Seretide disk 500

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 all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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 them, 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.

Contents of the leaflet:

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 such a medicine 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 a 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 blood potassium levels,
• active tuberculosis, previously treated tuberculosis, or other lung infections.

If the patient experiences blurred vision or other vision disturbances, they should contact a doctor.
Seretide Dysk and other medicines
Tell the doctor about all medicines the patient is currently taking, has recently taken, or plans to take, including medicines used for asthma and those available without a prescription. Seretide Dysk should not be used with certain medicines.
Before starting Seretide Dysk, inform the 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 diseases.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including certain medicines used in the treatment of 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. The doctor may wish to closely monitor the patient’s condition when taking such medicines.
• Corticosteroids (oral or injectable). 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, often 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 child, she should consult a 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 directed by the doctor. If in doubt, consult the doctor or pharmacist.

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

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, the 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 the doctor instructs the patient how many inhalations to take and how often. If the patient is using Seretide Dysk for asthma, the doctor will regularly monitor symptoms.
If asthma symptoms worsen or asthma control deteriorates, contact the doctor immediately.
There may be an increase in wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting, inhaled medicine to help breathing. In such a case, continue using Seretide Dysk, but do not increase the number of inhalations. Asthma symptoms may worsen and the patient's condition may deteriorate. Contact the doctor, as additional treatment may be needed.

Instructions for using the Dysk inhaler device

• The doctor, nurse, or pharmacist should instruct the patient on how to properly use the inhaler device. They should periodically check that the patient is using the inhaler correctly. Incorrect use of Seretide Dysk or improper use of the inhaler device may result in the medicine not producing the expected improvement in asthma or COPD.
• When removed from the packaging for the first time, the inhaler device 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 of medicine remain in the device. The counter displays the dose number 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 device
Follow the steps below:

1. OPENING: To open the Dysk inhaler device, hold the cover with one hand and place the thumb of the other hand in the indentation of the housing. Slide the thumb away from you until you hear a click. After performing this action, a small opening in the mouthpiece becomes visible.

2. SETTING THE DOSE: Hold the Dysk inhaler with the mouthpiece facing towards you. You may hold it with either the right or left hand. Slide the lever fully away from you until you hear a characteristic 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. INHALING: Before inhaling the medicine, carefully read the instructions below. Hold the Dysk inhaler at a certain distance from the mouth and breathe out calmly and deeply. Do not exhale into the Dysk inhaler device. Place the mouthpiece in the mouth; inhale deeply from the Dysk inhaler through the mouth, not through the nose. Hold your breath, then remove the Dysk inhaler from the mouth. Hold your breath for approximately 10 seconds, or as long as is comfortable, then breathe out calmly.

4. CLOSING: To close the Dysk inhaler, insert the thumb into the housing indentation and slide it towards you.

When closing the Dysk inhaler, a "click" sound is heard. The dose-setting slider 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 inhaling the medicine 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 device as instructed. If a higher than recommended dose is accidentally used, inform the 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 the 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 use of Seretide Dysk
It is very important to take Seretide Dysk daily as directed. Continue taking the medicine until the doctor advises otherwise. Do not suddenly stop taking Seretide Dysk or reduce the dose, as symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of Seretide Dysk may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may sometimes lead to 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 any of these adverse effects occur, inform the doctor or pharmacist. To prevent these symptoms, the doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone).
If there are any further doubts regarding the use of this medicine, consult the doctor, nurse, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
To reduce the risk of adverse effects, your doctor will prescribe the lowest dose of
Seretide Diskus that provides control of asthma or COPD.
Allergic reactions: The patient may experience sudden breathing difficulties immediately
after using Seretide Diskus. 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). 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 Diskus, stop using Seretide Diskus immediately and contact your doctor
without delay. Allergic reactions to Seretide Diskus occur uncommonly
(may occur in fewer than 1 in 100 people).
Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD)
(common adverse reaction)
Tell your doctor if any of the following symptoms occur while using Seretide Diskus – 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 reactions:
Very common adverse reactions (may occur in more than 1 in 10 people):

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

Common adverse reactions (may occur in fewer 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 be helpful. Your doctor may prescribe an antifungal medicine to treat oral thrush.
• Joint pain, swelling of joints, and muscle pain.
• Muscle cramps.

The following adverse reactions 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 reactions (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 may be necessary, and the dose of currently used antidiabetic medicines may need to be adjusted.
• Cataract (clouding of the eye lens).
• Very fast 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, with symptoms such as chest pain or tightness, and shortness of breath.
• Sleep disturbances.
• Feeling of anxiety (this reaction occurred mainly in children).
• Allergic skin rash.

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

• Worsening of wheezing or breathing difficulties occurring immediately after taking Seretide Diskus. If such symptoms occur, stop using Seretide Diskus, use a fast-acting inhaled medicine to relieve breathing difficulties, and contact your doctor immediately.
• Seretide Diskus may interfere with the body's normal production of steroid hormones, especially when high doses are used for a long time. These effects may include:
• slowed growth in children and adolescents,
• decreased bone mass,
• glaucoma,
• increased body weight,
• facial rounding (moon-shaped face) (Cushing's syndrome). Your doctor will regularly check whether such adverse effects occur and will ensure that you are using the lowest dose of Seretide Diskus 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 Diskus unless your doctor advises you to do so.
  • Fungal infection of the oesophagus, which may cause difficulty swallowing.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this 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 stated month. 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. These measures 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 powder for inhalation from atmospheric conditions.
The Dysk inhaler device 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:
GSK Services Sp. z o.o.
tel. (22) 576-90-00
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