Skip to Content

UK Edition. Click here for US version.

RELENZA 5MG INHALATION POWDER

Active substance(s): ZANAMIVIR / ZANAMIVIR

View full screen / Print PDF » Download PDF ⇩
Transcript
1 What Relenza is and what it is used for

Package Leaflet: Information for the User

2 What you need to know before you
use Relenza
3 How to use Relenza
4 Possible side effects

5 mg per dose, inhalation powder,
pre-dispensed
zanamivir
Read all of this leaflet carefully before you start
using this 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’t pass it on to others. It may harm them, even
if their signs of illness are the 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.

Reporting of side effects
If you get 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: 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 Relenza
Keep this medicine out of the sight and reach
of children.
Don’t use 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).

10000000139181

What Relenza looks like and
contents of the pack
Relenza powder is contained in the
four blisters on the silver-coloured
aluminium foil disk, called a Rotadisk.
Each blister contains 5 mg of
zanamivir. The medicine is inhaled
through the mouth from the Rotadisk
using a plastic device called a
Diskhaler.

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, which belongs to
a group of medicines called antivirals.
Relenza is 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 needs to be inhaled (breathed in)
into the lungs, because it is poorly absorbed
into the body if it is swallowed. The flu virus
infects the lungs, and when you inhale
Relenza it works directly on the virus inside
your lungs.
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.

Relenza is supplied in 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.

before you use Relenza

Don’t use Relenza:
• if you’re allergic 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
• other lung 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 medication for 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.

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name:
Relenza 5 mg
Reference number: 10949/0327
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in: December 2015
Relenza, Diskhaler and Rotadisk are trade
marks of the GSK group of companies.
© 2015 GSK group of companies

If you use inhaled medication for 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’ inhaler to 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 medication for asthma or
other breathing problems, make sure you
have read the advice above.
If you have been advised to have a flu
vaccination
You can be vaccinated at any time, even if
you’re using Relenza to help prevent you
from getting flu.

Don’t take it apart until you have
looked at the step-by-step guide.

Pregnancy and breast-feeding
If you are breast-feeding, 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 use this medicine exactly as your doctor
or pharmacist has told you to. Check with your
doctor or pharmacist if you’re not sure.
Relenza is a powdered medicine, which you
inhale into your lungs through your mouth,
using the Diskhaler™ device. The powder is
contained in blisters on a Rotadisk™ — a foil
disk which you load into the Diskhaler.

Don’t give Relenza to children under 5 years old.

If there is a flu outbreak in your local community:

When to start using Relenza

• 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 have flu, for maximum benefit, you
should start using Relenza as soon as possible
when you get flu symptoms:
• for adults, within 48 hours after the first
symptoms

If you use more Relenza than you
should

• for children, within 36 hours after the first
symptoms.

If you accidentally use too much Relenza, it’s
unlikely to cause you any problems.

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:

But if you’re worried, or you feel unwell,
especially if you have asthma or other lung
problems:
➔ Ask your doctor for advice.

• For adults and children, within 36 hours of
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 depends on
whether you already have flu, or you are
using Relenza 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 prevent flu:
• If someone in your household has flu:
Adults and children (aged 5 years or
more): the usual dose is 2 inhalations
(2 blisters) once a day for 10 days.

The medicine in the Rotadisks must only be
inhaled using the Diskhaler device.

If you forget to use Relenza
If you forget a dose of Relenza, take your
usual dose as soon as you remember, then
carry on as before.
Don’t use a double dose to make up for a
forgotten dose.

If you stop using Relenza
For treating flu, it’s important 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 it carefully before you use 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, although not everybody gets them.

Conditions you need to look out for:
Severe allergic reactions
These are rare and affect less than 1 in
1,000 people 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 1,000 people 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 less than 1 in 100 people 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 Relenza and get medical help
immediately. Contact your doctor or the
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.
turn over

Step-by-step guide to using your Relenza Diskhaler

The Diskhaler has three parts:

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd,
Stockley Park West,
Uxbridge, Middlesex, UB11 1BT.
Manufacturer:
Glaxo Operations UK Limited (trading as
Glaxo Wellcome Operations), Harmire Road,
Barnard Castle, County Durham, DL12 8DT,
United Kingdom
Other formats:
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

Using Relenza with inhaled
medication for breathing problems

2 What you need to know

10000000139181

What is in this leaflet

Cover

Remove the blue cover.
Check that the
mouthpiece is clean,
inside and outside.

2

Hold the white sliding
tray as shown and pull
it out until it stops.

Sliding tray
Mouthpiece
(with a small airhole on each side)

Main body

To inhale your dose of Relenza:

To load a Rotadisk into the Diskhaler:

1

Wheel
The Rotadisk fits onto this.
Finger grip
Piercing needle
This pierces the blisters on the Rotadisk,
to make the medicine ready to inhale.

The Rotadisk fits onto the wheel of the
Diskhaler.
Each of the four blisters on the Rotadisk
contains a single dose of Relenza.

4

• You can keep a Rotadisk on the Diskhaler between doses, but
don’t pierce a blister until just before you inhale your dose.
• Keep the Diskhaler clean. Wipe the mouthpiece with a tissue
after you use it, and replace the blue cover between uses.

If you’re not ready to inhale a dose of Relenza
straight away, replace the blue cover.

Don’t put the Diskhaler into your mouth yet.
Breathe out as far as is comfortable, keeping the Diskhaler
away from your mouth. Don’t blow into the Diskhaler. If
you do, you’ll blow the powder out of the Rotadisk.
Place the mouthpiece between your teeth. Close your lips
firmly around the mouthpiece.
Don’t bite the mouthpiece. Don't block the airholes on the
side of the mouthpiece.
Take one quick, deep breath in through the mouthpiece.
Hold this breath for a few seconds.
Remove the Diskhaler from your mouth.
Carry on holding your breath for a few more seconds or as
long as is comfortable.

Keep the Diskhaler horizontal

Don’t do this until just before you inhale a dose.

3

The Rotadisk fits into the Diskhaler

Important: • Don’t pierce any of the blisters on the Rotadisk before you
load it onto the Diskhaler.

7

Push the white tray back
into the main body.

To get your dose ready to inhale:

Hinged lid
Refer to the
step-by-step guide

5

Gently squeeze the
finger grips on the sides
of the white tray.
Remove the tray from
the main body.
The white tray should
come out easily.

Place a new Relenza
Rotadisk on the wheel.
Make sure the printed
side is up, with the
blisters facing
downwards.
The blisters fit into the
holes in the wheel.

6

Hold the Diskhaler
horizontally.
Flip the lid up as far as
it will go.
The lid must be fully
vertical, to make sure
that the blister is
pierced at both the top
and bottom.

To prepare the next blister (the second part of your dose):

8

Pull the white tray out as far as it will go (don’t remove it
completely), then push it back in again.
This will turn the wheel so the next blister will appear.
Repeat if necessary until a full blister is positioned under
the piercing needle.
Repeat steps 6 and 7 to inhale the medicine.

9

After you’ve inhaled the full dose (normally two blisters):
Wipe the mouthpiece with a tissue and replace the blue
cover. It’s important to keep the Diskhaler clean.

Keep the Diskhaler
horizontal

Push the lid back down.
Your Diskhaler is now ready for use.
Keep it horizontal until you have inhaled your
dose.
If you use other inhaled medication, make sure
you read ‘Using Relenza with inhaled medication
for breathing problems’ in Section 2 of this leaflet.

To replace the Rotadisk:

10

When all four blisters are empty, remove the Rotadisk from
the Diskhaler and insert a new one, using steps 1 to 5.

Page 1 of 2

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide