ALIFLUS 50 МКГ/100 МКГ Ингаляционный порошок

Содержание инструкции

1. ALIFLUS 25 micrograms/50 micrograms/dose pressurized suspension for inhalation, 25 micrograms/125 micrograms/dose pressurized suspension for inhalation, 25 micrograms/250 micrograms/dose pressurized suspension for inhalation
   1. What is Aliflus and what is it used for
   2. What you need to know before using Aliflus
   3. How to use Aliflus
   4. POSSIBLE SIDE EFFECTS
   5. How to store Aliflus
   6. Package Contents and Other Information
   7. What is Aliflus and what is it used for
   8. What you need to know before using Aliflus
   9. How to use Aliflus
   10. Possible side effects
   11. How to store Aliflus
   12. Contents of the pack and other information

ALIFLUS 25 micrograms/50 micrograms/dose pressurized suspension for inhalation, 25 micrograms/125 micrograms/dose pressurized suspension for inhalation, 25 micrograms/250 micrograms/dose pressurized suspension for inhalation

salmeterol / fluticasone propionate

Read this leaflet carefully before you start using this medicineas it contains important
information for you.
.

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

Contents of this leaflet:

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

1. What is Aliflus and what is it used for

Aliflus contains two medicines, salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier to get air in and out. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as
asthma.
You should use Aliflus every day as prescribed by your doctor. This ensures that the
medicine works correctly to control asthma.

Aliflus helps to block the onset of shortness of breath and wheezing. However, Aliflus
should not be used to treat a sudden attack of shortness of breath or wheezing.
If this occurs, you should use a reliever medicine (“rescue”) that works quickly
like salbutamol.
You should always have your quick-relief medicine with you.

2. What you need to know before using Aliflus

Do not use Aliflus:

• If you are allergic to salmeterol, fluticasone propionate or the other excipient norflurane (HFA 134a).

Warnings and precautions
Talk to your doctor before taking Aliflus if you have:

• Heart disease, including irregular or fast heartbeat
• Hyperthyroidism (overactive thyroid gland)
• High blood pressure
• Diabetes mellitus (Aliflus can increase blood sugar levels)
• Low levels of potassium in the blood
• Tuberculosis (TB) now or in the past, or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Aliflus
Tell your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines, including medicines for asthma or any over-the-counter medicines. This is because it may not be appropriate to take Aliflus with some other
medicines.
Tell your doctor if you are taking the following medicines before starting to use Aliflus:

• beta-blockers (such as atenolol, propranolol and sotalol). Beta-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines for the treatment of infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for the treatment of HIV (such as ritonavir and medicinal products containing cobicistat). Some of these medicines can increase the amount of fluticasone propionate or salmeterol in the body. This can increase the risk of experiencing undesirable effects with Aliflus, including irregular heartbeats or worsening of undesirable effects. Your doctor may want to monitor you closely if you are taking these medicines.
• Corticosteroids (by mouth or by injection). If you have taken one of these drugs recently, this may increase the risk that this medicine interferes with the adrenal gland.
• Diuretics, used for the treatment of high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine-based medicines. These are often used for the treatment of asthma.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.

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

For athletes:
The use of the drug without therapeutic need constitutes doping and may still
result in a positive anti-doping test.

3. How to use Aliflus

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.

• Use Aliflus every day, until your doctor tells you to stop the treatment. Do not exceed the recommended dose. If you have any doubts, consult your doctor or pharmacist.
• Do not stop using Aliflus or reduce the dosage of Aliflus without first consulting your doctor.
• Aliflus must be inhaled into the lungs through the mouth.

Adults and adolescents aged 12 years and over

• Aliflus 25/50 - 2 inhalations twice a day
• Aliflus 25/125 - 2 inhalations twice a day
• Aliflus 25/250 - 2 inhalations twice a day

Children from 4 to 12 years of age

• Aliflus 25/50 - 2 inhalations twice a day
• Aliflus is not recommended for use in children under 4 years of age.

Symptoms can be well controlled by using Aliflus twice a day. In this case, your doctor may decide to reduce the dose to once a day. The dose can be modified in:

• once in the evening if you suffer from nighttimesymptoms
• once in the morning if you suffer from daytimesymptoms.

It is very important to follow your doctor's prescription regarding the number of puffs to take and how often to take the medicine. If you are using Aliflus for asthma, your doctor will regularly check your symptoms. If your asthma or breathing gets worse, tell your doctor immediately.You may notice that your breathing becomes more labored, that you feel chest tightness more often, or that you need to use your reliever medicine more often. If any of these conditions occur, you should continue to use Aliflus but do not increase the number of doses you take. Your respiratory condition may worsen to become particularly serious. Consult your doctor as you may require additional therapy.

Instructions for use

• Your doctor, nurse or pharmacist will show you how to use the inhaler. They should check how you use the inhaler from time to time. If you do not use Aliflus correctly or as prescribed, it may not treat asthma as it should.
• The medicine is contained in a pressurized canister placed inside a plastic casing with a mouthpiece.
• The canister is connected to a counter on the back that shows the number of doses of medicine remaining. Each time you press the canister, a puff of medicine is released and the counter decreases by one dose.
• Be careful not to drop the inhaler as this may decrease the number of doses reported by the counter.

Checking the operation of the inhaler

• 1. Before using the inhaler for the first time, check that it works. Remove the mouthpiece cover by gently pressing the sides of the cover with your thumb and index finger and pull it off.

• 2. To make sure it works, shake the inhaler well, point the mouthpiece away from yourself, then press the canister and spray a puff into the air. Repeat this operation shaking the inhaler before releasing each puff, until the dose counter indicates the number
• 120. If you have not used your inhaler for a week or more, release two puffs of medicine into the air.

Using the inhaler
It is important to start inhaling as slowly as possible immediately before using the inhaler.

• 1. Stand or sit upright while using your inhaler.
• 2. Remove the mouthpiece cover (as shown in the first figure). Check inside and outside to make sure the mouthpiece is clean and free of loose parts.
• 3. Shake the inhaler 4 or 5 times to make sure any loose parts present have been removed and that the contents of the inhaler are mixed evenly.

• 4. Hold the inhaler in a vertical position holding your thumb on the base, under the mouthpiece. Exhale as much as possible.

• 5. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite the mouthpiece.
• 6. Inhale through your mouth slowly and deeply. Immediately after starting to inhale, press firmly on the top of the canister to release a puff of medicine. Meanwhile continue to inhale steadily and deeply.

• 7. Hold your breath, remove the inhaler from your mouth and stop pressing your finger on the top of the inhaler. Continue to hold your breath for a few seconds or as long as possible.

• 8. Wait about half a minute between taking each puff and then repeat steps 3 to 7.
• 9. Afterwards rinse your mouth with water and spit it out, and/or brush your teeth. This may help prevent the occurrence of thrush (oral candidiasis) and hoarseness.
• 10. After use, always immediately replace the mouthpiece cover to prevent dust from entering. When the mouthpiece protective cap is positioned correctly, you will hear a click. If you do not hear the click, turn the

mouthpiece cover in the other direction and try again. Do not use too much force.
Do not rush during steps 4, 5, 6 and 7. It is important that you inhale as slowly as possible just before using the inhaler. The first few times you should use the inhaler standing in front of a mirror. If you notice product leakage, which appears as “mist”, coming from the top of the inhaler or from the sides of the mouth, you should start again from step number

• 3.

As with all inhalers, people who care for children prescribed Aliflus Diskus should make sure they use the correct inhalation technique, as described above.
If you or your child find it difficult to use the pressurized inhaler, your doctor and a nurse or other healthcare professional may advise you to use a spacer such as the Volumatic or Aerochamber Plus together with the inhaler. Your doctor, nurse, pharmacist or other healthcare professional should show you how to use the spacer with the inhaler and how to care for the spacer and answer any questions you may have. It is important that if you use a spacer with the inhaler you do not stop using it without first talking to your doctor or nurse. It is also important that you do not change the type of spacer you use without talking to your doctor. If you stop using a spacer or change the type of spacer you use, it may be necessary to change the dose of medicine needed to control your asthma.
Always talk to your doctor before making changes to your asthma treatment.
Older children or people with weak hands may find it easier to hold the inhaler with both hands. Place both index fingers on the top of the inhaler and both thumbs on the bottom under the mouthpiece.

Get a new pack of medicine when the dose counter shows the number 020. Stop using the inhaler when the counter shows the number 000 as some puffs remaining in the canister may not be enough to provide you with a full dose. Do not attempt to alter the number of doses shown on the counter or detach the counter from the canister.

Cleaning 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 protective cap.
• Do not remove the metal canister from the plastic inhaler under any circumstances.
• Clean the inside and outside of the mouthpiece and the plastic inhaler with a dry cloth or tissue.
• Replace the protective cap on the mouthpiece. You will hear a click when the cap is positioned correctly. If you do not hear the click, turn the mouthpiece cap in the other direction and try again. Do not use too much force.

Do not put the metal container in water.

If you use more Aliflus than you should
It is important to use the inhaler as instructed. If you accidentally take a dose higher than recommended, tell your doctor or pharmacist. You may notice an increase in heart rate and a feeling of tremor. You may also experience dizziness, headache, muscle weakness and joint pain.
If you have taken higher doses for a long period of time, you should consult your doctor or pharmacist. This is because higher doses of Aliflus can reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Aliflus
Do not take a double dose to make up for a missed dose. Just take the next dose at the usual time.

If you stop taking Aliflus
It is very important to take Aliflus every day as prescribed by your doctor. Continue to take it until your doctor tells you to stop the treatment. Do not stop or reduce the dose of Aliflus abruptly. This may cause your breathing to worsen.
In addition, if you stop or reduce the dose of Aliflus abruptly, this can cause (very rarely) problems with the adrenal glands (adrenal insufficiency) which can sometimes cause side effects.

• Stomach pain
• Fatigue and loss of appetite, feeling unwell
• Nausea and diarrhea
• Weight loss
• Headache or drowsiness
• Lowering of blood sugar levels
• Lowering of blood pressure and seizures

When the body is under stress, following a fever, trauma (such as after a car accident), an infection, or surgery, adrenal insufficiency can worsen and one of the side effects listed above may occur.
If you experience any of the side effects, see your doctor or pharmacist.
To prevent these symptoms from occurring, your doctor may prescribe you to take additional doses of corticosteroids in the form of tablets (such as prednisolone).
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 everyone will experience them.
To reduce the possibility of experiencing side effects, your doctor will prescribe the lowest dose of
Aliflus needed to control your asthma.

Allergic reactions: you may notice that your breathing gets worse suddenly immediately
after taking Aliflus. You may have very shortness of breath and cough. You may also
notice itching, rash (urticaria) and swelling (usually of the face, lips, tongue or throat), or you
may suddenly feel that your heart is beating very fast or feel weak and dizzy (which may cause you
to collapse or lose consciousness). If you experience any of these effects or if they occur
suddenly after using Aliflus, stop using Aliflus and inform your doctor immediately. Allergic
reactions to Aliflus are uncommon (affecting less than 1 in 100 people). Other side effects are listed
below:

Very common(affecting more than 1 in 10 people)

• Headache, which usually improves as therapy continues.
• In patients with chronic obstructive pulmonary disease (COPD), an increase in the number of colds has been reported.

Common(affecting less than 1 in 10 people)

• Thrush (painful, raised, yellowish-cream colored patches) in the mouth and throat. Also, soreness of the tongue, hoarseness and irritation of the throat. Rinsing your mouth with water and spitting it out immediately and/or brushing your teeth after taking each dose of medicine may help. Your doctor may prescribe an antifungal to treat thrush.
• Pain, swelling of the joints and muscle pain.
• Muscle cramps. In patients with Chronic Obstructive Pulmonary Disease (COPD), the following side effects have also been reported:
• Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms: increased production of sputum, change in the color of sputum, fever, chills, increased cough, increased breathing problems.
• Bruising and fractures.
• Inflammation of the sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes accompanied by a throbbing pain).
• Decreased potassium levels in the blood (you may experience irregular heartbeat, muscle weakness, cramps).

Uncommon(affecting less than 1 in 100 people)

• Increased sugar (glucose) levels in the blood (hyperglycemia). If you have diabetes, you may need more frequent blood glucose monitoring and, possibly, an adjustment of your antidiabetic therapy.
• Cataract (clouding of the lens of the eye).
• Very fast heartbeat (tachycardia).
• Shaking sensation (tremor) and fast or irregular heartbeat (palpitations) - these side effects are generally harmless and decrease as therapy continues.
• Chest pain.
• Feeling of anxiety (these effects occur particularly in children).
• Disturbed sleep.
• Allergic skin rash.

Rare (affecting less than 1 in 1000)

• Difficulty breathing or worsening wheezing immediately aftertaking Aliflus. If this happens, immediately stop using the Aliflus inhaler. Use your fast-acting medicine to help your breathing and inform your doctor immediately.
• Aliflus can alter the normal production of steroid hormones in the body, particularly if you have taken high doses for a prolonged period of time. The effects include:
• Slowed growth in children and adolescents
• Thinning of the bones
• Glaucoma
• Weight gain
• Rounded (moon-shaped) appearance of the face (Cushing's syndrome). Your doctor will check you regularly to verify the presence of any of these side effects and will ensure that you take the lowest dose of Aliflus to control your asthma.
• Changes in behavior, such as unusual hyperactivity and irritability (these effects occur particularly in children).
• Irregular heartbeat or presence of extra heartbeats (arrhythmia). Tell your doctor but do not stop taking Aliflus unless your doctor tells you to stop taking the medicine.
• A fungal infection of the esophagus (throat), which may cause difficulty swallowing.

Frequency not known, but may occur

• Depression or aggression. These are more likely to occur in children.
• Blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store Aliflus

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and the packaging after Exp. The expiry date refers to the last day of the month.
• Do not store at a temperature above 25°C.
• Do not store Aliflus in a cold place as it may not work properly.
• The container contains a pressurized liquid. Do not expose to temperatures above 50°C, protect from direct sunlight. Do not puncture or burn the container, even when it is empty. As with most inhaled medicines in pressurized containers, the therapeutic effect of this medicine may decrease when the container is cold.

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.

6. Package Contents and Other Information

What Aliflus Contains

• Each dose (delivered by the metering valve) contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or 250 micrograms of fluticasone propionate.
• The other excipient is the propellant: norflurane (HFA 134a).

Description of Aliflus and Package Contents

• Aliflus is supplied in a metered-dose inhaler that delivers the medicine in the form of a pressurized suspension for inhalation into the lungs through the mouth.
• The pressurized container contains a suspension for inhalation ranging in color from white to off-white.
• The containers are inserted into a plastic bag incorporating a mouthpiece and are filled with powder capsules.
• The inhalers are packaged in cardboard boxes containing 1, 3 or 10 inhalers. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. – Avenue de la Gare, 1, Luxembourg
under license from GlaxoSmithKline S.p.A.

Sales Representative:

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi, 3 - Florence.

Manufacturer responsible for batch release
Glaxo Wellcome Production
Zone Industrielle n.2, 23 Rue Lavoisier, La madeleine, 27000 - Evreux – France.
Tel: +33 2 3225500; Fax: +33 2 3225558
or
Glaxo Wellcome S.A.
Avenida de Extremadura, 3 - 09400, Aranda de Duero, Burgos, Spain
Tel: +34 947 529 700; Fax: +34 947 529 800
or

• A. Menarini Manufacturing Logistics and Services S.r.l. Via Sette Santi, 3 - Florence - Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Samtoral Dosieraerosol
Finland Viani Evohaler
Germany Viani
Ireland Viani Evohaler
Italy Aliflus
Portugal Veraspir Inalador
Spain Brisair
United Kingdom Viani Evohaler

This leaflet was last updated on
Aliflus Diskus 50 micrograms/100 micrograms/dose powder for inhalation in a
single-dose container
Aliflus Diskus 50 micrograms/250 micrograms/dose powder for inhalation in a
single-dose container
Aliflus Diskus 50 micrograms/500 micrograms/dose powder for inhalation in a
single-dose container
salmeterol / fluticasone propionate

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 or pharmacist.
• 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Aliflus is and what it is used for
• 2. What you need to know before you use Aliflus
• 3. How to use Aliflus
• 4. Possible side effects
• 5. How to store Aliflus
• 6. Package Contents and Other Information

1. What is Aliflus and what is it used for

Aliflus contains two medicines, salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier to breathe in and out. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and inflammation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as:

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD). Aliflus Diskus, at a dose of 50/500 micrograms, reduces the number of exacerbations of COPD symptoms.

You must use Aliflus every day as prescribed by your doctor. This ensures that the medicine
works correctly to control asthma or COPD.

Aliflus helps to block the onset of shortness of breath and wheezing. However, Aliflus
should not be used to treat a sudden attack of shortness of breath or wheezing.
If this occurs, you should use a fast-acting relief medicine (“rescue”) such as salbutamol. You should always have your fast-acting relief medicine
with you.

2. What you need to know before using Aliflus

Do not use Aliflus:
if you are allergic to salmeterol, fluticasone propionate or the excipient lactose monohydrate.

Warnings and precautions
Talk to your doctor before taking Aliflus if you have:

• Heart disease, including irregular or fast heartbeat
• Hyperactivity of the thyroid gland
• High blood pressure
• Diabetes mellitus (Aliflus can increase blood sugar levels)
• Low levels of potassium in the blood
• Tuberculosis (TB) now or in the past, or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Aliflus
Tell your doctor or pharmacist if you are taking, have recently taken or might
take other medicines, including medicines for asthma or any medicine obtained without
prescription. This is because it may not be appropriate to take Aliflus with some other
medicines.
Tell your doctor if you are taking the following medicines before starting to use Aliflus:

• - blockers (such as atenolol, propranolol and sotalol). - blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines for the treatment of infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for the treatment of HIV (such as ritonavir and medicinal products containing cobicistat). Some of these medicines can increase the amount of fluticasone propionate or salmeterol in the body. This can increase the risk of experiencing undesirable effects with Aliflus, including irregular heartbeats or worsening of undesirable effects. Your doctor may want to keep you under close observation if you are taking these medicines.
• Corticosteroids (by mouth or by injection). If you have taken one of these drugs recently, this may increase the risk that this medicine interferes with the adrenal gland.
• Diuretics, used for the treatment of high blood pressure.
• Other bronchodilators (such as salbutamol). Xanthine-based medicines. These are often used for the treatment of asthma.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.

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

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still
result in a positive anti-doping test.

Aliflus contains lactose
Aliflus Diskus contains up to 12.5 milligrams of lactose monohydrate in each dose. The amount
of lactose in this medicine normally does not cause problems in patients who are
intolerant to lactose. The excipient lactose contains small amounts of milk proteins, which
can cause allergic reactions.

3. How to use Aliflus

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.

• Use Aliflus every day, until your doctor tells you to stop the treatment. Do not exceed the recommended dose. If you have any doubts, consult your doctor or pharmacist.
• Do not stop using Aliflus or reduce the dosage of Aliflus without first consulting your doctor.
• Aliflus must be inhaled into the lungs through the mouth.
• You may not be able to taste the flavour or feel the powder on your tongue, even if you have used Aliflus Diskus correctly.

For asthma
Adults and adolescents aged 12 years and over

• Aliflus 50/100 Diskus - one inhalation twice a day
• Aliflus 50/250 Diskus - one inhalation twice a day
• Aliflus 50/500 Diskus - one inhalation twice a day

Children aged 4 to 12 years

• Aliflus 50/100 Diskus - one inhalation twice a day
• Aliflus is not recommended for use in children under 4 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• Aliflus 50/500 Diskus - one inhalation twice a day

Symptoms may be well controlled by using Aliflus twice a day. In this case, your doctor may decide to reduce the dose to once a day. The dose may be modified in:

• once in the evening if you suffer from night-timesymptoms
• once in the morning if you suffer from daytimesymptoms. It is very important to follow your doctor's prescription regarding the number of inhalations to take and how often to take the medicine.

If you are using Aliflus for asthma, your doctor will regularly check your symptoms. If your asthma or breathing gets worse, inform your doctor immediately.You may notice that your breathing becomes more short of breath, that you feel chest tightness more often, or that you need to use your reliever medicine more often. If any of these phenomena occur, you should continue to use Aliflus but do not increase the number of doses you take. Your respiratory condition may worsen to become particularly serious. You should consult your doctor as you may require additional therapy.

Instructions for use

• Your doctor, nurse or pharmacist will show you how to use the inhaler. They should check how you use the inhaler from time to time. Incorrect or not as prescribed use of Aliflus Diskus may result in it not treating asthma or COPD as it should.
• The Diskus device contains doses (blisters) containing Aliflus in powder form.
• There is a counter on the top of the Diskus that indicates how many doses are remaining. The counter reaches 0 and the numbers from 5 to 0 appear in red to warn when only a few doses remain. Once the counter reads 0, the inhaler is empty.

Using the inhaler

• 2. To open the Diskus, hold the outer part with one hand and place your thumb of the other hand on the appropriate recess. Push with your thumb forward until it is possible. You will hear a click. This will open a small hole in the mouthpiece.

• 3. Hold the Diskus with the mouthpiece facing towards you. You can hold it with your right or left hand. Slide the lever forward until it is possible. You will hear a click. This deposits a dose of the medicine into the mouthpiece.

Each time the lever is slid backwards, a blister inside is opened and the powder for inhalation becomes available. Do not play with the lever as this will open the blister and therefore waste medicine.

• 4. Hold the Diskus away from your mouth. Exhale as deeply as possible. Never blow into the Diskus.
• 5. Put the mouthpiece between your lips. Inhale deeply and steadily through the Diskus and not through your nose. Remove the Diskus from your mouth. Hold your breath for about 10 seconds or as long as possible. Exhale slowly.

• 6. Afterwards rinse your mouth with water and spit it out, and/or brush your teeth. This can help prevent the occurrence of thrush (oral candidiasis) and hoarseness.
• 7. To close the Diskus, position your thumb in the appropriate recess and slide it back to the end of its travel. You will hear a click. The lever returns automatically to its original position.

The Diskus is then ready to be used again.
As with all inhalers, people who care for children who have been prescribed Aliflus Diskus must ensure that they use the correct inhalation technique, as described above.

Cleaning the inhaler
Rub the mouthpiece of the Diskus with a dry cloth to clean it.

If you use more Aliflus than you should
It is important to use the inhaler as instructed. If you accidentally took a dose higher than the recommended one, inform your doctor or pharmacist. You may observe an increase in heart rate and a feeling of tremor. You may also feel dizzy, have a headache, muscle weakness and joint pain.
If you have taken higher doses for a long period of time, you should consult your doctor or pharmacist. This is because higher doses of Aliflus can reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Aliflus
Do not take a double dose to make up for a missed dose. Just take the next dose at the usual time.

If you stop using Aliflus
It is very important to take Aliflus every day as prescribed by your doctor. Continue to take it until your doctor tells you to stop the treatment. Do not stop or suddenly reduce the dose of Aliflus.This may cause your breathing to worsen.
Furthermore, if you stop or suddenly reduce the dose of Aliflus, this can cause (very rarely) problems with the adrenal glands (adrenal insufficiency), which can sometimes cause side effects. These side effects may include any of the following:

• Stomach pain
• Fatigue and loss of appetite, feeling unwell
• Nausea and diarrhoea
• Weight loss
• Headache or drowsiness
• Lowering of blood sugar levels
• Lowering of blood pressure and seizures. When the body is under stress, following a fever, trauma (such as after a car accident), an infection, surgery, adrenal insufficiency can worsen and one of the side effects listed above may occur. If you experience any of the side effects, see your doctor or pharmacist. To prevent these symptoms from occurring, your doctor may prescribe you to take additional doses of corticosteroids in tablet form (such as prednisolone).

If you have any doubts about the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
To reduce the possibility of side effects occurring, your doctor will prescribe the lowest dose of
Aliflus needed to control your asthma or COPD.

Allergic reactions: you may notice that your breathing gets worse suddenly immediately after
taking Aliflus. You may have very wheezy breathing and coughing or feel short of breath.
You may also notice itching, rash (hives) and swelling (usually of the face, lips, tongue or
throat), or you may suddenly feel your heart is beating very fast or feel weak and dizzy (which
may cause you to collapse or lose consciousness). If you have any of these effects or if they occur
suddenly after using Aliflus, stop using Aliflus and tell your doctor immediately. Allergic
reactions to Aliflus are uncommon (affecting less than 1 in 100 people).

Pneumonia (lung infection) in patients with COPD(common side effect).

Tell your doctorif you have any of the following symptoms while taking Aliflus, they may be
symptoms of a lung infection:

• fever or chills,
• increased mucus production, changes in mucus colour,
• increased coughing or greater difficulty breathing. Other side effects are listed below:

Very common (affecting more than 1 in 10 people)

• Headache, which usually improves as treatment continues.
• In patients with COPD, an increase in the number of colds has been reported

Common (affecting less than 1 in 10 people)

• Thrush (painful, raised, yellowish-white patches) in the mouth and throat. Also soreness of the
  tongue, hoarseness and irritation of the throat. Rinsing your mouth with water and spitting it out
  immediately and/or brushing your teeth after taking each dose of medicine may help. Your doctor
  may prescribe an antifungal medicine to treat thrush.
• Pain, swelling of the joints and muscle pain.
• Muscle cramps.

In patients with Chronic Obstructive Pulmonary Disease (COPD) the following side effects have
also been reported:

• Bruising and fractures
• Inflammation of the sinuses (a feeling of tension or fullness in the nose, cheeks and behind the
  eyes, sometimes accompanied by a throbbing pain)
• Reduced potassium levels in the blood (you may notice an irregular heartbeat, muscle weakness,
  cramps).

Uncommon (affecting less than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, you may need to
  check your blood sugar more frequently and, possibly, adjust your antidiabetic therapy.
• Cataract (clouding of the lens of the eye).
• Very fast heartbeat (tachycardia).
• Shaking (tremor) and fast or irregular heartbeat (palpitations) - these side effects are generally
  harmless and decrease as treatment continues.
• Chest pain.
• Feeling anxious (these effects occur particularly in children).
• Disturbed sleep
• Allergic skin rash

Rare (affecting less than 1 in 1000 people)

• Difficulty breathing or wheezing that gets worse immediately after taking Aliflus. If this
  happens, stop using your Aliflus inhaler immediately. Use your reliever inhaler to help your
  breathing and tell your doctor immediately.
• Aliflus can alter the normal production of steroid hormones in the body, particularly if you have
  taken high doses for a prolonged period of time. The effects include:
• Slowed growth in children and adolescents,
• Thinning of the bones,
• Glaucoma,
• Weight gain,
• A rounded (moon-shaped) face (Cushing's syndrome). Your doctor will check you regularly to
  check for any of these side effects and ensure that you are taking the lowest dose of Aliflus to
  control your asthma.
• Changes in behaviour, such as unusual hyperactivity and irritability (these effects occur
  particularly in children).
• Irregular heartbeat or presence of extra beats (arrhythmia). Tell your doctor but do not stop
  taking Aliflus unless your doctor tells you to stop taking the medicine.
• A fungal infection of the oesophagus (throat), which can cause difficulty swallowing.

Frequency not known, but may occur

• Depression or aggression. These are more likely to occur in children.
• Blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 Aliflus

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and the packaging after “Exp.”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.

Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aliflus contains

• Each delivered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 100, 250 or 500 micrograms of fluticasone propionate.
• The excipient is lactose monohydrate (which contains milk proteins).

Description of the appearance of Aliflus and contents of the pack

• Aliflus Diskus contains a laminate strip. The laminate protects the powder for inhalation from the effects of the atmosphere.
• Each dose is pre-dosed.
• The devices are packaged in cardboard boxes containing: 1 Diskus with 28 doses or 1, 2, 3 or 10 Diskus each containing 60 doses.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A. – Luxembourg
Trademark owned by companies of the GSK group or licensees
© 2021 GSK group company or licensor

Sales representative:

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi 3, Florence

Manufacturer responsible for batch release
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations),
Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.
Tel: +44 (0) 1920 463993; Fax: +44 (0) 1920 864000
Glaxo Wellcome Production
Zone Industrielle No.2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France.
Tel: +33 2 322 5500; Fax: +33 2 322 5558
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
Tel: +49 4531 8020; Fax: +49 4531 84956

• A. Menarini Manufacturing Logistics and Services S.r.l. Via Sette Santi, 3 - Florence - Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Samtoral Diskus
France Pavtide Diskus
Germany Viani Diskus
Italy Aliflus Diskus
Portugal Vesaspir Diskus
Romania Pavtide Diskus
Slovenia Viani Diskus
Sweden Viani Diskus
Hungary Thoreus Diskus