Seretide 100 Accuhaler
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Very rare (affects less than 1 in 10,000)
• Breathing difficulties or wheezing that gets worse straight after taking Seretide. If this happens stop using your Seretide
Accuhaler. Use your fast-acting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.
• Seretide may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include:
slowing of growth in children and
adolescents,
thinning of the bones
cataract and glaucoma
weight gain
rounded (moon shaped) face (Cushing's Syndrome).
Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of Seretide to control your asthma.
• Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Seretide unless they tell you to stop.
• Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
• Feeling worried, disturbed sleep and behavioural changes, such as being unusually active and irritable (these effects mainly occur in children).
• Aching, swollen joints and muscle pain.
If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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 protect the environment.
6. FURTHER INFORMATION What Seretide contains
Each blister contains 50 micrograms of active ingredient salmeterol (as the xinafoate) together with 100 microgram of the active ingredient fluticasone propionate and lactose which acts as ‘carier’.
What Seretide looks like and contents of pack
It is a plastic inhaler device containing a foil strip with 60 blisters. .
Manufacturer: Glaxo Wellcome Operations UK Limited, Ware, UK.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0278
Seretide™ and Accuhaler™ are trademarks of the GlaxoSmithKline group of companies.
Leaflet revision and issue date (Ref.) 13.05.15
5. HOW TO STORE SERETIDE ACCUHALER
• Keep all medicines out of the reach and sight of children.
• Do not store above 30°C.
• The expiry date of this product is printed on the pack. Do not use your Seretide Accuhaler after this date.
• If you ate told to stop taking this medicine return your Seretide Accuhaler to your pharmacist to be destroyed.
• If your Seretide Accuhaler show signs of any deterioration, you should seek the advice of your pharmacist.
PATIENT INFORMATION LEAFLET
SERETIDE™ 100 ACCUHALER™
(salmeterol/fluticasone propionate)
2. BEFORE YOU USE SERETIDE ACCUHALER
Your medicine is available using the name
Seretide 100 Accuhaler but will be referred to as
Seretide Accuhaler throughout this leaflet.
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. 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. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Seretide Accuhaler is and what it is used for
2. Before you use Seretide Accuhaler
3. How to use Seretide Accuhaler
4. Possible side effects
5. How to store Seretide Accuhaler
6. Further Information
Seretide contains two medicines, salmeterol and
1. WHAT SERETIDE ACCUHALER IS AND WHAT IT IS USED FOR
fluticasone.
• Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours.
• Fluticasone is a corticosteroid which reduces swelling and irritation in the lungs.
The doctor has prescribed this medicine to help prevent breathing problems such as:
• Asthma
You must use Seretide Accuhaler every day as directed by your doctor. This will make sure that it works properly in controlling your asthma.
Seretide helps to stop breathlessness and wheeziness coming on. It does not work once you are breathless or wheezy. If that happens you need to use a fast acting ‘reliever’ medication, such as salbutamol.
Do not take Seretide if:
You are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or to the other ingredient lactose monohydrate.
Take special care with Seretide
Your doctor will supervise your treatment more closely if you have medical conditions such as:
• heart disease, including an irregular or fast heart beat
• overactive thyroid gland
• high blood pressure
• diabetes mellitus (Seretide may increase your blood sugar)
• low potassium in your blood
• Tuberculosis (TB) now or in the past.
If you have ever had any of these conditions, tell your doctor before you use Seretide.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines for asthma or any medicines obtained without a prescription. This is because Seretide may not be suitable to be taken with some other medicines.
Tell your doctor if you are taking the following medicines, before starting to use Seretide:
• Beta-blockers (such as atenolol, propranolol, sotalol). Beta-blockers are mostly used for high blood pressure or other heart conditions.
• Antiviral and antifungal medicines (such as ritonavir, ketoconazole and Itraconazole). Some of these medicines may increase the amount of fluticasone in your body. This can increase your risk of having side effects.
• Corticosteroids (by mouth or injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.
3. HOW TO USE SERETIDE ACCUHALER
Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant, or breast-feeding, talk to your doctor before taking Seretide. Your doctor will access whether you can take Seretide during this time.
Driving and using machines
Seretide is not likely to affect your ability to drive or use machines.
Important information about some of the ingredients of Seretide
Seretide Accuhaler contains up to 12.5 milligrams of lactose in each dose. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.
• Use your Seretide every day, until your doctor advises you to stop.
• Always use Seretide exactly as your doctor has told you.
For asthma
Adults and adolescents aged 12 years and
over
• Seretide 50/100 Accuhaler - One inhalation twice a day.
Children 4 to 12 years of age
• Seretide 50/100 Accuhaler - One inhalation twice a day
• Seretide is not recommended for use in children below 4 years of age.
Instructions for use
• Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from time to time. Not using the Seretide Accuhaler properly or as prescribed may mean that it will not help your asthma as it should.
• The Seretide Accuhaler device holds blisters containing Seretide as powder.
• There is a counter on top of the Seretide Accuhaler which tells you how many doses are left. It counts down to 0. The numbers 5 to 0 will appear in red to warn you when there are only a few doses left. Once the counter shows 0, your inhaler is empty.
Using your inhaler
1. To open your Seretide Accuhaler, hold the outer case in one hand and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go. You will hear a click. This will open a small hole in the mouthpiece.
2. Hold your Seretide Accuhaler with the mouthpiece towards you. You can hold it in either your right or left hand. Slide the lever away from you as far as it will go. You will hear a click. This places a dose of your medicine in the mouthpiece.
Every time the lever is pushed back a blister is opened inside and the powder made ready for you to inhale. Do not play with the lever as this opens the blister and wastes the medicine.
3. Hold the Seretide Accuhaler away from your mouth, breathe out as far as is comfortable. Do not breathe into your Seretide Accuhaler.
4. Put the mouthpiece to your lips; breathe in steadily and deeply through the Seretide Accuhaler, not through your nose.
Remove the Seretide Accuhaler from your mouth.
Hold your breath for about 10 seconds or for as long as is comfortable.
Breathe out slowly.
5. Afterwards rinse your mouth with water and spit it out. This may help to stop you getting thrush and being hoarse.
4. POSSIBLE SIDE EFFECTS
6. To close the Seretide Accuhaler, slide the thumb grip back towards you, as far as it will go.
You will hear a click. The lever will return to its original position and is reset.
Your Seretide Accuhaler is now ready for you to use again.
Cleaning your inhaler
Wipe the mouthpiece of the Seretide Accuhaler with a dry tissue to clean it.
If you use more Seretide than you should
It is important to use inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart is beating faster than usual and that you feel shaky. You may also have a headache, muscle weakness and aching joints.
If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Seretide may reduce the amount of steroid hormones produced by the adrenal gland.
If you forget to use Seretide
If you forget to use your inhaler, take your next dose when it is due. Do not take a double dose to replace the one you forgot.
If you stop using Seretide
It is very important that you take Seretide every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Seretide. This could make your breathing problem worse and very rarely side effects could occur. These include:
• stomach pain
• tiredness and loss of appetite
• sickness and diarrhoea
• weight loss
• headache or drowsiness
• low levels of potassium in your blood
• low blood pressure and seizures
Very rarely, if you get an infection or at times of extreme stress (such as after a serious accident or if you have surgery), you may get similar side effects.
To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids (like prednisolone).
If you have any further questions on using the inhaler, ask your doctor or pharmacist.
Like all medicines, Seretide can cause side effects, although not everybody gets them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of Seretide to control your asthma.
Allergic reactions: you may notice your breathing suddenly gets worse after using Seretide. You may be very wheezy and cough. You may also notice itching and swelling (usually of the face, lips, tongue, or throat). If you get these effects or if they happen suddenly after using Seretide, tell your doctor straight away. Allergic reactions to Seretide are very rare (they affect less than 1 person in 10,000).
Other side effects are listed below:
Very Common (affects more than 1 person in 10)
• Headache - this usually gets better as treatment continues.
Common (affects less than 1 person in 10)
• Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue, throat and hoarse voice. Rinsing your mouth out with water and spitting it out immediately after taking each puff may help. Your doctor may prescribe an anti fungal medication to treat the thrush.
• Feeling shaky and fast or uneven heartbeat (palpitations) - these are usually harmless and gets less as treatment continues.
• Muscle cramps.
Uncommon (affects less than 1 person in 100)
• Rash.
• Very fast heartbeat (tachycardia).