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Relenza (Zanamivir) 5 mg per Dose, Inhalation Powder

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.

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.

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.

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.

Possible side effects

Like all medicines, Relenza can cause side effects, although not everybody gets them.

Very rare serious skin reactions

These side effects have occurred in a very small number of people but their exact frequency is not known, the frequency cannot be estimatec from the available data:

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 ras with blisters and peeling skin, particularly arou the mouth, nose, eyes and genitals (Stevens-Johnson Syndrome), extensive peeling of the si on much of the body surface – (toxic epiderma necrolysis)

If you notice any of these symptoms contact a doctor urgently. Stop taking Relenza.

Other very rare side effects

These affect less than 1 in 10,000 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
  • Skin rash or hives (itchy bumps on your skin)

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.

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.

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.

Step-by-step guide to using your Relenza Diskhaler

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.

To load a Rotadisk into the Diskhaler:

Remove the blue cover.

1.  Check that the mouthpiece is clean, inside and outside.

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

3.   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.

4.  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.

5.  Push the white tray back into the main body.

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

To get your dose ready to inhale:

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

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 completely.

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 inhale your dose of Relenza:

7.   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.

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.

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.

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