Seretide 250

Patient Information Leaflet

Seretide 50, (50 μg + 25 μg)/inhalation dose, pressurised inhalation aerosol, suspension
Seretide 125, (125 μg + 25 μg)/inhalation dose, pressurised inhalation aerosol, suspension
Seretide 250, (250 μg + 25 μg)/inhalation dose, pressurised inhalation aerosol, suspension
Fluticasone propionate + Salmeterol
Please read this entire leaflet carefully before using this medicine, as it contains
important information for the patient.

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

Table of Contents:

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

1. What Seretide is and what it is used for

Seretide contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open, making it easier for air to flow into and out of the lungs. Its effect lasts 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.
To properly control asthma, Seretide must be used every day as directed by your doctor.
Seretide helps prevent episodes of breathlessness and wheezing. However, it should not be used
to relieve sudden asthma attacks or sudden 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 readily available.

2. Important information before using Seretide

When not to use Seretide

• if the patient is allergic to salmeterol, fluticasone propionate, or norflurane (HFA 134a), an excipient of the medicine.

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

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Seretide 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 visual disturbances, they should contact their doctor.
Seretide and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those used for asthma and over-the-counter medicines. Seretide should not be used with certain medicines. Before starting Seretide, inform the doctor if the patient is taking any of the following medicines:

• Medicines belonging to the class of -adrenolytics (e.g. atenolol, propranolol, and sotalol). -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 side effects. The doctor may wish to closely monitor the patient 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 to treat 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 become pregnant, she should consult her doctor before using this medicine. The doctor will assess whether the patient can take Seretide during this period.
Driving and operating machinery
It is unlikely that Seretide will affect the ability to drive or operate machinery.

3. How to use Seretide

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

• Seretide should be taken daily unless otherwise advised by the doctor. Do not take more than the recommended dose. If in doubt, consult the doctor or pharmacist.
• Do not stop using Seretide or reduce the dose without consulting the doctor.
• Seretide should be inhaled into the lungs through the mouth.

Adults and adolescents aged 12 years and older:

• Seretide 50: two inhalations twice daily.
• Seretide 125: two inhalations twice daily.
• Seretide 250: two inhalations twice daily.

Children aged 4 to 12 years:

• Seretide 50: two inhalations twice daily.
• Seretide is not recommended for use in children under 4 years of age.

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

• once daily in the evening, if the patient's symptoms occur at night,
• once daily in the morning, if the patient's symptoms occur 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 for asthma, the doctor will regularly monitor symptoms.
If asthma symptoms worsen or asthma control deteriorates, contact the 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, but do not increase the number of inhalations. Symptoms may worsen and the patient's condition may deteriorate. Contact the doctor, as additional treatment may be needed.

Instructions for using the inhaler

• The doctor, nurse, or pharmacist should instruct the patient on the correct use of the inhaler. They should periodically check that the patient is using the inhaler properly. Incorrect use of Seretide or improper use of the inhaler may result in the medicine not providing the expected improvement in asthma.
• The medicine is contained in a pressurized canister within a plastic housing with a mouthpiece.
• On the back of the inhaler there is a dose counter showing how many doses of medicine remain in the inhaler. Each time the canister is pressed, a dose of medicine is released and the counter display decreases by one.
• Be careful not to drop the inhaler, as this may cause the counter display to decrease.

Checking the inhaler

1. Before first use, check that the inhaler is working. Remove the mouthpiece cap by gently pressing the sides of the cap with the thumb and index finger.

2. To ensure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release a dose of medicine into the air. Repeat this step, shaking the inhaler vigorously before releasing each dose, until the counter displays 120. If the inhaler has not been used for one week or longer, remove the mouthpiece cap, shake the inhaler vigorously, and release two doses of medicine into the air.

Using the inhaler
It is important to begin breathing slowly and as deeply as possible even before using the inhaler.

1. Use the inhaler while standing or sitting.
2. Remove the mouthpiece cap from the inhaler (as shown in Figure 1). Check the mouthpiece inside and outside to ensure it is clean and free of foreign objects.
3. Shake the inhaler 4 or 5 times to remove any foreign particles and to ensure the contents are evenly mixed.

4. Hold the inhaler upright with your fingers, placing your thumb under the base of the inhaler, below the mouthpiece. Breathe out deeply, as deeply as possible.

5. Place the mouthpiece in your mouth and close your lips tightly around it. Do not bite the mouthpiece.

6. Begin a slow and deep inhalation. Immediately after starting to inhale through the mouth, press down on the inhaler to release a dose of Seretide, then continue a slow, deep inhalation.

7. Hold your breath, remove the inhaler from your mouth, and lift your finger from the top of the inhaler. Hold your breath for several seconds or as long as is comfortable, then breathe out slowly.

8. If the doctor has prescribed two inhalations, wait approximately half a minute before repeating steps 3–7.
9. Rinsing the mouth with water and spitting it out and/or brushing teeth after inhalation helps prevent hoarseness and oral thrush.
10. After inhalation, always replace the mouthpiece cap to prevent dust from entering. Push the cap firmly into place. If you do not hear a click when replacing the cap, remove it, turn it around, and try again. Do not use excessive force.

Do not rush through steps 4, 5, 6, and 7. It is important to breathe as slowly as possible immediately before inhalation. To ensure correct inhalation technique, initially practice using the inhaler in front of a mirror. If a "mist" is seen escaping from the inhaler, mouth, or nose during inhalation, this indicates incorrect technique. Repeat the steps starting from step 3.

