50 micrograms / 100 micrograms / dose, 50 micrograms / 250 micrograms / dose, 50 micrograms / 500 micrograms / dose of inhalation powder , divided dose
of salmeterol / fluticasone propionate
What Salmex is and what it is used for
Salmex contains two medicines, salmeterol and fluticasone propionate:
- 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). Salmex 50 micrograms / 500 micrograms per dose reduce the number of worsening periods of COPD.
Salmex must be taken regularly every day according to the doctor’s instructions for it to work in the best way and give control of your asthma or COPD.
Salmex prevents breathing problems and wheezing. However, Salmex 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 “if needed” inhaler with you.
Salmeterol and fluticasone propionate contained in Salmex 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.
What you need to know before you use Salmex
Do not take Salmex:
if you are allergic to salmeterol, fluticasone propionate, or the other ingredient lactose monohydrate.
Warnings and cautions
Talk to your doctor before using Salmex if you have:
- Cardiovascular disease, including irregular or rapid heartbeat
- Increased thyroid function ( hyperthyroidism )
- High blood pressure
- Diabetes (as Salmex may increase blood sugar)
- Decreased potassium content in the blood
- or have had tuberculosis (TB) or other lungs infection.
Contact a doctor if you experience blurred vision or other visual disturbances.
Other medicines and Salmex
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 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 Salmex 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 Salmex:
- β-blockers (eg atenolol, propranolol, and sotalol). β-blockers are most commonly used to treat high blood pressure or other heart conditions
- Medicines used to treat infections (eg ketoconazole, itraconazole, and erythromycin) include certain medicines used to treat HIV (eg ritonavir, medicines containing cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects with Salmex, including irregular heartbeat, or aggravate the side effects. 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
Salmex is 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.
Salmex contains lactose
Salmex contains approximately 13.5 mg of lactose monohydrate per dose. This amount normally does not cause any problems for lactose-intolerant people. The excipient lactose monohydrate contains small amounts of milk protein, which may cause allergic reactions.
How to use Salmex
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Use Salmex every day until your doctor advises you to stop. Do not use more than the recommended dose. Ask your doctor or pharmacist if you are unsure.
- Do not stop taking Salmex or reduce the dose of Salmex without talking to a doctor first.
- Salmex should be inhaled through the mouth into the lungs.
For asthma:
Adults and young people from 12 years
- Salmex 50 micrograms / 100 micrograms / dose 1 inhalation twice daily
- Salmex 50 micrograms / 250 micrograms / dose 1 inhalation twice daily
- Salmex 50 micrograms / 500 micrograms / dose 1 inhalation twice daily
Children from 4 years and up to 12 years
- Salmex 50 micrograms / 100 micrograms / dose 1 inhalation twice daily
- Salmex is not recommended for children under 4 years of age.
For adults with chronic obstructive pulmonary disease (COPD)
- Salmex 50 micrograms / 500 micrograms / dose 1 inhalation twice daily
If the symptoms are well controlled when you take Salmex twice a day, your doctor may reduce the dose to 1 inhalation once a day. Dose one can be changed to:
- 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 Salmex 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 Salmex 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.
Instructions for use
- Your doctor, nurse, or pharmacist should show you how to use the inhaler. From time to time, they should also check how you use it. It is important that Salmex is used correctly and as prescribed so that you can have the intended effect on your asthma or COPD.
- The Salmex inhaler contains blisters containing salmeterol/fluticasone propionate as powder.
- A dose counter on the top of the Salmex inhaler shows how many doses you have left. The dose counter counts down to 0.
- Numbers 5 to 0 are marked with a black dot to warn that only a few doses are left. When the dose counter shows 0, the inhaler is empty.
How to use the inhaler
1. To open the Salmex inhaler, hold it as shown. Move the thumb grip in the direction of the arrow as far as it will go – a click will be heard. A small hole in the nozzle has now been opened. See picture 1.
