FLUTIFORM suspension for inhalation 125 mcg. / 5 mcg. 

What Flutiform and what it is used
Please note:
The product name is Flutiform suspension pressurized inhalation , but in this leaflet is a shortened Flutiform inhaler. Sometimes it may be for a specified amount of active substance in the dosage unit .

Flutiform represents inhaler (slurry pressurized inhalation ) , which contains two active components:
fluticasone propionate belongs to a group of medicines called steroids. They help to reduce swelling and inflammation in the lungs ;
formoterol fumarate dihydrate, which belongs to a group of medicines called beta 2 -agonists, long-acting . These are long acting bronchodilators , which help the airways in the lungs to remain open , making it easier breathing.
Together, these two active ingredients help to improve breath . Recommended that you use this medicine every day as directed by your doctor.
This medicine helps to prevent breathing problems such as asthma and helps to stop receiving shortness of breath and wheezing. It does not work if you already have an asthma attack , ie If you already have wheezing and shortness of breath . If this happens , you need to use fast-acting reliever medication such as salbutamol .

2 . BEFORE YOU USE FLUTIFORM
Do not use Flutiform :
if you are allergic (hypersensitive) to fluticasone propionate, formoterol fumarate or any of the other ingredients (see section 6 "Further information").
Take special care with Flutiform
Before treatment with this inhaler , tell your doctor or pharmacist if you have:
current or previous tuberculosis. Symptoms include persistent cough , often with phlegm, mixed with blood , fever , fatigue , loss of appetite, weight loss and night sweats ;
infection of the lungs or chest ;
heart disease , such as for example a blood supply to the heart or a narrowing of the heart valves ( aortic ) , heart failure , which may cause shortness of breath , or swelling of the ankles, a condition in which the heart muscle is an enlarged ( hypertrophic obstructive cardiomyopathy ) , irregular heartbeat (cardiac arrhythmias) or if you are told that you have an abnormal recordings of heart rate ( QTc prolongation ) ;
abnormal bulging of the wall of a blood vessel ( aneurysm) ;
diabetes ;
hypertension ;
overactive thyroid gland , which may cause increased appetite , weight loss or sweat ( Thyrotoxicosis ) ;
low levels of potassium in the blood, which can cause muscle weakness, twitching or abnormal heart rhythm ( hypokalemia ) ;
impaired adrenal function (if the adrenal glands are not working properly , you may have symptoms such as headache , weakness , fatigue , abdominal pain , loss of appetite , weight loss , dizziness, very low blood pressure , diarrhea, feeling sick or vomiting or seizures) or an adrenal gland tumor ( pheochromocytoma ) ;
liver problems.
If you are going to have an operation or you feel strongly stressed, please inform your doctor as you may need additional steroid treatment for asthma control .

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including other drugs and inhalers for asthma medicines obtained without a prescription. If you use this inhaler with some other drugs of its or their effects can be changed.

Tell your doctor or pharmacist if :
drugs known as beta- blockers ( such as atenolol in treatment of hypertension, sotalol for the treatment of irregular heartbeat , metoprolol for the treatment of fast heart beat or timolol eye drops for the treatment of glaucoma ) ;
other drugs used in the treatment of asthma or respiratory diseases ( such as aminophylline or theophylline ) ;
drugs containing epinephrine or similar materials (including other beta - agonists such as salbutamol , or beta- blockers including atenolol, metoprolol, propranolol, timolol ) . This inhaler does not need to use additional beta2- agonists. If your asthma is getting worse between doses Flutiform then immediate relief must use your fast acting ' reliever ' inhaler ;
drugs for treating allergic reactions ( antihistamines ) ;
drugs for the treatment of high blood pressure or fluid retention by increasing the produced amount of urine ( diuretics) ;
drugs used in the treatment of heart failure ( such as digoxin ) ;
drugs for the treatment of abnormal cardiac rhythm ( such as quinidine, disopyramide , procainamide ) ;
medicines to treat symptoms of depression or psychiatric disorders such as monoamine oxidase inhibitors (eg phenelzine or isocarboxazid ) , tricyclic antidepressants (eg, amitriptyline and imipramine ) , or if you are taking these types of drugs in the last two weeks ;
drugs used to treat psychiatric or mental disorders ( phenothiazines or anti-psychotics ) ;
other medicines containing steroids ;
antifungals ( such as ketoconazole or itraconazole ) ;
drugs used to treat viral infections, including human immunodeficiency virus disease (HIV) ( for example ritonavir , atazanavir , indinavir, saquinavir or nelfinavir ) ;
antibiotics ( such as clarithromycin , telithromycin or furazolidone ) ;
medicament for the treatment of Parkinson's disease ( levodopa) ;
medicament for the treatment of underactive thyroid gland ( levothyroxine ) ;
medicament for the treatment of Hodgkin's disease ( Procarbazine ) ;
medicine to induce labor ( oxytocin ) .
If you are going to have an operation under general anesthetic , please tell your doctor at the hospital that you are using this inhaler.

Pregnancy and lactation
If you are pregnant or think you may be pregnant, planning to become pregnant or breast-feeding , talk to your doctor about using this inhaler. It will tell you whether you should take this medicine.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive and use machines.

Important information about some of the ingredients of Flutiform
This product contains small amounts of ethanol ( alcohol ), i.e. 1,00 mg per injection . Contains a very small amount of sodium cromoglycate , but patients currently receiving cromoglycate (used to treat asthma , allergic rhinitis and allergic conjunctivitis) should continue as usual.

3 . HOW TO USE FLUTIFORM
Always use this inhaler exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist. To get the most out of your inhaler should use it regularly ie two puffs in the morning and two in the evening every day, unless your doctor tells you otherwise or has advised you to stop . Do not take more than the prescribed dose. Your doctor may have prescribed inhaler other indication other than asthma / or different dose that usually prescribed and as described in this leaflet. If you are unsure how much to take or how often you use the inhaler please consult your doctor or pharmacist.

Adults and adolescents over 12 years of age
The usual dose is two inhalations twice daily , which means two puffs in the morning and two at night . Your doctor will prescribe the dose required to treat your asthma. Teenagers should not use the inhaler with the largest amount of active ingredient strength ( Flutiform mikrograma/10 250 micrograms).
Flutiform should not be used in children under 12 years of age .
Instructions for use
Read this leaflet carefully before using the inhaler and follow the instructions in the text and diagrams below. Your doctor or pharmacist will tell you how to use the inhaler correctly. The drug is contained in an aerosol vial, which is located in a plastic dispenser (aka atomizer ) . The atomiser has also a counter that indicates how many pulses remaining after loading it . When the number approaches zero , you should contact your doctor to replace the inhaler. Do not use the inhaler when the counter shows zero.

Before using the inhaler for the first time, has not been used for more than 3 days or if it has been exposed to freezing
If the inhaler is new or has not been used for more than 3 days and it has to be " trained " to ensure proper operation and supply of the correct dose .
If the dispenser has been exposed to freezing , to be allowed to warm to room temperature for 30 min, then to be " trained " to ensure proper operation and supply of the correct dose .

Preparation of the inhaler
Remove the mouthpiece cover and shake the inhaler well .
Point the mouthpiece away from yourself and spray once by pressing the aerosol can . This step must be repeated 4 times.
The inhaler must always be shaken before use.

Use of the inhaler
If you feel that you get shortness of breath or wheezing while using Flutiform , you should continue to use it , but see your doctor as soon as possible as you may need additional treatment . Once your asthma is well controlled , your doctor may consider it appropriate to gradually reduce the dose Flutiform .
Perform slow steps 2 to 5 below .
1. Remove the mouthpiece cover (see diagram 2 ) and check that the inhaler is clean and free of dust. The inhaler should be CE shake before each injection ( push) .
2 . Straighten or become . Exhale as slowly and deeply , and as long as no discomfort .
3 . Hold the inhaler upright and place the mouthpiece in your mouth, with your lips around it . Hold the inhaler with the thumb on the base of the mouthpiece and the pointer / bookmarks on the upper part of the inhaler. Do not bite the mouthpiece.
4 . Inhale slowly and deeply through your mouth while pressing the aerosol can to spray once. Continue to breathe in steadily and deeply .
5 . Continue to hold your breath as long as possible as long as no discomfort (ideally about 10 seconds) . Finally , remove the inhaler from your mouth and exhale slowly. Do not breathe into the inhaler .
6 . Hold the inhaler in an upright position for about half a minute and then shake the inhaler before slowly repeat steps 2 to 5.
7 . Attach the mouthpiece cover .

You can practice in front of a mirror. If while using the inhaler to go see " fog " from its top or side of your mouth , you may not have inhaled the medicine properly . Take another dose, repeat the action starting with step 2 above .
Always after using the inhaler , rinse your mouth , gargle with water or brush your teeth and spit the rest . This can help prevent sores in the mouth or throat or on the occurrence of hoarseness .
If you have a weakness in the hands , it may be easier to hold the inhaler with both hands, place bookmarks on the aerosol can and thumbs - the base of the inhaler.
If you have trouble using the inhaler , your doctor may advise you to use a device called volumetric chamber AeroChamber Plus, to help you breathe the medicine into the lungs properly. Your doctor or pharmacist will advise you how to use the displacement chamber AeroChamber Plus with the inhaler . AeroChamber Plus will be accompanied by instructions for use and instructions for care and cleaning, which must be read carefully .

Care inhaler
It is important to carefully follow these instructions to clean the inhaler every week. To clean it :
Remove the mouthpiece cover .
Do not remove the aerosol bottle atomizer .
Wipe the inside and outside of the mouthpiece and atomizer with a clean, dry cloth or towel.
Put the cover back on the mouthpiece.
Do not place the canister in water.
If you use more than the amount Flutiform
It is important to take your dose as stated on the label for pharmacist or as recommended by your doctor. You should not increase or decrease your dose without consulting their health care providers .
If you take more of this medicine , contact your doctor or pharmacist for advice. You may experience severe chest pain (angina) , high or low blood pressure , headache , muscle cramps, disturbed sleep , nervousness , dry mouth , loss of appetite , seizures , seizures or convulsions. You may feel a tremor , dizziness , fainting , fatigue , nausea and malaise . You may also notice changes in incidence of heart attacks and can get reduced levels of potassium and an increased amount of blood sugar in the blood. It is also possible to suffer from symptoms such as abdominal pain , vomiting, weight loss , decreased level of consciousness (which may make you feel sleepy or confused ), or low blood sugar.
If you have taken more than the prescribed dose for an extended period , you should consult with your doctor or pharmacist. This is necessary since large doses may decrease the amount of steroid hormones produced naturally by the adrenal glands you (see section 4 ) .

If you forget to use Flutiform
If you miss a dose, take it as soon as you remember it . However, if it is almost time for your next dose , skip the missed dose. Do not take a double dose to make up for a missed dose.

If you stop using Flutiform
It is important to use this inhaler every day as directed by your doctor even if you feel good because it helps to control your asthma . If you want to stop using the inhaler , first consult your doctor. It will tell you how to do it , usually by gradually lowering the dose to not trigger an asthma attack.

4 . POSSIBLE SIDE EFFECTS
As with all drugs , this inhaler can cause side effects, although not everyone gets them. Your doctor will prescribe the lowest dose needed to control your asthma , which can reduce the possibility of adverse reactions.
All medicines can cause allergic reactions although serious allergic reactions have been reported rarely . Tell your doctor if you experience sudden swelling of eyelids, face , throat , tongue or lips, rash or itching , especially if they cover the whole body , symptoms such as dizziness, weakness or fainting or sudden changes in breathing , especially increased wheezing or shortness of breath .
Like other inhalers , breathing may worsen immediately after using the inhaler. You may notice an increase in wheezing and shortness of breath . If this happens , stop using Flutiform and use your fast-acting reliever medication . Immediately contact your doctor. He will examine you and may order a different course of treatment. You should always carry with you the facilitating their inhaler

Uncommon side effects ( likely to affect less than 1 in 100 people using this inhaler) :
Increased amount of blood sugar. If you have diabetes , you may need to check your blood sugar more often and adjust your usual diabetic treatment. It may be necessary for your doctor to monitor you more closely ;
Worsening asthma ;
headache ;
trembling ;
Irregular heartbeat or palpitations ;
dizziness ;
Altered sense of taste or change in voice / hoarseness ;
Dry mouth , pain or irritation in the throat ;
Swelling of the hands, ankles or feet .
Rare side effects ( likely to affect less than 1 in 1000 people using this inhaler) :
Thrush - a fungal infection of the mouth and throat ;
Inflammation of the sinuses ( sinusitis ) ;
Fast heartbeat ;
Chest pain associated with heart disease ;
Muscle spasms ;
Cough or shortness of breath ;
diarrhea ;
Indigestion ;
Feeling of dizziness or lightheadedness ;
Unusual dreams or disturbed sleep ;
agitation ;
rash ;
High blood pressure;
Unusual feeling of weakness.
Not known , but it may also occur :
Sleep problems , depression or anxiety , anxiety , nervousness, excitability or irritability. More likely, these reactions occur in children.
The following side effects are associated with formoterol fumarate, but have not been reported in clinical trials with this inhaler :
Low levels of potassium in the blood, which can cause muscle weakness, twitching or abnormal heart rhythm
Variation in the recording of the heart potentially leading to an abnormal heart rhythm ( QTc prolongation ) ;
Elevated levels of lactic acid in the blood ;
nausea ;
Muscle pain .
Inhaled steroids can affect the normal production of steroid hormones in the body , especially if you use high doses for a long time . The effects include:
Change in bone mineral density ( bone thinning ) ;

Keep out of reach of children.
The expiry date refers to the last day of that month.