Hitaxa metmin-spray

Package leaflet: Information for the patient

HITAXA METMIN-SPRAY, 50 micrograms/dose, nasal spray, suspension
Mometasoni furoas
For use in adults
Before using the medicine, read the package leaflet carefully and review the educational
materials. These are available by scanning the QR code on the packaging with a smartphone,
and on the website: pacjent.hitaxametminspray.pl (see also section 6 of the patient leaflet).
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, contact your doctor.

Table of contents

1. What Hitaxa Metmin-Spray is and what it is 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 Hitaxa Metmin-Spray is and what it is 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 taken in tablet or injectable form and misused by some athletes. When administered nasally, mometasone furoate reduces inflammation of the nasal mucosa (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and decreases nasal discharge.

What is Hitaxa Metmin-Spray used for?
Hitaxa Metmin-Spray is used in adults (aged over 18 years) for the treatment of symptoms of hay fever (also known as seasonal allergic rhinitis), previously diagnosed by a doctor.
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.
Hitaxa Metmin-Spray reduces swelling and irritation of the nasal mucosa, thereby relieving symptoms caused by hay fever, such as sneezing, itching, nasal congestion, and decreased nasal discharge.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.

2. Important information before using Hitaxa Metmin-Spray

When not to use Hitaxa Metmin-Spray

• 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 infection of the nasal mucosa. Using Hitaxa Metmin-Spray during an untreated nasal infection, such as herpes simplex, may worsen the infection symptoms. Nasal spray should not be used until the infection has resolved.
• If the patient has recently undergone nasal surgery or suffered nasal trauma. Do not use the nasal spray until wounds have healed.

Warnings and precautions
Before starting to use Hitaxa Metmin-Spray, 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, e.g. fungal or bacterial,
• if the patient is taking other corticosteroids orally or by injection,
• if the patient has cystic fibrosis.

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

• if the patient's immune system is not working properly (difficulty fighting infections) and the patient 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 3 months or longer,
• if the patient has persistent nasal or throat irritation.

If nasal corticosteroid sprays are used at high doses for prolonged periods, adverse effects due to systemic absorption of the medicine may occur.
If eye itching or irritation occurs, the doctor may recommend alternative treatment with Hitaxa Metmin-Spray.
If the patient experiences blurred vision or other visual disturbances, contact the 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
When treating allergies with other corticosteroids taken orally or by injection, the treating doctor may advise the patient to discontinue their use when starting Hitaxa Metmin-Spray. Some patients may experience adverse symptoms after stopping oral or injectable corticosteroids, such as: joint or muscle pain, weakness, and depression. 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.
Some medicines may increase the effect of Hitaxa Metmin-Spray. The doctor may then closely monitor the patient taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
No interactions have been observed between Hitaxa Metmin-Spray and loratadine (used in the treatment of 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 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 Hitaxa Metmin-Spray on the ability to drive or operate machinery.

Hitaxa Metmin-Spray contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per dose.
Benzalkonium chloride may cause nasal irritation or swelling, especially if used for prolonged periods.

Hitaxa Metmin-Spray contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning 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 information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not use more of this medicine, more often, or for longer than recommended in the leaflet.

Recommended dose:
Adults aged 18 years and older, including elderly patients
The usual dose is two sprays into each nostril once daily.
In some patients, symptom relief may occur within 12 hours after the first dose of Hitaxa Metmin-Spray, but full benefits of treatment may not be apparent during the first two days of treatment. Therefore, regular use should be continued to achieve the full therapeutic effect.

• After symptoms improve, your doctor may recommend reducing the dose to one spray into each nostril once daily.
• If the patient does not experience improvement, contact your doctor.

If symptoms do not improve or improvement is insufficient after 14 days of treatment, consult your doctor.
Do not use this medicine for longer than 3 months without consulting your doctor.
If a patient has severe hay fever symptoms, the treating doctor may recommend starting treatment with Hitaxa Metmin-Spray before the start of pollen season to help prevent hay fever symptoms. Improvement may occur toward the end of the pollen season, and treatment may no longer be necessary.

