Relenza
Package Leaflet: Information for the user
Relenza
5 mg perdose, inhalation powder, pre-dispensed
Read all of this leaflet carefully before you start usingthis medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Don’tpass it on to others. Itmay harm them, even if their signs of illness arethe same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1 What Relenza is and what it is used for
2 What you need to know before you useRelenza
3 How to useRelenza
4 Possible side effects
5 How to store Relenza
6 Contents of the pack and other information
1. What Relenza is and what it is used for
Relenza contains zanamivir, whichbelongs to a group of medicines called antivirals.
Relenzais used to treat flu(influenza virus infection). It reduces the symptoms of flu, and helps you recover more quickly.
Relenza is also used to help prevent you from getting flu, during a flu outbreak.
Adults and children aged 5 years or more can be treated with Relenza.
Relenza needsto be inhaled (breathed in) into the lungs, becauseit is poorlyabsorbed into the body if it isswallowed. The fluvirus infects the lungs, and whenyou inhale Relenza it works directly on the virus inside yourlungs.
Relenza is not a substitute for flu vaccination. You still need to talk to your doctor about whether you need to be vaccinated against flu.
2. What you need to know before you use Relenza
Don’t use Relenza:
if you’reallergic to zanamivir or any of the other ingredients of this medicine (listed in section 6).
Take special care with Relenza
If you feel tightness in your throat or chest when you use Relenza
In very rare cases, Relenza can cause a reaction including:
tightness of the throat and chest
difficulty breathing.
If you get any of these symptoms when you use Relenza:
Stop using Relenza and get medical help immediately. Contact your doctor or the nearest hospital emergency department.
Don’t give Relenza to children under 5 years old.
If you have asthma, or other problems with your lungs or your breathing
Your doctor needs to know if you have:
asthma
otherlung disease that causes breathing problems— for example,emphysema, chronic obstructive pulmonary disease (COPD),or chronic bronchitis.
Tell your doctor before you use Relenza, so that he or she can supervise you more closely to check that your condition is being controlled.
If you use inhaled medicationfor your asthma or other breathing problem, read the next part of this leaflet — Using Relenza with inhaled medication for breathing problems— carefully, before you use Relenza.
Using Relenza with inhaled medication for breathing problems
If you use inhaled medicationfor asthma or any other breathing problem, carry on using your inhaler(s) at the usual times.
If you have been advised to use Relenza at the same time of day as your other inhaled medication, use the other medication a few minutes before you use Relenza.
Make sure you have your fast-acting ‘reliever’ inhaler(such as salbutamol) to hand when you use Relenza.
In very rare cases, Relenza can cause a reaction including:
tightness of the throat and chest
difficulty breathing.
If you get any of these symptoms when you use Relenza:
Stop using Relenza. Use your fast-acting ‘reliever’ inhalerto help your breathing. Get medical help immediately. Contact your doctor or the nearest hospital emergency department.
Other medicines and Relenza
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
If you use inhaled medicationfor asthma or other breathing problems, make sure you have read the advice above.
If you have been advised to have afluvaccination
You can be vaccinated at any time, even if you’re using Relenza to help prevent you from getting flu.
Pregnancy and breast feeding
If you are breastfeeding, pregnant, or if you could be pregnant:
Talk to your doctor before you use Relenza.
There is only limited information about the safety of Relenza for pregnant women. Although there is no evidence so far that Relenza harms unborn babies, your doctor may advise you not to use it during pregnancy.
You should not breast feed while you are using Relenza.The active ingredient (zanamivir) could get into breast milk.
Driving and using machines
Relenza should not affect your ability to drive or use machines.
Relenza contains lactose and milk protein.
Relenza contains a sugar called lactose, and may contain milk protein.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to use Relenza
Always usethis medicine exactly as your doctor or pharmacist has told youto. Checkwith your doctor or pharmacist if you’re not sure.
Relenza is a powdered medicine,which you inhaleinto yourlungs through your mouth, using the Diskhalerdevice.The powder is contained inblisters ona Rotadisk—a foil disk which you loadinto the Diskhaler.
The medicine
in the Rotadisks must only be inhaled using the Diskhaler
device.
Don’t give Relenza to children under 5 years old.
When to start using Relenza
If you have flu,for maximum benefit, you should start using Relenza as soon as possible when you get flu symptoms:
for adults,within 48 hoursafter the first symptoms,
for children,within 36 hoursafter the first symptoms.
To help prevent flu
If someone in your household has flu, to help prevent you getting it, you should start using Relenza as soon as possible after you have come into contact with them:
For adults and children, within 36 hoursof contact with the infected person.
If there is a flu outbreak in your local community, follow your doctor’s advice on when to start using Relenza.
How much Relenza to use
The amount of Relenza you use dependson whether you already have flu, or you are usingRelenza to help prevent flu.
If you have flu:
Adults and children (aged 5 years or more):the usual dose is 2 inhalations (2 blisters) twice a day for 5 days.
To help preventflu
If someone in
your household has flu:
Adults and
children (aged 5 years or more):theusual dose is 2 inhalations
(2 blisters) once a day for 10days.
If there is a
flu outbreak in your local community:
Adults and children (aged 5 years or more):The recommended dose is 2 inhalations (2 blisters) once a
day for up to 28 days
If you usemore Relenza than you should
If you accidentally usetoo much Relenza, it’sunlikely to cause you any problems.
But if you’re worried, or youfeel unwell, especiallyif you have asthma or other lung problems:
Ask your doctor for advice.
If you forget to useRelenza
If you forget a dose of Relenza, take your usual dose as soon as you remember,then carry onas before.
Don’t usea double dose to make up for a forgotten dose.
If you stop using Relenza
For treating flu,it’simportant that you complete the full course of treatment(normally 5 days), even if you are feeling better. Otherwise,the flu symptoms may come back.
If you think you may want to stop your Relenza treatment early:
Ask your doctor for advice.
There’s a step-by-step guide on the other side of this leaflet, showing you how to use the Relenza Diskhaler.
Read itcarefully before youuse your first dose. If you’re still not sure how to use the Diskhaler, ask your pharmacist to go through the instructions with you.
4. Possible side effects
Like all medicines, this medicine can cause side effects, althoughnot everybodygets them.
Conditions you need to look out for:
Severe allergic reactions
These are rare and affect less than 1 in 1000people using Relenza. Signs include:
Raised and itchy rash (hives).
Swelling, sometimes of the face, mouth or throat, causing difficulty in breathing.
Collapse.
If you get any of these symptoms:
Contact your doctor immediately.
Serious skin reactions
These side effects are rare and may affect less than 1 in 1,000people using Relenza:
Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), extensive peeling of the skin on much of the body surface – (toxic epidermal necrolysis).
If you notice any of these symptoms contact a doctor immediately. Stop taking Relenza.
Other common side effects
These
affect less than 1 in 10
people using Relenza:
Skin rash
Other uncommon side effects
These affect lessthan 1 in 100people using Relenza:
Tightness of the throat or chest, feeling short of breath,or sudden difficulty in breathing. If you have lung disease (such as asthma or COPD), you may need to be monitored while you’re using Relenza in case you get this side effect.
Swelling of the face, mouth or throat.
Hives(itchy bumps on your skin).
Fainting and feeling lightheaded. If you are feeling unwell when you take Relenza you may faint or become lightheaded after inhaling Relenza. You must sit down in a relaxed position before inhaling the dose of Relenza, and you must only hold your breath for as long as is comfortable after inhaling the dose.
If you are feeling unwell, you are advised to have someone with you while you are inhaling the dose of Relenza.
If you get any of these effects:
Stop using Relenzaand get medical helpimmediately. Contact your doctor orthe nearest hospital emergency department.
Sudden changes in behaviour, hallucinations and fits
During treatment with Relenza, changes in behaviour such as confusion and unresponsiveness have occurred. Some people may also have hallucinations (seeing, hearing, or feeling things not there) or fits (seizures) which can lead to loss of consciousness. Parents should be especially careful to watch out for these symptoms if their child or teenager has flu. These symptoms have been seen in people with flu who were not taking Relenza. Therefore it is not known if Relenza played a part in causing them.
If you get any of these symptoms:
Contact your doctor immediately.
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 national reporting system listed in
Appendix V.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Relenza
Keep this medicineout of the sight and reach of children.
Don’tuse Relenza or the Diskhaler after the expiry date which is stated on the pack.
Don’t store Relenza above 30 °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 Relenza contains
The active substance is zanamivir (5 mg per dose).
The other ingredient is lactose monohydrate (which contains milk protein).
What Relenza looks like and contents of the pack
Relenza powder is contained in the fourblisters on the silver-colouredaluminium foil disk, called a Rotadisk. Each blistercontains 5 mg of zanamivir.Themedicine is inhaled through the mouth from the Rotadisk using a plastic device called a Diskhaler.
Relenza is suppliedin two types of pack:
a 1-day starter pack containing one Relenza Rotadisk and one Diskhaler
a 5 -day treatment pack containing five Relenza Rotadisks and one Diskhaler
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline AB
169 29 Solna
Sweden
Manufacturer
Glaxo Wellcome Production
Zone Industrielle No.2
23 Rue Lavoisier
27000 Evreux
France
Aspen Bad
Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Harmire Road
Barnard Castle
County Durham
DL12 8DT
United Kingdom
<Local representative-to be completed nationally>
This leaflet was last revised in: 2016-01-14
The Diskhaler has three parts:
Don’t take it apart until you have looked at the step-by-step guide.