MORCO 27.5 micrograms/spray nasal suspension

1. What is Morco and what is it used for

Morco belongs to a group of medicines called glucocorticoids. Fluticasone furoate acts by reducing inflammation caused by allergy (rhinitis) and thus reduces the symptoms of the allergy.

Morco nasal spray suspension is used for the treatment of symptoms of allergic rhinitis, including nasal congestion, increased nasal secretion, and nasal itching, sneezing, and runny or itchy eyes in adults and children 6 years and older.

Allergic symptoms may appear at certain times of the year due to allergy to plant or tree pollen (hay fever), or may occur throughout the year due to allergy to animals, dust mites, or molds, among others.

2. What you need to know before you use Morco

Do not use Morco

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Morco.

Children and adolescents

Do not use in children under 6 years.The use of Morco:

• may cause a delay in the growth of children when used for long periods. The doctor will regularly check the child's height and ensure that the child receives the minimum effective dose;
• may cause eye disorders such as glaucoma (increased eye pressure) or cataracts (loss of lens transparency). Inform your doctor if you have had any of these disorders in the past or if you experience blurred vision or other visual disturbances while using fluticasone furoate.

Other medicines and Morco

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

It is especially important that you tell your doctor if you are using or have recently used any of the following medicines:

• steroids in tablets or injectable steroids
• steroids in creams
• medicines for asthma
• ritonavir or cobicistat, used in the treatment of AIDS
• ketoconazole, used in the treatment of fungal infections

Your doctor will decide if you should use fluticasone furoate with these medicines. Some medicines may increase the side effects of Morco, so your doctor will monitor you closely if you are taking these medicines.

Fluticasone furoate should not be used at the same time as other nasal sprays that contain steroids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Do not use Morco if you are pregnant, or are planning to become pregnant, unless your doctor or pharmacist tells you to.

Do not use Morco if you are breastfeedingunless your doctor or pharmacist tells you to.

Driving and using machines

Morco is unlikely to affect your ability to drive or use machines.

Morco contains benzalkonium chloride

This medicine contains 8.25 micrograms of benzalkonium chloride and 13.75 micrograms of polysorbate in each spray.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment.

Polysorbates may cause allergic reactions.

Tell your doctor or pharmacist if you experience discomfort when using the spray.

3. How to use Morco

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

When to use Morco

• Use once a day.
• Use at the same time every day.

This medicine will treat your symptoms throughout the day and night.

How long it takes for Morco to work

Some people may not feel the full effects until several days after starting to use Morco.

However, it is usually effective within 8 to 24 hours after use.

How much to use

Adults and children 12 years and older

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

Children 6 to 11 years

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

How to use the nasal spray

Morco has almost no taste or smell. It is sprayed into the nose as a fine mist. Be careful not to spray the medicine into your eyes. If this happens, rinse your eyes with water.

There is a step-by-step guide for using the nasal spray after section 6 of this leaflet. Follow the guide carefully to get the full benefit of using Morco.

See the sectionStep-by-step guide for using the nasal spray after section6.

If you use more Morco than you should

Talk to your doctor or pharmacist.

If you forget to use Morco

If you miss a dose, use it as soon as you remember.

If it is almost time for your next dose, wait until then. Do not use a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, or if you experience any discomfort when using the nasal spray, ask your doctor or pharmacist .

4. Possible side effects

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

Allergic reactions: seek medical help immediately

Allergic reactions to Morco are rare and affect less than 1 in 1,000 people. In a small number of people, allergic reactions can become more serious, even life-threatening if not treated. The symptoms include:

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

In many cases, these symptoms will be signs of less serious side effects. However, you should be aware that they can be potentially serious;therefore, if you notice any of these symptoms:

Contact your doctor as soon as possible.

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

Nosebleeds (usually minor), especially if you use Morco for more than 6 weeks in a row.

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

• Nasal ulcers, which can cause irritation or discomfort in the nose. You may notice blood when you blow your nose.
• Headache.
• Shortness of breath.

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

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

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

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

Frequency not known(cannot be estimated from the available data)

• Slowing of growth in children.
• Blurred vision or temporary changes in vision with long-term use.
• Chest tightness causing difficulty breathing.
• Voice disorder, loss of voice.
• Taste disorder, loss of taste, loss of smell.

The use of nasal corticosteroids may affect the normal production of hormones in your body, especially if used in high doses for long periods. In children, these side effects may cause slower growth.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist , even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Morco

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

It is best to store Morco 27.5 micrograms/spray, nasal spray suspension, in an upright position.

Always keep the cap on.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown. Once opened, the validity period of Morco is 2 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

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

Appearance of the product and pack contents

The medicine is a white nasal spray suspension presented in a 15ml amber glass bottle with a metered-dose pump, a nasal applicator (actuator), and a cap.

Morco is available in one pack size: 1 bottle of 120 sprays.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

SUBSTIPHARM

24 Rue Erlanger

75016 Paris

France

Manufacturer

CURIDA AS

Solbærvegen 5 Elverum 2409

Norway

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

Austria: Morco 27,5 Mikrogramm/Sprühstoß Nasenspray, Suspension

Spain: Morco 27,5 micrograms/spray, suspension for nasal spray

Date of last revision of this leaflet:06/2024

Other sources of information

Step-by-step guide for using the nasal spray.

STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAY

Appearance of the nasal spray

The nasal spray comes in an amber glass bottle. It will contain 120 sprays.

Five important things you need to know about using the nasal spray

• Morco comes in an amber glass bottle. If you need to check how much is left, hold the nasal spray upright against a light. This way, you will be able to see the level through the window.
• When you use the nasal spray for the first time, you will need to shake it vigorouslywith the cap on for 10 seconds. This is important because Morco is a thick suspension that becomes liquid when shaken well. It will only spray when it becomes liquid.
• You must press the dosing button firmly and completelyto release the mist through the nasal applicator – see drawing a.
• Always keep the cap onthe nasal spray when not in use. The cap prevents dust from entering, seals tightly under pressure, and prevents the nasal applicator from becoming blocked.
• Never use a pinor any other sharp object to unblock the nasal applicator. This will damage the nasal spray.

Preparing the nasal spray for use You must prepare the nasal spray:

• before using it for the first time
• if you have left it uncapped for 5 days or have not used the nasal spray for 30 days or more.

Preparing the nasal spray helps ensure that you always receive the full dose of the medicine. Follow these steps:

1. Shake the nasal spray vigorouslywith the cap on for 10 seconds.
2. Remove the cap.
3. Hold the nasal spray upright, then tilt it and point the nasal applicator away from you.
4. Press the dosing button firmlyand completely – see drawing a. Do this at least 6 timesuntil a fine spray mist is released into the air.

a

The nasal spray is now ready for use.Using the nasal spray

1. Shake the nasal sprayvigorously.

2.

1. Blow your noseto clear your nostrils, then tilt your head slightly forward.
2. Put the nasal applicator in one of your nostrils. Point the tip of the applicator slightly outward, away from the nasal septum. This helps the medicine reach the right part of the nose – see drawing b.

b

1. Press the dosing button firmlyand completely while breathing in through your nose.
2. Remove the applicator and breathe out through your mouth.
3. If your dose is 2 sprays in each nostril, repeat steps 4 to 6.
4. Repeat steps 4 to 7 in the other nostril.
5. Put the cap backon the nasal spray.

Cleaning the nasal spray

After each use:

1. Clean the nasal applicator with a dry and clean tissue.
2. Do not use water to clean it.
3. Never use a pinor any other sharp object in the nasal applicator.
4. Always put the cap backonce you have finished.

If the nasal spray seems not to be working:

• Check if there is still medicine left. Look at the level through the window. If the level is very low, it may not be enough for the nasal spray to work.
• Check if the nasal spray has been damaged.
• If you think the nasal applicator may be blocked, do not use a pinor any other sharp object to unblock it.
• Try to restart it by following the instructions mentioned in “Preparing the nasal spray for use”.
• If it still does not work, or if a stream of liquid is produced, take the nasal spray to the pharmacy and ask your pharmacist.