SEREFLO 25 MICROGRAMS / 125 MICROGRAMSPER ACTUATION PRESSURISED INHALATION SUSPENSION - patient leaflet, side effects, dosage

Sereflo

Read this leaflet carefully be 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, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms 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.

This medicine is available using the above name but will be referred to as Sereflo throughout this leaflet. Also available in another strength.

What is in this leaflet

• 1.What Sereflo is and what it is used for

• 2.What you need to know before you use Sereflo

• 3. How to use Sereflo

• 4.Possible side-effects

• 5.How to store Sereflo

• 6.Contents of the pack and other information

1. what sereflo is and what it is used for

Sereflo 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. You must use Sereflo every day as directed by your doctor. This will make sure that it works properly in controlling your asthma.

Sereflo helps to stop breathlessness and wheeziness coming on. However, Sereflo should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fastacting ‘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 sereflo

Do not take Sereflo:

If you are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the other ingredient norflurane (HFA 134a).

Warnings and precautions

Talk to your doctor before using Sereflo if you have:

• Heart disease, including an irregular or fast heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Sereflo may increase your blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now, or in the past, or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Sereflo

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 Sereflo 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 Sereflo:

• p blockers (such as atenolol, propranolol and sotalol). p 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 Sereflo, including irregular heartbeats, or may make side effects worse. Your doctor may wish to monitor you carefully if you are taking these medicines.
• 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.
• Some medicines may increase the effects of [product name] and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

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

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

3. how to use sereflo

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 Sereflo 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 Sereflo or reduce the dose of Sereflo without talking to your doctor first.
• Sereflo should be inhaled through the mouth into the lungs.

Adults

Sereflo is indicated for use in adults 18 years of age and older only.

• Sereflo 25 microgram/125 microgram – 2 puffs twice a day
• Sereflo 25 microgram/250 microgram – 2 puffs twice a day

Adolescents aged 13 to 17 years

Sereflo is not indicated for the management of asthma in adolescents 13 to 17 years of age.

No data are available on the use of Sereflo in this age group.

Children 12 years of age and younger:

Sereflo is not indicated for the management of asthma in children 12 years of age and younger. No data are available on the use of Sereflo in this age group. Neither of the two strengths of Sereflo can be used in the management of asthma in children as the dose of the corticosteroid (fluticasone propionate) in both strengths of Sereflo is too high for use in this young age group.

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’ inhaler. If any of these happen, you should continue to take Sereflo 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 straightaway as you may need additional treatment.

Your doctor will assess your asthma symptoms regularly to make sure you are taking the correct dose of Sereflo and will reduce your dose to the lowest dose required to control your symptoms.

However Sereflo is only available in two strengths, 25/125 micrograms and 25/250 micrograms. If your doctor feels that you need a lower dose of your inhaler than is available with Sereflo, your doctor will change you to an alternative combination product containing the same two medicines but in a lower strength. This is currently available on the market. It is very important to follow your doctor’s instruc­tions on how many puffs to take and how often to take your medicine.

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 Sereflo inhaler properly or as prescribed may mean that it will not help your asthma as it should.
• The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.
• There is a indicator on the front of the inhaler. The dose indicator will show the number of doses left in the canister through a window in the plastic actuator. As you use the inhaler the dose indicator will typically rotate during every five to seven puffs towards next decreasing number. The dose indicator will show the approximate number of puffs remaining in the inhaler.

You should get a replacement when the indicator shows the number ‘40’ and the Color on the dose indicator will change from green to red. Stop using the inhaler when the indicator shows ‘0’ as any puffs left in the device may not be enough to give you a full dose.

• Take care not to drop the inhaler as this may cause the indicator to count down.

Testing your inhaler

• 1.When using your inhaler for the first time, test that it is working. Remove the mouthpiece cover by gently squeezing the sides with your thumb and forefinger and pull apart.

• 2.To make sure that it works,

  
  

shake it well, point the mouthpiece away from you and press the canister to release four puffs into the air. The dose indicator will show the number ‘120’ indicating the number of puffs in the inhaler. If you have not used your inhaler for a week or more, release two puffs of medicine into the air.

Using your inhaler

It is important to start to breathe as slowly as possible just before using your inhaler.

• 1.Stand or sit upright when using your inhaler.

• 2. Remove the mouthpiece cover (as shown in first picture). Check inside and outside to make sure that the mouthpiece is clean and free of loose objects

• 3. Shake the inhaler 4 or 5 times to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.

• 4. Hold the inhaler upright with your thumb on the base below the mouthpiece. Breathe out as far as is comfortable.

• 5. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite.

6.Breathe in through your mouth slowly and deeply. Just after starting to breathe in, press firmly down on the top of the canister to release a puff of medicine. Do this while still breathing in steadily and deeply.

• 7. Hold your breath, take the inhaler from your mouth and your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as is comfortable.

• 8.Wait about half a minute between taking each puff of medicine and then repeat steps 3 to 7.

  
  
  
  
  
  
  
  
  
  

• 9.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.

