SERETIDE ACCUHALER 50 micrograms/250 micrograms INHALATION, POWDER FOR INHALATION

2. What you need to know before you use Seretide

Do not use Seretide

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

Warnings and precautions

Talk to your doctor before starting treatment if you have:

• Heart problems, including a fast 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) now or in the past, or other lung infections.

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

Other medicines and Seretide

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those for asthma or those bought without a prescription. The reason is that, in some cases, Seretide should not be taken with other medicines.

Tell your doctor if you are taking any of the following medicines before starting to use 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 side 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 taken these medicines recently, you may be at increased risk of this medicine affecting your adrenal gland.
• Diuretics, also known as water pills, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthines, often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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 per dose. The amount of lactose in this medicine normally does not cause problems in people with lactose intolerance. It may cause allergic reactions in patients with cow's milk protein allergy. If your doctor has told you that you have an intolerance to some sugars, consult them before using this medicine.

3. How to use Seretide

Follow the instructions for administration of this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask 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 you are unsure, ask your doctor or pharmacist.
• Do not stop taking Seretide or reduce your dose without talking to your doctor first.
• Seretide should be inhaled through the mouth into the lungs.
• You may not be able to taste or feel the powder in 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 of age

• 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 this is the case, your doctor may decide to reduce your dose to once a day. The dose may change to:

• once at night if you have night-timesymptoms,
• once in the morning if you have day-timesymptoms.

It is very important that you follow your doctor's instructions about how many applications and how often you should take your medicine.

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

If your asthma gets worse or you have more difficulty breathing, see your doctor immediately. You may notice more wheezing or shortness of breath more often, or you may need to use your quick-acting "rescue" medication more frequently. If any of these things happen, you should continue to use Seretide, but do not increase the number of applications. Your respiratory disease may worsen and become severe. 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 check how you use it from time to time. Not using Seretide Accuhaler correctly or as prescribed may result in your asthma or COPD not improving as it should.
• This Accuhaler contains blisters that contain Seretide powder.
• There is a dose counter on the top of the Accuhaler that shows how many doses are left. It counts down to 0. The numbers from 5 to 0 will appear in red to warn you that there are few doses left. Once the counter reads 0, your inhaler is empty.

Using your inhaler

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

1. Hold the device with the mouthpiece towards you. You can hold it with either your right or left hand. Slide the lever away from you. You will hear a "click". This will place the dose of medicine in the mouthpiece.

Each time the lever is pulled back, a blister is opened and the powder is prepared for inhalation. Do not play with the lever, as blisters will open and medication will be wasted.

1. Hold the Accuhaler away from your mouth. Breathe out as much as you can. Do not breathe into the Accuhaler.

1. Put the mouthpiece in your mouth; take a slow, steady breath in through the Accuhaler, not through your nose.

Take the Accuhaler out of your mouth.

Hold your breath for about 10 seconds or as long as you comfortably can.

Breathe out slowly.

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

1. To close the Accuhaler, slide the lever back towards you 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 to use again.

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

Cleaning your inhaler

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

If you use more Seretide than you should

It is very important to use the inhaler exactly as you have been told. If you accidentally take a higher dose than recommended, talk to your doctor or pharmacist. You may notice that your heart beats faster than normal and you feel shaky. You may also feel dizzy, have a headache, weakness, and pain in the joints.

If you have used high doses for long periods of time, you should ask your doctor or pharmacist for advice. This is because high levels 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, phone: 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Seretide

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

If you stop using Seretide

It is very important that you use Seretide every day as you have been told. Keep taking it until your doctor tells you to stop. Do not stop taking Seretide suddenly.This could make your breathing worse.

Also, if you stop taking Seretide suddenly or reduce your dose, you may (very rarely) get problems with your adrenal gland (adrenal insufficiency), which can sometimes cause side effects.

These side effects can include any of the following:

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

When your body is under stress, such as with fever, injury (e.g., car accident), infection, or surgery, adrenal insufficiency can worsen and you may get any of the above side effects.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe you an additional dose of corticosteroids in tablets 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 all people suffer from them. To reduce the appearance 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 immediatelyafter using Seretide. You may suffer from wheezing and coughing or shortness of breath. You may also notice itching, rash (hives) and swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel like you are losing consciousness, and feel dizzy (which can lead to collapse or loss of consciousness). If you experience any of these effects or ifthey 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 adverse effect)

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

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

The following are other adverse effects:

Very common (may affect more than 1 in 10 people)

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

Common(may affect up to 1 in 10 people)

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

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

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

Uncommon(may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetic treatment if necessary.
• Cataracts (opacity of the eye lens).
• Very fast heart rate (tachycardia).
• Feeling tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and decrease when treatment is continued.
• Chest pain.
• Feeling of anxiety (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 happens, stop using Seretide.Use your rapid-acting "rescue" inhaler 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. The effects include:
• Delayed growth in children and adolescents.
• Decreased bone mineral density.
• Glaucoma.
• Weight gain.
• Rounded face (moon face) (Cushing's syndrome).

Your doctor will regularly monitor any of these adverse 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 extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Seretide unless your doctor tells you to do so.
• Fungal infection in the esophagus (throat), which can 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the label and on the carton after CAD. The expiration date is the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Seretide Composition

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

Product Appearance and Package Contents

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

Each dose is pre-dispensed.

The devices are available 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 marketed.

Marketing Authorization Holder and Manufacturer

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:

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 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 last revision of this leaflet:July 2020

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