SAFUMIX 50 МКГ/250 МКГ Ингаляционный порошок

Содержание инструкции

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

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Scan this code or visit www.oeh.fi/sfit to see the instructions on how to use the Easyhaler
Safumix 50 micrograms/250 micrograms/dose, powder for inhalation
Safumix 50 micrograms/500 micrograms/dose, powder for inhalation
salmeterol/fluticasone propionate

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• 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 Safumix is and what it is used for
• 2. What you need to know before you use Safumix
• 3. How to use Safumix
• 4. Possible side effects
• 5. How to store Safumix
• 6. Contents of the pack and other information

1. What is Safumix and what is it used for

Safumix 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 for 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). Safumix, at a dose of 50/500 micrograms, reduces the number of COPD exacerbations

You should use Safumix every day as prescribed by your doctor. This ensures that the medicine works
correctly to control asthma or COPD.
Safumix helps to avoid the onset of shortness of breath and wheezing. However, Safumix should not be
used to relieve a sudden attack of shortness of breath or wheezing. In this case you should use a
“symptomatic” (“emergency”) fast-acting inhaler, such as salbutamol. You should always have a
fast-acting “emergency” inhaler readily available.

2. What you need to know before using Safumix

Do not take Safumix

• 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 Safumix if you suffer from:

• Heart disease, including irregular or fast heartbeat
• Hyperactivity of the thyroid gland
• High blood pressure
• Diabetes mellitus (Safumix may 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 Safumix
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.
Safumix may not be suitable to be taken with certain other medicines.
Before using Safumix, tell your doctor if you are taking the following medicines:

• Beta-blockers (such as atenolol, propranolol and sotalol). Beta-blockers are used mainly 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 may increase the amount of fluticasone propionate or salmeterol in the body. This may increase the effects of Safumix and consequently may 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 may increase the risk that Safumix 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 Safumix will affect your ability to drive or operate machinery.

Safumix contains lactose
Safumix 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 with lactose intolerance. Lactose contains small amounts of
milk proteins that may cause allergic reactions.

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

3. How to use Safumix

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

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

Asthma
Adults and adolescents 12 years of age and older

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

Children under 12 years of age

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

Adults with Chronic Obstructive Pulmonary Disease (COPD)

• Safumix 50/500 - One inhalation twice a day

Symptoms may be well controlled using Safumix twice a day. In this case, your 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 your doctor's instructions on how many inhalations and how often to take the medicine.

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

If your asthma or breathing gets worse, tell your doctor immediately.You may feel your wheezing
increase, experience a feeling of tightness in your chest more often, or need to use your
“rescue” medicine more frequently. If any of these occur, continue to take Safumix, but do not
increase the number of doses. Your chest condition may be getting worse and you may become
seriously ill. See your doctor immediately, as you may need other therapies.

If you use more Safumix 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. Your heart may beat faster than usual and you may feel weak. You may also
experience dizziness, headache, muscle weakness, and joint pain.
If you have used too many doses of Safumix for a long time, consult your doctor or pharmacist. This is because excessive use of Safumix can reduce the amount of steroid hormones produced by the adrenal glands.

If you forget to use Safumix
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 Safumix
It is very important to take Safumix every day as prescribed. Continue to take it until your doctor
tells you to stop. Do not stop treatment and do not suddenly reduce the dose of Safumix. In
otherwise, your breathing problems may worsen.
Also, if you suddenly stop taking Safumix or reduce the dose of Safumix, problems with the adrenal glands (adrenal insufficiency) may occur (very rarely) which sometimes cause
undesirable 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 (convulsions)

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 Safumix that
controls your asthma or COPD.

Allergic reactions: breathing may worsen immediately after using Safumix.
Wheezing, coughing or shortness of breath may occur. Itching, rash
(urticaria) and swelling (usually of the face, lips, tongue or throat) may also occur, or your heart rate may
suddenly become very fast and you may feel faint and dizzy
(possibly with collapse or loss of consciousness). If any of these occur, or if they
occur suddenly after using Safumix, stop using Safumix and inform
your doctor immediately. Allergic reactions to Safumix 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 Safumix, 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 colds 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 antifungal 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).

• Reduced amount of potassium in the blood (may cause 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 of wheezing immediately after using Safumix.In this case, stop using the Safumix inhaler. Use your fast-acting ‘reliever’ inhaler to breathe more easily and tell your doctor immediately.
• Safumix 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 you receive the lowest dose of Safumix that controls your asthma.
• Changes in behaviour, 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 treatment with Safumix unless your doctor tells you to.
• Fungal infection in the esophagus (the tube 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 Safumix

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, on the aluminium blister and on the inhaler label after Exp. The expiry date refers to the last day of that month.
• Replace Safumix (50/250) after 1 month or Safumix (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 humidity. Keep the Easyhaler closed in its protective cover.
• If Safumix gets wet, it must be replaced with a new one.
• Do not dispose of any medicine in wastewater 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 Safumix 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 Safumix and contents of the pack
Safumix 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.
Safumix 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
Detailed and up-to-date information on this product is available by scanning this QR code
(also included on the carton and inhaler label) with a smartphone. The same information is also available
at the following URL: www.oeh.fi/sfit
QR Code

How to use the Easyhaler inhaler
Information about Easyhaler
Safumix 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 mean you do not receive the correct amount of medicine.
This may make you feel unwell or may mean that asthma and COPD are not treated properly.
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 are unsure, contact your doctor, nurse or pharmacist.
As with all inhalers, healthcare professionals should ensure that children who are prescribed Safumix
use the correct inhalation technique, as described below. You can also use the instructional video
available at www.oeh.fi/sfit

First use of the Easyhaler

The Easyhaler is supplied in an aluminium pouch. Do not open the pouch until you are ready to use the medicine, as it helps to keep the powder dry in the inhaler. Open the pouch and mark the date, for example, on the calendar to when you are ready to start treatment. n Use the inhaler within 1 month (50/250) or 2 months (50/500) from opening the aluminium pouch.

d e l

CORRECT USE

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

a SHAKE x 3-5 t I a

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

upright between the index and thumb Press down until you hear a click and let it click again. This releases a dose Press down only once

Press down only once If you accidentally press more than o once, empty the powder from the mouthpiece, as shown below c Press to release the dose before inhaling, do not press and a inhale at the same time Keep the inhaler in an upright position while you press and m while you inhale 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 an upright 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

INHALE e d a n a i l

a Important points to remember F Make sure the entire mouthpiece is well inserted into your mouth, so that the medicine enters your l lungs Make sure your lips close tightly around the mouthpiece Do not exhale into the inhaler. This is important: it could block 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 prevent thrush and becoming hoarse.

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

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.

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 questions about using this medicine, ask your doctor or pharmacist.

Using the Easyhaler with a protective cover You can use a protective cover with the inhaler. This helps to improve the product's shelf life. When you first insert the inhaler into the protective cover, make sure the mouthpiece cover is on the inhaler, as this prevents accidental activation of the inhalation. 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: Keep the inhaler in an upright position when you press Close the mouthpiece cover after taking the dose as this prevents accidental activation of the inhalation.

d e l F a r m a

n When to get a new Easyhaler device a The dose counter shows how many doses are left. The dose counter rotates after every five actuations. When the dose counter starts to turn red, there are still 20 doses to deliver. l If you do not already have a new Easyhaler, contact your doctor for a a new prescription. When the dose counter reaches zero (0), you need to replace the Easyhaler. t If you are using the protective case, store and insert the new I inhaler into it.