RELENZA 5 mg/dose INHALATION POWDER (SINGLE UNIT)

Introduction

Package Leaflet: Information for the User

RELENZA

5mg/dose powder for inhalation (single-dose)

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Relenza is and what it is used for
2. What you need to know before you use Relenza
3. How to use Relenza
4. Possible side effects
5. Storing Relenza
6. Contents of the pack and further information

1. What Relenza is and what it is used for

Relenza contains zanamivir and belongs to a group of medicines called antivirals.

Relenza is used to treat flu(infection caused by the flu virus). It reduces the symptoms of flu and helps you recover more quickly.

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

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

It must be inhaled (breathed in) into the lungs because the body absorbs very little of the medicine if it is swallowed. The flu virus infects the lungs, and when you inhale Relenza, the medicine works directly on the virus in your lungs.

Relenza does not replace flu vaccination. You should go to your doctor to have them assess the need for you to be vaccinated against flu.

2. What you need to know before you use Relenza

Do not use Relenza

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

• (see ‘Relenza contains lactose and milk proteins’ and section 6).

Do not give Relenza to children under 5 years of age.

Be careful with Relenza

If you feel tightness in the throat or chest when using Relenza

Very rarely, Relenza can cause the following reactions:

• tightness in the throat and chest
• difficulty breathing

If you experience any of these symptoms when taking Relenza:

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

If you have asthma or other respiratory problems or lung problems

Your doctor should know if you have:

• asthma
• another lung disease that causes breathing problems, such as emphysema, chronic obstructive pulmonary disease (COPD), or chronic bronchitis

Tell your doctor before taking Relenzaso that they can closely monitor that your disease is being treated properly.

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 using your inhaler(s) as usual.

• If you have been told to use Relenza at the same time as your other inhaled medication, use your other inhaled medication a few minutes before using Relenza
• Make sure you have your quick-acting rescue inhaler (such as salbutamol) nearbywhen you use Relenza

Other medicines and Relenza

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those bought 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 flu vaccination

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

The active substance (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 using machines

Relenza should not affect your ability to drive or use machines.

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 some sugars, consult them before taking this medicine.

3. How to use Relenza

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Relenza is a medicine in the form of a powder that is inhaled into the lungs using the Diskhalerdevice in the mouth. The powder is in blisters in a Rotadisk– a laminated disc that is loaded into the Diskhaler.

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

Do not give Relenza to children under 5 years of age.

When to start using Relenza

If you have flu, to get the most benefit, you should start taking Relenza as soon as possible when you notice the symptoms of flu:

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

To help prevent flu

If someone you live with has flu, to help prevent you from catching it, you shouldstart using Relenza as soon as possible after being in contact with the infected person:

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

If there is a flu epidemic in your community, follow your doctor's instructions on when to start using Relenza.

How much Relenza to use

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

If you have flu:

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

To help prevent flu

If someone you live with has flu:

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

If there is a flu epidemic in your community:

• Adults and children (5 years or older): the recommended dose is 2 inhalations (2 blisters) 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 medicine and the amount used. It is recommended to take the packaging and leaflet to the healthcare professional.

If you forget to use Relenza

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

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Relenza

To treat flu, it is important that, even if you feel better, you complete the full treatment course(usually 5 days). If not, the symptoms of flu may come back.

If you are thinking of stopping treatment with Relenza before completing 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.

4. Possible side effects

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

Symptoms to look out for:

Severe allergic reactions

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

• Hives (itchy, raised rash).
• Swelling, sometimes of the face, mouth, or throat, which can cause difficulty breathing.
• Collapse.

If you have any of these symptoms:

• Contact your doctor immediately.

Severe skin reactions

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

• Skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler 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), peeling of the skin over much of the body surface (toxic epidermal necrolysis).

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

Stop using Relenza.

Other common side effects

These may affect up to 1 in 10people who use Relenza:

• Skin rash.

Other uncommon side effects

These may affect up 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 in case you have this side effect.
• Swelling of the face, mouth, or throat.
• Hives (itchy, raised rash).

• Fainting and dizziness. If you feel unwell while using Relenza, you may faint or feel dizzy after inhaling Relenza. You should sit in a relaxed position before inhaling the dose of Relenza and hold your breath until you feel well before inhaling the dose.

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

If you have any of these reactions:

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

Sudden changes in behavior, hallucinations, and seizures

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 (fits) that can lead to loss of consciousness. Parents should pay special attention to the appearance of these symptoms if their child has flu. These symptoms have also occurred in patients with flu who were 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 a temperature above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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

6. Package Contents and Additional Information

Composition of Relenza

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

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

Appearance of Relenza and Package Contents

The Relenza powder is distributed in 4 blisters in a silver-colored aluminum disk called Rotadisk. Each blister contains 5 mg of zanamivir. The medication is inhaled from the Rotadisk, through the mouth, using a plastic device called the Diskhaler.

Relenza is available in two packages:

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

Only some package sizes may be marketed.

Marketing Authorization Holder and 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]

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

Date of Last Revision of this Leaflet:December 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (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 blisters. Each blister contains 5 mg of zanamivir. The dose is usually two blisters (10 mg).

Important:

• Do not open any of the blisterson the Rotadisk before loading the Diskhaler.
• You can leave the Rotadisk in the Diskhaler between doses. However, do not open a blister 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 it is used again.

Tell your doctor or pharmacist about any malfunction or problem you detect in the Diskhaler or Rotadisk.

STEP-BY-STEP GUIDE TO USING YOUR RELENZA 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 out to the stop.

3 Carefully press the striated grip areas 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 on the wheel.

Make sure the printed side is facing up and the blisters are facing down.

The blisters fit into the holes in 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 of the inhaler back on.

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

Lift the lid up to the stop

The lid should be in a completely vertical position to ensure that the blister has been pierced from above and below.

Lower the lid back to its initial position

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

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

Inhaling the medication:

7 Do not put the Diskhaler in your mouth yet.Exhale as far as possible while keeping the Diskhaler away from your mouth. Do not blow into the Diskhaler.If you do, you will spread the powder from the Rotadisk.

Keep the Diskhaler in a horizontal position

Place 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.

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

Remove the Diskhaler from your mouth.

Continue holding your breathfor a few more seconds if possible.

Preparing the next blister(the second intake of your dose):

8 Remove the white platform to the stop(do not remove it completely) and put it back.

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

Repeat this step if necessary until an unused blister is positioned under the piercing needle.

Repeat steps 6and 7to inhale the medication.

9After you have inhaled a complete dose (usually two blisters):

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

Reloading the Rotadisk:

10When the four blisters are empty, remove the Rotadisk from the Diskhaler and put a new one in, following steps 1to 5.