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«RELENZA™ 5 mg per dose, inhalation powder, pre-dispensed zanamivir Read all of this leaflet carefully before you start using this medicine. Keep ...»

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Package Leaflet: Information for the User

RELENZA™

5 mg per dose, inhalation powder, pre-dispensed

zanamivir

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 questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Don’t pass it on to others. It may harm

them, even if their symptoms are the same as yours.

If you have serious side effects, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

In this leaflet 1 What Relenza is and what it is used for 2 Before you use Relenza 3 How to use Relenza 4 Possible side effects 5 How to store Relenza 6 Further 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.

2 Before you use Relenza

Don’t use Relenza:

• if you’re allergic (hypersensitive) to zanamivir

• if you’re allergic (hypersensitive) to lactose or milk protein.

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.

Using Relenza with inhaled medication for breathing problems 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.

Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken 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.

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.

Important information about some of the ingredients of Relenza Relenza contains lactose and milk protein Relenza contains a sugar called lactose, and may contain milk protein.

If you have an intolerance to lactose or any other sugars, or to milk protein:

→ Don’t use Relenza. Ask your doctor for advice about treating or preventing flu.





3 How to use Relenza Always use Relenza exactly as your doctor 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.

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 hours after the first symptoms

• for children, within 36 hours after 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 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.

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

But if you’re worried, or you feel unwell, especially if you have asthma or other lung

problems:

→ Ask your doctor for advice.

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, Relenza 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.

If you get other side effects → If you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

5 How to store Relenza Keep Relenza out of the reach and sight 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.

Relenza Rotadisks should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further 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 four blisters on the silver-coloured 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.

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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Glaxo Wellcome UK Ltd trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT.

Manufacturer:

Glaxo Wellcome Production, Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call,

free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

–  –  –

This is a service provided by the Royal National Institute of Blind People.

Leaflet date: March 2013 Relenza, Diskhaler and Rotadisk are registered trademarks of the GlaxoSmithKline group of companies.

© 2013 GlaxoSmithKline group of companies

The Diskhaler has three parts:

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

–  –  –

The Rotadisk fits into the Diskhaler The Rotadisk fits onto the wheel of the Diskhaler.

Each of the four blisters on the Rotadisk contains a single dose of Relenza.

Important:

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

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.

Step-by-step guide to using your Relenza diskhaler

To load a Rotadisk into the Diskhaler:

Remove the blue cover.



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