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

Preparing the nasal spray for use
Hitaxa Metmin-Spray contains a protective cap on the bottle that covers the spray nozzle and prevents contamination. Remember to remove it before using the spray and to replace it after use.

Before first use, prime the spray 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 spray nozzle, and your thumb underneath the bottle. Do not pierce the nasal spray nozzle.
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 it again by pressing the pump 2 times until a uniform mist is produced before next use.

How long the package lasts
If the patient uses two sprays into each nostril once daily, the medicine will last for 15 days (for bottles containing 60 metered doses), 30 days (for bottles containing 120 metered doses), or 35 days (for bottles containing 140 metered doses).

How to use the nasal spray

1. Gently shake the bottle and remove the protective cap.
2. Gently blow your nose (Figure 1).
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. The nozzle should be directed toward the side of the nostril, not toward the center (i.e., not toward the nasal septum) (Figure 3). WARNING! Keeping the bottle in an upright position is very important, as incorrect spraying may damage the nasal septum.
4. Begin a gentle and slow inhalation through the nose while pressing down once with your fingers to release the nasal spray (as a fine mist).
5. Exhale through your mouth. Then 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 4).

After using the nasal spray, gently wipe the nozzle with a clean tissue or cloth and replace the protective cap to prevent dust from entering.

Cleaning the bottle

• It is important to clean the nasal spray bottle regularly, otherwise it may not work 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 spray device 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 spray device works properly by spraying twice.

Use of a higher than recommended dose of Hitaxa Metmin-Spray
If you accidentally use more medicine than recommended, consult your doctor.
If corticosteroids are used for a long time 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 Hitaxa Metmin-Spray
If you forget to use the nasal spray at your usual time, take it as soon as you remember, then continue treatment at your 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 may occur within 12 hours after the first dose of Hitaxa Metmin-Spray, but full benefits of treatment may only become apparent after 2 days of use. It is very important that the patient uses the nasal spray regularly. Do not stop treatment even if you feel better, unless your doctor specifically advises you to do so.

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 will experience them.
Immediate hypersensitivity (allergic) reactions, with unknown frequency, may occur after using this medicine. These reactions can be severe. You must stop using HITAXA METMIN-SPRAY and seek immediate medical help if you experience symptoms such as:

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

If nasal corticosteroid aerosols are used in high doses for a prolonged period, adverse effects may occur due to systemic absorption of the drug.

Other adverse effects
Most people do not report any adverse effects after using a nasal aerosol.
However, in some individuals, the following adverse effects have been reported after using HITAXA METMIN-SPRAY or another corticosteroid in the form of a nasal aerosol:

Common adverse effects (may affect fewer than 1 in 10 people):

• headache
• sneezing and irritation and/or burning of the nasal mucosa
• nosebleeds [very commonly reported (may affect more than 1 in 10 people) in patients with nasal polyps who used two doses of mometasone in each nostril twice daily]
• nasal or throat pain
• nasal mucosal ulceration
• upper respiratory tract infection

Frequency unknown (frequency cannot be estimated from available data):

• increased intraocular pressure (glaucoma) and/or cataract leading to 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 any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Hitaxa Metmin-Spray

Keep the medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the bottle and carton: Expiry date (EXP) or EXP. The expiry date refers to the last day of the stated month.
The shelf life after first opening the bottle is 2 months.
Do not use this medicine if the bottle or the dispenser is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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 contents of the pack
Hitaxa Metmin-Spray is a nasal aerosol, suspension.
The bottle contains one spray mechanism.
Each bottle contains 60, 120 or 140 doses of the medicinal product.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Manufacturer:

Adamed Pharma S.A.
5 Józefa Piłsudski Marshal Street
95-200 Pabianice
Poland
Detailed and up-to-date information about this medicinal product is available by scanning with a smartphone
the QR code located below in the leaflet and on the packaging. The same information is also available
on the website: pacjent.hitaxametminspray.pl
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