Serevent

Leaflet accompanying the packaging: information for the user

Serevent, 25 micrograms/dose inhalation, inhalation aerosol, suspension

Salmeterol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Serevent and what is it used for

• Serevent contains the active substance salmeterol. It is a long-acting bronchodilator. It allows the airways in the lungs to expand. It facilitates the flow of air into and out of the lungs. The action usually starts within 10 to 20 minutes and lasts for 12 hours or longer.
• The doctor has prescribed this medicine to prevent breathing difficulties. They may be caused by asthma. Regular use of Serevent helps prevent asthma attacks. This also applies to asthma caused by exercise or symptoms of asthma that occur only at night.
• Regular use of Serevent also prevents breathing difficulties caused by other chest diseases, such as chronic obstructive pulmonary disease (COPD).
• Serevent helps to interrupt an attack of shortness of breath or wheezing in the airways. However, it does not act immediately in case of an attack of shortness of breath or wheezing in the airways. If this happens, a fast-acting bronchodilator, such as salbutamol, should be used.
• Serevent is supplied in the form of an aerosol. The medicine is inhaled directly into the lungs.

In patients with asthma, Serevent should always be used with an inhaled steroid.

2. Important information before using Serevent

When not to use Serevent

• if the patient is allergic (hypersensitive) to salmeterol xinafoate or any other component of the medicine, norflurane (HFA 134a).

Warnings and precautions

• If asthma or breathing difficulties worsen, the doctor should be contacted immediately.This may be indicated by an increase in wheezing, more frequent feeling of chest tightness, or increased use of fast-acting bronchodilators. In the event of such symptoms, the number of Serevent inhalations should not be increased. The chest condition may worsen seriously. The doctor should be contacted, as a change in asthma treatment may be necessary.
• In the event of achieving proper control of asthma symptoms, the doctor may consider gradually reducing the dose of Serevent.
• If the doctor has prescribed Serevent for asthma, other asthma medications currently being used should be continued. These may include inhaled steroids or oral steroids. The treatment should be continued with the previously used dose, even if an improvement is felt, unless the doctor recommends a different dosage. Inhaled steroids (or oral steroids) should not be stopped after starting Serevent.
• The doctor will regularly monitor the patient's health if they have hyperthyroidism, diabetes (Serevent may increase blood sugar levels), or heart disease, including irregular or rapid heartbeat.

Serevent and other medicines

• The doctor should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take. This applies to asthma medications and other medications available without a prescription. It may not be appropriate to use Serevent with other medications.
• Before using Serevent, the doctor should be informed if the patient is currently being treated with antifungal medications containing ketokonazole or itraconazole for any fungal infections, or if they are being treated with ritonavir for HIV infection. These medications may increase the risk of side effects associated with Serevent, including irregular heartbeat, or may worsen existing side effects.
• While using Serevent, medications that block beta-adrenergic receptors should be avoided, unless the doctor recommends using such medications. Beta-adrenergic receptor blockers, such as atenolol, propranolol, and sotalol, are primarily used to treat high blood pressure or other heart conditions. The doctor should be told about any beta-adrenergic receptor blockers currently being taken or recently taken, as these medications may reduce or inhibit the action of salmeterol.
• Serevent may decrease blood potassium levels. If this happens, the patient may observe irregular heartbeat, muscle weakness, or cramps. This is more likely if the patient takes Serevent with certain medications used to treat high blood pressure (diuretics) and other medications used to treat breathing difficulties, such as theophylline or steroids. The doctor may recommend that the patient have blood tests to determine their blood potassium levels. In case of doubts, the doctor should be contacted.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that side effects associated with Serevent will affect the ability to drive or use machines.

3. How to use Serevent

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.

• In patients with asthma, Serevent should always be used with an inhaled steroid.
• Serevent should be used daily, unless the doctor recommends stopping the treatment.
• The patient may feel that the medicine is working within the first day of use.

Serevent is intended for inhalation use only through the mouth.

Adults and adolescents over 12 years old with asthma

• The usual starting dose is 2 inhalations twice a day.
• In people with severe asthma, the doctor may increase the dose to 4 inhalations twice a day.

Children with asthma

• In children aged 4 to 12 years, the usual dose is 2 inhalations twice a day.
• Serevent is not recommended for use in children under 4 years old.

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

• The usual starting dose is 2 inhalations twice a day.
• This does not apply to children and adolescents.

Instructions for use

The doctor, nurse, or pharmacist should show the patient how to use the inhaler. From time to time, they should check how the patient uses the inhaler. Incorrect use of the Serevent inhaler or use not in accordance with the recommendations may mean that the medicine does not help the patient with asthma or COPD.
The medicine is in a metal container under pressure, placed in a plastic casing with a mouthpiece.

Checking the inhaler

• 1. When using the inhaler for the first time, check that it is working properly. Remove the cap from the inhaler mouthpiece by gently holding it between the thumb and index finger.
• 2. To make sure the inhaler is working, shake it vigorously, point the mouthpiece in the air, not in your direction, and press the container to release two doses of the medicine into the air. If the inhaler has not been used for a week or longer, also release two doses of the medicine into the air.

Using the inhaler

It is essential to start breathing slowly, as slowly as possible, before using the inhaler.

• 1. Inhalation of the medicine should be performed standing or sitting.
• 2. Remove the cap from the inhaler mouthpiece (as shown in figure 1). Check the mouthpiece outside and inside to ensure it is clean and free of foreign objects.

• 3. Shake the inhaler 4 or 5 times to ensure that any accidental contamination is removed and the contents of the inhaler are evenly mixed.

• 4. Hold the inhaler vertically between the fingers and thumb, with the thumb on the base of the inhaler, under the mouthpiece. Exhale until you feel comfortable.

• 5. Put the mouthpiece in your mouth and seal it with your lips. Do not bite the mouthpiece.

• 6. Inhale through your mouth. Immediately after starting inhalation, press the inhaler to release a dose of the medicine. Continue with a calm, deep breath.

• 7. Hold your breath, remove the inhaler from your mouth, and remove your finger from the inhaler cap. Continue holding your breath for a few seconds or as long as it does not cause discomfort.
• 8. Wait about half a minute before taking the next dose of the medicine and repeat the steps described in points 3 to 7.
• 9. After inhalation, always put the cap back on the mouthpiece to prevent dust from entering. Put the cap back on firmly, pressing it into the correct position.

The first few inhalations should be performed in front of a mirror. If a "mist" is observed coming out of the top of the inhaler or the corners of the mouth, the inhalation should be started again.
In case of difficulties with using the inhaler in an adult patient or a child, the Volumatic inhalation chamber can help use Serevent. The doctor or pharmacist should be contacted.

Cleaning the inhaler

To prevent the inhaler from becoming blocked, it should be cleaned at least once a week.
To clean the inhaler:

• Remove the cap from the mouthpiece.
• Never remove the metal container from the plastic casing.
• Clean the mouthpiece inside and outside and the plastic casing outside with a dry cloth or tissue.
• Put the cap back on the mouthpiece.

Do not immerse the metal container in water.

Using a higher dose of Serevent than recommended

It is essential to use the inhaler as directed by the doctor. If a higher dose of Serevent than recommended is taken accidentally, the doctor or pharmacist should be consulted. The patient may experience rapid heartbeat, tremors, and (or) dizziness. They may also experience headache, feeling of muscle weakness, and joint pain.

Missing a dose of Serevent

Do not take a double dose of the medicine to make up for a missed dose.
Take the next dose at the usual time.
In case of any further doubts about using the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To minimize the likelihood of side effects, the doctor will prescribe the patient the smallest dose of Serevent that controls asthma or COPD. The following are side effects observed in patients taking Serevent.

Allergic reactions: after using Serevent, severe breathing difficulties may occur

in the airways.Wheezing and coughing may worsen. Symptoms such as itching and swelling (usually of the face, lips, tongue, or throat) may also occur. If such symptoms are observed or occur suddenly after using Serevent, the doctor should be notified immediately.Allergic reactions after using Serevent are very rare (may affect up to 1 in 10,000 people).
Other side effects are listed below:

Common (may affect up to 1 in 10 people):

• Muscle cramps.
• Feeling of tremors; rapid or irregular heartbeat (palpitations), headache, trembling hands (tremors). Tremors may occur more frequently if the patient takes more than two inhalations twice a day. These side effects do not last long and usually decrease over time while continuing treatment with Serevent.

Uncommon (may affect up to 1 in 100 people):

• Rash.
• Very rapid heartbeat (tachycardia). The occurrence of this symptom is more likely if the patient takes more than two inhalations twice a day.
• Feeling of restlessness.

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

• Feeling of dizziness.
• Insomnia or difficulty falling asleep.
• Decreased blood potassium levels (may cause irregular heartbeat, muscle weakness, cramps).

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

• Breathing difficulties or wheezing in the airways worsening immediately after using Serevent.If such symptoms occur, the use of Serevent should be stopped.A fast-acting, inhaled bronchodilator should be used to facilitate breathing, and the doctor should be contacted immediately.
• Irregular heartbeat or extra beats (heart rhythm disorders). In such a situation, the use of Serevent should not be stopped, but the doctor should be informed.
• Increased blood sugar (glucose) levels (hyperglycemia). If the patient has diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of antidiabetic medications currently being used.
• Pain in the mouth and throat.
• Nausea.
• Pain, swelling of the joints, or chest pain.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Serevent

• Store out of sight and reach of children.
• After inhalation, always put the cap back on the mouthpiece, pressing it into the correct position. Do not force the cap.
• Do not store above 30°C.
• The metal container contains a pressurized suspension. Do not expose to temperatures above 50°C. Do not pierce, damage, or burn, even if the container appears to be empty.
• Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Serevent contains

• The active substance of the medicine is salmeterol.
• Each inhalation contains 25 micrograms of the active substance - salmeterol.
• Each inhaler contains 120 doses.
• The other ingredient of the medicine is norflurane (HFA 134a).

This medicine contains fluorinated greenhouse gases. Each inhaler contains 12 g of HFC-134a (also known as norflurane or HFA 134a), which corresponds to 0.0172 tons of CO2 equivalent (global warming potential GWP = 1430).

What Serevent looks like and what the pack contains

Inhalation aerosol, suspension. The pressurized container contains a white or almost white suspension for inhalation.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer

Glaxo Wellcome Production
Zone Industrielle 2
Rue Lavoisier 23
F-27000 Evreux
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
Serevent Evohaler
Belgium
Serevent Evohaler
Denmark
Serevent
Estonia
Serevent
Hungary
Serevent Evohaler
Iceland
Serevent
Ireland
Serevent Evohaler
Lithuania
Serevent
Luxembourg
Serevent Evohaler
Malta
Serevent Evohaler
Netherlands
Serevent Inhalator
Norway
Serevent
Poland
Serevent
Slovakia
Serevent Inhaler N
Slovenia
Serevent
Sweden
Serevent Evohaler
Date of last revision of the leaflet:January 2025