Flutiform 125 micrograms / 5 micrograms inhalation suspension for inhalation in pressurized container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flutiform 125 micrograms/5 micrograms/dose, suspension for pressurised inhalation

Fluticasone propionate/formoterol fumarate dihydrate

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

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

Leaflet contents

1. What Flutiform is and what it is used for
2. What you need to know before using Flutiform
3. How to use Flutiform
4. Possible side effects
5. How to store Flutiform
6. Contents of the pack and other information

1. What Flutiform is and what it is used for

Note:

The medicine's full name is Flutiform pressurised inhalation suspension, however throughout this leaflet it is referred to as Flutiform. Sometimes a specific dose is referenced.

Flutiform is an inhaler (a pressurised inhalation suspension) that contains two active substances:

• Fluticasone propionate, which belongs to a group of medicines called corticosteroids. Corticosteroids help reduce swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate, which belongs to a group of medicines known as long-acting beta2 agonists. Long-acting beta2 agonists 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 should use this medicine every day as directed by your doctor.

This medicine helps prevent breathing problems such as asthma and helps avoid shortness of breath and breathing difficulties. However, it does not work during an asthma attack, that is, if you are already experiencing breathlessness and wheezing. If this happens, you will need to use a fast-acting "rescue" medicine such as salbutamol.

2. What you need to know before starting to use Flutiform

Do not use Flutiform if:

• you are allergic to fluticasone propionate, formoterol fumarate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

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

• Active or past tuberculosis (TB). Symptoms include a persistent cough, often with blood-stained sputum, fever, fatigue, loss of appetite, weight loss, and night sweats.
• A lung or chest infection.
• Heart problems, such as reduced blood flow to the heart, narrowing of one of the heart valves (aortic valve), heart failure (which may cause difficulty breathing or swelling of the ankles), a condition in which the heart muscle is thickened (hypertrophic obstructive cardiomyopathy), irregular heartbeat (cardiac arrhythmias), or if you have been told that your electrocardiogram (ECG) is abnormal (prolonged QTc interval).
• An abnormal bulging of a blood vessel wall (aneurysm).
• Diabetes.
• High blood pressure.
• Overactive thyroid gland, which may cause increased appetite, weight loss, or sweating (thyrotoxicosis).
• Low blood potassium levels, which may cause muscle weakness, muscle cramps, or irregular heartbeat (hypokalaemia).
• Adrenal gland dysfunction (if the adrenal gland is not working properly, you may experience symptoms such as headaches, weakness, fatigue, abdominal pain, loss of appetite, weight loss, dizziness, very low blood pressure, diarrhoea, feeling unwell, or seizures), or a tumour of the adrenal gland (pheochromocytoma).
• Liver problems.

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

If you are undergoing surgery or are under extreme stress, inform your doctor, as you may need additional steroid treatment to control your asthma.

Other medicines and Flutiform

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Using this inhaler with other medicines may alter the effect of this inhaler or the other medicine.

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

• Medicines known as beta-blockers (such as atenolol for treating high blood pressure, sotalol for treating irregular heart rhythms, metoprolol for treating fast heart rate, or timolol in eye drops for treating glaucoma).
• Other medicines used to treat asthma or breathing problems (such as theophylline or aminophylline).
• Medicines containing adrenaline or related substances (including other beta agonists such as salbutamol or beta antagonists such as atenolol, metoprolol, propranolol, timolol). Other long-acting beta2 agonists should not be used together with this inhaler. If your asthma worsens between doses of Flutiform, you should use your fast-acting "rescue" inhaler for immediate relief.
• Medicines for treating allergic reactions (antihistamines).
• Medicines for treating high blood pressure or fluid retention by increasing urine output (diuretics).
• Medicines used to treat heart failure (such as digoxin).
• Medicines for treating abnormal heart rhythms (such as quinidine, disopyramide, procainamide).
• Medicines for treating symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), tricyclic antidepressants (e.g. amitriptiline and imipramine), or if you have taken any of these medicines within the last two weeks.
• Medicines used to treat psychiatric or mental disorders (phenothiazines or antipsychotics).
• Other medicines containing steroids.
• Antifungal medicines (such as ketoconazole or itraconazole).
• Some medicines may increase the effects of Flutiform, and your doctor may want to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, atazanavir, indinavir, nelfinavir, saquinavir, or cobicistat).
• Antibiotics (such as clarithromycin, telithromycin, or furazolidone).
• Medicines for treating Parkinson's disease (levodopa).
• Medicines for treating underactive thyroid gland (levothyroxine).
• Medicines for treating Hodgkin's disease (procarbazine).
• Medicines to induce labour (oxytocin).

If you are undergoing surgery under general anaesthesia, please inform your hospital doctor that you are using this inhaler.

