125 micrograms/dose Inhalation spray, suspension
Fluticasone propionate
1. What Icsori is and what it is used for
This medicine contains the active substance fluticasone propionate, which belongs to the group of corticosteroids. Icsori works by reducing inflammation in the lungs. This helps prevent asthma attacks in people who need regular treatment. It takes 4-7 days before the medicine has a full effect and you must use it regularly.
Icsori does not help with acute asthma attacks as you feel short of breath. Another drug is used to treat acute attacks.
Fluticasone propionate contained in Icsori may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Icsori
Do not use Icsori
- if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Discontinue treatment with Icsori immediately
- if you experience difficulty breathing with wheezing that worsens immediately after taking a dose of this medicine.
Talk to your doctor, pharmacist, or nurse before using Icsori
- if you have ever been treated for tuberculosis (TB)
- if you have or have had diabetes mellitus (because fluticasone may raise your blood sugar)
- if you have used high doses of this medicine for long periods and noticed any of the following:
- weight gain and a rounded face (full moon face) (Cushing’s syndrome)
- vague symptoms such as abdominal pain, vomiting, diarrhea, headache or dizziness (adrenal suppression, acute adrenal crisis). This is more likely during an infection such as a viral infection or in case of stomach upset
- reduced bone density
- eye problems ( cataracts and glaucoma )
- delayed growth (occurs mainly in children and adolescents)
Contact a doctor if you experience blurred vision or other visual disturbances.
If you are not sure if any of the above applies to you, talk to your doctor, nurse, or pharmacist before using Icsori.
Other medicines and Icsori
Tell your doctor if you have recently taken, or might take any other medicines, including medicines obtained without a prescription. You must tell your doctor or pharmacist if you are taking any of the following:
- medicines for different types of infection are, for example, ketoconazole , clarithomycin, telithromycin, ritonavir, cobicistat, atazanavir, indinavir, nelfinavir or saquvinavir. These medicines may increase the effects of Icsori and your doctor may want to monitor you closely if you are taking these medicines.
- steroid tablets together with your Icsori inhaler or if you have just stopped taking steroid tablets. You should carry a special card stating that you are using steroids as there is a risk of impaired adrenal function, especially in stressful situations such as a serious accident or before surgery. Your doctor may then decide to give you an extra supplement of steroid during this time.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Icsori.
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 or pharmacist for advice before taking this medicine.
Driving and using machines
Icsori is unlikely to affect your ability to drive or use tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
3. How to use Icsori
Icsori is available in two different strengths for use in oral inhalation only. Your doctor will decide what strength you need. Always take Icsori exactly as your doctor has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.
How to use the medicine
- Icsori can be used with Volumatic Respiratory Containers by patients who find it difficult to inject a dose by pressing the trigger just as they begin to inhale.
- The starting dose must be adapted to the severity of the disease. Your doctor will work with you to reduce the dose to one of the lowest doses that provides effective asthma control.
Instructions for use
Your doctor, nurse, or pharmacist should instruct you on how to use your inhaler. From time to time, they should also check how you use it. Improper use of Icsori or use that is not as prescribed may mean that the medicine does not have the intended effect on your asthma.
This medicine is contained in a pressure vessel in a plastic housing with a nozzle. To prevent the inhaler from clogging, it is important to clean it at least once a week.
How to check the inhaler
1. When the inhaler is used for the first time, test spray to make sure it works. Remove the nozzle by tapping both sides of it with your thumb and forefinger and pulling it apart.
2. To check that the inhaler works, shake it well, direct the nozzle away from you, push the container down and spray into the air. If you have not used the inhaler for a week or more, spray two puffs in the air.
How to use the inhaler
It is important to breathe as slowly as possible just before using the inhaler.
1. You should either stand up or sit upright when using the inhaler.
2. Remove the cover on the nozzle. Check that the nozzle is clean and free of foreign objects both inside and outside (picture A).
3. Shake the inhaler 4 or 5 times so that any loose objects are removed and the contents of the inhaler are mixed well.
4. Hold the inhaler upright with your thumb on the bottom, under the mouthpiece. Exhale as far as you feel comfortable (picture C). Do not inhale again.
5. Place the mouthpiece in your mouth between your teeth. Close your lips around the nozzle. Do not bite (picture D).
6. Inhale through the mouth. Just as you begin to inhale, press down on the top
of the container to spray a dose. Continue to breathe calmly and deeply (picture D).
7. Hold your breath, remove the inhaler from your mouth and release your finger from the top of the inhaler. Continue to hold your breath for a few seconds or as long as it feels comfortable (picture E).
8. If your doctor has told you to take two doses, wait about half a minute before repeating treatment from point 3 to 7.
9. Rinse mouth afterward with water and spit out to avoid side effects in mouth and throat. You can also brush your teeth.
10. Always put the protective cap back on as a dust cover after using the inhaler. A snap is heard when the protective hood is pressed into place.
Practice in front of a mirror the first few times. If it snorts from the top of the inhaler or out through the sides of your mouth, start again.
Older children or people with weak hands may find it easier to hold the inhaler with both hands. Place both index fingers on top of the inhaler and both thumbs under the mouthpiece. If you are not sure, talk to your doctor, nurse, or pharmacist.
How to clean the inhaler
To prevent the inhaler from clogging, it is important to clean it at least once a week.
To clean the inhaler:
- Remove the protective cap on the nozzle.
- Do not remove the metal container from the plastic cover. Wipe the inside and outside of the nozzle and plastic wrap with a dry towel or paper towel.
- Put the protective cap back on the nozzle.
Do not place the metal container in water.
Adults and young people over 16 years
The recommended dose is 50-500 micrograms twice daily.
Use for children
Icsori is not recommended for children under 16 years of age.
If you use high doses of inhaled steroids for long periods, you may sometimes need an extra supplement of steroids, for example in stressful situations such as a traffic accident or before an operation. Your doctor may then decide to give you an extra supplement of steroid during this time.
If you use more Icsori than you should
If you have used too much, talk to a doctor as soon as possible.
You must take dose one according to the label on the package or as your doctor’s prescription. Do not increase or decrease the dose without consulting a doctor.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Icsori
- Take the next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose .
If you stop using Icsori
Do not stop the treatment even if you feel better other than on the doctor’s prescription. Patients treated with a high dose of your steroid for a long time should not stop taking their medication suddenly without first talking to their doctor, as this can worsen asthma symptoms. Abrupt discontinuation of treatment may also make you feel unwell and may cause symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar, and seizures (convulsions).
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following serious side effects, stop using this medicine and contact a doctor immediately.
You may need urgent medical attention.
- allergic reaction (may affect up to 1 in 100 people) or severe allergic reaction (may affect up to 1 in 10 000) characters include a rash, redness , itching or protrusions in the skin as hives or nettle rash and swelling of the face, lips , mouth, tongue or throat that can cause difficulty breathing, itching , fainting, dizziness and intoxication and collapse.
- your breathing or hissing worsens immediately after you use the inhaler.
Other side effects include:
Very common (may affect more than 1 in 10 people)
- fungal infection of the mouth and throat
Common (may affect up to 1 in 10 people)
- huskiness
- bruises
- pneumonia in COPD patients
Tell your doctor if you have any of the following symptoms while taking Icsori because they
may be symptoms of pneumonia:
- fever or chills
- increased mucus production, changed color of the mucus
- increased cough or increased difficulty breathing
Rare (may affect up to 1 in 1,000 people)
- fungal infection (cod) in the esophagus
Very rare (may affect up to 1 in 10,000 people)
- difficulty sleeping or anxiety, overactivity and irritability (seen mainly in children)
- joint pain
- indigestion
- elevated blood sugar (blood glucose)
- use of high doses of Icsori for prolonged periods can cause: adrenal insufficiency, acute adrenal crisis, Cushing’s syndrome (overproduction of adrenal hormones), decreased bone density, eye problems (such as cataracts and glaucoma which means that the pressure in the eye is too high) and delayed growth in children and adolescents (see section 2 Warnings and precautions). To prevent this, your doctor will make sure that you use the lowest dose of a steroid that provides symptom control.
Has been reported (occurs in an unknown number of users)
- Depression
- restlessness or nervousness (seen mainly in children)
- nosebleeds
- dimsyn
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Icsori
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
- The container contains a liquid under pressure. Do not expose to temperatures above 50 ° C. The container must not be punctured. Protected against frost and direct sunlight.
- If the inhaler has cooled down, remove the metal container from the plastic cover and heat it between your hands for a few minutes. Never use anything else to heat the inhaler.
- The contents of the metal container are under pressure. It must not be punctured, broken or burned, even if the container appears to be empty
- 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.
- If you are told to stop taking this medicine, return the inhaler to your pharmacist, who will dispose of it appropriately.
6. Contents of the packaging and other information
Content declaration
- The active substance is fluticasone propionate. A measured dose ( dose leaving the valve) contains 125 and 250 micrograms of fluticasone propionate, respectively. This corresponds to a given dose ( dose leaving the inhaler) of 110 and 220 micrograms fluticasone propionate, respectively.
- The other ingredients are norflurane (HFA 134a).
What the medicine looks like and contents of the pack
Icsori is a white suspension in a metal container closed with a metering valve, trigger, and protective cap.
Each container contains 120 doses of either 125 or 250 micrograms of fluticasone propionate.
Pack sizes:
1 or 2 (2 x 1) containers of 120 doses.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Cipla Europe NV
De Keyserlei 58-60, Box 19
2018 Antwerp
Belgium
Manufacturer
Cipla (EU) Limited
4th Floor
1 Kingdom Street
London, W2 6BY
UK
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
2care4 Generics ApS
Stenhuggervej 12-14
DK-6710 Esbjerg V
Denmark
info@2care4generics.dk