SEREVENT 25 MICROGRAMS Прессurized ингаляционная суспензия

Содержание инструкции

1. Serevent 25 micrograms/actuation Pressurized Suspension for Inhalation
   1. What is Serevent pressurised suspension and what it is used for
   2. What you need to know before using Serevent pressurized inhaler
   3. How to use Serevent pressurized suspension
   4. Possible side effects
   5. How to store Serevent pressurised suspension
   6. Contents of the pack and other information
2. Serevent Diskus 50 mcg Powder for inhalation
   1. What is Serevent Diskus 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

Serevent 25 micrograms/actuation Pressurized Suspension for Inhalation

salmeterol xinafoate

Read this leaflet carefully before you start to use this medicine as it contains
important information for you.

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

Contents of this leaflet:

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

1. What is Serevent pressurised suspension 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 enter and leave. The effects are usually felt within 10 - 20 minutes and last for 12 hours or more.
• Your doctor has prescribed this medicine to help you prevent breathing problems. These may be caused by asthma. Taking Serevent pressurised suspension regularly helps to prevent asthma attacks. This includes asthma brought on by exercise or night-time asthma.
• Taking Serevent pressurised suspension regularly will also help to treat breathing problems caused by other lung diseases, such as chronic obstructive pulmonary disease (COPD).
• Serevent pressurised suspension helps to prevent shortness of breath and wheezing. It does not work once you are already breathless or wheezing. If this happens, you need to use a 'reliever' medicine that works quickly, such as salbutamol.
• Serevent pressurised suspension is supplied in an inhaler. The medicine is breathed directly into the lungs.
• Serevent pressurised suspension contains norflurane. It is less harmful to the environment than older inhalers.

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

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

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 check your symptoms regularly.
• If your asthma or breathing gets worse, tell your doctor immediately. You may feel your breathing becoming more difficult, experience chest tightness more often, or you may need to use your 'reliever' inhaler more frequently. If any of these occur, do not increase the number of puffs of Serevent. Your lung problems may be getting worse and you could become seriously ill. See your doctor, as a change to your asthma treatment may be needed.
• Once your asthma is well controlled, your doctor may decide to gradually reduce the dose of Serevent.
• If Serevent has been prescribed to you for asthma, continue to use any other asthma medicine you are already taking. These medicines may include a steroid inhaler or steroid tablets. Continue to take the same doses as before, 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 check your health regularly if you have an overactive thyroid gland, diabetes mellitus (Serevent can increase your blood sugar level) or a heart condition, including an irregular or fast heartbeat.

Other medicines and Serevent

• Tell your doctor if you are taking, have recently taken or might take any other medicines, including those you bought without a prescription. These include herbal medicines. This is because Serevent may not be suitable to be taken with other medicines.
• Tell 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 can increase the risk that you have unwanted effects with Serevent, including irregular heartbeats, or they can make unwanted effects worse.
• During treatment with Serevent, beta-blockers should be avoided unless your doctor tells you to take them. Beta-blockers including atenolol, propranolol and sotalol, are mainly used for high blood pressure or other heart conditions. Tell your doctor if you are taking beta-blocker medicines or if they have been prescribed to you recently as they can reduce or cancel out the effect of salmeterol.
• Serevent can reduce the amount of potassium in your blood. In this case, you may notice an abnormal heartbeat, muscle weakness or cramps. This is more likely to happen if you take Serevent with some medicines used to treat high blood pressure (diuretics) and other medicines used to treat breathing problems such as theophylline or steroids. Your doctor may ask you to have blood tests to check the amount of potassium in your blood. If you are concerned, ask your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are 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 affect your ability to drive or use
machines.

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

3. How to use Serevent pressurized suspension

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

• If you are being treated for asthma, you should always be given both Serevent and an inhaler ofsteroids 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 be administered only by inhalation through the mouth.

Adults with asthma

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

Children over 4 years of age

• In children aged between 4 and 12 years the usual dose is 2 puffs twice a day.
• Serevent is not recommended in 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 a day.
• It does not apply to children and adolescents.

Instructions for use

• Your doctor, nurse or pharmacist should show you how to use the inhaler. If you do not use the inhaler correctly or as prescribed, it may mean that the medicine does not relieve your asthma or COPD as it should.

The medicine is contained in a pressurized canister in a plastic container with a mouthpiece.

Checking the inhaler is working

	time, check if it works. Remove the cap of the mouthpiece by gently pressing the sides with your thumb and index finger and pull it off. 2 To make sure 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 a week or more, spray into the air for two times.	m a c o
	Using the inhaler Before using the inhaler it is important to start breathing as slowly as possible. 1 When using the inhaler remain standing or sitting upright. 2 Remove the cap of the mouthpiece (as shown in the first image). Check inside and outside that the mouthpiece is clean and free from objects.	e l F a r
	3 Shake the inhaler 4 or 5 times to make sure that any objects are removed and that the contents of the inhaler are mixed evenly.	a n a d
	i l 4 Hold the inhaler in a vertical position with a your thumb on the base, under the mouthpiece. Exhale until you feel comfortable. Do not inhale yet. I a i
	z 5 Position the mouthpiece in your mouth between your teeth. Close your lips around it without biting it.

6Inhale through your mouth. Immediately after
starting to inhale, press down on the canister cap to release a puff of
medicine. Do this while inhaling steadily and deeply.

7Hold 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 you feel comfortable.

8Wait about half a minute before inhaling another dose repeating steps 3 to 7.

9After use, replace the mouthpiece cap to prevent dust from settling on it.
Close the cap firmly by pressing it until you hear the click when it is in position.
For the first few times, practice in front of a mirror. If you see a 'mist' coming from the
top of the inhaler or from the sides of your mouth, you should start again.
If you have difficulty using Serevent pressurized 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. Ask 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 cap.
• Never remove the metal canister from the plastic casing.
• Clean the inside and outside of the mouthpiece and the plastic casing with a dry cloth or a paper handkerchief.
• Replace the mouthpiece cap.

Do not put the metal canister in water.

If you use more Serevent pressurized suspension than you should
It is important to use the inhaler following the instructions. If you accidentally take a dose higher than
recommended, contact your doctor or pharmacist. You may feel your heart beating faster than
usual and experience tremors and/or dizziness. You may have a headache, muscle weakness and joint pain.

If you forget to use Serevent pressurized suspension
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 doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To reduce the chances of side effects, your doctor will prescribe the lowest dose of Serevent needed to control your asthma or COPD. These are the side effects reported by people taking Serevent.

Allergic reactions: you may notice that your breathing suddenly gets worse after using Serevent.
You may be very wheezy and have a cough. You may also notice itching and swelling (usually of the face, lips,
tongue or throat). If you have these reactions or if they happen suddenly after using
Serevent, tell your doctor immediately. Allergic reactions to Serevent are very rare
(affecting less than 1 in 10,000 people).
Other side effects are listed below:

Common (may affect less than 1 in 10 people)

• muscle cramps
• tremor; fast or irregular heartbeat (palpitations), headache. Tremor is more likely if the dose you are taking is more than one puff twice a day. These side effects do not last long and are less likely to occur with continued treatment with Serevent.

Uncommon (may affect less than 1 in 100 people)

• Skin rash
• Very fast heartbeat (tachycardia). This is more likely to happen if you are taking more than one puff twice a day
• Nervousness.

Rare (may affect less than 1 in 1,000 people)

• Dizziness
• Inability or difficulty sleeping
• Low levels of potassium in the blood (you may have an irregular heartbeat, muscle weakness or cramps).

Very rare (may affect less than 1 in 10,000 people)

• Difficulty breathing or wheezing that gets worse immediately after using Serevent. If this happens do not use Serevent pressurized suspension anymore. Use your 'reliever' inhaler to help your breathing and tell your doctor immediately
• Irregular heartbeat or the heart beats too hard (arrhythmias). If this happens do not stop using Serevent but tell your doctor
• Increased amount of sugar (glucose) in the blood (hyperglycaemia). If you have diabetes, you may need to check your blood sugar more frequently and possibly adjust your usual diabetes treatment
• Irritation of the mouth or throat
• Nausea
• Joint pain, or chest pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system reported at the address: 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.
• Immediately after use, firmly reposition the mouthpiece cover and snap it into place. Do not apply excessive force.
• Do not store above 30° C.
• The metal canister contains a liquid under pressure. Do not expose to temperatures exceeding 50°C. Do not puncture, break or burn even when it is thought to be empty.
• Do not use this medicine after the expiry date which is stated on the label and the carton after 'EXP'. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

What Serevent pressurized suspension contains

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

Description of the appearance of Serevent pressurized suspension and contents of the pack
Pressurized suspension for inhalation. The pressurized canister contains a suspension for
inhalation ranging in color from white to off-white.

Marketing authorization holder and manufacturer
Marketing authorization holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona, Italy.

Manufacturer
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux - France

Serevent Diskus 50 mcg Powder for inhalation

salmeterol xinafoate
Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, 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 you use 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 is Serevent Diskus and what it is used for

• Serevent powder for inhalation contains the medicine salmeterol. It is a 'long-acting bronchodilator'. It helps the airways in the lungs to remain open. This makes it easier for air to enter and exit. The effects are usually felt within 10-20 minutes and last for 12 hours or more.
• Your doctor has prescribed this medicine to help you prevent breathing problems. These may be caused by asthma. Taking Serevent powder for inhalation regularly helps to prevent asthma attacks. This includes asthma caused by exercise or nocturnal asthma.
• Taking Serevent powder for inhalation regularly will also help to treat breathing problems caused by other lung diseases, such as chronic obstructive pulmonary disease (COPD).
• Serevent powder for inhalation helps to prevent shortness of breath and wheezing
• . It does not work once you are breathless or wheezing. If this happens, you need to use a 'reliever' medicine that works quickly, such as salbutamol.
• Serevent is supplied in an inhaler called Diskus. The medicine is inhaled directly into the lungs.

If you are being treated for asthma, you should always be given both Serevent and a steroid inhaler
to use 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 check your symptoms regularly.
• If your asthma or breathing gets worse, tell your doctor immediately. You may feel your breathing becoming more difficult, feel a tightness in your chest more often, or you may need to use your 'reliever' inhaler more often. If any of these happen, do not increase the number of puffs of Serevent. Your lung problems may be getting worse and you could become seriously ill. See your doctor, as your asthma treatment may need to be changed.
• Once your asthma is well controlled, your doctor may decide to gradually reduce the dose of Serevent.
• If you have been prescribed Serevent for asthma, continue to use any other asthma medicine that you are already taking. These medicines may include a steroid inhaler or steroid tablets. Continue to take the same doses as before, unless your doctor tells you to do 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 check your health regularly if you have an overactive thyroid gland, diabetes mellitus (Serevent can increase your blood sugar level) or a heart condition, including an irregular or fast heartbeat.

Other medicines and Serevent

• Tell your doctor if you are taking, have recently taken or might take any other medicines, including those you bought without a prescription. These include herbal medicines. This is because Serevent may not be suitable to be taken with other medicines.
• Tell your doctor before using Serevent if you are currently being treated for a fungal infection with medicines that contain ketoconazole or itraconazole, or if you are being treated with ritonavir for HIV infection. These medicines can increase the risk of you having unwanted effects with Serevent, including irregular heartbeats, or they can make unwanted effects worse.
• During treatment with Serevent, beta-blockers should be avoided unless your doctor tells you to take them. Beta-blockers including atenolol, propranolol and sotalol, are mainly used for high blood pressure or other heart conditions. Tell your doctor if you are taking beta-blocker medicines or if they have been prescribed to you recently as they can reduce or cancel out the effect of salmeterol.
• Serevent can reduce the amount of potassium in your blood. In this case you may notice an abnormal heartbeat, muscle weakness or cramps. This is more likely to happen if you take Serevent with some medicines used for the treatment of high blood pressure (diuretics) and other medicines used for the treatment of breathing problems such as theophylline or steroids. Your doctor may ask for blood tests to check the amount of potassium in your blood. If you are concerned, ask your doctor.

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

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

For athletes
The use of the drug without therapeutic need constitutes doping and may still result in a positive
doping test.
Serevent contains lactose. If your doctor has diagnosed you with intolerance to some sugars, contact
him/her before taking this medicine.
The excipient lactose contains small amounts of milk proteins, so if you have a confirmed intolerance to
milk proteins, contact your doctor before taking the medicine.

3. How to use Serevent Diskus

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

• If you are being treated for asthma, you should always be given both Serevent and an inhaler ofsteroids to use together.
• Use Serevent every day, until your doctor tells 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 a day.
• For people with more severe asthma, your doctor may increase the dose to 2 inhalations twice a day.