10. After use always replace the mouthpiece cover straight away to keep out dust. When the mouthpiece cover is fitted correctly it will ‘click’ into position. If it does not ‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use too much force.

Do not rush steps 4, 5, 6 and 7. It is important that you breathe in as slowly as possible just before using your inhaler. You should use your inhaler whilst standing in front of a mirror for the first few times. If you see “mist” coming from the top of your inhaler or the sides of your mouth, you should start again from step 3.

As with all inhalers, caregivers should ensure that patients prescribed Sereflo use correct inhalation technique, as described above.

Spacer device

If you find it difficult to use the inhaler, either your doctor or other healthcare provider may recommend using a spacer device such as the Volumatic® or AeroChamber Plus® with your inhaler. Limited data available from a study shows that the spacer to be washed and dried prior to use.

Your doctor, nurse, pharmacist or other healthcare provider should show you how to use the spacer device with your inhaler and how to wash and care for your spacer device correctly and will answer any questions you may have.

However, a spacer device is recommended only for use with the Sereflo 25 microgram/250 microgram Inhaler (the high strength inhaler): a spacer device is NOT recommended for use with Sereflo 25 microgram/ 125 microgram Inhaler (the lower strength inhaler). If you need to use a spacer device with this lower strength inhaler, you will have to change to an alternative inhaler containing the same medicines, that is salmeterol 25 microgram and fluticasone propionate 125 microgram, licensed for use with a spacer device.

If you have previously used an alternative product and spacing device and are then transferred to these new fixed-dose combination inhalers with or without a spacing device, re-titration of your dose to the lowest effective dose should always be carried out. Patients should continue to use the same make of spacer device, either the Volumatic spacer device or the AeroChamber Plus spacer device, as switching between spacer devices can result in changes in the dose delivered to the lungs. It is important that if you are using a spacer device with your inhaler 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 spacer device that you use without talking to your doctor or nurse.

If you stop using a spacer device or change the type of spacer device that you use your doctor may need to change the dose of medicine required to control your asthma. Always talk to your doctor before making any changes to your asthma treatment.

People with weak hands may find it easier to hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the bottom below the mouthpiece.

You should get a replacement when the indicator shows the number ‘40’ and the colour on the dose indicator will change from green to red. Stop using the inhaler when the indicator shows ‘0’ as any puffs left in the device may not be enough to give you a full dose. Never try to alter the numbers on the indicator or detach the indicator from the actuator. The indicator cannot be reset and is permanently attached to the actuator.

Cleaning your inhaler

To stop your inhaler blocking, it is important to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece cover.
• Do not remove the metal canister from the plastic casing at any time.
• Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cover. It will ‘click’ into place when fitted correctly. If it does not ‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use too much force.

Do not put the metal canister in water.

If you use more Sereflo 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 Sereflo may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Sereflo

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 Sereflo

It is very important that you take your Sereflo every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Sereflo. This could make your breathing worse.

In addition, if you suddenly stop taking Sereflo or reduce your dose of Sereflo 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 Sereflo to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Sereflo. You may need to use your fastacting ‘reliever’ inhaler to help your breathing. 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 that your heart is 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 Sereflo, stop using Sereflo and tell your doctor straight away.

Allergic reactions to Sereflo 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 people) Headache – this usually gets better as treatment continues.
• Increased number of colds have been reported in patients with chronic obstructive pulmonary disease (COPD).
• 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 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.
• Throat irritation. Rinsing your mouth out with water and spitting it out immediately after taking each puff may help.
• 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 heartbeat, muscle weakness, cramp).
• 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 heartbeat (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 gets worse straight after taking Sereflo. If this happens stop using your Sereflo. Use your fastacting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.
• Sereflo 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 Sereflo 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 Sereflo unless the doctor tells you to stop.
• Thrush, a fungal infection in the oesophagus (gullet, food canal), which might cause difficulties in swallowing.
• Depression or aggression. These effects are more likely to occur in children.
• Blurred vision.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store sereflo 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 25°C.
• The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C, protect from direct sunlight. Do not pierce or burn the canister even when empty.
• As with most inhaled medicinal products in pressurised canisters, the beneficial effects of your medicine may decrease when the canister is cold.
• 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.
• If your medicines show any signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.

6. contents of the pack and other informationwhat sereflo containsthe active substances are salmeterol and fluticasone propionate.

Each metered dose provides 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate.

The other ingredient propellant: norflurane (HFA 134a).

What Sereflo looks like and contents of the pack

The inhaler consists of an aluminium container with a suitable metering valve and a polypropylene actuator in a white case with dose indicator and fitted with pink colour dust cap in a sealed pouch with a silica gel bag.

The container contains a white homogeneous suspension.

Each container is filled to deliver 120 actuations.

Pack sizes: 120 metered doses.

Manufacturer and product licence holder

Manufactured by:

Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, UK.

Cipla Europe NV, De Keyserlei 58–60, Box 19, B-2018 Antwerp, Belgium. Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1 XD. Repackaged by Servipharm Ltd.

POM PL 20636/3267

Leaflet revision and issue date (Ref) 18.08.20[3]

Sereflo is trademark of Cipla Limited.

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