Seretide 250 Accuhaler

United Kingdom - English - eMC (Electronic Medicines Compendium)

Buy It Now

Active ingredient:
Fluticasone propionate; Salmeterol xinafoate
Available from:
CST Pharma Ltd
ATC code:
R03AK06
INN (International Name):
Fluticasone propionate; Salmeterol xinafoate
Dosage:
250microgram/1dose ; 50microgram/1dose
Pharmaceutical form:
Inhalation powder
Administration route:
Inhalation
Class:
No Controlled Drug Status
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 03020000; GTIN: 5055946801162

Page 1 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

SERETIDE™ 250 ACCUHALER™

(salmeterol xinafoate / fluticasone propionate)

Seretide Accuhaler is available in different strengths. Seretide 250 Accuhaler will be referred to

as Seretide Accuhaler throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

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 only. Do not pass it on to others. It may harm

them, even if their symptoms and signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.

What Seretide Accuhaler is and what it is used for

2.

What you need to know before you use Seretide Accuhaler

3.

How to use Seretide Accuhaler

4.

Possible side effects

5.

How to store Seretide Accuhaler

6.

Contents of the pack and other information

1.

WHAT SERETIDE ACCUHALER IS AND WHAT IT IS USED FOR

Seretide Accuhaler contains two medicines, salmeterol and fluticasone propionate:

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 propionate 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

Chronic Obstructive Pulmonary Disease (COPD). Seretide Accuhaler, at a dose of 50/500

micrograms, reduces the number of flare ups of COPD symptoms.

You must use Seretide Accuhaler every day as directed by your doctor. This will make sure that

it works properly in controlling your asthma or COPD.

Seretide Accuhaler helps to stop breathlessness and wheeziness coming on. However

Seretide Accuhaler should not be used to relieve a sudden attack of breathlessness or

wheezing. If this happens you need to use a fast-acting ‘reliever’ (‘rescue’) inhaler,

such as salbutamol. You should always have your fast-acting ‘rescue’ inhaler with

you.

2.

WHAT YOU NEED TO KNOW BEFORE YOU USE SERETIDE ACCUHALER

Do not take Seretide Accuhaler:

If you are allergic to salmeterol, fluticasone propionate or to the other ingredient lactose.

Warnings and precautions

Talk to your doctor before using Seretide Accuhaler if you have:

Heart disease, including an irregular or fast heart beat

Overactive thyroid gland

High blood pressure

Diabetes mellitus (Seretide Accuhaler may increase your blood sugar)

Low potassium in your blood

Tuberculosis (TB) now or in the past, or other lung infections

Other medicines and Seretide Accuhaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other

medicines. This includes medicines for asthma or any medicines obtained without a prescription.

This is because Seretide Accuhaler 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

Accuhaler:

β blockers (such as atenolol, propranolol and sotalol). β blockers are mostly used for high

blood pressure or other heart conditions.

Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and

erythromycin). Some of these medicines may increase the amount of fluticasone propionate

or salmeterol in your body. This can increase your risk of experiencing side effects with

Seretide Accuhaler, including irregular heart beats, or may make side effects worse.

Corticosteroids (by mouth or by injection). If you have had these medicines recently, this

might increase the risk of this medicine affecting your adrenal gland.

Diuretics, also known as ‘water tablets’ used to treat high blood pressure.

Other bronchodilators (such as salbutamol).

Xanthine medicines. These are often used to treat asthma.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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

Seretide Accuhaler is not likely to affect your ability to drive or use machines.

Seretide Accuhaler contains lactose

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.

3.

HOW TO USE SERETIDE ACCUHALER

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

Use your Seretide Accuhaler every day until your doctor advises you to stop. Do not take

more than the recommended dose. Check with your doctor or pharmacist if you are not

sure.

Do not stop taking Seretide Accuhaler or reduce the dose of Seretide Accuhaler without

talking to your doctor first.

Seretide Accuhaler should be inhaled through the mouth into the lungs.

For asthma

Adults and adolescents aged 12 years and over

Seretide 100 Accuhaler - One inhalation twice a day

Seretide 250 Accuhaler - One inhalation twice a day

Seretide 500 Accuhaler - One inhalation twice a day

Children 4 to 12 years of age

Seretide 100 Accuhaler - One inhalation twice a day

Seretide Accuhaler is not recommended for use in children below 4 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

Seretide 500 Accuhaler - One inhalation twice a day

Your symptoms may become well controlled using Seretide Accuhaler twice a day.

If so, your doctor may decide to reduce your dose to once a day. The dose may change to:

once at night - if you have night-time symptoms

once in the morning - if you have daytime symptoms.

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

how often to take your medicine.

If you are using Seretide Accuhaler for asthma, your doctor will want to regularly check your

symptoms.

If your asthma or breathing gets worse tell your doctor straight away. You may find

that you feel more wheezy, your chest feels tight more often or you may need to use more of

your fast-acting ‘reliever’ medicine. If any of these happen, you should continue to take

Seretide Accuhaler but do not increase the number of puffs you take. Your chest condition may

be getting worse and you could become seriously ill. See your doctor as you may need

additional treatment.

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 or COPD as it should.

The Accuhaler device holds blisters containing Seretide as a powder.

There is a counter on top of the 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

To open your 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.

Hold your 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 pulled 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 blisters and wastes medicine.

Hold the Accuhaler away from your mouth, breathe out as far as is

comfortable. Do not breathe into your Accuhaler.

Put the mouthpiece to your lips; breathe in steadily and deeply

through the Accuhaler, not through your nose. Remove the

Accuhaler from your mouth. Hold your breath for about 10 seconds

or for as long as is comfortable. Breathe out slowly.

Afterwards, rinse your mouth with water and spit it out, and/or

brush your teeth. This may help to stop you getting thrush and

becoming hoarse.

To close the Accuhaler, slide the thumbgrip 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 Accuhaler is now ready for you to use

again.

As with all inhalers, caregivers should ensure that children prescribed Seretide Accuhaler use

correct inhalation technique, as described above.

Thumbgrip

Lever

Mouthpiece

Outer Case

Counter

Full Empty

Page 2 of 2

Cleaning your inhaler

Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.

If you use more Seretide Accuhaler than you should

It is important to use the inhaler as instructed. If you accidentally take a larger dose than

recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than

usual and that you feel shaky. You may also have dizziness, 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 Accuhaler may reduce the

amount of steroid hormones produced by the adrenal gland.

If you forget to use Seretide Accuhaler

Do not take a double dose to make up for a forgotten dose. Just take your next dose at the

usual time.

If you stop using Seretide Accuhaler

It is very important that you take your Seretide Accuhaler every day as directed. Keep taking

it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of

Seretide Accuhaler. This could make your breathing worse.

In addition, if you suddenly stop taking Seretide Accuhaler or reduce your dose of Seretide

Accuhaler this may (very rarely) cause you to have problems with your adrenal gland (adrenal

insufficiency) which sometimes causes side effects.

These side effects may include any of the following:

Stomach pain

Tiredness and loss of appetite, feeling sick

Sickness and diarrhoea

Weight loss

Headache or drowsiness

Low levels of sugar in your blood

Low blood pressure and seizures (fits)

When your body is under stress such as from fever, trauma (such as a car accident), infection,

or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed

above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms

occurring, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).

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

pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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

Accuhaler to control your asthma or COPD.

Allergic reactions: you may notice your breathing suddenly gets worse immediately

after using Seretide Accuhaler. You may be very wheezy and cough or be short of breath.

You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue, or

throat), or you may suddenly feel your heart beating very fast or you feel faint and light headed

(which may lead to collapse or loss of consciousness). If you get any of these effects or if

they happen suddenly after using Seretide Accuhaler, stop using Seretide Accuhaler

and tell your doctor straight away.

Allergic reactions to Seretide Accuhaler are uncommon (they affect less than 1 person in 100).

Other side effects are listed below:

Very Common (affects more than 1 person in 10)

Headache - this usually gets better as treatment continues.

Increased number of colds have been reported in patients with COPD.

Common (affects less than 1 person in 10)

Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue and

hoarse voice and throat irritation. Rinsing your mouth out with water and spitting it out

immediately and/or brushing your teeth after taking each dose of your medicine may help.

Your doctor may prescribe an anti-fungal medication to treat the thrush.

Aching, swollen joints and muscle pain.

Muscle cramps.

The following side effects have also been reported in patients with Chronic Obstructive

Pulmonary Disease (COPD):

Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following

symptoms: increase in sputum production, change in sputum colour, fever, chills, increased

cough, increased breathing problems.

Bruising and fractures.

Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the

eyes, sometimes with a throbbing ache).

A reduction in the amount of potassium in the blood (you may get an uneven heart beat,

muscle weakness, cramp).

Uncommon (affects less than 1 person in 100)

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.

Cataract (cloudy lens in the eye).

Very fast heart beat (tachycardia).

Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually

harmless and get less as treatment continues.

Chest pain.

Feeling worried (this effect mainly occurs in children).

Disturbed sleep.

Allergic skin rash.

Rare (affects less than 1 person in 1000)

Breathing difficulties or wheezing that get worse straight after taking Seretide

Accuhaler. 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 Accuhaler 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

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 Accuhaler to control your asthma.

Behavioural changes, such as being unusually active and irritable (these effects mainly occur

in children).

Uneven heart beat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not

stop taking Seretide Accuhaler unless the doctor tells you to stop.

A fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing.

Frequency not known, but may also occur:

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.

HOW TO STORE SERETIDE ACCUHALER

Keep your Seretide Accuhaler out of the sight and reach of children.

Do not store above 30°C.

Do not use after the date shown as 'EXP' on the carton and device.

If you are told to stop taking this medicine return your Seretide Accuhaler to your pharmacist to

be destroyed.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Seretide Accuhaler contains

Each blister contains 50 micrograms of the active ingredient salmeterol (as the xinafoate)

together with 250 micrograms respectively of the active ingredient fluticasone propionate and

lactose, which acts as the 'carrier'.

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of

47 micrograms of salmeterol (as salmeterol xinafoate) and 231 micrograms of fluticasone

propionate. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol

(as salmeterol xinafoate) and 250 micrograms fluticasone propionate

What Seretide Accuhaler looks like and contents of the pack

Seretide Accuhaler container is a two tone purple, circular moulded plastic device containing

white inhalation powder and with a dose counter showing the number of doses remaining.

An Accuhaler is an easy to use inhaler which is designed to release a dose of medicine into your

lungs when you take a breath in.

The blister protects the powder for inhalation from the effects of the atmosphere.

The device has a counter which tells you the number of blisters remaining. It counts down from

60 to 0. To show when you have reached the last five blisters, the numbers will appear in red.

When the counter shows 0, your inhaler is empty and should be disposed of.

Manufacturer

Seretide Accuhaler is manufactured by: Glaxo Wellcome Production, Evreux, France.

Procured from within the EU and repackaged by:

Doncaster pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder:

BR Lewis Pharmaceuticals Ltd, Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0002

Seretide™ and Accuhaler™ are both trademarks of the GlaxoSmithKline group of companies.

Leaflet revision and issue date (Ref.) 01.02.17

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 01302 365000 (Regulatory)

Please be ready to give the following

information:

Product name: Seretide 250 Accuhaler

Reference No: 08929/0002

Product Summary

Trade Name of the Medicinal Product

Not applicable.

2.

Qualitative and Quantitative Composition

Not applicable.

3.

Pharmaceutical Form

Not applicable.

Clinical Particulars

4.1.

Therapeutic Indications

As per UK PL no 00057/0277

4.2.

Posology and Method of Administration

As per UK PL no 00057/0277

4.3.

Contra-indications

As per UK PL no 00057/0277

4.4.

Special Warnings and Precautions for Use

As per UK PL no 00057/0277

4.5.

Interactions with other Medicaments and other forms of Interaction

As per UK PL no 00057/0277

4.6.

Pregnancy and Lactation

As per UK PL no 00057/0277

4.7.

Effects on Ability to Drive and Use Machines

As per UK PL no 00057/0277

4.8.

Undesirable Effects

As per UK PL no 00057/0277

4.9.

Overdose

As per UK PL no 00057/0277

Pharmacological Properties

5.1.

Pharmacodynamic Properties

As per UK PL no 00057/0277

5.2.

Pharmacokinetic Properties

As per UK PL no 00057/0277

5.3.

Preclinical Safety Data

None stated.

Pharmaceutical Particulars

6.1.

List of Excipients

As per ECMA no 026821013 issued by Italy

6.2.

Incompatibilities

As per UK PL no 00057/0277

6.3.

Shelf Life

36 Months (unopened)

6.4.

Special Precautions for Storage

Store below 30°C.

6.5.

Nature and Contents of Container

Blister strips in cardboard carton

Pack size : 30

6.6.

Instruction for Use/Handling

None stated.

Administrative Data

Marketing Authorisation Holder

Waymade Plc

Miles Gray Road

Basildon

Essex SSl4 3FR

8.

Marketing Authorization Number

PLPI 06464/0315

9.

Date of First Authorisation/Renewal of Authorisation

None stated.

10.

Date of (Partial) Revision of the Text

None stated.

Similar products

Search alerts related to this product

View documents history

Share this information