mite 50 micrograms / 100 micrograms / dose, 50 micrograms / 250 micrograms / dose, forte 50 micrograms / 500 micrograms / dose inhalation powder, divided dose
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 in the lungs.
Your doctor has prescribed this medicine to prevent breathing problems in:
- Asthma
- Chronic obstructive pulmonary disease (COPD). Seretide Diskus forte (50 micrograms / 500 micrograms per dose ) reduces the number of worsening periods of COPD.
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 or COPD.
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 “if needed” 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 lactose monohydrate.
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.
Seretide contains lactose
Seretide Diskus contains lactose monohydrate up to 12.5 mg / dose. This amount normally does not cause any problems for lactose-intolerant people. The excipient lactose contains small amounts of milk protein which may cause allergic reactions.
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.
- You may not be able to taste or powder the tongue, even if you have used the inhaler correctly.
For asthma:
Adults and young people from 12 years
| • Seretide Diskus mite | 1 inhalation 2 times daily |
| • Seretide Diskus | 1 inhalation 2 times daily |
| • Seretide Diskus forte | 1 inhalation 2 times daily |
Children from 4 years and up to 12 years
| • Seretide Diskus mite | 1 inhalation 2 times daily |
| • Seretide is not recommended for children under 4 years of age. |
For adults with chronic obstructive pulmonary disease (COPD)
| • Seretide Diskus forte | 1 inhalation 2 times daily |
If the symptoms are well controlled when you take Seretide 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 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, 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 show you how to use Seretide Diskus. From time to time, they should also check how you use it. It is important that Seretide Diskus is used correctly and as prescribed so that you can have the intended effect on your asthma or COPD.
- The Diskus inhaler contains blisters with Seretide powder.
- A dose counter on the top of Diskus shows how many doses you have left. The dose counter counts down to 0. Numbers 5 to 0 are marked in red to warn that only a few doses are left. When the dose counter shows 0, the inhaler is empty.
How to use the inhaler
Cleaning
Wipe the Diskus nozzle with a dry paper towel.
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 beating faster than usual and shivering. You may also experience dizziness, headaches, and joint, and muscle aches.
If you have taken larger amounts of medicine for a long time or if, for example, a child has 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 using 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 worsen your symptoms.
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 and loss of appetite, malaise
- Nausea and diarrhea
- 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
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 or COPD.
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, 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).
Pneumonia in COPD patients (common side effect )
Tell your doctor if you have any of the following symptoms while taking Seretide as they may be symptoms of pneumonia:
• fever or chills
• increased mucus production, changed the color of the mucus
• increased cough or increased breathing difficulties
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 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 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. If this happens: 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
- Cataract ( 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 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 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 o C
Contents of the packaging and other information
Content declaration
- Each metered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 100, 250, or 500 micrograms of fluticasone propionate
- The other ingredient is lactose monohydrate (which contains milk protein)
What the medicine looks like and the contents of the pack
- Seretide Diskus contains a foil strip. The foil protects the inhalation powder from external influences
- Each dose is a divided dose
- Seretide Diskus is packed in cartons of 1 Diskus with 28 doses or 1, 2, 3, or 10 Diskus with 60 doses
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 medicine is authorized in the European Economic Area
and in the United Kingdom (Northern Ireland) under the names:
| Austria | Seretide Diskus |
| Belgium | Seretide Diskus |
| Croatia | Seretide Diskus |
| Cyprus | Seretide Diskus |
| Czech Republic | Seretide Diskus |
| Denmark | Seretide |
| Estonia | Seretide Diskus |
| Finland | Seretide Diskus |
| France | Seretide Diskus |
| Germany | atmadisc Diskus |
| Greece | Seretide Diskus |
| Hungary | Seretide Diskus |
| Iceland | Seretide |
| Ireland | Seretide Diskus |
| Italy | Seretide Diskus |
| Luxembourg | Seretide Diskus |
| Malta | Seretide Diskus |
| Netherlands | Seretide Diskus |
| Portugal | Seretaide Diskus |
| Romania | Seretide Diskus |
| Slovakia | Seretide Diskus |
| Spain | Seretide Accuhaler |
| Sweden | Seretide Diskus |
| United Kingdom (Northern Ireland) | Seretide Accuhaler |