Sereflo Ciphaler 50 micrograms / 250 micrograms per dose inhalation powder Predispensed – patient leaflet, side effects, dosage

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

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

Sereflo Ciphaler helps to stop breathlessness and wheeziness coming on. However Sereflo Ciphaler 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 Sereflo Ciphaler

Do not use Sereflo Ciphaler:

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

Warnings and precautions

Talk to your doctor before using Sereflo Ciphaler if you have:

• Heart disease, including an irregular or fast heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus Sereflo Ciphaler 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.

Children and adolescents

Sereflo Ciphaler should not be used in children under 12 years of age.

Other medicines and Sereflo Ciphaler Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines including medicines for asthma or any medicines obtained without a prescription. This is because Sereflo Ciphaler may not be suitable to be used with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to use Sereflo Ciphaler:

• 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 ketoconazole, itraconazole and erythromycin) including some medicines for HIV treatment (such as ritonavir, cobicistat containing products). 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 Ciphaler, including irregular heart beats, 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.

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

Sereflo Ciphaler contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. The excipient lactose monohydrate contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Sereflo Ciphaler

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

Adults and adolescents aged 12 years and over

• Sereflo Ciphaler 50 micrograms/250 micrograms - One inhalation twice a day

Use in children

Sereflo Ciphaler is not recommended for children under 12 years of age.

Your symptoms may become well controlled using Sereflo Ciphaler 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 Sereflo Ciphaler 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 Sereflo Ciphaler 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 Sereflo Ciphaler properly or as prescribed may mean that it will not help your asthma as it should.
• The inhaler device holds blisters containing Sereflo Ciphaler as a powder.

• There is a counter on top of the inhaler 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. See Figure A.

  Figure A

Using your inhaler

1. 1. To open your Sereflo Ciphaler Inhaler, 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. See Figure B

Figure B

1. 2. Hold your inhaler 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. See Figure C.

Figure C

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.

1. 3. Hold the inhaler away from your mouth, breathe out as far as is comfortable. Do not breathe into your inhaler. See Figure D.

Figure D

1. 4. Put the mouthpiece to your lips; breathe in steadily and deeply through the inhaler, not through your nose. See Figure E.

Remove the inhaler from your mouth. Hold your breath for about 10 seconds or for as long as is comfortable.

Breathe out slowly.

Figure E

1. 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. See Figure F.

Figure F

1. 6. To close the inhaler, 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. See Figure G.

Figure G

Your inhaler is now ready for you to use again.

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

Cleaning your inhaler

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

60

Outer Case

Mouthpiece

Thumb Grip Counter

Lever

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

If you forget to use Sereflo Ciphaler

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 Ciphaler

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

In addition, if you suddenly stop taking Sereflo Ciphaler or reduce your dose of Sereflo Ciphaler 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, pharmacist or nurse.

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 Ciphaler to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Sereflo Ciphaler. 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 Ciphaler, stop using Sereflo Ciphaler and tell your doctor straight away. Allergic reactions to Sereflo Ciphaler are uncommon (may affect up to 1 in 100 people).

Other side effects are listed below:

Very Common (may affect more than 1 in 10 people)

• Headache - this usually gets better as treatment continues.

Common (may affect up to 1 in 10 people)

• 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.

Uncommon (may affect up to 1 in 100 people)

• 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 (may affect up to 1 in 1,000 people)

• Breathing difficulties or wheezing that get worse straight after taking Sereflo Ciphaler. If this happens stop using your Sereflo Ciphaler inhaler. Use your fast-acting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.

• Sereflo Ciphaler 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 Ciphaler 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 Ciphaler unless the doctor tells you to stop.
• A fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing.

Not known (frequency cannot be estimated from the available data):

• 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 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: https://yellowcard.mhra.gov.uk/ 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 Ciphaler

• 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.
• This medicine does not require any special storage conditions. Do not refrigerate or freeze.
• Once a foil pouch has been opened, the medicine inside should be used within 1 month. Do not store the opened product above 25°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 Sereflo Ciphaler contains

• The active substances are salmeterol and fluticasone propionate. Each pre-dispensed dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate.

What Sereflo Ciphaler looks like and contents of the pack

• The Sereflo Ciphaler are supplied as a disposable rubine red-white plastic inhaler containing a blister strip with 60 regularly placed blisters. The blister contains a white to off-white powder. The blister consists of 3 layered forming foil (OPA/ALU/PVC) and a lidding peelable foil (PAPER / PET/ALU/HSL). The inhaler is packaged in a laminated aluminium foil pouch. Laminated aluminium foil pouch consists of 4 layers (PET / PE /Alu Foil / PE).
• Each dose is pre-dispensed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder

Cipla (EU) Limited

Dixcart House

Addlestone Road,

Bourne Business Park

Addlestone, Surrey, KT152LE,

United Kingdom

Manufacturer

Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT152LE, United Kingdom

Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

Times New Roman Regular Times New Roman Bold Body text : 9pt

Sub Heading : 10pt

Main Heading : 12pt

Leading : 3pt

SAP Code: 21103676 (Ver. 01)

Actual Size: 240 x 520 mm

Size after folding: 60 x 40 mm