VERIFLO (25 mcg + 250 mcg) Aerosol

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Veriflo, (25 micrograms + 50 micrograms)/metered dose, inhalation aerosol,
   1. Veriflo, (25 micrograms + 125 micrograms)/metered dose, inhalation aerosol, suspension
   2. Veriflo, (25 micrograms + 250 micrograms)/metered dose, inhalation aerosol, suspension
   3. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   4. Table of contents of the leaflet
3. What is Veriflo and what is it used for
   1. Veriflo prevents shortness of breath and wheezing in the airways. However, Veriflo should not be used to relieve sudden attacks of shortness of breath or wheezing in the airways. If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately.
4. Important information before using Veriflo
   1. When not to use Veriflo
   2. Warnings and precautions
   3. Veriflo and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
5. How to use Veriflo
   1. Adults and children over 12 years old
   2. Children from 4 to 12 years old
   3. If your asthma symptoms get worse or your breathing gets worse, you should
   4. Instructions for use
   5. Checking the inhaler:
   6. Warnings
   7. How to use the inhaler
   8. Cleaning the inhaler
   9. Using more Veriflo than recommended
   10. Missing a dose of Veriflo
   11. Stopping use of Veriflo
6. Possible side effects
   1. Allergic reactions: You may experience sudden breathing difficulties immediately after using Veriflo
   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 1000 people)
   6. Frequency not known (cannot be estimated from the available data)
   7. Reporting side effects
7. How to store Veriflo
8. Contents of the pack and other information
   1. What Veriflo contains
   2. What Veriflo looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. GENETIC S.p.A.
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. For further information about this medicine, you should contact your local representative of the marketing authorization holder:
   8. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Veriflo, (25 micrograms + 50 micrograms)/metered dose, inhalation aerosol,

suspension

Veriflo, (25 micrograms + 125 micrograms)/metered dose, inhalation aerosol, suspension

Veriflo, (25 micrograms + 250 micrograms)/metered dose, inhalation aerosol, suspension

Salmeterol + Fluticasone propionate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 Veriflo and what is it used for
• 2. Important information before using Veriflo
• 3. How to use Veriflo
• 4. Possible side effects
• 5. How to store Veriflo
• 6. Contents of the pack and other information

1. What is Veriflo and what is it used for

Veriflo contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to keep the airways open, making it easier to breathe in and out. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and inflammation in the lungs.

Your doctor has prescribed this medicine to prevent breathing problems that occur in asthma. Veriflo must be used every day, as directed by your doctor. This will ensure that your asthma is properly controlled.

Veriflo prevents shortness of breath and wheezing in the airways. However, Veriflo should not be used to relieve sudden attacks of shortness of breath or wheezing in the airways. If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately.

You should always carry such a medicine with you.

2. Important information before using Veriflo

When not to use Veriflo

• if you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Veriflo, you should talk to your doctor or pharmacist if you have:

• heart disease, including irregular or fast heartbeat,
• overactive thyroid gland,
• high blood pressure,
• diabetes (Veriflo may increase blood sugar levels),
• low potassium levels in the blood,
• tuberculosis currently being treated or previously treated, or other lung infections.

If you experience blurred vision or other vision problems, you should contact your doctor.

Veriflo and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about any medicines you plan to take, including those used for asthma and those available without a prescription. This is important because Veriflo should not be used with some other medicines.

Before starting to use Veriflo, you should inform your doctor about taking the following medicines:

• Beta-blockers (e.g., atenolol, propranolol, and sotalol). Beta-blockers are most commonly used to treat high blood pressure or other heart diseases.
• Medicines used to treat infections (e.g., ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (e.g., ritonavir, cobicistat-containing products). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects of Veriflo, including irregular heartbeat, or may worsen existing side effects. Your doctor may want to monitor your condition closely while you are taking such medicines.
• Corticosteroids (orally or by injection). If you have recently taken such medicines, it may increase the risk of adrenal gland problems.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

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

3. How to use Veriflo

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

• Veriflo should be used every day, until your doctor tells you to stop. Do not take more than the recommended dose. If you are unsure, consult your doctor or pharmacist.
• Do not stop using Veriflo or reduce the dose without consulting your doctor.
• Veriflo should be inhaled into the lungs through the mouth. The inhaler is designed for 120 doses. However, it cannot be determined when the inhaler is empty and when 120 puffs have been released. There may still be a small amount of liquid left in the container.

You should make sure that the inhaler is replaced after 120 puffs have been released, to ensure that you receive the correct amount of medicine in each puff.

Adults and children over 12 years old

• Veriflo (25 micrograms + 50 micrograms)/metered dose - two inhalations twice a day.
• Veriflo (25 micrograms + 125 micrograms)/metered dose - two inhalations twice a day.
• Veriflo (25 micrograms + 250 micrograms)/metered dose - two inhalations twice a day.

Children from 4 to 12 years old

• Veriflo (25 micrograms + 50 micrograms)/metered dose - two inhalations twice a day.
• Veriflo is not recommended for use in children under 4 years old.

