Relenza 5 mg/dose powder for inhalation (single dose)
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
RELENZA
5 mg/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 as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Relenza is and what it is used for
- What you need to know before using Relenza
- How to use Relenza
- Possible adverse effects
- How to store Relenza
- Contents of the pack and other information
1. What Relenza is and what it is used for
Relenza contains zanamivir and belongs to a group of medicines known as antivirals.
Relenza is used to treat influenza (infection caused by the influenza virus). It reduces influenza symptoms and helps speed up recovery.
It is also used to help prevent influenza 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 swallowed. The influenza virus infects the lungs, and when Relenza is inhaled, the medicine acts directly on the virus in the lungs.
Relenza does not replace influenza vaccination. You should consult your doctor to assess whether you need to be vaccinated against influenza.
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 administer Relenza to children under 5 years of age.
Take special care with Relenza
If you feel tightness in the throat or chest when using Relenza
Very rarely, Relenza may cause the following reactions:
- tightness in the throat and chest
- difficulty breathing.
If any of these symptoms occur when taking Relenza:
Stop using Relenza and seek medical help as soon as possible. Contact your doctor or go to the nearest hospital emergency department.
If you have asthma or other respiratory or lung problems
Your doctor should know if you have:
- asthma
- another lung disease causing breathing difficulties, such as emphysema, chronic obstructive pulmonary disease (COPD), or chronic bronchitis.
Inform your doctor before taking Relenza so that your condition can be closely monitored to ensure it is being adequately treated.
If you are using inhaled medication for asthma or other respiratory problems, please read carefully the section 'Use of Relenza together with inhaled medication for respiratory problems' in the leaflet before using Relenza.
Use of Relenza together with inhaled medication for respiratory problems
If you use inhaled medication for asthma or other respiratory problems, continue using your inhaler(s) as usual.
- If you have been advised to use Relenza at the same time as your other inhaled medication, use the other inhaled medication a few minutes before using Relenza
- Make sure you have your fast-acting rescue inhaler (e.g., salbutamol) readily available when using Relenza.
Other medicines and Relenza
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
If you use inhaled medication for asthma or other respiratory problems, make sure you have read the recommendation above.
If you have been advised to receive influenza vaccination
You may be vaccinated at any time, even if you are using Relenza to help prevent catching influenza.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
There is very limited information available on the safety of Relenza in pregnant women. Although there is currently no evidence that Relenza has harmful effects on unborn babies, you should not use it during pregnancy unless your doctor has specifically recommended it.
The active ingredient (zanamivir) may be excreted in breast milk; therefore, you should not breastfeed while using Relenza. You should discuss with your doctor whether you should discontinue or avoid treatment with Relenza or discontinue breastfeeding, depending on what is best for you and your baby.
Driving and using machines
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 informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to use Relenza
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Relenza is a powder medicine that is inhaled into the lungs using the Diskhaler device in the mouth. The powder is contained in blisters on a Rotadisk – a foil disk that is loaded into the Diskhaler.
The medicine contained in Rotadisks must only be used with the Diskhaler device.
Do not administer Relenza to children under 5 years of age.
When to start using Relenza
If you have the flu, for maximum benefit, you should start taking Relenza as soon as possible after noticing flu symptoms:
- Adults, within 48 hours after the onset of the first symptoms.
- Children, within 36 hours after the onset of the first symptoms.
To help prevent the flu
If someone you live with has the flu, to help prevent infection, you should start using Relenza as soon as possible after contact with the infected person:
- Adults and children, within 36 hours after contact with the infected person.
If there is an epidemic outbreak in your community, follow your doctor's instructions on when to start using Relenza.
How much Relenza to use
The amount of Relenza you should take depends on whether you already have the flu or are using Relenza to help prevent the flu.
If you have the flu:
- Adults and children (5 years of age or older): the usual dose is 2 inhalations (2 blisters) twice daily for 5 days.
To help prevent the flu
If someone you live with has the flu:
- Adults and children (5 years of age or older): the usual dose is 2 inhalations (2 blisters) once daily for 10 days.
If there is an epidemic outbreak in your community:
- Adults and children (5 years of age or older): the recommended dose is 2 inhalations (2 blisters) once daily 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 feel unwell, especially if you have asthma or other lung problems:
Ask your doctor.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 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 missed doses.
If you stop treatment with Relenza
When treating the flu, it is important that you complete the full course of treatment (usually 5 days), even if you feel better. Otherwise, flu symptoms may return.
If you are considering stopping treatment with Relenza before completing it:
Ask your doctor.
On the reverse side of this leaflet there is a detailed guide describing 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 adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Symptoms to be aware of:
Severe allergic reactions
These are rare and may affect up to 1 in 1,000 people who use Relenza. Signs include:
- Raised, itchy rash (urticarial wheals).
- Swelling, sometimes of the face, mouth or throat, which may cause difficulty breathing.