Children over 4 years of age with asthma

• In children aged between 4 and 12 years, the usual dose is 1 inhalation twice a day.
• Serevent is not recommended in 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 a day.
• It does not apply to children and adolescents.

Instructions for use

• Your doctor, nurse or pharmacist should show you how to use the inhaler. If you do not use Serevent Diskus correctly or as prescribed, it may mean that the medicine does not provide asthma relief as it should.
• The Diskus device contains blisters that are filled with Serevent in powder form.
• A counter on the top of Serevent Diskus shows the number of doses remaining. It counts down to 0. The numbers from 5 to 0 will appear in red to warn you when only a few doses remain. Once the counter has shown 0, the inhaler will be empty.
• You may not be able to taste or feel the powder on your tongue, even if the Diskus has been used correctly.

Using the inhaler

n 1. To open Serevent Diskus, hold the sides with one hand and place your thumb on the indentation on the other hand. Push with your thumb rotating the inner part A of the device until you hear a click. A small hole will open in the mouthpiece.

2. Hold Serevent Diskus with the mouthpiece towards you. You can hold it in your left or right hand. Push the lever forward as far as it will go. You will hear a click. This places a dose of the medicine in the mouthpiece. Each time the lever is slid, a blister is opened inside and the powder is made available for inhalation. Do not play with the lever as it opens the alveoli and results in waste of the medicine.	r m a c o
3. Hold Serevent Diskus away from your mouth, exhale until you feel comfortable. Do not blow into Serevent Diskus.	F a
4. Put the mouthpiece between your lips; inhale steadily and deeply through Serevent Diskus with your mouth, not through your nose. Remove the Diskus from your mouth. Hold your breath for about 10 a seconds or until you feel comfortable. i l Exhale slowly.	n a d e l
a 5. Afterwards, rinse your mouth with water t and spit. I 6. To close Serevent Diskus, place your thumb in the indentation and slide it back to the end of its travel. You will hear a click. The lever will return to its original position and the device is restored. 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 following the instructions. If you accidentally take a dose higher than
the recommended one, contact your doctor or pharmacist. You may feel your heart beating faster
than usual and experience tremors or dizziness. You may have a 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 further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
To reduce the chance of side effects, your doctor will prescribe the lowest dose of Serevent needed to control your asthma or COPD. These are the side effects reported by people taking Serevent.

Allergic reactions: you may notice that your breathing suddenly gets worse after using Serevent.
You may be very wheezy and cough. You may also notice itching and swelling (usually of the face, lips,
tongue or throat). If you have these reactions or if they happen suddenly after using
Serevent, tell your doctor immediately. Allergic reactions to Serevent are very rare
(affecting less than 1 in 10,000 people).
Other side effects are listed below:

Common (may affect less than 1 in 10 people)

• muscle cramps
• tremor; fast or irregular heartbeat (palpitations), headache. Tremor is more likely if the dose you are taking is more than one inhalation twice a day. These side effects do not last long and are less likely to happen with continued treatment with Serevent.

Uncommon (may affect less than 1 in 100 people)

• Skin rash
• Very fast heartbeat (tachycardia). This is more likely to happen if you are taking more than one inhalation twice a day
• Nervousness

Rare (may affect less than 1 in 1,000 people)

• Dizziness
• Inability or difficulty sleeping
• Low levels of potassium in the blood (you may have an irregular heartbeat, muscle weakness or cramps).

Very rare (may affect less than 1 in 10,000 people)

• Difficulty breathing or wheezing that gets worse immediately after using Serevent. If this happens do not use your Serevent Diskus again. Use your ‘reliever’ inhaler to help your breathing and tell your doctor straight away.
• Irregular heartbeat or the heart beats too hard (arrhythmias). If this happens do not stop using Serevent but tell your doctor
• Increased amount of sugar (glucose) in the blood (hyperglycaemia). If you have diabetes, you may need to check your blood sugar more often and, if necessary, adjust your usual diabetes treatment
• Irritation of the mouth or throat
• Nausea
• Joint pain, or chest pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 the package after 'EXP'. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

What Serevent Diskus contains

• The active ingredient 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 laminate strip. The laminate blister protects the powder for inhalation from the effects of the atmosphere.
• Each dose is pre-metered.
• 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 – Great Britain
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux - France