Flurhinal

Leaflet attached to the packaging: patient information

Flurhinal, 125 micrograms/dose, inhalation aerosol, suspension

Flurhinal, 250 micrograms/dose, inhalation aerosol, suspension

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 or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given 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 listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Flurhinal and what is it used for
• 2. Important information before using Flurhinal
• 3. How to use Flurhinal
• 4. Possible side effects
• 5. How to store Flurhinal
• 6. Contents of the packaging and other information

1. What is Flurhinal and what is it used for

This medicine contains, as an active substance, fluticasone propionate, which belongs to a group of medicines called corticosteroids. The action of Flurhinal is to reduce swelling and irritation in the lungs. Since the medicine is inhaled directly into the lungs, only a very small amount of the medicine is needed.
This medicine is prescribed by a doctor to treat:

• asthma in adults and in adolescents over 16 years of age;
• chronic obstructive pulmonary disease (COPD) only in adults and in combination with other medicines (called long-acting beta-agonists, such as salmeterol) that dilate the airways.

Flurhinal should be used every day as recommended by the doctor, even if the patient does not experience any symptoms. This will ensure the proper effect of the medicine in controlling the symptoms of asthma or COPD.

2. Important information before using Flurhinal

When not to use Flurhinal:

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

Warnings and precautions

Before starting to use Flurhinal, the patient should discuss this with their doctor or pharmacist:

• if the patient has ever been treated for tuberculosis;
• if the patient has ever suffered from oral thrush;
• if the patient has diabetes (as fluticasone may cause an increase in blood sugar levels);
• if the patient has been taking high doses of this medicine for a long time and has noticed any of the following symptoms:
• weight gain and rounding of the face (so-called moon face) - symptoms of Cushing's syndrome;
• various non-specific symptoms, such as abdominal pain, nausea, diarrhea, headache, or drowsiness (symptoms of adrenal insufficiency, acute adrenal crisis) these symptoms are more likely to occur during infection, e.g. viral infection or gastroenteritis;
• thinning of bone tissue;
• eye diseases (cataract and glaucoma);
• growth retardation (mainly in children and adolescents).

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
In case of any doubts whether any of the above warnings apply to the patient, before using Flurhinal, they should consult their doctor or pharmacist.

Children and adolescents

Flurhinal is recommended for use in the treatment of asthma in adults and adolescents over 16 years of age, and in chronic obstructive pulmonary disease (COPD) only in adults.

Flurhinal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This also applies to herbal medicines. The patient should remember to take this medicine with them when going to the hospital.
Before starting to use Flurhinal, the patient should inform their doctor if they are taking:

• certain medicines that may enhance the effect of Flurhinal and the doctor may want to closely monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat),
• medicines used to treat infections (e.g. ketoconazole and erythromycin).

Using Flurhinal with food and drink

Flurhinal can be taken at any time of day, with or without food.

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

No studies have been conducted on the effect of this medicine on the ability to drive and use machines. However, it is unlikely that this medicine will have a negative effect.

3. How to use Flurhinal

This medicine should always be taken as recommended by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Flurhinal is available in two different strengths and is intended for inhalation only. The doctor will decide which strength the patient should use.

How to use this medicine

• If the doctor has prescribed higher doses of the medicine (more than 1000 micrograms per day), Flurhinal should be taken using a Volumatic inhalation chamber to minimize side effects in the mouth and throat. The doctor or pharmacist will provide more information on this.
• Some patients have difficulty releasing the dose of the medicine when they start inhaling. In this case, it is recommended to use a Volumatic inhalation chamber. The doctor or pharmacist will provide more information on this.

The effect of this medicine may only become apparent after several days or months of use

so it is very important to take it regularly.

Asthma

Adults and adolescents over 16 years of age

Mild asthma

• The usual initial dose is up to 250 micrograms twice a day.

Moderate asthma

• The usual initial dose is 250 to 500 micrograms twice a day.

Severe asthma

• The usual initial dose is 500 to 1000 micrograms twice a day.

Chronic obstructive pulmonary disease (COPD)

Adults

• 500 micrograms twice a day.

In the treatment of chronic obstructive pulmonary disease, Flurhinal is used in combination with another medicine from the group of long-acting bronchodilators.

Use in children and adolescents

Flurhinal is recommended for use in the treatment of asthma in adults and adolescents over 16 years of age, and in chronic obstructive pulmonary disease (COPD) only in adults.
If the dose of the medicine is increased, the doctor may prescribe Flurhinal at a strength of 250 micrograms.
If the patient has been taking high doses of inhaled steroids for a long time, they may need to take additional steroids, e.g. in stressful situations, such as a car accident or before surgery.
The doctor may prescribe additional oral steroid doses during such periods.
Patients who have been taking high doses of steroids, including Flurhinal, for a long time should not stop taking these medicines abruptly without consulting their doctor first. Stopping these medicines abruptly may cause the patient to feel unwell and experience symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, decreased blood sugar levels, and convulsions.

Instructions for use

The doctor or pharmacist should show the patient how to use the inhaler properly.
They should check the patient's inhaler technique from time to time.
Using Flurhinal incorrectly or not in accordance with the doctor's recommendations may mean that the medicine is not as effective in treating asthma or COPD as it should be.
The medicine is in a pressurized container in a plastic casing with a mouthpiece. To prevent the inhaler from clogging, it should be cleaned at least once a week.

Checking the inhaler

1
Before using the inhaler for the first time, the patient should check if it is working properly.
The patient should remove the cap from the mouthpiece of the inhaler by gently squeezing the sides with their thumb and index finger.
2
To make sure the inhaler is working, the patient should shake it vigorously, point the mouthpiece away from themselves, and press the container to release four doses into the air. If the inhaler has not been used for five days or more, the patient should release two doses of the medicine into the air.

Using the inhaler

Just before using the inhaler, the patient should start breathing as slowly as possible.
1
The inhaler should be used while sitting upright or standing.
2
The patient should remove the cap from the mouthpiece of the inhaler. They should look inside and outside the mouthpiece to make sure it is clean and free of any solid particles (Figure A).

3
The patient should shake the inhaler 4 or 5 times to remove any solid particles and mix the contents of the inhaler evenly (Figure B).

4
The patient should hold the inhaler upright with their thumb on the base, below the mouthpiece. They should take a deep breath out, as deep as possible (Figure C). At this stage, they should not inhale.

5
The patient should put the mouthpiece in their mouth, between their upper and lower teeth, and close their lips tightly around it. They should not bite the mouthpiece (Figure D).

6
The patient should start inhaling slowly through their mouth. As soon as they start inhaling, they should press the top of the container to release a dose of the medicine. They should continue inhaling slowly and deeply (Figure D).
7
The patient should hold their breath, take the inhaler out of their mouth, and remove their finger from the top of the inhaler. They should hold their breath for a few seconds or as long as possible (Figure E).

8
If the doctor has prescribed two inhalations of the medicine (two puffs), the patient should wait about half a minute after taking the first inhalation, and then repeat the steps described in points 3 to 7 to take the second inhalation.
9
After finishing the inhalation, the patient should rinse their mouth with water and spit it out. This is to prevent side effects in the mouth and throat. They can also brush their teeth.
10 Immediately after using the inhaler, the patient should put the cap back on the mouthpiece to prevent dust from entering it. The cap should be pushed back into place with a firm click.
The patient should practice all the above steps in front of a mirror several times before using the inhaler for the first time.
If a mist is released from the top of the inhaler or from the corners of the mouth, the patient should start again.
Older children and people with weak hands may find it easier to use the inhaler if they hold it with both hands. To do this, they should put their index fingers on the top of the inhaler and their thumbs on the bottom, below the mouthpiece. The doctor or pharmacist will provide more information on this.

Cleaning the inhaler

To prevent the inhaler from clogging, it should be cleaned at least once a week.

Next steps when cleaning the inhaler

• Remove the cap from the mouthpiece of the inhaler.
• Never remove the metal container from the plastic casing.
• Wipe the mouthpiece inside and outside and the plastic casing outside with a dry cloth or sanitary wipe.
• Put the cap back on the mouthpiece.

Do not immerse the metal container in water.

Using a higher dose of Flurhinal than recommended

If the patient takes a higher dose of the medicine than recommended, they should inform their doctor as soon as possible.
It is very important that the patient takes the medicine as directed on the label or as recommended by the doctor. The patient should not increase or decrease the dose without consulting their doctor.

Missing a dose of Flurhinal

• If the patient misses a dose of Flurhinal, they should wait until it is time for the next dose.
• The patient should not take a double dose to make up for the missed dose.

Stopping use of Flurhinal

Even if the patient feels better, they should not stop taking this medicine unless their doctor tells them to. Patients who have been taking high doses of steroids for a long time should not stop taking these medicines abruptly without consulting their doctor first, as this may cause their asthma symptoms to worsen. Stopping these medicines abruptly may also cause the patient to feel unwell and experience symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, decreased blood sugar levels, and convulsions.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking this medicine and contact their doctor immediately.

The patient may need urgent medical attention.

• Allergic reactions (may occur in less than 1 in 100 people) symptoms include: skin rash, skin redness, skin itching, or the formation of blisters resembling hives.
• Severe allergic reactions (may occur in less than 1 in 10,000 people) symptoms include: swelling of the face, lips, mouth, tongue, or throat, which may make swallowing or breathing difficult, itching rash, feeling of weakness, and impending fainting, as well as anaphylaxis.
• Worsening of breathing difficulties or wheezing after using the inhaler.

Other side effects:

Very common side effects(may occur in more than 1 in 10 people)

• thrush (a type of fungal infection) with painful, creamy-yellow patches (thrush) in the mouth and throat.

Common side effects(may occur in less than 1 in 10 people)

• throat or tongue pain
• hoarseness The occurrence of symptoms in the mouth and throat can be limited by performing certain actions immediately after taking a dose of the inhaler. These actions include rinsing the mouth and throat with water and spitting it out. Oral thrush can be treated with antifungal medicines without stopping the use of fluticasone. If the patient experiences any of these symptoms in the mouth or throat, they should inform their doctor, but not stop taking the medicine unless their doctor tells them to.
• In patients with chronic obstructive pulmonary disease (COPD), the following side effects have also been reported:
• pneumonia (lung infection) The patient should tell their doctor if they experience any of the following symptoms of lung infection while taking Flurhinal: fever or chills, increased production of sputum, change in the color of sputum, worsening cough or increased breathing difficulties.
• bruises.

Uncommon side effects(may occur in less than 1 in 100 people)

• thrush of the esophagus.

Rare side effects(may occur in less than 1 in 1,000 people)

• sleep problems or feeling anxious, overexcited, and irritable. These side effects occur more frequently in adolescents.
• nausea.
• joint pain.
• increased blood sugar (glucose) levels.
• adrenal insufficiency (due to the effect of fluticasone on the production of steroid hormones in the body). The risk of this side effect is higher in patients taking high doses of the medicine for a long time (e.g. 400 micrograms per day in children). This can lead to:
• growth retardation in children and adolescents,
• a condition known as Cushing's syndrome. This occurs when there is too much steroid hormone in the body and can cause thinning of bone tissue (osteoporosis) and eye diseases, such as cataracts or glaucoma (increased pressure in the eyeball).

The doctor will try to prevent this by using the lowest dose of steroids that effectively controls the symptoms of the disease.
Side effects with unknown frequency(frequency cannot be estimated from available data)

• depression.
• psychomotor agitation or nervousness.
• nosebleeds.
• blurred vision.

These side effects occur more frequently in children and adolescents.

In the following situations, the patient should consult their doctor as soon as possible:

• If, after 7 days of using Flurhinal, the shortness of breath or wheezing does not decrease or worsens.
• If the patient is taking high doses of inhaled steroids and experiences non-specific symptoms such as abdominal pain, nausea, diarrhea, headache, and drowsiness. This may occur during infection, e.g. viral infection or gastroenteritis. The patient should not stop taking steroids abruptly, as this may worsen their asthma and cause hormonal disturbances.

If any of the side effects worsen or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Flurhinal

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 refers to the last day of the month.
Do not store above 30°C.
Do not store in the refrigerator or freeze.
Protect from frost and direct sunlight.
If the inhaler becomes very cold, the patient should remove the metal container from the plastic casing and warm it in their hands for a few minutes before use. The inhaler should not be heated in any other way.
The metal container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the metal container.
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.
If the doctor advises the patient to stop taking the medicine, they should take the inhaler to a pharmacy, where it will be disposed of properly.

6. Contents of the packaging and other information

What Flurhinal contains

• The active substance of the medicine is fluticasone propionate. One dose contains 125 micrograms or 250 micrograms of fluticasone propionate. This corresponds to a delivered dose (the dose released from the mouthpiece) of 110 micrograms or 227 micrograms of fluticasone propionate.
• The other ingredient is: HFC-134a (norflurane).
• This medicine contains fluorinated greenhouse gases. Each inhaler contains 12.5 g of HFC-134a (norflurane), which corresponds to 0.018 tons of CO2 equivalent (GWP = 1430).

What Flurhinal looks like and contents of the pack

Flurhinal is a white homogeneous suspension, which is placed in an aluminum pressurized container with a suitable metering valve and a plastic mouthpiece. The body is white, and the cap is yellow.
Pack sizes:

• 1 or 2 containers. One container contains 120 metered doses, each containing 125 or 250 micrograms of fluticasone propionate. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Marketing authorization holder:
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Importer:

S&D Pharma CZ, spol. s r.o
Theodor 28
273 08 Pchery
Czech Republic
Cipla Europe NV
De Keyserlei 60C
Bus-1301, 2018 Antwerp
Belgium
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

A large print version of the leaflet is available on request.

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

For more information, the patient should contact the representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]
Date of last revision of the leaflet:March 2025