Relenza

PACKAGE LEAFLET

Package leaflet: information for the user

RELENZA

5 mg/dose inhalation powder in a single-dose container
zanamivir
Please read this entire leaflet carefully before you start using this medicine, as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet
1. What Relenza is and what it is used for
2. What you need to know before using Relenza
3. How to use Relenza
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, which belongs to a group of medicines called antivirals.
Relenza is used to treat influenza (infection caused by the influenza virus). It reduces influenza symptoms and helps you recover more quickly.
Relenza is also used to help prevent influenza during an influenza outbreak.
Relenza can be used in adults and children aged 5 years and older.
Relenza must be inhaled (breathed in) into the lungs, as it is poorly absorbed into the body if swallowed. The influenza virus infects the lungs, and when Relenza is inhaled, it acts directly on the virus within the lungs.
Relenza does not replace the annual influenza vaccination. You should consult your doctor regarding the need for influenza vaccination.

2. What you need to know before using Relenza

Do not use Relenza:

• if you are allergic to zanamivir or to any of the other ingredients of this medicine (listed in section 6).
• if you have a milk protein allergy (see “Relenza contains lactose and milk proteins” and section 6)

Do not give Relenza to children under 5 years of age.
Be especially careful with Relenza
If you experience a tight feeling in your throat or chest when using Relenza
Very rarely, Relenza may cause a reaction including:
tightness in the throat and chest
difficulty breathing.
If you experience any of these symptoms when using Relenza:
stop using Relenza and seek immediate medical help. Contact your doctor or the nearest emergency department.
If you have asthma or other lung or respiratory problems
Your doctor needs to know if you have:
asthma
other lung diseases causing breathing problems – for example, emphysema,
chronic obstructive pulmonary disease (COPD), or chronic bronchitis.
Inform your doctor before using Relenza, so they can monitor you more closely and ensure
your condition is under control.
If you use inhaled medicines for asthma or other respiratory problems, please read the next section of this leaflet – Use of Relenza with inhaled medicines for respiratory problems – before using Relenza.
Use of Relenza with inhaled medicines for respiratory problems
If you use inhaled medicines for asthma or any other respiratory problem, continue using your inhaler as usual.
If you have been instructed to use Relenza at the same time of day as your other inhaled medicines, use those medicines several minutes before using Relenza.
Make sure you have your reliever inhaler readily available (e.g. salbutamol) when using Relenza.
Other medicines and Relenza
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those without a prescription.
If you use inhaled medicines for asthma or other respiratory problems, make sure you have read the warnings above.
If you have been advised to have the influenza vaccination
You may be vaccinated at any time, even if you are using Relenza to help prevent influenza.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor for advice before taking this medicine.
There is limited information available on the safety of Relenza in pregnant women. Although there is currently no evidence that Relenza is harmful to unborn babies, you should not use it during pregnancy unless your doctor has specifically advised you to do so.
The active ingredient (zanamivir) may pass into breast milk; therefore, you should not breastfeed while being treated with Relenza. Discuss with your doctor whether you should stop or refrain from taking Relenza or whether you should stop breastfeeding, depending on what is best for you and your baby.
Driving and using machines
Relenza is unlikely to affect your ability to drive or operate machinery.
Relenza contains lactose and milk proteins.
Relenza contains a sugar called lactose and contains milk proteins.
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Relenza

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Relenza is a powder medicine that is inhaled into the lungs through the mouth using the Diskhaler device.
The powder is contained in blisters on a Rotadisk – a foil disk that is inserted into the Diskhaler.
The medicine contained in the Rotadisks must only be inhaled using the Diskhaler device.
Do not give Relenza to children under 5 years of age.

When to start using Relenza
If you have influenza, for maximum benefit, you should start using Relenza as soon as possible after
experiencing flu symptoms:
for adults, within 48 hours of the first symptoms,
for children, within 36 hours of the first symptoms.

