Hitaxa Metmin-sprai

Package Leaflet: Information for the Patient

HITAXA METMIN-SPRAY, 50 micrograms/dose, nasal spray, suspension

Mometasone furoate
For use in adults
Before using the medicine, read the leaflet carefully and familiarize yourself with the educational materials. This information is available after scanning the QR code on the packaging with a smartphone and on the website: patient.hitaxametminspray.pl (see also section 6 of the patient leaflet).

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

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Hitaxa Metmin-Spray and what is it used for
• 2. Important information before using Hitaxa Metmin-Spray
• 3. How to use Hitaxa Metmin-Spray
• 4. Possible side effects
• 5. How to store Hitaxa Metmin-Spray
• 6. Contents of the pack and other information

1. What is Hitaxa Metmin-Spray and what is it used for

What is Hitaxa Metmin-Spray?

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

What is Hitaxa Metmin-Spray used for?

Hitaxa Metmin-Spray is used in adults (over 18 years of age) to treat the symptoms of hay fever (also known as seasonal allergic rhinitis) after diagnosis by a doctor.
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.
Hitaxa Metmin-Spray reduces swelling and irritation of the nasal mucosa and thus relieves the symptoms caused by hay fever, such as sneezing, itching, the feeling of a blocked nose, and reduces the amount of nasal discharge.
If after 14 days there is no improvement or you feel worse, consult your doctor.

2. Important information before using Hitaxa Metmin-Spray

When not to use Hitaxa Metmin-Spray

• If you are allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
• If you have an untreated nasal mucosa infection. Using Hitaxa Metmin-Spray during an untreated infection in the nasal cavity, such as herpes, may worsen the symptoms of the infection. You should wait until the infection has cleared before using the nasal spray.
• If you have recently undergone nasal surgery or nasal injury. You should not use the nasal spray until the wounds have healed.

Warnings and precautions

Before starting to use Hitaxa Metmin-Spray, discuss it with your doctor or pharmacist:

• if you currently have or have had tuberculosis in the past,
• if you have any other infection, such as fungal or bacterial,
• if you are taking other corticosteroids orally or by injection,
• if you have cystic fibrosis.

While using Hitaxa Metmin-Spray, discuss it with your doctor:

• if your immune system is not working properly (you have difficulty fighting infections) and you have been in contact with someone who has chickenpox or shingles. You should avoid contact with people who have these infections.
• if you have a nose or throat infection,
• if the medicine is used for 3 months or longer,
• if you have long-term nose or throat irritation.

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 you experience itching or irritation of the eyes, your doctor may prescribe a different treatment with Hitaxa Metmin-Spray.
If you experience blurred vision or other vision disturbances, consult your doctor.
Children and adolescents
Hitaxa Metmin-Spray should not be used in children and adolescents under 18 years of age.

Hitaxa Metmin-Spray and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In the case of allergy treatment with other corticosteroids orally or by injection, your doctor may advise you to stop taking them when you start using Hitaxa Metmin-Spray. 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 of the eyes, or red and itchy spots on the skin, may also appear. Consult your doctor if you experience any of these symptoms.
Some medicines may enhance the effect of Hitaxa Metmin-Spray. Your doctor may then carefully monitor your condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).
No interaction has been shown between Hitaxa Metmin-Spray and loratadine (used to treat allergies).

Pregnancy, breastfeeding, and fertility

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 have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Hitaxa Metmin-Spray contains benzalkonium chloride

This medicine contains 20 micrograms of benzalkonium chloride per dose.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

Hitaxa Metmin-Spray contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Hitaxa Metmin-Spray

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The medicine should not be used in larger doses or more frequently, or for longer than recommended in the leaflet.
Recommended dose:

Adults from 18 years of age, including elderly patients

Usually, two doses of the nasal spray are used for each nostril once a day.
In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Hitaxa Metmin-Spray, but the full benefits of treatment may not be observed within the first two days of treatment. Therefore, you should continue to use the medicine regularly to get the full benefits of treatment.

• After improvement, your doctor may recommend reducing the dose to one dose of the nasal spray for each nostril once a day.
• If you do not feel any improvement, consult your doctor.

If there is no improvement in symptoms or the improvement is insufficient after 14 days of use, consult your doctor.
The medicine should not be used for more than 3 months without consulting a doctor.
If you have severe symptoms of hay fever, your doctor may recommend starting to use Hitaxa Metmin-Spray 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.

Use in children and adolescents

Hitaxa Metmin-Spray should not be used in children and adolescents under 18 years of age.

Preparing the nasal spray for use

Hitaxa Metmin-Spray has a protective cap on the bottle that protects the tip of the dispenser and prevents it from getting dirty. Remember to remove it before using the nasal spray and put it back on after use.
Before the first use of the nasal spray, check its operation by pressing the pump 10 times until a fine mist is obtained:

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

If the nasal spray has not been used for 14 days or longer, press the pump 2 times before the next use until a fine mist is obtained.

How long will the package last

If you use two doses of the nasal spray for each nostril once a day, the medicine will last for 15 days of treatment (for bottles containing 60 measured doses) or 30 days (for bottles containing 120 measured doses) or 35 days (for bottles containing 140 measured doses).

How to use the nasal spray

• 1. Shake the bottle gently and remove the protective cap.
• 2. Gently blow your nose (Figure 1).
• 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. The tip of the dispenser should be pointed towards the nostril, not towards the nasal septum (Figure 3).

IMPORTANT! Keeping the bottle upright is very important, as improper spraying may damage the nasal septum.

• 4. Start a gentle and slow inhalation through the nose, during which you should spray the nasal spray (in the form of a fine mist), pressing DOWN with your fingers ONCE.
• 5. Exhale through the mouth. Then repeat the actions described in point 4 to administer a second dose of the nasal spray to the same nostril, if necessary.
• 6. Remove the tip of the dispenser from the nostril and exhale through the mouth.
• 7. Repeat the actions described in points 3 to 6 to administer the nasal spray to the other nostril (Figure 4).

After use, gently wipe the tip of the dispenser with a clean cloth or tissue and put the protective cap back on to prevent dust from entering.

Cleaning the bottle

• 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 puncturing it with a needle or other sharp object, as this will damage the dispenser and may cause you not to receive the correct dose of the medicine.
• 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 if the dispenser is working properly and spray the aerosol 2 times.

Using a higher dose of Hitaxa Metmin-Spray than recommended

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

Missing a dose of Hitaxa Metmin-Spray

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

Stopping treatment with Hitaxa Metmin-Spray

In some patients, improvement occurs 12 hours after administration of the first dose of Hitaxa Metmin-Spray, but the full benefits of treatment may only be visible after 2 days of treatment. It is very important to use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor has explicitly advised you to.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using this medicine, immediate allergic reactions (allergic) may occur with an unknown frequency. These reactions can be severe. You should stop using Hitaxa Metmin-Spray 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 do not report any side effects after using the nasal spray.
However, some people have reported the following side effects after using Hitaxa Metmin-Spray or another corticosteroid nasal spray:

• headache
• sneezing and irritation and (or) burning of the nasal mucosa
• nasal bleeding [very common (may occur more frequently than 1 in 10 people) in patients with nasal polyps who used two doses of mometasone for each nostril twice a day]
• nasal or throat pain
• 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) cataract causing vision disturbances
• damage to the nasal septum separating the nostrils
• disturbances of taste and smell
• breathing difficulties and (or) wheezing
• blurred vision

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.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 Hitaxa Metmin-Spray

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the bottle and carton after: Expiry date (EXP) or EXP. The expiry date refers to the last day of the month stated.
The shelf life after first opening the bottle is 2 months.
Do not use this medicine if you notice that the bottle or dispenser is damaged.
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 Hitaxa Metmin-Spray contains

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

What Hitaxa Metmin-Spray looks like and what the pack contains

Hitaxa Metmin-Spray is a nasal spray, suspension.
The bottle has a spray mechanism.
Each bottle contains 60, 120, or 140 doses of the medicine.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Manufacturer:
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
Detailed and up-to-date information about this medicine is available after scanning the QR code on the leaflet below and on the packaging. The same information is also available on the website: patient.hitaxametminspray.pl

Date of last revision of the leaflet:

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