2. Hold the Salmex inhaler with the mouthpiece facing you. You can hold it in either the right or left hand. Move the feed lever away from you, as far as it will go – a click will be heard. The powder dose is now ready to be inhaled from the mouthpiece. See picture 2.
Each time the lever is pulled out, a powder dose is opened that is ready to be inhaled. Do not play with the feed lever as this will open the powder doses and waste medicine.
3. Keep the Salmex inhaler away from your mouth. Exhale as deeply as you feel comfortable. Never exhale through the inhaler.
4. Then bring the Salmex inhaler to your mouth and close your lips around the mouthpiece. Inhale steadily and deeply through the inhaler n, not through the nose. See picture 3.
Remove the Salmex inhaler from your mouth.
Hold your breath for about 10 seconds or as long as it feels comfortable. Exhale slowly.
5. The risk of fungal infection and hoarseness is reduced if you rinse your mouth with water and spit it out and/or brush your teeth after each inhalation.
6. Close the Salmex inhaler by moving the thumb grip towards you as far as it will go. A click is heard when the inhaler is closed. The feed lever has now automatically returned to its original position. See picture 4.
Your Salmex inhaler is now ready to use again.
As with any inhaler, caregivers should ensure that children prescribed Salmex use the correct inhalation technique, as described above.
Cleaning your inhaler
Wipe the nozzle on Salmex with a dry paper towel.
If you use more Salmex 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, headaches, and joint, and muscle aches.
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 Salmex may reduce cortisone formation in the adrenal glands.
If you forget to use Salmex
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you stop using Salmex
You must take Salmex daily as directed until your doctor tells you to stop. Do not suddenly stop taking Salmex or reduce your dose as this may worsen your symptoms.
In addition, if you suddenly stop taking Salmex or reduce the dose of one of Salmex, 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 (such as 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, nurse, or pharmacist.
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 Salmex. You may experience wheezing and coughing 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 Salmex if you notice any of this or if it happens suddenly after you take Salmex. Allergic reactions are less common (affect less than 1 in 100 people).
Pneumonia in COPD patients (common side effect )
Tell your doctor if you have any of the following symptoms while taking Salmex as they may be symptoms of pneumonia:
• fever or chills
• increased mucus production, changed the color of the mucus
• increased cough or increased difficulty breathing
Other side effects are listed below:
Very common (may affect more than 1 user in 10):
- Headache – usually gets better after a certain period of use
- More cold spells 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 your medicine. To treat ‘cod’ ( Candida ), your doctor may prescribe medicines for fungal infections
- Painful, swollen joints and muscle aches
- Muscle cramps.
The following 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 Salmex. If this happens: Stop taking Salmex. Use the inhaler with the fast-acting bronchodilator medicine and contact a doctor immediately.
- Salmex 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 Rounder (moon-shaped) 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 (occurs mainly in children)
- Irregular heartbeat or extra heartbeat ( arrhythmia ). Tell your doctor but do not stop taking Salmex 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 Salmex
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 label and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package. Moisture sensitive.
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.
Contents of the packaging and other information
Content declaration
- The active substances are salmeterol and fluticasone propionate.
- Each inhalation provides a given dose (the dose leaving the mouthpiece) of 45 micrograms of salmeterol (as salmeterol xinafoate) and 93, 233, or 465 micrograms of fluticasone propionate. This corresponds to a divided dose of 50 micrograms salmeterol (as salmeterol xinafoate) and 100, 250, or 500 micrograms fluticasone propionate.
- The other ingredient is lactose monohydrate (which contains milk proteins).
What the medicine looks like and the contents of the pack
- Each dose is a divided dose
- The inhaler is packed in cartons containing:1 x 60 dos er 2 x 60 dos er3 x 60 dos er10 x 60 dos er
Molded plastic inhaler containing a foil strip with 60 regularly placed blisters.
Marketing Authorization Holder and Manufacturer
Manufacturer:
Celon Pharma SA
Marymoncka 15
05-152 Kazun Nowy
Poland