Serevent Disk

Leaflet accompanying the packaging: patient information

Serevent Disk 50 micrograms/dose, inhalation powder

Salmeterol

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Serevent Disk and what is it used for

Serevent Disk contains the active substance: salmeterol.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open. This makes it easier for air to get in and out of the lungs. The effect usually starts within 10 to 20 minutes and lasts for 12 hours or longer.
• Your doctor has prescribed this medicine to prevent breathing difficulties. These may be caused by asthma. Regular use of Serevent Disk helps prevent asthma attacks. This includes asthma caused by exercise or symptoms that occur only at night.
• Regular use of Serevent Disk also helps prevent breathing difficulties caused by other chest conditions, such as chronic obstructive pulmonary disease (COPD).
• Serevent Disk helps stop an asthma attack or wheezing in the airways. However, it does not work immediately in case of an asthma attack or wheezing in the airways. If this happens, a fast-acting bronchodilator, such as salbutamol, should be used.
• Serevent Disk is provided in a powder form in a Disk inhaler device. The medicine is inhaled directly into the lungs.

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

2. Important information before using Serevent Disk

When not to use Serevent Disk

• if the patient is allergic to salmeterol xinafoate or lactose monohydrate, an excipient of the medicine.

Warnings and precautions

• If asthma or breathing difficulties worsen, the doctor should be contacted immediately.This may be indicated by worsening wheezing, a feeling of tightness in the chest, or increased use of fast-acting bronchodilators. In such cases, the number of Serevent Disk 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.
• If the doctor has prescribed Serevent Disk for asthma, other asthma medicines that have been used so far should be continued. These may include inhaled steroids or steroids in tablets. The treatment should be continued with the same dose, even if an improvement is felt, unless the doctor recommends a different dosage. Inhaled steroids (or steroids in tablets) should not be stopped after starting Serevent Disk.

Disk.

• The doctor will regularly check the patient's health if they have hyperthyroidism, diabetes (Serevent Disk may increase blood sugar levels), or heart disease, including irregular or rapid heartbeat.

Serevent Disk and other medicines

• The doctor should be informed about all medicines taken recently. This includes asthma medicines and other medicines that are available without a prescription. It may not be appropriate to use Serevent Disk with other medicines.
• The doctor should be informed if the patient is currently being treated with antifungal medicines containing ketokonazole or itraconazole for any fungal infections, or if they are being treated with ritonavir for HIV infection. These medicines may increase the risk of side effects associated with Serevent Disk, including irregular heartbeat, or may worsen existing side effects.
• While using Serevent Disk, beta-blocker medicines should be avoided, unless the doctor recommends their use. Beta-blocker medicines, such as atenolol, propranolol, and sotalol, are mainly used to treat high blood pressure or other heart conditions. The doctor should be told about any beta-blocker medicines being taken, as they may reduce or block the effect of salmeterol.
• Serevent Disk may decrease blood potassium levels. If this happens, the patient may experience irregular heartbeat, muscle weakness, or muscle cramps. This is more likely to happen if the patient is taking Serevent Disk with certain medicines used to treat high blood pressure (diuretics) and other breathing difficulties, such as theophylline or steroids. The doctor may recommend blood tests to check 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 before using this medicine.

Driving and using machines

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

Serevent Disk contains lactose monohydrate

Each dose of Serevent Disk contains about 12.5 mg of lactose. In people with lactose intolerance, this amount of lactose is unlikely to cause problems. If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to use Serevent Disk

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 Disk should always be used with an inhaled steroid.
• Serevent Disk 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 Disk is for inhalation use only.
• Do not exceed the recommended dose.

Adults with asthma

• The usual dose is one inhalation twice a day.
• In patients with severe asthma, the doctor may increase the dose to 2 inhalations twice a day.

Children with asthma

• In children aged 4 to 12 years, the usual dose is one inhalation twice a day.
• Serevent Disk is not recommended for use in children under 4 years of age.

Adults with chronic obstructive pulmonary disease (COPD)

• The usual dose is one inhalation twice a day. This does not apply to children and adolescents.

Instructions for using the Disk inhaler device

The doctor, nurse, or pharmacist should instruct the patient on how to use the Disk inhaler device properly. They should check periodically that the patient is using the Disk inhaler device correctly. Not using Serevent Disk as recommended by the doctor or not using the Disk inhaler device correctly may mean that the medicine does not work as well as expected for asthma or COPD.
After removing the Disk inhaler device from the packaging for the first time, it is in the closed position.

• The Disk inhaler device contains Serevent Disk in the form of consecutive doses of inhalation powder.
• The Disk inhaler device has a dose counter that shows how many doses of medicine are left in the device. The counter shows the dose number down to 0, with numbers from 5 to 0

appearing in red to warn that there are only a few doses of medicine left in the device. If the counter shows 0, it means that the Disk inhaler device is empty.
Using the Disk inhaler device
Follow the steps below:

• 1. OPENING: To open the Disk inhaler device, hold the cover with one hand and place the thumb of the other hand in the indentation on the casing. Slide the thumb in the indentation away from you – until it clicks. After doing this, a small hole appears in the mouthpiece.