Pregnancy and breastfeeding

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

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

Flutiform contains ethanol (alcohol) and sodium cromoglicate

This medicine contains 2 mg of alcohol per dose (2 inhalations). The amount per dose is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine has no significant 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 usual.

3. How to use Flutiform

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must use your inhaler regularly, i.e., two inhalations (actuations) in the morning and two inhalations (actuations) at night every day, in order to obtain the maximum benefit from your inhaler, unless your doctor gives you different instructions or advises you to stop treatment. Do not take more doses than prescribed. Your doctor may have prescribed your inhaler for a condition other than asthma or at a different dose than normally prescribed and described in this leaflet. You must always use your inhaler exactly as recommended by your doctor. If you are unsure about how much to take or how often you should use the inhaler, please consult your doctor or pharmacist.

Adults, adolescents, and children aged 5 years and older

The usual dose is two inhalations twice daily, i.e., two inhalations (actuations) in the morning and two at night. Your doctor will prescribe the dose necessary to treat your asthma. Only adults should use the higher-dose inhaler (Flutiform 250 micrograms/10 micrograms).

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

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

Instructions for use

Read the leaflet carefully before using the inhaler and follow the instructions for use in the text and diagrams shown below. Your doctor or pharmacist will show you how to use your inhaler correctly. The medicine is contained within an aerosol cartridge (see Diagram 1), which in turn is housed inside a plastic dispenser (also known as an actuator). The actuator also has a dose counter to indicate how many inhalations (actuations) remain after priming. This counter also features a colour code: it starts in green, then changes to yellow when fewer than 50 actuations remain, and turns red when fewer than 30 actuations remain. When the counter approaches zero, you should contact your doctor to obtain a replacement inhaler. Do not use your inhaler when the counter reads zero.

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

If your inhaler is new or has not been used for more than 3 days, you must prime it to ensure it functions properly and delivers the correct dose.

If your inhaler has been exposed to freezing temperatures, allow it to warm to room temperature for 30 minutes, then prime it to ensure it functions properly and delivers the correct dose.

To prime the inhaler

• Remove the mouthpiece cap and shake the inhaler well.
• Point the mouthpiece away from you and release one spray (one actuation) by pressing down on the aerosol cartridge. This step must be repeated four times.

The inhaler must always be shaken immediately before use.

Using the inhaler

If while using Flutiform you experience difficulty breathing or wheezing, continue using Flutiform but contact your doctor as soon as possible, as you may require additional treatment. Once your asthma is well controlled, your doctor may consider gradually reducing the dose of Flutiform.

Slowly perform steps 2 to 5 shown below.

1. Remove the mouthpiece cap (see Diagram 2) and check that your inhaler is clean and free of dust.
2. Shake the inhaler immediately before each actuation to ensure the contents are uniformly mixed.
3. Sit upright or stand. Breathe out comfortably, as slowly and deeply as possible.

1. Hold your inhaler upright (as shown in Diagram 3) and place the mouthpiece in your mouth, sealing your lips around it. Hold the inhaler with your thumb(s) on the base of the mouthpiece and your index finger(s) on 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 one spray (actuation). Continue inhaling steadily and deeply (approximately 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 as long as comfortable. Do not exhale into the inhaler.
2. For the second actuation, keep the inhaler upright, then repeat steps 2 to 6.
3. Replace the mouthpiece cap.

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

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

If you have weak hand strength, it may be 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 a spacer chamber, AeroChamber Plus® Flow-Vu®, to help deliver the medicine properly to your lungs. Your doctor or pharmacist will advise you on how to use the AeroChamber Plus® Flow-Vu® spacer with your inhaler. The AeroChamber Plus® Flow-Vu® comes with instructions for use, care, and cleaning, which you must read carefully.

Caring for your inhaler

It is important to follow these instructions carefully and to clean your inhaler weekly. To clean your inhaler:

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

If you use more Flutiform than you should

It is important to take your doses exactly as instructed by your doctor or pharmacist. Do not increase or decrease your dose without medical advice.

If you use more Flutiform than prescribed, contact your doctor or pharmacist immediately for advice. You may experience severe chest pain (angina), high or low blood pressure, headache, muscle cramps, difficulty sleeping, nervousness, dry mouth, loss of appetite, restlessness, fits or seizures. You may feel unsteady, dizzy, weak, tired, unwell, or experience general malaise. You may also notice changes in your heart rate, low blood potassium levels, or increased blood sugar levels. You may also experience symptoms such as abdominal pain, feeling unwell, weight loss, reduced level of consciousness (which may cause drowsiness or confusion), or low blood sugar levels.

If you have taken more than the prescribed dose over a long period, speak to your doctor or pharmacist for advice on what to do. This is because high doses may reduce the amount of steroid hormones normally produced by the adrenal glands (see section 4 “Possible side effects”).

If you forget to use Flutiform

If you forget to inhale a dose, take it as soon as you remember. 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 very important to use this inhaler every day as directed by your doctor, even if you feel well, as it will help control your asthma. If you wish to stop using your inhaler, speak to your doctor first. They will advise you on how to do this, usually by gradually reducing the dose, to avoid triggering an asthma attack.

4. Possible adverse effects

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

All medicines can cause allergic reactions, although serious allergic reactions are rare. Inform your doctor immediately if you suddenly develop swelling of the eyelids, face, throat, tongue or lips; if you develop a rash or itching, especially if widespread; or if you experience symptoms such as dizziness, feeling faint or fainting, or sudden changes in your breathing such as increased wheezing or difficulty breathing.

As with other inhalers, your breathing may worsen immediately after using the inhaler. You may notice increased wheezing and difficulty breathing. If this happens, stop using Flutiform and use your fast-acting 'rescue' inhaler. Contact your doctor immediately. Your doctor will assess you and may start you on a different type of treatment. You must carry your 'rescue' inhaler with you at all times.

Uncommon adverse effects (may affect up to 1 in 100 people)

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

Rare adverse 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 more frequently and adjust your usual diabetes treatment. Your doctor may need to monitor you more closely.
• Oral or throat fungal infection (e.g. candidiasis).
• Inflammation of the sinuses (sinusitis).
• Rapid heartbeat.
• Chest pain associated with heart disease.
• Muscle spasms.
• Cough or difficulty breathing.
• Diarrhoea.
• Indigestion.
• Taste disturbances.
• Dizziness or sensation of spinning.
• Abnormal dreams.
• Restlessness.
• Itching of the skin.
• High blood pressure.
• Unusual weakness.
• Swelling of hands, ankles or feet.

Frequency not known: cannot be estimated from available data

• Blurred vision.
• Sleep problems, depression or feelings of worry, aggression, anxiety, restlessness, nervousness, excessive excitement or irritability. These effects are more likely to occur in children.

The following adverse effects have been associated with formoterol fumarate but have not been reported in clinical trials with this inhaler:

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

Inhaled corticosteroids may affect the normal production of steroid hormones in your body, especially if high doses are used over a long period of time. Effects include:

• Changes in bone mineral density (thinning of the bones).
• Cataracts (clouding of the eye lens).
• Glaucoma (increased pressure in the eye).
• Bruising or thinning of the skin.
• Increased susceptibility to infections.
• Slowed growth in children and adolescents.
• Rounded face (moon face).
• An effect on the adrenal gland (a small gland above the kidney), leading to symptoms such as weakness, fatigue, difficulty coping with stress, abdominal pain, loss of appetite, weight loss, headache, dizziness, very low blood pressure, diarrhoea, feeling unwell or seizures.

These effects are much less likely to occur with inhaled corticosteroids than with oral steroid tablets.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Flutiform

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

Do not use this medicine after the expiry date stated on the label, the aluminium pouch, and the cardboard box, after EXP. The expiry date refers to the last day of the month indicated. EXP: 08-2020 means that you should not use the inhaler after the last day of that month, i.e. August 2020.

Do not store above 25°C. Do not refrigerate or freeze. If the inhaler has been exposed to freezing conditions, allow it to reach room temperature for 30 minutes, then prime it before use (see section 3 “How to use Flutiform”). Do not use the inhaler if it has been removed from the aluminium pouch for more than 3 months, or if the dose indicator reads ''0''.

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure how to dispose of unused medicines and their packaging, ask your pharmacist. This helps protect the environment.

6. Contents of the container and additional information

Composition of Flutiform

• The active substances are fluticasone propionate and formoterol fumarate dihydrate. Each inhalation (actuation) contains 125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate.

• The other components (excipients) are:

  • Sodium cromoglicate
  • Ethanol
  • HFA 227 (propellant)

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 11.2 grams of the fluorinated greenhouse gas HFA227, equivalent to 0.036 tonnes of CO2 (global warming potential GWP = 3220).

Appearance of Flutiform and contents of the pack

This inhaler is a small aerosol cartridge containing a white to off-white liquid suspension, equipped with a metering valve. The cartridge is inserted into a grey and white plastic dispenser (actuator) with a light grey mouthpiece cap. Each inhaler contains 120 doses (inhalations). There is one inhaler per pack. The multipack contains 3 x 1 inhaler (120 inhalations).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Tel.: 91 3821870

Manufacturer(s)

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

The Netherlands

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

Flutiform:

Austria

Belgium

Bulgaria

Croatia

Cyprus

Czech Republic

Denmark

Finland

France

Germany

Hungary

Republic of Ireland

Iceland

Luxembourg

Netherlands

Norway

Poland

Portugal

Romania

Slovak Republic

Slovenia

Spain

Sweden

Flutiformo:

Italy

Date of latest revision of this package leaflet: 02/2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/