Salflumix Easyhaler - Salmeterol / fluticasone propionate uses, dose and side effects

Salmeterol is a long-acting tracheal dilator. Tracheal dilators act on the airways in the lungs to keep them dilated and make it easier to breathe. The effect lasts for at least 12 hours.

Fluticasone propionate is a corticosteroid ( cortisone ) that reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine to prevent breathing problems in:

Asthma
Chronic obstructive pulmonary disease (COPD). Salflumix Easyhaler (50 micrograms / 500 micrograms per dose ) reduces the number of worsening periods of COPD.

Salflumix Easyhaler must be taken every day according to the doctor’s instructions for it to work in the best way and give control of your asthma or COPD.marketing

Salflumix Easyhaler prevents breathing problems and wheezing. However, Salflumix Easyhaler should not be used to relieve a sudden onset of shortness of breath or wheezing. If this happens, take a fast-acting “if needed” inhaler, such as salbutamol. You should always have your fast-acting inhaler with you.

Salmeterol and fluticasone propionate contained in Salflumix Easyhaler may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

BEFORE YOU USE SALFLUMIX EASYHALER

Do not take Salflumix Easyhaler:

if you are allergic to salmeterol, fluticasone propionate, or the ingredient lactose (which contains small amounts of milk protein).

Warnings and cautions

Talk to your doctor before using Salflumix Easyhaler if you have:

Heart disease includes rapid and irregular heartbeat
Increased thyroid function
High blood pressure
Diabetes (as Salflumix Easyhaler may increase blood sugar)
Decreased potassium content in the blood

or have had tuberculosis (TB), or other infections in your lungs.

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

Other medicines and Salflumix Easyhaler

Tell your doctor or pharmacist if you have recently taken, or might take any other medicines. This also includes asthma medications and over-the-counter medications. This is because the effect of the treatment can be affected if Salflumix Easyhaler and certain other medicines are taken at the same time.

Tell your doctor if you are taking any of the following medicines before you start using Salflumix Easyhaler:

Beta-blockers (eg atenolol, propranolol, and sotalol). Beta-blockers are most commonly used to treat high blood pressure or other heart conditions.
Medicines used to treat infections (such as ketoconazole, itraconazole, and erythromycin, and some anti-HIV medicines: ritonavir, cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in the body. This may increase the effect of Salflumix Easyhaler and thus increase the risk of side effects, including irregular heartbeat. Your doctor may want to monitor you closely if you are taking these medicines.
Cortisone (tablets or in injection ). If you have recently been treated with these drugs, it may increase the risk of affecting the function of the adrenal glands.
Diuretics, also known as diuretics, are used to treat high blood pressure.
Other bronchodilators (eg salbutamol ).
Xanthines. These are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

The effects or possible side effects of Salflumix Easyhaler are unlikely to affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Salflumix Easyhaler contains lactose

Salflumix Easyhaler contains up to 17.1 mg / dose of lactose . 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.

HOW TO USE SALFLUMIX EASYHALER

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Use Salflumix Easyhaler every day until your doctor advises you to stop. Do not use more than the recommended dose.
Do not stop taking Salflumix Easyhaler or reduce the dose of Salflumix Easyhaler without talking to your doctor first.
Salflumix Easyhaler should be inhaled through the mouth into the lungs.

For asthma:

Adults and young people from 12 years

Salflumix Easyhaler 50/250 – 1 inhalation twice daily
Salflumix Easyhaler 50/500 – 1 inhalation twice daily

Children up to 12 years

Salflumix Easyhaler is not recommended for children under 12 years of age.

For adults with chronic obstructive pulmonary disease (COPD)

Salflumix Easyhaler 50/500 – 1 inhalation twice daily

If the symptoms are well controlled when you take Salflumix Easyhaler 2 times a day, your doctor may reduce the dose to 1 inhalation once a day:

1 time in the evening – if you have problems at night.
Once in the morning – if you have problems during the day.

It is very important to follow your doctor’s instructions on how many inhalations you should take and how often.

If you use Salflumix Easyhaler for asthma, your doctor will want to monitor your symptoms regularly.

Contact a doctor immediately if your asthma or breathing worsens. If you feel that your breathing becomes more wheezing/wheezing, that the feeling of tightness in your chest increases, or that you need to take more of your fast-acting bronchodilator medication, continue to take Salflumix Easyhaler but do not increase the number of doses. Your breathing problems may worsen and you may become seriously ill. Contact your doctor as you may need additional asthma treatment.

If you use more Salflumix Easyhaler than you should

You must follow the dosing instructions. If you accidentally ingest more than the recommended dose, talk to your doctor or pharmacist. You may feel your heart beating faster than usual and shivering. You may also experience dizziness, headache, muscle weakness, and joint pain.

If you have taken larger amounts of medication for a long time or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Larger amounts of Salflumix Easyhaler may reduce cortisone formation in the adrenal glands.

If you forget to take Salflumix Easyhaler

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

If you stop taking Salflumix Easyhaler

You must take Salflumix Easyhaler every day according to the instructions. Keep taking Salflumix Easyhaler until your doctor tells you to stop. Do not suddenly stop taking Salflumix Easyhaler or reduce your dose as this may make your symptoms worse.

