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Zanamivir - Relenza Diskinhaler. 1 Diskinhaler and 5 Rotadisks with 5 mg. Zanamivir
Name of the medicinal product
RELENZA (Zanamivir)
Inhalation powder, pre-dispensed.
Composition
The active ingredient is zanamivir.
Each pre-dispensed quantity of inhalation powder (one blister) contains 5 mg. zanamivir. Each delivered inhalation (the amount that leaves the mouthpiece of the Diskhaler) contains 3,6 mg. zanamivir.
Excipients: lactose monohydrate.
1.WHAT RELENZA - ZANAMIVIR IS AND WHAT IT IS USED FOR
Pharmaceutical form and content
RELENZA - ZANAMIVIR inhalation powder is packed in a circular aluminium foil disk (a Rotadisk) with four regularly distributed blisters. An inspiration driven inhaler made of plastic (a Diskhaler) is used for administration of doses (the contents of 2 blisters constitute a dose) from these foil disks, and is provided in the pack.
The pack contains 5 foil disks and a Diskhaler.
Pharmacotherapeutic group
RELENZA - ZANAMIVIR belongs to a group of medications called antiviral agents. It is used to treat infection caused by influenza A and B viruses in adults and adolescents over 12 years of age. RELENZA - ZANAMIVIR reduces the propagation of the influenza virus in the respiratory tract by inhibiting the release of infectious influenza virions from the epithelial cells of the respiratory tract.
Therapeutic Indications
RELENZA - ZANAMIVIR is indicated for treatment of both influenza A and B in adults and adolescents ( 12 years) who present with symptoms typical of influenza when influenza is circulating in the community.
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2. BEFORE YOU TAKE RELENZA - ZANAMIVIR
Do not take RELENZA - ZANAMIVIR:
If you are hypersensitive (allergic) to zanamivir or any ingredient of the preparation.
Take special care with RELENZA - ZANAMIVIR:
Due to the limited number of patients with severe asthma or with other chronic respiratory disease, patients with unstable chronic illnesses or immunocompromised patients who have been treated, it has not been possible to demonstrate the efficacy and safety of RELENZA - ZANAMIVIR in these groups.
If you suffer severe asthma, only use RELENZA - ZANAMIVIR under close medical supervision. Consult your doctor or pharmacist for more information.
Pregnancy:
Consult your doctor or pharmacist before taking any medication.
The safe use of RELENZA - ZANAMIVIR during pregnancy has not been established.
RELENZA - ZANAMIVIR should not be used in pregnancy unless the expected benefit to the mother is thought to outweigh any possible risk to the foetus.
Lactation:
Consult your doctor or pharmacist before taking any medication.
The use of zanamivir is not recommended in mothers who are breast feeding.
Taking other medicines:
Clinically significant drug interactions are unlikely. However, it is important that you inform your doctor or pharmacist if you are taking or have recently taken any other medication, even those not prescribed.
Zanamivir, when given for 28 days, did not impair the immune response to influenza vaccine.
Driving and using machines
RELENZA - ZANAMIVIR has no known effect on the ability to drive or use machines.
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3. HOW TO USE RELENZA - ZANAMIVIR
Follow these instructions unless your doctor has indicated otherwise.
Remember to take your medication.
Your doctor will indicate the duration of your treatment with RELENZA - ZANAMIVIR. Do not discontinue treatment unless your doctor has told you to do so.
Treatment should begin as soon as possible, within 48 hours after onset of symptoms.
RELENZA - ZANAMIVIR is for administration to the respiratory tract by oral inhalation only, using the Diskhaler device provided. One blister should be utilized for each inhalation.
The recommended dose of RELENZA - ZANAMIVIR is two inhalations (2 x 5 mg.) twice daily for five days, providing a total daily inhaled dose of 20 mg.
Inhaled drugs, e.g. asthma medication, should be administered prior to administration of RELENZA - ZANAMIVIR (see section: "Precautions").
Instructions for the correct use of your Diskhaler device
The powdered medicine is inhaled through the mouth into the lungs. The Diskhaler device is loaded with a foil disk (Rotadisk) that contains the medicine in individual blisters which are opened when both surfaces of the foil are pierced.
A RELENZA - ZANAMIVIR Rotadisk may be kept in the Diskhaler at all times but a blister should only be pierced immediately prior to use. Failure to observe this instruction will affect operation of the Diskhaler.
The Diskhaler is a device which is used together with a Rotadisk for inhaling medication.
Parts of the DISKHALER:
(LEFT SIDE OF PICTURE)
- Rotadisk
- Blister
- White mouthpiece where the medicine is inhaled by mouth.
(RIGHT SIDE OF PICTURE)
- Piercing needle: is used to puncture the blister and makes the medicine ready to inhale.
- Raised ridges (to place your fingers).
- Dark wheel to support the Rotadisk.
- White tray.
- Small air holes on sides.
- Dark cover: keeps the inhaler clean and protects it from being damaged.
How to load a Rotadisk into the Diskhaler
(PICTURE SHOWING REMOVAL OF THE WHITE TRAY FROM THE DISKHALER BODY).
Remove the dark cover and pull the white tray out as far as it will go.
Press the finger grips on either side of the white tray with your finger and thumb and gently pull the white tray out of the Diskhaler body.
(PICTURE SHOWING THE LOADED WHITE TRAY BEING PUSHED BACK INTO THE DEVICE BODY).
Place a new Rotadisk on the dark wheel with the blisters facing down and push the loaded white tray back into the inhaler - holding the device as shown in the picture. If you do not need to take a dose at the time of loading, put the dark cover back on the Diskhaler until you need to take a dose. Replace the used Rotadisk once you have used all four blisters.
Getting the Diskhaler ready to use
(PICTURE SHOWING THE DISKHALER WITH THE COVER REMOVED AND A NEW BLISTER IN PLACE).
Remove the dark cover and check the mouthpiece is clean, inside and outside. Check also that there is a new blister showing under the piercing needle as shown in the picture.
(PICTURE SHOWING THE WHITE TRAY BEING PULLED OUT AND IN).
If the blister is already punctured pull the white tray out as far as it will go and then push back in again. This will turn the wheel and the next blister will appear.
(PICTURE SHOWING THE BLISTER BEING PIERCED WITH THE LID IN AN UPWARD POSITION).
Lift the hinged lid with the piercing needle as far as it will go into the fully upright position. This will ensure the blister is pierced completely.
(PICTURE SHOWING THE DISKHALER IN A READY TO USE POSITION).
Keep your Diskhaler level (horizontal) until you have inhaled your medicine. Push the hinged lid with the piercing needle back down. The Diskhaler is now ready to use.
How to inhale your medicine
(PICTURE SHOWING THE DISKHALER POSITIONED IN THE MOUTH, IN A HORIZONTAL POSITION, KEEPING THE AIR HOLES UNCOVERED).
Breathe out as far as is comfortable, keeping the Diskhaler level, place the mouthpiece between your teeth. Close your lips firmly around the mouthpiece - but do not bite it or block the small air holes on either side. Breathe in through your mouth steadily and deeply through the mouthpiece.
Hold this breath in for several seconds; this helps medicine reach the lungs. Remove the Diskhaler from your mouth.
Once you have taken the full dose, replace the mouthpiece cover after use to keep the Diskhaler clean.
Each Rotadisk consists of 4 blisters containing medication. When the Rotadisk is empty, it should be replaced with a new Rotadisk by repeating the abovementioned steps.
If you take more RELENZA - ZANAMIVIR than you should
An overdose with this medication is unlikely to occur. If for any reason you take more RELENZA - ZANAMIVIR than you should have, drink a lot of water and immediately consult your doctor or pharmacist or your local poison centre (Servicio de Información Toxicológica (Telephone 91 562 04 20)).
If you forget to take RELENZA - ZANAMIVIR
If you forget to take a dose of RELENZA - ZANAMIVIR, take it as soon as you remember, then go back to taking it as you would normally. Do not take a double dose to make up for the dose that you missed.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, RELENZA - ZANAMIVIR can have side effects. Most patients do not experience any type of adverse reaction after taking RELENZA - ZANAMIVIR.
However, there have been rare reports of nausea, headache, stomach discomfort or upset, bronchitis and cough, tightness of the chest or throat tightness, wheezing, difficulty in breathing, swelling of the face or infection of the throat, mouth or nose, or skin rash. If you experience any of the abovementioned symptoms, you should stop taking RELENZA - ZANAMIVIR immediately and contact your doctor for advice as soon as possible.
If you notice any other side effects or unusual symptoms not mentioned in this leaflet, please inform your doctor or pharmacist as soon as possible.
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5. STORING RELENZA - ZANAMIVIR
Do not store RELENZA - ZANAMIVIR above 30°C.
Expiry:
Do not use this medication after the expiry date printed on the carton.
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