Leaflet: information for the user

Seretide Accuhaler 50 micrograms/250 micrograms/inhalation, powder for inhalation

salmeterol/fluticasone propionate

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Seretide contains two active ingredients, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier for air to enter and leave. 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 medication to help prevent respiratory problems such as:

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

You must use Seretide every day as recommended by your doctor. This will ensure the medication acts correctly in controlling your asthma or COPD.

Seretide helps prevent shortness of breath and wheezing. However, Seretide should not be used to relieve a sudden attack of shortness of breath or wheezing. In such a case, you must use your quick-relief medication, such as salbutamol. You should carry your quick-relief medication with you at all times.

Do not use Seretide

• If you are allergic to salmeterol, fluticasone propionate or to any other component, lactose monohydrate.

Warnings and precautions

Consult your doctor before starting treatment if you have:

• Cardiac alterations including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Seretide may increase blood sugar levels).
• Low levels of potassium in the blood.
• Tuberculosis (TB) today or in the past or other lung infections.

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

Other medications and Seretide

Inform your doctor or pharmacist if you are using, have used recently or may need to use any othermedication, including those for asthma or those obtained without a prescription. The reason isthat, in some cases, Seretide should not be administered with other medications.

Inform your doctor if you take any of the following medications, before starting to use Seretide:

• β blockers (such as atenolol, propranolol and sotalol). β blockers are used in most cases to treat hypertension or other cardiac conditions.
• Medications to treat infections (such as ketoconazole, itraconazole and erythromycin) including some HIV medications (such as ritonavir, cobicistat).Some of these medications may increase the amount of fluticasone propionate or salmeterol in your body.This may increase your risk of experiencing adverse effects with Seretide, including irregular heartbeats, or may worsen the adverse effects, so your doctor will make close checks if you are taking these medications.
• Corticosteroids (oral or injectable). If you have taken these medications recently,you may increase the risk of this medication affecting your adrenal gland.
• Diuretics, also known as medications to urinate, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medications containing xanthine. They are often used to treat asthma.

Pregnancy and breastfeeding

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

Driving and using machines

Seretide is unlikely to affect your ability to drive or use machines.

Seretide Accuhaler contains lactose

Seretide Accuhaler contains up to 12.5 milligrams of lactose monohydrate in each dose.The amount of lactose in this medication usually does not cause problems in people with lactose intolerance..It may causeallergic reactions in patients with milk protein allergy. If your doctor hasindicated that you have an intolerance to certain sugars, consult with him before using thismedication.

Follow exactly the administration instructions of this medication as indicated 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 talking to your doctor first.
• Seretide must be inhaled through the mouth into the lungs.
• You may not be able to taste or feel the powder on your tongue, even if you have used the Accuhaler correctly.

For asthma

Adults and adolescents 12 years and older

• Seretide 50/100 Accuhaler - One inhalation twice a day
• Seretide 50/250 Accuhaler - One inhalation twice a day
• Seretide 50/500 Accuhaler - One inhalation twice a day

Children 4 to 12 years old

• Seretide 50/100 Accuhaler - One inhalation twice a day

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 a day

Your symptoms may be well controlled using Seretide twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to:

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

It is very important that you follow your doctor's instructions on how many applications 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 greater difficulty breathing, see your doctor immediately. You may notice more wheezing or a feeling of choking more often or that you need to use your rescue medication more frequently. If any of these things happen, you should continue using Seretide, but do not increase the number of applications. Your respiratory disease 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 teach you how to use your inhaler. They should periodically check how you use it. Not using Seretide Accuhaler properly or as prescribed may result in your asthma or COPD not improving as it should.
• This Accuhaler contains alveoli that contain Seretide in powder form.
• There is a dose counter on the top of the Accuhaler that indicates how many doses are left. Counts back, to 0. The numbersfrom 5 to 0 will appear in red to warn you that there are few doses left. Once the counter marks 0, your inhaler is empty.

Using your inhaler

1. To open the Accuhaler, hold the outer casing with one hand and place your thumb in the reserved hole. Push with your thumb, moving it away from you, until it reaches. You will hear a "click". This will open a small hole in the mouthpiece.

2. Hold the device with the mouthpiece towards you. You can hold it with your right or left hand. Slide the lever back. You will hear a "click". This will place the medication dose in the mouthpiece.

Each time the lever is pushed back, an alveolus opens and the powder is prepared to be inhaled. Do not play with the lever, as the alveoli will open and the medication will be wasted.

3.Hold theAccuhaleraway from your mouth. Breathe out as much as possible. Do not breathe into theAccuhaler.

4.Place the mouthpiece in your mouth; take a progressive and intense breath through theAccuhaler, not through your nose.

Remove theAccuhalerfrom your mouth.

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

Breathe out slowly.

5.After rinsing your mouth with water and spitting it out and/or brushing your teeth. This may help prevent mouth ulcers and hoarseness.

6.To close theAccuhaler, slide the lever towards you as far as possible. You will hear a "click".

The lever will automatically return to its original position.

TheAccuhaleris now ready to be used again.

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

Cleaning your inhaler

To clean it, pass a dry cloth over the mouthpiece of theAccuhaler.

If you use more Seretide than you should

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

If you have used high doses for long periods of time, you should consult your doctor or pharmacist. This is because high concentrations of Seretide can reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Seretide

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

If you interrupt treatment with Seretide

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

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

These adverse effects may include any of the following:

• Abdominal pain.
• Fatigue and loss of appetite, feeling unwell.
• Discomfort and diarrhea.
• Weight loss.
• Headache or drowsiness.
• Low blood sugar levels.
• Hypotension and seizures (convulsions).

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

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

If you have any other questions about the use of this medication, ask your doctor, nurse, or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. To reduce the occurrence of side 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 and coughing or shortness of breath. You may also notice itching, hives (urticaria) and swelling (usually of the face, lips, tongue or throat). You may also feel, suddenly, that your heart is beating very fast, feel like you lose consciousness and dizziness (which can lead to collapse or loss of consciousness).If you experience any of these effects or if they appear suddenly after using Seretide, stop taking Seretide and inform your doctor immediately.Allergic reactions to Seretide are rare (they can affect up to 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (frequent side effect)

Inform your doctorif you have any of the following symptoms while inhaling Seretide, they may be symptoms of a lung infection:

• Fever or chills.
• Increased mucus production, change in mucus color.
• Increased coughing or difficulty breathing.

The following are other side effects:

Very frequent (can affect more than 1 in 10 people))

• Headache, which usually improves as treatment continues.
• A higher number of colds has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD).

Frequent (can affect up to 1 in 10 people))

• Candidiasis (itching, appearance of yellowish cream-colored ulcers) in the mouth and throat. Also mouth pain, hoarse voice and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medication may help. Your doctor may prescribe antifungal medication (for the treatment of fungal infections) for the treatment of candidiasis.
• Pain, inflammation in the joints and muscle pain.
• Muscle cramps.

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

• Cardenales and fractures.
• Swelling of the sinuses (sensation of tension or congestion in the nose, cheeks and behind the eyes, sometimes with a pulsating pain).
• Reduction of potassium levels in the blood (you may feel irregular heartbeats, muscle weakness, cramps).

Rare (can affect up to 1 in 100 people))

• Increased blood sugar levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment as needed.
• Cataracts (opacity of the lens of the eye).
• Very fast heart rate (tachycardia).
• You may feel tremors and a very fast or irregular heart rate (palpitations). These side effects are usually harmless and decrease when treatment continues.
• Chest pain.
• Feeling anxious (mainly occurs in children).
• Sleep disturbances.
• Skin rash.
• Allergic rash on the skin.

Rare (can affect up to 1 in 10,000 people)

• Difficulty breathing (or wheezing) that worsens immediately after using Seretide.If this happens, stop using Seretide. Use your rescue inhaler for quick action to improve your breathing and inform 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. The effects include:
• Delayed growth in children and adolescents.
• Decreased bone mineral density.
• Glaucoma.
• Weight gain.
• Round face (moon-shaped) (Cushing's syndrome).

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

• Changes in behavior, such as hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeats or an extra heartbeat (arrhythmias). Consult your doctor, but do not stop taking Seretide unless your doctor tells you to.
• Infection caused by fungi in the esophagus (throat), which can cause difficulty swallowing.

Unknown: the frequency cannot be estimated from available data

• Depression or aggression. It is more likely that these effects will appear in children.
• Blurred vision.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Seretide after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so,you will help protect the environment.

Composition of Seretide

• Each pre-dispensed dose contains 50 micrograms of salmeterol (as xinafoate of salmeterol) and 250 micrograms of fluticasone propionate.
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the product and contents of the package

Seretide Accuhaler contains a strip of alveoli. The alveoli protect the inhalation powder from atmospheric effects.

Each dose is pre-dispensed.

The devices are found in packages of:

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer responsible:

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 medicine is authorized in the member states of the European Economic Area with the following names:

AustriaSeretide Diskus

BelgiumSeretide Diskus

CroatiaSeretide Diskus

CyprusSeretide Diskus

Czech RepublicSeretide Diskus

DenmarkSeretide

EstoniaSeretide Diskus

FinlandSeretide Diskus

FranceSeretide Diskus

Germanyatmadisc Diskus

GreeceSeretide Diskus

HungarySeretide Diskus

IcelandSeretide

IrelandSeretide Diskus

ItalySeretide Diskus

LuxembourgSeretide Diskus

MaltaSeretide Diskus

NetherlandsSeretide Diskus

PortugalSeretaide Diskus

RomaniaSeretide Diskus

SlovakiaSeretide Diskus

SpainSeretide Accuhaler

SwedenSeretide Diskus

Last review date of this leaflet:July 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/