To help prevent influenza
If someone in your household has influenza, to help prevent infection, you should start using
Relenza as soon as possible after contact with them:
for adults and children, within 36 hours of contact with an infected person.
If an influenza outbreak occurs in your community, follow your doctor’s advice on when to start
using Relenza.

How much Relenza to use
The amount of Relenza to use depends on whether you already have influenza or are using Relenza to help
prevent influenza.

If you have influenza:
adults and children (aged 5 years or older): the recommended dose is 2 inhalations (2 blisters) twice
daily for 5 days.

To help prevent influenza
If someone in your household has influenza:
adults and children (aged 5 years or older): the recommended dose is 2 inhalations (2 blisters) once
daily for 10 days.

If an influenza outbreak occurs in your community:
adults and children (aged 5 years or older): the recommended dose is 2 inhalations (2 blisters) once
daily for up to 28 days.

If you use more Relenza than you should
If you accidentally use too much Relenza, it is unlikely to cause problems.
However, if you are concerned or do not feel well, especially if you have asthma or other lung problems:
consult your doctor.

If you forget to use Relenza
If you miss a dose of Relenza, take your usual dose as soon as you remember, then continue as before.
Do not take a double dose to make up for a forgotten dose.

If you stop using Relenza
For treatment of influenza, it is important that you complete the full course of treatment
(typically 5 days), even if you feel better. Otherwise, influenza symptoms may return.
If you think you want to stop treatment with Relenza early:
consult your doctor.

On the reverse side of this leaflet there is a guide showing step by step how to use Relenza
Diskhaler.
Please read it carefully before using your first dose. If you are still unsure about 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 requiring caution:

Severe allergic reactions
These reactions are rare and affect less than 1 in 1,000 people using Relenza. Signs include:
raised, itchy skin rash (urticaria)
swelling, sometimes of the face, mouth or throat, causing breathing difficulties
collapse.
If you experience any of these symptoms:

• contact your doctor immediately.

Severe skin reactions
These side effects are rare and may affect less than 1 in 1,000 people using Relenza:
skin rash with blister-like lesions resembling small targets (dark spots in the centre, surrounded by a light area with a dark ring around the edge – erythema multiforme), widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), extensive peeling of the skin over most of the body surface (toxic epidermal necrolysis).
If you notice any of these symptoms, contact your doctor immediately. Stop taking Relenza.

Other common side effects
These affect less than 1 in 10 people using Relenza:
rash

Other uncommon side effects
These affect less than 1 in 100 people using Relenza:
tightness in the throat or chest, shortness of breath, or sudden difficulty in breathing. If you have a lung disease (such as asthma or chronic obstructive pulmonary disease – COPD), you may need to be monitored while using Relenza in case you experience this side effect.
Swelling of the face, mouth or throat
Urticaria (itchy, swollen areas on the skin).
Fainting and dizziness. You may feel unwell when taking Relenza and may faint or feel dizzy after inhaling Relenza. You should sit in a relaxed position before inhaling the dose of Relenza, and you should only hold your breath for as long as you comfortably can after inhaling the dose.
If you feel unwell, it is recommended that someone is with you while you inhale your dose of Relenza.
If you experience any of these effects:
stop using Relenza and seek immediate medical help. Contact your doctor or the nearest emergency department.

Sudden changes in behaviour, hallucinations and seizures
During treatment with Relenza, changes in behaviour such as confusion and lack of responsiveness have occurred. Some people may also experience hallucinations (seeing, hearing or feeling things that are not real) or seizures, which may lead to loss of consciousness. Parents should pay particular attention to these symptoms if their child or adolescent has influenza. These symptoms have also been observed in people with influenza who were not taking Relenza. Therefore, it is not known whether Relenza plays a role in causing these symptoms.
If you experience any of these symptoms:

• contact your doctor immediately.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: “www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”. 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.
Do not use Relenza or the Diskhaler after the expiry date (Exp.) stated on the packaging.
Do not store Relenza at temperatures above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Relenza contains
The active substance is zanamivir (5 mg per dose).
The other component is lactose monohydrate (which contains milk proteins).

