Veriflo

Patient Information Leaflet

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
Salmeterolum + Fluticasoni propionas
Please read this leaflet carefully before using this medicine, as it contains important
information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Veriflo is and what it is 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 Veriflo is and what it is used for

Veriflo contains two active substances: salmeterol and fluticasone propionate.

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

Your doctor has prescribed this medicine to prevent breathing problems associated with
asthma.
Veriflo must be used every day as directed by your doctor to ensure proper asthma control.
Veriflo helps prevent shortness of breath and wheezing. However, Veriflo must not be used
to relieve sudden asthma attacks or sudden wheezing. If such an attack occurs, a fast-acting
bronchodilator such as salbutamol should be used immediately. You should always have
this medicine available.

2. Important information before using Veriflo

When not to use Veriflo

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

Warnings and precautions
Before starting treatment with Veriflo, speak to a doctor or pharmacist if the patient has:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Veriflo may increase blood glucose levels),
• low blood potassium levels,
• active or previously treated tuberculosis or other lung infections.

If the patient experiences blurred vision or other disturbances in eyesight, they should contact a doctor.
Veriflo and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those used for asthma and medicines available without a prescription. This is important because Veriflo should not be used with certain other medicines.
Before starting Veriflo, inform the doctor if the patient is taking any of the following medicines:

• Medicines belonging to the beta-blocker group (e.g. atenolol, propranolol, and sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including certain medicines used to treat HIV (e.g. ritonavir, drugs containing cobicistat). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects of Veriflo, including irregular heartbeat, or may worsen existing side effects. The doctor may wish to closely monitor the patient's condition when taking such medicines.
• Corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal gland dysfunction.
• Diuretics used in the treatment of high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, often used in the treatment of asthma.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
It is unlikely that Veriflo will affect the ability to drive or operate machinery.

3. How to use Veriflo

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.

• Veriflo should be used daily until your doctor advises otherwise. Do not take more than the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop using Veriflo or reduce the dose without first consulting your doctor.
• Veriflo should be inhaled into the lungs through the mouth. The inhaler is designed to deliver 120 doses. However, it is not possible to determine when the inhaler is empty or when 120 actuations have been delivered.
  A small amount of liquid may still remain in the container.
  You must ensure that the inhaler is replaced after 120 actuations to make sure that each dose contains the correct amount of medicine.

Adults and adolescents aged 12 years and older

• Veriflo (25 micrograms + 50 micrograms)/metered dose – two inhalations twice daily.
• Veriflo (25 micrograms + 125 micrograms)/metered dose – two inhalations twice daily.
• Veriflo (25 micrograms + 250 micrograms)/metered dose – two inhalations twice daily.

Children aged 4 to 12 years

• Veriflo (25 micrograms + 50 micrograms)/metered dose – two inhalations twice daily.
• Veriflo is not recommended for use in children under 4 years of age.

Using Veriflo twice daily may result in good asthma control. Your doctor may then recommend reducing the frequency of administration to once daily. The dose may be changed and administered:

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

It is very important that your doctor instructs you how many inhalations to take and how often.
If you are using Veriflo for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or breathing becomes more difficult, contact your doctor immediately.
This may include worsening wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting inhaled medicine to help breathing. In any of these situations, continue using Veriflo, but do not increase the number of inhalations. Symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler. They should periodically check that you are using it correctly. Incorrect or improper use of Veriflo may result in the medicine not providing the expected improvement in asthma.
• The medicine is contained under pressure in a metal canister within a plastic casing with a mouthpiece.
• A new, full inhaler contains enough medicine for at least 120 doses. After 120 actuations, the inhaler may no longer contain sufficient medicine to deliver a full dose.

Checking the inhaler:

1. Before first use, check that the inhaler works. Remove the mouthpiece cap by gently pressing the sides of the cap with your thumb and index finger.
2. To ensure the inhaler works, shake the canister vigorously, move the mouthpiece away from you, and press down on the canister to release a dose into the air. Repeat this a second time, shaking the inhaler before releasing the second dose into the air. Before each use, release two doses into the air.
3. After the first two test actuations, you may begin using the inhaler.
4. If the inhaler has not been used for a week or longer, or if the inhaler is very cold (below 0°C), release two doses into the air before use.

Warnings
Never detach the metal canister from the inhaler.
Only if the inhaler is very cold (below 0°C), remove the metal canister from the plastic casing and warm it in your hands for several minutes before use. Never use any other method to warm it. After warming, firmly press the canister back into place and release two actuations into the air before use.

How to use the inhaler
It is important to start breathing as slowly as possible just before using the inhaler.

1. Use the inhaler while standing or sitting.
2. Remove the mouthpiece cap (Figure A).
3. Check the mouthpiece inside and outside to ensure it is clean and free from foreign objects.
4. Shake the inhaler 4 or 5 times to ensure the contents are properly mixed (Figure B).
5. Hold the inhaler upright, with your thumb placed under the base of the inhaler below the mouthpiece. Breathe out fully, as far as comfortable (Figure C).
6. Place the mouthpiece between your teeth. Close your lips around it. Do not bite the mouthpiece.
7. Begin a slow and deep inhalation through your mouth. Immediately after starting to inhale, press firmly on the top of the canister to release the medicine. Continue inhaling steadily and deeply (Figure D).
8. Hold your breath and remove the inhaler from your mouth. Remove your finger from the base of the inhaler. Hold your breath for several seconds, or as long as comfortable without discomfort.
9. To repeat the inhalation, wait about half a minute before repeating steps 4–8.
10. After inhalation, rinse your mouth with water, then spit out the water and (or) brush your teeth. This may help prevent oral and throat fungal infections (thrush) and hoarseness.
11. Always immediately replace the mouthpiece cap after inhalation to prevent dust from entering (Figure E). The cap should snap securely into place. Do not use excessive force.

Do not rush steps 5, 6, 7, and 8. It is very important that patients begin breathing as slowly as possible just before using the inhaler. Initially, inhalations should be performed while standing in front of a mirror. If a "mist" is seen escaping from the inhaler or from the corners of the mouth during inhalation, repeat the steps starting from step 4.

As with other inhalers, caregivers should ensure that children prescribed Veriflo use the correct inhalation technique as described above.
If you or your child has difficulty using the inhaler, your doctor or another healthcare professional may recommend using the inhaler with a spacer device, such as AeroChamber Plus. Your doctor, nurse, pharmacist, or other healthcare professional should demonstrate how to use the spacer and how to care for the device, and answer any questions you may have. If you use the inhaler with a spacer, it is important not to stop using it without consulting your doctor or nurse. Other spacer devices are not recommended for use with Veriflo, and the AeroChamber Plus device should not be replaced with another. It is also important not to change the type of spacer or stop using it without consulting your doctor, who may need to adjust your dose. Always talk to your doctor before making any changes to your asthma treatment.

Older children or individuals with weaker hand strength may find it easier to hold the inhaler with both hands. Place both index fingers on top of the inhaler and both thumbs under the base below the mouthpiece.

Cleaning the inhaler
To prevent blockage, it is important to clean the inhaler at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Never remove the metal canister from the plastic casing.
• Wipe the mouthpiece inside and outside, and the outside of the plastic casing, with a dry cloth or tissue.
• Replace the mouthpiece cap. The cap should snap securely into place.
• Do not use excessive force.
• Do not immerse the metal canister in water.

Accidental overdose of Veriflo
It is important to use the inhaler exactly as instructed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist. Symptoms may include: faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.
If larger doses have been used for a prolonged period, consult your doctor or pharmacist. High doses of Veriflo may reduce the production of steroid hormones by the adrenal glands.

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

Stopping Veriflo treatment
It is very important to take Veriflo every day as directed. Continue taking it until your doctor advises you to stop. Do not suddenly stop taking Veriflo or reduce the dose. This could cause increased breathing difficulties.

Additionally, abruptly stopping or reducing the dose of Veriflo may (very rarely) lead to adrenal insufficiency (adrenal gland dysfunction), which may cause adverse effects.

These adverse effects may include any of the following:

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

When the body is under stress due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the adverse effects listed above may occur.

If you experience any of these adverse effects, inform your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone).

If you have any further questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
To reduce the risk of adverse effects, your doctor will prescribe the lowest dose of Veriflo that provides asthma control.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Veriflo. Worsening of wheezing, cough, or shortness of breath may occur, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). There may also be a sensation of very rapid heartbeat, weakness, or dizziness (which may lead to falling or loss of consciousness). If any of these symptoms occur, including sudden onset after using Veriflo, treatment with Veriflo must be stopped immediately and medical advice must be sought without delay. Allergic reactions to Veriflo are uncommon (may occur in fewer than 1 in 100 people).

Other adverse effects:
Very common (may occur in more than 1 in 10 people)

• Headache – this adverse effect usually diminishes over time with continued treatment.
• Increased incidence of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).

Common (may occur in fewer than 1 in 10 people)

• Oral and pharyngeal candidiasis (painful, creamy-white lesions), tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

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

• Pneumonia and bronchitis (lung infection). Inform your doctor if any of the following symptoms occur: increased mucus production, change in mucus colour, fever, chills, worsening cough, or increased difficulty breathing.
• Easy bruising and fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon (may occur in fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of the dose of currently used antidiabetic medications may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and diminish with continued treatment.
• Chest pain.
• Restlessness (this effect occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (may occur in fewer than 1 in 1000 people)

• Breathing difficulties or worsening wheezing occurring immediately after taking Veriflo. If such symptoms occur, treatment with Veriflo must be stopped. A fast-acting inhaled medicine to relieve breathing should be used and medical advice must be sought immediately.
• Veriflo may interfere with the body's normal production of steroid hormones, especially when high doses are used for a prolonged period. These effects include:
  • Slowed growth in children and adolescents
  • Reduced bone mass
  • Glaucoma
  • Increased body weight
  • Facial rounding (moon-shaped face) (Cushing's syndrome).

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

• Behavioural changes such as excessive excitability and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra beats (cardiac arrhythmias). Inform your doctor, but do not stop using Veriflo unless instructed by your doctor.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

Frequency not known (cannot be estimated from available data)

• Depression or aggression. These effects are more likely in children.
• Blurred vision.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Veriflo

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton following EXP. The expiry date (EXP) refers to the last day of the stated month.
• Do not store above 25°C.
• The container is under pressure. 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 you notice any visible signs of deterioration.
• As with most inhaled medicines in pressurized containers, the medicine may be less effective if the inhaler is cold.

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.

6. Contents of the pack and other information

What Veriflo contains

• The active substances in this medicine 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 this medicine is the propellant gas: norflurane (HFA-134a).

What Veriflo looks like and contents of the pack

• Veriflo is an inhalation aerosol with a metering device that delivers the medicine as a pressurized suspension to the lungs during inhalation through the mouth.
• The pressurized container holds a white, homogeneous suspension for inhalation.
• The container is placed in a plastic housing with a mouthpiece and is equipped with a lilac dust cap. or
• The container is placed in a plastic housing with a mouthpiece and is equipped with a purple dust cap. or
• The container is placed in a plastic housing with a mouthpiece and is equipped with a violet dust cap.
• Each pack contains 1 inhaler. Each inhaler contains 120 doses.

Marketing Authorisation 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 authorised for sale in the European Economic Area countries 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 on this medicine, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00