80 micrograms / 4.5 micrograms / inhalation, inhalation powder 
budesonide / formoterol fumarate dihydrate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Shake click inhale
Bufomix QR code

Scan the QR code or go to  to see instructions on how to use Easyhaler.

– Save this information, you may need to read it again.

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

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bufomix Easyhaler 80 micrograms / 4.5 micrograms / inhalation is and what it is used for 
2. What you need to know before you use Bufomix Easyhaler 
3. How to use Bufomix Easyhaler 
4. Possible side effects 
5. How to store Bufomix Easyhaler 
6. Contents of the packaging and other information 

What Bufomix Easyhaler 80 micrograms / 4.5 micrograms / inhalation is and what it is used for

Bufomix Easyhaler is an inhaler used to treat asthma in adults, adolescents and children from 6 years of age. It contains two different drugs: budesonide and formoterol fumarate dihydrate.

  • Budesonide belongs to a group of medicines called “corticosteroids”. It works by reducing and preventing swelling and inflammation in the lungs.
  • Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta2-adrenoreceptor agonists’ or ‘tracheal dilators’. It works by getting the muscles in your airways to relax, which helps you breathe easier.

This medicine is not suitable for patients with severe asthma. It can be prescribed for asthma in two different ways.

a) Some people are prescribed two asthma inhalers: Bufomix Easyhaler and a separate seizure inhaler.

  • They use Bufomix Easyhaler every day, which helps prevent the onset of asthma symptoms.
  • They use their seizure machine when they get asthma symptoms to make it easier to breathe again.

b) Some people are prescribed Bufomix Easyhaler as their only asthma inhaler.

  • They use Bufomix Easyhaler every day, which helps prevent the onset of asthma symptoms.
  • They also use Bufomix Easyhaler when they need extra dose to treat asthma symptoms and make it easier to breathe again. They do not need a separate inhaler for this.

Budesonide / formoterol fumarate dihydrate contained in Bufomix Easyhaler may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Bufomix Easyhaler

Do not use Bufomix Easyhaler

  • if you are allergic to budesonide, formoterol or any of the other ingredients of this medicine (listed in section 6), in this case lactose (which contains small amounts of milk protein).

Warnings and cautions

Talk to your doctor or pharmacist before taking Bufomix Easyhaler if you:

  • have diabetes
  • have a lung infection
  • have high blood pressure or if you have ever had heart problems (including irregular heartbeat, very
  • fast pulse, narrowing of the artery engines, or heart failure )
  • have problems with the thyroid gland or with the adrenal glands
  • have low levels of potassium in the blood
  • have severe liver problems.

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

Rinse mouth after inhaling your dose to avoid fungal infection in the mouth.

Other medicines and Bufomix Easyhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Bufomix Easyhaler and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines:

  • Beta-blockers (such as atenolol and propranolol for high blood pressure ), including eye drops (such as timolol against glaucoma ).
  • Medicines for fast or irregular heartbeat (such as quinidine ).
  • Drugs such as digoxin are often used for heart failure.
  • Diuretics, also known as “diuretic tablets” (such as furosemide ). These are used for high blood pressure.
  • Steroids are taken by mouth ( cortisone such as prednisolone ).
  • Xanthines (such as theophylline or aminophylline). These are often used to treat asthma.
  • Other bronchodilators (such as salbutamol ).
  • Tricyclic antidepressant drugs (such as amitriptyline) and the antidepressant drug nefazodone.
  • Phenothiazines (such as chlorpromazine and prochlorperazine).
  • Medicines for infection (such as ketoconazole , itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
  • Medicines for Parkinson’s disease (such as levodopa ).
  • Medicines for thyroid problems (such as levothyroxine).

If any of the above apply to you, or if you have any further questions, ask your doctor or pharmacist before using Bufomix Easyhaler.

If you will need anesthesia in connection with an operation or a dental procedure, tell your doctor or pharmacist.

Pregnancy and breastfeeding

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • Do not use Bufomix Easyhaler unless your doctor advises you to do so.
  • If you become pregnant while taking Bufomix Easyhaler, do not stop using Bufomix Easyhaler but contact your doctor immediately.

Driving and using machines

Bufomix Easyhaler has no or negligible effect on your ability to drive or use tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Bufomix Easyhaler contains lactose which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.

The excipient lactose contains small amounts of milk protein which may cause allergic reactions.

3. How to use Bufomix Easyhaler

  • Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
  • It is important to use Bufomix Easyhaler every day, even if you do not have any symptoms of asthma at that time .
  • Your doctor will check your asthma symptoms regularly.

If you have been taking steroid tablets ( cortisone ) for asthma, your doctor will reduce the number of tablets you should take when you start using Bufomix Easyhaler. If you have been taking steroid tablets for a long time, your doctor may want to take blood samples from time to time. As you reduce the number of tablets, you may generally feel worse even if your chest symptoms improve. You may experience symptoms such as nasal congestion or runny nose, weakness, joint or

muscle pain or rash ( eczema ). If any of the symptoms become bothersome or if you experience symptoms such as headache, fatigue, nausea or vomiting, contact your doctor immediately. You may need to change medication if you get symptoms of allergy or arthritis ( arthritis ). Contact your doctor if you are worried about continuing to use Bufomix Easyhaler.

Your doctor may consider adding steroid tablets ( cortisone ) to your regular treatment during stress

periods (for example, if you have a respiratory infection or before an operation).

Important information about your asthma symptoms

If you feel short of breath or wheezing while using Bufomix Easyhaler, you should continue to use Bufomix Easyhaler, but consult a doctor as soon as possible as you may need further treatment.

Contact a doctor immediately if:

  • your breathing deteriorates or if you often wake up at night with asthma
  • you begin to feel pressure over your chest in the morning or if the pressure over your chest lasts longer than usual.

These signs may indicate that your asthma is not being adequately controlled and you may need immediate or additional treatment.

ASTHMA

Bufomix Easyhaler 80 micrograms / 4.5 micrograms/inhalation can be prescribed for asthma in two different ways. The amount of Bufomix Easyhaler to use and when to use depends on how the preparation was prescribed for you.

  1. If you have been prescribed Bufomix Easyhaler and a separate attack cooper, read the section entitled “A) Using Bufomix Easyhaler and a separate attack cooper”.
  2. If you have been prescribed Bufomix Easyhaler as your only inhaler, read the section entitled “B) Using Bufomix Easyhaler as your only asthma inhaler”.

A) Using the Bufomix Easyhaler and a separate attack copier

Use your Bufomix Easyhaler 80 micrograms / 4.5 micrograms/inhalation daily. This helps prevent the onset of asthma symptoms.

Adults (18 years and older)

  • The usual dose is 1 or 2 inhalations, twice a day.
  • Your doctor may increase this to 4 inhalations, twice a day.
  • If the symptoms are well controlled, your doctor may ask you to take the medicine once a day.

Young people (12 to 17 years)

  • The usual dose is 1 or 2 inhalations, twice a day.
  • If the symptoms are well controlled, your doctor may ask you to take the medicine once a day.

Children (6 to 11 years)

  • The usual dose is 2 inhalations, twice a day.

Bufomix Easyhaler 80 micrograms / 4.5 micrograms/inhalation is not recommended for children under 6 years of age.

Your doctor (or asthma nurse) will help you manage your asthma. They will adjust the dose of one of the drugs to the lowest dose needed to control asthma. Do not adjust dose one without talking to a doctor (or asthma nurse) first.

Use your separate seizure machine to treat asthma symptoms as they occur. Always carry your seizure (a fast-acting asthma medicine) with you so you can use it when you need it. Do not use Bufomix Easyhaler to treat your asthma attacks – use your attack superior.

B) Using Bufomix Easyhaler as your only asthma inhaler.

Only use Bufomix Easyhaler in this way if your doctor tells you to and only if you are 12 years or older.

Use your Bufomix Easyhaler every day. This helps prevent the onset of asthma symptoms. You can take:

  • 1 inhalation in the morning and 1 inhalation in the evening

or

  • 2 inhalation is in the morning

or

  • 2 inhalation you in the evening.

Also use Bufomix Easyhaler 80 micrograms / 4.5 micrograms / inhalation as a seizure suppressant to treat asthma symptoms when they occur.

  • If you get asthma symptoms, inhale once and wait a few minutes.
  • If you do not feel better, inhale again.
  • Do not take more than 6 inhalations at one and at the same time.

Always carry your Bufomix Easyhaler inhaler with you so you can use it whenever you need.

A total daily dose of more than 8 inhalations is not normally needed. However, your doctor may tell you to take up to 12 inhalations per day for a limited period.

If you regularly need 8 inhalations or more during a day, visit your doctor or nurse, they may need to change your treatment.

Do not use more than a total of 12 inhalations in one day.

If you exercise and get asthma symptoms, use Bufomix Easyhaler as described here. However, do not use Bufomix Easyhaler just before exercise to prevent asthma symptoms from occurring.

It is important that you take a dose as stated on the package label or as your doctor has informed you. Do not exceed dose one without consulting a doctor.

The most common symptoms that can occur if you use too much Bufomix Easyhaler are tremors, headaches and fast heartbeat.

If you forget to use Bufomix Easyhaler

  • If you forget to take a dose, take it as soon as you remember. However, if it is soon time for your next dose, skip the missed dose.
  • Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Instructions on how to use the inhaler can be found at the end of the leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following occur, stop using Bufomix Easyhaler and contact your doctor immediately:

  • Swelling of the face, especially around the mouth (tongue and/or throat and/or difficulty swallowing) or hives along with difficulty breathing ( angioedema ) and/or a sudden feeling of fainting. This may mean that you have an allergic reaction. This is rare, it happens to less than 1 in 1000 users.
  • Sudden, acute wheezing or shortness of breath after inhaling the medicine. If any of these symptoms occur, stop using the Bufomix Easyhaler inhaler immediately and use your seizure suppressant (fast-acting asthma medicine). Contact a doctor immediately as you may need to change your treatment. This is very rare, occurring in less than 1 in 10,000 users.

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Palpitations (you feel your heartbeat), tremors, or tremors. If these effects occur, they are usually mild and disappear as you continue to use Bufomix Easyhaler.
  • Cod (fungal infection) in the mouth. This is less likely to occur if you rinse your mouth with water after using your inhaler.
  • Slight sore throat, cough, and hoarse voice.
  • Headache.

Uncommon ( may affect up to 1 in 100 people)

  • Feeling of restlessness, nervousness, or upset.
  • Disturbed sleep.
  • Dizziness.
  • Nausea.
  • Fast heartbeat.
  • Bruises on the skin.
  • Muscle cramps.
  • Dimsyn.

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

  • Rash, itching.
  • Spasm of the trachea (a contraction of the muscles of the airways, causing wheezing). If wheezing occurs suddenly after using Bufomix Easyhaler, stop using Bufomix Easyhaler and contact a doctor immediately.
  • Low levels of potassium in the blood.
  • Uneven heart rhythm.

Very rare ( may affect up to 1 in 10,000 people)

  • Depression.
  • Behavioral changes, especially in children.
  • Chest pain or pressure over the chest (angina).
  • An increased amount of sugar ( glucose ) in the blood.
  • Taste changes, such as an unpleasant taste in the mouth.
  • Changes in blood pressure et.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body.

especially if you use high doses for a long time. The effects include:

  • Changes in bone mineral density (thinning of the skeleton).
  • Cataracts (cloudiness of the lens of the eye).
  • Cataracts (increased pressure in the eye).
  • A subdued growth rate in children and adolescents.
  • An effect on the adrenal glands (a small gland that sits next to the kidney).

The likelihood of these effects occurring is much less for inhaled corticosteroids than for cortisone tablets.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Bufomix Easyhaler

  • 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, foil bag, and label on the inhaler after EXP. The expiration date is the last day of the specified month.
  • After opening the foil bag, store at a maximum of 25 ° C and store protected from moisture. It is recommended to store Easyhaler in this case.
  • If your Bufomix Easyhaler gets damp, you will need to replace it with a new one.
  • Replace Bufomix Easyhaler 4 months after opening the foil pouch. Write down the date you opened the bag to help you remember
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 80 micrograms budesonide and 4.5 micrograms formoterol fumarate dihydrate.
  • The other ingredient is lactose monohydrate (which contains milk proteins).

What the medicine looks like and the contents of the pack

Bufomix Easyhaler 80 / 4.5 is an inhaler that contains medicines. The inhalation powder is white to yellowish in color. Each inhaler contains 60 or 120 doses and is white with a red upper.

Bufomix Easyhaler 80 / 4.5 is available in packs of 1 or 3 inhalers (s).

Not all pack sizes may be marketed.

Your package may contain a case. If you need a case, contact the marketing authorization holder (details below).

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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