Seretide disk 100

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask 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, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Seretide Dysk 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 Dysk 500 reduces the number of exacerbations of COPD symptoms.

To properly control asthma or COPD, Seretide Dysk must be used every day as directed by your doctor.
Seretide Dysk helps prevent episodes of breathlessness and wheezing. However, it must not be used
to relieve sudden attacks of breathlessness or wheezing. If such an attack occurs, a fast-acting
bronchodilator, such as salbutamol, must be used immediately. You should always have this
medicine readily available.

2. Important information before using Seretide Dysk

When not to use Seretide Dysk

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

Warnings and precautions
Talk to your doctor before starting to use Seretide Dysk if the patient has:

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

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Seretide Dysk 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 asthma medications and over-the-counter medicines. Seretide Dysk should not be used with certain medicines.
Before starting Seretide Dysk, inform your doctor if the patient is taking the following medicines:

• Medicines from the group of β-adrenolytics (e.g. atenolol, propranolol, and sotalol). β-adrenolytics are commonly used to treat high blood pressure or other heart conditions.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including certain medicines used to treat HIV (e.g. ritonavir, medicines containing cobicistat). Some of these medicines may increase the levels 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 (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction.
• Diuretics used to treat high blood pressure.
• Other bronchodilator medicines (such as 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 Dysk during this period.
Driving and operating machinery
It is unlikely that Seretide Dysk will affect the ability to drive or operate machinery.
Seretide Dysk contains lactose
Each dose of Seretide Dysk 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 prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• Seretide Dysk should be taken every day until your doctor advises otherwise. Do not exceed the prescribed 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 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 taking Seretide Dysk twice daily, your doctor may recommend reducing the frequency of administration to once daily. The dose may be taken:

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

It is very important that your doctor instructs you on how many inhalations to take and how often.
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 immediately, 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 properly. 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 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 that shows how many doses remain in the inhaler. The counter displays numbers down to 0. Numbers from 5 to 0 appear in red as a warning that only a few doses remain. 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 of the casing. Slide the thumb away from you until you hear a click. 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 use either hand. Slide the lever fully away from you until you hear a distinct sound. 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 lever, as this will release the next dose and reduce the number of remaining doses.

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

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

While closing the Dysk inhaler, you will hear a "click." The dose-setting lever automatically returns to its original position. The Dysk inhaler is now ready for the next use.
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.

Using more than the recommended dose 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 adrenal glands' production of steroid hormones.

Missing a 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 prescribed. Continue taking the medicine until your doctor advises you to stop. Do not suddenly stop taking Seretide Dysk or reduce the dose, as symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of Seretide may (very rarely) cause adrenal dysfunction (adrenal insufficiency), which may lead to adverse effects.

These adverse effects may include any of the following:

• 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 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 everybody will experience them.
To reduce the risk of adverse effects, your doctor will recommend the lowest dose of
Seretide Disk that provides control of asthma or COPD.
Allergic reactions: The patient may experience sudden difficulty in breathing immediately
after using Seretide Disk. Worsening of wheezing, coughing, or shortness of breath may occur,
as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat).
There may also be a sensation of very rapid heartbeat, weakness, or dizziness (which may lead to
falling or loss of consciousness). If any of these symptoms occur suddenly after using
Seretide Disk, stop using Seretide Disk immediately and contact your doctor without delay.
Allergic reactions to Seretide Disk are not very common (may occur in less 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 while using Seretide Disk – they may
be signs of lung infection:

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

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

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

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

• Oral thrush (painful, creamy-white lesions in the mouth and throat), as well as 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 oral thrush.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

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

• Easy bruising 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 less 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 the dose of currently used antidiabetic medicines 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 decrease with continued treatment.
• Atrial fibrillation.
• Ischaemic heart disease, which may present as chest pain or tightness, and shortness of breath.
• Sleep disturbances.
• Feeling of anxiety (this effect occurred mainly in children).
• Allergic skin rash.

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

• Worsening of wheezing or breathing difficulties occurring immediately after taking Seretide Disk. If such symptoms occur, stop using 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. These effects include:
  • Slowed growth in children and adolescents,
  • Reduced bone mass,
  • Glaucoma,
  • Increased body weight,
  • Facial rounding (moon face) (Cushing's syndrome). Your doctor will regularly check whether you are experiencing such adverse effects and will ensure that you are using the lowest dose of Seretide Disk that controls your 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 your doctor advises you to do so.
  • Fungal infection of the oesophagus, which may cause difficulty in 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, tell 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 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 at a temperature not exceeding 30°C.
• Do not use Seretide Dysk after the expiry date stated on the packaging. The expiry date (EXP) refers to the last day of the month indicated. The Lot number indicates the batch number.

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

6. Contents of the pack and other information

What Seretide Dysk 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 Dysk looks like and contents of the pack
Powder for inhalation.
Pack
Seretide Dysk contains a strip of foil with doses placed on it. The foil protects the inhalation powder from atmospheric conditions.
The Dysk inhaler containing 60 doses of powder, equipped with a mouthpiece and a 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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