In addition, if you suddenly stop taking Salflumix Easyhaler or reduce the dose of one of Salflumix Easyhaler, it can very rarely lead to problems with your adrenal glands (adrenal insufficiency) and in some cases cause side effects.

The side effects may include any of the following:

Stomach pain
Fatigue and loss of appetite, malaise
Nausea and diarrhea
Weight loss
Headache and drowsiness
Low blood sugar levels
Low blood pressure and seizures (seizures).

When your body is under stress e.g. Due to fever, trauma (eg a car accident), infection, or surgery, adrenal insufficiency may get worse and you may have any of the side effects described above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these side effects from happening, your treatment may need to be supplemented with cortisone in tablet form (eg prednisolone ).

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

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

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the risk of side effects, your doctor will prescribe the lowest dose needed for you to be free of your asthma or COPD.

Allergic reactions: if you suddenly notice difficulty breathing immediately after taking Salflumix Easyhaler. The breathing becomes wheezing and you may have a cough or shortness of breath. You may also notice itching, rash ( hives ), and swelling (usually on the face, lips, tongue, or throat), or you may suddenly feel your heart beating very fast or feel weak and dizzy (which may lead to collapse or unconsciousness). Contact a doctor immediately and stop taking Salflumix Easyhaler if you notice any of this or if it happens suddenly after you take Salflumix Easyhaler. Allergic reactions are less common (may affect up to 1 in 100 people).

Pneumonia in COPD patients (common side effect )

Tell your doctor if you have any of the following symptoms while taking Salflumix Easyhaler as they may be symptoms of pneumonia:

fever or chills
increased mucus production changed color of the mucus
increased cough or increased difficulty breathing

Other side effects:

Very common (may affect more than 1 user in 10):

Headache – which is often transient and usually disappears after a few days of use
Multiple cold spells (upper respiratory tract infections) have been reported in patients with COPD.

Common (may affect up to 1 in 10 people):

Fungal infection (so-called ‘cod’, sore, yellowish, creamy spots) in the mouth and throat. Irritation of the tongue and throat and hoarseness. The risk of fungal infection is reduced if you rinse your mouth with water and spit it out immediately and/or brush your teeth after each inhalation with the medicine. To treat ‘cod’, your doctor may prescribe a medicine for fungal infections
Painful, swollen joints and muscle aches
Muscle cramps.

The following common side effects have also been reported in patients with COPD (chronic obstructive pulmonary disease ):

Bruises and broken bones
Sinusitis (a feeling of pressure or tightness in the nose, cheeks, or behind the eyes, sometimes with throbbing pain)
Decreased potassium content in the blood (which can cause irregular heartbeat, muscle weakness, and cramps).

Uncommon (may affect up to 1 in 100 people):

Elevated blood glucose levels (hyperglycemia). If you have diabetes, you may need to have more frequent blood sugar checks and possibly change your usual diabetes treatment
Cataracts (cloudy lens in the eye)
Very fast heartbeat ( tachycardia )
The feeling of shaking ( tremor ) and rapid or irregular heartbeat ( palpitation ). This is often harmless and disappears after a certain period of use
Chest pain
The feeling of anxiety (especially in children)
Difficulty sleeping
Allergic skin rash.

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

Difficulty breathing or wheezing that worsens shortly after taking Salflumix Easyhaler. If this happens: Stop taking Salflumix Easyhaler. Use the inhaler with the fast-acting bronchodilator medicine and contact a doctor immediately.
Salflumix Easyhaler can also affect the normal production of steroid hormones in the body, especially if you have been taking high doses for a long time. Effects of this can give:

– Delayed height growth in children and adolescents

– Reduced bone density

– Cataracts ( glaucoma )

– Weight gain

– Moon face (Cushing’s syndrome).

Your doctor will monitor your treatment regularly to make sure you are on the lowest dose that keeps your asthma under control to reduce the risk of these side effects.

Behavioral disorders, e.g. that you become unusually active and irritable (seen mainly in children)
Irregular heartbeat or extra heartbeat ( arrhythmia ). Tell your doctor but do not stop taking Salflumix Easyhaler until your doctor advises you to stop.
Fungal infection of the esophagus (esophagus), can cause difficulty swallowing.

Has been reported (occurs in an unknown number of users):

Depression or aggression. These side effects are more likely to occur in children.
Dimsyn

HOW TO STORE SALFLUMIX 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, sachet, or label on the inhaler after EXP. The expiration date is the last day of the specified month.
Replace Salflumix Easyhaler 1 month (50/250) or 2 months (50/500) after opening the foil pouch. Write down the date you opened the bag to help you remember.
Store below 25 ° C after opening the foil pouch and store protected from moisture. It is recommended that Easyhaler be stored in the case.
If your Salflumix Easyhaler gets damp, you will need to replace it with a new one.
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.

FURTHER INFORMATION

Content declaration

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).

What the medicine looks like and the contents of the pack

Salflumix Easyhaler is an inhaler that contains medicines. The inhalation powder is white. Each inhaler contains 60 doses and is white with a purple upper.

Salflumix Easyhaler is available in packs of 1, 2, or 3 inhaler (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

Orionvägen 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma