FLUTICASONE DOK 125 MICROGRAMMI Sprężony roztwór do inhalacji

Treść ulotki

1. FLUTICASONE DOC 125 micrograms per actuation, pressurized suspension for inhalation, 250 micrograms per actuation, pressurized suspension for inhalation
   1. What is FLUTICASONE DOC and what is it used for
   2. What you need to know before using FLUTICASONE DOC
   3. How to use FLUTICASONE DOC
   4. Possible side effects
   5. How to store FLUTICASONE DOC
   6. Package contents and other information

FLUTICASONE DOC 125 micrograms per actuation, pressurized suspension for inhalation, 250 micrograms per actuation, pressurized suspension for inhalation

Equivalent medicinal product

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. (See section 4).

Contents of this leaflet

• 1. What FLUTICASONE DOC is and what it is used for
• 2. What you need to know before you use FLUTICASONE DOC
• 3. How to use FLUTICASONE DOC
• 4. Possible side effects
• 5. How to store FLUTICASONE DOC
• 6. Contents of the pack and other information

1. What is FLUTICASONE DOC and what is it used for

This medicine contains the active ingredient fluticasone propionate which belongs to a group of medicines
called corticosteroids.
FLUTICASONE DOC works by reducing inflammation in the lungs.
This helps to prevent asthma attacks in those who need regular treatment. It takes
4-7 days for this medicine to take effect and it is very important to use it regularly.
FLUTICASONE DOC is not indicated for the treatment of sudden asthma attacks when you feel short of
breath.

• To treat sudden asthma attacks, another medicine is used

2. What you need to know before using FLUTICASONE DOC

Do not use FLUTICASONE DOC

• if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Stop taking FLUTICASONE DOC immediately

• if you experience difficulty breathing with an immediate increase in wheezing shortly after taking a dose of this medicine.

Contact your doctor, pharmacist or nurse before using FLUTICASONE DOC

• if you have ever been treated for tuberculosis (TB);
• if you have a history of diabetes mellitus (because fluticasone can increase blood sugar levels);
• if you have used high doses of this medicine for a long period of time and notice any of the following conditions:
• weight gain and a rounded (moon-shaped) face (Cushing's syndrome),
• vague symptoms such as stomach pain, nausea, diarrhoea, headache or drowsiness (adrenal suppression, acute adrenal crisis). This is more likely during an infection such as a viral infection or stomach pain,
• thinning of the bones,
• eye problems (cataracts and glaucoma),
• slowed growth (this occurs mainly in children and adolescents).

If you are not sure if any of the above applies to you, contact your doctor, pharmacist or nurse before
using FLUTICASONE DOC.
Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and FLUTICASONE DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:

• medicines used for the treatment of various types of infections such as ketoconazole, clarithromycin, telithromycin, ritonavir, cobicistat, atazanavir, indinavir, nelfinavir or saquinavir. These medicines can increase the effects of FLUTICASONE DOC and your doctor may want to monitor you carefully if you are taking these medicines. steroid tablets together with FLUTICASONE DOC by inhalation, or if you have just finished taking steroid tablets. You should carry a warning card indicating that you are taking steroids as there is a possibility of impaired adrenal function, especially in stressful situations such as a serious accident or surgery, and your doctor may decide to give you additional steroid medicines during those periods.

If you are not sure if any of the above applies to you, contact your doctor or pharmacist before using
FLUTICASONE DOC.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that FLUTICASONE DOC will affect your ability to drive or operate machinery.

3. How to use FLUTICASONE DOC

FLUTICASONE DOC is available in two different concentrations for inhalation use only. The
doctor will decide which concentration you need. Use this medicine following the doctor’s instructions exactly.
If you have any doubts, ask your doctor, pharmacist or nurse.

Taking this medicine

• FLUTICASONE DOC can be used with the Volumatic spacer device by patients who have difficulty operating a spray (delivery) of medicine immediately after starting to inhale.
• The initial dose should be appropriate based on the severity of the disease. The doctor will work with you to reduce the dose to the lowest dose capable of effectively controlling asthma.

Adult and adolescent patients over 16 years of age
The recommended dose is 50-500 micrograms twice a day.
Use in children
FLUTICASONE DOC is not recommended for children under 16 years of age.
If you are using high doses of an inhaled steroid for a long time, you may sometimes need additional steroids, for example during stressful circumstances such as a car accident or before surgery. The
doctor may decide to give you additional steroids during that period.

Instructions for use
The doctor, nurse or pharmacist must show you how to use the inhaler. They should
periodically check how you are using it. Using FLUTICASONE DOC incorrectly or as prescribed may prevent
the medicine from controlling asthma as it should.
The medicine is contained in a pressurized canister placed in a plastic container with
a mouthpiece. To prevent the inhaler from becoming blocked, it is important to clean it at least once a week.

Checking the inhaler is working
1When you use the inhaler for the first time, try it to make sure it is working. Remove the
mouthpiece cap by gently squeezing it on the sides with your index finger and thumb to detach it.

2To make sure it works, shake the inhaler well, point the mouthpiece away from yourself and press the
canister to release four puffs into the air. If you have not used the inhaler for a week or more,
release two puffs into the air.

How to use the inhaler
It is important to start breathing as slowly as possible just before using the inhaler.
1 You should stand or sit upright when using the inhaler.
2 Remove the mouthpiece cap. Check the inside and outside to make sure the mouthpiece
is clean and free from objects (figure A).

3 Shake the inhaler 4 or 5 times to make sure any loose object is removed and that the content
of the inhaler is mixed evenly (figure B).

4 Hold the inhaler in a vertical position with your thumb on the base, under the mouthpiece. Exhale as
long as possible (figure C). Do not inhale again.

5 Position the mouthpiece in your mouth between your teeth, closing your lips around it.
Do not bite the mouthpiece (figure D).

6 Inhale through your mouth. Immediately after starting to inhale, press the top
of the canister to release a puff of medicine. Do this while continuing to inhale
steadily and deeply (figure D).
7 While holding your breath, remove the inhaler from your mouth and release the pressure of your finger on the top
of the inhaler. Continue to hold your breath for a few seconds, or as long as possible (figure E).

If your doctor has told you that you need to take two puffs, wait about half a minute before taking an
additional puff by repeating steps 3 to 7.
8 Then rinse your mouth with water and spit it out. This is to avoid unwanted effects on
the mouth or throat. You can also brush your teeth.
9 After using the inhaler, always reposition the mouthpiece cap to protect it from
dust. Position the cap by pressing it until you hear a click.
The first few times, practice in front of a mirror. If you see a “mist” coming from the top
of the inhaler or from the sides of your mouth, you should repeat the operation.
Older children or people with little strength in their hands may find it easier to hold the inhaler with
both hands. Place both index fingers on top of the inhaler and both thumbs on the base, under the mouthpiece.
The doctor, nurse or pharmacist will be able to advise you.

How to clean the inhaler
To prevent the inhaler from becoming blocked, it is important to clean it at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Never remove the metal canister from the plastic case.
• Clean the inside and outside of the mouthpiece and the plastic case with a dry cloth or a tissue.
• Replace the mouthpiece cap.

Do not immerse the metal canister in water.
If you use more FLUTICASONE DOC than you should
If you have taken more medicine than you should, inform your doctor as soon as possible.
It is important that you take the dose indicated on the pharmacist’s label or recommended by your doctor. Do not increase or
decrease the dose without consulting your doctor.

If you forget to use FLUTICASONE DOC

• Take the next dose when it is due.
• Do not take a double dose to make up for a missed dose.

If you stop using FLUTICASONE DOC
Do not stop treatment even if you feel better unless your doctor has told you to do so. Patients who have taken high doses of steroids for a long time should not suddenly stop
taking the medicine without talking to their doctor, as this could worsen asthma.
Stopping treatment suddenly can also make you feel unwell and cause symptoms such as vomiting,
drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels and seizures.
If you have any questions about using this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects stop using this medicine and
tell your doctor immediately. Urgent medical treatment may be needed.

• allergic reaction (may affect up to 1 in 100 people) or severe allergic reactions (may affect up to 1 in 10,000) the signs include skin rashes, redness, itching or hives and
• swelling of the face, lips, mouth, tongue or throat which can cause difficulty swallowing or breathing, itchy rash, feeling faint and dizziness and collapse.
• your breathing or wheezing gets worse immediately after using the inhaler.

Other side effects include:
Very common(affects more than 1 in 10 people)

• Thrush (candidiasis) in the mouth and throat

Common(affects less than 1 in 10 people)

• Hoarseness
• bruising
• pneumonia (lung infection) in patients with COPD

Tell your doctor if you have any of the following symptoms while taking FLUTICASONE DOC, they could
be symptoms of a lung infection:

• fever or chills
• increased mucus production, changes in mucus colour
• increased cough or more difficulty breathing

Rare(may affect up to 1 in 1000)

• thrush (candidiasis) in the esophagus

Very rare(affects less than 1 in 10,000)

• difficulty sleeping or feeling worried, excited and irritable (these effects occur mainly in children)
• joint pain
• indigestion
• the level of sugar (glucose) in the blood may increase
• using high doses of FLUTICASONE DOC for a prolonged period may cause: adrenal suppression, adrenal crisis, Cushing's syndrome, thinning of the bones, problems with your eyes (such as cataracts and glaucoma which is characterised by high pressure in the eye) and slowed growth in children and adolescents (see section 2 "Warnings and precautions") Your doctor will help prevent this by making sure you use the lowest dose of steroid that controls your symptoms.

Not known(frequency cannot be estimated from the available data)

• depression
• feeling restless or nervous (these effects occur mainly in children).
• nosebleeds
• blurred vision

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store FLUTICASONE DOC

• Keep this medicine out of the sight and reach of children.
• Clean your inhaler weekly and if it becomes blocked as described in the “How to clean the inhaler” section.
• Do not use this medicine after the expiry date stated on the label and the package after Exp. The expiry date refers to the last day of that month.
• The canister contains liquid under pressure. Do not expose to temperatures above 50  C. Do not puncture the canister. Do not refrigerate or freeze. Protect from freezing or direct sunlight.
• If the inhaler becomes very cold, remove the metal canister from the plastic casing and warm it with your hands for a few minutes before use. Never use anything else to warm it.
• The metal canister is pressurised. Do not puncture, crush or burn it even when apparently empty.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
• If you are told to stop taking this medicine, return the inhaler to your pharmacist for appropriate disposal.

6. Package contents and other information

What FLUTICASONE DOC contains

• The active ingredient is fluticasone propionate. A metered dose (from the valve) contains 125 or 250 micrograms of fluticasone propionate, respectively. This is equivalent to a delivered dose (from the actuator) of 110 mcg or 227 mcg of fluticasone propionate, respectively.
• The other component is norflurane (HFA 134a).

Description of the appearance of FLUTICASONE DOC and package contents

• FLUTICASONE DOC is a white suspension contained in an aluminum alloy canister sealed with a metering valve, an actuator, and a dust cap.
• Each canister contains 120 actuations of 125 or 250 micrograms of fluticasone propionate.

Pack sizes:
Single pack: each single pack contains one canister with 120 actuations.
Multipack: pack of 2 or 3 single packs.
Hospital pack: pack of 10 single packs.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
DOC Generici Srl
Via Turati 40
20121 Milan

Manufacturer
S&D Pharma CZ, spol. s r.o
Theodor 28, 273 08 Pchery (Pharmos a.s. facility)
Czech Republic
Cipla (EU) Limited,
Dixcart House, Addlestone Road, Bourne Business Park,
Addlestone, Surrey, KT15 2LE,
United Kingdom.
Cipla Europe NV
De Keyserlei 58-60,
Box-19, 2018 Antwerp,
Belgium
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

This leaflet is available in large print on request.
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: