Serevent

Package leaflet: information for the patient

Serevent 25 micrograms/dose Pressurised suspension for inhalation

salmeterol xinafoate
Please read carefully all of this leaflet before taking 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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Serevent pressurised suspension is and what it is used for

• Serevent pressurised suspension contains the medicine salmeterol. It is a 'long-acting bronchodilator'. It helps the airways in the lungs to stay open. This makes it easier for air to flow in and out. The effects are usually felt within 10–20 minutes and last for 12 hours or more.
• Your doctor has prescribed this medicine to help prevent breathing problems. These may be caused by asthma. Taking Serevent pressurised suspension regularly helps prevent asthma attacks, including those triggered by exercise or occurring at night (nocturnal asthma).
• Taking Serevent pressurised suspension regularly will also help treat breathing difficulties caused by other lung diseases, such as chronic obstructive pulmonary disease (COPD).
• Serevent pressurised suspension helps prevent breathlessness and wheezing. It does not work once you are already breathless or wheezing. If this happens, you must use a 'reliever' medicine that works quickly, such as salbutamol.
• Serevent pressurised suspension is supplied in an inhaler. The medicine is inhaled directly into the lungs.
• Serevent pressurised suspension contains norflurane. This is less harmful to the environment than older types of inhalers.

If you are being treated for asthma, you must always be prescribed both Serevent and a steroid inhaler to use together.

2. What you need to know before using Serevent pressurized suspension

Do not use Serevent if:
you are allergic (hypersensitive) to salmeterol or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions

• If you are using Serevent for asthma, your doctor will want to monitor your symptoms regularly.
• If your asthma or breathing worsens, inform your doctor immediately. You may feel more breathless, experience chest tightness more frequently, or find you need to use your rapid-acting 'reliever' medicine more often. If any of these occur, do not increase the number of Serevent puffs. Your lung problems may be getting worse and you could become seriously ill. Consult your doctor, as your asthma treatment may need to be changed.
• Once your asthma is well controlled, your doctor may consider gradually reducing your dose of Serevent.
• If Serevent has been prescribed for your asthma, continue using any other asthma medicines you are already taking. These may include a steroid inhaler or steroid tablets. Continue taking the same doses unless your doctor tells you otherwise. Do this even if you feel much better. Do not stop using your steroid inhaler (or steroid tablets) when you start using Serevent.
• Your doctor may decide to monitor your health regularly if you have an overactive thyroid gland, diabetes mellitus (Serevent may increase blood sugar levels), or a heart condition, including irregular or rapid heartbeat.

Other medicines and Serevent

• Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This includes herbal remedies. The reason is that Serevent may not be suitable to take with certain other medicines.
• Inform your doctor before using Serevent if you are currently being treated for a fungal infection with medicines containing ketoconazole or itraconazole, or if you are being treated with ritonavir for HIV infection. These medicines may increase the risk of side effects with Serevent, including irregular heartbeats, or may worsen side effects.
• Beta-blockers should be avoided during treatment with Serevent, unless your doctor specifically instructs you otherwise. Beta-blockers, including atenolol, propranolol, and sotalol, are mainly used for high blood pressure or other heart conditions. Inform your doctor if you are taking beta-blockers or have recently been prescribed them, as they may reduce or block the effect of salmeterol.
• Serevent may reduce the amount of potassium in your blood. You may notice an abnormal heartbeat, muscle weakness, or cramps. This is more likely if you take Serevent together with certain medicines used to treat high blood pressure (diuretics), or other medicines used for respiratory problems such as theophylline or steroids. Your doctor may request blood tests to monitor your potassium levels. If in doubt, consult your doctor.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
It is unlikely that the possible effects of Serevent will affect your ability to drive or operate machinery.

For athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Serevent pressurised suspension

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

• If you are being treated for asthma, you must always be prescribed both Serevent and a steroid inhaler to use together.
• Use Serevent every day, until your doctor advises you to stop.
• You will start to feel the medicine working from the first day of use.

Serevent must only be administered by inhalation through the mouth.
Adults with asthma

• The usual starting dose is 2 puffs twice daily.
• For people with more severe asthma, your doctor may increase the dose to 4 puffs twice daily.

Children above 4 years of age

• In children aged between 4 and 12 years, the usual dose is 2 puffs twice daily.
• Serevent is not recommended for children under 4 years of age.

Adults with chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema

• The usual starting dose is 2 puffs twice daily.
• Not applicable to children and adolescents.

Instructions for use

• Your doctor, nurse or pharmacist should show you how to use the inhaler. Not using the inhaler correctly or as prescribed may result in the medicine not providing the expected relief from asthma or COPD.

The medicine is contained in a pressurised canister inside a plastic holder with a mouthpiece.
Checking the inhaler's function

• Before first use, and if the inhaler has not been used for more than 7 days, prime the inhaler by releasing two test sprays into the air, away from the face.
• Shake the inhaler well before each use.
• Remove the cap from the mouthpiece and check that it and the mouthpiece are clean.
• Breathe out fully, away from the inhaler.
• Place the mouthpiece between your lips, forming a tight seal.
• Start to breathe in slowly and deeply through the mouth, and at the same time press down firmly on the canister to release one puff of medicine.
• Continue to breathe in deeply, then hold your breath for as long as comfortable (about 10 seconds), to allow the medicine to reach deep into the lungs.
• Breathe out slowly.
• If a second puff is needed, wait about 30 seconds, shake the inhaler again, and repeat the steps above.
• After use, replace the cap on the mouthpiece.
• Rinse your mouth with water after using Serevent, especially if you are also using a corticosteroid inhaler, to reduce the risk of oral thrush.

Keep the inhaler clean and dry. Clean the mouthpiece regularly with a dry cloth. Do not immerse the metal canister in water.

	1 When using the inhaler for the first
	time, test whether it works. Remove the mouthpiece cover by gently pressing the sides with your thumb and index finger and pull it off. 2 To ensure that it works, shake well, point the mouthpiece away from you and spray a dose into the air. If you have not used the inhaler for one week or more, spray into the air twice.
	Using the inhaler Before using the inhaler, it is important to begin breathing as slowly as possible. 1 When using the inhaler, remain standing or sitting in an upright position. 2 Remove the mouthpiece cover (as shown in the first image). Check inside and outside that the mouthpiece is clean and free of objects.
	3 Shake the inhaler 4 or 5 times to ensure that any obstructions are removed and that the contents of the inhaler are uniformly mixed.
	4 Hold the inhaler in an upright position with your thumb on the base, below the mouthpiece. Breathe out fully until you feel comfortable. Do not inhale yet.
	5 Place the mouthpiece in your mouth between your teeth. Close your lips around it without biting it.

6 Breathe in through your mouth. Immediately after
starting to inhale, press down on the top of the
canister to release a puff of medicine. Do this
while breathing in steadily and deeply.
7 Hold your breath; remove the inhaler from your
mouth and your finger from the top of the
inhaler.
Continue to hold your breath for a few
seconds, or longer if comfortable.
8 Wait about half a minute before inhaling another dose, repeating steps 3 to 7.
9 After use, replace the mouthpiece cover to prevent dust from entering.
Close the cover firmly by pressing it until it clicks into place.
At first, practise in front of a mirror. If you see a 'mist' coming from the top of the inhaler or from the sides of your mouth, start again.
If you have difficulty using Serevent pressurised suspension, it can be used with other devices to make it easier to use; for example, a spacer. Serevent is also available in an alternative device. Please consult your doctor, nurse or pharmacist for further advice.
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 cover.
• Never remove the metal canister from the plastic holder.
• Wipe the inside and outside of the mouthpiece and the plastic holder with a dry cloth or tissue paper.
• Replace the mouthpiece cover.

Do not put the metal container in water.
If you use more Serevent pressurised suspension than you should
It is important to use the inhaler as instructed. If you accidentally take more than the recommended dose, contact your doctor or pharmacist. You may notice your heart beating faster than usual, and may experience tremors and/or dizziness. You may also have a headache, muscle weakness and joint pain.
If you forget to use Serevent pressurised suspension
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual scheduled time.
If you have any questions about the use of this medicine, consult your doctor 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, your doctor will prescribe the lowest dose of Serevent needed to control your asthma or COPD. The following are side effects reported by people taking Serevent.
Allergic reactions: you may notice that your breathing suddenly worsens after using Serevent.
You may become very wheezy and develop coughing. You may also notice itching and swelling (usually of the face, lips,
tongue or throat). If you experience these reactions, or if they occur suddenly after using
Serevent, contact your doctor immediately. Allergic reactions to Serevent are very rare
(affecting fewer than 1 in 10,000 people).
Other side effects are listed below:
Common (may affect up to 1 in 10 people)

• Muscle cramps
• Tremor; fast or irregular heartbeat (palpitations), headache. Tremor is more likely if your dose is higher than one puff twice daily. These side effects do not last long and become less frequent with continued treatment with Serevent.

Uncommon (may affect up to 1 in 100 people)

• Skin rash
• Very fast heart rate (tachycardia). This is more likely if you are taking more than one puff twice daily
• Nervousness.

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

• Dizziness
• Difficulty or inability to sleep
• Reduction in blood potassium levels (you may experience irregular heartbeat, muscle weakness or cramps).

Very rare (may affect up to 1 in 10,000 people)

• Breathing difficulties or wheezing that worsen immediately after taking Serevent. If this occurs, do not use Serevent pressurised suspension again. Use your fast-acting 'reliever' inhaler to help your breathing and contact your doctor immediately
• Irregular heartbeat or extra heartbeats (arrhythmias). If this occurs, do not stop using Serevent, but inform your doctor
• Increase in blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, you may be required to monitor your blood sugar levels more frequently and your usual diabetes treatment may need adjustment
• Irritation of the mouth or throat
• Nausea
• Joint pain, or chest pain.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Serevent pressurised suspension

• Keep this medicine out of the sight and reach of children.
• After use, firmly replace the mouthpiece cover and snap it securely into place. Do not apply excessive force.
• Do not store above 30°C.
• The metal container holds a pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce, break or burn, even if you think it is empty.
• 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 dispose of medicines 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 Serevent pressurised suspension contains

• The active substance is salmeterol xinafoate.
• Each spray delivers 25 micrograms of the active substance salmeterol.
• Each canister contains 120 sprays, equivalent to 60 single doses.
• The other component is norflurane (HFA 134a).

Description of the appearance of Serevent pressurised suspension and contents of the pack
Pressurised suspension for inhalation. The pressurised canister contains a white to almost white inhalation suspension.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona, Italy.
Manufacturer
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux - France

Package leaflet: Information for the user

Serevent Diskus 50 mcg Powder for Inhalation

salmeterol xinafoate
Please read this leaflet carefully before taking 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 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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

3. What Serevent Diskus is and what it is used for

• Serevent inhalation powder contains the medicine salmeterol. It is a 'long-acting bronchodilator'. It helps the airways in the lungs stay open, making it easier for air to flow in and out. The effects are usually felt within 10–20 minutes and last for 12 hours or longer.
• Your doctor has prescribed this medicine to help prevent breathing problems, which may be caused by asthma. Taking Serevent inhalation powder regularly helps prevent asthma attacks, including those triggered by exercise or occurring at night (nocturnal asthma).
• Taking Serevent inhalation powder regularly also helps treat breathing difficulties caused by other lung diseases, such as chronic obstructive pulmonary disease (COPD).
• Serevent inhalation powder helps prevent shortness of breath and wheezing.
• It does not work once you are already short of breath or wheezing. If this happens, you must use a fast-acting 'reliever' medicine, such as salbutamol.
• Serevent is provided in an inhaler called a Diskus. The medicine is inhaled directly into the lungs.

If you are being treated for asthma, you must always be prescribed both Serevent and a steroid inhaler
to be used together.

