Metmin

Package Leaflet: Information for the User

Metmin, 50 micrograms/dose, nasal spray, suspension

Mometasone furoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

• 1. What is Metmin and what is it used for
• 2. Important information 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 is Metmin and what is it used for

What is Metmin?

Metmin contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate administered intranasally relieves the symptoms of inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, and a feeling of a blocked nose, and reduces the amount of nasal discharge. Mometasone furoate should not be confused with anabolic steroids in tablet or injection form, which are misused by some athletes.

What is Metmin used for?

Hay fever and perennial allergic rhinitis Metmin is used to treat the symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial allergic rhinitis in adults and children aged 3 and older. Hay fever, which occurs at certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as mold and fungal spores. Perennial allergic rhinitis occurs throughout the year, and symptoms can be caused by sensitivity to various factors, including house dust mites, animal dander (or shed skin), feathers, and some foods. Metmin reduces the swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, a feeling of a blocked nose, or runny nose caused by hay fever or perennial allergic rhinitis. Nasal polyps Metmin is used to treat nasal polyps in adults aged 18 and older. Nasal polyps are small growths on the nasal mucosa, usually occurring in both nostrils. Metmin reduces the inflammation in the nose, causing the polyps in the nose to gradually shrink, thereby reducing the feeling of a blocked nose, which can make breathing difficult.

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 infection in the nasal cavity, such as herpes, may worsen the symptoms of the infection. The nasal spray should not be used until the infection has been treated.
• If the patient has recently had nasal surgery or a nasal injury. The nasal spray should not be used until the wounds have healed.

Warnings and precautions

Before starting to use Metmin, you should discuss this with your doctor or pharmacist:

• if the patient currently has or has 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, you should discuss this with your doctor:

• if the patient's immune system is not working properly (has difficulty fighting infection) and the patient has come into contact with someone who has chickenpox or shingles. Contact with people who have these infections should be avoided;
• if the patient has a nasal or throat infection;
• if the medicine is used for several months or longer;
• if the patient has persistent irritation of the nose or throat;
• if the patient experiences blurred vision or other vision disturbances.

If corticosteroids in the form of a nasal spray are taken in large doses for a long time, side effects may occur due to the absorption of the medicine into the body. If itching or irritation of the eyes occurs, the doctor may recommend other treatment with Metmin. You should tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription. Some medicines may enhance the effect of Metmin, and the doctor may want to closely monitor the condition of the patient taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Children

If corticosteroids in the form of a nasal spray are used in large doses for a long time, they may cause certain side effects, such as slowing down the growth rate in children. It is recommended that the growth of children receiving long-term treatment with nasal corticosteroids be regularly monitored, and if any changes are observed, the doctor should be informed.

Metmin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or plan to take. If you are taking other corticosteroids orally or by injection, your doctor may recommend that you stop taking them when you start using Metmin. In some patients, after stopping oral or injectable corticosteroids, side effects such as joint or muscle pain, weakness, and depression may occur. Other allergic symptoms, such as itching, tearing, or red and itchy skin patches, may also appear. You should contact your doctor if you experience any of these symptoms.

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 you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

There are no data on the effect of Metmin on the ability to drive and use machines.

Metmin contains benzalkonium chloride

This medicine contains 0.02 mg of benzalkonium chloride in one dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Metmin

Metmin should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. The nasal spray should not be used more frequently, for a longer period, or in larger doses than recommended by your doctor.

Treatment of hay fever and perennial allergic rhinitis

Use in adults and children over 12 years of age

Typically, two doses of the nasal spray are used in each nostril once a day.

• After improvement, your doctor may recommend reducing the dose.
• If you do not feel any improvement, you should contact your doctor, who may recommend increasing the dose: the maximum daily dose is four doses of the nasal spray in each nostril once a day.

Use in children aged 3 to 11 years

Typically, one dose of the nasal spray is used in each nostril once a day.

If you have severe symptoms of hay fever, your doctor may recommend starting to use Metmin before the start of the pollen season. This will help prevent the symptoms of hay fever from occurring. At the end of the pollen season, improvement may occur, and treatment may no longer be necessary.

Nasal polyps

Use in adults over 18 years of age

Typically, two doses of the nasal spray are used in each nostril once a day.

• If after 5 to 6 weeks of using the medicine, no improvement occurs, the doctor may recommend increasing the dose to two doses of the nasal spray in each nostril twice a day. After improvement, the doctor may recommend reducing the dose of the medicine.
• If after 5 to 6 weeks of using the medicine twice a day, no improvement occurs, you should contact your doctor.

Preparing the nasal spray for use

Metmin nasal spray contains a protective cap that protects the tip of the dispenser and prevents it from becoming contaminated. Remember to remove it before using the spray and put it back on after use. Before using the spray for the first time, you should check its operation by pressing the pump 10 times until a fine mist is produced:

• 1. Gently shake the bottle.
• 2. Place your index and middle fingers on either side of the tip of the dispenser, and your thumb under the bottle. Do not puncture the nasal spray dispenser.
• 3. With the tip of the dispenser pointing away from you, press your fingers together to spray the medicine 10 times until a fine mist is produced.

If the nasal spray has not been used for 14 days or longer, before using it again, you should press the pump 2 times until a fine mist is produced.

How to use the nasal spray

• 1. Shake the bottle gently and remove the protective cap. (Figure 1)
• 2. Gently blow your nose.
• 3. Close one nostril and insert the tip of the dispenser into the other nostril, as shown in the picture. (Figure 2) Tilt your head slightly forward, holding the bottle upright.
• 4. Start to breathe in gently and slowly through your nose, while spraying the medicine (in the form of a fine mist) into your nose, pressing DOWN ONCE with your fingers.
• 5. Breathe out through your mouth. Repeat the steps described in point 4 to administer a second dose of the spray to the same nostril, if necessary.
• 6. Remove the tip of the dispenser from your nostril and breathe out through your mouth.
• 7. Repeat the steps described in points 3 to 6 to administer the spray to the other nostril (Figure 3).

After using the spray, you should carefully wipe the tip of the dispenser with a clean tissue or cloth and put the protective cap back on.

Fig. 1

Fig. 2

Fig. 3

Cleaning

• It is important to regularly clean the nasal spray bottle, as it may not work properly otherwise.
• Remove the protective cap and gently pull off the tip of the dispenser.
• Wash the tip of the dispenser and the protective cap in warm water, then rinse under running water.
• Do not unblock the tip of the dispenser by piercing it with a needle or other sharp object, as this will damage the dispenser and the correct dose of the medicine will not be delivered.
• Leave the protective cap and the tip of the dispenser in a warm place to dry.
• Put the tip of the dispenser back on the bottle, then put the protective cap back on.
• After cleaning, check that the dispenser is working properly and spray the medicine 2 times.

Using a higher dose of Metmin than recommended

If you accidentally use a higher dose of the medicine than recommended, you should contact your doctor. If steroids are used for a long time or in large doses, they may have an adverse effect on the patient's hormones. In children, they may affect growth and development.

Missing a dose of Metmin

If you forget to use the nasal spray at the right time, you should use it as soon as you remember, and then continue treatment at the usual time. Do not use a double dose to make up for a missed dose.

Stopping treatment with Metmin

In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Metmin, but the full benefits of treatment may only be apparent after 2 days of using the medicine. It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor recommends it. If you have any further questions about using this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metmin can cause side effects, although not everybody gets them. After using this medicine, immediate allergic reactions (hypersensitivity) may occur. These reactions can be severe. You should 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 corticosteroids in the form of a nasal spray are taken in large doses for a long time, side effects may occur due to the absorption of the medicine into the body. Other side effects Most people using nasal sprays do not report any side effects. However, in some people, after using Metmin or another corticosteroid nasal spray, the following side effects have occurred: Very common side effects (may occur more frequently than 1 in 10 people):

• nasal bleeding (occurred in patients with nasal polyps who used two doses of Metmin in each nostril twice a day)

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

• headache
• sneezing
• irritated nose or sore throat
• ulceration of the nasal mucosa
• upper respiratory tract infection

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

• increased intraocular pressure (glaucoma) and/or cataracts causing vision disturbances,
• damage to the nasal septum separating the nostrils
• disturbances of taste and smell
• difficulty breathing and/or wheezing
• blurred vision

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C 02-222 Warsaw tel.: 22 49-21-301 fax: 22 49-21-309 e-mail: ndl@urpl.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metmin

Keep the medicine out of the 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 that month. Shelf-life after first opening the bottle: 2 months. Only open one bottle at a time. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Metmin contains

• The active substance ismometasone furoate. Each delivered dose contains 50 micrograms of mometasone furoate in the form of a monohydrate.
• 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 spray, suspension. The bottle contains 60 or 140 doses. The pack contains 1 bottle with 60 or 140 doses, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Dania – Metmin

Estonia – Breso

Węgry – Metmin 50 µg / adag, Szuszpenziós orrspray

Łotwa – Breso 50 mikrogrami / devā degunā aerosols, suspensija

Litwa – Breso 50 mikrogramų/dozėje nosies purškalas (suspensija)

Polska – Metmin, aerozol do nosa, zawiesina

Date of last revision of the package leaflet: