Seretide Disk 500

Leaflet attached to the packaging: patient information

Seretide Disk 100, (100 g + 50 g)/inhalation dose, inhalation powder
Seretide Disk 250, (250 g + 50 g)/inhalation dose, inhalation powder
Seretide Disk 500, (500 g + 50 g)/inhalation dose, inhalation powder
Fluticasone propionate + Salmeterol

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to a specific person. 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 Seretide Disk and what is it used for
• 2. Important information before using Seretide Disk
• 3. How to use Seretide Disk
• 4. Possible side effects
• 5. How to store Seretide Disk
• 6. Contents of the packaging and other information

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

Seretide Disk contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help maintain airway patency. This facilitates airflow to and from the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation of the lungs.

The doctor has prescribed this medicine to the patient to prevent breathing disorders that occur in:

• asthma,
• chronic obstructive pulmonary disease (COPD). Seretide Disk 500 reduces the number of exacerbations of COPD symptoms.

To ensure proper control of asthma or COPD, Seretide Disk must be used every day, as recommended by the doctor.

Seretide Disk prevents the occurrence of shortness of breath and wheezing in the airways. However, it should not be used to control sudden attacks of shortness of breath or wheezing in the airways. If such an attack occurs, it is necessary to use a fast-acting, inhaled bronchodilator, such as salbutamol, immediately. The patient should always have such a medicine with them.

It is recommended to always carry a fast-acting, inhaled bronchodilator, such as salbutamol.

2. Important information before using Seretide Disk

When not to use Seretide Disk

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

Warnings and precautions

Before starting to use Seretide Disk, the patient should talk to their doctor if they have:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Seretide Disk may increase blood glucose levels),
• low potassium levels in the blood,
• tuberculosis currently being treated or a history of tuberculosis or other lung infections.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Seretide Disk and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including asthma medicines and over-the-counter medicines. Seretide Disk should not be used with certain medicines.

Before starting to use Seretide Disk, the patient should inform their doctor about taking the following medicines:

• β-blockers (e.g., atenolol, propranolol, and sotalol). β-blockers are most commonly used to treat high blood pressure or other heart diseases.
• Medicines used to treat infections (e.g., ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (e.g., ritonavir, cobicistat-containing products). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects, including irregular heartbeat, or worsen existing side effects. The doctor may want to closely monitor the patient's condition while taking such medicines.
• Corticosteroids (orally or by injection). If the patient has recently taken such medicines, it may increase the risk of adrenal gland disorders.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, often used to treat asthma.

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. The doctor will assess whether the patient can take Seretide Disk during this period.

Driving and using machines

It is unlikely that Seretide Disk will affect the patient's ability to drive or use machines.

Seretide Disk contains lactose

Each dose of Seretide Disk contains up to 12.5 mg of lactose. In people with lactose intolerance, this amount of lactose is unlikely to cause any problems. Lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Seretide Disk

Seretide Disk should always be used as recommended by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

• Seretide Disk should be used every day, until the doctor recommends otherwise. The patient should not take a higher dose than recommended. If they have any doubts, they should consult their doctor or pharmacist.
• The patient should not stop using Seretide Disk or reduce the dose without consulting their doctor.
• Seretide Disk should be inhaled into the lungs through the mouth.
• Patient may not feel the medicine or its taste, even if they use the Disk inhaler correctly.

Asthma

Adults and adolescents from 12 years of age

• Seretide Disk 100: one inhalation twice a day.
• Seretide Disk 250: one inhalation twice a day.
• Seretide Disk 500: one inhalation twice a day.

Children from 4 to 12 years of age

• Seretide Disk 100: one inhalation twice a day.
• Seretide Disk is not recommended for use in children under 4 years of age.

Adults with chronic obstructive pulmonary disease (COPD)

• Seretide Disk 500: one inhalation twice a day.

If the patient's asthma symptoms are well-controlled while using Seretide Disk twice a day, the doctor may recommend reducing the frequency of Seretide Disk use to once a day. The dose can be taken:

• once a day, in the evening, if the patient's symptoms occur at night,
• once a day, in the morning, if the patient's symptoms occur during the day.

It is very important that the doctor instructs the patient on how many inhalations and how often to use them. If the patient is using Seretide Disk for asthma, the doctor will regularly check the patient's symptoms.

If the patient's asthma symptoms worsen or asthma control deteriorates, they should

contact their doctor immediately.The patient may experience increased wheezing, more frequent chest tightness, or may need to use more of a fast-acting, inhaled bronchodilator. In this situation, the patient should continue to use Seretide Disk, but not increase the number of inhalations. The patient's symptoms may worsen, and their condition may deteriorate. The patient should contact their doctor, as they may need additional treatment.

Instructions for using the Disk inhaler

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

• The Disk inhaler contains Seretide in the form of consecutive doses of inhalation powder.
• The Disk inhaler has a dose counter that shows how many doses of medicine are left in the inhaler. The counter shows the dose number down to 0, and the numbers from 5 to 0 appear in red to warn that there are only a few doses of medicine left in the inhaler. If the counter shows 0, it means that the inhaler is empty.

Using the Disk inhaler
Follow these steps:

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

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

• 3. TAKING A BREATH: Before taking a breath, read the following instructions carefully. Hold the Disk inhaler away from your mouth and take a slow, deep breath out. Do not breathe out into the Disk inhaler. Put the mouthpiece in your mouth; take a deep breath in through the Disk inhaler, not through your nose. Hold your breath, take the Disk inhaler out of your mouth. Hold your breath for about 10 seconds or as long as it is comfortable, then breathe out slowly.

• 4. CLOSING: To close the Disk inhaler, put your thumb in the recess of the casing and slide it towards you.

When closing the Disk inhaler, you will hear a "click". The dose-setting lever returns to its original position automatically. The Disk inhaler is ready to use again.
Rinsing the mouth with water and spitting it out and (or) brushing teeth after inhaling the medicine helps prevent hoarseness and thrush.
As with all inhalers, caregivers should ensure that children prescribed Seretide Disk use the Disk inhaler correctly, as described above.

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

Using a higher dose of Seretide Disk than recommended

It is essential to use the Disk inhaler as instructed. If a higher dose than recommended is used accidentally, the patient should tell their doctor or pharmacist.
The following may occur: faster than usual heartbeat, tremors, dizziness, headache, weakness, and joint pain.
If higher doses are used for a long time, the patient should contact their doctor or pharmacist for advice, as high doses of Seretide Disk may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Seretide Disk

The patient should not take a double dose of the medicine to make up for a missed dose. They should take the next dose at the scheduled time.

Stopping the use of Seretide Disk

It is crucial to take Seretide Disk every day as recommended by the doctor. The patient should
continue to take the medicine until the doctor advises them to stop.The patient should not stop taking Seretide Disk suddenly or reduce the dose, as the symptoms of the disease may worsen.
Additionally, sudden stopping or reducing the dose of Seretide Disk may (very rarely) cause adrenal gland disorders (adrenal insufficiency), which can sometimes cause side effects. These side effects may include:

• abdominal pain,
• fatigue and loss of appetite, nausea,
• vomiting and diarrhea,
• weight loss,
• headache and drowsiness,
• low blood sugar,
• low blood pressure and seizures. When the body is under stress, such as from fever, injury (e.g., a car accident), infection, or surgery, adrenal insufficiency may worsen, and any of the above side effects may occur.

If the patient experiences any of these side effects, they should tell their doctor or pharmacist. To prevent these symptoms, the doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone).
If the patient has any further doubts about using this medicine, they should consult their doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, Seretide Disk can cause side effects, although not everybody gets them.
To minimize the risk of side effects, the doctor will recommend the lowest dose of Seretide Disk that controls asthma or COPD.

Allergic reactions: The patient may experience sudden breathing difficulties immediately

after using Seretide Disk.The patient may experience increased wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). The patient may also experience a very fast heartbeat, weakness, and dizziness (which can lead to falls or loss of consciousness). If the patient experiences any of these symptoms suddenly after using Seretide Disk, they should
stop using Seretide Disk and contact their doctor immediately.Allergic reactions to Seretide Disk are uncommon (they may occur less often than in 1 in 100 people).

Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect)

The patient should tell their doctorif they experience any of the following symptoms while using Seretide Disk - they may be symptoms of a lung infection:

• Fever or chills.
• Increased production of mucus, change in mucus color.
• Worsening cough or increased breathing difficulties.

Other side effects:
Very common side effects(may occur more often than in 1 in 10 people):

• Headache - this side effect usually decreases over time while continuing treatment.
• Increased frequency of colds has been reported in patients with COPD.

Common side effects(may occur less often than in 1 in 10 people):

• Thrush (painful, creamy-white patches) in the mouth and throat, as well as tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and (or) brushing teeth after each inhalation may be helpful. The doctor may prescribe an antifungal medicine to treat thrush.
• Pain, swelling of joints, and muscle pain.
• Muscle cramps.

The following side effects have been reported in patients with chronic obstructive pulmonary disease (COPD):

• Easier bruising and fractures.
• Sinusitis (feeling of tension and fullness in the nose, cheeks, and behind the eyes, sometimes with a throbbing headache).
• Decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, and cramps).

Uncommon side effects(may occur less often than in 1 in 100 people):

• Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of antidiabetic medicines being taken.
• Cataract (clouding of the lens of the eye).
• Very fast heartbeat (tachycardia).
• Feeling of trembling and fast or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease over time while continuing treatment.
• Atrial fibrillation.
• Ischaemic heart disease, which may cause chest pain and shortness of breath.
• Sleep disturbances.
• Feeling of anxiety (this side effect mainly occurred in children).
• Allergic skin rash.

Rare side effects(may occur less often than in 1 in 1000 people):

• Wheezing or breathing difficulties worsening immediately after taking Seretide Disk.If the patient experiences such symptoms, they should stop using Seretide Disk,use a fast-acting, inhaled bronchodilator, and contact their doctor immediately.
• Seretide Disk may disrupt the normal production of steroid hormones by the body, especially when taking high doses of the medicine for a long time. These symptoms include:
• slowed growth in children and adolescents,
• decreased bone density,
• glaucoma,
• weight gain,
• rounding (moon-shaped) face (Cushing's syndrome). The doctor will regularly check for these side effects and ensure that the patient is taking the lowest dose of Seretide Disk that controls their asthma.
• Changes in behavior, such as excessive restlessness and irritability (these symptoms mainly occurred in children).
• Irregular heartbeat or extra heartbeats (heart rhythm disturbances). The patient should inform their doctor, but not stop using Seretide Disk unless the doctor advises them to do so.
• Fungal infection of the esophagus, which can cause difficulty swallowing.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• Depression or aggression. The occurrence of these side effects is more likely in children.
• Blurred vision.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 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 gather more information on the safety of this medicine.

5. How to store Seretide Disk

• Keep out of sight and reach of children.
• Store in a temperature not exceeding 30°C.
• Do not use Seretide Disk after the expiry date stated on the packaging. The expiry date (EXP) is the last day of the month stated. The batch number is indicated by the abbreviation Lot.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Seretide Disk contains

• Each measured dose contains 50 µg (micrograms) of salmeterol (as salmeterol xinafoate) and 100, 250, or 500 µg (micrograms) of fluticasone propionate.
• The other ingredient is lactose monohydrate (which contains milk proteins).

What Seretide Disk looks like and what the packaging contains

Inhalation powder.

Packaging

Seretide Disk contains a foil strip with doses on it. The foil protects the inhalation powder from the environment.
The Disk inhaler, containing 60 doses of powder, with a mouthpiece and dose counter, is packaged in a cardboard box.

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, the patient should contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
phone: (22) 576-90-00
{logo of the marketing authorization holder}
Date of last revision of the leaflet:January 2025