Description of the appearance of Relenza and contents of the pack
Relenza powder is contained in four blisters located on a silver-coloured aluminium foil disc 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.
Relenza is available in two pack types:
A starter pack for 1 day of treatment containing one Relenza Rotadisk and one Diskhaler
A pack for 5 days of treatment containing five Relenza Rotadisks and one Diskhaler
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Via A. Fleming, 2
37135 Verona
Italy

Manufacturer
Glaxo Wellcome Production
Zone Industrielle No 2
23 Rue Lavoisier
27000 Evreux
France
or
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
or
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Harmire Road
Barnard Castle
County Durham
DL12 8DT
United Kingdom

The Diskhaler consists of three parts:
Do not disassemble it until you have read the step-by-step guide.

The Rotadisk fits inside the Diskhaler

The Rotadisk fits onto the wheel of the Diskhaler.
The Rotadisk contains four blisters. Each blister contains 5 mg of zanamivir. A dose is normally two blisters (10 mg).

Important:
Do not pierce any blister on the Rotadisk before loading it onto the Diskhaler.
You may leave a Rotadisk on the Diskhaler between administrations, but do not pierce the blister until
immediately before inhaling the dose.
Keep the Diskhaler clean. Clean the mouthpiece with a cloth after use and replace the blue mouthpiece cap between administrations.

STEP-BY-STEP GUIDE FOR USING RELENZA DISKHALER

To load a Rotadisk into the Diskhaler:
1 Remove the blue mouthpiece cap.

Check that the mouthpiece is clean both inside and outside.

2 Hold the white removable cartridge as shown in the figure and pull it out until it stops.

3 Gently press the finger grips on the sides of the white cartridge.
Remove the cartridge from the main body.

The white cartridge should come out easily.

4 Place a new Relenza Rotadisk onto the wheel.

Ensure the printed side is facing upwards with the blisters facing downwards.
The blisters fit into the holes of the wheel.

5 Push the white cartridge back into the main body.

If you are not ready to inhale a dose immediately, replace the blue mouthpiece cap.

To prepare the dose for inhalation:
Do not do this until immediately before inhaling the dose.

6 Hold the Diskhaler horizontally.

Hold the Diskhaler horizontally.
Push the lid fully upwards as far as it will go.
The lid must be in a perfectly vertical position to ensure the blister is punctured both on the top and bottom.
Push the lid down.
The Diskhaler is now ready for use. Keep it horizontal until the dose has been inhaled.

If you are using another inhaled medicine, make sure you read "Use of Relenza with inhaled medicines for respiratory problems" in paragraph 2 of this leaflet.

To inhale the dose of Relenza:
7 Do not put the Diskhaler in your mouth yet. Breathe out as fully as possible, keeping the Diskhaler away from your mouth. Do not blow into the Diskhaler. If you do, you will blow the powder out of the Rotadisk.

Hold the Diskhaler horizontally.
Place the mouthpiece between your teeth. Close your lips tightly around the mouthpiece.
Do not bite the mouthpiece. Do not cover the air intake holes on the sides of the mouthpiece.
Take a quick, deep breath in through the mouthpiece. Hold your breath for a few seconds.
Remove the Diskhaler from your mouth.
Continue holding your breath for a few more seconds or as long as you can.

To prepare the next blister (the second part of the dose):
8 Pull the white cartridge out as far as possible (without removing it completely), then push it back in again.

This will rotate the wheel so that the next blister is positioned.
Repeat if necessary until the blister is correctly positioned under the piercing needle.
Repeat steps 6 and 7 to inhale the medicine.

9 After inhaling the full dose (normally two blisters):
Clean the mouthpiece with a cloth and replace the blue mouthpiece cap. It is important to keep the Diskhaler clean.

Replacing the Rotadisk:
10 When all four blisters are empty, remove the Rotadisk from the Diskhaler and insert a new one by repeating steps 1 to 5.