SAFUBREF 50 MICROGRAMS/250 MICROGRAMS Inhalation powder

Зміст інструкції

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

QR code at the URL: www.oeh.fi/sfia
Scan this code or visit www.oeh.fi/sfia to see the instructions on how to use
the Easyhaler
Safubref 50 micrograms/250 micrograms/dose, powder for inhalation
Safubref 50 micrograms/500 micrograms/dose, powder for inhalation
salmeterol/fluticasone propionate

Read this leaflet carefully before you start to take this medicine because 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 to keep the airways in the lungs open. This makes it easier for air to enter and leave. The 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 help prevent breathing problems such as:

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

You must use Safubref every day as prescribed by your doctor. This ensures that the medicine works
correctly to control asthma or COPD.
Safubref helps to prevent shortness of breath and wheezing. However, Safubref should not
be used to relieve a sudden attack of shortness of breath or wheezing. In
this case you should use a “reliever” (“emergency”) fast-acting inhaler, such as
salbutamol. You should always have your fast-acting “emergency” 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 any other ingredient of this medicine, which is lactose (which contains small amounts of milk proteins).

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

• A heart condition, including irregular or fast heartbeat
• Hyperthyroidism (overactive thyroid gland)
• High blood pressure
• Diabetes mellitus (Safubref can increase blood sugar levels)
• Low levels of potassium in the blood
• Tuberculosis (TB) currently or in the past, 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 medicine. This includes other medicines for asthma or other medicines obtained
without a prescription. Safubref may not be suitable to be taken with certain other medicines.
Before using Safubref, tell 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 medicines for HIV: ritonavir, cobicistat). Some of these medicines can increase the amount of fluticasone propionate or salmeterol in the body. This can increase the effects of Safubref and consequently can increase the risk of side effects, including irregular heartbeat. Your doctor may want to monitor you carefully if you take these medicines.
• Corticosteroids (by mouth or by injection). Recent use of these medicines can increase the risk that Safubref will impair the adrenal glands.
• 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, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice 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 in each dose. The amount of lactose contained in
this medicine usually does not cause problems in people who are lactose intolerant. Lactose contains
small amounts of milk proteins that can cause allergic reactions.

For athletes
The use of the medicine without therapeutic need constitutes doping and may still
result in a positive doping test.

3. How to use Safubref

Use this medicine following the doctor's or pharmacist's instructions exactly. If you have any doubts, consult your doctor or pharmacist.

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

Asthma
Adults and adolescents 12 years of age and over

• Safubref 50/250 - One inhalation twice a day
• Safubref 50/500 - One inhalation twice a day

Children under 12 years of age

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

Adults with Chronic Obstructive Pulmonary Disease (COPD)

• Safubref 50/500 - One inhalation twice a day

Symptoms can be well controlled using Safubref twice a day. In this case, the doctor may decide to reduce the dose to once a day. The dose may change to:

• once at night - if you have nighttime symptoms
• once in the morning - if you have daytime symptoms. It is very important to follow the doctor's instructions on how many inhalations and how often to take the medicine.

If you are taking Safubref for asthma, the doctor will regularly check your symptoms.

If asthma or breathing worsens, inform your doctor immediately.You may feel your wheezing increase, experience a feeling of chest tightness more often, or have to use your fast-acting “rescue” medicine more frequently. If any of these occur, continue taking Safubref, but do not increase the number of doses. Your chest condition may be worsening and you may become seriously ill. Consult your doctor immediately, as you may need other therapies.

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. It is possible that your heart beats faster than usual and that you feel weak. Dizziness, headache, muscle weakness and joint pain may also occur.
If you have used too many doses of Safubref for a long time, consult your doctor or pharmacist. This is because prolonged overuse of Safubref can 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 the usual time.

If you stop taking 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 and do not suddenly reduce the dose of Safubref. Otherwise, your breathing problems may worsen.
In addition, if you suddenly stop taking Safubref or reduce the dose of Safubref, problems with the adrenal glands (adrenal insufficiency) may occur (very rarely), which sometimes cause side effects.
These side effects can include any of the following:

• Stomach pain
• Fatigue and loss of appetite, nausea
• Vomiting and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures

If your body is under stress, such as with fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can worsen and any of the above side effects may occur.
If you experience any side effect, contact your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe you additional corticosteroids in tablet form (such as prednisolone).

If you have any doubts about using this medicine, contact your doctor, pharmacist or nurse.

Instructions on how to use the inhaler are at the end of the 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 controls your asthma or COPD.

Allergic reactions: breathing may worsen immediately after using Safubref.
Wheezing, coughing or shortness of breath may occur. Itching, skin rash (urticaria) and swelling (usually of the face, lips, tongue or
throat) may also appear, or the heartbeat may suddenly become very rapid and you may feel
a sensation of fainting and dizziness (possibly with collapse or loss of consciousness). If you
experience any ofthese effects, or if they occur suddenly after using
Safubref, stop usingSafubref and inform your doctor immediately. Allergic
reactions to Safubref are uncommon (may affect up to 1 in 100 people).

Pneumonia (lung infection) in patients with COPD. (Common side effect)
Tell your doctorif you develop any of the following symptoms while using Safubref, as
they may be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• increased cough or greater 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 increase in cases of the common cold has been reported.

Common (may affect up to 1 in 10 people)
 Thrush (raised, creamy-yellow patches in the mouth and throat). Also
irritation of the tongue, hoarseness and irritation of the throat. It may be helpful to rinse your mouth
with water and spit it out immediately and/or brush your teeth after taking each dose of
the medicine. Your doctor may prescribe an anti-fungal medicine to treat thrush.
 Pain and swelling in the joints and muscle pain.
 Muscle cramps.
The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD):
 Bruising and fractures.
 Inflammation of the sinuses (a feeling of tension or fullness in the nose, cheeks and
behind the eyes, sometimes with throbbing pain).

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

Uncommon (may affect up to 1 in 100 people)

• Increased sugar (glucose) in the blood (hyperglycemia). If you have diabetes, you may need more frequent blood sugar checks and possibly an adjustment to your usual diabetes treatment.
• Cataract (clouding of the lens in the eye).
• Very fast heartbeat (tachycardia).
• Feeling unwell (tremor) and fast or irregular heartbeat (palpitations) - these effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling anxious (this effect occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

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

• Difficulty breathing or worsening wheezing immediately after usingSafubref.In this case, stop using the Safubref inhaler. Use your ‘reliever’ inhaler to breathe better and tell your doctor immediately.
• Safubref can alter the normal production of steroid hormones in the body, particularly if you have taken high doses for prolonged periods. The effects include:
• Delayed growth in children and adolescents
• Thinning of the bones
• Glaucoma
• Weight gain
• Rounded face (moon face) (Cushing's syndrome) Your doctor will regularly check for any of these side effects and ensure that you receive the lowest dose of Safubref that controls your asthma.
• Changes in behavior, such as unusual activity and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra beats (arrhythmias). Tell your doctor, but do not stop taking Safubref unless your doctor tells you to.
• Fungal infection in the esophagus (the channel through which food passes), which can cause difficulty swallowing.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the carton, the aluminium blister and the inhaler label 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 blister. Note the date you opened the blister to help you remember.
• After opening the aluminium blister do not store at a temperature 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 in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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 powder for inhalation 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 needed,
contact the marketing authorisation holder (details provided below).

Marketing authorisation 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 updated information on this product is available by scanning this
QR code (also included on the box and on the inhaler label) with a smartphone. The same
information is also available at the following URL: www.oeh.fi/sfia
QR code at the URL: www.oeh.fi/sfia

How to use the Easyhaler inhaler
Information on Easyhaler
Safubref may be different from inhalers you have used in the past. Therefore, it is very important that
you use it correctly, as incorrect use may result in not receiving the correct amount
of medicine. This may make you feel unwell or may mean that asthma and COPD are not
treated correctly.
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 you have any doubts, contact your doctor,
nurse or pharmacist. As with all inhalers, healthcare professionals should ensure that
children prescribed Safubref use the correct inhalation technique, as described
below. You can also use the instructional video available at www.oeh.fi/sfia

First use of the Easyhaler

CORRECT USE

Step 1: SHAKE a Remove the mouthpiece cover i Shake the inhaler 3 to 5 z times in a vertical position n e g A

I SHAKE x 3-5

Important points to remember It is important to keep the inhaler in a vertical position If you accidentally click while shaking the inhaler, empty the powder from the mouthpiece as shown below

Step 2: PRESS Continue to hold the inhaler in a vertical position between your index and thumb Press down until you hear a click and let it click again. This releases a dose Press down only once

PRESS x 1 l e

Important points to remember o The inhaler will not click if the mouthpiece cover is still c inserted Press down only once If you accidentally press more than once, empty 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 a vertical 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 to hold the inhaler in a vertical position Exhale normally Put the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece Inhale strongly and deeply Remove the inhaler from your mouth, holding your breath for at least 5 seconds, then exhale normally

a INHALE n a i l a t I

Important points to remember Make sure the entire mouthpiece is well inserted into your mouth, so that the medicine enters your lungs Make sure your lips close tightly around the mouthpiece Do not exhale into the inhaler. This is important: it could clog the inhaler. If you exhale into the inhaler, empty the powder from the mouthpiece, as shown below

After using the inhaler:

• Put the mouthpiece cover back on the mouthpiece. This prevents accidental activation of the inhalation.
• After taking the dose, rinse your mouth with water, spit it out and/or brush your teeth. This may help to avoid thrush and becoming hoarse.

How to empty the powder from the mouthpiece If you accidentally press the inhaler or it has been pressed more than once or if you have exhaled into it, empty the mouthpiece. Tap the mouthpiece on the table or on the palm of your hand to dislodge the powder. Then start again with the Shake-Press- Inhale steps.

a r m a c o

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

a Using the Easyhaler with a protective cover n You can use a protective cover with the inhaler. This helps to improve the product's durability. When you a first insert the inhaler into the protective cover, make sure that the mouthpiece cover is on the inhaler, i as this prevents accidental activation of the inhalation. l You can use the inhaler without removing it from the protective a cover. t Follow the same instructions as above, 1. Shake - 2. I Press - 3. Inhale. a Remember to: Keep the inhaler in a vertical position when pressing i Close the mouthpiece cover after taking the dose z as this prevents accidental activation.

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 from moisture.

If you have any further questions, ask your doctor or pharmacist.

F a r m a c o