Aliflus

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

salmeterol / fluticasone propionate
Please read all of this leaflet carefully before you start using this medicine
because 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 other people, even if their symptoms seem identical to yours, as it may be harmful.
• If you experience any side effect, including 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 using 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 Aliflus is and what it is used for

Aliflus contains two medicines, salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open. This makes it easier to breathe in and out. The effects last for at least 12 hours.
• Fluticasone propionato 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 must use Aliflus every day as prescribed by your doctor. This ensures that the medicine works properly to control your asthma.
Aliflus helps prevent the onset of breathlessness and wheezing. However, Aliflus must not be used to treat a sudden attack of breathlessness or wheezing. If this occurs, you must use a fast-acting reliever medicine, such as salbutamol.
You must always have your fast-acting reliever 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 to the excipient norflurane (HFA 134a).

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

• Heart disease, including irregular or fast heartbeat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Aliflus may increase blood sugar levels)
• Low levels of potassium in the blood
• Tuberculosis (TB), currently 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 certain other medicines.
Inform your doctor if you are taking the following medicines before starting 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 may increase the amount of fluticasone propionate or salmeterol in the body. This may increase the risk of experiencing side effects with Aliflus, including irregular heartbeats or worsening of side effects. Your doctor may want to monitor you closely if you are taking these medicines.
• Corticosteroids (taken orally or by injection). If you have recently taken one of these medicines, this may increase the risk that this medicine interferes with the adrenal gland.
• Diuretics, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine-based medicines. These are often used to treat asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
Driving and using machines
It is unlikely that Aliflus will affect your ability to drive or operate machinery.
For those engaged in sports:
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Aliflus

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Use Aliflus every day until your doctor tells you to stop 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 without first consulting your doctor.
• Aliflus must be inhaled into the lungs through the mouth.

Adults and adolescents aged 12 years and older

• Aliflus 25/50 – 2 inhalations twice daily
• Aliflus 25/125 – 2 inhalations twice daily
• Aliflus 25/250 – 2 inhalations twice daily

Children aged 4 to 12 years

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

Symptoms may be well controlled by using Aliflus twice daily. In such cases, your doctor may decide to reduce the dose to once daily. The dose may be adjusted as follows:

• once in the evening if you suffer from night-time symptoms
• once in the morning if you suffer from day-time symptoms.

It is very important to follow your doctor's instructions regarding the number of puffs and how frequently to take the medicine.
If you are using Aliflus for asthma, your doctor will regularly monitor your symptoms. If your asthma
or breathing worsens, inform your doctor immediately. You may notice that your breathing becomes more laboured, that you feel chest tightness more frequently, or that you need to use your reliever medicine more often. If any of these conditions occur, continue using Aliflus but do not increase the number of doses you take. Your respiratory condition could worsen and become particularly severe. 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 your inhaler technique from time to time. If Aliflus is not used correctly or as prescribed, it may not control your asthma as intended.
• The medicine is contained in a pressurized canister inside a plastic casing fitted with a mouthpiece.
• The canister is connected to a counter on the back that displays the number of remaining doses. Each time the canister is pressed, a spray of medicine is released and the counter decreases by one dose.
• Be careful not to drop the inhaler, as this may cause the counter to display an incorrect number of remaining doses.

Checking the inhaler is working

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

2. To ensure it works, shake the inhaler well, point the mouthpiece away from you, press down on the canister and release one spray into the air. Repeat this step, shaking the inhaler before each spray, until the dose counter shows the number 120. If you have not used your inhaler for one week or more, release two sprays 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 cap (as shown in the first figure). Check inside and outside to ensure the mouthpiece is clean and free of foreign objects.
3. Shake the inhaler 4 or 5 times to ensure any loose particles are removed and the contents are evenly mixed.

4. Hold the inhaler upright, placing your thumb on the base below the mouthpiece. Breathe out as fully as possible.

5. Place the mouthpiece in your mouth, between your teeth. Close your lips around it. Do not bite the mouthpiece.

6. Breathe in slowly and deeply through your mouth. Immediately after starting to inhale, press firmly on the top of the canister to release one spray of medicine. Continue inhaling steadily and deeply throughout this process.

7. Hold your breath, remove the inhaler from your mouth, and stop pressing the canister. Continue holding your breath for a few seconds, or as long as possible.

8. Wait about half a minute between each puff, 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 oral candidiasis (thrush) and hoarseness.
10. After use, always immediately replace the mouthpiece cap to prevent dust from entering. When the protective mouthpiece cap is correctly positioned, you will hear a click. If you do not hear a click, turn the mouthpiece cap the other way and try again. Do not use excessive force.

Do not rush 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, use the inhaler while standing in front of a mirror. If you see loss of product, appearing as a "mist", coming from the top of the inhaler or from the sides of your mouth, start again from step 3.

As with all inhalers, caregivers of children prescribed Aliflus Diskus must ensure that the correct inhalation technique, as described above, is used.

If you or your child finds it difficult to use the pressurized inhaler, your doctor, nurse, or another healthcare professional may advise you to use a spacer device such as the Volumatic or Aerochamber Plus with the inhaler. Your doctor, nurse, pharmacist, or other healthcare professional will show you how to use the spacer with the inhaler, 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 discussing it with your doctor or nurse. It is also important not to change the type of spacer you are using without consulting your doctor. If you stop using a spacer or change the type of spacer used, the required dose of medicine for asthma control may need to be adjusted.

Always talk to your doctor before making any 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, below the mouthpiece.

Get a new pack of medicine when the dose counter shows 020. Stop using the inhaler when the counter displays 000, as any remaining puffs in the canister may not deliver a full dose. Never try to alter the number of doses shown on the counter or remove the counter from the canister.

Cleaning the inhaler
To prevent blockage of the inhaler, it is important to clean it at least once a week.
To clean the inhaler:

• Remove the protective mouthpiece cap.
• Never remove the metal canister from the plastic inhaler casing.
• Clean the inside and outside of the mouthpiece and plastic inhaler with a dry cloth or tissue.
• Replace the protective mouthpiece cap. You will hear a click when the cap is correctly positioned. If you do not hear a click, turn the mouthpiece cap the other way and try again. Do not use excessive force.

Do not put the metal canister in water.

If you use more Aliflus than you should
It is important to use the inhaler as directed. If you have accidentally taken more than the recommended dose, inform your doctor or pharmacist. You may experience an increased heart rate and a trembling sensation. You may also feel dizzy, have a headache, muscle weakness, or joint pain.
If you have used higher doses for a prolonged period, consult your doctor or pharmacist. This is because higher doses of Aliflus may reduce the amount of steroid hormones produced by the adrenal glands.

If you forget to use Aliflus
Do not take a double dose to make up for a forgotten dose. Take only the next dose at your usual time.

If you stop treatment with Aliflus
It is very important to take Aliflus every day as prescribed. Continue taking it until your doctor tells you to stop. Do not stop or suddenly reduce the dose of Aliflus. This could cause your breathing to worsen.

Additionally, if you stop or suddenly reduce the dose of Aliflus, this may (very rarely) cause problems with the adrenal glands (adrenal insufficiency), which may sometimes lead to adverse effects.

These adverse effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling unwell
• Nausea and diarrhoea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures

When the body is under stress due to fever, trauma (such as after a car accident), infection, or surgery, adrenal insufficiency may worsen and one of the adverse effects listed above may occur.

If any of these adverse effects occur, consult your doctor or pharmacist.

To prevent these symptoms from occurring, your doctor may prescribe additional doses of corticosteroids in tablet form (such as prednisolone).

If you have any questions about using this medicine, consult your doctor, nurse, or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. To reduce the possibility of adverse reactions occurring, your doctor will prescribe the lowest dose of Aliflus necessary to control your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after taking Aliflus. You may experience severe shortness of breath and coughing. You might also observe itching, skin 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 could 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 immediately and contact your doctor without delay. Allergic reactions to Aliflus are uncommon (affecting fewer than 1 in 100 people).

Other adverse reactions are listed below:

Very common (affects more than 1 in 10 people)

• Headache, which usually improves with continued treatment.
• In patients with chronic obstructive pulmonary disease (COPD), an increased frequency of colds has been reported.

Common (affects less than 1 in 10 people)

• Oral or pharyngeal candidiasis (raised, painful yellow-cream patches in the mouth and throat). In addition, soreness of the tongue, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out immediately and/or brushing teeth after each dose of medicine may help. Your doctor may prescribe an antifungal to treat the candidiasis.
• Joint pain, swelling of joints, and muscle pain.
• Muscle cramps. In patients with chronic obstructive pulmonary disease (COPD), the following adverse reactions have also been reported:
• Pneumonia and bronchitis (lung infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased coughing, or worsening breathing problems.
• Bruising and fractures.
• Sinus inflammation (a feeling of pressure or fullness in the nose, cheeks, and behind the eyes, sometimes accompanied by throbbing pain).
• Decreased potassium levels in the blood (you may notice irregular heartbeat, muscle weakness, or cramps).

Uncommon (affects less than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, more frequent blood glucose monitoring may be required, and your anti-diabetic therapy may need adjustment.
• Cataract (clouding of the eye's lens).
• Very rapid heartbeat (tachycardia).
• Tremor and fast or irregular heartbeat (palpitations) – these adverse reactions are generally harmless and tend to decrease with continued treatment.
• Chest pain.
• Feelings of anxiety (these effects occur particularly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (affects less than 1 in 1,000 people)

• Breathing difficulties or wheezing that worsens immediately after taking Aliflus. If this occurs, stop using the Aliflus inhaler immediately. Use your fast-acting medicine to help with breathing and contact your doctor immediately.
• Aliflus may alter the normal production of steroid hormones in the body, particularly if high doses have been taken for a prolonged period. Effects include:
• Slowed growth in children and adolescents
• Thinning of the bones
• Glaucoma
• Weight gain
• Rounded (moon-shaped) face (Cushing's syndrome). Your doctor will monitor you regularly for any of these adverse effects and ensure you are taking the lowest effective dose of Aliflus to control your asthma.
• Behavioral changes such as unusual hyperactivity and irritability (these effects occur particularly in children).
• Irregular heartbeat or extra heartbeats (arrhythmia). Inform your doctor, but do not stop taking Aliflus unless your doctor tells you to do so.
• Fungal infection of the esophagus (throat), which may cause difficulty swallowing.

Frequency not known, but possible

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

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, 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 stated on the label and the carton after Exp. The expiry date refers to the last day of the month.
• Do not store 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 pierce or burn the container, even when it is empty. As with most pressurized inhalation medicines, the therapeutic effect of this medicine may be reduced when the container is cold.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in 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 the appearance of Aliflus and package contents

• Aliflus is supplied in a pressurized metered-dose inhaler that delivers the medicine as a pressurized suspension for inhalation into the lungs via the mouth.
• The pressurized container holds a white to off-white inhalation suspension.
• The containers are placed in 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 licence from GlaxoSmithKline S.p.A.
Sales Licence Holder:
A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi, 3 - Florence, Italy
Responsible Pharmacist 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 authorized in the European Economic Area countries under the following names:
Austria Samtoral Metered Dose Inhaler
Finland Viani Evohaler
Germany Viani
Ireland Viani Evohaler
Italy Aliflus
Portugal Veraspir Inhaler
Spain Brisair
United Kingdom Viani Evohaler

This leaflet was last updated on

PACKAGE LEAFLET: INFORMATION FOR THE USER
Aliflus Diskus 50 micrograms/100 micrograms per dose inhalation powder in single-dose container
Aliflus Diskus 50 micrograms/250 micrograms per dose inhalation powder in single-dose container
Aliflus Diskus 50 micrograms/500 micrograms per dose inhalation powder in single-dose container
salmeterol / fluticasone propionate

Read this entire 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 give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform 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 using Aliflus
3. How to use Aliflus
4. Possible side effects
5. How to store Aliflus
6. Package contents and other information

1. What Aliflus is and what it is used for

Aliflus contains two medicines: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier to breathe in and out. The effects last for at least 12 hours.
• Fluticasone propionato 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 the 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 properly to control your asthma or COPD.
Aliflus helps prevent the onset of breathlessness and wheezing. However, Aliflus must not be used to treat a sudden attack of breathlessness or wheezing. If this occurs, you must use a fast-acting "reliever" medicine such as salbutamol. You should always have your fast-acting reliever medicine with you.

2. What you need to know before using Aliflus

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

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

• Heart disease, including irregular or rapid heartbeat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Aliflus may increase blood sugar levels)
• Low potassium levels in the blood
• Tuberculosis (TB), either currently or in the past, or other lung infections.

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

Other medicines and Aliflus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines for asthma or any medication obtained without a prescription. This is because it may not be appropriate to take Aliflus with certain other medicines.
Inform your doctor if you are taking any of the following medicines before starting 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, itraconazolo, and erythromycin), including some medicines used to treat HIV (such as ritonavir and medicinal products containing cobicistat). Some of these medicines may increase the amount of fluticasone propionato or salmeterol in your body. This may increase the risk of experiencing side effects with Aliflus, including irregular heartbeats or worsening of side effects. Your doctor may wish to monitor you closely if you are taking these medicines.
• Corticosteroids (taken by mouth or by injection). If you have recently taken any of these medicines, this may increase the risk that this medicine interferes with the adrenal gland.
• Diuretics, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol). Xanthine-based medicines. These are often used to treat asthma.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.

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

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

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

3. How to use Aliflus

Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

• Use Aliflus every day until your doctor tells you to stop 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 without first consulting your doctor.
• Aliflus must be inhaled into the lungs through the mouth.
• You may not be able to taste or feel the powder on your tongue, even if you have used Aliflus Diskus correctly.

For asthma
Adults and adolescents aged 12 years and older

• Aliflus 50/100 Diskus – one inhalation twice daily
• Aliflus 50/250 Diskus – one inhalation twice daily
• Aliflus 50/500 Diskus – one inhalation twice daily

Children aged 4 to 12 years

• Aliflus 50/100 Diskus – one inhalation twice daily
• 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 daily

Symptoms may be well controlled by using Aliflus twice daily. In such cases,
your doctor may decide to reduce the dose to once daily. The dose may be adjusted
to:

• once in the evening if you suffer from nocturnal symptoms
• once in the morning if you suffer from daytime symptoms. It is very important to follow your doctor’s instructions regarding the number of inhalations to take and how frequently to take the medicine.

If you are using Aliflus for asthma, your doctor will regularly monitor your symptoms. If your asthma
or breathing worsens, inform your doctor immediately. You may notice that your
breathing becomes more labored, that you feel chest tightness more frequently, or that you
need to use your reliever medicine more often. If any of these events occur, continue using Aliflus but do not increase the number of doses you take. Your respiratory condition could worsen significantly. You must 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 your inhaler technique from time to time. Incorrect or improper use of Aliflus Diskus may result in inadequate treatment of asthma or COPD.
• The Diskus device contains doses (blister packs) containing Aliflus in powder form.
• There is a counter on the top of the Diskus indicating how many doses remain. The counter goes down to 0, and the numbers from 5 to 0 appear in red to warn you when only a few doses remain. When the counter reaches 0, the inhaler is empty.

Using the inhaler

2. To open the Diskus, hold the outer case with one hand and place the thumb of your other hand on the designated groove. Push the thumb forward as far as possible. You will hear a click. This opens a small hole in the mouthpiece.

3. Hold the Diskus with the mouthpiece facing toward you. You may hold it with either your right or left hand. Slide the lever forward as far as possible. You will hear a click. This delivers a dose of medicine into the mouthpiece.

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

4. Hold the Diskus away from your mouth. Breathe out as deeply as possible. Never breathe into the Diskus.
5. Place the mouthpiece between your lips. Breathe in deeply and steadily through the Diskus, not through your nose. Remove the Diskus from your mouth. Hold your breath for about 10 seconds, or as long as possible. Breathe out slowly.

6. Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This may help prevent the occurrence of candidiasis (thrush) and hoarseness.
7. To close the Diskus, place your thumb in the designated groove and slide it backward until it stops. You will hear a click. The lever automatically returns to its original position.

The Diskus is now ready for use again.
As with all inhalers, caregivers of children prescribed Aliflus Diskus must ensure that they use the correct inhalation technique as described above.
Cleaning the inhaler
Wipe the Diskus mouthpiece with a dry cloth to clean it.
If you use more Aliflus than you should
It is important to use the inhaler as directed. If you accidentally take a higher dose than recommended, inform your doctor or pharmacist. You may experience an increased heart rate and a trembling sensation. You may also experience dizziness, headache, muscle weakness, and joint pain.
If you have taken higher doses for a prolonged period, consult your doctor or pharmacist. This is because higher doses of Aliflus may reduce the amount of steroid hormones produced by the adrenal glands.
If you forget to use Aliflus
Do not take a double dose to make up for a missed dose. Take only the next dose at your usual time.
If you stop using Aliflus
It is very important to take Aliflus every day as prescribed. Continue taking it until your doctor tells you to stop treatment. Do not stop or suddenly reduce the dose of Aliflus. This could cause worsening of breathing.
Moreover, if you stop or suddenly reduce the dose of Aliflus, this may (very rarely) lead to adrenal gland problems (adrenal insufficiency), which may sometimes cause adverse effects. These adverse effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling unwell
• Nausea and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and collapse (convulsions). When the body is under stress due to fever, trauma (such as after a car accident), infection, or surgery, adrenal insufficiency may worsen and one of the adverse effects listed above may occur. If any of these adverse effects occur, contact your doctor or pharmacist. To prevent such symptoms, your doctor may prescribe additional corticosteroid doses in tablet form (such as prednisolone).

If you have any questions about the use of this medicine, consult 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 suddenly worsens immediately after
taking Aliflus. You may experience severe shortness of breath, coughing, or difficulty breathing.
You may also develop itching, skin rash (urticaria), or swelling (usually of the face, lips, tongue, or
throat), or you may suddenly feel your heart 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 immediately and contact your doctor.
Allergic reactions to Aliflus are uncommon (affecting fewer than 1 in 100 people).
Pneumonia (lung infection) in patients with COPD (common side effect).
Contact your doctor if you experience any of the following symptoms while taking Aliflus, as they
may indicate a lung infection:

• fever or chills,
• increased mucus production or changes in mucus colour,
• worsening cough or increased breathing difficulties.

Other side effects are listed below:

Very common (affects more than 1 in 10 people)

• Headache, which usually improves with continued treatment.
• In patients with COPD, an increased frequency of colds has been reported.

Common (affects fewer than 1 in 10 people)

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

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

• Bruising and fractures
• Sinus inflammation (a feeling of pressure or fullness in the nose, cheeks, and behind the eyes, sometimes accompanied by a pulsating pain)
• Decreased potassium levels in the blood (you may notice an irregular heartbeat, muscle weakness, or cramps).

Uncommon (affects fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, more frequent blood glucose monitoring and possible adjustment of your antidiabetic therapy may be needed.
• Cataract (clouding of the eye's lens).
• Very fast heartbeat (tachycardia).
• Shaking sensation (tremor) and fast or irregular heartbeat (palpitations) – these side effects are generally harmless and decrease with continued treatment.
• Chest pain.
• Feeling of anxiety (these effects occur particularly in children).
• Disturbed sleep
• Allergic skin rash

Rare (affects fewer than 1 in 1000 people)

• Breathing difficulties or worsening wheezing immediately after taking Aliflus. If this occurs,
  stop using the Aliflus inhaler immediately. Use your fast-acting medicine to help with breathing and
  contact your doctor immediately.
• Aliflus may alter the normal production of steroid hormones in the body, particularly if high doses have been taken for a prolonged period. Effects include:
• Slowed growth in children and adolescents,
• Thinning of the bones,
• Glaucoma,
• Weight gain,
• Rounded (moon-shaped) face (Cushing's syndrome). Your doctor will monitor you regularly for any of these side effects and ensure you are taking the lowest effective dose of Aliflus to control your asthma.
• Behavioural changes such as unusual hyperactivity and irritability (these effects occur particularly in children).
• Irregular heartbeat or extra heartbeats (arrhythmia). Inform your doctor, but do not stop taking Aliflus unless your doctor tells you to.
• Fungal infection of the oesophagus (gullet), which may cause difficulty swallowing.

Frequency not known, but possible

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

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 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 on the carton after “Exp.”. The expiry date refers to the last day of that month.
• Do not store above 30°C.

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. Package contents 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 monohydrate lactose (which contains milk proteins).

Description of the appearance of Aliflus and package contents

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

It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A. – Luxembourg
Trademark owned by companies within the GSK group or by licensors
© 2021 Companies within the GSK group or licensor
Sales licence holder:
A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi 3, Florence
Responsible manufacturer 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 European Economic Area Member States under the
following names:
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
This patient information leaflet was last approved on