4. What you need to know before using Serevent Diskus

Do not use Serevent if:
you are allergic (hypersensitive) to salmeterol xinafoate or to any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions

• If you are using Serevent for asthma, your doctor will want to monitor your symptoms regularly.
• If your asthma or breathing worsens, inform your doctor immediately. You may notice increased breathlessness, more frequent chest tightness, or you may need to use your fast-acting 'reliever' medicine more often. If any of these occur, do not increase the number of Serevent inhalations. Your lung problems may be getting worse and you could become seriously ill. Consult your doctor, as your asthma treatment may need to be changed.
• Once your asthma is well controlled, your doctor may consider gradually reducing the dose of Serevent.
• If Serevent has been prescribed for your asthma, continue using any other asthma medicines you are already taking. These may include a steroid inhaler or oral steroids. Continue taking the same doses unless your doctor tells you otherwise. Do this even if you feel much better. Do not stop using your steroid inhaler (or steroid tablets) when you start using Serevent.
• Your doctor may decide to monitor your health regularly if you have an overactive thyroid gland, diabetes mellitus (Serevent may increase blood sugar levels), or a heart condition, including irregular or rapid heartbeat.

Other medicines and Serevent

• Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This includes herbal remedies. This is because Serevent may not be suitable to take with other medicines.
• Inform your doctor before using Serevent if you are currently being treated for a fungal infection with medicines containing ketoconazole or itraconazole, or if you are being treated with ritonavir for HIV infection. These medicines may increase the risk of you experiencing side effects from Serevent, including irregular heartbeats, or may worsen side effects.
• Beta-blockers should be avoided during treatment with Serevent, unless your doctor specifically instructs you otherwise. Beta-blockers, including atenolol, propranolol, and sotalol, are mainly used for high blood pressure or other heart conditions. Inform your doctor if you are taking beta-blockers or have recently been prescribed them, as they may reduce or counteract the effect of salmeterol.
• Serevent may reduce the amount of potassium in your blood. If this happens, you may notice an abnormal heartbeat, muscle weakness, or cramps. This is more likely if you take Serevent together with certain medicines used to treat high blood pressure (diuretics), or other medicines used for respiratory problems such as theophylline or steroids. Your doctor may request blood tests to monitor your potassium levels. If in doubt, consult your doctor.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that the possible effects of Serevent will impair your ability to drive or operate machinery.

For athletes
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Serevent contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
The excipient lactose contains small amounts of milk proteins; therefore, if you have a confirmed milk protein intolerance, contact your doctor before taking this medicine.

3. How to use Serevent Diskus

Use this medicine exactly as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

• If you are being treated for asthma, you must always be prescribed both Serevent and a steroid inhaler to use together.
• Use Serevent every day, until your doctor advises you to stop.
• You will start to feel the medicine working from the first day of use.

Serevent must only be administered by inhalation through the mouth.

Adults with asthma

• The usual starting dose is 1 inhalation twice daily.
• For people with more severe asthma, your doctor may increase the dose to 2 inhalations twice daily.

Children above 4 years of age with asthma

• In children aged 4 to 12 years, the usual dose is 1 inhalation twice daily.
• Serevent is not recommended for children under 4 years of age.

Adults with chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema

• The usual starting dose is 1 inhalation twice daily.
• This does not apply to children and adolescents.

Instructions for use

• Your doctor, nurse, or pharmacist should show you how to use the inhaler. Not using Serevent Diskus correctly or as prescribed may mean the medicine does not provide the expected asthma relief.
• The Diskus device contains blisters filled with Serevent as a powder.
• A dose counter on the top of the Serevent Diskus displays the number of doses remaining. It counts down to 0. Numbers from 5 to 0 will appear in red to warn you when only a few doses are left. Once the counter shows 0, the inhaler is empty.
• You may not taste or feel the powder on your tongue, even when the Diskus has been used correctly.

