AIRFLUSAL FORSPIRO 50 µg/500 µg Inhalation powder, pre-dispensed

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER AIRFLUSAL FORSPIRO 50 µg/500 µg Inhalation powder, pre-dispensed SALMETEROL/ FLUTICASONE PROPIONATE This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine, which outlines the conditions under which the medicine should be used and information on its known safety The product information may be updated several times within its shelf life, and there could be differences between the version of information shown here and other information in the public domain or in the package insert This leaflet may not contain all the information about the medicine or the information may not be the most up to date version for this product If you have any questions or are not sure about anything, ask your doctor or pharmacist Read all of this leaflet carefully before you start taking 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 or pharmacist This medicine has been prescribed for you only Do not pass it on to others It may harm them, even if their signs of illness are the same as yours If you get any side effects, talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet What is in this leaflet? 1. What AIRFLUSAL FORSPIRO Inhalation powder is and what it is used for 2. Before you take AIRFLUSAL FORSPIRO 3. How to take use AIRFLUSAL FORSPIRO 4. Possible side effects 5. How to store AIRFLUSAL FORSPIRO 6. Further information 1. WHAT AIRFLUSAL FORSPIRO IS AND WHAT IT IS USED FOR AIRFLUSAL FORSPIRO is used in the treatment of breathing problems such as: Asthma Chronic obstructive pulmonary disease (COPD). This disease is characterized by constant breathing difficulties due to narrowing of the airways, often accompanied with cough and mucous. This medicine reduces recurrence of COPD symptoms.

2 AIRFLUSAL FORSPIRO contains two medicines, salmeterol and fluticasone propionate: Salmeterol is a long-acting bronchodilator which helps the airways in the lungs to stay open. This makes it easier for air to get in and out. Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs. A doctor may prescribe a different dose or use that is not listed in this leaflet. Always follow your doctor's instructions and the instructions contained in this leaflet. 2. BEFORE YOU TAKE AIRFLUSAL FORSPIRO Do not take AIRFLUSAL FORSPIRO If you are allergic to salmeterol, fluticasone propionate or to the other ingredient lactose monohydrate. Take special care with AIRFLUSAL FORSPIRO Talk to your doctor before using Airflusal Forspiro if you have: Heart disease, including an irregular or fast heart beat Overactive thyroid gland High blood pressure Diabetes mellitus (Airflusal Forspiro may increase your blood sugar) Low potassium in your blood Tuberculosis (TB), now or have had it in the past, or other lung infection Airflusal Forspiro helps stop breathlessness and wheeziness coming on. However Airflusal Forspiro should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting reliever ( rescue ) inhaler, such as salbutamol. Talk to your doctor if your asthma gets worse or if your breathing becomes difficult. You may feel: that your wheezing worsens that you have more frequent chest tightness than usual that you have an increased need for the use of fast-acting medication for an asthma attack. If you encounter any of the above, you should continue to use AirFluSal Forspiro; but do not increase the number of inhalations you take. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need additional treatment.

3 Children and adolescents AirFluSal Forspiro is not recommended for children under the age of 12. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you are taking the following medicines, before starting to use Airflusal Forspiro: medicines used for hypertension, heart disease or other diseases and which contain an active substance which name ends in "lol" (a beta blocker), such as atenolol, propranolol and sotalol medicines used to treat viral infections, such as ritonavir medicines used for the treatment of fungal infections, such as ketoconazole or itraconazole adrenocortical hormones which are used by mouth or by injection: medicines used to treat inflammation (a condition which is similar to inflammation), or to prevent transplant rejection. Pregnancy and breastfeeding 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 Airflusal Forspiro is not likely to affect your ability to drive or use machines. Important information about some of the ingredients of Airflusal Forspiro If you were told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine. 3. HOW TO TAKE AIRFLUSAL FORSPIRO When using AIRFLUSAL FORSPIRO solution strictly follow the instructions given to you by your doctor. AirFlusal Forspiro 50 µg / 500 µg / dose Asthma The recommended dose for adults and children over 12 years: One inhalation twice daily.

4 Your doctor will regularly check the condition of asthma symptoms. Chronic obstructive pulmonary disease The recommended dose for adults is: One inhalation twice daily. If you gain control of your symptoms of disease using two inhalations AirFluSal Forspiro per day, the doctor may want to reduce the dose to: one inhalation in the evening if you suffer from asthma symptoms during the night one inhalation in the morning if you suffer from asthma symptoms during the day. Usage Use AirFluSal Forspiro every day according to the instructions provided by your doctor, preferably just before meals, morning and / or evening. After use, rinse your mouth with water. If you do not use AirFluSal Forspiro properly or as instructed by your doctor, your breathing difficulties can get worse. To achieve the best results, please use AirFluSal Forspiro every day, even if you don t have symptoms. Instructions for use Patients should be demonstrated how to use the Forspiro inhaler and correct use should be checked regularly. The inhaler contains 60 doses of powder medication in a coiled strip of foil. It has a dose counter which indicates how many doses are left counting down from 60 to 0. When the last 10 doses have been reached the numbers will be on a red background. The inhaler is not refillable it should be disposed of when it is empty and be replaced with a new one. Before using the inhaler The transparent side chamber door should be opened. The foil strip should be removed from the side chamber by carefully tearing away the full length of strip against the 'teeth' of the side chamber as shown below. The strip should not be pulled or tugged.

5 The side chamber door should be closed and the used strip should be disposed of. Note: As the inhaler is used the side chamber will gradually fill up with used strip. The foil strips with black bars don't contain medication. Eventually the numbered sections of the strip will appear in the side chamber. There should never be more than 3 sections of foil strip in the side chamber as they may cause the inhaler to jam. The strip should be torn away carefully as shown above, and disposed of safely. Using the inhaler The inhaler should be held in hands, as seen in the pictures. 1. Open The protective cap should be opened downwards to reveal the mouthpiece. The dose counter should be checked to see how many doses are left. 2. Preparation of the dose The edge of the white lever should be lifted up. The side chamber should be closed. Note: The white lever should only be operated when the patient is ready to inhale a dose of the medication. If the patient plays with the white lever he/she will waste doses. Open: The white lever should be moved over fully as far as it will go and until it clicks. This action moves a new dose into position with the number at the top. Close: Afterwards the white lever should be closed fully so that it clicks back into its original position. The inhaler is now ready for immediate use.

6 3. Inhalation of the dose Away from the inhaler mouthpiece, the patient should breathe out as much as is comfortable. It should never be breathed directly into the inhaler as this could affect the dose. The inhaler should be held level with the protective cap pointing downwards. The lips should be closed firmly around the mouthpiece. The patient should breathe in steadily and deeply through the inhaler, not through the nose. Cleaning The inhaler should be removed from the mouth and the breath should be held for 5-10 seconds or as long as is possible without causing discomfort. Afterwards, the patient should breathe out slowly, but not into the inhaler. The protective cap should be closed over the mouthpiece. The mouth should be rinsed with water, which should be spat out afterwards. This may help to prevent getting fungal infections in the mouth and becoming hoarse. The outside of the mouthpiece should be wiped with a clean, dry tissue if necessary. The inhaler should not be taken apart to clean it or for any other purpose. The inhaler parts must not be cleaned with water or wet wipes as dampness can affect the dose. Pins or other sharp objects must never be inserted into the mouthpiece, or any other part, as this may damage the inhaler. If you take more AIRFLUSAL FORSPIRO than you should It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. The signs and symptoms of salmeterol overdose are dizziness increases in systolic blood pressure tremor headache tachycardia

7 muscle weakness If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Airflusal Forspiro may reduce the amount of steroid hormones produced by the adrenal gland. If you forget to take AIRFLUSAL FORSPIRO If you forgot to apply AIRFLUSAL FORSPIRO solution do it as soon as possible and then continue as usual. Do not apply double dose to make up for a forgotten dose. If you stop using Airflusal Forspiro Do not stop or suddenly reduce your dose of Airflusal Forspiro. This could make your breathing worse. In addition, if you suddenly stop taking Airflusal Forspiro or reduce your dose of Airflusal Forspiro this may (very rarely) cause side effects. These side effects may include any of the following: Stomach pain Tiredness and loss of appetite, feeling sick Sickness and diarrhea Weight loss Headache or drowsiness Low levels of sugar in your blood Low blood pressure and seizures (fits) When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above. Talk to your doctor or pharmacist if you have any additional questions. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of Airflusal Forspiro to control your asthma or COPD. Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Airflusal Forspiro. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue, or throat), or you may suddenly feel your heart beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of these effects or if they happen suddenly after using Airflusal Forspiro, stop using Airflusal Forspiro and tell your

8 doctor straight away. Allergic reactions to Airflusal Forspiro are uncommon (they affect less than 1 person in 100). Other side effects are listed below: Very Common (affects more than 1 person in 10) Headache - this usually gets better as treatment continues. Increased number of colds has been reported in patients with COPD. Common (affects less than 1 person in 10) Thrush (sore, creamy-yellow, raised patches) in the mouth and throat, also sore tongue and hoarse voice and throat irritation. Rinsing your mouth out with water and spitting it out immediately and/or brushing your teeth after taking each dose of your medicine may help. Your doctor may prescribe an anti-fungal medication to treat the thrush. Aching, swollen joints and muscle pain. Muscle cramps. Irritation of the throat. After each inhalation, immediately rinse your mouth with water and spit it out. The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD): Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms: increase in sputum production, change in sputum colour, fever, chills, increased cough, and increased breathing problems. Bruising and fractures. Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache). A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle weakness, cramp). Uncommon (affects less than 1 person in 100) Increase in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required. Cataract (cloudy lens in the eye). Very fast heart beat (tachycardia). Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually harmless and get less as treatment continues. Chest pain. Feeling worried (this effect mainly occurs in children). Disturbed sleep.

9 Allergic skin rash. Rare (affects less than 1 person in 1000) Breathing difficulties or wheezing that get worse straight after taking Airflusal Forspiro. If this happens stop using your Airflusal Forspiro inhaler. Use your fast-acting reliever inhaler to help your breathing and tell your doctor straight away. Airflusal Forspiro may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include: Slowing of growth in children and adolescents Thinning of the bones Glaucoma Weight gain Rounded (moon shaped) face (Cushing s Syndrome) Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of Airflusal Forspiro to control your asthma. Behavioural changes, such as being unusually active and irritable (these effects mainly occur in children). Uneven heart beat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Airflusal Forspiro unless the doctor tells you to stop. A fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing. Frequency not known, but may also occur: Depression or aggression. These effects are more likely to occur in children. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE AIRFLUSAL FORSPIRO Keep out of the reach and sight of children. Do not store above 25 ºC. Shelf life: 2 years. Do not use AIRFLUSAL FORSPIRO after the expiry date which is stated on the label.

10 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. 6. FURTHER INFORMATION What AIRFLUSAL FORSPIRO contains Every individual dose of AirFluSal Forspiro 50 mcg / 500 mcg contains: 50 mcg of salmeterol (salmeterol in the form of xinafoate) and 500 mcg of fluticasone propionate. This corresponds to a dose of: 45 mcg salmeterol (as samleterol xinafoate) and 465 mcg fluticasone propionate. Other ingredients: lactose monohydrate. What AIRFLUSAL FORSPIRO looks like and contents of the pack Purple plastic dry powder inhaler comprising aluminum blister strips containing 60 doses of powder mixtures. 1 inhaler with 60 doses. Regime of dispensing The medicine is issued on prescription. Manufacturer Lek farmacevtska družba d.d., Verovškova 57, Ljubljana, Slovenia Manufacturer of the medicinal product Lek Pharmaceuticals dd, Verovškova 57, Ljubljana, Slovenia Lek Pharmaceuticals dd, Trimlini 2D, Lendava, Slovenia Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Barleben, Germany Aeropharm GmbH, Francois-Mitterrand-Allee 1, Rudolstadt, Germany