Leaflet: information for the user

Flutiform 50 micrograms/5 micrograms/inhalation, suspension for inhalation in a pressurized container

Fluticasone propionate/formoterol fumarate dihydrate

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What Flutiform is and for what it is used

2.What you need to know before starting to useFlutiform

3.How to use Flutiform

4.Possible side effects

5.Storage ofFlutiform

6.Contents of the container and additional information

Note:

The name of the medication is Flutiform suspension for inhalation in a pressurized container, however, throughout this prospectus it is shortened to Flutiform. Sometimes a specific dose is referred to.

Flutiform is an inhaler (a suspension for inhalation in a pressurized container) that contains two active substances:

• Fluticasone propionate, which belongs to a group of medications called steroids. Steroids help reduce swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate, which belongs to a group of medications called long-acting beta2agonists. Long-acting beta2agonists are long-acting bronchodilators that help keep the airways in the lungs open, making breathing easier.

These two active substances together help improve breathing. You must use this medication every day, following the instructions of your doctor.

This medicationhelps prevent respiratory problems such as asthma and helps prevent shortness of breath and respiratory difficulty.However, it does not work if you are already having an asthma attack, that is, if you are out of breath and with wheezing breathing. If this happens, you will have to use a quick-acting rescue medication such as salbutamol.

Do not use Flutiform if:

• You are allergic to fluticasone propionate, formoterol fumarate, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Flutiform.

Before starting treatment with this inhaler, inform your doctor or pharmacist or nurse if you have:

• Active tuberculosis (TB) or if you had it in the past. Symptoms include persistent cough, often with bloody mucus, fever, fatigue, loss of appetite, weight loss, and night sweats.
• A lung or chest infection.
• Heart problems, such as problems with blood flow to the heart or narrowing of one of the heart valves (aortic valve), heart failure, which can cause difficulty breathing or swelling of the ankles, a condition in which the heart muscle is enlarged (hypertrophic obstructive cardiomyopathy), irregular heartbeat (cardiac arrhythmias), or if your electrocardiogram (ECG) is abnormal (prolongation of the QTc interval).
• An abnormal bulging of a blood vessel wall (aneurysm).
• Diabetes.
• High blood pressure.
• Hyperthyroidism, which can cause increased appetite, weight loss, or sweating (thyrotoxicosis).
• Low potassium levels in the blood, which can cause muscle weakness, muscle spasms, or abnormal heart rhythm (hypokalemia).
• Adrenal gland dysfunction (if the adrenal gland is not functioning correctly, you may have symptoms such as headaches, weakness, fatigue, abdominal pain, loss of appetite, weight loss, dizziness, very low blood pressure, diarrhea, feeling unwell, or attacks) or an adrenal gland tumor (pheochromocytoma).
• Liver problems.

Contact your doctor if you experience blurred vision or other visual disturbances.

If you are to undergo surgery or are extremely stressed, inform your doctor, as you may need additional treatment with steroids to control your asthma.

Other medications and Flutiform

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. If you use this inhaler with other medications, the effect of this inhaler or the other medication may be altered.

Inform your doctor or pharmacist if you are taking the following medications:

• Medications known as beta-blockers (such as atenolol for high blood pressure, sotalol for irregular heart rhythms, metoprolol for rapid heart rate, or timolol in eye drops for glaucoma).
• Other medications used to treat asthma or respiratory disorders (such as theophylline or aminophylline).
• Medications containing adrenaline or related substances (including other beta agonists such as salbutamol or beta antagonists such as atenolol, metoprolol, propranolol, or timolol). Do not use other long-acting beta2 agonists with this inhaler. If your asthma worsens between Flutiform administrations, use your rescue inhaler for rapid relief.
• Medications to treat allergic reactions (antihistamines).
• Medications to treat high blood pressure or fluid accumulation through increased urine production (diuretics).
• Medications used to treat heart failure (such as digoxin).
• Medications to treat abnormal heart rhythms (such as quinidine, disopyramide, or procainamide).
• Medications to treat depression or mental disorders, such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), tricyclic antidepressants (e.g., amitriptyline and imipramine), or if you have taken any of these types of medications in the last two weeks.
• Medications used to treat psychiatric or mental disorders (phenothiazines or antipsychotics).
• Other medications containing steroids.
• Antifungal medications (such as ketoconazole or itraconazole).
• Some medications may increase the effects of Flutiform, and your doctor may want to closely monitor you if you are taking these medications (including some HIV medications: ritonavir, atazanavir, indinavir, nelfinavir, saquinavir, or cobicistat).
• Antibiotics (such as clarithromycin, telithromycin, or furazolidone).
• Medications to treat Parkinson's disease (levodopa).
• Medications to treat hypothyroidism (levothyroxine).
• Medications to treat Hodgkin's disease (procarbazine).
• Medications to induce labor (oxytocin).

If you are to undergo surgery under general anesthesia, please inform your doctor in the hospital that you are using this inhaler.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will advise you on whether to use this medication.

Driving and operating machinery

This medication is unlikely to affect your ability to drive or operate machinery.

Flutiform contains ethanol (alcohol) and sodium cromoglicate

This medication contains 2 mg of alcohol in each dose (2 inhalations). The amount in each dose is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication has no notable effects. It also contains a very small amount of sodium cromoglicate, however, patients currently taking cromoglicate (used to treat asthma, allergic rhinitis, and allergic conjunctivitis) should continue taking it as normal.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must use your inhaler regularly, that is, two inhalations (puffs) in the morning and two inhalations (puffs) at night every day, in order to obtain the greatest benefit from your inhaler, unless your doctor has given you other instructions or recommended that you interrupt treatment. Do not administer more doses than prescribed. Your doctor may have prescribed your inhaler for a different indication than asthma or a different dose than the usual one and as described in this leaflet. You must always use your inhaler exactly as recommended by your doctor. If you are not sure how much to administer or how often to use the inhaler, please consult your doctor or pharmacist.

Adults, adolescents, and children 5 years and older

The usual dose is two inhalations twice a day, that is, two inhalations (puffs) in the morning and two at night. Your doctor will prescribe the necessary dose to treat your asthma.Only adults should use the high-dose inhaler (Flutiform 250 micrograms/10 micrograms).

Only adults and adolescents over 12 years of age should use the intermediate-dose inhaler (Flutiform 125 micrograms/5 micrograms).

Flutiform should not be used in children under 5 years of age.

Instructions for use

Read this leaflet carefully before using the inhaler and follow the instructions for use of the text and diagrams shown below. Your doctor or pharmacist will teach you how to use your inhaler correctly. The medication is inside, in an aerosol cartridge (see Diagram 1) which is in turn inside a plastic dispenser (also known as an applicator). The applicator also has a counter to indicate how many inhalations (puffs) are left, after it has been loaded. This counter also has a color code. It starts in green, then changes to yellow when there are less than 50 puffs (inhalations) left, and changes to red when there are less than 30 puffs (inhalations) left. When it is near zero, you should contact your doctor to replenish the inhaler.

Before using your inhaler for the first time, or if you have not used it for a period of more than 3 days, or if you have been exposed to freezing conditions

If your inhaler is new or you have not used it for more than 3 days, you must load it to ensure it works correctly and administers the correct dose.

If your inhaler has been exposed to freezing temperatures, you must let it thaw at room temperature for 30 minutes and then load it to ensure it works correctly and administers the correct dose.

Loading the inhaler

• Remove the cap from the mouthpiece and shake the inhaler well.
• Point the mouthpiece away from you and release a discharge (a puff) by pressing down on the aerosol cartridge. This step must be done 4 times.

The inhaler must always be shaken immediately before use.

Using the inhaler

If during the use of Flutiform you feel you have difficulty breathing or wheezing, you must continue using Flutiform, but go to 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 of Flutiform.

Perform the steps 2 to 5 below slowly.

1. Remove the cap from the mouthpiece (see Diagram 2) and check that your inhaler is clean and free of dust.
2. Shake the inhaler immediately before each discharge (puff) to ensure that the contents of your inhaler are uniformly mixed.
3. Sit up or stand up. Exhale as far as you feel comfortable and as slowly and deeply as possible.

1. Hold your inhaler vertically (as shown in Diagram 3) and place the mouthpiece in your mouth, surrounding it with your lips. Hold the inhaler with your thumb(s) at the base of the mouthpiece and your index finger(s) at the top of the inhaler. Do not bite the mouthpiece.
2. Breathe in slowly and deeply through your mouth and, at the same time, press down on the aerosol cartridge to release a discharge (puff). Continue breathing in constantly and deeply (preferably for about 2-3 seconds for children and 4-5 seconds for adults).

1. While holding your breath, remove the inhaler from your mouth. Continue holding your breath while you feel comfortable. Do not exhale into the inhaler.
2. To administer the second discharge (puff), keep the inhaler in a vertical position, and repeat steps 2 to 6.
3. Replace the cap on the mouthpiece.

You can practice in front of a mirror. If when using your inhaler you see a "fine mist" coming out of the top of the inhaler or around your mouth, you may not have inhaled the medication correctly. Administer another dose, repeating the process from step 2 explained above.

After each inhalation, rinse your mouth, gargle with water, or brush your teeth and spit out the residue. This may help prevent the risk of developing mouth and throat ulcers or hoarseness.

If you have little strength in your hands, you may find it easier to hold the inhaler with both hands, placing both index fingers on the aerosol cartridge and both thumbs on the base of the inhaler.

If you have difficulty using your inhaler, your doctor may provide you with a device called the AeroChamber Plus Flow-Vu spacer, to help the medication reach your lungs properly. Your doctor or pharmacist will inform you on how to use the AeroChamber Plus Flow-Vu spacer with your inhaler. The AeroChamber Plus Flow-Vu spacer comes with instructions for use and care and cleaning that you should read carefully.

Care of your inhaler

It is essential that you follow these instructions carefully and clean your inhaler weekly. To clean your inhaler:

• Remove the cap from the mouthpiece.
• Do not remove the aerosol cartridge from the plastic casing.
• Clean the inside and outside of the mouthpiece and plastic casing with a dry and clean cloth or a paper tissue.
• Replace the cap on the mouthpiece.
• Do not submerge the metal cartridge in water.

If you use more Flutiform than you should

It is essential that you administer your doses as indicated by your doctor or pharmacist. Do not increase or decrease your dose without medical advice.

If you use more Flutiform than you should, contact your doctor or pharmacist immediately for advice. You may experience intense chest pain (angina), high or low blood pressure, headache, muscle cramps, difficulty sleeping, nervousness, dry mouth, loss of appetite, agitation, seizures, or convulsions. You may feel unstable, dizzy, weak, tired, sick, or experience general discomfort. You may also notice changes in your heart rate and may have low levels of potassium in your blood or high levels of sugar in your blood. You may also experience symptoms such as abdominal pain, feeling unwell, weight loss, decreased level of consciousness (which may cause drowsiness or confusion) or low levels of sugar in your blood.

If you have administered more doses than prescribed for a long period of time, you should talk to your doctor or pharmacist to find out what to do. This is because high doses may reduce the amount of naturally produced hormones by the adrenal glands (see section 4 "Possible side effects").

If you forget to use Flutiform

If you forget to inhale a dose, do it as soon as you remember. However, if there is not much time left before the next dose, skip the missed dose. Do not administer a double dose to compensate for the missed doses.

If you interrupt treatment with Flutiform

It is very important that you administer this inhaler every day, following your doctor's instructions, even if you feel well, as it will help you control your asthma. If you want to stop using your inhaler, talk to your doctor first. He will tell you how to do it; usually, by gradually reducing the dose, to avoid triggering an asthma attack.

Like all medicines, this inhaler can cause side effects, although not everyone will experience them.Your doctor will prescribe the lowest dose necessary to control your asthma, which may reduce the likelihood of side effects.

All medicines can cause allergic reactions, although severe allergic reactions are rare. Inform your doctor immediately if you suddenly experience swelling of the eyelids, face, throat, tongue, or lips; if you have a skin rash or feel itchy, especially if it covers your entire body; if you experience symptoms such as dizziness, feeling of drowsiness, or fainting, or sudden changes in your breathing, such as increased wheezing or difficulty breathing.

Like other inhalers, your breathing may worsen immediately after using the inhaler. You may notice an increase in wheezing and difficulty breathing. If this happens, stop using Flutiform and use your rescue inhaler with quick action. Contact your doctor immediately. They will evaluate you and may start a different type of treatment. You should carry your rescue inhaler with you at all times.

Less common side effects (may affect up to 1 in 100 people)

• Worsening of asthma.
• • Headache.
  • Tremors.
  • Irregular heartbeat or palpitations.
  • Dizziness.
  • Difficulty sleeping.
  • Voice changes / hoarseness.
  • Dry mouth, sores, or throat irritation.
  • Rash.

Rare side effects (may affect up to 1 in 1,000 people)

• Increased blood sugar levels. If you are diabetic, you may need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment. Your doctor may need to monitor you more closely.
• Candidiasis or other fungal infections in the mouth and throat.
• Paranasal sinusitis (inflammation of the sinuses).
• Accelerated heart rate.
• Chest pain associated with heart disease.
• Muscle spasms.
• Cough or difficulty breathing.
• Diarrhea.
• Indigestion.
• Changes in taste.
• Sensation of dizziness or spinning.
• Abnormal dreams.
• Agitation.
• Itching skin.
• High blood pressure.
• Unusual feeling of weakness.
• Swelling of hands, ankles, or feet.

Unknown frequency: cannot be estimated from available data

• Blurred vision.
• Sleep problems, depression, or feeling of concern, aggression, anxiety, restlessness, nervousness, excessive excitement, or irritability. This is more likely to occur in children.

The following side effects have been associated with formoterol fumarate, but have not been recorded during clinical trials with this inhaler:

• Low potassium levels, which can cause muscle weakness, muscle spasms, or abnormal heart rhythm.
• Abnormal electrocardiogram that may indicate an abnormal heart rhythm (prolongation of the QTc interval).
• High levels of lactic acid in the blood.
• Feeling unwell.
• Muscle pain.

Inhaled steroids can affect the normal production of steroid hormones in your body, especially if you use high doses for a long period. The effects include:

• Bone density changes (thinning of bones).
• Cataracts (opacity of the crystalline lens of the eye).
• Glaucoma (increased eye pressure).
• Bruising or thinning of the skin.
• Increased likelihood of infection.
• Slowed growth in children and adolescents.
• Rounded face (moon face).
• Effect on the adrenal gland (a small gland above the kidney), which may cause symptoms such as weakness, fatigue, difficulty coping with stress, abdominal pain, loss of appetite, weight loss, headache, dizziness, very low blood pressure, diarrhea, feeling unwell, or seizures.

These effects are much less likely to occur with inhaled steroids than with oral steroids.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label, the aluminum foil pouch, and the cardboard box, after CAD. The expiration date is the last day of the month indicated. CAD: 08-2020 means that you should not use the inhaler after the last day of that month, that is, August 2020.

Do not store at a temperature above 25°C. Do not refrigerate or freeze.If the inhaler is exposed to freezing conditions, let it temper to room temperature for 30 minutes and then recharge it before use (see section 3 “How to use Flutiform”). Do not use the inhaler if it has been removed from the aluminum foil pouch for more than 3 months, or if the dose indicator marks ''0''.

Do not expose to temperatures above 50°C. The aerosol cartridge contains a pressurized liquid, so do not pierce, break, or burn the cartridge, even if it appears to be empty.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Flutiform

- The active principles are fluticasone propionate and formoterol fumarate dihydrate.Cada inhalación (pulsación) contains 50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate.

-The other components (excipients) are:

• Sodium cromoglicate
• Etanol
• Apaflurane HFA 227 (propellant)

This medicine contains greenhouse gases.

Cada inhalador contains 11.2 grams of greenhouse gas HFA227 equivalent to 0.036 tons of CO2equivalent (global warming potential PCG = 3220).

Appearance of Flutiform and contents of the package

This inhaler is a small aerosol cartridge containing a white to off-white liquid suspension equipped with a dosing valve. The cartridge is inserted into a grey and white plastic dispenser (applicator) with a mouthpiece cover in a light grey colour. Cada inhalador contains 120 doses (inhalations). There is one inhaler in each package. The multiple package is 3 x 1 inhaler (120 inhalations).

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Tel.: 91 3821870

Responsible manufacturer

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

Netherlands

This medicine is authorized in the Member States of the European Economic Area with the following names:

Flutiform:

Austria

Belgium

Bulgaria

Croatia

Cyprus

Czech Republic

Denmark

Finland

France

Germany

Hungary

Ireland

Slovenia

Iceland

Luxembourg

Netherlands

Norway

Poland

Portugal

Romania

Slovakia

Spain

Sweden

Flutiformo:

Italy

Last review date of thisleaflet:02/2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/