VERIFLO (25 mcg + 50 mcg) Aerosol

Contents of the leaflet

1. Leaflet accompanying 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 between 4 and 12 years old
   3. In case of worsening asthma symptoms or difficulty breathing, the patient should
   4. Instructions for use
   5. Checking the inhaler:
   6. Warnings
   7. How to use the inhaler
   8. Cleaning the inhaler
   9. Using a higher dose of Veriflo than recommended
   10. Missing a dose of Veriflo
   11. Stopping use of Veriflo
6. Possible side effects
   1. Allergic reactions: The patient may experience sudden difficulty breathing immediately after
   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 (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, the patient should contact their local representative of the marketing authorization holder:
   8. Date of last revision of the leaflet:

Leaflet accompanying 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not mentioned 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. This makes it easier for air to get in and out of the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and inflammation in the lungs.

The doctor has prescribed this medicine for the patient to prevent breathing difficulties that occur in asthma. Veriflo must be used every day as recommended by the doctor. This will ensure that the 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.

The patient should always carry such a medicine with them.

2. Important information before using Veriflo

When not to use Veriflo

Warnings and precautions

Before starting to use Veriflo, the patient should talk to their doctor or pharmacist if they have:

• heart disease, including irregular or rapid 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 a history of tuberculosis or other lung infections.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Veriflo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about any medicines they 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, the patient should inform their 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 conditions.
• 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. The doctor may want to closely monitor the patient's condition while taking such medicines.
• Corticosteroids (oral or injectable). If the patient has 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to use Veriflo

This medicine should always be used as recommended by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

• Veriflo should be used every day, unless the doctor advises otherwise. The patient should not take a higher dose than recommended. If in doubt, they should consult their doctor or pharmacist.
• The patient should not stop using Veriflo or reduce the dose without consulting their 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.
The patient should make sure to replace the inhaler after 120 puffs have been released to ensure that they 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 between 4 and 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 asthma symptoms under control. Then, the 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 the patient has symptoms at night,
• once a day, in the morning, if the patient has symptoms during the day.

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

In case of worsening asthma symptoms or difficulty breathing, the patient should

contact their doctor immediately.There may be an increase in wheezing, more frequent chest tightness, or a need for a higher dose of a fast-acting inhalation medicine to facilitate breathing. In any of these situations, the patient should continue using Veriflo, but not increase the number of inhalations. The symptoms of the disease may worsen, and the patient's condition may deteriorate. The patient should contact their doctor, as they may need additional treatment.

Instructions for use

• The doctor, nurse, or pharmacist should instruct the patient on how to use the inhaler. They should periodically check that the patient is using it correctly. Incorrect use of Veriflo or not using it as recommended by the doctor may result in the medicine not producing the expected improvement in 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 deliver a full dose.

Checking the inhaler:

• 1. Before first use, the patient should check that the inhaler is working. The patient should remove the mouthpiece cover by gently squeezing the sides of the cover with their thumb and index finger.
• 2. To ensure the inhaler is working, the patient should shake the container vigorously, move the mouthpiece away from them, and press the container to release a dose of medicine into the air. These steps should be repeated a second time, shaking the inhaler before releasing the second dose into the air. Before each use of the inhaler, the patient should release two doses into the air.
• 3. After the first two test sprays, the patient 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), the patient should release two doses of medicine into the air.

Warnings

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

How to use the inhaler

It is essential that the patient starts breathing in as slowly as possible just before using the inhaler.

• 1. The patient should use the inhaler standing or sitting up.
• 2. Remove the mouthpiece cover (Figure A)
• 3. Check the mouthpiece for any blockages and make sure it is clean.
• 4. Shake the inhaler 4 or 5 times to ensure the contents are well mixed (Figure B).
• 5. Hold the inhaler upright with the 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 the mouth between the teeth. Close the lips around the mouthpiece. Do not bite the mouthpiece.
• 7. Take a slow, deep breath in through the mouth. As soon as the patient starts to breathe in, they should press the top of the container to release the medicine. At the same time, they should continue to breathe in slowly and deeply (Figure D).
• 8. The patient should hold their breath and take the inhaler out of their mouth, and remove their finger from the base of the inhaler. The patient should hold their breath for a few seconds or as long as is comfortable.
• 9. To take another inhalation, the patient should wait about half a minute before repeating the steps from 4 to 8.
• 10. After inhalation, the patient should rinse their mouth with water and spit it out, and/or brush their teeth. This may help prevent thrush (fungal infection) in the mouth and throat, as well as hoarseness.
• 11. The patient should always replace the mouthpiece cover immediately after use to prevent dust from entering the inhaler (Figure E). The mouthpiece cover should click into place. The patient should not use excessive force.

