Prospecto: information for the user

RELENZA

5mg/dose powder for inhalation (single dose)

zanamivir

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they do not appear in this prospect. See section 4.

1.What is Relenza and for what it is used

2.What you need to know before starting to use Relenza

3.How to use Relenza

4.Possible adverse effects

5.Storage of Relenza

6.Contents of the package and additional information

Relenza contains zanamivir and belongs to a group of medications calledantivirals.

Relenza is used to treat the flu(infection caused by the flu virus). It reduces the symptoms of the flu and helps in a faster recovery.

It is also used to help prevent the flu during an epidemic outbreak.

Relenza can be used by adults and children aged 5 years and above.

It must be inhaled (inspired) into the lungs as the body absorbs very little medication if it is swallowed. The flu virus infects the lungs and when Relenza is inhaled, the medication acts directly on the virus present in the lungs.

Relenza does not replace flu vaccination. You should consult your doctor to assess the need for flu vaccination.

Do not use Relenza

• if you are allergicto zanamivir or to any of the other ingredients of this medicine (listed in section 6)

• if you have an allergy to milk proteins(see ‘Relenza contains lactose and milk proteins’ and section 6)

Do not administer Relenza to children under 5 years old.

Be particularly careful with Relenza

If you experience throat or chest tightness when using Relenza

Relenza may rarely cause the following reactions:

• throat and chest tightness
• difficulty breathing.

If any of these symptoms appear when you take Relenza:

Stop using Relenza and seek medical help as soon as possible. Consult your doctor or the nearest hospital emergency service.

If you have asthma or other respiratory or lung problems

Your doctor should know if you have:

• asthma
• another lung disease that causes respiratory problems, such asemphysema, chronic obstructive pulmonary disease (COPD)orchronic bronchitis.

Inform your doctor before taking Relenzaso that they can closely monitor your condition.

If you use inhaled medicationfor asthma or other respiratory problems, read the section ‘Using Relenza with inhaled medication for respiratory problems’ in the leaflet carefully before using Relenza.

Using Relenza with inhaled medication for respiratory problems

If you use inhaled medicationfor asthma or other respiratory problems, continue to use your inhaler as usual.

• If you have been told to use Relenza at the same time as the other inhaled medication, use the other inhaled medication a few minutes before using Relenza
• Make sure you have your rescue inhaler with quick action(e.g. salbutamol) nearby when using Relenza.

Other medicines and Relenza

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine,including those obtained without a prescription.

If you use inhaled medicationfor asthma or other respiratory problems, make sure you have read the previous recommendation.

If you have been recommended to receive a flu vaccination

You can be vaccinated at any time, even if you are using Relenza to help prevent flu.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding,think you may be pregnant orintend to become pregnant,consult your doctor before using this medicine.

There is very little information available about the safety of Relenza in pregnant women. Although there is currently no evidence that Relenza has a harmful effect on unborn babies, you should not use it during pregnancy unless your doctor recommends it.

The active ingredient (zanamivir) may be excreted in breast milk, so you should not breastfeed while using Relenza. You should talk to your doctor about whether you should stop or avoid treatment with Relenza or stop breastfeeding, depending on what is best for you and your baby.

Driving and operating machinery

Relenza should not affect your ability to drive or operate machinery.

Relenza contains lactose and milk proteins

Relenza contains a sugar called lactose, and may contain milk proteins.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Relenza is a powder medication that is inhaled into the lungs using the deviceDiskhalerin the mouth. The powder is located in alveoli in aRotadisk– a laminar disk that is loaded into the Diskhaler.

The medication contained in the Rotadisks should onlybe used with the Diskhaler device.

Do not administer Relenza to children under 5 years old.

When to start using Relenza

If you have the flu,for your maximum benefit, you should start taking Relenza as soon as possible when you notice the symptoms of the flu:

• Adults, within 48 hoursafter the appearance of the first symptoms.
• Children, within 36 hoursafter the appearance of the first symptoms.

To help prevent the flu

If anyone you live with has the flu, to help prevent them from getting infected, you shouldstart using Relenza as soon as possible after having been in contact with the infected person:

• Adults and children, within 36 hoursafter having been in contact with the infected person.

If there is an epidemic outbreak in your community,follow the instructions of your doctor on when to start using Relenza.

How much Relenza can be used

The amount of Relenza you are to take will depend on whether you already have the flu or if you are using Relenza to help prevent the flu.

If you have the flu:

• Adults and children (5 years or older): the usual dose is 2inhalations (2alveoli) twice a day for 5 days.

To help prevent the flu

If anyone you live with has the flu:

• Adults and children (5 years or older):the usual dose is 2inhalations (2alveoli) once a day for 10 days.

If there is an epidemic outbreak in your community:

• Adults and children (5 years or older): the recommended dose is 2inhalations (2alveoli) once a day for 28 days.

If you use more Relenza than you should

If you accidentally use more Relenza than you should, 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:

Ask your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and leaflet to the healthcare professional.

If you forgot to use Relenza

If you forget a dose of Relenza, administer your usual dose as soon as you remember and then continue as before.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Relenza

To treat the flu, it is essential that, although you feel better, you complete the full treatment(usually 5 days). If not, the flu symptoms may reappear.

If you are thinking of stopping the treatment with Relenza before finishing it:

Ask your doctor.

On the other side of this leaflet there is a detailed guide that describes step by step how to use the Relenza Diskhaler.

Read it carefully before taking the first dose. If you are still unsure about how to use the Diskhaler, ask your pharmacist to help you understand the instructions.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Symptoms to be aware of:

Severe allergic reactions

These are rare and may affectup to 1 in 1,000people who use Relenza. The signs include:

• Hives.
• Swelling, sometimes of the face, mouth or throat that can cause difficulty breathing.
• Loss of consciousness.

If you have any of these symptoms

• Contact your doctor immediately.

Severe skin reactions

These side effects are rare and may affectup to 1 in 1,000people who use Relenza:

• Skin rash, which may form blisters that look like small dots (central dark spot surrounded by a lighter area, with a dark ring around the edge – erythema multiforme), generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), widespread skin peeling over a large area of the body (toxic epidermal necrolysis).

If you notice any of these symptoms contact your doctor immediately.

Stop using Relenza.

Other frequent side effects

These may affectup to 1 in 10people who use Relenza:

• Skin rash.

Other infrequent side effects

These may affectup to 1 in 100people who use Relenza

• Feeling of tightness in the throat or chest, difficulty breathing that can occur suddenly.If you have a lung disease (such as asthma or COPD), you will need to be under medical supervision while using Relenza for this side effect.
• Inflammation of the face, mouth or throat.
• Hives.

• Loss of consciousness and dizziness. If you feel unwell while using Relenza you may lose consciousness or feel dizzy after inhaling Relenza. Sit in a relaxed position before inhaling the Relenza dose and hold your breath until you feel well before inhaling the dose.

If you feel unwell, it is recommended that someone be with you while inhaling the Relenza dose.

If you have any of these reactions:

Stop using Relenza and consult your doctor immediately.Consult your doctor or the hospital emergency service nearest to you.

Sudden changes in behavior, hallucinations and convulsions

During treatment with Relenza, changes in behavior such as confusion and indifference have occurred. Some people may also have hallucinations (seeing, hearing or feeling things that are not real) or seizures (convulsions) that can lead to loss of consciousness. Parents should pay special attention to the appearance of these symptoms if their child has the flu. These symptoms have also appeared in patients with the flu who are not using Relenza. Therefore, it is not known if Relenza was the cause.

If you have any of these symptoms:

• Consult your doctor immediately.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use Relenza or the Diskhaler after the expiration date (CAD) that appears on the packaging.

Do not store Relenza at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

If in doubt, ask your pharmacist how to dispose of the Diskhaler that you no longer need. By doing so, you will help protect the environment.

Composition of Relenza

The active ingredient is zanamivir (5mg per dose).

The other components are lactose monohydrate (which contains milk proteins).

