Metmin

Package leaflet: Information for the user

Metmin, 50 micrograms/dose, nasal spray, suspension
Mometasoni furoas
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. 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 them even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Metmin is and what it is used for

What is Metmin?
Metmin contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate administered intranasally reduces inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and decreases nasal discharge.
Mometasone furoate should not be confused with anabolic steroids in tablet or injectable form, which are sometimes misused by certain athletes.

What is Metmin used for?
Allergic rhinitis and perennial rhinitis
Metmin is used to treat symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 years and older.
Hay fever, which occurs at specific times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as mold and fungal spores.
Perennial rhinitis occurs throughout the year, and symptoms may be triggered by various allergens, including house dust mites, animal dander (or shed skin), pet hair, and certain foods. Metmin reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, nasal congestion, or nasal discharge caused by hay fever or perennial rhinitis.

Nasal polyps
Metmin is used in the treatment of nasal polyps in adults aged 18 years and older.
Nasal polyps are small growths on the nasal mucosa, usually occurring in both nostrils. Metmin reduces nasal inflammation, leading to gradual shrinkage of nasal polyps, thus improving nasal congestion and facilitating nasal breathing.

2. Important information before using Metmin

When not to use Metmin:

• If the patient is allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
• If the patient has an untreated nasal infection. Using Metmin during an untreated nasal infection, such as herpes, may worsen the symptoms of infection. Wait until the infection has healed before using the nasal spray.
• If the patient has recently undergone nasal surgery or suffered a nasal injury. Do not use the nasal spray until wounds have healed.

Warnings and precautions
Before starting to use Metmin, discuss with your doctor or pharmacist:

• if the patient currently has or has ever had tuberculosis in the past.
• if the patient has any other infection.
• if the patient is taking other corticosteroids orally or by injection.
• if the patient has cystic fibrosis.

While using Metmin, discuss with your doctor:

• if the patient's immune system does not function properly (difficulty fighting infections) and has been in contact with someone who has measles or chickenpox. Avoid contact with people who have these infections;
• if the patient has a nasal or throat infection;
• if the medicine has been used for several months or longer;
• if the patient has persistent nasal or throat irritation;
• if the patient experiences blurred vision or other visual disturbances.

If nasal corticosteroid sprays are used at high doses for a prolonged period,
adverse effects due to systemic absorption of the drug may occur.
If eye itching or irritation occurs, the doctor may recommend alternative treatment with Metmin.
Inform the doctor about all medicines currently or recently taken by the patient, including those
available without a prescription.
Some medicines may increase the effect of Metmin, and the doctor may need to closely monitor the
patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Children
If nasal corticosteroid sprays are used at high doses for a prolonged period, they may cause certain
adverse effects, such as slowed growth rate in children.
It is recommended to regularly monitor the growth of children receiving long-term treatment with
intranasal corticosteroids, and if any changes are noticed, inform the doctor.
Metmin and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
If the patient is taking other corticosteroids orally or by injection, the treating doctor may advise the patient to discontinue their use when starting Metmin. In some patients, after stopping oral or injectable corticosteroids, adverse symptoms such as joint or muscle pain, weakness, and depression may occur. Other allergic symptoms may also appear, such as itching, watery eyes, or red, itchy skin rashes. Contact your doctor if any of these symptoms occur in the patient.
Pregnancy and breastfeeding
There are no data or only limited data on the use of mometasone furoate in pregnant women. It is not known whether mometasone furoate passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
There are no data on the effect of Metmin on the ability to drive or operate machinery.
Metmin contains benzalkonium chloride
This medicine contains 0.02 mg of benzalkonium chloride per dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use Metmin

Metmin should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist. The nasal spray should not be used more frequently, for longer periods, or in higher doses than prescribed by your doctor.

Treatment of seasonal allergic rhinitis and perennial allergic rhinitis

Use in adults and children aged above 12 years
The usual dose is two sprays into each nostril once daily.

• After improvement is achieved, your doctor may recommend reducing the dose.
• If no improvement is observed, contact your doctor, who may recommend increasing the dose: the maximum daily dose is four sprays into each nostril once daily.

Use in children aged 3 to 11 years
The usual dose is one spray into each nostril once daily.
If a patient has severe seasonal allergic rhinitis symptoms, the doctor may recommend starting treatment with Metmin before the pollen season begins. This may help prevent the onset of hay fever symptoms. Improvement may occur towards the end of the pollen season, and treatment may no longer be necessary.

Nasal polyps

Use in adults aged above 18 years
Initially, the usual dose is two sprays into each nostril once daily.

• If there is no improvement after 5 to 6 weeks of treatment, your doctor may recommend increasing the dose to two sprays into each nostril twice daily. After improvement is achieved, your doctor may recommend reducing the dose.
• If there is no improvement after 5 to 6 weeks of twice-daily treatment, the patient should contact their doctor.

Preparing the nasal spray for use

Metmin nasal spray contains a protective cap that covers the spray nozzle and prevents contamination. Remember to remove it before using the spray and replace it after each use.

Before first use, prime the pump by pressing down 10 times until a fine mist appears:

1. Gently shake the bottle.
2. Place your index and middle fingers on either side of the spray nozzle and your thumb underneath the bottle. Do not pierce the nasal spray dispenser.
3. Pointing the nozzle away from you, press down with your fingers 10 times until a uniform mist is produced.

If the nasal spray has not been used for 14 days or longer, prime the pump by pressing it twice before next use until a uniform mist is produced.

How to use the nasal spray

1. Gently shake the bottle and remove the protective cap. (Figure 1)
2. Gently blow your nose.
3. Close one nostril and insert the spray nozzle into the other nostril as shown in the illustration. (Figure 2) Tilt your head slightly forward and hold the bottle upright.
4. Begin a gentle and slow inhalation through the nose while pressing down once with your fingers to release a spray (as a fine mist) into the nostril.
5. Exhale through your mouth. Repeat step 4 to administer a second spray into the same nostril, if required.
6. Remove the spray nozzle from the nostril and exhale through your mouth.
7. Repeat steps 3 to 6 to administer the spray into the other nostril. (Figure 3)

After using the nasal spray, carefully wipe the spray nozzle with a clean tissue or cloth and replace the protective cap.

Fig. 1

Fig. 2
Fig. 3
Cleaning

• It is important to clean the nasal spray bottle regularly, otherwise it may not function properly.
• Remove the protective cap and gently pull off the spray nozzle.
• Wash the spray nozzle and protective cap with warm water, then rinse under running water.
• Do not unblock the spray nozzle by piercing it with a needle or any other sharp object, as this may damage the dispenser and result in incorrect dosing.
• Leave the protective cap and spray nozzle in a warm place to dry.
• Reattach the spray nozzle to the bottle, then replace the protective cap.
• After cleaning, check that the dispenser works properly by spraying twice.

Use of more than the recommended dose of Metmin

If more Metmin has been used than recommended, consult your doctor. If steroids are used for long periods or in high doses, they may rarely have an adverse effect on the patient's hormones. In children, they may affect growth and development.

Missed dose of Metmin

If a dose of nasal spray is missed at the scheduled time, the patient should take it as soon as they remember, then continue treatment at the usual time. Do not use a double dose to make up for a missed dose.

Stopping Metmin

In some patients, symptom relief may occur within 12 hours after the first dose of Metmin, but full benefits of treatment may not be evident until after 2 days of use. It is very important that the patient uses the nasal spray regularly. Do not stop treatment, even if the patient feels better, unless instructed by the doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Immediate allergic (hypersensitivity) reactions may occur after using this medicine.
These reactions can be severe. You must stop using Metmin and seek medical help immediately if you experience symptoms such as:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives
• wheezing or difficulty breathing

If nasal corticosteroid sprays are used at high doses over a long period, adverse effects may occur due to systemic absorption of the medicine.
Other adverse effects
Most people using nasal sprays do not report any adverse effects. However, the following adverse effects have been reported in some individuals after using Metmin or other nasal corticosteroid sprays:

Very common adverse effects (may occur in more than 1 in 10 people):

• nosebleeds (observed in patients with nasal polyps who used two doses of Metmin into each nostril twice daily)

Common adverse effects (may occur in less than 1 in 10 people):

• headache
• sneezing
• irritated nose or sore throat
• nasal mucosal ulceration
• upper respiratory tract infection

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

• increased intraocular pressure (glaucoma) and/or cataract causing visual disturbances
• damage to the nasal septum separating the nostrils
• disturbances in taste and smell
• breathing difficulties and/or wheezing
• blurred vision

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Email: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Metmin

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use Metmin after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of the stated month.
Shelf life after first opening the bottle: 2 months. Only open one bottle at a time.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine Metmin contains

• The active substance is mometasone furoate. Each delivered dose contains 50 micrograms of mometasone furoate in monohydrate form.
• The other ingredients are: benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose and sodium carmellose, citric acid monohydrate, sodium citrate, purified water.

What Metmin looks like and contents of the pack
Metmin is a nasal aerosol, suspension.
The bottle contains 60 or 140 doses.
The pack contains 1 bottle with 60 or 140 doses, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer:
Farmea
10, rue Bouché Thomas Z.A.C d’Orgemont
49000 Angers
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark – Metmin
Estonia – Breso
Hungary – Metmin 50 µg / adag, Szuszpenziós orrspray
Latvia – Breso 50 mikrogrami / devā degunā aerosols, suspensija
Lithuania – Breso 50 mikrogramų/dozėje nosies purškalas (suspensija)
Poland – Metmin, nasal aerosol, suspension