As with all inhalers, caregivers should ensure that children prescribed Seretide use the inhaler correctly as described above.
If the patient has difficulty coordinating breathing with inhalation from the inhaler, a spacer device may be recommended. The doctor, nurse, or pharmacist should instruct the patient on the correct use of the inhaler with a spacer, how to maintain the spacer, and answer any related questions. If a spacer is used, it is important not to stop using it without consulting the doctor or nurse. It is also important not to change the type of spacer without consulting the doctor. If the patient stops using a spacer or changes the type, the doctor may decide to adjust the dose of medicine needed to control asthma symptoms. Always consult the doctor before making any changes to asthma treatment.

Older children or people with weak hands may find it easier to hold the inhaler with both hands. Hold the inhaler with both index fingers on top and both thumbs underneath, below the mouthpiece.

If the counter displays 020, remember that a new inhaler will soon be needed. Replace the inhaler when the counter reaches 000, as the remaining medicine may be insufficient for a full dose. Never attempt to increase the counter display, as it cannot be reset.

Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Do not remove the metal canister from the plastic housing during cleaning or at any other time.
• Wipe the mouthpiece inside and outside and the outside of the plastic housing with a dry cloth or tissue.
• Replace the mouthpiece cap. A click should be heard when the cap is properly replaced. If no click is heard, remove the cap, turn it around, and try again. Do not use excessive force.

Do not immerse the metal canister in water.

Use of more than the recommended dose of Seretide
It is important to use the inhaler exactly as instructed. If more than the recommended dose is accidentally taken, 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 may reduce the production of steroid hormones by the adrenal glands.

Missed dose of Seretide
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
It is very important to take Seretide every day as directed. Continue taking the medicine until the doctor advises otherwise. Do not suddenly stop taking Seretide or reduce the dose, as symptoms may worsen.

Additionally, abruptly stopping or reducing the dose of Seretide may (very rarely) cause adrenal gland 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 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 you have any further questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
To reduce the risk of adverse effects, your doctor will prescribe the lowest dose of
Seretide that controls asthma effectively.
Allergic reactions: The patient may experience sudden breathing difficulties immediately
after using Seretide. This may include worsening of wheezing, cough, or shortness of breath, 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,
stop using Seretide immediately and contact your doctor without delay. Allergic reactions to Seretide occur uncommonly (may occur in 1 to 10 out of 1,000 patients taking the medicine).
Other adverse reactions:
Very common adverse reactions (may occur in more than 1 out of 10 patients):

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

Common adverse reactions (may occur in 1 to 10 out of 100 patients):

• Oral or pharyngeal candidiasis (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 after each inhalation may be helpful. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

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

• Pneumonia (lung infection). Inform your doctor if any of the following symptoms occur during treatment with Seretide – they may indicate a lung infection: fever or chills, increased mucus production, change in mucus color, worsening cough, or increased breathing difficulties.
• 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, or cramps).

Uncommon adverse reactions (may occur in 1 to 10 out of 1,000 patients):

• 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 adjustment.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and tend to decrease with continued treatment.
• Atrial fibrillation.
• Ischaemic heart disease, with symptoms such as chest pain or pressure, and shortness of breath.
• Sleep disturbances.
• Anxiety.
• Allergic skin rash.

Rare adverse reactions (may occur in 1 to 10 out of 10,000 patients):

• Worsening of wheezing or breathing difficulties occurring immediately after taking Seretide. If such symptoms occur, stop using Seretide immediately, use a fast-acting inhaled medicine to relieve breathing, and contact your doctor immediately.
• Seretide may interfere with the body's normal production of steroid hormones, especially when high doses are used for prolonged periods. 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 monitor for such adverse effects and ensure that you are using the lowest dose of Seretide that controls asthma.
• Behavioral 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 unless instructed by your doctor.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Seretide medicine

• Keep the medicine out of the sight and reach of children.
• Do not use Seretide after the expiry date stated on the package. The expiry date (EXP) refers to the last day of the stated month. The Lot number indicates the batch number.
• Store below 30°C. Do not refrigerate or freeze.
• As with most pressurized inhalers, the therapeutic effect of this medicine may be reduced if the canister is cold.
• The metal canister contains a pressurized suspension. Do not expose to temperatures above 50°C and protect from direct sunlight. Do not pierce or burn the canister, even if it seems empty. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Seretide contains

• The active substances in this medicine are: salmeterol and fluticasone propionate. Each metered dose contains 25 micrograms (µg) of salmeterol (as salmeterol xinafoate) and 50, 125 or 250 micrograms (µg) of fluticasone propionate.
• The other ingredient is a propellant gas: 1,1,1,2-tetrafluoroethane (norflurane, HFA 134a).

This medicine contains fluorinated greenhouse gases.
Each inhaler contains [g amount], equivalent to [tonnage] tonnes of CO₂ equivalent (global warming potential GWP = [value]).
What Seretide looks like and contents of the pack

• Seretide is supplied in an inhaler containing a pressurised suspension for oral inhalation into the lungs.
• The pressurised container holds a white to off-white inhalation suspension.
• Pack contents: An aluminium pressurised canister fitted with a metering valve, assembled in a plastic actuator with dose counter, presented in a cardboard carton. One pressurised canister contains 120 doses.

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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