Fluticomb

Patient Information Leaflet

Fluticomb, (25 micrograms + 50 micrograms)/metered dose, inhalation aerosol,
suspension
Fluticomb, (25 micrograms + 125 micrograms)/metered dose, inhalation aerosol,
suspension
Fluticomb, (25 micrograms + 250 micrograms)/metered dose, inhalation aerosol,
suspension
Salmeterol + Fluticasone propionate
Please read this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Fluticomb is and what it is used for

Fluticomb contains two active substances: salmeterol (as salmeterol xinafoate)
and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open. This makes it easier for air to flow into and out of the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine to prevent breathing problems caused by asthma.
To ensure proper asthma control, Fluticomb must be used every day as directed by your doctor.
Fluticomb helps prevent episodes of breathlessness and wheezing. However, it should not be
used to relieve sudden attacks of breathlessness or wheezing. If such an attack occurs,
you must use a fast-acting bronchodilator, such as salbutamol, immediately. You should
always have such a medicine available.

2. Important information before using Fluticomb

When not to use Fluticomb:

• if the patient is allergic to salmeterol, fluticasone propionate, or to any other component of this medicine – norflurane (HFA-134a).

Warnings and precautions
Before starting treatment with Fluticomb, discuss this with your doctor or pharmacist,
especially if the patient has:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Fluticomb may increase blood glucose levels),
• low potassium levels in the blood,
• active or past tuberculosis or other lung infections.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Fluticomb and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including asthma medications and over-the-counter medicines.
Fluticomb should not be used with certain medicines.
Before starting Fluticomb, inform your doctor if the patient is taking any of the following medicines:

• Medicines belonging to the β-blockers group (e.g. atenolol, propranolol, sotalol). β-blockers are commonly used to treat high blood pressure or other heart conditions.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, erythromycin), including certain medicines used in HIV treatment (e.g. ritonavir, medicines containing cobicistat). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects, including irregular heartbeat, or may worsen existing side effects. Your doctor may wish to closely monitor the patient’s condition when such medicines are used.
• Corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, often used in asthma treatment.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Driving and operating machinery
It is unlikely that Fluticomb will affect the ability to drive or operate machinery.
Patients engaged in sports
Using this medicine without therapeutic need constitutes doping and may still lead to a positive result in anti-doping tests.

3. How to use Fluticomb

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.

• Fluticomb should be taken daily until your doctor advises otherwise. Do not take a higher dose than recommended. If in doubt, consult your doctor or pharmacist.
• Do not stop using Fluticomb or reduce the dose without consulting your doctor.
• Fluticomb should be inhaled into the lungs through the mouth.
• Always keep track of the number of doses used. The inhaler is designed to deliver 120 doses. However, it is not possible to determine when the inhaler is empty or when 120 doses have been released. A small amount of suspension may remain in the container. Therefore, ensure that the inhaler is replaced after 120 doses have been delivered to ensure you receive the correct amount of medicine with each dose.

Adults and adolescents aged 12 years and older:

• Fluticomb (25 micrograms + 50 micrograms): two inhalations twice daily.
• Fluticomb (25 micrograms + 125 micrograms): two inhalations twice daily.
• Fluticomb (25 micrograms + 250 micrograms): two inhalations twice daily.

Children aged 4 to 12 years:

• Fluticomb (25 micrograms + 50 micrograms): two inhalations twice daily.
• Fluticomb is not recommended for use in children under 4 years of age.

If symptoms are well controlled while taking Fluticomb twice daily, your doctor may recommend reducing the frequency of Fluticomb to once daily. The dose may be taken:

• once daily in the evening, if symptoms occur at night,
• once daily in the morning, if symptoms occur during the day.

It is very important to follow your doctor's instructions regarding how many inhalations to take and how often.
If you are using Fluticomb to treat asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or asthma control deteriorates, you must
contact your doctor immediately. This may include increased wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting inhaled medicine to relieve breathing difficulties. In such a case, continue using Fluticomb, but do not increase the number of inhalations. Symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.

Instructions for using the inhaler

• Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler correctly. They should periodically check that you are using the inhaler properly. Incorrect use of Fluticomb or improper use of the inhaler may result in the medicine not providing the expected improvement in asthma control.
• The medicine is contained under pressure in a plastic housing with a mouthpiece.
• A new, full inhaler contains enough medicine for at least 120 doses. After 120 actuations, the inhaler may no longer contain sufficient medicine to deliver the required full dose.

