OChiesi

PACKAGE LEAFLET: INFORMATION FOR USER

PREVENTER

Clenil® Modulite® 50 micrograms per actuation pressurised inhalation solution Clenil® Modulite® 100 micrograms per actuation pressurised inhalation solution Clenil® Modulite® 200 micrograms per actuation pressurised inhalation solution Clenil® Modulite® 250 micrograms per actuation pressurised inhalation solution

beclometasone dipropionate

Read all of this leaflet carefully before you start using 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 on to others. It may harm them even if their symptoms are the same as yours.

-    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.

In this leaflet:

1.    What Clenil Modulite is and what it is used for

2.    Before you use Clenil Modulite

3.    How to use Clenil Modulite

4.    Possible side effects

5.    How to store Clenil Modulite

6.    Further information

1.    What Clenil Modulite is and what it is used for

Clenil Modulite pressurised inhalation solution is used to help prevent the symptoms of mild, moderate or severe asthma. The active ingredient, beclometasone dipropionate, is one of a group of medicines called corticosteroids which are often referred to simply as steroids. Steroids have an antiinflammatory action reducing the swelling and irritation in the walls of the small air passages in the lungs, and so ease breathing problems.

2.    Before you use Clenil Modulite

Do not use Clenil Modulite:

•    if you are allergic to any of the ingredients of this medicine or to any other medicines used to treat asthma.

•    to treat a sudden attack of breathlessness. It will not help. Use a quick-acting ‘reliever' inhaler for this purpose and carry it with you at all times.

Take special care with Clenil Modulite and always tell your doctor if:

•    you are being, or have ever been, treated for tuberculosis (TB).

•    you must avoid alcohol for any reason.

•    your asthma seems to be getting worse. Perhaps you are more wheezy and short of breath than usual, your ‘reliever' inhaler seems to be less effective, you require more puffs from your ‘reliever' inhaler than usual, or you do not seem to be getting better.

Your doctor may need to increase the dose of your steroid inhaler or give you a course of steroid tablets, or change your treatment altogether. If you have an infection in your chest your doctor may prescribe a course of antibiotics.

•    when transferring from steroid tablets to an inhaler you find that, even if your chest is getting better, you feel generally unwell, you develop a rash, eczema ora runny nose and sneezing (rhinitis). Do not stop treatment with your inhaler unless your doctor tells you to.

If you have been treated for a long time with high doses of inhaled steroid, you may require a course of steroid tablets or possibly a steroid injection in times of stress. For example, during admission to hospital after a serious accident, before an operation, during an acute attack of asthma or if you have a chest infection or other serious illness. Your doctor will decide if you need any extra steroid treatment and will also advise you as to how long you need to take the course of steroid tablets and how you should reduce these as you get better.

If you are using Clenil Modulite instead of, or as well as taking steroid tablets, or if your doctor is trying to reduce the dose of your steroid tablets, you should carry a steroid warning card until your doctor tells you that you don't need to.

Taking other medicines:

Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Remember to take these medicines and your inhalers with you if you have to go into hospital.

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, or could become pregnant, talk to your doctor before using your inhaler.

Important information about some of the ingredients of Clenil:

Clenil Mindulite contains a small ameunt of alcohel. Ench actuation (puff) from your inhaler contains about 9 mg of ethanol.

3.    How to use Clenil Modulite

Clenil Modulite is available in 4 different strengths. Your doctor will have decided which strength you need. Clenil Modulite 200 and Clenil Modulite 250 are not suitable for children.

Always use your inhaler exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Instructions for using your inhaler are given after the dosage section.

It takes a few days for your inhaler to work. It is very important that you use it regularly.

Do not stop treatment even if you feel better unless told to do so by your doctor. Do not stop using your inhaler abruptly.

While you are using Clenil Modulite your doctor will want to check your asthma regularly by carrying out simple breathing tests and may need to carry out blood tests from time to time.

Dosage:

The starting dose will depend on how severe your asthma is and will be decided by your doctor.

It may be higher than the doses given below. Your doctor will prescribe the lowest dose of Clenil Modulite ttiat will control yous symptoms.

A device called a Volumatic spacer should always be used when:

•    edults, the elde^ and adolescents 16 years of age and otoer are taking total daily doses of Clenil Modulite of 1,000 micrograms or more,

•    when Clenil Modulite is used in P^oildnen and adolescents 15 years of age and under whatever (dose has beMn ^escribed.

Clenil Modulite 50 micrograms

The common starting dose is:

Adults and the elderly: 200 micrograms (4 puffs) twice a day Children:    100    micrograms    (2    puffs)    twice a day

Usually the most you would take in a day is:

Adults and the elderly: 800 micrograms (16 puffs)

Children:    400    micrograms    (8    puffs)

The total daily dose may be divided into 2, 3 or 4 doses per day.

Clenil Modulite 100 micrograms

The common starting dose is:

Adults and the elderly: 200 micrograms (2 puffs) twice a day Children:    100 micrograms (one puff) twice a day

Usually the most you would take in a day is:

Adults and the elderly: 800 micrograms (8 puffs)

Children:    400    micrograms    (4    puffs)

The total daily dose may be divided into 2, 3 or 4 doses per day.

Clenil Modulite 200 micrograms

The common starting dose is:

Adults and the elderly only: 200 micrograms (1 puff) twice a day

Usually the most you would take in a day is: 800 micrograms (4 puffs)

The total daily dose may be divided into 2, 3 or 4 doses per day.

This product strength is not suitable for children

Clenil Modulite 250 micrograms

The common starting dose is:

Adults and the elderly only: 500 micrograms (2 puffs) twice a day

Usually the most you would take in a day is: 2,000 micrograms (8 puffs)

The total daily dose may be divided into 2, 3 or 4 doses per day.

This product strength is not suitable for children

It takes a few days for this medicine to work. It is very important that you use it regularly.

Do no^s atop treatment even ^e you feel better unless told to da so by your doctor. Do not stop using younnhaler abruptly.

If you use more Clenil Modulite than you should:

Tell your doctor as soon as possible. Your doctor may want to check the cortisol levels in your blood and toerefore, may need to take a b.ood sample (cortisol is a steeoid hormons whip^c occurs naturally in the body).

Iⁿ is ^|mportant that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should not increase or decrease ^dose dose Ctoout see^ping madical advice.

If you forget to use Clenil Modulite:

If you forget to take your Clenil Modulite, miss out your forgotten dose and take the next dose when it is due.

Do no^f take more ^euffs toan you wdr^ told to take.

Please read back of this leaflet

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Instructions for use:

It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist will show you how to use your inhaler correctly and will check regularly that you are using your inhaler correctly. You must follow their instructions carefully, so that you know how, when and how many puffs to inhale and how often you must use your inhaler. The instructions should be on the pharmacist's label and are given in this leaflet. If you are not sure what to do or have problems inhaling then ask your doctor, nurse or pharmacist for advice.

1. To remove the mouthpiece cover, hold between the thumb and forefinger, squeeze gently and pull apart as shown. Check inside and outside to make sure that the mouthpiece is clean, and that there are no foreign objects.

Testing Your Inhaler: If the inhaler is new or if it has not been used for three days or more, one puff should be released into the air to make sure that it works.

2.    Hold the inhaler upright as shown, with your thumb on the base, below the mouthpiece. Breathe out as far as is comfortable.

3.    Place the mouthpiece in your mouth between your teeth and close your lips around it but do not bite it.

4.    Just after starting to breathe in through your mouth press down on the top of the inhaler to release a puff while still breathing in steadily and deeply

5.    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. Breathe out slowly.

6.    If you are to take another puff, keep the inhaler upright and wait about half a minute before repeating steps 2 to 5.

7.    After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly and snap into position.

Important: Do not rush steps 2, 3, 4 and 5.

It is important that you start to breathe in as slowly as possible just before operating the inhaler. Practice in front of a mirror for the first few times.

If you see ‘mist' coming from the top of the inhaler or the sides of your mouth, Clenil will not get into your lungs as it should. Take another puff, carefully following the instructions from Step 2 onwards.

People with weak hands or children 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.

If you find it difficult to operate the inhaler while starting to breathe in you may use the Volumatic spacer device. Ask your doctor, pharmacist or a nurse about this device.

However, the Volumatic spacer device must always be used if:

•    you are an adult, elderly or an adolescent 16 years of age and older and are taking total daily doses of Clenil Modulite of 1,000 micrograms or more,

•    Clenil Modulite is used in children and adolescents 15 years of age and younger, whatever dose has been prescribed.

Young children may find it difficult to use the inhaler properly and will require help. Using the inhaler with the Volumatic spacer device with a face mask may help in children under 5 years. Tell your doctor, nurse or pharmacist if you have any difficulties.

Cleaning:

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

•    Pull the metal canister out of the plastic case of the inhaler and remove the mouthpiece cover.

•    Rinse the plastic case and the mouthpiece cover in warm water. If you use a mild liquid detergent, rinse carefully with clean water before drying. Do not put the metal canister into water.

•    Leave to dry thoroughly in a warm place. Avoid excessive heat.

•    Replace the canister and mouthpiece cover.

It is important that you also read the Package leaflet which is supplied with your Volumatic spacer device and that you follow the instructions on how to use the Volumatic and on how to clean it, carefully.

4. Possible side effects

Like all medicines, Clenil Modulite can cause side effects, although not everybody gets them.

If you notice an immediate increase in wheezing, shortness of breath and cough straight after using your inhaler, stop using Clenil Modulite and use a quick-acting ‘reliever' inhaler immediately. Contact your doctor straightaway. Your doctor will review your asthma and may change your treatment and may prescribe a different inhaler to treat your asthma.

The following side effects have bedn reported. Tell your doctor as soon as possible if you suffer from any of these side effects but do not stop treatment unless toldto do so. Your doctor wilt tro to prevent these effects by prescribing Clenil Modulite in the lowest dose possible to control your asthma.

• Alleraic reactions including skin rashes, hives, itching or redness, or swelling of the face, eyes, lips and throat.

• Thrush in the mouth and throat. This is more likely if the daily dose taken is greater thus 400 micrograms. Thrngh oan tie treated with anti-fungal medicines whilst you continue to use Clenil Modulite. Brosting your tepte, on throughly rinsing your mouth with water immediately after each dose may help prevent thrush.

• Hoarse voice or a sore throst or tongue. Using aVolumatic spacer device or rinsing your mouth with water immediately after using your inhaler may help prevent this.

• Changes to the normal production of the steriods in the body, particularly after treatment with Clenil Modulite at high doses over a long period of time.

• If you become unwell or (develop symptoms such as loss of appetite, abdominal pain, weight loss, tiredne^si_t nausua (feeling sidr) vomiting (being sick) feeling faint_p oweating and possible convuls i oos fits), you should asnsult your (doctor. Thi s i s pert i cularly i mportant i f you have been exposed to stress such as surgery, infection, an acute attack of asthma, or other serious illness.

Your bodtor may carry out blood test from time to time to monitor the levels of steroids in your body.

• Children and adoleocents may grow more slowly and msy need to have their height checked regulsrly by their dpctor. This occurs particularly after treatment with Clenil Modulite at high doses over a long period of time.

• A decrease in bone mineral density (telming and weakening os the bones) and eye problems which include the formation of cataracts and glaucoma (increased pressure in the eye).

•    Sleeping problems, dypression or feeling worried, restless, nervous, over-excited or irritable. These

effects are more likely to occur in children.

• Headaches

• Nausea (feeling sick)

tf any ur the side effecfe gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting on side effects

e you gnt any side effects talk to your doctor, pharmacist, or nurse. This includYs any possible side effects not listed in this; leaflet. You can also report side effects directlp via the YellowCard Scneme 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 Clenil ModuNte

•    Keep this mtidic^iMe out of the sight and reach of children.

• So not use Clenil Modulite after the expiry date which is stated on the carton and label. The expiry date refers th the last day of th at month.

• Do not store the inhaler abova 30^oC. Protect from frost and Sirect sunlight.

• If the inhaler gets veiy sold, take the metal canisten out of ths ptastic case and warm it in your hands fos a hew minutes before use. Never usw anything else to warm it up.

•    Medicines should not be disposed oI via wastewateh or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Warning: The canister contains a pressurised liquid. Keep away from heat and direct sunlight, do not expose to high temperatures (above 50°C) and do not puncture or burn (incinerate), even when empty.

6.    Further information

What Clenil Modulite contains

The active subatance of your inntler is beclometasone dipropionate. Each puff contains 50, 100, 200 or 250 micrograms os beclgmetasone dipropionate.

The other ingredients are glyserot ethanol aco the CFC-free propellant norflurane (HFA-134a).

To oelp prated the environment, the inhaler contains the CFC-free proaeilant HFA-l34a, which replsces completely the chloro nuorocarbon (CF C) propellants and appear! ta have a less damaging effect on the ozone layer The on ly differences you might notice from your previous CFC-containing inhaler are the taste and the feel of the spray in your mouth.

Whint Clenil Modulite looks like aad content of tce pack

Clenil Modulite is a pressurised inhalation solution contained in an aluminum can with plastic actuator and protective cap. Each canister contains 200 puffs.

Marketing Authorisation Holder and Manufacturer

The MarSeting Autnorisation Holder of Clenil Modulite is Chiesi Limited, 333 Styal Ro;

M22 5LG, Uctted Kingdom.

The manufacturer of Clenil Modulite is Chiesi Farmaceutici S.p.A., 26/A Via Palermo,

43122 Parma, Italy.

Is this leaflet hard to see or read?

Phone 0161 488 5555 for help.

The leaflet was last revided in 07/2015

Volumatic is a registered trademark of the GlaxoSmithKline Group of Companies.

CP0016/9    87K89.14/01

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