Flurhinal

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Flurhinal is and what it is used for
2. Before you use 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.

Flurhinal 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 have no 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, consult a doctor or pharmacist:

• if the patient has ever been treated for tuberculosis;
• if the patient has ever suffered from oral candidiasis;
• if the patient has been diagnosed with diabetes (because fluticasone may increase blood sugar levels);
• if the patient has long-term used high doses of this medicine and has noticed any of the following symptoms:
• 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;
• thinning of bone structure;
• eye disorders (cataract and glaucoma);
• growth retardation (mainly concerning children and adolescents).

If the patient experiences blurred vision or any other visual disturbances, medical advice should be sought.
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
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used, including herbal medicines. Remember to bring this medicine with you when going to hospital.
Before starting 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 have a child, she should consult her 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 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 your doctor. If you have any doubts,
consult your doctor or pharmacist.
Flurhinal is available in two different strengths and is intended for inhalation use only.
Your doctor will decide which strength you should use.

How to use this medicine

• If your doctor has prescribed a higher dose (more than 1000 micrograms per day), Flurhinal should be used with a Volumatic spacer device to minimize unwanted effects in the mouth and throat. Your doctor or pharmacist will provide further information on this.
• Some patients may have difficulty coordinating the release of the dose with the start of inhalation. In such cases, use of a Volumatic spacer device is recommended. Your doctor or pharmacist can provide further advice.
• The effect of this medicine may not become apparent for several days or even several months after starting treatment; therefore, it is very important to use it regularly.

Asthma
Adults and adolescents aged above 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
together with another medicine from the group of long-acting bronchodilators.

Use in children and adolescents
Flurhinal is recommended for the treatment of asthma in adults and adolescents above 16 years
of age, and for chronic obstructive pulmonary disease (COPD) only in adults.
If the dose needs to be increased, your doctor may prescribe Flurhinal 250 micrograms.
If you have been taking high doses of inhaled corticosteroids for a long time, you may require
additional steroid treatment in certain situations, such as during periods of stress, for example
after a traffic accident or before surgery. Your doctor may prescribe additional oral steroid
doses during such periods.
Patients who have been taking high doses of corticosteroids for a prolonged period, including
Flurhinal, must not stop taking these medicines suddenly without first consulting their doctor.
Sudden discontinuation may cause unpleasant symptoms such as vomiting, drowsiness,
nausea, headache, fatigue, loss of appetite, low blood sugar levels, and seizures.

Instructions for use
Your doctor or pharmacist should show you how to use the inhaler correctly. They should
periodically check your inhaler technique.
Incorrect or improper use of Flurhinal may mean that the medicine is not as effective in treating
asthma or COPD as it should be.
The medicine is contained under pressure in a plastic casing with a mouthpiece. To prevent
blockage, the inhaler should be cleaned at least once a week.

Checking the inhaler
1 Before using the inhaler for the first time, check that it works properly. Remove the mouthpiece
cap by gently squeezing its sides with your 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 puffs into the air. If the inhaler has not been used for
five days or more, release two puffs into the air before use.

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 of any solid particles (Figure A).

3 Shake the inhaler 4 or 5 times to dislodge any particles and to ensure the contents are
well mixed (Figure B).

4 Hold the inhaler upright, with your thumb 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 your upper and lower teeth and close your lips tightly around
it. Do not bite the mouthpiece (Figure D).

6 Begin inhaling slowly and deeply through your mouth. Immediately after starting to inhale,
press down on the top of the canister to release a dose of medicine. Continue to inhale
slowly and deeply (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 a few seconds, or as long as possible (Figure E).

8 If your doctor has prescribed two inhalations (two sprays), wait about half a minute after the
first inhalation, then repeat steps 3 to 7 to take the second inhalation.
9 After inhalation, rinse your 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 use, replace the mouthpiece cap to prevent dust from entering. Push the
cap firmly into place until you hear a click.

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 your 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 of both hands on the top of the inhaler and both
thumbs at the base, below the mouthpiece. Your doctor or pharmacist can provide further
information on this.

Cleaning the inhaler
To prevent blockage, clean the inhaler 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 casing.
• Wipe the mouthpiece inside and outside, and the outside of the plastic casing, with a dry cloth or tissue.
• Replace the mouthpiece cap.

Do not immerse the metal canister in water.

Taking more Flurhinal than prescribed
If you take more Flurhinal than prescribed, contact your doctor immediately.
It is very important to take this medicine exactly as stated on the label or as directed by your
doctor. Do not increase or decrease the dose without consulting your doctor.

Missed dose of Flurhinal

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

Stopping 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 corticosteroids for a long time must not stop
taking these medicines suddenly without first consulting their doctor, as this may worsen
asthma symptoms. Sudden discontinuation may also cause unpleasant symptoms such as
vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels,
and seizures.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the following serious adverse effects, use of this medicine must be stopped immediately and the patient should contact a doctor.
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 skin eruptions resembling 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, lightheadedness and collapse.
• Worsening of breathing difficulties or wheezing after using the inhaler.

The following other adverse effects have been reported:
Very common adverse effects (may affect more than 1 in 10 people)

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

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

• Pain in the tongue or throat
• Hoarseness. The occurrence of effects in the mouth and throat may be reduced by performing certain actions immediately after inhaling the medicine. These actions include rinsing the mouth and throat with water and then 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, the doctor should be informed, but the medicine should not be discontinued unless otherwise 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 affect fewer than 1 in 1,000 people)

• Oesophageal candidiasis.

Rare adverse effects (may affect 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 (caused by 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,
• 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 try to prevent this by using the lowest dose of inhaled steroid that effectively 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.

These adverse effects 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 treatment with 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. Do not stop steroid treatment abruptly, as this may cause worsening of asthma 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 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 stated 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, before use remove the metal container from the plastic housing and warm it by holding it in your hands for several minutes. The inhaler must not be warmed in any other way.
The metal container holds a pressurised 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. This 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 released from the valve) contains either 125 micrograms or 250 micrograms of fluticasone propionate. This corresponds to the delivered dose (dose released from the mouthpiece) of either 110 micrograms or 227 micrograms of fluticasone propionate, respectively.
• 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 equivalent (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 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 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 version of the leaflet available on request.
This medicine is authorised in the member countries of the European Economic Area under the following names:

For more detailed information, please contact the
responsible entity's representative:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3
00-728 Warsaw
Email: [email protected]