Seretide 500 Accuhaler

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Fluticasone propionate; Salmeterol xinafoate
Available from:
CST Pharma Ltd
ATC code:
R03AK06
INN (International Name):
Fluticasone propionate; Salmeterol xinafoate
Dosage:
500microgram/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: 5055946801186

PACKAGE LEAFLET: INFORMATION FOR THE USER

SERETIDE

®

500 ACCUHALER

®

(salmeterol xinafoate/ fluticasone propionate)

The name of your medicine is Seretide 500 Accuhaler but will

be referred to Seretide 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:

What Seretide is and what it is used for

What you need to know before you use Seretide

How to use Seretide

Possible side effects

How to store Seretide

Contents of the pack and other information

1.

What Seretide is and what it is used for

Seretide 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 every day as directed by your doctor.

This will make sure that it works properly in controlling your

asthma or COPD.

Seretide helps to stop breathlessness and wheeziness

coming on. However Seretide 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

Do not take Seretide:

If you are allergic to salmeterol, fluticasone propionate or to

the other ingredient lactose monohydrate.

Warnings and precautions

Talk to your doctor before using Seretide if you have:

heart disease, including an irregular or fast heartbeat

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, or other lung

infections.

Other medicines and Seretide

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 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:

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,

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 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

Seretide 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

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 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 or reduce the dose of

Seretide without talking to your doctor first.

Seretide should be inhaled through the mouth into the

lungs.

For asthma

Adults and adolescents aged 12 years and over

Seretide Accuhaler 50/500 - One inhalation twice a day

Seretide Accuhaler 50/100 - One inhalation twice a day

Seretide Accuhaler 50/250 - One inhalation twice a day

Children 4 to 12 years of age

Seretide Accuhaler 50/100 - One inhalation twice a day

Seretide is not recommended for use in children below 4

years of age.

For adults with Chronic Obstructive Pulmonary Disease

(COPD)

Seretide 50/500 Accuhaler - One inhalation twice a day

Your symptoms may become well controlled using Seretide

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 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 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

1.

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

2.

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.

3.

Hold the Accuhaler away from your mouth, breathe out as

far as is comfortable. Do not breathe into your Accuhaler.

4.

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.

5.

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.

6.

To close the Accuhaler, slide the

thumbgrip back towards you, as far as it

will go. You will hear a click.

By addisonf at 9:08 am, Jun 08, 2016

Assessed against UK PIL dated March 2015

Assessed against UK PIL dated March 2015

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.

Cleaning your inhaler

Wipe the mouthpiece of the Accuhaler with a dry tissue to

clean it.

If you use more Seretide 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 may reduce the amount of

steroid hormones produced by the adrenal gland.

If you forget to use Seretide

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

It is very important that you take your 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 worse.

In addition, if you suddenly stop taking Seretide or reduce

your dose of Seretide 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 to control your asthma or COPD.

Allergic reactions: you may notice your breathing

suddenly gets worse immediately after using Seretide.

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, stop using

Seretide and tell your doctor straight away.

Allergic reactions to Seretide 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. If this happens stop using your

Seretide inhaler. 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

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.

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 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

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 expiry date

refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help

protect the environment.

6.

Contents of the pack and other information

What Seretide Accuhaler contains

Each single inhalation provides a delivered dose (the

dose leaving the mouthpiece) of 47 micrograms of

salmeterol (as xinafoate) and 460 micrograms of

fluticasone propionate. This corresponds to a pre-

dispensed dose of 50 micrograms of salmeterol (as

xinafoate) and 500 micrograms of fluticasone

propionate.

The other ingredient is lactose monohydrate (which

contains milk proteins).

What Seretide Accuhaler looks like and contents of the

pack

The Seretide Accuhaler contains a foil strip. The foil

protects the powder for inhalation from the effects of the

atmosphere.

Each dose is pre-dispensed.

The devices are packed in cartons which hold:

1 x Accuhaler containing 60 inhalations.

Manufacturer

Glaxo Wellcome Production, Zone Industrielle No.2, 23 Rue

Lavoisier, La Madeleine, 27000 Evreux, France.

Product procured from within the EU and repackaged by;

PCO Manufacturing, Unit 10, Ashbourne Business Park,

Rath, Ashbourne, Co. Meath, Ireland.

Product Licence Holder: NIP Pharma, Unit 8C, Loughway

Business Park, Greenbank Industrial Estate, Newry, Co.

Down BT34 2TH

PL 25820/0099 POM

Other formats

To listen to or request a copy of this leaflet in Braille, large

print or audio please call free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Seretide Accuhaler

This is a service provided by the Royal National Institute of

Blind People.

Accuhaler and Seretide are registered trademarks of the

GSK group of companies.

This leaflet was last revised in 09/08/2016.

By addisonf at 11:43 am, Aug 09, 2016

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

Not applicable.

4.2.

Posology and Method of Administration

Not applicable.

4.3.

Contra-indications

Not applicable.

4.4.

Special Warnings and Precautions for Use

Not applicable.

4.5.

Interactions with other Medicaments and other forms of Interaction

Not applicable.

4.6.

Pregnancy and Lactation

Not applicable.

4.7.

Effects on Ability to Drive and Use Machines

Not applicable.

4.8.

Undesirable Effects

Not applicable.

4.9.

Overdose

Not applicable.

Pharmacological Properties

5.1.

Pharmacodynamic Properties

Not applicable.

5.2.

Pharmacokinetic Properties

Not applicable.

5.3.

Preclinical Safety Data

Not applicable.

Pharmaceutical Particulars

6.1.

List of Excipients

Not applicable.

6.2.

Incompatibilities

Not applicable.

6.3.

Shelf Life

Not applicable.

6.4.

Special Precautions for Storage

Not applicable.

6.5.

Nature and Contents of Container

Not applicable.

6.6.

Instruction for Use/Handling

Not applicable.

Administrative Data

Marketing Authorisation Holder

Not applicable.

8.

Marketing Authorization Number

Not applicable.

9.

Date of First Authorisation/Renewal of Authorisation

Not applicable.

10.

Date of (Partial) Revision of the Text

Not applicable.

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