Seretide disk 250

Package leaflet: Information for the patient

Seretide Disk 100, (100 µg + 50 µg)/inhalation dose, powder for inhalation
Seretide Disk 250, (250 µg + 50 µg)/inhalation dose, powder for inhalation
Seretide Disk 500, (500 µg + 50 µg)/inhalation dose, powder for inhalation
Fluticasone propionate + Salmeterol
Please read this leaflet carefully before using the medicine, as it contains important
information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Seretide Disk is and what it is 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 pack and other information

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

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

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open. This makes it easier for air to flow into and out of the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine to prevent breathing problems associated with:

• 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 directed by your doctor.
Seretide Disk helps prevent episodes of breathlessness and wheezing. However, it should not be used
to relieve sudden attacks of breathlessness or wheezing. If such an attack occurs, a fast-acting
bronchodilator such as salbutamol should be used immediately. The patient should always have
this medicine readily available.

2. Important information before using Seretide Disk

When not to use Seretide Disk

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

Warnings and precautions
Talk to your doctor before starting treatment with Seretide Disk if the patient has:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Seretide Disk may increase blood glucose levels),
• low blood potassium levels,
• active or previously treated tuberculosis or other lung infections.

If the patient experiences blurred vision or other disturbances in vision, contact a doctor.
Seretide Disk and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those used for asthma and over-the-counter medicines. Seretide Disk should not be used with certain medicines.
Before starting treatment with Seretide Disk, inform your doctor if the patient is taking any of the following medicines:

• Medicines from the group of β-adrenolytics (e.g. atenolol, propranolol, and sotalol). β-adrenolytics are commonly used in the treatment of high blood pressure or other heart conditions.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (e.g. ritonavir, medicines containing cobicistat). Some of these medicines may increase the concentration of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects, including irregular heartbeat, or may worsen existing adverse effects. Your doctor may wish to closely monitor the patient’s condition when taking such medicines.
• Corticosteroids (administered orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction.
• Diuretics used in the treatment of high blood pressure.
• Other bronchodilators (e.g. salbutamol).
• Medicines containing xanthine derivatives, commonly used in the treatment of asthma.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine. The doctor will assess whether the patient can take Seretide Disk during this period.
Driving and operating machinery
It is unlikely that Seretide Disk will affect the ability to drive or operate machinery.
Seretide Disk contains lactose
Each dose of Seretide Disk contains up to 12.5 mg of lactose. In individuals with lactose intolerance, this amount of lactose usually does not cause problems. Lactose contains small amounts of milk proteins which may cause allergic reactions.

3. How to use Seretide Dysk

Seretide Dysk must always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.

• Seretide Dysk should be used daily unless otherwise advised by your doctor. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop using Seretide Dysk or reduce the dose without consulting your doctor.
• Seretide Dysk should be inhaled into the lungs through the mouth.
• Patients may not feel or taste the medicine, even when using the Dysk inhaler correctly.

Bronchial asthma
Adults and adolescents aged 12 years and older

• Seretide Dysk 100: one inhalation twice daily.
• Seretide Dysk 250: one inhalation twice daily.
• Seretide Dysk 500: one inhalation twice daily.

Children aged 4 to 12 years

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

Adults with chronic obstructive pulmonary disease (COPD)

• Seretide Dysk 500: one inhalation twice daily.

If asthma symptoms are well controlled while using Seretide Dysk twice daily, your doctor may recommend reducing the frequency of Seretide Dysk to once daily. The dose may be administered:

• once daily in the evening, if the patient experiences symptoms at night,
• once daily in the morning, if the patient experiences symptoms during the day.

It is very important that your doctor instructs you on the number of inhalations and how often to use them.
If you are using Seretide Dysk for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or asthma control deteriorates, contact your doctor immediately.
This may include increased wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting, inhaled medicine to relieve breathing difficulties. In such a case, continue using Seretide Dysk, but do not increase the number of inhalations. Symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.

Instructions for using the Dysk inhaler

• Your doctor, nurse, or pharmacist should instruct you on the correct use of the inhaler. They should periodically check that you are using the inhaler correctly. Incorrect use of Seretide Dysk or improper use of the inhaler may result in the medicine not providing the expected improvement in asthma or COPD.
• When removed from the packaging for the first time, the Dysk inhaler is in the closed position.

• The Dysk inhaler contains Seretide as individual doses of inhalation powder.
• The Dysk inhaler is equipped with a dose counter indicating how many doses remain in the inhaler. The counter displays the number of doses down to 0. Numbers from 5 to 0 appear in red as a warning that only a few doses remain in the inhaler. When the counter shows 0, the inhaler is empty.

Using the Dysk inhaler
Follow the steps below:

1. OPENING: To open the Dysk inhaler, hold the cover with one hand and place the thumb of the other hand in the indentation on the casing. Slide the thumb away from you until it stops and a click is heard. After this, a small opening in the mouthpiece becomes visible.

2. DOSE PREPARATION: Hold the Dysk inhaler with the mouthpiece facing toward you. You may hold it with either your right or left hand. Push the slide fully away from you until a characteristic sound is heard. The Dysk inhaler is now ready for use. Each time the lever is moved, the next dose of powder is prepared for inhalation. Do not play with the slide, as this will open the next dose and reduce the number of doses available.

3. INHALATION: Before inhaling the medicine, carefully read the instructions below. Hold the Dysk inhaler at a short distance from the mouth and breathe out slowly and deeply. Do not exhale into the Dysk inhaler. Place the mouthpiece in the mouth and inhale deeply through the mouth (not through the nose) from the Dysk inhaler. Hold your breath, remove the Dysk inhaler from your mouth. Hold your breath for about 10 seconds, or as long as comfortable, then breathe out slowly.

4. CLOSING: To close the Dysk inhaler, place your thumb in the indentation on the casing and slide it toward you.

When closing the Dysk inhaler, a "click" is heard. The dose-setting slide automatically returns to its original position. The Dysk inhaler is now ready for reuse.
Rinsing the mouth with water and spitting it out and/or brushing teeth after inhalation helps prevent hoarseness and oral thrush.
As with all inhalers, caregivers should ensure that children prescribed Seretide Dysk use the inhaler correctly as described above.

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

Accidental overdose of Seretide Dysk
It is important to use the inhaler exactly as instructed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist.
Symptoms may include: faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.
If higher doses have been used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of Seretide Dysk may reduce the production of steroid hormones by the adrenal glands.

Missed dose of Seretide Dysk
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

Stopping treatment with Seretide Dysk
It is very important to take Seretide Dysk every day as directed. Continue taking the medicine until your doctor advises otherwise. Do not suddenly stop taking Seretide Dysk or reduce the dose, as symptoms may worsen.
Additionally, sudden discontinuation or dose reduction of Seretide Dysk may (very rarely) lead to adrenal insufficiency, which may cause adverse effects.
These adverse effects may include any of the following:

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

If you experience any of these adverse effects, inform your doctor or pharmacist.
To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone).
If you have any further questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
To reduce the risk of adverse effects, your doctor will prescribe 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. Worsening of wheezing, cough, or shortness of breath may occur,
as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue,
or throat). A sensation of very rapid heartbeat, weakness, or dizziness (which may lead to
falling or loss of consciousness) may also occur. If any of these symptoms occur suddenly
after using Seretide Disk, discontinue use of Seretide Disk immediately and contact your doctor
without delay. Allergic reactions to Seretide Disk occur uncommonly (may occur in fewer than 1 in 100 people).
Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD)
(common adverse effect)
Tell your doctor if any of the following symptoms occur during treatment with Seretide Disk – they may be signs of lung infection:

• Fever or chills.
• Increased mucus production, change in mucus colour.
• Worsening cough or increased difficulty breathing.

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

• Headache – this adverse effect usually diminishes with continued treatment.
• Increased incidence of colds has been reported in patients with COPD.

Common adverse effects (may occur in fewer than 1 in 10 people):

• Oral and pharyngeal candidiasis (painful, creamy-white lesions), tongue pain, hoarseness, loss of voice, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

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

• Increased tendency to bruise and traumatic fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon adverse effects (may occur in fewer than 1 in 100 people):

• Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of previously used antidiabetic medication doses may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and diminish with continued treatment.
• Atrial fibrillation.
• Ischaemic heart disease, with symptoms such as chest pain and pressure, shortness of breath.
• Sleep disturbances.
• Feeling of anxiety (this effect occurred mainly in children).
• Allergic skin rash.

Rare adverse effects (may occur in fewer than 1 in 1000 people):

• Wheezing or breathing difficulties worsening immediately after taking Seretide Disk. If such symptoms occur, discontinue use of Seretide Disk immediately, use a fast-acting inhaled medicine to relieve breathing and contact your doctor immediately.
• Seretide Disk may interfere with the body's normal production of steroid hormones, especially when high doses are taken for a long time. Symptoms include:
• slowed growth in children and adolescents,
• reduced bone mass,
• glaucoma,
• increased body weight,
• rounded (moon-shaped) face (Cushing's syndrome). Your doctor will regularly check for these adverse effects and ensure that you are using the lowest dose of Seretide Disk that controls asthma.
  • Behavioural changes such as excessive excitability and irritability (these effects occur mainly in children).
  • Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop using Seretide Disk unless instructed by your doctor.
  • Fungal infection of the oesophagus, which may cause difficulty swallowing.

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

• Depression or aggression. These effects are more likely in children.
• Blurred vision.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder or its representative.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Seretide Dysk

• Keep out of the sight and reach of children.
• Store below 30ºC.
• Do not use Seretide Dysk after the expiry date stated on the container. The expiry date (EXP) refers to the last day of the specified month. Lot number indicates the batch number.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Seretide Disk contains

• Each metered 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 contents of the pack
Powder for inhalation.
Pack
Seretide Disk contains a strip of foil with doses placed on it. The foil protects the powder for inhalation from atmospheric conditions.
The Disk inhaler device containing 60 doses of powder, supplied with a mouthpiece and dose counter, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Manufacturer:
GlaxoSmithKline Trading Services Limited Glaxo Wellcome Production
12 Riverwalk Zone Industrielle No. 2
Citywest Business Campus 23, rue Lavoisier
Dublin 24 27000 Evreux
D24 YK11 France
Ireland
For further information, please contact the Marketing Authorisation Holder's representative:
GSK Services Sp. z o.o.
tel. (22) 576-90-00
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