Leaflet

PulviSal CP0017-3 Type IB Paediatric Safety update approved 101212:Leaflet 11/12/2012 15:05 Page 1 PACKAGE LEAFLET: INFORMATION FOR THE USER
RELIEVER
Pulvinal® Salbutamol 200 micrograms
Read al of this leaflet careful y 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 - If any of the side ef ects become serious, or if you notice any side ef ects not listed in this leaflet, please tel 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. How to 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 il nesses and to avoid asthma symptoms brought on by exercise or other ‘triggers’. Common ‘triggers’ include pol en, cigaret e smoke, house dust, cats and dogs.
The active ingredient, salbutamol, is one of a group of medicines cal ed bronchodilators or ‘relievers’. Salbutamol relaxes the muscles in the wal s of the
smal 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 al ergic to salbutamol or any of the other ingredients contained in • to treat premature labour or a threatened miscarriage.
Take special care with Pulvinal Salbutamol and always tel your doctor if:
• you suf er from an over active thyroid gland • your asthma seems to be get ing worse. Perhaps you are more wheezy or short of breath than usual, your inhaler seems to be less ef ective, you require more puf s from your inhaler than usual, or you do not seem to be get ing bet er. Your doctor wil re-assess your asthma and may change your treatment or give you an extra medicine.
• you suf er from any disease of the heart or if your symptoms appear to be • you experience chest pains
Taking other medicines
Before starting treatment, please tel your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a Remember to take these medicines and your inhalers with you if you have to go into hospital.
In particular, tel your doctor if you are taking: • beta-blockers (such as propanolol) or water tablets (diuretics), used to treat • theophyl ine, aminophyl ine 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 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. How to 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 wil 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 ef ects).
Dosage
Adults, adolescents aged 12 years and over, and children 4 to 11 years of age
Take one puf (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 pol en, cigaret e smoke, house dust, cats and dogs, take one puf (200 micrograms) 10-15 minutes before exercise or exposure to a ‘trigger’.
After taking a puf , you must wait for four hours before taking another puf .
Do not take more than 4 puf s (800 micrograms) in any 24 hour period.
If you use more Pulvinal Salbutamol than you should
If you accidental y take more puf s than you should, you may notice that your heart is beating faster than usual and that you feel shaky. These ef ects usual y disappear after a few hours, but you must tel your doctor as soon as possible.
Please read the back of this leaflet
PulviSal CP0017-3 Type IB Paediatric Safety update approved 101212:Leaflet 11/12/2012 15:05 Page 2 Instructions for use
It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist wil show you how to use your inhaler correctly and wil check regularly that you are using your inhaler correctly. You must fol ow their instructions careful y, so that you know how, when and how many puf s 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.
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. If necessary, wipe the mouthpiece with a fibre-free tissue or soft cloth. Hold the inhaler upright and tap it gently 1 against a hard surface to level the powder in the container.
B. Loading the dose
2. Hold the inhaler upright, press the blue but on on the mouthpiece with one hand and with the other hand rotate the inhaler anti-clockwise through 180 degrees until a red mark
shows through the hole in the mouthpiece. This is the loading 2 position.
3. Keep holding the inhaler upright, and rotate the inhaler 3 clockwise through 180 degrees until it makes a click and a green
mark shows through the hole in the mouthpiece. This is the dose-delivery position.
C. Administration
4. Breathe out deeply (not through the inhaler) as far as is comfortable.
5. Put the inhaler between your lips, keep holding the inhaler 5 upright and breathe in through your mouth as quickly and deeply
as possible. Hold your breath for a few seconds.
D. Closing
6. Remove the inhaler from your mouth. Replace the protective General Advice
- Always keep the inhaler upright during the loading of the dose and - How wil you know when your inhaler is empty? When you can see a red
ring at the bot om of the container your inhaler needs to be replaced. If you continue to use your inhaler when you can see the red ring you may not get the correct dose that has been prescribed for you.
- When you have finished using Pulvinal, check that the hole in the mouthpiece is placed over the green mark. Then close the inhaler.
- If you can feel a slightly sweet tasting powder in your mouth after inhaling, you have received the dose and the active substance has reached your lungs.
- The inhaler base contains a desiccant capsule to keep the powder inside your inhaler dry. Always replace the inhaler cap after you have used the inhaler.
If, however, you leave the inhaler cap of for short periods (e.g. 24 hours) at room temperature, it is stil alright to use the inhaler.
- If you accidental y blow into the inhaler, simply hold the inhaler upside down and tap it onto a hard surface to empty the powder out of the dosage chamber.
If you think you may have accidental y loaded two or more doses into the chamber, hold the inhaler upside down and tap it on a hard surface to empty - During use, regularly wipe the mouthpiece with a fibre-free tissue or soft cloth.
4. Possible side effects
Like al medicines, Pulvinal Salbutamol can cause side ef ects, although not
Very rare al ergic reactions, including net le rash or hives, wheezing, fal in blood pressure, col apse or painless swel ing of the skin on the face, neck, hands, feet and lips have been reported. If you experience any of these, contact your doctor or If your breathing or wheezing gets worse straight after using your inhaler,
stop using Pulvinal Salbutamol and contact your doctor straightaway. Your doctor
wil review your asthma and may change your treatment and may prescribe a dif erent inhaler to treat your asthma.
Abnormal y low levels of potassium in the blood (hypokalaemia) can be caused
by regular use of ‘reliever’ inhalers, such as Pulvinal Salbutamol. The low levels of potassium, which can cause you to feel weak and thirsty, can worsen during an acute asthma at ack. Therefore, while you are using Pulvinal Salbutamol your doctor may need to carry out blood tests from time to time.
Throat irritation or cough sometimes occurs if you are sensitive to inhaling a dry powder. Rinsing your mouth after inhalation may help prevent this.
The fol owing side effects have also been reported. Tel your doctor as soon as
possible if you suf er from any of these side ef ects but do not stop treatment
unless told to do so:Common (af ects less than 1 in 10 people) • headacheUncommon (af ects less than 1 in 100 people) Rare (af ects less than 1 in 1,000 people) • increased blood flow to your extremities • muscle crampsVery rare (af ects less than 1 in 10,000 people) • irregular heartbeat or an extra beat of the heart • rapid heartbeats with or without flushingUnknown • restriction of bloodflow to the heart • dizzinessIf any of the side ef ects get serious, or if you notice any side ef ects not listed in this leaflet, please tel your doctor or pharmacist.
5. How to store Pulvinal Salbutamol
• Keep out of the reach and sight of children.
• Do not use Pulvinal Salbutamol after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
• Do not store above 30ºC. Keep the container tightly closed.
• Always replace the cap after use.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures wil help to protect the environment.
6. Further information
What Pulvinal Salbutamol contains
The active substance of your inhaler is salbutamol. Each puf contains 200 micrograms of salbutamol.
The other ingredient is lactose monohydrate.
What Pulvinal Salbutamol looks like and contents of the pack
Pulvinal Salbutamol is an inhalation powder contained in a multi-dose container with plastic mouthpiece and protective cap. Each pack contains one inhaler which provides 100 puf s.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder of Pulvinal Salbutamol is Chiesi Ltd, Cheadle Royal Business Park, The manufacturer of Pulvinal Salbutamol is Chiesi Farmaceutici S.p.A., 26/A Via Palermo, 43100 Parma, Italy.
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Pulvinal® is a trade mark of Chiesi Farmaceutici S.p.A.
Pulvinal® is a trade mark of the same patented Chiesi DPI.

Source: http://www.chiesi.uk.com/system/files/31/original/Pulvinal_Salbutamol_CP0017-3_.pdf?1355493441