• 2. SETTING THE DOSE: Hold the Disk inhaler device with the mouthpiece facing you. You can hold it with either your right or left hand. Slide the dose slider away from you until it clicks. The Disk inhaler device is now ready to use. Each time the slider is moved, the next dose is prepared for inhalation. Do not play with the slider, as the next dose will open and the number of doses available for inhalation will decrease.

• 3. TAKING A BREATH: Before taking a breath (inhalation) of the medicine, read the instructions below carefully.
• Hold the Disk inhaler device away from your mouth and take a slow, deep breath out. Do not breathe out into the Disk inhaler device;
• Put the mouthpiece in your mouth; take a deep breath in through the Disk inhaler device, not through your nose.
• Hold your breath, take the Disk inhaler device out of your mouth. Hold your breath for about 10 seconds or as long as is comfortable, then breathe out slowly.
• Patient may not feel or taste the medicine, even if they are using the Disk inhaler device correctly.

• 4. CLOSING:
• To close the Disk inhaler device, put your thumb in the indentation on the casing and slide it towards you.
• When closing the Disk inhaler device, you will hear a "click". The dose slider returns to its original position automatically. The Disk inhaler device is now ready to use again.

Cleaning
To clean the mouthpiece of the Disk inhaler device, wipe it with a dry, soft cloth.

Using a higher dose of Serevent Disk than recommended

It is important to use the inhaler as directed. If a higher dose than recommended is used by mistake, the doctor or pharmacist should be told.
The following may occur: faster than normal heartbeat, tremors, and/or dizziness. There may also be an increase in systolic blood pressure, headache, muscle weakness, and joint pain.

Missing a dose of Serevent Disk

If a dose is missed, the next dose should be taken at the scheduled time.
Do not take a double dose of the medicine to make up for a missed dose.
In case of doubts about using the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

Allergic reactions: The patient may experience sudden breathing difficulties after using

Serevent Disk.Wheezing, coughing, as well as itching and swelling (usually of the face, lips, tongue, or throat) - anaphylactic reactions may occur. If such symptoms are noticed or occur suddenly after using Serevent Disk, the doctor should be contacted immediately.Allergic reactions to Serevent Disk are very rare (may occur in less than 1 in 10,000 patients).
Other side effects are listed below:
Common side effects(may occur in 1 to 10 in 100 patients):

• muscle cramps;
• feeling of trembling; fast or irregular heartbeat (palpitations), headache, tremors (e.g., trembling hands). The occurrence of tremors is more likely if the patient takes more than one inhalation twice a day. These side effects usually do not last long and decrease over time while continuing treatment with Serevent Disk.

Uncommon side effects(may occur in 1 to 10 in 1,000 patients):

• rash (itching and redness);
• very fast heartbeat (tachycardia). This may occur more frequently if the patient takes more than two inhalations twice a day;
• nervousness.

Rare side effects(may occur in 1 to 10 in 10,000 patients):

• dizziness;
• insomnia or difficulty sleeping;
• decreased blood potassium levels (may cause irregular heartbeat, muscle weakness, or muscle cramps).

Very rare side effects(may occur in less than 1 in 10,000 patients):

• breathing difficulties or wheezing worsening immediately after taking Serevent Disk(paradoxical bronchospasm). If such symptoms occur, Serevent Disk should be stopped.A fast-acting inhaled medicine that makes breathing easier should be used, and the doctor should be contacted immediately;
• irregular heartbeat (arrhythmias, such as extra beats, atrial fibrillation, or supraventricular tachycardia). In such cases, Serevent Disk should not be stopped, but the doctor should be informed;
• pain in the mouth and throat;
• increased blood sugar (glucose) levels;
• nausea;
• pains, swelling of joints, or chest pain.

If any side effect gets worse or if any side effects not listed in this leaflet occur, the doctor or pharmacist should be told.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist, or nurse should be told. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Serevent Disk

• Keep out of sight and reach of children.
• Store at a temperature not exceeding 30 °C.
• Do not use Serevent Disk after the expiry date stated on the label or carton. The expiry date (EXP) is the last day of the month stated. Batch number (Lot).

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 packaging and other information

What Serevent Disk contains

• Each inhalation dose contains 50 micrograms of the active substance - salmeterol (as salmeterol xinafoate, micronized).
• The other ingredient of the medicine is: lactose monohydrate (which contains milk proteins).

What Serevent Disk looks like and contents of the packaging

Inhalation powder.

Packaging:

The Disk inhaler device contains a strip of foil with doses of powder for inhalation. The foil protects the powder for inhalation from environmental conditions.
The Disk inhaler device, containing 60 doses of powder, with a mouthpiece and dose counter, is packaged in a carton.

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 No. 2
23, rue Lavoisier
27000, Evreux
France
To obtain more detailed information, please contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
phone: (22) 576-90-00
GSK logo
Date of last revision of the leaflet:January 2025