Flurhinal

Leaflet accompanying 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 this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, please tell your 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 widen the airways.

Flurhinal should be used every day as directed by your doctor, even if you do not have any symptoms. This will ensure that the medicine works properly to control your asthma or COPD symptoms.

2. Important information before using Flurhinal

When not to use Flurhinal:

• If you are 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, you should discuss this with your doctor or pharmacist:

• if you have ever been treated for tuberculosis;
• if you have ever suffered from oral thrush;
• if you have diabetes (as fluticasone may cause an increase in blood sugar levels);
• if you have been taking high doses of this medicine for a long time and have 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 you experience blurred vision or other vision disturbances, you should contact your doctor.
In case of any doubts whether any of the above warnings apply to you, you should consult your doctor or pharmacist before using Flurhinal.

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

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. This also applies to herbal medicines. Remember to take this medicine with you when you go to the hospital.
Before starting to use Flurhinal, you should inform your doctor if you are taking:

• certain medicines that may increase the effect of Flurhinal and your doctor may want to monitor your condition closely when taking such medicines (including certain 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 to have a negative effect.

3. How to use Flurhinal

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Flurhinal is available in two different strengths and is intended for inhalation only. Your doctor will decide which strength you should use.

How to use this medicine

• If your doctor has prescribed higher doses of the medicine (more than 1000 micrograms per day), Flurhinal should be used with a Volumatic inhalation chamber to minimize side effects in the mouth and throat. Your 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. Your 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 use it regularly.

Asthma

Adults and adolescents over 16 years of age

Mild asthma

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

Moderate asthma

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

Severe asthma

• The usual starting 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, your doctor may prescribe Flurhinal at a strength of 250 micrograms.
If you have been taking high doses of inhaled steroids for a long time, you may need to take additional steroids, e.g. in stressful situations, such as a car accident or before surgery.
Your 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 can cause discomfort and symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar, and seizures.

Instructions for use

Your doctor or pharmacist should show you how to use the inhaler properly.
They should check your inhaler technique from time to time.
Using Flurhinal incorrectly or not as directed by your doctor may mean that the medicine is not as effective in treating your 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, check that it is working properly.
Remove the cap from the mouthpiece by gently squeezing the sides with your thumb and index finger.
2
To make sure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and press the container to release four doses into the air. If the inhaler has not been used for five days or more, release two doses of the medicine into the air.

Using the inhaler

Just before using the inhaler, start breathing as slowly as possible.
1
Use the inhaler sitting upright or standing.
2
Remove the cap from the mouthpiece. Look inside and outside the mouthpiece to make sure it is clean and free of any solid particles (Figure A).

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

4
Hold the inhaler upright with your thumb on the base, below the mouthpiece. Take a deep breath out, as deep as possible (Figure C). Do not inhale at this stage.

5
Put the mouthpiece in your mouth between your upper and lower teeth and seal it with your lips. Do not bite the mouthpiece (Figure D).

6
Start inhaling slowly through your mouth. As soon as you start inhaling, press the top of the container to release a dose of the medicine. Continue with a slow, deep breath (Figure D).
7
Hold your breath, remove the inhaler from your mouth, and take your finger off the top of the inhaler. Hold your breath for a few seconds or as long as possible (Figure E).

8
If your doctor has prescribed two inhalations of the medicine (two puffs), wait about half a minute after the first inhalation, then repeat the steps described in points 3 to 7 to take the second inhalation.
9
After finishing the inhalation, rinse your mouth with water and spit it out. This is to prevent side effects in the mouth and throat. You can also brush your teeth.
10 Immediately after using the inhaler, put the cap back on the mouthpiece to prevent dust from entering. Put the cap back on with a firm click.

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.
• 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 hygienic tissue.
• Put the cap back on the mouthpiece.

Do not immerse the metal container in water.

Taking a higher dose of Flurhinal than recommended

If you take a higher dose of the medicine than recommended, you should inform your doctor as soon as possible.
It is very important that you use the medicine as directed on the label or as directed by your doctor. Do not increase or decrease the dose without consulting your doctor.

Missing a dose of Flurhinal

• If you miss a dose of Flurhinal, wait until it is time for your next dose.
• Do not take a double dose to make up for a missed dose.

Stopping use of Flurhinal

Even if you feel better, do not stop using this medicine unless your doctor tells you 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 worsen asthma symptoms. Stopping these medicines abruptly can also cause discomfort and symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar, and seizures.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop using this medicine and contact your doctor immediately.

You 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 blistering like 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, and 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 white-yellowish patches (thrush) in the mouth and throat.

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

• pain in the tongue or throat
• hoarseness The occurrence of symptoms in the mouth and throat can be limited by performing certain actions immediately after taking a dose of the medicine. 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 you experience any of these symptoms in your mouth or throat, inform your doctor, but do not stop using the medicine unless your doctor tells you to.
• In patients with chronic obstructive pulmonary disease (COPD), the following side effects have also been reported:
• pneumonia (lung infection) You should tell your doctor if you experience any of the following symptoms of lung infection while using Flurhinal; these may include:
• fever or chills
• increased production of mucus, change in mucus color
• worsening cough or increased breathing difficulties
• bruises.

Rare side effects(may occur in less than 1 in 1000 people)

• thrush of the esophagus.

Very rare side effects(may occur in less than 1 in 10,000 people)

• sleep problems or feeling anxious, overexcited, and irritable. These side effects occur more frequently in adolescents.
• nausea.
• joint pain.
• high 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).

Your doctor will try to prevent this by using the lowest dose of steroids that will effectively control your 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, you should consult your doctor as soon as possible:

• If, after 7 days of using Flurhinal, your shortness of breath or wheezing does not decrease or worsens.
• If you are taking high doses of inhaled steroids and experience unusual symptoms such as abdominal pain, nausea, diarrhea, headache, and drowsiness. This may occur during infection, e.g. viral infection or gastroenteritis. Do not stop taking these medicines abruptly, as this may worsen asthma symptoms and cause hormonal disorders.

If any of the side effects get worse or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flurhinal

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 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 significantly cooled, remove the metal container from the plastic casing and warm it in your hands for a few minutes before use. Do not heat the inhaler 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
If your doctor advises you to stop using the medicine, take the inhaler to a pharmacy where it will be disposed of in a suitable manner.

6. Contents of the packaging and other information

What Flurhinal contains

• The active substance is fluticasone propionate. One dose contains 125 micrograms or 250 micrograms of fluticasone propionate. This corresponds to a delivered dose 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 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 leaflet version in large print is available on request.

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

For more information, 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