Flurhinal

Patient Information Leaflet

Flurhinal, 125 micrograms/inhalation dose, inhalation aerosol, suspension
Flurhinal, 250 micrograms/inhalation dose, inhalation aerosol, suspension
Fluticasone propionate
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Flurhinal is and what it is 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 pack and other information

1. What Flurhinal is and what it is used for

This medicine contains fluticasone propionate as the active substance, which belongs to a group of medicines called corticosteroids. Flurhinal works by reducing swelling and irritation in the lungs. Because the medicine is inhaled directly into the lungs, only a very small amount is needed.

This medicine is prescribed by a doctor for the treatment of:

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

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

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 treatment with Flurhinal, discuss with your doctor or pharmacist if:

• the patient has ever been treated for tuberculosis;
• the patient has ever suffered from oral candidiasis;
• the patient has been diagnosed with diabetes (because fluticasone may increase blood glucose levels);
• the patient has long-term used high doses of this medicine and has noticed any of the symptoms described below:
• weight gain and facial rounding (so-called "moon face") – symptoms of Cushing's syndrome;
• various non-specific symptoms such as abdominal pain, nausea, diarrhoea, headache or drowsiness (symptoms of adrenal suppression, acute adrenal crisis); these symptoms are more likely to occur during infections, e.g. viral infection or gastroenteritis;
• osteoporosis (thinning of bone structure);
• eye disorders (cataract and glaucoma);
• growth retardation (mainly in children and adolescents).

If the patient experiences blurred vision or any other visual disturbances, they should contact a doctor.
If there is any doubt whether any of the above contraindications apply to the patient, consult a doctor or pharmacist before using Flurhinal.

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

Flurhinal and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal medicines. Remember to bring this medicine with you when going to hospital.
Before starting treatment with Flurhinal, the patient should inform the doctor if they are taking:

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

Taking 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, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery. However, it is unlikely that this medicine would have a negative effect.

3. How to use Flurhinal

This medicine should always be taken as directed by the doctor. If in doubt, consult the
doctor or pharmacist.
Flurhinal is available in two different strengths and is intended for inhalation use only. The doctor will decide which strength the patient should use.
Instructions for using this medicine

• If the doctor has prescribed a higher dose of the medicine (above 1000 micrograms per day), Flurhinal should be used with a Volumatic spacer device to minimize unwanted effects in the mouth and throat. Further information on this will be provided by the doctor or pharmacist.
• Some patients may have difficulty releasing the dose at the moment they start inhaling. In such cases, use of a Volumatic spacer device is recommended. Further information on this will be provided by the doctor or pharmacist.
• The effect of this medicine may only become apparent after several days or several months of use; therefore, it is very important to use it regularly.

Asthma
Adults and adolescents aged over 16 years
Mild asthma

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

Moderate asthma

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

Severe asthma

• The usual starting dose is 500 to 1000 micrograms twice daily.

Chronic obstructive pulmonary disease (COPD)
Adults

• 500 micrograms twice daily.

In the treatment of chronic obstructive pulmonary disease (COPD), Flurhinal is used in combination with another long-acting bronchodilator medicine.
Use in children and adolescents
Flurhinal is recommended for the treatment of asthma in adults and adolescents aged over 16 years, as well as for chronic obstructive pulmonary disease (COPD) in adults only.
If the dose of the medicine needs to be increased, the doctor may prescribe Flurhinal 250 micrograms.
If a patient has been taking high doses of inhaled corticosteroids for a long time, additional corticosteroids may be required in certain situations, such as during periods of stress, for example after a traffic accident or before surgery. The doctor may prescribe additional oral corticosteroid doses during such periods.
Patients who have been taking high doses of corticosteroids for a prolonged period, including Flurhinal, must not suddenly stop taking these medicines without first consulting their doctor. Abruptly stopping these medicines may cause unpleasant symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels, and seizures.
Instructions for use
The doctor or pharmacist should demonstrate to the patient how to use the inhaler correctly.
They should periodically check the patient's inhaler technique.
Incorrect or off-label use of Flurhinal may mean that the medicine will not be as effective in treating asthma or COPD as it should be.
The medicine is contained in a pressurized canister within a plastic housing with a mouthpiece. To prevent blockage of the inhaler, it should be cleaned at least once a week.
Checking the inhaler
1 Before using the inhaler for the first time, check whether it is working properly. Remove the mouthpiece cap by gently squeezing its sides with the thumb and index finger.
2 To ensure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and press the canister to release four doses into the air. If the inhaler has not been used for five days or longer, release two doses into the air.
Using the inhaler
Immediately before using the inhaler, begin breathing as slowly as possible.
1 Use the inhaler while sitting upright or standing.
2 Remove the mouthpiece cap. Inspect the mouthpiece inside and outside to ensure it is clean and free from solid particles (Figure A).

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

4 Hold the inhaler upright, with the thumb placed at the base, below the mouthpiece. Breathe out deeply, as deeply as possible (Figure C). Do not inhale at this stage.

5 Place the mouthpiece between the upper and lower teeth and seal lips tightly around it. Do not bite the mouthpiece (Figure D).

6 Begin inhaling slowly through the mouth. Immediately after starting to inhale, press down on the top of the canister to release the dose. Continue a slow, deep inhalation (Figure D).
7 Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Hold your breath for several seconds, or as long as possible (Figure E).

8 If the doctor has prescribed two inhalations (two puffs), wait approximately half a minute after the first inhalation, then repeat steps 3 to 7 to take the second inhalation.
9 After inhalation, rinse the mouth with water and spit it out. This helps prevent unwanted effects in the mouth and throat. You may also brush your teeth.
10 Immediately after using the inhaler, replace the mouthpiece cap to prevent dust from entering. Push the cap firmly into place until a click is heard.
All the steps described above should be practiced several times in front of a mirror.
If mist escapes from the top of the inhaler or from the corners of the mouth, start again.
Older children and patients with weak hands may find it easier to use the inhaler with both hands. To do this, place the index fingers on the top of the inhaler and both thumbs at the bottom, below the mouthpiece. Further information on this will be provided by the doctor or pharmacist.
Cleaning the inhaler
To prevent blockage, the inhaler should be cleaned at least once a week.
Steps for cleaning the inhaler

• Remove the mouthpiece cap.
• Under no circumstances should the metal canister be removed from the plastic housing.
• Wipe the mouthpiece inside and outside, and the outside of the plastic housing, with a dry cloth or tissue.
• Replace the mouthpiece cap.

Do not immerse the metal canister in water.
Use of more Flurhinal than prescribed
If a patient takes more medicine than prescribed, they should contact their doctor as soon as possible.
It is very important that the patient uses the medicine exactly as indicated on the label or as directed by the doctor. Do not increase or decrease the dose without consulting the doctor.
Missed dose of Flurhinal

• If a dose of Flurhinal is missed, wait until the next scheduled dose.
• Do not use a double dose to make up for a missed dose.

Stopping Flurhinal
Even if the patient feels better, they should not stop using this medicine unless advised by the doctor. Patients who have been taking high doses of corticosteroids for a prolonged period must not suddenly stop taking these medicines without first consulting their doctor, as this may worsen asthma symptoms. Abruptly stopping these medicines may also cause unpleasant symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels, and seizures.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If the patient experiences any of the following serious adverse effects, administration of this medicine must be stopped immediately and the doctor contacted without delay.
The patient may require urgent treatment.

• Allergic reactions (may occur in fewer than 1 in 100 people), symptoms include: skin rash, redness of the skin, itching or hives.
• Severe allergic reactions (may occur in fewer than 1 in 10,000 people), symptoms include: swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing, itchy rash, feeling weak or faint, and collapse.
• Worsening of breathing difficulties or wheezing after using the inhaler.

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

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

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

• Pain in the tongue or throat
• Hoarseness. The occurrence of mouth and throat symptoms can be reduced by performing certain actions immediately after inhaling the medicine. These actions include rinsing the mouth and throat with water and spitting it out. Oral and throat candidiasis can be treated with antifungal medicines without discontinuing fluticasone. If the patient experiences the described symptoms in the mouth or throat, they should inform the doctor, but should not stop using the medicine unless advised by the doctor.
• In patients with chronic obstructive pulmonary disease (COPD), the following adverse effects have also been reported:
• Pneumonia (lung infection). Inform the doctor if any of the following symptoms occur during treatment with Flurhinal; these may be signs of lung infection:
• fever or chills
• increased mucus production, change in mucus colour
• worsening cough or increased difficulty in breathing
• Bruising.

Uncommon adverse effects (may occur in fewer than 1 in 1,000 people)

• Oesophageal candidiasis.

Rare adverse effects (may occur in fewer than 1 in 10,000 people)

• Sleep problems or feelings of anxiety, excessive excitement and irritability. These adverse effects occur more frequently in children and adolescents.
• Dyspepsia.
• Joint pain.
• Increased blood sugar (glucose) levels.
• Adrenal suppression (due to the effect of inhaled fluticasone on steroid hormone production in the body). The risk of this effect is higher in patients receiving long-term treatment with high doses of this medicine (e.g. 400 micrograms per day in children). This may lead to:
• slowed growth rate in children and adolescents,
• a condition known as Cushing's syndrome. This occurs when the patient's body has too much steroid hormone and may lead to bone thinning (osteoporosis) and eye disorders such as cataracts or glaucoma (increased intraocular pressure).

The doctor will aim to prevent this by using the lowest effective dose of steroid that adequately controls the disease symptoms.
Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• Depression.
• Psychomotor agitation or nervousness.
• Epistaxis (nosebleed).
• Blurred vision.

The adverse effects listed above occur more frequently in children and adolescents.
The doctor should be consulted as soon as possible in the following situations:

• If, after 7 days of using Flurhinal, breathlessness or wheezing does not improve or worsens.
• If the patient is taking high doses of inhaled steroids and develops unusual symptoms such as abdominal pain, nausea, diarrhoea, headache and drowsiness. This may occur during an infection, e.g. viral infection or gastroenteritis. Inhaled steroids must not be stopped abruptly, as this may trigger an asthma exacerbation and hormonal disturbances.

If any of the adverse effects worsen, or if any adverse effects not listed in this leaflet occur, inform the doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform the 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 Flurhinal

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 the abbreviation EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Do not store in a refrigerator or freeze.
Protect from frost and direct sunlight.
If the inhaler becomes significantly cooled, remove the metal container from the plastic housing and warm it by holding it in your hands for several minutes before use. The inhaler must not be warmed in any other way.
The metal container holds a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the metal container.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
If your doctor advises you to discontinue this medicine, take the inhaler to a pharmacy where it will be properly disposed of.

6. Contents of the pack and other information

What Flurhinal contains

• The active substance is fluticasone propionate. Each metered dose (dose delivered from the valve) contains either 125 micrograms or 250 micrograms of fluticasone propionate. This corresponds to the delivered dose (dose delivered from the mouthpiece) of either 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), equivalent to 0.018 tonnes of CO₂ (global warming potential GWP = 1430).

What Flurhinal looks like and contents of the pack
Flurhinal is a white, homogeneous suspension contained in an aluminium pressurised canister fitted with a suitable metering valve and a plastic mouthpiece. The body of the inhaler is white and the cap is yellow.
Pack sizes:

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Large-print package leaflet available on request.
This medicine is authorised in the European Economic Area countries under the following names:

For more detailed information, please contact the representative of the marketing authorisation holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego Street 3
00-728 Warsaw
Email: [email protected]