Safubref

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the Easyhaler
Patient Information Leaflet

Safubref 50 micrograms/250 micrograms/dose, powder for inhalation, 50 micrograms/500 micrograms/dose, powder for inhalation

salmeterol/fluticasone propionate
Please read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Safubref is and what it is used for

Safubref contains two medicines, 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 flow in and out. The effect lasts for at least 12 hours.
• Fluticasone propionato is a corticosteroid that reduces swelling and irritation in the lungs.

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

• asthma
• chronic obstructive pulmonary disease (COPD). Safubref, at the dose of 50/500 micrograms, reduces the number of exacerbations of COPD.

You must use Safubref every day as prescribed by your doctor. This ensures that the medicine works properly to control your asthma or COPD.
Safubref helps prevent the onset of breathlessness and wheezing. However, Safubref must not be used to relieve a sudden attack of breathlessness or wheezing. In such cases, you must use a fast-acting "reliever" ("rescue") inhaler, such as salbutamol. You must always keep your fast-acting "rescue" inhaler readily available.

2. What you need to know before using Safubref

Do not take Safubref

• if you are allergic to salmeterol, fluticasone propionate, or to any of the other ingredients of this medicine, lactose (which contains small amounts of milk proteins).

Warnings and precautions
Talk to your doctor before using Safubref if you suffer from:

• Heart disease, including irregular or rapid heartbeat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Safubref may increase blood sugar levels)
• Low levels of potassium in the blood
• Active or past tuberculosis (TB), or if you have other lung infections

Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Safubref
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes other asthma medicines or any other medicines obtained without prescription. Safubref may not be suitable to take with certain other medicines.
Before using Safubref, inform your doctor if you are taking the following medicines:

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines used to treat infections (such as ketoconazole, itraconazole, and erythromycin, and some HIV medicines: ritonavir, cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may enhance the effects of Safubref and consequently increase the risk of side effects, including irregular heartbeat. Your doctor may need to monitor you closely if you are taking these medicines.
• Corticosteroids (taken orally or by injection). Recent use of these medicines may increase the risk that Safubref could impair adrenal gland function.
• Diuretics, also known as "water tablets", used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to treat asthma.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Safubref will affect your ability to drive or operate machinery.
Safubref contains lactose
Safubref contains up to 17.1 milligrams of lactose per dose. The amount of lactose contained in this medicine is generally not expected to cause problems in people with lactose intolerance. However, lactose contains small amounts of milk proteins that may cause allergic reactions.
For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Safubref

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• Use Safubref every day until your doctor tells you to stop. Do not take a higher dose than recommended.
• Do not stop treatment with Safubref or reduce the dose without first consulting your doctor.
• Safubref must be inhaled through the mouth into the lungs.

Asthma
Adults and adolescents aged 12 years and older

• Safubref 50/250 – One inhalation twice daily
• Safubref 50/500 – One inhalation twice daily

Children under 12 years of age

• Safubref is not recommended for children under 12 years of age

Adults with Chronic Obstructive Pulmonary Disease (COPD)

• Safubref 50/500 – One inhalation twice daily

Symptoms may be well controlled by using Safubref twice daily. In such cases, your doctor may
decide to reduce the dose to once daily. The dose may be adjusted as follows:

• once at night – if you have nighttime symptoms
• once in the morning – if you have daytime symptoms

It is very important to follow your doctor's instructions regarding how many inhalations and how often to take the medicine.

If you are taking Safubref for asthma, your doctor will regularly monitor your symptoms.
If your asthma or breathing worsens, inform your doctor immediately. You may experience increased wheezing, more frequent chest tightness, or find you need to use your rapid-acting "reliever" medicine more often. If any of these occur, continue taking Safubref, but do not increase the number of doses. Your condition may be worsening and you could become seriously ill. Contact your doctor immediately, as you may need additional treatment.

If you use more Safubref than you should

It is important to use the inhaler as prescribed. If you accidentally take more doses than recommended, contact your doctor or pharmacist. You may experience a faster than normal heartbeat and feel weak. Dizziness, headache, muscle weakness, and joint pain may also occur.

If you have used too many doses of Safubref for a prolonged period, consult your doctor or pharmacist. Excessive use of Safubref may reduce the amount of steroid hormones produced by the adrenal glands.

If you forget to use Safubref

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

If you stop using Safubref

It is very important to take Safubref every day as prescribed. Continue taking it until your doctor tells you to stop. Do not stop treatment or suddenly reduce the dose of Safubref. Otherwise, breathing problems may worsen.

