twice a day

Children:100 micrograms (2 puffs) twice a day

Normally, the maximum you will inhale in a day is:

Adults and elderly patients:800 micrograms (16 puffs)

Children:400 micrograms (8 puffs)

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

If you use more Soprobec than you should:

Let your doctor know as soon as possible. Your doctor may want to check your blood cortisol levels, so you will need to take a blood sample (cortisol is a naturally occurring steroid hormone in the human body).

It is essential that you take your dose as your doctor tells you. Do not increase or decrease your dose without medical supervision.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forgot to use Soprobec:

Do not take a double dose to compensate for the missed doses, simply wait for the next dose. Do not take more puffs than prescribed.

Method of administration

Soprobec is for inhalation use.

Instructions for use:

It is essential that you know how to use your inhaler correctly. Your doctor, nurse, or pharmacist will teach you how to use your inhaler correctly and check it periodically to ensure you are using it correctly. You must follow the instructions carefully, so you knowhow,when, andhow manypuffs to inhale and how often to use your inhaler. If you are unsure of what to do or have trouble inhaling, consult your doctor, nurse, or pharmacist.

1. To remove the protective cover, hold it between your index finger and thumb, gently press and remove the cover as shown. Check that the mouthpiece is clean inside and out, and there are no foreign objects.

Checking the inhaler:If the inhaler is new or has not been used for 3 or more days, perform a puff to the air to make sure it works.

1. Place the inhaler in a vertical position as shown, with your thumb on the base, under the mouthpiece. Exhale as much as is comfortable.

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

1. Just as you start to inhale through your mouth, press the top of the inhaler to make a puff while continuing to inhale deeply and uniformly.

1. Hold your breath; remove the inhaler from your mouth and your finger from the top of the inhaler. Continue to hold your breath for a few seconds or as long as is comfortable. Exhale slowly.
2. If you are going to make another puff, keep the inhaler vertical and wait half a minute before repeating steps 2 to 5.

1. After use, always put the protective cover back on to prevent dust and lint. Reattach it firmly and insert it into its position.Reattach it firmly and insert it into its position.

Important: Do not perform steps 2, 3, 4, and 5 quickly.

It is essential that you start inhaling as slowly as possible before operating the inhaler. Practice in front of a mirror the first few times.

If you see 'steam' coming out of the top of the inhaler or the sides of your mouth, the beclometasone will not reach your lungs properly. Take another puff, following the instructions carefully from step 2 onwards.

People with weak hands or children may find it easier to hold the inhaler with both hands. Place both index fingers on the top of the inhaler and both thumbs under the mouthpiece.

If you find it difficult to manage the inhaler while inhaling, use the Volumatic™ spacer inhalation chamber. Consult your doctor, nurse, or pharmacist about this device.

The Volumatic™ spacer inhalation chamber must always be used when:

• You are an adult, elderly patient, or adolescent 16 years or older who takes a total daily dose of Soprobec equal to or greater than 1,000 micrograms.
• Soprobec is used in children and adolescents under 15 years at any prescribed dose.

Young children may find it difficult to use the inhaler and may require assistance. Using the inhaler with a mask can help children under 5 years old.Inform your doctor, nurse, or pharmacist if you experience difficulties.

Cleaning:

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

• Remove the metal container from the plastic case and remove the protective cover.
• Wipe the plastic case and protective cover with warm water. If you use a mild detergent, wipe carefully with clean water before drying. Do not immerse the metal container in water.
• Let it dry well in a warm place. Avoid excessive heat.
• Put the metal container and protective cover back on.

It is essential that you read the attached prospectus with the Volumatic™ spacer inhalation chamber and follow the usage and cleaning instructions for the Volumatic™.

Like all medicines, Soprobec can cause side effects, although not everyone will experience them.

Stop taking Soprobec and consult your doctor if:

• You experience hypersensitivity reactions such as skin rashes, urticaria, itching, or redness, or swelling of the face, eyes, lips, and throat.
• You notice a sudden increase in wheezing, difficulty breathing, and cough after using your inhaler, stop using Soprobec and use a rescue inhaler with quick action immediately. Contact your doctor immediately. Your doctor will evaluate your asthma and may change your treatment and prescribe a different inhaler for your asthma.

The following side effects have been reported.Inform your doctor as soon as possibleif you experience any of these side effects butdo not interrupt treatmentunless instructed to do so. Your doctor will try to prevent these side effects by prescribing Soprobec at the lowest dose possible to control your asthma.

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

• Mouth and/or throat candidiasis (thrush). This is more likely if the dose is higher than 400 micrograms. Thrush can be treated with antifungals while you continue using Soprobec. Rinsing your mouth or gargling with water immediately after each dose may help prevent thrush.

Common (may affect up to 1 in 10 people)

• Hoarseness or throat irritation. Using a spacer for inhalation, Volumatic, or gargling with water immediately after each dose may help.

Rare (may affect up to 1 in 100 people)

• Rashes, urticaria, pruritus, and/or erythema.

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

• Allergies, which manifest as swelling of the eyelids, face, lips, and/or throat (angioedema).
• Respiratory alterations such as dyspnea (sensation of lack of air or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air entry).
• Anaphylactic or anaphylactoid reactions (severe allergic reactions that may impair breathing and alter consciousness).
• Delayed growth in children and adolescents, they may need to have their height checked periodically by the doctor. This occurs particularly after long-term treatment with Soprobec at high doses.
• Rounded face (moon face) (Cushing's syndrome).
• Bone density loss (narrowing and weakening of the bones)
• Eye problems such as cataract formation or glaucoma (increased eye pressure).
• Paradoxical bronchospasm.

Unknown frequency:

• Problems with sleep, depression, or feeling worried, nervous, overexcited, or irritable. These effects are more likely to occur in children.
• Blurred vision.
• Headache.
• Nausea.

Ifyou becomeill or develop symptoms such asloss of appetite, abdominal pain, weight loss, fatigue, nausea (feeling unwell), vomiting, dizziness, and possible seizures (attacks), you should consult your doctor. This is particularly important if you have been exposed to stressful situations such as surgery, infection, an acute asthma attack, or another serious illness. Your doctor may perform a blood test to monitor the levels of steroids in your body.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the outer packaging and label, after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Store in the original packaging to protect it from light.

If the inhaler becomes very cold, remove the metal container from the plastic case and warm itin your handsfor a few minutes before use.Neveruse anything else to warm it.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at thePharmacy Take-Back Point. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Warning:The container contains a pressurized liquid. Keep away from heat and direct sunlight, do not expose to high temperatures (above 122°F or 50°C) and do not pierce or burn (incinerate), even when empty.

Composition of Soprobec

• The active ingredient of its inhaler is dipropionate of beclometasone. Each actuation contains 50 micrograms of dipropionate of beclometasone.
• The other excipients are glycerol, anhydrous ethanol, and norflurane (HFC-134a).

This medication contains fluorinated greenhouse gases.

Each inhaler contains 11.808 g of HFC-134a, which corresponds to 0.017 tons of CO2 equivalent (global warming potential = 1430).

Appearance of Soprobec and contents of the package

Soprobec 50 micrograms/inhalation:

Soprobec is a solution for inhalation in a pressurized aluminum container with a plastic actuator of cream color and a dark brown protective cover. Each package contains a single inhaler or two inhalers. Each package contains 200 actuations.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Glenmark Arzneimittel GmbH

Industriestr. 31, Grobenzell

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire

WD18 8YA, United Kingdom

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoke Myto

Czech Republic

Synoptis Industrial Sp. z.o.o.

Ul. Rabowicka 15, 62-020 Swarzedz

Poland

Further information about this medication can be obtained by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:January 2021.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://aemps.gob.es/.

Volumatic™ is a registered trademark of GlaxoSmithKline Group of Companies.