The patient should not rush the steps in points 5, 6, 7, and 8. It is essential that the patient starts breathing in as slowly as possible just before using the inhaler. Initially, the patient should practice inhalations standing in front of a mirror. If a "mist" is seen coming from the inhaler or from the corners of the mouth during inhalation, the patient should repeat the steps, starting from point 4.
As with other inhalers, caregivers should ensure that children who have been prescribed Veriflo use the correct inhalation technique, as described above.
If the patient or child has difficulty using the inhaler, the doctor or another healthcare professional may recommend using the inhaler with a spacer device, such as the AeroChamber Plus. The doctor, nurse, or pharmacist, or another healthcare professional, should demonstrate how to use the spacer device and how to care for it, and answer any questions the patient may have. If the patient uses the inhaler with a spacer device, it is essential that they do not stop using it without consulting their doctor or nurse. Other spacer devices are not recommended for use with Veriflo, and the patient should not change the AeroChamber Plus for another device.It is also essential that the patient does not change the type of spacer device or stop using it without consulting their doctor, who may decide to change the dose. Before making any changes to asthma treatment, the patient should always talk to their doctor.
Older children or people with less hand strength may find it easier to hold the inhaler with both hands. The patient should put their thumbs on the inhaler and their fingers 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 plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cover. The cover should click into place. The patient should not use excessive force.
• Do not put the metal container in water.

Using a higher dose of Veriflo than recommended

It is essential to use the inhaler as instructed. If the patient accidentally uses a higher dose than recommended, they should tell their doctor or pharmacist. The patient may experience: a faster than normal heartbeat, shaking, dizziness, headache, weakness, and muscle or joint pain.
If the patient uses higher doses for a long time, they should consult their doctor or pharmacist. High doses of Veriflo may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Veriflo

The patient should not take a double dose of the medicine to make up for a missed dose. The patient should take the next dose at the scheduled time.

Stopping use of Veriflo

It is very important that the patient takes Veriflo every day, as recommended by the doctor. The patient should continue to take the medicine until the doctor advises them to stop. The patient should not suddenly stop taking Veriflo or reduce the dose. This may cause greater difficulty breathing.
Additionally, sudden stopping or reduction 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 the patient experiences any of these side effects, they should tell their doctor or pharmacist. To prevent these symptoms, the doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone).
If the patient has any further doubts about using this medicine, they should consult their 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, the doctor will prescribe the lowest dose of Veriflo that controls the asthma.

Allergic reactions: The patient may experience sudden difficulty breathing immediately after

using Veriflo. There may be an increase in wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). The patient may also experience a very fast heartbeat, weakness, and dizziness (which can lead to falls or loss of consciousness). If the patient experiences any of these symptoms, including if they occur suddenly after using Veriflo, they should stop using Veriflo and contact their 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 the patient continues treatment.
• 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 the mouth with water and spitting it out, and/or brushing the teeth, after each inhalation may help. The doctor may prescribe an antifungal medicine to treat thrush.
• Pain, swelling of the joints, and muscle pain.
• Muscle spasms.

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

• Pneumonia and bronchitis (lung infection). The patient should tell their doctor if they experience any of the following symptoms: increased mucus production, change in mucus 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 (the patient 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 shaking and fast or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease over time as the patient continues treatment.
• Chest pain.
• Anxiety (this side effect occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

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

• Difficulty breathing or wheezing worsening immediately after taking Veriflo.If the patient experiences such symptoms, they should stop using Veriflo. The patient should use a fast-acting, inhaled bronchodilator and contact their doctor immediately.
• Veriflo may affect the normal production of steroid hormones in the body, especially when using high doses for a long time. These symptoms include:
• Slowed growth in children and adolescents
• Decreased bone density
• Glaucoma
• Weight gain
• Moon face (Cushing's syndrome).

The doctor will regularly check if the patient is experiencing any of these side effects and ensure that the patient is using the lowest dose of Veriflo that controls their asthma.

• Changes in behavior, such as excessive restlessness and irritability (these symptoms occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmia). The patient should inform their doctor, but not stop using Veriflo unless the doctor advises them to do so.
• 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, more information can be gathered on the safety of the medicine.

5. How to store Veriflo

• •The medicine should be stored out of 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) is 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 above 50°C, and protect it from direct sunlight. Do not pierce or burn the container, even if it appears to be empty.
• Do not use this medicine if visible signs of deterioration are observed.
• 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Veriflo contains

• The active substances of Veriflo 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 of the medicine is the propellant: norflurane (HFA-134a).

What Veriflo looks like and contents of the pack

• Veriflo is an inhalation aerosol, metered dose, which delivers the medicine in the form of a suspension under pressure to the lungs when inhaled through the mouth.
• The container is a pressurized canister containing a white, homogeneous suspension for inhalation.
• The container is fitted into a plastic casing with a mouthpiece and is provided 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, the patient should contact their 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: