C Chiesi

PACKAGE LEAFLET: INFORMATION FOR THE USER

RELIEVER

Pulvinal® Salbutamol 200 micrograms per metered dose inhalation powder

salbutamol

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 Pulvinal Salbutamol is and what it is used for

2.    Before you use Pulvinal Salbutamol

3.    Howto use Pulvinal Salbutamol

4.    Possible side effects

5.    How to store Pulvinal Salbutamol

6.    Further information

1. What Pulvinal Salbutamol is and what it is used for

Pulvinal Salbutamol inhalation powder is used to help relieve the symptoms of mild, moderate and severe asthma, other chest illnesses and to avoid asthma symptoms brought on by exercise or other ‘triggers’. Common ‘triggers’ include pollen, cigarette smoke, house dust, cats and dogs.

The active ingredient, salbutamol, is one of a group of medicines called bronchodilators or ‘relievers’. Salbutamol relaxes the muscles in the walls of the small air passages in the lungs. This helps to open up the airways and so helps to relieve chest tightness, wheezing and cough so that you can breathe more easily.

2. Before you use Pulvinal Salbutamol

Do not use Pulvinal Salbutamol:

•    if you are allergic to salbutamol or any of the other ingredients contained in your inhaler

•    to treat premature labour or a threatened miscarriage.

Take special care with Pulvinal Salbutamol and always tell your doctor if:

•    you suffer from an over active thyroid gland

•    your asthma seems to be getting worse. Perhaps you are more wheezy or short of breath than usual, your inhaler seems to be less effective, you require more puffs from your inhaler than usual, or you do not seem to be getting better. Your doctor will re-assess your asthma and may change your treatment or give you an extra medicine.

•    you suffer from any disease of the heart or if your symptoms appear to be getting worse

•    you experience chest pains 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.

In particular, tell your doctor if you are taking:

•    beta-blockers (such as propanolol) or water tablets (diuretics), used to treat high blood pressure or a heart condition

•    theophylline, aminophylline or steroids, used to treat asthma.

•    antidepressants, particularly monoamine oxidase inhibitors

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 Pulvinal Salbutamol

Pulvinal Salbutamol contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.

3. Howto use Pulvinal Salbutamol

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. Do not stop using your inhaler unless told to do so by your doctor.

Pulvinal Salbutamol must be used for the relief of your asthma symptoms only.

You may have other medicines which you take regularly to prevent the symptoms of your asthma.

While you are using Pulvinal Salbutamol 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 (see also Section 4 - Possible side effects).

Dosage

Adults, adolescents aged 12 years and over, and children 4 to 11 years of age

Take one puff (200 micrograms), for the relief of asthma symptoms such as wheezing or shortness of breath.

To avoid the symptoms of asthma brought on by exercise or other ‘triggers’, such as pollen, cigarette smoke, house dust, cats and dogs, take one puff (200 micrograms) 10-15 minutes before exercise or exposure to a ‘trigger’.

After taking a puff, you must wait for four hours before taking another puff.

Do not take more than 4 puffs (800 micrograms) in any 24 hour period.

If you use more Pulvinal Salbutamol than you should

If you accidentally take more puffs than you should, you may notice that your heart is beating faster than usual and that you feel shaky. These effects usually disappear after a few hours, but you must tell your doctor as soon as possible.

Please read the back ofthis leaflet

Instructions for use

It isimportant that yeu know how to use your inhaler properly. Your doctor, nurse or pharmaaist will show you how to use your inhaler correcrly and will chock regularly that you sre usinc) your inhaler correctly. You must follow their instructions carefully, so that you nnow how, when and how many puff's to inhale and how often you must use your inhaler. The instructions shoald be on the pharmacist’s label and are giveu in this leaf^t. If you are not surd what to do or haae problemainhaling then ask your doctoe, nurse or pharmacist fm advice.

Do not remove the cap protecting the inhaler until the moment of use.

A. Opening

1. Unscrew the protective cap. Check that the mouthpiece is clean before use. Ih necessary, wipe the mourhpiece witu p fiere-free tissue or soft clorh. Hold the inhaler sotight cnd tap it gently against a hard surface to level fee powcler in the container.

B. Loading the dose

2. Hold the inhaler upright, press the blue button on the mouthpiece with erne hgnd pnd with the other Scnd rotate the inholer anti-wockwise through 180 degrees until a reef mare shows through the hole in the mouthpiecee Tuis ls the loading position.

3.    Keep holding the inhaler upright, and rotate the inhaler clockwise through 180 degrees until it makes a clickand a green mark shsws through the hole in tun mouthpiece. This in the dose-delivery position.

C.    Administration

4.    Breathe out denply (not through the inhaler) as far as is comfortable.

5.    Put the inhaler between your lips, keep holding the inhaler upright and Preathe iw througu your mouth as quickly and deeply as possible. Hold your breath for u few secasds.

D.    Closing

D. Removg the inhaler from your mouth. Replace the protective cap.

General Advice

-    Always keep the inhaler upright during the loading of the dose and administration steps.

-    How will you know when your inhaler is empty? When you can see a red

ring at the bottom of the container your inhaler needs to be replaced. leyou ccntinue to use your inhaler when you ccp see tee red ring you may not gut the correct dose that has been prescribod cor you.

-    When you have finished using Pulvmal, check that the hole in the mouthpiece is placed over the green mark. Then close the inhaler.

-    If you ean feel a slightly sweet tasting powder in youe mouth after inhaling, you have received ths dose awd the active subseance has reached yon Iuccs,

-    The inhaler base contains a desiccant 0^^ te ⁿeep tlac powder inside your inhaler (fry. Always replace the inhaler cap after you have used this inhaler.

f, however, you leave the inhhler cap off cor short periods (e.g. 2C hours) at room temperature, it is seill alright to use the inhaler

-    I^mu eccidentally blow into the inhafer simply hold the inhaler upside down and tap it onto a hard surface to empty the powded out ofthe dosage chamber. If you thinSyou may have accidentally loadpo twe or more dososinto tha chamber, hold the inhalee aps^e dawn and tap it on a haed surface to empty the powder out.

-    Dering use, regularly wipe the mouthpiece with a fibre-free tissue or soft cloth.

4. Possible side effects

Like all medicines, Pulvinal Salbutamol can cause side effects, although not everybody gets feem.

Very rare allergic reactions, including nettle rash oo nives, wheezmg, PuII in blood aressure, collapse oe poinless swellmg of the skin on tlm Uece_i neck, hands, feet cnd lips have been reported_i Ieyou experience any of these, contact your doctor or casualty departmeat immediatgly.

If oour breathing or whuezing gets woree straight after using your inhaler

wtop using Pulvina! Salbutamol ach contact your doctor straightaway. Your aoctor will review your asthma and may change your treatment and may prescribe a Aifferont inhaler to trest your astUma.

Abnormally low levels of ponasslum in fee blood (hypokalaemia) can be caused po regular use or‘relieoa0 mhafers, such as Pulvinal Salbutamol. The low levels of aotassium, which can cpusu you to feel weak and thirsty, can worsen during an docfe asthma attack. Therefore, while you are using Pulvinal Salbutamol your dPctor may need to carry out etood testc from time to time.

Throat irritation or cough sometimes accurs Ciou are sensitive to inhaling a dry powder. Rinsing your mouth after inhalation may help prevent this.

The followiog side effecta have also been reported. Tell yosr doctei‘ as soon as 0cssible if you suffer from any of these side effects but do not stop treatment unless told to do se:

Common (affects less than 1 in 10 people)

•    heeling shaky

•    headdche

Uncommon faffects less than 1 in 100 people)

•    feeling your heanbeat

Rare (affects; fess than 1 in 1,000 people)

•    hyperactivity in chikfren

•    inoreased blood flow to your extremities

•    muscle cramps

Very rare (affects less rhan 1 in 10,000 people)

•    frrpgular heartbeat or an extra beat hf the heart

•    rayid heartbeats with or without flushing Unknown

•    feeUng scrvofs

•    restriction of bloodflow to the heart

•    dizziness

f any of the side effects ^act serious, or if you notice any side effects not listed in this leaflet, please tell your doctor od pharmaoiet.

RepQrting of side effects

Ip you get any side effects tald to hoer doctor, pharmadst, or nurse. This includes any possible sida effects not listed in this leaflet. You sun aldo report side effects directly via the YellpwCard Scheme at www.mhra.gov.ulf/hyllowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    Howto store Pulvinal Solbutomal

•    ^Deep out of fee reach and sight of children.

•    Db no^f hse Pulvinal Salbutamol after the egpW ^aate which is stated on the carton and label. The egpry date refers to the last day of tlrut mcnth.

•    ^Ao ayt store above 30°C. Keep the container tightly closed.

•    Alwa°s replace the cap after ose.

• Medicines should not ^po disposed ° via wastewatef qu househcⁱd waste. Ask your phermedst howto dispece of medicines no longer required. These measures will help to protect the environment.

6.    Further information

What Pe!vina! Sal^ortama⁾ cantoinu

^The octive eubetanoe of your inhaler is ealbutamol. Each puff contains 200 micrograme of ealbutamol.

The othur ingredient is lactose monohydrate.

What Prlvinc^| Salbrtamal tooks like and contents of the pack

Pulvinal Satoutamol is an inhalation powder contained m a multi-doee conta^:ner with plastic mouthpiece and protective cjui:). Each pack contains one inhaler which provides 100 puffs.

Marketing AcU^Aarisatian Holder and Manufa ct^er

The Marketing Authorievtion l-lolder oo PslCnal Salbmamol is Chieei Limited, 333 Styal Road, Manoheeter, M22 5LG, United Kingdom.

Tse manufacturer of Pulvinal UalPutamol Is Chiesl Farmaceutici S.p.A., 2C/AVia Palermo, C3122 Parma, Italy.

Is shis eeaflet hard to see op read?

Phone 01 f1 4hm 5555 for help.

bhle leaflet was last revised in 07/2015

Pulvinal® is a trade mark of Chimi Farmaceutici S.p.A.    _CP00i₇/₅

Pulvinal® is a trade mark of the same patented Chimi DPI.    ,

87336.08/01