Using Veriflo twice a day may help keep your asthma symptoms under control. Then, your doctor may recommend reducing the frequency of use to once a day. The dose may be changed and may be given:

• once a day, in the evening, if symptoms occur at night,
• once a day, in the morning, if symptoms occur during the day.

It is very important that your doctor instructs you on how many inhalations to use and how often. If you are using Veriflo for asthma, your doctor will regularly check your symptoms.

If your asthma symptoms get worse or your breathing gets worse, you should

contact your doctor immediately. You may experience increased wheezing, more frequent chest tightness, or need to use more of a fast-acting inhalation medicine to help you breathe. In any of these cases, you should continue to use Veriflo, but do not increase the number of inhalations. Your symptoms may worsen, and your condition may deteriorate. You should contact your doctor, as you may need additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler. They should check periodically that you are using it correctly. Incorrect use of Veriflo or not using it as directed by your doctor may mean that the medicine does not work as well as expected to control your asthma.
• The medicine is in a pressurized container in a plastic casing with a mouthpiece.
• A new, full inhaler has enough medicine for at least 120 doses. After 120 puffs, the inhaler may not have enough medicine to give a full dose.

Checking the inhaler:

• 1. Before first use, check that the inhaler is working. Remove the mouthpiece cover from the inhaler by gently squeezing the sides of the cover between your thumb and index finger.
• 2. To make sure the inhaler is working, shake the container vigorously, move the mouthpiece away from you, and press the container to release a dose into the air. Repeat this process a second time, shaking the inhaler before releasing the second dose into the air. Before each use of the inhaler, release two doses into the air.
• 3. After the first two test sprays, you can start using the inhaler.
• 4. If the inhaler has not been used for a week or more, or if the inhaler is very cold (below 0°C), release two doses into the air.

Warnings

Never remove the metal container from the inhaler. Only if the inhaler is very cold (below 0°C), remove the metal container from the plastic casing and warm it in your hands for a few minutes before use. Never use anything else to heat it. After warming and before use, press the container firmly to release two sprays into the air.

How to use the inhaler

It is essential to start breathing in as slowly as possible just before using the inhaler.

• 1. The inhaler should be used standing or sitting up.
• 2. Remove the mouthpiece cover (Figure A)
• 3. Check the mouthpiece for any blockages, and make sure it is clean and free from any foreign objects.
• 4. Shake the inhaler 4 or 5 times to ensure the contents are well mixed (Figure B).
• 5. Hold the inhaler in a vertical position, with your thumb on the base of the inhaler below the mouthpiece. Take a deep breath out, as far as is comfortable (Figure C).
• 6. Put the mouthpiece in your mouth, between your teeth. Close your lips around the mouthpiece. Do not bite the mouthpiece.
• 7. Take a slow, deep breath in through your mouth. As you start to breathe in, press the top of the container to release the medicine. Continue to breathe in slowly and deeply (Figure D).
• 8. Hold your breath and take the inhaler out of your mouth, and take your finger off the base of the inhaler. Hold your breath for a few seconds or as long as is comfortable.
• 9. To take another inhalation, wait about half a minute before repeating the steps from 4 to 8.
• 10. After use, rinse your mouth with water and spit it out, and/or brush your teeth. This may help prevent thrush (fungal infection) of the mouth and throat, and hoarseness.
• 11. Always replace the mouthpiece cover after use, to prevent dust from getting in (Figure E). The mouthpiece cover should click into place. Do not use excessive force.

Do not rush the steps from 5, 6, 7, and 8. It is essential that you start breathing in as slowly as possible just before using the inhaler. Initially, inhalations should be done in front of a mirror. If you see a "mist" coming out of the inhaler or the corners of your mouth during inhalation, you should repeat the steps, starting from step 4.

As with other inhalers, caregivers should ensure that children who have been prescribed Veriflo use the correct inhalation technique, as described above. If you or your child have difficulty using the inhaler, your doctor or another healthcare professional may recommend using the inhaler with a spacer device, such as the AeroChamber Plus. Your doctor, nurse, or pharmacist should show you how to use the spacer device and how to care for it, and answer any questions you may have. If you use the inhaler with a spacer device, it is essential that you do not stop using it without consulting your doctor or nurse.

Other spacer devices are not recommended for use with Veriflo, and you should not change the AeroChamber Plus for another device.It is also essential that you do not change the type or stop using the spacer device without consulting your doctor, who may decide to change the dose. Before making any changes to your asthma treatment, you should always talk to your doctor.

Older children or people with weaker hands may find it easier to hold the inhaler with both hands. You should put your two index fingers on the inhaler, and your thumbs on the bottom of the inhaler below the mouthpiece.

Cleaning the inhaler

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

• Remove the mouthpiece cover.
• Never remove the metal container from the plastic casing.
• Wipe the mouthpiece and the outside of the plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cover. The mouthpiece cover should click into place.
• Do not use excessive force.
• Do not put the metal container in water.

Using more Veriflo than recommended

It is essential to use the inhaler as directed. If you accidentally use more than the recommended dose, you should tell your doctor or pharmacist. You may experience:

rapid heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain. If you use higher doses for a long time, you should consult your doctor or pharmacist. High doses of Veriflo may affect the production of steroid hormones by the adrenal glands.