Using the inhaler

1. To open the Serevent Diskus, hold the outer part with one hand and place the thumb of the other hand in the designated groove. Push with your thumb, rotating the inner part of the device until you hear a click. A small hole will open in the mouthpiece.
2. Hold the Serevent Diskus with the mouthpiece facing towards you. You may hold it in either your left or right hand. Push the lever forward as far as possible. You will hear a click. This delivers a dose of the medicine into the mouthpiece. Each time the lever is moved, a blister inside is opened and the powder becomes available for inhalation. Do not play with the lever, as this opens the blisters and results in wastage of the medicine.
3. Keep the Serevent Diskus away from your mouth and breathe out fully until comfortable. Do not blow into the Serevent Diskus.
4. Place the mouthpiece between your lips; breathe in steadily and deeply through the Serevent Diskus with your mouth, not through your nose. Remove the Diskus from your mouth. Hold your breath for about 10 seconds, or as long as comfortable. Breathe out slowly.
5. Afterwards, rinse your mouth with water and spit. 6. To close the Serevent Diskus, place your thumb in the designated groove and slide it backwards until it stops. You will hear a click. The lever will return to its original position and the device is reset. The Diskus is now ready for use again.

Cleaning the inhaler
To clean the mouthpiece of Serevent Diskus, wipe it with a dry cloth.
If you use more Serevent than you should
It is important to use the inhaler as instructed. If you accidentally take a higher dose than
recommended, contact your doctor or pharmacist. You may notice your heart beating faster than
usual, and you may feel tremors or dizziness. You might also experience headache, muscle weakness, and joint pain.
If you forget to use Serevent

• Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

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 likelihood of side effects, your doctor will prescribe the lowest dose of Serevent needed to control your asthma or COPD. The following are side effects reported in people taking Serevent.
Allergic reactions: you may notice that your breathing suddenly worsens after using Serevent.
You may become very wheezy and develop coughing. You may also experience itching and swelling (usually of the face, lips, tongue or throat). If you experience these reactions, or if they occur suddenly after using Serevent, contact your doctor immediately. Allergic reactions to Serevent are very rare (affecting fewer than 1 in 10,000 people).

Other side effects are listed below:
Common (may affect up to 1 in 10 people)

• Muscle cramps
• Tremor; fast or irregular heartbeat (palpitations), headache. Tremor is more likely if your dose is higher than one inhalation twice daily. These side effects do not last long and become less frequent with continued treatment with Serevent.

Uncommon (may affect up to 1 in 100 people)

• Rash
• Very fast heart rate (tachycardia). This is more likely if you are taking more than one inhalation twice daily
• Nervousness

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

• Dizziness
• Difficulty or inability to sleep
• Decreased levels of potassium in the blood (you may experience irregular heartbeat, muscle weakness or cramps)

Very rare (may affect up to 1 in 10,000 people)

• Breathing difficulties or wheezing that worsen immediately after taking Serevent. If this occurs, do not use Serevent Diskus any further. Use your fast-acting 'reliever' inhaler to help with breathing and contact your doctor immediately.
• Irregular heartbeat or extra heartbeats (arrhythmias). If this occurs, do not stop using Serevent, but inform your doctor
• Increased levels of sugar (glucose) in the blood (hyperglycaemia). If you have diabetes, you may need to monitor your blood sugar levels more frequently and your usual diabetes treatment may need to be adjusted
• Irritation of the mouth or throat
• Nausea
• Joint pain or chest pain

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 website.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Serevent Diskus

• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C.
• Do not use this medicine after the expiry date which is stated on the label and on the box after 'EXP'. The expiry date refers to the last day of that month.

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 Serevent Diskus contains

• The active substance is salmeterol xinafoate.
• The other component is lactose (which contains milk proteins).

Description of the appearance of Serevent Diskus and contents of the pack

• Serevent Diskus contains a laminated strip. The laminated blister protects the inhalation powder from atmospheric effects.
• Each dose is pre-measured.
• The devices are packaged in cartons containing one Diskus with 60 inhalations.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Via A. Fleming, 2
Verona
Manufacturer
Glaxo Operations UK Ltd – Priory Street – Ware – United Kingdom
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux - France