Fluticasone furoate Substipharm

A. PACKAGE LEAFLET

Package leaflet: Information for the user

Fluticasone Furoato Substipharm 27.5 micrograms/dose, nasal spray, suspension

fluticasone furoate
Generic medicine
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Fluticasone Furoate Substipharm is and what it is used for

Fluticasone Furoate Substipharm belongs to a group of medicines called glucocorticoids.
Fluticasone furoate works by reducing inflammation caused by allergy (rhinitis), thereby relieving allergy symptoms.
Fluticasone Furoate Substipharm nasal spray is used to treat symptoms of allergic rhinitis, including blocked, runny or itchy nose, sneezing, watery eyes, and itchy or red eyes, in adults and children aged 6 years and older.
Allergy symptoms may occur during specific times of the year and may be due to allergy to grass or tree pollen (hay fever), or may occur throughout the year and be caused by allergy to animals, house dust mites, moulds, among some of the most common triggers.

2. What you need to know before taking Fluticasone Furoate Substipharm

Do not use Fluticasone Furoate Substipharm

• If you are allergic to fluticasone furoate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Fluticasone Furoate Substipharm.
Children and adolescents
Do not use in children under 6 years of age.
Taking Fluticasone Furoate Substipharm:

• may cause children to grow more slowly if taken over a long period of time. Your doctor will regularly monitor the child's height and ensure they are receiving the lowest effective dose possible.
• may cause eye disorders such as glaucoma (increased pressure in the eye) or cataracts (clouding of the eye's lens). Inform your doctor if you have previously had these conditions or if you notice blurred vision or other visual disturbances while taking fluticasone furoate.

Other medicines and Fluticasone Furoate Substipharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
It is especially important to inform your doctor if you are taking or have recently taken any of the following medicines:

• steroid tablets or steroid injections
• steroid creams
• medicines for asthma
• ritonavir or cobicistat, used to treat HIV
• ketoconazole, used to treat fungal infections

Your doctor will check whether you can take fluticasone furoate with these medicines. Your doctor may want to closely monitor you if you are taking any of these medicines, as they can increase the side effects of Fluticasone Furoate Substipharm.
Fluticasone furoate must not be used at the same time as other nasal sprays containing steroids.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Do not use Fluticasone Furoate Substipharm if you are pregnant or planning to become pregnant, unless your doctor or pharmacist has instructed you to do so.
Do not use Fluticasone Furoate Substipharm if you are breastfeeding unless your doctor or pharmacist has instructed you to do so.
Driving and using machines
It is unlikely that Fluticasone Furoate Substipharm will affect your ability to drive or operate machinery.
Fluticasone Furoate Substipharm contains benzalkonium chloride
This medicine contains 8.25 micrograms of benzalkonium chloride and 13.75 micrograms of polysorbate per spray.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for long periods.
Polysorbates may cause allergic reactions.
Inform your doctor or pharmacist if you experience discomfort when using the spray.

3. How to take Fluticasone Furoato Substipharm

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
When to use Fluticasone Furoato Substipharm

• Take it once daily
• Take it every day at the same time. This helps control your symptoms throughout the day and night.

How long does it take for Fluticasone Furoato Substipharm to work?
Some people may experience the full effect of Fluticasone Furoato Substipharm several days
after first use. However, it is generally effective within 8–24 hours after the first nasal
administration.

How much Fluticasone Furoato Substipharm to use
Adults and children aged 12 years and older

• The usual starting dose is 2 sprays in each nostril once a day, every day.
• Once symptoms are under control, the dose may be reduced to 1 spray in each nostril once a day, every day.

Children aged 6 to 11 years

• The usual starting dose is 1 spray in each nostril once a day.
• If symptoms are very severe, your doctor may increase the dose to 2 sprays in each nostril once a day, every day, until symptoms are under control. The dose may then be reduced to 1 spray in each nostril once a day, every day.

How to use the nasal spray
Fluticasone Furoato Substipharm has virtually no taste or smell. It is sprayed into the nose
as a fine mist. Be careful not to spray it into the eyes. If this happens, rinse the eyes with water.
There is a step-by-step guide on how to use the nasal spray after section 6 of this patient information leaflet.
Follow the guide carefully to get the maximum benefit from using Fluticasone Furoato
Substipharm
  Please refer to the Step-by-step guide on how to use the nasal spray after section 6.
If you take more Fluticasone Furoato Substipharm than you should
Inform your doctor or pharmacist.
If you forget to take Fluticasone Furoato Substipharm
If you miss a dose, take it as soon as you remember.
If it is almost time for your next dose, wait until then. Do not take a double dose to make up for a missed one.
If you have further questions about the use of this medicine or if you have any difficulty using the nasal
spray, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Allergic reactions: consult a doctor immediately
Allergic reactions to Fluticasone Furoato Substipharm are rare and affect fewer than 1 in 1,000 people. In a small number of individuals, allergic reactions may develop into a more serious, potentially life-threatening condition if not treated. Symptoms include:

• onset of wheezing, coughing, or difficulty breathing
• sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness)
• swelling of the face
• skin rash or redness

In many cases, these symptoms may indicate less serious side effects. However, you should be aware that they could potentially be serious. Therefore, if you experience any of these symptoms: Consult a doctor as soon as possible.

Very common side effects (may affect more than 1 in 10 people)

• Nosebleeds (generally mild), particularly if you take Fluticasone Furoato Substipharm for more than 6 consecutive weeks.

Common side effects (may affect up to 1 in 10 people)

• Nasal ulceration – which may cause irritation or discomfort in the nose. You may also notice streaks of blood when blowing your nose.
• Headache
• Shortness of breath.

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

• Pain, burning, irritation, or dryness inside the nose.

Very rare side effects (may affect up to 1 in 10,000 people)

• Small holes (perforations) in the cartilaginous part of the nasal septum that separates the nostrils.

Side effects of unknown frequency (frequency cannot be estimated from the available data)

• Slowed growth in children.
• Blurred vision or temporary changes in eyesight with prolonged use.
• Chest tightness causing breathing difficulties.

Nasally administered corticosteroids may interfere with the normal production of steroid hormones in your body, particularly if high doses are used over a long period of time. In children, this side effect may result in slower growth compared to other children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluticasone Furoate Substipharm

Keep this medicine out of the sight and reach of children.
The best way is to store Fluticasone Furoate Substipharm 27.5 micrograms per spray, nasal spray
suspension, in an upright position.
Always keep the cap attached.
Do not use this medicine after the expiry date stated on the label and carton after "Exp". The expiry date refers to the last day of that month. After first opening, Fluticasone Furoate Substipharm must be used within 2 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluticasone Furoate Substipharm contains

• The active substance is fluticasone furoate. Each spray delivers 27.5 micrograms of fluticasone furoate.
• The excipients are glucose, microcrystalline cellulose (E460), sodium carmellose (E466), polysorbate 80 (E433), benzalkonium chloride, edetate disodium, purified water (see section 2).

Description of the appearance of Fluticasone Furoate Substipharm and contents of the pack
The medicine is a nasal spray in the form of a white suspension contained in a 15 mL amber glass
type III bottle equipped with a metering pump, a nasal applicator (actuator), and a cap.
Fluticasone Furoate Substipharm is available in one pack size: 1 bottle containing 120 sprays.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder:
SUBSTIPHARM
24 Rue Erlanger
75016 Paris - France
Manufacturer
CURIDA AS
Solbærvegen 5
2409 Elverum
Norway
This medicine is authorised in the European Economic Area Member States under the
following names:
Austria Fluticasonfuroat Substipharm 27.5 microgram/spray nasal spray, suspension
Sweden Fluticasone furoate Substipharm 27.5 microgram/spray dose nasal spray suspension
Denmark Fluticasonfuroat Substipharm
Finland Fluticasone furoate Substipharm 27.5 microgram/spray nasal spray suspension
Fluticasone furoate Substipharm 27.5 microgram/spray dose nasal spray suspension
Italy Fluticasone Furoato Substipharm
France Fluticasone furoate Substipharm 27.5 micrograms/spray, suspension for nasal
spray
Other sources of information
Step-by-step guide on how to use the nasal spray
STEP-BY-STEP GUIDE ON HOW TO USE THE NASAL SPRAY
What the nasal spray looks like
The nasal spray comes in an amber glass bottle. The bottle contains 120 sprays.
Five important things you need to know about using the nasal spray

• Fluticasone Furoate Substipharm comes in an amber glass bottle. To check how much medicine is left in the bottle, hold the nasal spray upright against the light. This allows you to see the level of the medicine through the glass.
• When using the nasal spray for the first time, you must shake it vigorously for about 10 seconds, with the cap in place. This is important because Fluticasone Furoate Substipharm is a dense suspension that becomes liquid when shaken well. The medicine will only spray when it becomes liquid.
• The pump must be pressed down firmly and completely to release the mist through the nozzle – see figure a.
• Always keep the cap on the nasal spray when not in use. The cap keeps dust away, seals by pressure, and prevents the nozzle from becoming blocked.
• Do not use a pin or any sharp object to clean the nozzle. This would block the nasal spray.

Preparing the nasal spray for use
The nasal spray must be prepared:

1. before first use
2. if it has been left without the cap for 5 days or if the nasal device has not been used for 30 days or more
   Preparing the nasal spray ensures that the full dose of medicine is delivered.

Follow these steps:
1 Shake the nasal spray vigorously with the cap on for about 10 seconds.
2 Remove the cap.
3 Hold the nasal spray upright, then tilt it and point the nozzle away from you.
4 Press the pump firmly down completely. Repeat this at least 6 times until a fine mist is seen in the air.

a
The nasal spray is now ready for use.
Using the nasal spray
1. Shake the nasal spray vigorously.
2. Remove the cap.

3. Blow your nose to clear the nostrils, then tilt your head slightly forward.
4. Insert the nozzle into one nostril. The nozzle should be placed inside the nostril pointing towards the outer side of the nose, away from the central septum. This helps deliver the medicine to the correct area of the nose – see figure b.

b

5. Press the pump firmly down completely, while breathing in through your nose.
6. Remove the nozzle and breathe out through your mouth.
7. If the prescribed dose is 2 sprays in each nostril, repeat steps 4 to 6.
8. Repeat steps 4 to 7 for the other nostril.
9. Replace the cap on the nasal spray.

Cleaning the nasal spray
After each use:
1 Wipe the nozzle with a clean, dry cloth.
2 Do not use water to clean the nasal spray.
3 Never use a pin or any sharp object on the nozzle.
4 Always replace the cap on the nasal spray after use.
If the nasal spray does not seem to work:

• Check whether any medicine remains. Look at the level of the medicine through the glass. If the level is very low, there may not be enough medicine left for the nasal spray to work.
• Check whether the nasal spray has been damaged.
• If you think the nozzle may be blocked, do not use a pin or any sharp object to clean it.
• Try to get it working again by following the instructions in the section “Preparing the nasal spray for use”.
• If the nasal spray still does not work, or if it delivers a stream of liquid instead of a spray, return it to your pharmacist for advice.