Seretide Accuhaler 50 microgram/500 microgram/inhalation, powder for inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

Seretide Accuhaler 50 micrograms/500 micrograms/inhalation, inhalation powder

salmeterol/fluticasone propionate

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Seretide is and what it is used for

2. What you need to know 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 in the lungs open, making it easier to breathe in and out. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces inflammation and irritation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as:

• Asthma.
• Chronic Obstructive Pulmonary Disease (COPD). Seretide Accuhaler, at a dose of 50/500 micrograms, reduces the number of exacerbations of COPD symptoms.

You should use Seretide every day as directed by your doctor. This will ensure that the medication works effectively to control your asthma or COPD.

Seretide helps prevent shortness of breath and wheezing. However, Seretide must not be used to relieve a sudden attack of breathlessness or wheezing. In such cases, you must use your fast-acting "reliever" medication, such as salbutamol. You should always carry your fast-acting reliever medication with you.

2. What you need to know before using Seretide

Do not use Seretide

• if you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients, lactose monohydrate.

Warnings and precautions

Consult your doctor before starting treatment if you have:

• Heart problems, including rapid or irregular heartbeat.
• Overactive thyroid gland.
• High blood pressure.
• Diabetes mellitus (Seretide may increase blood sugar levels).
• Low levels of potassium in the blood.
• Tuberculosis (TB) currently or in the past, or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Seretide

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those for asthma or medicines obtained without a prescription. This is because, in some cases, Seretide should not be administered together with certain other medicines.

Tell your doctor if you are taking any of the following medicines before starting Seretide:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some medicines for HIV (such as ritonavir, cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of adverse effects with Seretide, including irregular heartbeats, or may worsen side effects, so your doctor will monitor you closely if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have recently taken these medicines, there may be an increased risk that this medicine could affect your adrenal gland.
• Diuretics, also known as "water pills," used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthines. These are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Seretide is unlikely to affect your ability to drive or operate machinery.

Seretide Accuhaler contains lactose

Seretide Accuhaler contains up to 12.5 milligrams of lactose monohydrate per dose. The amount of lactose in this medicine is unlikely to cause problems in people with lactose intolerance. However, it may cause allergic reactions in patients who are allergic to cow's milk protein. If your doctor has informed you that you have an intolerance to certain sugars, consult him before using this medicine.

3. How to use Seretide

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Use Seretide every day until your doctor tells you to stop. Do not take more than the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop taking Seretide or reduce your dose without first speaking to your doctor.
• Seretide must be inhaled through the mouth into the lungs.
• You may not taste or feel the powder on your tongue, even if you have used the Accuhaler correctly.

For asthma

Adults and adolescents aged 12 years and older

• Seretide 50/100 Accuhaler – One inhalation twice daily
• Seretide 50/250 Accuhaler – One inhalation twice daily
• Seretide 50/500 Accuhaler – One inhalation twice daily

Children aged 4 to 12 years

• Seretide 50/100 Accuhaler – One inhalation twice daily

Seretide is not recommended for use in children under 4 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• Seretide 50/500 Accuhaler – One inhalation twice daily

Your symptoms may become well controlled with twice-daily use of Seretide. If so, your doctor may decide to reduce your dose to once daily. The dose may be changed to:

• once at night if you have nocturnal symptoms,
• once in the morning if you have diurnal symptoms.

It is very important that you follow your doctor’s instructions on how many inhalations and how often you should take your medication.

If you are using Seretide to treat asthma, your doctor will want to monitor your symptoms regularly.

If your asthma worsens or you have increasing difficulty breathing, see your doctor immediately. You may notice more wheezing or breathlessness, or find that you need to use your fast-acting rescue medication more often. If any of these occur, you should continue using Seretide, but do not increase the number of inhalations. Your respiratory condition may worsen and you may become seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should show you how to use your inhaler. They should periodically check your inhaler technique. Incorrect or inappropriate use of the Seretide Accuhaler may result in your asthma or COPD not being properly controlled.
• This Accuhaler contains blisters containing Seretide powder.
• There is a dose counter on the top of the Accuhaler indicating how many doses remain. It counts down to 0. Numbers from 5 to 0 appear in red to warn you that only a few doses remain. Once the counter reaches 0, your inhaler is empty.

How to use your inhaler

1. To open the Accuhaler, hold the outer case in one hand and place the thumb of the other hand in the designated thumb grip. Push the thumb away from you as far as it will go. You will hear a “click”. This opens a small hole in the mouthpiece.

2. Hold the device with the mouthpiece facing you. You may hold it with either your right or left hand. Slide the lever away from you. You will hear a “click”. This delivers the dose of medication into the mouthpiece.

Each time the lever is slid back, a blister is opened and the powder is prepared for inhalation. Do not play with the lever, as this opens the blisters and wastes medication.

3. Keep the Accuhaler away from your mouth. Breathe out as much as you reasonably can. Do not breathe into the Accuhaler.

4. Place the mouthpiece in your mouth; breathe in steadily and deeply through the Accuhaler, not through your nose.

Remove the Accuhaler from your mouth.

Hold your breath for about 10 seconds, or as long as possible.

Breathe out slowly.

5. Afterwards, rinse your mouth with water, spit it out, and/or brush your teeth. This may help prevent mouth ulcers and hoarseness.

6. To close the Accuhaler, slide the lever towards you with your thumb as far as it will go. You will hear a “click”.

The lever will automatically return to its original position.

The Accuhaler is now ready for reuse.

As with all inhalers, caregivers must ensure that children using Seretide Accuhaler use the inhalation technique described above correctly.

Cleaning your inhaler

To clean, wipe the mouthpiece of the Accuhaler with a dry tissue.

If you use more Seretide than you should

It is very important to use the inhaler exactly as instructed. If you accidentally take a higher dose than recommended, consult your doctor or pharmacist. You may notice your heart beating faster than normal and feel tremors. You may also experience dizziness, headache, muscle weakness, and joint pain.

If you have used large doses over long periods of time, you should seek advice from your doctor or pharmacist. This is because high concentrations of Seretide may reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medication and the amount taken.

If you forget to use Seretide

Do not take a double dose to make up for missed doses. Take the next dose at your usual time.

If you stop treatment with Seretide

It is very important that you use Seretide every day as instructed. Continue taking it until your doctor tells you to stop. Do not stop your treatment with Seretide abruptly. This could cause your breathing to worsen.

Additionally, if you stop taking Seretide suddenly or reduce your dose, you could (very rarely) develop problems with your adrenal gland (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

• Stomach pain.
• Tiredness and loss of appetite, feeling unwell.
• Malaise and diarrhoea.
• Weight loss.
• Headache or drowsiness.
• Low blood sugar levels.
• Low blood pressure and seizures (fits).

When your body is under stress such as fever, trauma (e.g., traffic accident), infection, or surgery, adrenal insufficiency may worsen and you may experience any of the adverse effects listed above.

If you experience any adverse effects, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of oral corticosteroids during that time (such as prednisolone).

If you have any further questions about the use of this medicine, ask 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 likelihood of adverse effects, your doctor will prescribe the lowest dose of Seretide that controls your asthma or Chronic Obstructive Pulmonary Disease (COPD).

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Seretide. You may experience wheezing, coughing, or shortness of breath. You may also notice itching, rash (urticaria), or swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel dizzy, or feel like you might lose consciousness (which could lead to collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Seretide, stop using Seretide and contact your doctor immediately. Allergic reactions to Seretide are uncommon (may affect up to 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (common adverse effect)

Inform your doctor if you experience any of the following symptoms while inhaling Seretide, as they could be signs of a lung infection:

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

Other adverse effects listed below:

Very common (may affect up to 1 in 10 people)

• Headache, which usually improves with continued treatment.
• Increased incidence of colds has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD).

Common (may affect up to 1 in 10 people)

• Oral candidiasis (itching, creamy yellowish sores) in the mouth and throat. Also, tongue pain, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medication may help. For treatment of candidiasis, your doctor may prescribe antifungal medication (to treat fungal infections).
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

The following adverse effects have been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Bruising and fractures.
• Sinus inflammation (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with throbbing pain).
• Decreased blood potassium levels (you may feel irregular heartbeats, muscle weakness, or cramps).

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, your blood sugar levels will need to be monitored more frequently and your usual diabetes treatment may need to be adjusted if necessary.
• Cataracts (clouding of the eye's lens).
• Very fast heart rate (tachycardia).
• Tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and tend to decrease with continued treatment.
• Chest pain.
• Feeling anxious (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic skin rash.

Rare (may affect up to 1 in 1,000 people)

• Difficulty breathing (or wheezing) that worsens immediately after using Seretide. If this occurs, stop using Seretide. Use your fast-acting "rescue" inhaler to improve your breathing and contact your doctor immediately.
• Seretide may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods of time. Effects include:
• Growth retardation in children and adolescents.
• Decreased bone mineral density.
• Glaucoma.
• Weight gain.
• Rounded face (moon face) (Cushing's syndrome).

Your doctor will regularly monitor for any of these adverse effects and ensure you are taking the lowest effective dose of Seretide to control your asthma.

• Changes in behaviour, such as hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Seretide unless your doctor tells you to.
• Fungal infection of the oesophagus (gullet), which may cause difficulty swallowing.

Not known: frequency cannot be estimated from available data

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Seretide

Keep this medicine out of the sight and reach of children.

Do not use Seretide after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Seretide

• Each pre-dispensed dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate (contains milk proteins).

Nature of the product and contents of the pack

Seretide Accuhaler contains a blister strip. The blisters protect the inhaled powder from atmospheric effects.

Each dose is pre-dispensed.

The devices are available in packs of:

• 1 Accuhaler x 28 inhalations or
• 1, 2, 3 or 10 Accuhaler x 60 inhalations each.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Glaxo Wellcome Production

Zone Industrielle nº 2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France

Tel: +33 2 3223 5500

Fax: +33 2 3223 5558

This medicinal product is authorised in the European Economic Area member states under the following names:

Austria Seretide Diskus

Belgium Seretide Diskus

Croatia Seretide Diskus

Cyprus Seretide Diskus

Czech Republic Seretide Diskus

Denmark Seretide

Estonia Seretide Diskus

Finland Seretide Diskus

France Seretide Diskus

Germany atmadisc Diskus

Greece Seretide Diskus

Hungary Seretide Diskus

Iceland Seretide

Ireland Seretide Diskus

Italy Seretide Diskus

Luxembourg Seretide Diskus

Malta Seretide Diskus

Netherlands Seretide Diskus

Portugal Seretaide Diskus

Romania Seretide Diskus

Slovakia Seretide Diskus

Spain Seretide Accuhaler

Sweden Seretide Diskus

Date of the most recent review of this leaflet: July 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/