Safumix

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Package leaflet: Information for the user

Safumix 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 using 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 Safumix is and what it is used for

Safumix contains two medicines, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open. This makes 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). Safumix, at the dose of 50/500 micrograms, reduces the number of exacerbations of COPD.

You must use Safumix every day as prescribed by your doctor. This ensures that the medicine works properly to control your asthma or COPD.
Safumix helps to prevent the occurrence of breathlessness and wheezing. However, Safumix 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 Safumix

Do not take Safumix

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

Warnings and precautions
Talk to your doctor before using Safumix if you have:

• A heart condition, including irregular or rapid heartbeat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Safumix 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 Safumix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes other asthma medications or any medicines obtained without a prescription.
Safumix may not be suitable to take together with certain other medicines.
Before using Safumix, inform your doctor if you are taking any of 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, erythromycin, and certain HIV medicines: ritonavir, cobicistat). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in your body. This could enhance the effects of Safumix 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 Safumix could impair your 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 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 which may cause allergic reactions.
For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Safumix

Use this medicine exactly as instructed by 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 or reduce the dose of Safumix without first consulting your doctor.
• Safumix must be inhaled through the mouth into the lungs.

Asthma
Adults and adolescents aged 12 years and older

• Safumix 50/250 - One inhalation twice daily
• Safumix 50/500 - One inhalation twice daily

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 daily

Symptoms may be well controlled by using Safumix twice daily. In such cases, your doctor may decide to
reduce the dose to once daily. The dose may be adjusted 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 monitor your symptoms.
If your asthma or breathing worsens, inform your doctor immediately. You may notice increased wheezing,
more frequent episodes of chest tightness, or a need to use your fast-acting “reliever” medicine more often. If any of these occur, continue taking Safumix, but do not increase the number of doses. Your respiratory condition may be worsening and you could become seriously ill. Contact your doctor immediately, as you may need additional treatment.
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. Dizziness, headache, muscle weakness, and joint pain may also occur.
If you have used too many doses of Safumix for a prolonged period, consult your doctor or pharmacist. This is because excessive use of Safumix may 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 forgotten dose. Take the next dose at your usual time.
If you stop using Safumix
It is very important to take Safumix every day as prescribed. Continue taking it until your doctor tells you to
stop. Do not stop treatment or suddenly reduce the dose of Safumix. Otherwise, breathing problems may worsen.
Additionally, if you suddenly stop treatment with Safumix or reduce the dose of Safumix, 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 unwanted effects listed above may occur.
If you experience any adverse effect, contact 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 Safumix that
is sufficient to control your asthma or COPD.
Allergic reactions: breathing may worsen immediately after using Safumix.
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), or your heartbeat may suddenly become very rapid, accompanied by dizziness, lightheadedness, fainting, or even collapse or loss of consciousness. If you experience any of these effects, or if they occur suddenly after using Safumix, stop using Safumix immediately and contact your doctor without delay. Allergic reactions to Safumix are not common (may affect up to 1 in 100 people).
Pneumonia (lung infection) in patients with COPD (common side effect)
Inform your doctor if you experience any of the following symptoms while using Safumix, as they may indicate a lung infection:

• fever or chills;
• increased mucus production or change in mucus color;
• 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 (raised, yellow-cream colored patches) in the mouth and throat. Also, irritation of the tongue, 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 the thrush.
 Joint pain and swelling, 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).

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

Uncommon (may affect up to 1 in 100 people)

• Increase in blood sugar (glucose) (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring may be needed and your usual diabetes treatment may require adjustment.
• Cataract (clouding of the eye's lens).
• Very rapid heartbeat (tachycardia).
• Feeling of discomfort (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 mainly 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 Safumix. In such a case, stop using the Safumix inhaler. Use your fast-acting "rescue" inhaler to help you breathe better and contact your doctor immediately.
• Safumix may alter the normal production of steroid hormones in the body, especially if high doses have been taken for prolonged periods. Effects include:
• Slowed growth in children and adolescents
• Thinning of bones
• Glaucoma
• Weight gain
• Rounded face (moon face) (Cushing's syndrome). Your doctor will regularly monitor for any of these side effects and ensure you receive the lowest dose of Safumix that controls your asthma effectively.
• Changes in behaviour, such as unusual hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop treatment with Safumix unless instructed by your doctor.
• Fungal infection of the esophagus (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 to occur 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 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, aluminium foil, and 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 foil. Write down the date you opened the foil to help you remember.
• After opening the aluminium foil, do not store at temperatures above 25°C and protect from moisture. 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in 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 ingredient 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 inhalation powder is white. Each inhaler contains 60 doses and
has a white body with a purple top.
Safumix is available in packs containing 1, 2 or 3 inhalers.
Not all pack sizes may be marketed.
The pack may include a protective cap. If a protective cap 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
Detailed and up-to-date information about 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/sfit
QR code

How to use the Easyhaler inhaler
Information about Easyhaler
Safumix may differ from inhalers you have used previously. 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 lead to asthma or COPD not being 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 Safumix use the correct inhalation technique, as described below. Instructional videos are also available at www.oeh.fi/sfit
First use of the Easyhaler

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

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 press while shaking the inhaler, empty the powder from the mouthpiece as shown below
Step 2: PRESS • Continue holding the inhaler in an upright position	PRESS x 1	Important points to remember  The inhaler will not release a dose if the mouthpiece cover is still in place
between 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 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 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 the mouth between the teeth and close lips tightly around the mouthpiece • Breathe in quickly and deeply • Remove the inhaler from the mouth, hold breath for at least 5 seconds, then breathe out normally	INHALE	Important points to remember  Make sure the entire mouthpiece is properly placed in the mouth so that the medicine reaches the lungs  Ensure 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, empty the powder from the mouthpiece as shown below

After using the inhaler:

• Replace the mouthpiece cover over the mouthpiece. This prevents accidental activation of the inhaler.
• 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 becoming hoarse.

How to clear the powder from the mouthpiece If you press the inhaler accidentally, press it more than once, or if you have breathed out into it, clear the mouthpiece.  Tap the mouthpiece on the table or in the palm of your hand to remove the powder.  Then start again 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 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 activation of the dose. You may 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 down  Close the mouthpiece cover after taking the dose, as this prevents accidental activation.

When to get a new Easyhaler device The dose counter shows how many doses remain. The dose counter advances after every five doses. 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.