- Collapse.
If you experience any of these symptoms:
- Contact your doctor immediately.
Serious skin reactions
These adverse effects are rare and may affect up to 1 in 1,000 people who use Relenza:
- Skin rash, which may blister and appear as "target" lesions (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme), widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), widespread peeling of the skin over large areas of the body (toxic epidermal necrolysis).
If you notice any of these symptoms, contact your doctor immediately.
Stop using Relenza.
Other common adverse effects
These may affect up to 1 in 10 people who use Relenza:
- Skin rash.
Other uncommon adverse effects
These may affect up to 1 in 100 people who use Relenza:
-
Feeling of tightness in the throat or chest, difficulty breathing that may occur suddenly. If you have a lung disease (such as asthma or COPD), you should be under medical supervision while using Relenza in case you experience this adverse effect.
-
Swelling of the face, mouth or throat.
-
Urticarial wheals (itchy, raised patches on the skin).
-
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 your dose of Relenza and continue breathing normally until you feel well again before inhaling the dose.
If you feel unwell, it is recommended that someone be with you while you inhale your dose of Relenza.
If you experience any of these reactions:
Stop using Relenza and consult your doctor immediately. Contact your doctor or the nearest hospital emergency department.
Sudden changes in behaviour, hallucinations and seizures
During treatment with Relenza, changes in behaviour such as confusion and indifference have occurred. Some people may also experience hallucinations (seeing, hearing or feeling things that are not real) or seizures (fits), which may lead to loss of consciousness. Parents should pay particular attention to the appearance of these symptoms if their child has influenza. These symptoms have also occurred in patients with influenza who were not using Relenza. Therefore, it is not known whether Relenza was the cause.
If you experience any of these symptoms:
- Contact your doctor immediately.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
If in doubt, ask your pharmacist how to dispose of any unused Diskhaler. This will help protect the environment.
6. Contents of the pack and other information
Composition of Relenza
The active substance is zanamivir (5 mg per dose).
The other component is lactose monohydrate (which contains milk proteins).
Appearance of Relenza and contents of the pack
Relenza powder is distributed into 4 blisters on an aluminum foil disk called a Rotadisk. Each blister contains 5 mg of zanamivir. The medicine is inhaled from the Rotadisk through the mouth using a plastic device called the Diskhaler.
Relenza is available in two pack sizes:
- 1-day starter pack containing one Rotadisk of Relenza and one Diskhaler
- 5-day treatment pack containing five Rotadisks of Relenza and one Diskhaler.
Only certain pack sizes may be commercially available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Diskhaler Manufacturer
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Date of the most recent review of this leaflet: December 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of 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 step-by-step guide describing how to use it.
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 usual dose is two blisters (10 mg).
Important:
- Do not open any of the blisters in the Rotadisk before loading the Diskhaler.
- You may leave the Rotadisk in the Diskhaler between doses. However, do not open a blister until just before inhaling its contents.
- Keep the Diskhaler clean. Wipe the mouthpiece with a tissue after use, and replace the blue cover until the next use.
Inform your doctor or pharmacist of any malfunction or problem you notice with the Diskhaler or Rotadisk.
STEP-BY-STEP GUIDE ON HOW TO USE 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 tray as shown in the figure and pull it out fully.
3. Gently press the ridged gripping areas on the sides of the white tray with your index finger and thumb.
Pull it out completely from the main body of the inhaler.
The white tray should come out easily.
4. Place a new Relenza Rotadisk onto the wheel.
Ensure the printed side is facing upwards and the blisters are facing downwards.
The blisters fit into the holes in the wheel.
5. Reinsert the white tray back into the main body of the inhaler.
If you are not going to inhale a dose of Relenza immediately, replace the blue cover on the inhaler.
Preparing the dose for inhalation:
Do not perform this step until just before you are ready to inhale a dose.
6. Hold the Diskhaler in a horizontal position.
Keep the Diskhaler in a horizontal position
Lift the lid fully upwards.
The lid must be in a completely vertical position to ensure the blister is punctured from both top and bottom.
Lower the lid back to its original position.
The Diskhaler is now ready for use. Keep it in a horizontal position until you have inhaled your dose.
If you are using other inhaled medication, make sure to read the section ‘Use of Relenza with inhaled medicines for respiratory problems’ in section 2 of this leaflet.
Inhaling the medicine:
7. Do not place 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. Doing so may disperse 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 breath for a few more seconds, as long as comfortable.
Preparing the next blister (the second dose of your dose):
8. Pull the white tray out fully (but do not remove it completely) and push it back in again.
This will rotate the wheel, bringing the next blister into position.
Repeat this step if necessary until an unused blister is positioned beneath the piercing needle.
Repeat steps 6 and 7 to inhale the medicine.
9. After inhaling a complete dose (usually two blisters):
Wipe the mouthpiece with a tissue and replace the blue cover. 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 following steps 1 to 5.