Missing a dose of Veriflo

Do not take a double dose of the medicine to make up for a missed dose. Take the next dose at the scheduled time.

Stopping use of Veriflo

It is essential to take Veriflo every day, as directed by your doctor. You should continue to take the medicine until your doctor tells you to stop. Do not stop taking Veriflo or reduce the dose without consulting your doctor. This may cause your breathing to become more difficult.

Additionally, stopping or reducing the dose of Veriflo may (very rarely) cause adrenal gland problems (adrenal insufficiency), which can sometimes cause side effects. These side effects may include:

• Abdominal pain
• Fatigue and loss of appetite, nausea
• Vomiting and diarrhea
• Weight loss
• Headache and drowsiness
• Low blood sugar
• Low blood pressure and seizures (fits).

If you experience any of these side effects, you should tell your doctor or pharmacist. To prevent these side effects, your doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone). If you experience any further doubts about using this medicine, you should consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, Veriflo can cause side effects, although not everybody gets them. To minimize the risk of side effects, your doctor will prescribe the lowest dose of Veriflo that controls your asthma.

Allergic reactions: You may experience sudden breathing difficulties immediately after using Veriflo

. You may experience increased wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). You may also experience a very fast heartbeat, weakness, and dizziness (which can lead to falls or loss of consciousness). If you experience any of these symptoms, including if they occur suddenly after using Veriflo, you should stop using Veriflo and contact your doctor immediately. Allergic reactions to Veriflo are uncommon (they may occur less often than in 1 in 100 people).

Other side effects:

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

• Headache - this side effect usually decreases over time as treatment continues.
• Increased frequency of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).

Common (may affect up to 1 in 10 people)

• Thrush (painful, creamy-white patches) in the mouth and throat, as well as sore tongue, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out, and/or brushing your teeth after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat thrush.
• Pain, swelling of the joints, and muscle pain.
• Muscle cramps.

The following side effects have been reported in patients with chronic obstructive pulmonary disease (COPD):

• Pneumonia and bronchitis (lung infection). You should tell your doctor if you experience any of the following symptoms: increased production of sputum, change in sputum color, fever, chills, increased coughing, or increased difficulty breathing.
• Easier bruising and fractures.
• Sinusitis (feeling of tension and fullness in the nose, cheeks, and behind the eyes, sometimes with a pulsating headache).
• Low potassium levels in the blood (you may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of antidiabetic medicines.
• Cataracts (clouding of the lens in the eye).
• Very fast heartbeat (tachycardia).
• Feeling of trembling and fast or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease over time as treatment continues.
• Chest pain.
• Restlessness (this side effect occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (may affect up to 1 in 1000 people)

• Breathing difficulties or wheezing worsening immediately after taking Veriflo. If you experience such symptoms, you should stop using Veriflo. You should use a fast-acting inhalation medicine to help you breathe and contact your doctor immediately.
• Veriflo may affect the production of steroid hormones by the body, particularly when taking high doses for a long time. These side effects may include:
• Slowed growth in children and adolescents
• Decreased bone density
• Glaucoma
• Weight gain
• Roundness (moon face) of the face (Cushing's syndrome).

Your doctor will regularly check for these side effects and ensure that you are using the lowest dose of Veriflo that controls your asthma.

• Changes in behavior, such as excessive excitement and irritability (these side effects occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmias). You should inform your doctor, but do not stop using Veriflo unless your doctor tells you to.
• Fungal infection of the esophagus, which can cause difficulty swallowing.

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

• Depression or aggression. The occurrence of these side effects is more likely in children.
• Blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 Veriflo

• •You should keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date (EXP) refers to the last day of the month stated.
• Do not store above 25°C.
• The container contains a pressurized liquid. Do not expose the container to temperatures higher than 50°C, and protect from direct sunlight. Do not pierce or burn the container, even if it appears to be empty.
• Do not use this medicine if you notice any visible signs of deterioration.
• As with most inhalers, the effectiveness of the medicine may be less if the inhaler is cold.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Veriflo contains

• The active substances are salmeterol (as salmeterol xinafoate) and fluticasone propionate. Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125, or 250 micrograms of fluticasone propionate.
• The other ingredient is the propellant: norflurane (HFA-134a).

What Veriflo looks like and contents of the pack

• Veriflo is an inhalation aerosol with a metered dose, which delivers the medicine in the form of a suspension under pressure to the lungs during inhalation through the mouth.
• The container is a pressurized container containing a white, homogeneous suspension for inhalation.
• The container is in a plastic casing with a mouthpiece and is equipped with a lilac, purple, or violet protective cap.
• Each pack contains 1 inhaler. Each inhaler contains 120 doses.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer/Importer

GENETIC S.p.A.

Contrada Canfora
84084 Fisciano (SA)
Italy

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

Denmark:Salmeterol/Fluticasone Zentiva
Poland:Veriflo
Portugal:Everio
Sweden:Salmeterol/Fluticasone Zentiva
Italy:Salmeterolo e Fluticasone Zentiva Italia

For further information about this medicine, you should contact your local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

Date of last revision of the leaflet: