Seretide

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

salmeterol/fluticasone propionate
Read this entire leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Seretide is and what it is used for

Seretide 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 irritation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.
You must use Seretide every day as prescribed by your doctor. This ensures that the medicine works
properly to control your asthma.
Seretide helps prevent the onset of breathlessness and wheezing. However, Seretide 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 should know before using Seretide

Do not use Seretide:
if you are allergic to salmeterol, fluticasone propionate, or to the excipient norflurane (HFA 134a).

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

• Heart disease, including irregular or fast heartbeat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Seretide may 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 Seretide
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 Seretide with certain other medicines.

Inform your doctor if you are taking any of the following medicines before starting Seretide:

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines for treating infections (such as ketoconazole, itraconazole, 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 propionate or salmeterol in your body. This may increase the risk of experiencing side effects with Seretide, 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 adrenal gland function.
• 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 might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.

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

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

3. How to use Seretide

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
ask your doctor or pharmacist.

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

Adults and adolescents aged 12 years and older

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

Children aged 4 to 12 years

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

Symptoms may be well controlled by using Seretide twice daily. In this case, 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 sprays and how often to take the medicine.
If you are using Seretide 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 Seretide but do not increase the number of doses you take. Your breathing 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 you do not use Seretide properly or as prescribed, it may not treat your asthma effectively.
• 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 which shows the number of doses of medicine remaining. 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 that the inhaler is working

1. Before using the inhaler for the first time, check that it is working. 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, then press the canister to release one spray into the air. Repeat this step, shaking the inhaler before releasing each spray, until the dose counter reads 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 loose parts.
3. Shake the inhaler 4 or 5 times to ensure any loose parts are removed and the contents are evenly mixed.

4. Hold the inhaler upright, with your thumb on the base below the mouthpiece. Breathe out as far 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 a spray of medicine. Continue breathing in steadily and deeply.

7. Hold your breath, remove the inhaler from your mouth, and release pressure from the top of the inhaler. Continue holding your breath for a few seconds, or as long as possible.

8. Wait about half a minute between each spray, 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 thrush (candidiasis) 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 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. At first, use the inhaler while standing in front of a mirror. If you see a 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 Seretide Pressurised Inhalation Suspension must ensure they use the correct inhalation technique as described above.

If you or your child finds it difficult to use the pressurised inhaler, your doctor, nurse, or other healthcare professional may advise you to use a spacer device such as 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 use without discussing it with 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, under the mouthpiece.

Get a new medicine pack when the dose counter shows 020. Stop using the inhaler when the counter reads 000, as any remaining sprays 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 the inhaler from becoming blocked, 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 cap the other way and try again. Do not use excessive force.

Do not put the metal container in water.

If you use more Seretide than you should
It is important to use the inhaler as directed. If you accidentally take more than the recommended dose, inform your doctor or pharmacist. You may notice 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 Seretide may reduce the amount of steroid hormones produced by the adrenal glands.

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

If you stop using Seretide
It is very important to take Seretide every day as prescribed. Continue taking it
until your doctor tells you to stop. Do not stop or suddenly reduce
your dose of Seretide. This could cause your breathing to worsen.
In addition, stopping or suddenly reducing the dose of Seretide may (very rarely) cause problems with the adrenal glands (adrenal insufficiency), which may sometimes lead to unwanted effects.

These unwanted 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 collapse (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 unwanted effects listed above may occur. If any of these unwanted effects occur, contact your doctor or pharmacist. To prevent these symptoms from occurring, your doctor may prescribe additional corticosteroid doses in tablet form (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 gets them. To reduce the likelihood of side effects occurring, your doctor will prescribe the lowest dose of Seretide needed to control your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after taking Seretide. You may experience severe shortness of breath and coughing. You might 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 could cause you to collapse or lose consciousness). If you experience any of these effects, or if they occur suddenly after using Seretide, stop using Seretide immediately and contact your doctor without delay. Allergic reactions to Seretide are not common (affecting fewer than 1 in 100 people).

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 chronic obstructive pulmonary disease (COPD), an increased number of colds has been reported.

Common (affects less than 1 in 10 people)

• Oral thrush (raised, painful yellow-cream patches) in the mouth and throat. In addition, soreness of the tongue, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out immediately and/or brushing your 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:

• Pneumonia and bronchitis (lung infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, 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 experience 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 and possible adjustment of your antidiabetic therapy may be required.
• Cataract (clouding of the eye's lens).
• Very fast heartbeat (tachycardia).
• Trembling sensation (tremor) and fast or irregular heartbeat (palpitations) – these side effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling of anxiety (these effects occur particularly in children).
• Disturbed sleep.
• Allergic skin rash.

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

• Breathing difficulties or wheezing that worsens immediately after taking Seretide. If this occurs, stop using the Seretide inhaler immediately. Use your fast-acting medicine to help with breathing and contact your doctor immediately.

• Seretide may affect the normal production of steroid hormones in the body, especially if taken at high doses 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 Seretide 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 Seretide 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 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 www.aifa.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 Seretide

• Keep this medicine out of the sight and reach of children.
• Do not use Seretide Pressurized Inhalation Suspension 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 Seretide in a cold place, as it may not work properly.
• The container holds a pressurized liquid. Do not expose to temperatures above 50°C. Protect from direct sunlight. Do not pierce or burn the container, even when 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 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 Seretide 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 Seretide and package contents

• Seretide is supplied in a pressurised metered-dose inhaler that delivers the medicine as a pressurised suspension for inhalation into the lungs through the mouth.
• The pressurised container holds a white to almost white inhalation suspension.
• The containers are placed in a plastic pouch 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 Authorisation Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona
Responsible person for batch release
Glaxo Wellcome Production
Zone Industrielle No.2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France.
Tel: +33 2 3223 5500; Fax: +33 2 3223 5558
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
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36, D-23843, Bad Oldesloe, Germany
Tel: +49 4531 8020; Fax: +49 4531 84956
Austria Seretide Dosieraerosol
Belgium Seretide
Denmark Seretide
Finland Seretide Evohaler
France Seretide
Germany atmadisc
Greece Seretide Inhaler
Iceland Seretide
Ireland Seretide Evohaler
Italy Seretide
Luxembourg Seretide Inhaler
Netherlands Seretide
Portugal Seretide Inalador
Spain Seretide
Sweden Seretide Evohaler
United Kingdom Seretide Evohaler
This leaflet was last updated in

PACKAGE LEAFLET: INFORMATION FOR THE USER

Seretide Diskus 50 micrograms/100 micrograms per dose inhalation powder in single-dose container
Seretide Diskus 50 micrograms/250 micrograms per dose inhalation powder in single-dose container
Seretide Diskus 50 micrograms/500 micrograms per dose inhalation powder in single-dose container
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 are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Seretide is and what it is used for

Seretide 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). Seretide Diskus, at the dose of 50/500 micrograms, reduces the number of exacerbations of COPD symptoms. You must use Seretide every day as prescribed. This ensures that the medicine works properly to control your asthma or COPD.

Seretide helps to prevent the onset of breathlessness and wheezing. However, Seretide
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 keep your fast-acting reliever medicine with you.

2. What you should know before using Seretide

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

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

• Heart disease, including irregular or rapid heartbeat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Seretide may increase blood sugar levels)
• Low potassium levels 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 Seretide
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines for asthma or any medicines obtained without a prescription. This is because it may not be appropriate to take Seretide with certain other medicines.

Tell your doctor if you are taking the following medicines before starting to use Seretide:

• - 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 used to treat 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 from Seretide, including irregular heartbeat 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 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, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.

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

For athletes
Using this medicine without a medical need constitutes doping and may lead to a positive anti-doping test.

Seretide contains lactose
Seretide Diskus contains up to 12.5 milligrams of lactose monohydrate in each 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 Seretide

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

• Use Seretide 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 Seretide or reduce the dose without first consulting your doctor.
• Seretide must be inhaled into the lungs through the mouth.
• You may not taste or feel the powder on your tongue, even if you have used Seretide Diskus correctly.

For asthma
Adults and adolescents aged 12 years and older

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

Children aged 4 to 12 years

• Seretide 50/100 Diskus – one inhalation twice daily
• Seretide is not recommended for use in children under 4 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• Seretide 50/500 Diskus – one inhalation twice daily

Symptoms may be well controlled by using Seretide 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 inhalations and how often to take the medicine.

If you are using Seretide for asthma, your doctor will monitor your symptoms regularly.
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 occur, continue using Seretide but do not increase the number of doses you take. Your breathing condition could worsen and become particularly serious. 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 Seretide Diskus may result in inadequate treatment of asthma or COPD.
• The Diskus device contains doses (blister packs) of Seretide in powder form.
• There is a counter on the top of the Diskus that shows how many doses remain. The counter goes down to 0. The numbers from 5 to 0 appear in red to warn you when only a few doses are left. Once the counter reads 0, the inhaler is empty.

Using the inhaler

1. To open the Diskus, hold the outer case with one hand and place the thumb of your other hand in the thumb grip. Push the thumb forward as far as it will go. You will hear a click. This opens a small hole in the mouthpiece.

2. Hold the Diskus with the mouthpiece facing you. You may hold it with either your right or left hand. Slide the lever forward as far as it will go. You will hear a click. This releases one dose of the 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 the blister and waste the medicine.

3. Hold the Diskus away from your mouth. Breathe out as deeply as possible. Never breathe into the Diskus.
4. 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. Then breathe out slowly.

5. Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This may help prevent the occurrence of oral thrush (candidiasis) and hoarseness.
6. To close the Diskus, place your thumb in the thumb grip and slide it back as far as it will go. You will hear a click. The lever automatically returns to its original position.

The Diskus is now ready for the next use.
As with all inhalers, caregivers of children prescribed Seretide Diskus must ensure that the child uses the correct inhalation technique as described above.

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

If you use more Seretide than you should
It is important to use the inhaler exactly as instructed. If you accidentally take a higher dose than recommended, inform your doctor or pharmacist. You may notice 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 Seretide may reduce the amount of steroid hormones produced by the adrenal glands.

If you forget to use Seretide
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 Seretide
It is very important to take Seretide every day as prescribed. Continue taking it
until your doctor tells you to stop treatment. Do not stop or suddenly reduce
your dose of Seretide. This could cause worsening of breathing.
In addition, stopping or suddenly reducing the dose of Seretide may (very rarely) lead to problems with the adrenal glands (adrenal insufficiency), which may sometimes cause unwanted effects.

These unwanted 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 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 above-mentioned unwanted effects may occur. If any of these effects occur, consult 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 doubts about using this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

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

Allergic reactions: you may notice that your breathing suddenly worsens immediately after taking Seretide.
You may experience severe shortness of breath, coughing, or difficulty breathing. You may also notice itching, skin rash (urticaria), or 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 Seretide, stop using Seretide immediately and contact your doctor without delay. Allergic reactions to Seretide are uncommon (affect fewer than 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (common side effect).
Inform your doctor if you experience any of the following symptoms while taking Seretide, as they may indicate a lung infection:

• fever or chills,
• increased mucus production, changes in the colour of mucus,
• worsening cough or increased difficulty breathing.

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 number of colds has been reported

Common (affects less than 1 in 10 people)

• Oral thrush (raised, painful, cream-yellow patches) in the mouth and throat. Also, soreness of the tongue, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out immediately and/or brushing your teeth after each dose of medicine may help. Your doctor may prescribe an antifungal medicine to treat oral 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 throbbing pain)
• Decreased potassium levels in the blood (you may notice an 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 and possibly adjustment of your antidiabetic therapy may be required
• Cataract (clouding of the eye's lens)
• Very fast heartbeat (tachycardia)
• Trembling 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 less than 1 in 1000 people)

• Breathing difficulties or wheezing that worsens immediately after taking Seretide. If this occurs, stop using the Seretide inhaler immediately. Use your fast-acting medicine to help with breathing and contact your doctor immediately.
• Seretide may affect 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 Seretide 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 Seretide unless your doctor tells you to stop.
• Fungal infection of the oesophagus (gullet), which may cause difficulty in 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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the [relevant national reporting system].
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seretide

• Keep this medicine out of the sight and reach of children.
• Do not use Seretide after the expiry date stated on the label and 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Seretide 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 Seretide and Package Contents

• Seretide Diskus contains a laminated strip. The laminate protects the inhalation powder from atmospheric effects.
• Each dose is pre-measured.
• 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 Authorization Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 – 37135 Verona, Italy
Manufacturer
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
Austria Seretide Diskus
Belgium Seretide Diskus
Croatia Seretide Diskus
Cyprus Seretide Diskus
Czech Republic Seretide Diskus
Denmark Seretide
Estonia Seretide Diskus
Finland Seretide Diskus
France Seretide Diskus
Germany atmadisc Diskus
Greece Seretide Diskus
Hungary Seretide Diskus
Iceland Seretide
Ireland Seretide Diskus
Italy Seretide Diskus
Luxembourg Seretide Diskus
Malta Seretide Diskus
Netherlands Seretide Diskus
Portugal Seretaide Diskus
Romania Seretide Diskus
Slovakia Seretide Diskus
Spain Seretide Accuhaler
Sweden Seretide Diskus
United Kingdom Seretide Accuhaler
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