Appearance of Relenza and packaging contents

Relenza powder is distributed in 4 alveoli in a silver aluminum laminar disc called Rotadisk. Each alveolus contains 5mg of zanamivir. The medication is inhaled from the Rotadisk, through the mouth, using a plastic device called the Diskhaler.

Relenza is presented in two packaging:

• 1-day starter packcontaining a Relenza Rotadisk and a Diskhaler
• 5-day treatment packcontaining five Relenza Rotadisks and a Diskhaler.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible manufacturer

Glaxo Wellcome Production,

Zone Industrielle nº 2

23 Rue Lavoisier - 27000 Evreux

France

or

GlaxoSmithKline Trading Services Limited

12 Riverwalk,

Citywest Business Campus

Dublin 24,

Ireland

Manufacturer of the Diskhaler

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Last review date of this leaflet:December 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es)

The Diskhaler has three parts:

Do not open the Diskhaler until you have read the detailed guide that describes how to use it step by step.

The Rotadisk fits into the Diskhaler

The Rotadisk fits into the wheel of the Diskhaler.

The Rotadisk contains four alveoli. Each alveolus contains5mg of zanamivir. The dose is usually two alveoli (10mg).

Important:

• Do not open any of the alveoliof the Rotadisk before loading the Diskhaler.
• You can leave the Rotadisk in the Diskhaler between doses. However,do not open a alveolus until just before inhaling its contents.
• Keep the Diskhaler clean.Clean the mouthpiece with a tissue after use, and put the blue cover back on until the next use.

Inform your doctor or pharmacist of any faulty operation or problem you detect in the Diskhaler or the Rotadisk.

STEP-BY-STEP GUIDE ON HOW TO USE YOUR RELLENZA DISKHALER

Loading the Rotadisk into the Diskhaler:

1 Remove the blue cover.

Check that the mouthpiece is clean inside and out.

2 Hold the white platform as shown in the figure and pull it up to the top.

3 Press gently the ridged grip areas located on the sides of the white platform with your index and thumb fingers.

Pull it out until it comes out of the main body of the inhaler.

The white platform should come out easily.

4 Put a new Relenza Rotadisk into the wheel.

Make sure the printed side is up and the alveoli are down.

The alveoli fit into the holes of the wheel.

5 Put the white platform back into the main body of the inhaler.

If you are not going to inhale a dose of Relenza immediately, put the blue cover back on the inhaler.

Preparing the dose for inhalation:

Do not follow this step until just before you are going to inhale a dose.

6 Hold the Diskhaler in a horizontal position.

Keep the Diskhaler in a horizontal position

Turn the top up

The top must be in a completely vertical position to ensure that the alveolus has been pierced from top to bottom.

Turn the top back down to its initial position

The Diskhaler is ready for use. Keep it in a horizontal position until you have inhaled your dose.

If you use another inhalation medication, make sure to read the section‘Using Relenza with inhalation medication for respiratory problems’in section 2 of this leaflet.

Inhaling the medication:

7 Do not put the Diskhaler in your mouth yet.Breathe out as much as possible while keeping the Diskhaler away from your mouth.Do not blow into the Diskhaler.This will spread the powder from the Rotadisk.

Keep the Diskhaler in a horizontal position

Put the mouthpiece between your teeth. Close your lips firmly around the mouthpiece.

Do not bite the mouthpiece. Do not block the holes on the side of the mouthpiece.

Breathe in quickly and deeply through the mouthpiece.Hold your breath for a few seconds.

Remove the Diskhaler from your mouth.

Continue to hold your breathfor a few more seconds while you can.

Preparing the next alveolus(the second dose of your medication):

8 Pull the white platform up to the top(do not pull it out completely)and put it back.

This will make the wheel turn and the next alveolus will appear.

Repeat this step if necessary until an unused alveolus is placed under the piercing needle.

Repeat steps6and7to inhale the medication.

9After inhaling a complete dose (usually two alveoli):

Clean the mouthpiece with a tissue and put the blue cover back on.It is essential to keep the Diskhaler clean.

Recycling the Rotadisk:

10When the four alveoli are empty, remove the Rotadisk from the Diskhaler and put a new one in following steps1to5.