Additionally, if you suddenly stop treatment with Safubref or reduce the dose abruptly, adrenal problems (adrenal insufficiency) may occur (very rarely), which can sometimes cause unwanted effects.

These unwanted effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, nausea
• Vomiting and diarrhoea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures (fits)

If your body is under stress, such as during fever, trauma (e.g. a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the above unwanted effects may occur.

If you experience any unwanted effect, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (such as prednisolone).

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.
Instructions on how to use the inhaler are at the end of this leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To reduce the likelihood of side effects occurring, your doctor will prescribe the lowest dose of Safubref that is effective in controlling your asthma or COPD.

Allergic reactions: breathing may worsen immediately after using Safubref.
You may experience pronounced wheezing, coughing, or shortness of breath. You may also develop itching, skin rash (urticaria), or swelling (usually of the face, lips, tongue, or throat). Additionally, your heartbeat may suddenly become very rapid, and you may feel faint, dizzy (possibly with collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Safubref, stop using Safubref immediately and contact your doctor without delay. Allergic reactions to Safubref are not common (may affect up to 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (common side effect)
Contact your doctor if, during treatment with Safubref, you experience any of the following symptoms, as they may indicate a lung infection:

• fever or chills
• increased mucus production or change in mucus colour
• worsening cough or increased difficulty breathing.

Other side effects are listed below:

Very common (may affect more than 1 in 10 people)
 Headache – usually improves with continued treatment.
 In patients with COPD, an increased incidence of colds has been reported.

Common (may affect up to 1 in 10 people)
 Oral thrush (yellow-cream coloured, raised plaque-like lesions) in the mouth and throat. Also, tongue irritation, hoarseness, and throat irritation. It may be helpful to rinse your mouth with water and spit it out immediately and/or brush your teeth after each dose of the medicine. Your doctor may prescribe an antifungal medicine to treat thrush.
 Joint pain and swelling, and muscle pain.
 Muscle cramps.

The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD):
 Bruising and fractures.
 Sinusitis (a feeling of pressure or swelling in the nose, cheeks, and behind the eyes, sometimes with throbbing pain).

• Decreased potassium levels in the blood (may cause irregular heartbeat, muscle weakness, cramps).

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring may be required and your usual diabetes treatment may need adjustment.
• Cataract (clouding of the eye's lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these effects are usually harmless and tend to decrease with continued treatment.
• Chest pain.
• Feeling of anxiety (this effect occurs particularly in children).
• Sleep disturbances.
• Allergic skin rash.

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

• Difficulty breathing or worsening of wheezing immediately after using Safubref. In such cases, stop using the Safubref inhaler, use your fast-acting "rescue" inhaler to help you breathe better, and contact your doctor immediately.
• Safubref may alter the normal production of steroid hormones in the body, particularly if high doses have been taken for prolonged periods. Effects may include:
• Growth retardation in children and adolescents
• Thinning of the bones
• Glaucoma
• Weight gain
• Rounded, moon-shaped face (Cushing's syndrome)
  Your doctor will regularly monitor for any of these side effects and ensure you receive the lowest effective dose of Safubref needed to control your asthma.
• Behavioural changes such as unusual hyperactivity and irritability (these effects occur particularly in children).
• Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop treatment with Safubref unless instructed by your doctor.
• Fungal infection of the oesophagus (the tube through which food passes), which may cause difficulty swallowing.

Frequency not known (cannot be estimated from available data), but may also occur:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Safubref

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, aluminium pouch and label of the inhaler after Exp. The expiry date refers to the last day of that month.
• Replace Safubref (50/250) after 1 month or Safubref (50/500) after 2 months from opening the aluminium pouch. Note the date on which you opened the pouch to help you remember.
• After opening the aluminium pouch, do not store at temperatures above 25°C and protect from moisture. Keep the Easyhaler closed in its protective cover.
• If Safubref gets wet, it must be replaced with a new one.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Safubref contains

• Each dose contains salmeterol xinafoate equivalent to 50 micrograms of salmeterol and 250 or 500 micrograms of fluticasone propionate.
• The other component is lactose monohydrate (which contains milk proteins).

Description of the appearance of Safubref and contents of the pack
Safubref is an inhaler containing the medicine. The inhalation powder is white. Each inhaler
contains 60 doses and has a white body with a purple top.
Safubref is available in packs of 1, 2 or 3 inhalers.
Not all pack sizes may be marketed.
The pack may contain a protective cover. If a protective cover is required,
please contact the marketing authorization holder (details provided below).
Marketing Authorization Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Exclusive distributor for sale
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 20143 Milano
Detailed and up-to-date information on this product is available by scanning this
QR code (also included on the box and inhaler label) with a smartphone. The same
information is also available at the following URL: www.oeh.fi/sfia
QR code URL: www.oeh.fi/sfia
How to use the Easyhaler inhaler
Information about Easyhaler
Safubref may be different from the inhalers you have used before. Therefore, it is very important that
you use it correctly, as incorrect use may result in you not receiving the correct amount of medicine.
This could make you feel unwell or may mean that your asthma or COPD is not properly treated.
Your doctor, nurse or pharmacist will show you how to use the inhaler correctly.
Make sure you understand the correct way to use the inhaler. If in doubt, contact your doctor,
nurse or pharmacist. As with all inhalers, healthcare professionals must ensure that
children prescribed Safubref use the correct inhalation technique as described below.
Instructional videos are also available at www.oeh.fi/sfia
First use of the Easyhaler

CORRECT USE

Step 1: SHAKE • Remove the mouthpiece cover • Shake the inhaler 3 to 5 times in an upright position	SHAKE x 3-5	Important points to remember  It is important to keep the inhaler in an upright position  If you accidentally click while shaking the inhaler, clear the powder from the mouthpiece as shown below
Step 2: PRESS  Continue holding the inhaler upright between your index finger and thumb  Press down until you feel a click and allow it to click again. This releases one dose  Press down only once	PRESS x 1	Important points to remember  The inhaler will not click if the mouthpiece cover is still in place  Press down only once  If you accidentally press more than once, clear the powder from the mouthpiece as shown below  Press to release the dose before inhaling; do not press and inhale at the same time  Keep the inhaler in an upright position while pressing and while inhaling the dose. If you turn it upside down, the powder may fall out before being inhaled.
Step 3: INHALE  Continue holding the inhaler in an upright position  Breathe out normally  Place the mouthpiece in your mouth between your teeth and close your lips tightly around it  Breathe in quickly and deeply  Remove the inhaler from your mouth, hold your breath for at least 5 seconds, then breathe out normally	INHALE	Important points to remember  Make sure the entire mouthpiece is properly placed in your mouth so that the medicine reaches your lungs  Ensure your lips are tightly sealed around the mouthpiece  Do not breathe out into the inhaler. This is important: it could clog the inhaler. If you do breathe out into the inhaler, clear the powder from the mouthpiece as shown below

After using the inhaler:

• Replace the mouthpiece cover over the mouthpiece. This prevents the inhaler from being accidentally activated.
• After taking the dose, rinse your mouth with water, spit it out, and/or brush your teeth. This may help prevent developing oral thrush and hoarseness.

How to clear powder from the mouthpiece If you have pressed the inhaler accidentally, pressed it more than once, or breathed out into it, clear the mouthpiece. Tap the mouthpiece on the table or your palm to remove the powder. Then restart with the steps Shake-Press-Inhale.

Cleaning the Easyhaler
Keep the inhaler dry and clean. If necessary, clean the mouthpiece of the inhaler with a dry cloth or dry tissue. Do not use water: the powder in the Easyhaler is sensitive to moisture.

Using the Easyhaler with a protective cover You may use a protective cover with the inhaler. This helps improve the product's lifespan. When placing the inhaler into the protective cover for the first time, ensure that the mouthpiece cover is in place on the inhaler, as this prevents accidental actuation of the inhaler. You can use the inhaler without removing it from the protective cover. Follow the same instructions as above: 1. Shake – 2. Press – 3. Inhale. Remember to:  Hold the inhaler upright when pressing  Close the mouthpiece cover after taking the dose, as this prevents accidental actuation of the inhaler.
When to get a new Easyhaler device The dose counter shows how many doses remain. The dose counter advances after every five actuations. When the dose counter begins to turn red, 20 doses remain. If you do not already have a new Easyhaler, contact your doctor for a new prescription. When the dose counter reaches zero (0), the Easyhaler must be replaced. If you are using the protective case, store and place the new inhaler in it.

Remember

• 1. Shake - 2. Press - 3. Inhale.
• After taking the dose, rinse your mouth with water, spit it out, and/or brush your teeth.
• Do not wet the inhaler; protect it from moisture.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.