Flutiformo

Patient Information Leaflet: Information for the User

Flutiform 50 micrograms/5 micrograms per dose, pressurised suspension for

inhalation
Flutiform 125 micrograms/5 micrograms per dose, pressurised suspension for
inhalation
Flutiform 250 micrograms/10 micrograms per dose, pressurised suspension for
inhalation
fluticasone propionate/formoterol fumarate dihydrate
Please read all of this leaflet carefully before you start using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4. Contents of this leaflet :
  1. What Flutiform is and what it is used for
  2. What you need to know before using Flutiform
  3. How to use Flutiform
  4. Possible side effects
  5. How to store Flutiform
  6. Contents of the pack and other information

1. What Flutiform is and what it is used for

Please note that:
Flutiform pressurised suspension for inhalation is the name of the product, which in this leaflet is abbreviated to Flutiform inhaler. In some cases, it may refer to a specific dosage.

Flutiform is an inhaler (a pressurised suspension for inhalation) containing two active substances:

• fluticasone propionate, belonging to a group of medicines called corticosteroids. Corticosteroids help reduce swelling and inflammation in the lungs;
• formoterol fumarate dihydrate, belonging to a group of medicines known as long-acting beta₂-agonists. Long-acting beta₂-agonists are long-acting bronchodilators that help keep the airways open, making breathing easier.

The combination of these two active substances helps improve breathing. You are advised to use the medicine every day as directed by your doctor.

This medicine helps prevent breathing problems such as asthma and helps avoid shortness of breath and wheezing. However, it is not effective during an acute asthma attack, that is, when you are already experiencing shortness of breath and wheezing. In such cases, you must use a fast-acting 'reliever' medicine such as salbutamol.

2. What you need to know before using Flutiform

Do not use Flutiform:

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using this inhaler.
Before using this inhaler, inform your doctor, pharmacist, or nurse if you:

• currently have or have previously had tuberculosis (TB). Symptoms of tuberculosis include a persistent cough often accompanied by blood-streaked sputum, fever, fatigue, loss of appetite, weight loss, and night sweats;
• have a lung or chest infection;
• have heart problems such as impaired blood flow to the heart or narrowing of one of the heart valves (aortic valve), heart failure which may cause breathlessness or swelling of the ankles, a condition causing thickening of the heart muscle (hypertrophic obstructive cardiomyopathy), irregular heartbeat (cardiac arrhythmias), or changes in the electrocardiogram (prolongation of QTc interval);
• have an abnormal swelling of the wall of a blood vessel (aneurysm);
• have diabetes;
• have high blood pressure;
• have overactivity of the thyroid gland, which may cause increased appetite, weight loss, or sweating (thyrotoxicosis);
• have low levels of potassium in the blood, which may cause muscle weakness, cramps, or changes in heart rhythm (hypokalaemia);
• have adrenal insufficiency (a disorder of adrenal gland function which may cause symptoms such as headache, weakness, fatigue, abdominal pain, loss of appetite, weight loss, dizziness, very low blood pressure, diarrhoea, nausea or vomiting, or seizures) or a tumour of the adrenal gland (phaeochromocytoma);
• have liver problems. Contact your doctor if you experience blurred vision or other visual disturbances. Inform your doctor if you are due to undergo surgery or are under severe stress, as you may need additional steroid treatment to control your asthma. For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and Flutiform
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including medicines without a prescription. Using this inhaler together with other medicines may alter the effect of the inhaler or of the other medicines.
Inform your doctor or pharmacist if you are taking:

• so-called beta-blockers (such as atenolol for high blood pressure, sotalol for irregular heartbeat, metoprolol for rapid heartbeat, or timolol eye drops for glaucoma);
• other medicines for asthma or other respiratory disorders (such as theophylline or aminophylline);
• medicines containing adrenaline or related substances (including other beta-agonists such as salbutamol, or beta-antagonists such as atenolol, metoprolol, propranolol, and timololo). Do not use other long-acting beta-agonists with this inhaler. If your asthma worsens between doses of Flutiform, use your fast-acting 'rescue' inhaler for immediate relief;
• medicines for allergic reactions (antihistamines);
• medicines for high blood pressure or fluid retention that work by increasing urine output (diuretics);
• medicines for heart failure (such as digoxin);
• medicines for heart rhythm disorders (such as quinidine, disopyramide, procainamide);
• medicines for depression or other mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide) or tricyclic antidepressants (e.g. amitriptyline and imipramine), or if you have taken any of these medicines within the last two weeks;
• medicines for psychiatric or mental disorders (phenothiazines or antipsychotics);
• other medicines containing steroids;
• antifungal medicines (such as ketoconazole or itraconazole);
• certain medicines that may increase the effects of Flutiform, and your doctor may need to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, atazanavir, indinavir, nelfinavir, saquinavir, or cobicistat);
• antibiotics (such as clarithromycin, telithromycin, or furazolidone);
• medicines for Parkinson's disease (levodopa);
• medicines for underactive thyroid (levothyroxine);
• medicines for Hodgkin's disease (procarbazine);
• medicines to induce labour (oxytocin). If you are undergoing surgery under general anaesthesia, inform the hospital doctor that you are using this inhaler.
  Pregnancy and breastfeeding
  If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this inhaler. Your doctor will advise you whether to take this medicine.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines.

Flutiform contains ethanol (alcohol) and sodium cromoglicate
This medicine contains 2 mg of ethanol per dose (2 inhalations). The amount per dose is equivalent to less than 1 ml of beer or wine.
The small amount of alcohol in this medicine will not produce any significant effects (see section “Warnings and precautions”).
It also contains a negligible amount of sodium cromoglicate: patients currently being treated with cromoglicate (used in the treatment of asthma, allergic rhinitis, and allergic conjunctivitis) should continue their treatment as usual.

3. How to use Flutiform

Use this inhaler exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. You should use it regularly, taking two inhalations (puffs) in the morning and two in the evening every day to get the maximum benefit from treatment, unless your doctor has given you different instructions or advised you to stop treatment. Do not take more than the prescribed dose. Your doctor may have prescribed the inhaler for a condition other than asthma, or at a different dose than normally recommended and described in this leaflet. Always use this inhaler exactly as instructed by your doctor. If you are unsure about the dose or how often to use it, consult your doctor or pharmacist.

Adults, adolescents and children aged 5 years and older
The usual dose is two inhalations twice daily, i.e. two puffs in the morning and two in the evening. Your doctor will prescribe the dose appropriate for your condition to treat your asthma. Only adults should use the higher-dose inhaler (Flutiform 250 micrograms/10 micrograms).
Only adults and adolescents over 12 years of age should use the medium-dose inhaler (Flutiform 125 micrograms/5 micrograms).
Flutiform must not be used in children under 5 years of age.

Instructions for use
Before using the inhaler, read this patient information leaflet carefully and follow the instructions provided in the text and illustrations below. Your doctor or pharmacist will show you how to use the inhaler correctly. The medicine is contained in an aerosol canister (see Figure 1) inserted into a plastic holder. The holder is equipped with a dose counter indicating the number of doses (puffs or actuations) remaining after activation. This counter is colour-coded: it is green when full, turns yellow when fewer than 50 puffs (actuations) remain, and turns red when fewer than 30 puffs (actuations) remain. When the number approaches zero, contact your doctor to request a new inhaler. Do not use the inhaler if the counter displays a '0' (zero).

Before using the inhaler for the first time, or if it has not been used for more than 3 days, or if it has been exposed to temperatures near freezing
If the inhaler is new or has not been used for more than 3 days, it must be 'primed' to ensure it functions correctly and delivers the correct dose.
If the inhaler has been exposed to temperatures near freezing, allow it to warm to room temperature for 30 minutes, then prime it to ensure it functions correctly and delivers the correct dose.

Priming the inhaler

• Remove the protective cap from the mouthpiece and shake the inhaler well.
• Hold the inhaler away from your face and release one dose (puff) by pressing down on the aerosol canister. Repeat this step four times. Always shake the inhaler immediately before use.

Using the inhaler
If you develop shortness of breath or wheezing while using Flutiform, continue using Flutiform but see your doctor as soon as possible, as you may need additional treatment. Once good asthma control is achieved, your doctor may consider gradually reducing your Flutiform dose.
Perform steps 2 to 5 slowly.

1. Remove the protective cap from the mouthpiece (see Figure 2) and check that the inhaler is clean and free of dust.
2. Shake the inhaler immediately before each dose (puff) to ensure the contents are uniformly mixed.
3. Stand or sit upright. Breathe out fully, as slowly and deeply as possible.

4. Hold the inhaler upright (Figure 3) and place the mouthpiece between your lips. Hold the inhaler with your thumb(s) at the base of the mouthpiece and your index finger(s) on the top of the inhaler. Do not bite the mouthpiece.
5. Breathe in slowly and deeply through your mouth while simultaneously pressing down on the aerosol canister to release one dose (puff). Continue breathing in steadily and deeply (ideally for 2–3 seconds in children or 4–5 seconds in adults).

6. While holding your breath, remove the inhaler from your mouth. Continue to hold your breath as long as possible without straining. Do not exhale into the inhaler.
7. For the second puff (actuation), keep the inhaler upright and repeat steps 2 to 6.
8. Replace the protective cap on the mouthpiece. You may practise in front of a mirror. If during inhalation you see a mist escaping from the top of the inhaler or from the sides of your mouth, you may not have inhaled the medicine correctly. Repeat the procedure starting from step 2 to take another dose. After inhalation, it is important to always rinse your mouth with water, gargle, or brush your teeth and spit out any residue to help prevent mouth and throat irritation or hoarseness. If you have weak hand strength, it may be easier to hold the inhaler with both hands, placing your index fingers on the aerosol canister and both thumbs at the base of the inhaler.

If you have difficulty using the inhaler, your doctor may prescribe a spacer device, AeroChamber Plus Flow-Vu, to help deliver the medicine to your lungs. Your doctor or pharmacist will show you how to use the AeroChamber Plus Flow-Vu spacer with the inhaler. The AeroChamber Plus Flow-Vu comes with instructions for use, maintenance, and cleaning, which must be read carefully.

Inhaler maintenance
It is important to follow these procedures and clean the inhaler once a week. To clean the inhaler:

• Remove the protective cap from the mouthpiece.
• Do not remove the aerosol canister from the holder.
• Clean the inside and outside of the mouthpiece and the holder with a clean, dry cloth or tissue.
• Replace the protective cap on the mouthpiece.
• Do not immerse the metal canister in water.

If you use more Flutiform than you should
It is important that you take the dose indicated on the label or prescribed by your doctor. Do not increase or decrease the dose without consulting a doctor.
If you take more medicine than you should, consult your doctor or pharmacist. You may develop severe chest pain (angina), low or high blood pressure, headache, muscle cramps, sleep disturbances, nervousness, dry mouth, loss of appetite, seizures, or epileptic fits. You may also feel unsteady, lightheaded, faint, or experience fatigue, nausea, or general malaise. You may also notice changes in heart rhythm, low potassium levels, or elevated blood glucose. You may also experience symptoms such as abdominal pain, vomiting, weight loss, impaired consciousness (which may cause drowsiness or confusion), or hypoglycaemia.
If you have taken more than the prescribed dose for a prolonged period, consult your doctor or pharmacist, as high doses of medicine may reduce the amount of steroid hormones normally produced by the adrenal glands (see section 4).

If you forget to use Flutiform
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop using Flutiform
It is very important that you use this inhaler every day as prescribed by your doctor, even if you feel well, as it helps you control your asthma. If you wish to stop using the inhaler, consult your doctor first. Your doctor will advise you on how to do this, usually by gradually reducing the dose to avoid triggering an asthma attack.

4. Possible side effects

Like all medicines, this inhaler may cause side effects, although not everyone experiences them. Your doctor will prescribe the lowest effective dose needed to control your asthma, which also helps reduce the likelihood of possible side effects.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Inform your doctor immediately if you experience sudden swelling of the face, throat, tongue, eyelids or lips, rash or itching, especially if widespread over the body, symptoms such as dizziness, lightheadedness or fainting, or sudden changes in your breathing pattern such as increased wheezing or breathlessness.

As with other inhalers, your breathing may worsen immediately after using this product. You may notice increased wheezing and shortness of breath. If this occurs, stop using the Flutiform inhaler and switch to your 'reliever' inhaler (a fast-acting inhaler). Contact your doctor immediately. Your doctor will assess you and may prescribe a different treatment. Always carry your 'reliever' inhaler with you.

Uncommon (may affect up to 1 in 100 people)

• Worsening of asthma
• Headache
• Tremor
• Irregular heartbeat or palpitations
• Dizziness
• Difficulty sleeping
• Taste disturbances or voice changes/hoarseness
• Dry mouth, sore throat or irritated throat
• Skin rash

Rare (may affect up to 1 in 1,000 people)

• Increased blood sugar levels. If you are diabetic, you may need to monitor your blood sugar levels more frequently and adjust your diabetes therapy accordingly. Your doctor may need to monitor you more closely.
• Oral or throat fungal infections (e.g. candidiasis/mouth thrush)
• Nasal sinus inflammation (sinusitis)
• Rapid heartbeat
• Chest pain associated with heart disease
• Muscle spasms
• Cough or breathlessness
• Diarrhoea
• Indigestion
• Taste disturbances
• Dizziness or vertigo
• Abnormal dreams
• Agitation
• Itching of the skin
• High blood pressure
• Unusual tiredness
• Swelling of the hands, ankles or feet

Not known: frequency cannot be estimated from available data

• Blurred vision
• Sleep disorders, depression or feelings of anxiety, aggression, anxiety, agitation, nervousness, hyperexcitability or irritability. These effects are more likely to occur in children.

The following side effects are associated with formoterol fumarate but have not been reported in clinical studies with this inhaler:

• Low levels of potassium in the blood, which may cause muscle weakness, cramps or changes in heart rhythm;
• Changes in the heart's electrical activity that could potentially lead to an irregular heartbeat (prolongation of the QTc interval);
• High levels of lactic acid in the blood (lactic acidosis);
• Nausea;
• Muscle pain.

Inhaled corticosteroids may interfere with the normal production of steroid hormones, particularly when used at high doses over a prolonged period. These effects include:

• Changes in bone mineral density (bone thinning);
• Cataract (clouding of the lens of the eye);
• Glaucoma (increased pressure in the eye);
• Bruising or thinning of the skin;
• Increased susceptibility to infections;
• Slowed growth rate in children and adolescents;
• Rounded face (moon face);
• An effect on the adrenal gland (a small gland located near the kidneys), with possible symptoms such as weakness, fatigue, inability to cope with stress, abdominal pain, loss of appetite, weight loss, headache, dizziness, very low blood pressure, diarrhoea, nausea or vomiting, or seizures.

These effects are much less likely with inhaled steroids than with oral steroid tablets.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Flutiform

Keep out of the sight and reach of children.
Do not use this inhaler after the expiry date which is stated on the label, on the pouch and on the
carton after Exp. The expiry date refers to the last day of that month. Exp. 08-2020 means that you
should not use this inhaler after the last day of the month indicated, in this case August 2020.
Store below 25°C. Do not refrigerate or freeze. If the inhaler has been exposed to temperatures close
to zero, it should be left at room temperature for 30 minutes and primed before use (see section 3
'How to use Flutiform'). Do not use the inhaler if it has been removed from the pouch for more than
3 months or if the dose indicator shows the number '0'.
Do not expose to temperatures above 50°C. The aerosol can contains a pressurised liquid.
Do not pierce, break or burn the can, even if it appears empty. Do not dispose of any medicine via
wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer
required. This will help protect the environment.

6. Package contents and other information

What Flutiformo contains
The active substances are fluticasone propionate and formoterol fumarate dihydrate. The inhaler is available in three different strengths.
50 micrograms/5 micrograms per dose, pressurised suspension for inhalation - only
Each dose (puff) contains 50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate
125 micrograms/5 micrograms per dose, pressurised suspension for inhalation - only
Each dose (puff) contains 125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate
250 micrograms/10 micrograms per dose, pressurised suspension for inhalation - only
Each dose (puff) contains 250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate
The other components are:

• sodium cromoglicate
• ethanol
• heptafluoropropane HFA 227 (propellant)

Description of the appearance of Flutiformo and contents of the pack
These inhalers are small aerosol cans equipped with a metering valve containing a white to off-white suspension. The aerosol cans are inserted into grey and white plastic inhaler devices with a light grey mouthpiece cap. Each inhaler delivers 120 doses (puffs). Each pack contains one inhaler.
Marketing Authorisation Holder
Mundipharma Pharmaceuticals Srl – via F. Turati, 40 20121 Milano, Italia
Responsible manufacturer for batch release
Mundipharma DC, Leusderend 16, 3832 RC, Leusden, Netherlands
This medicinal product is authorised in the European Economic Area Member States under the following names:
Flutiform:
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Finland
France
Germany
Hungary
Ireland
Iceland
Luxembourg
Netherlands
Norway
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Flutiformo:
Italy