Checking the inhaler

1. Before first use, check that the inhaler works. Remove the cap from the mouthpiece by gently pressing the sides of the cap with your thumb and index finger.
2. To ensure the inhaler works, shake it vigorously, point the mouthpiece away from you, and press the canister firmly to release one dose into the air. Repeat this step, shaking the inhaler again and releasing a second dose into the air. Two doses must be released into the air before the inhaler is used properly.
3. After these two test doses, the inhaler is ready for use.
4. If the inhaler has not been used for one week or longer, it should be tested. To do this, shake it vigorously, point the mouthpiece away from you, and press the canister firmly to release two doses into the air.

WARNING
Never remove the metal canister from the inhaler at any time.
Exceptionally, if the inhaler is very cold (below 0°C), remove the metal canister from the plastic housing and warm it in your hands for several minutes before use. Never use any other method to warm the inhaler. After warming, and before use, firmly press the canister to release two doses into the air.

Reordering
Before the inhaler runs out of doses, order a new inhaler. Remember to do this to avoid running out of medicine.

Using the inhaler
It is important to begin breathing slowly and as steadily as possible even before using the inhaler.

1. Use the inhaler while standing or sitting upright.
2. Remove the cap from the mouthpiece (as shown in Figure A).
3. Check the mouthpiece inside and outside to ensure it is clean and free of foreign objects.
4. Shake the inhaler 4 or 5 times to ensure the contents are properly mixed (Figure B).
5. Hold the inhaler upright with your fingers, placing your thumb under the base of the inhaler, below the mouthpiece. Breathe out fully, as deeply as possible (Figure C).
6. Place the mouthpiece between your upper and lower teeth and seal your lips tightly around it. Do not bite the mouthpiece.
7. Begin a slow and deep inhalation through your mouth. Immediately after starting to inhale, press down on the inhaler to release the dose, then continue a steady, deep inhalation (Figure D).
8. Hold your breath, remove the inhaler from your mouth, and remove your finger from the canister. Hold your breath for several seconds, or as long as is comfortable, then breathe out slowly.
9. Wait approximately 30 seconds before repeating steps 4 to 8.
10. Rinsing your mouth with water and spitting it out and/or brushing your teeth after inhalation helps prevent hoarseness and oral thrush.
11. After inhalation, always replace the cap on the mouthpiece to prevent dust from entering (Figure E). Push the cap firmly into place. When properly fitted, you will hear a click. Do not use excessive force.

Do not rush steps 5, 6, 7, and 8. It is important to breathe as slowly as possible immediately before inhalation. To ensure correct inhalation technique, initially check your technique in front of a mirror. Any "mist" escaping from the inhaler, mouth, or nose during inhalation indicates incorrect technique. Repeat the steps starting from step 4.
As with all inhalers, caregivers should ensure that children prescribed Fluticomb use the inhaler correctly as described above.
If you have difficulty coordinating your breath with inhalation from the inhaler, your doctor may recommend using the inhaler with an AeroChamber Plus spacer device. Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler correctly with the spacer, how to care for the spacer, and answer any related questions. If you use a spacer, it is important not to stop using it without consulting your doctor or nurse. Other spacer devices should not be used with Fluticomb, and you should not switch to a different type of spacer. It is also important not to change the type of spacer or stop using the spacer without consulting your doctor. Your doctor may decide to change your treatment. Always consult your doctor before making any changes to your asthma treatment.
Older children or people with weak hands may find it easier to hold the inhaler with both hands. Grip the inhaler with both index fingers on top and both thumbs underneath the base, below the mouthpiece.

Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week.
To clean the inhaler:

• Remove the cap from the mouthpiece.
• Do not remove the metal canister from the plastic housing during cleaning or at any other time.
• Wipe the mouthpiece inside and outside and the outside of the plastic housing with a dry cloth or tissue.
• Replace the cap on the mouthpiece. When properly fitted, you will hear a click.
• Do not use excessive force.
• Do not wash or immerse any part of the inhaler in water.

Accidentally using more than the recommended dose of Fluticomb
It is important to use the inhaler as instructed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist. Symptoms may include faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.
If higher doses are used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of Fluticomb may reduce the production of steroid hormones by the adrenal glands.

Missing a dose of Fluticomb
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

Stopping Fluticomb treatment
It is very important to take Fluticomb every day as directed. Continue taking it until your doctor advises stopping. Do not suddenly stop taking Fluticomb or reduce the dose, as symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of Fluticomb may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may lead to adverse effects.

These adverse effects may include any of the following:

• abdominal pain,
• fatigue and loss of appetite, nausea,
• vomiting and diarrhoea,
• weight loss,
• headache and drowsiness,
• low blood sugar,
• low blood pressure and seizures.

When the body is under stress due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the adverse effects listed above may occur.
If you experience any of these adverse effects, inform your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone).

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
To reduce the risk of adverse effects, your doctor will prescribe the lowest dose of
Fluticomb that controls asthma effectively.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Fluticomb. Wheezing, coughing, or shortness of breath may occur, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). There may also be a sensation of very rapid heartbeat, weakness, or dizziness (which may lead to falling or loss of consciousness). If any of these
symptoms occur suddenly after using Fluticomb, stop using Fluticomb
immediately and contact your doctor without delay. Allergic reactions to Fluticomb are uncommon (may occur in fewer than 1 in 100 people).
Other adverse effects:
Very common (may occur in more than 1 in 10 people):

• Headache – this adverse effect usually decreases over time with continued treatment.
• Increased frequency of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).

Common (may occur in fewer than 1 in 10 people):

• Oral thrush (painful, creamy-yellow lesions in the mouth and throat), as well as tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may be helpful. Your doctor may prescribe an antifungal medicine to treat oral thrush.
• Joint pain, swelling, and muscle pain.
• Muscle cramps.

The following adverse effects have been reported in patients with chronic obstructive pulmonary disease (COPD):

• Pneumonia and bronchitis (lung infection). Inform your doctor if you experience any of the following symptoms: increased mucus production, change in mucus colour, fever, chills, worsening cough, or increased breathing difficulties.
• Easy bruising and traumatic fractures.
• Sinusitis (a feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon (may occur in fewer than 1 in 100 people):

• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of previously taken antidiabetic medications may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and tend to decrease with continued treatment.
• Chest pain.
• Restlessness (mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (may occur in fewer than 1 in 1000 people):

• Wheezing or breathing difficulties worsening immediately after taking Fluticomb. If such symptoms occur, stop using Fluticomb , use a fast-acting inhaled medicine to relieve breathing difficulties, and contact your doctor immediately .
• Fluticomb may interfere with the body's normal production of steroid hormones, especially when high doses are taken for a prolonged period. Symptoms include:
  • slowed growth in children and adolescents,
  • reduced bone mass,
  • glaucoma,
  • weight gain,
  • facial rounding (moon-shaped face) (Cushing's syndrome). Your doctor will regularly monitor for such adverse effects and ensure that you are using the lowest effective dose of Fluticomb to control asthma.
• Behavioural changes such as excessive excitability and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop using Fluticomb unless instructed by your doctor.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

Adverse effects with unknown frequency (frequency cannot be estimated from available data) :

• Depression or aggression. These effects are more likely in children.
• Blurred vision.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Fluticomb

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
After using the inhaler, replace the cap on the mouthpiece by pressing it into place. Do not use
excessive force.
The metal container contains a pressurized suspension. Do not expose to temperatures above
50°C. Protect from direct sunlight. Do not pierce, break, or burn the container, even if it appears
to be empty.
As with most inhaled medicines in pressurized containers, the therapeutic effect of this medicine
may be reduced when the container is cold.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after EXP indicates the expiry date, and after Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fluticomb contains

• The active substances in Fluticomb are salmeterol and fluticasone propionate. Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or 250 micrograms of fluticasone propionate.
• The other ingredient is the propellant gas: norflurane (HFA - 134a). This medicine contains fluorinated greenhouse gases. Each 120-dose inhaler contains 11.2 g of HFA - 134a, equivalent to 0.016 tonnes of CO₂ (global warming potential GWP = 1430).

What Fluticomb looks like and contents of the pack
Fluticomb is supplied in a metered-dose inhaler containing the medicine as a pressurised suspension for oral inhalation into the lungs.
The pressurised container holds a homogeneous suspension for inhalation.
Pack: an aluminium canister closed with a metering valve, fitted with a plastic mouthpiece covered by a purple cap, all contained in a cardboard box.
Each pack contains 1 inhaler. Each inhaler contains 120 doses.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Poland