AbriFF

Patient Information Leaflet: Information for the User

Abriff 50 micrograms/5 micrograms per dose, pressurised inhalation suspension
Abriff 125 micrograms/5 micrograms per dose, pressurised inhalation suspension
Abriff 250 micrograms/10 micrograms per dose, pressurised inhalation suspension
fluticasone propionate/formoterol fumarate dihydrate
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Abriff is and what it is used for

Please note:
Abriff pressurised inhalation suspension is the name of the product which, in this patient information leaflet,
is abbreviated as Abriff inhaler. In some cases, it may refer to a specific dosage.
Abriff is an inhaler (a pressurised inhalation suspension) 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 called long-acting beta-agonists. Long-acting beta-agonists are long-acting bronchodilators that help keep the airways open, making breathing easier. The combination of these two active substances helps improve breathing. It is recommended to use the medicine daily 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 Abriff

Do not use Abriff:

• 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 sputum streaked with blood, 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, 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 the QTc interval);
• have an abnormal bulging of a blood vessel wall (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 that 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 epileptic seizures), or a tumour of the adrenal gland (pheochromocytoma);
• have liver problems.

Contact your doctor if you experience blurred vision or other visual disturbances.
Inform your doctor if you are undergoing surgery or are under severe stress, as you may require additional steroid treatment to control your asthma.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Abriff
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines. 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:

• medicines known as 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 Abriff, 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 Abriff; 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 to treat 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, are 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 operate machinery.

Abriff contains ethanol (alcohol) and sodium cromoglicate
This medicine contains 2 mg of ethanol per dose (2 inhalations). The amount in each dose is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce 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 Abriff

Use this inhaler exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. You should use it regularly, taking two inhalations (puffs) every morning and two in the evening to get the maximum benefit from the treatment, unless your doctor has given you different instructions or advised you to stop therapy. 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 directed by your doctor. If you are unsure about the dose or frequency of use, 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 for the treatment of asthma. Only adults
should use the higher-dose inhaler (Abriff 250 micrograms/10 micrograms).
Only adults and adolescents over 12 years of age should use the medium-dose inhaler (Abriff 125 micrograms/5 micrograms).
Abriff 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 in the figures 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 actuator. The actuator is equipped with a dose counter indicating the remaining doses (puffs or actuations) after activation. This counter is color-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 obtain 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 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 properly 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 mouthpiece 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 well immediately before each use.

Using the inhaler
If you develop shortness of breath or wheezing while using Abriff, continue using Abriff 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 dose of Abriff.

Follow 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 well 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 actuator. Do not bite the mouthpiece.
5. Breathe in slowly and deeply through your mouth while 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 (inhalation), keep the inhaler upright and repeat steps 2 to 6.
8. Replace the protective cap on the mouthpiece. You may practice in front of a mirror. If you see a mist escaping from the top of the inhaler or from the sides of your mouth during inhalation, 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 irritation of the mouth and throat 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 actuator.

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.

Maintenance of the inhaler
It is important to follow these procedures carefully 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 actuator.
• Clean the inside and outside of the mouthpiece and actuator 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 Abriff 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 your doctor.
If you take more medicine than prescribed, consult your doctor or pharmacist. You may experience 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 feel dizzy, lightheaded, faint, or experience fatigue, nausea, or general malaise. You may also notice changes in heart rhythm and may have low potassium levels or increased blood sugar. You may also experience symptoms such as abdominal pain, vomiting, weight loss, impaired consciousness (which may cause drowsiness or confusion), or hypoglycemia.
If you have taken more than the prescribed dose for a prolonged period, consult your doctor or pharmacist, as high doses of the medicine may reduce the amount of steroid hormones normally produced by the adrenal glands (see section 4).

If you forget to use Abriff
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 Abriff
It is very important that you use this inhaler every day as prescribed by your doctor, even if you feel well, because 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 necessary dose to control your asthma effectively and to minimize the potential occurrence of side effects.

All medicines can cause allergic reactions, although serious reactions are rarely reported. 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 breathing patterns such as increased wheezing or shortness of breath.

As with other inhalers, your breathing may worsen immediately after use. You may notice an increase in wheezing and breathlessness. If this occurs, stop using the Abriff inhaler and switch to your 'rescue' inhaler with rapid onset of action. Contact your doctor immediately; they will assess you and may prescribe a different treatment. Always carry your 'rescue' 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/hoarse voice.
• 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 have diabetes, you may need to monitor your blood sugar levels more frequently and adjust your antidiabetic therapy accordingly. Your doctor may need to monitor you more closely.
• Oral or throat fungal infections (e.g. candidiasis).
• Inflammation of the nasal sinuses (sinusitis).
• Rapid heartbeat.
• Chest pain associated with heart disease.
• Muscle spasms.
• Cough or breathlessness.
• Diarrhea.
• Indigestion.
• Taste disturbances.
• Dizziness or sensation of 'spinning' (vertigo).
• Abnormal dreams.
• Restlessness.
• Itching of the skin.
• High blood pressure.
• Unusual tiredness or fatigue.
• Swelling of hands, ankles or feet.

Not known: frequency cannot be estimated from available data

• Blurred vision;
• Sleep disorders, depression or feelings of anxiety, aggression, anxiety, restlessness, 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);
• Elevated levels of lactic acid in the blood (lactic acidosis);
• Feeling of 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 (thinning of the bones);
• Cataracts (clouding of the lens of the eye);
• Glaucoma (increased intraocular pressure);
• Bruising or thinning of the skin;
• Increased susceptibility to infections;
• Slowed growth rate in children and adolescents;
• Rounded face (moon face);
• Effects 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, diarrhea, nausea or vomiting, or epileptic seizures.

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

Reporting of side effects

If you experience any side effects, 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 Abriff

Keep out of the sight and reach of children.
Do not use this inhaler after the expiry date stated on the label, on the pouch, and on the cardboard packaging after Exp.. The expiry date refers to the last day of that month. Exp. 08-2020 means that you must 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 must be left at room temperature for 30 minutes and primed before use (see section 3 'How to use Abriff'). 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 to be empty. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Abriff 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
formoterolo fumarato diidrato
125 micrograms/5 micrograms per dose, pressurised suspension for inhalation - only
Each dose (puff) contains 125 micrograms of fluticasone propionate and 5 micrograms of
formoterolo fumarato diidrato
250 micrograms/10 micrograms per dose, pressurised suspension for inhalation - only
Each dose (puff) contains 250 micrograms of fluticasone propionate and 10 micrograms of
formoterolo fumarato diidrato
The other components are:

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

Description of the appearance of Abriff 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 S.r.l. – 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 countries under the following
names:
Abriff
Italy
Sweden