Seretide Evohaler mite 25 micrograms / 50 micrograms / dose, Seretide Evohaler 25 micrograms / 125 micrograms / dose, Seretide Evohaler forte 25 micrograms / 250 micrograms / dose inhalation spray , suspension
salmeterol / fluticasone propionate
What Seretide is and what it is used for
Seretide 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 ( inflammation ) in the lungs.
Your doctor has prescribed this medicine to prevent breathing problems in asthma.
Seretide 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.
Seretide prevents shortness of breath and wheezing. However, Seretide should not be used to relieve a sudden onset of shortness of breath or wheezing. If this happens, take a fast-acting tracheal dilator “if necessary” inhaler, such as salbutamol. You should always have your fast-acting “if needed” inhaler with you.
Salmeterol and fluticasone propionate contained in Seretide 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 Seretide
Do not use Seretide
- if you are allergic (hypersensitive) to salmeterol, fluticasone propionate, or the other ingredient norfluran (HFA 134a).
Warnings and cautions
Talk to your doctor before using Seretide if you have:
- Cardiovascular disease includes rapid and irregular heartbeat
- Increased thyroid function ( hyperthyroidism )
- High blood pressure
- Diabetes (because Seretide 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 Seretide
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines for asthma and over-the-counter medicines. This is because the effect of the treatment can be affected if Seretide 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 taking Seretide:
- 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 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 Seretide, 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
The effects or possible side effects of Seretide 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.
How to use Seretide
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Use Seretide 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 Seretide or reduce the dose of Seretide without talking to your doctor first.
- Seretide should be inhaled through the mouth into the lungs.
Adults and young people from 12 years
- Seretide Evohaler mite – 2 inhalations twice daily
- Seretide Evohaler – 2 inhalations twice daily
- Seretide Evohaler forte – 2 inhalations are 2 times daily.
Children from 4 years and up to 12 years
- Seretide Evohaler mite – 2 inhalations twice daily
- Seretide is not recommended for children under 4 years of age.
If the symptoms are well controlled when you take Seretide twice a day, your doctor may reduce the dose to one to two inhalations once a day:
- 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 prescription of how many inhalations you should take and how often.
A respirator can be used to improve treatment with Seretide, especially for young children, or for those who have difficulty squeezing a spray dose and inhaling through the mouth at the same time.
If you are using Seretide 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 or 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 Seretide 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 instruct you on how to use Seretide Evohaler inhalation spray. From time to time, they should also check how you use it. It is important that Seretide Evohaler is used correctly and as prescribed so that you can have the intended effect on your asthma.
- The medicine is stored under pressure in the metal container located in the plastic inhaler with the mouthpiece.
- A dose counter on the back of the inhaler shows how many doses you have left. Each time you press down on the metal container, a dose is sprayed and the dose counter counts down a dose.
- Be careful not to drop an inhalation spray. This may cause the meter to count down your dose.
How to check inhalation spray one
How to use inhalation spray one
It is important to breathe as slowly as possible before using an inhalation spray.
Sit or stand while inhaling.
2. Remove the protective cap (shown in the first picture). Check that the nozzle is clean on the inside and outside and free of loose objects.
8. Wait approximately half a minute between each dose before repeating steps 3-7.
9. Rinse your mouth with water and spit out and/or brush your teeth. This will help you reduce the risk of getting a fungal infection and becoming hoarse.
10. Always replace the protective cap after use as dust protection. A snap is heard when the protective hood is pressed into place. If it cannot be pushed into place, check that it is facing in the right direction and try again. You do not need to use much force.
Do not rush through steps 4, 5, 6, and 7. You must inhale as slowly as possible just before using the inhaler. You should use your inhaler while standing in front of a mirror for the first few times. If you see a “shower” coming from the top of the inhaler or the side of your mouth, start again from step 3.
As with any inhaler, caregivers should ensure that children prescribed Seretide Evohaler use proper inhalation techniques, as described above.
If you or your child finds it difficult to use an inhalation spray, either your doctor, nurse or other healthcare professional may recommend that you use a respirator with your inhaler. Your doctor, nurse, pharmacist, or another healthcare provider should show you how to use the respirator with your inhaler, how to care for the respirator, and will answer any questions you may have. If you use a respirator with your inhaler is important that you do not stop using it without talking to your doctor or nurse first. It is also important that you do not change the type of respirator you use without talking to your doctor. If you stop using a respirator or change the type of respirator you are using, your doctor may need to change the dose of one of the medicines needed to control your asthma.
Always talk to your doctor before making any changes to your asthma treatment.
Older children or people with weak hands may find it easier to hold the inhaler with both hands. Place the two index fingers on top of the inhaler and both thumbs on the bottom below the mouthpiece.
When the dose counter shows 020, be sure to have a new inhalation spray on hand. Stop using the inhaler when the dose counter shows 000. If there is still something left, it may not be a full dose. Never try to change the numbers in the dose counter or remove the dose counter from the metal container.
Cleaning
To prevent the inhaler from “plugging in”, it is important that the inhaler is cleaned at least once a week:
- Remove the protective cap
- Do not remove the metal container from the plastic inhaler when cleaning or at any other time
- Wipe the inside and outside of the nozzle and the plastic inhaler with a dry cloth or paper towel
- Replace the protective cap. A “click” is heard when pressed into place. If it cannot be pushed into place, check that it is facing in the right direction and try again. You do not need to use much force.
Do not immerse the metal container in water.
If you use more Seretide 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 beat faster and you will tremble. 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 Seretide may reduce cortisone formation in the adrenal glands.
If you forget to use Seretide
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 Seretide
You must take Seretide daily according to the instructions until your doctor tells you to stop.
Do not suddenly stop taking Seretide or reduce your dose as this may impair your breathing.
In addition, if you suddenly stop taking Seretide or reduce the dose of one of Seretide, 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, loss of appetite, and 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 extra cortisone in tablet form (eg prednisolone ).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
This medicine can cause side effects like all medicines, 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.
Allergic reactions: if you suddenly notice difficulty breathing immediately after taking Seretide. The breathing becomes wheezing and you may have a cough or shortness of breath. You may also notice itching, a 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 Seretide if you notice any of this or if it happens suddenly after you take Seretide. Allergic reactions are less common (affect less than 1 in 100 people).
Other side effects:
Very common (affects more than 1 in 10 people):
- 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 (affects more than 1 in 100 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 a medicine 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 ):
- Pneumonia and bronchitis ( tracheal catarrh ). Contact your doctor if you experience any of the following symptoms: increased mucus production, different color of the mucus, fever, chills, more cough, worsening breathing problems
- 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 in the blood (which can cause irregular heartbeat, muscle weakness, and cramps).
Uncommon (affects less than 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)
- Speedy 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 (affects less than 1 in 1,000 people)
- Difficulty breathing/wheezing that worsens shortly after taking Seretide. Stop taking Seretide. Use the inhaler with the fast-acting bronchodilator medicine and contact a doctor immediately.
- Seretide 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 and Glaucoma (Eye Diseases)
- 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 overactive and irritable (seen mainly in children).
- Irregular heartbeat or extra heartbeat ( arrhythmia ). Tell your doctor but do not stop taking Seretide 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 Seretide
- Keep out of sight and reach of children
- Do not use this medicine after the expiry date which is stated on the label/carton after EXP. The expiration date is the last day of the specified month.
- Do not store above 25 ° C. Store in a cold place. Do not freeze.
- As with most inhalation sprays, there is a risk that function and effect will deteriorate when the inhalation spray is cold.
- The contents of the metal container are under pressure. Do not expose it to temperatures above 50 ° C and store it in direct sunlight. Do not puncture, puncture or burn even if the container appears to be empty.
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
- Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125, or 250 micrograms of fluticasone propionate
- The other ingredient is the propellant: norflurane (HFA 134a) propellant
What the medicine looks like and the contents of the pack
- Seretide Evohaler is provided to you in a dose-controlled inhaler that delivers your medicine with a pressurized inhalation spray, suspension to be inhaled through the mouth into the lungs.
- The metal container contains a white to off-white suspension.
- The metal containers are placed in a plastic casing that contains a nozzle and provided with a protective casing.
- Seretide Evohaler is packaged in cartons of 1, 2, 3, or 10 inhalation sprays
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline AB
Box 516
169 29 Solna
Tel 08-638 93 00
Email: info.produkt@gsk.com
This medicinal product is authorized under the European Economic Area under the names:
| Austria | Seretide Dosieraerosol |
| Belgium | Seretide |
| Denmark | Seretide |
| Finland | Seretide Evohaler |
| France | Seretide |
| Germany | atmadisc |
| Greece | Seretide Inhaler |
| Iceland | Seretide |
| Ireland | Seretide Evohaler |
| Italy | Seretide |
| Luxembourg | Seretide |
| Netherlands | Seretide |
| Portugal | Seretide Salvador |
| Spain | Seretide |
| Sweden | Seretide Evohaler |
| Great Britain (Northern Ireland) | Seretide Evohaler |