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. 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 experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Veriflo is and what it is used for
2. What you need to know 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 for 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 caused by asthma.
Veriflo must be used every day as directed by your doctor to ensure proper asthma control.
Veriflo helps prevent breathlessness and wheezing. However, Veriflo must not be used to relieve sudden
attacks of breathlessness or wheezing. If such an attack occurs, you must use a fast-acting
bronchodilator, such as salbutamol, immediately. You should always have such a medicine readily 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 Veriflo, talk 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 past tuberculosis, or other lung infections.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Veriflo and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to take, such as asthma medications and over-the-counter medicines. 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:

• Beta-blockers (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 Veriflo side effects, including irregular heartbeat, or may worsen existing side effects. The doctor may need to closely monitor the patient’s condition while taking these 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 to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, commonly 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 your doctor or pharmacist has told you.
If you are unsure, ask your doctor or pharmacist.

• Veriflo should be used every day until your doctor tells you otherwise. Do not take a higher dose than recommended. If you are unsure, consult your doctor or pharmacist.
• Do not stop using Veriflo or reduce the dose without first talking to 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 tell when the inhaler is empty or when 120 actuations have been delivered. There may still be a small amount of liquid remaining in the container.

Make sure to replace the inhaler after 120 actuations to ensure you receive the correct amount of medicine with each dose.

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 help control asthma symptoms effectively. Your doctor may then recommend reducing the frequency of treatment to once daily. The dose may be changed and administered:

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

It is very important that your doctor advises 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 increased wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting inhaled medicine to relieve 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 and should periodically check that you are using it correctly. Incorrect or inconsistent use of Veriflo may result in the medicine not providing the expected improvement in asthma control.
• The medicine is contained under pressure in a metal container inside a plastic housing 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 container vigorously, point the mouthpiece away from you, and press down on the container to release a dose into the air. Repeat this step once more, 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 sprays, 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 remove the metal container from the inhaler.
Only if the inhaler is very cold (below 0°C), remove the metal container from the plastic housing and warm it in your hands for several minutes before use. Never use any other method to warm it. After warming, press the container firmly to release two sprays into the air before use.

How to use the inhaler
It is important to begin 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 of foreign objects.
4. Shake the inhaler 4 or 5 times to ensure the contents are well mixed (Figure B).
5. Hold the inhaler upright, with your thumb on the base below the mouthpiece. Breathe out slowly and deeply as comfortably as possible (Figure C).
6. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite the mouthpiece.
7. Begin a slow and deep breath in through your mouth. As soon as you start inhaling, press firmly on the top of the container 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.
9. To repeat the inhalation, wait about half a minute and repeat steps 4–8.
10. After inhaling, rinse your mouth with water, spit out the water, and (or) brush your teeth. This may help prevent oral and throat fungal infections (thrush) and hoarseness.
11. Always replace the mouthpiece cap immediately after use to prevent dust from entering (Figure E). The cap should snap securely into place. Do not use excessive force.

Do not rush the 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 device, how to care for it, and answer any questions you may have. If you use the inhaler with a spacer device, 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 people with weaker hand strength may find it easier to hold the inhaler with both hands. Place your two index fingers on top of the inhaler and both thumbs on 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 container from the plastic housing.
• Wipe the mouthpiece and the outside of the plastic housing 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 container in water.

Accidental overdose of Veriflo
It is important to use the inhaler as directed. 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 higher 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 difficulty breathing.

Additionally, abruptly stopping or reducing the dose of Veriflo may (very rarely) lead to adrenal gland dysfunction (adrenal insufficiency), which may sometimes 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, ask 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 controls asthma effectively.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Veriflo. Symptoms may include worsening of wheezing, cough, or shortness of breath, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). The patient may also experience 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 urgently. Allergic reactions to Veriflo occur uncommonly (may occur in fewer than 1 in 100 people).

Other adverse effects:
Very common (may affect 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 affect fewer than 1 in 10 people)

• Oral and pharyngeal candidiasis (painful, creamy-yellow lesions), as well as tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may be helpful. 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 potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon (may affect fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of previously prescribed 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 tend to diminish with continued treatment.
• Chest pain.
• Restlessness (this effect occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (may affect 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 difficulties 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 taken 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 effective dose of Veriflo to control asthma.

• Behavioural changes such as excessive excitability and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra beats (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 of Adverse Drug Reactions, 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 to provide more information on the safety of this medicine.

5. How to store Veriflo

• Keep the medicine out of the 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 contains pressurised 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 inhaled medicines in pressurised containers, the effectiveness of the medicine may be reduced if the inhaler is cold.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps 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 either 50, 125, or 250 micrograms of fluticasone propionate.
• The other ingredient in 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 valve that delivers the medicine as a pressurized suspension into 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 more detailed information about 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