5 mg/dose, inhalation powder, divided dose
zanamivir
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 ( flu virus infection ). It reduces flu symptoms and helps you recover faster.
Relenza is also used to prevent flu during an ongoing flu epidemic.
Adults and children 5 years and older can be treated with Relenza.
Relenza should be inhaled (inhaled) directly into the lungs as it is not absorbed by the body when swallowed. The influenza virus infects the lungs and therefore Relenza acts directly on the virus in the lungs after inhalation.
Relenza does not replace flu vaccination. You still need to talk to your doctor about the need for flu vaccination.
What you need to know before using Relenza
Do not use Relenza
- if you are allergic to zanamivir or 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 protein” and section 6).
Do not give Relenza to children under 5 years of age.
Take special care with Relenza
- if you feel tight in the throat or feel pressure over your chest when using Relenza.
In very rare cases, Relenza may cause reactions such as:
- tightness in the throat or pressure over the chest
- difficulty breathing.
If any of these symptoms occur while you are using Relenza:
- stop taking Relenza and seek medical help immediately. Contact a doctor or the nearest emergency department for advice.
If you have asthma or other lung or respiratory problems
Tell your doctor if you have:
- asthma
- another lung disease that causes breathing problems, e.g. emphysema, chronic obstructive pulmonary disease (COPD), or chronic bronchitis.
- Talk to your doctor before using Relenza for close monitoring and monitoring of your condition.
If you are taking medicines for inhalation for your asthma or other respiratory problems, you should carefully read the text below ” Using Relenza for concomitant treatment with inhaled medicines for respiratory problems ” before using Relenza.
Use of Relenza during concomitant treatment with inhaled medicinal products for respiratory distress
If you are taking medicines for inhalation for asthma or other respiratory problems, continue with this as before. If you have been prescribed Relenza for the same time of day as you are taking your second inhalation medicine, take the other medicine a few minutes before taking Relenza. Be sure to have your fast-acting bronchodilator medication (eg salbutamol ) on hand when using Relenza.
Other medicines and Relenza
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
If you are using inhaled medicines, e.g. for asthma or other respiratory problems, be sure to read the above advice.
If you have been advised to get vaccinated against the flu
You can be vaccinated at any time, even if you use Relenza to help prevent the flu.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant
or planning to have children, consult your doctor before using this medicine.
There is only limited information on the safety of Relenza during pregnancy. Although to date there is no evidence that Relenza affects the unborn baby, do not use it during pregnancy unless your doctor advises you to do so.
The active substance (zanamivir) may pass into breast milk and therefore you should not breastfeed while taking Relenza. Discuss with your doctor whether you should stop or stop using Relenza or stop breastfeeding, depending on what is best for you and your baby.
Driving and using machines
Relenza is unlikely to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Relenza contains lactose and milk protein
Relenza contains a sugar called lactose and contains milk protein.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Relenza
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Relenza is a powdered medicine that is inhaled through the mouth into the lungs using an inhaler ( Diskhaler ) contained in the pack. The powder is packed in blisters on a dosing disc ( Rotadisk ) which is placed in the Diskhaler.
The drug in the dosing discs (Rotadisk) may only be inhaled using the Diskhaler device.
Do not give Relenza to children under 5 years of age.
When to start treatment with Relenza
If you have the flu, you should, for maximum effect, start treatment with Relenza as soon as possible after you get the flu symptoms:
- adults: within 48 hours after the first symptoms
- children: within 36 hours after the first symptoms.
To help prevent flu
In case of flu in your family, after contacting this person, you should use Relenza as soon as possible to help prevent the flu:
- adults and children: within 36 hours after contact with the infected person.
In case of flu in your area, follow your doctor’s advice on when to start treatment with Relenza.
Dosage
The amount of Relenza you take varies depending on whether you have the flu or whether you use Relenza to help prevent the flu.
Treatment of influenza
- Adults and children 5 years and older: The usual dose is 2 inhalations (2 blisters) twice daily for 5 days.
To help prevent flu ( flu in the family).
- Adults and children 5 years and older: The usual dose is 2 inhalations (2 blisters) once daily for 10 days.
Influenza prevention ( local flu ).
- Adults and children 5 years and older: The recommended dose is 2 inhalations (2 blisters) once daily for up to 28 days.
If you use more Relenza than you should
If you accidentally take too high a dose of Relenza, this will probably not cause you any problems. However, you should contact your doctor if you are worried or unwell, especially if you have asthma or other lung problems.
If you have ingested too much medicine or if e.g. a child accidentally ingested the drug,
If you forget to use Relenza
If you forget to take a dose of Relenza, take your usual dose as soon as possible. Then continue to use your medicine as before.
Do not take a double dose to make up for a forgotten dose.
If you stop using Relenza
When treating the flu, you must complete the entire treatment (normally 5 days) even if you feel better, otherwise, the flu symptoms may return.
- Contact a doctor if you plan to stop treatment with Relenza prematurely.
There is a step-by-step instruction at the back of this leaflet that shows you how to use Diskhaler. Read it carefully before taking your first dose. If you are still unsure about how to use Diskhaler, ask someone at the pharmacy to review the instructions with you.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you need to be aware of:
Severe allergic reactions
These are rare and occur in less than 1 in 1000 users of Relenza. Signs of these include:
- Elevated and itchy rash (hives)
- Swelling – sometimes of the face, mouth, or throat, which makes it difficult to breathe
- Collapse.
If you get any of these symptoms:
- Contact a doctor immediately.
Severe skin reactions
These side effects are rare and may affect less than 1 in 1000 people in Relenza:
- Skin rashes, which can become blisters and look like small targets (dark spot in the middle surrounded by a lighter field and a dark ring along the edge – erythema multiforme), scattered skin rashes with blisters and flaking skin, occur especially around the mouth, nose, eyes and the genitals ( Stevens-Johnson syndrome ), extensive skin detachment on large parts of the body ( toxic epidermal necrolysis ).
- If you notice any of these symptoms, contact your doctor immediately. Stop using Relenza.
Other common side effects are
Occurs in less than 1 in 10 users of Relenza:
- Rash
Other less common side effects are
Occurs in less than 1 in 100 users of Relenza:
- Feeling of tightness in the throat or pressure over the chest, shortness of breath, or sudden difficulty breathing. If you have a lung disease (eg asthma or COPD) your treatment may need to be followed up while you are taking Relenza as you may experience this side effect.
- Swelling of the face, mouth, or throat.
- “Hives” (raised, itchy rash).
- Fainting and dizziness in the head. If you do not feel well when you take Relenza, you may faint or feel dizzy after inhaling Relenza. Before inhaling Relenza dose one, sit down in a relaxed position and only hold your breath for as long as it is comfortable after dose one has been inhaled.
If you feel unwell, you should have someone next to you when you inhale your dose of Relenza.
If you get any of these symptoms, you should:
- stop using Relenza and seek medical help immediately. Contact a doctor or the nearest emergency department for advice.
Sudden changes in behavior, hallucinations, and seizures
Behavioral changes such as confusion and incontestability have occurred during treatment with Relenza. Some people may also have hallucinations (see, hear or experience things that do not exist) or seizures that can lead to unconsciousness. Parents should pay special attention to these symptoms if their child or teen has the flu. These symptoms have been seen in people with the flu who have not used Relenza. It is therefore not known whether Relenza had a role in causing these symptoms.
If you get any of these symptoms:
- Contact a doctor immediately.
How to store Relenza
Keep out of sight and reach of children.
Use Relenza and Diskhaler before the expiry date which is stated on the carton.
Do not store above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is zanamivir (5 mg per dose ).
- The other ingredients are lactose monohydrate (which contains milk protein).
What the medicine looks like and the contents of the pack
Relenza inhalation powder is packaged in 4 blisters on a silver-colored dose plate of aluminum foil (Rotadisk). The powder in each of these blisters contains 5 mg zanamivir. The drug in the dosing discs is inhaled through the mouth using a plastic inhaler called Diskhaler.
Relenza is available in two different packages
- starter pack for 1 day that contains 1 dose plate Relenza Rotadisk and 1 Diskhaler
- pack for 5 days treatment containing 5 dose discs Relenza Rotadisk and 1 Diskhaler
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel: 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer
Glaxo Wellcome Production
Industrial Zone No.2
23 Rue Lavoisier
27000 Evreux
France
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland