Mometazon Doppelhezh

Leaflet attached to the packaging: patient information

Mometazon Doppelherz, 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 outer packaging and on the website: www.doppelherz.pl/zdrowie/alergia (see also point

• 6. 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, pharmacist, or nurse.

• 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, pharmacist, or nurse. See point 4.
• If there is no improvement after 14 days or if you feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is Mometazon Doppelherz and what is it used for
• 2. Important information before using Mometazon Doppelherz
• 3. How to use Mometazon Doppelherz
• 4. Possible side effects
• 5. How to store Mometazon Doppelherz
• 6. Contents of the packaging and other information

1. What is Mometazon Doppelherz and what is it used for

What is Mometazon Doppelherz?

Mometazon Doppelherz contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate administered nasally relieves inflammation symptoms (swelling and irritation of the nasal mucosa), sneezing, itching, and a stuffy nose, and reduces the amount of nasal discharge.

What is Mometazon Doppelherz used for?

Mometazon Doppelherz is used in adults to treat symptoms of hay fever (also known as seasonal allergic rhinitis) after prior 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.
Mometazon Doppelherz reduces swelling and irritation of the nasal mucosa and thus relieves symptoms caused by hay fever, such as: sneezing, itching, stuffy nose, and reduces the amount of nasal discharge.
If there is no improvement after 14 days or if you feel worse, consult your doctor.

2. Important information before using Mometazon Doppelherz

When not to use Mometazon Doppelherz

• if you are allergic to mometasone furoate or any of the other ingredients of this medicine (listed in point 6).
• if you have an untreated infection of the nasal mucosa. Using Mometazon Doppelherz 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 have nasal injuries. You should not use the nasal spray until the wounds have healed.

Warnings and precautions

Before starting to use Mometazon Doppelherz, 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, bacterial, or viral,
• if you are taking other corticosteroids orally or by injection,
• if you have cystic fibrosis.

While using Mometazon Doppelherz, discuss it with your doctor:

• if your immune system is not working properly (you have trouble fighting infections) and you have come into 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,
• you should contact your doctor if you experience 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 you experience eye itching or irritation, your doctor may prescribe a different treatment with Mometazon Doppelherz.
Children and adolescents
Mometazon Doppelherz should not be used in children and adolescents under 18 years of age.

Mometazon Doppelherz and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Some medicines may enhance the effect of Mometazon Doppelherz. Your doctor may then carefully monitor your condition while taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
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 Mometazon Doppelherz. 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, breastfeeding, and fertility

There is no data or only limited data on the use of Mometazon Doppelherz in pregnant women. It is not known whether mometasone furoate passes into breast 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 is no data on the effect of Mometazon Doppelherz on the ability to drive and use machines.

Mometazon Doppelherz contains benzalkonium chloride

Mometazon Doppelherz contains benzalkonium chloride, which may cause irritation or swelling inside the nose, especially if used for a long time.
This medicine contains 0.02 milligrams of benzalkonium chloride per 1 gram of nasal spray.

3. How to use Mometazon Doppelherz

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Treatment of hay fever

Use in adults

Typically, two sprays are used in each nostril once a day.

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

In some patients, symptom relief occurs within 12 hours of administration of the first dose of Mometazon Doppelherz, 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.
If you have severe symptoms of hay fever, your doctor may recommend starting to use Mometazon Doppelherz before the start of the pollen season. This will help prevent the symptoms of hay fever.

Preparing the nasal spray for use

Mometazon Doppelherz has a cap on the bottle that protects the tip of the dispenser and prevents it from getting dirty. Remember to remove it before using the spray and put it back on after use.
Before using the spray for the first time, 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 underneath the bottle. Do notpuncture the nasal spray dispenser with a needle or other sharp object.
• 3. With the tip of the dispenser pointing away from you, press your fingers to spray the medicine.

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

How to use the nasal spray

• 1. Shake the bottle gently and remove the protective cap.
• 2. Gently blow your nose.
• 3. Close one nostril and insert the tip of the dispenser into the other nostril. Tilt your head slightly forward, holding the bottle upright.
• 4. Start a gentle and slow inhalation through your nose, during which you should spray the nasal spray (in the form of a fine mist), pressing DOWN on the pump ONCE with your fingers.
• 5. Exhale through your mouth. Then 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 the nostril and exhale through your mouth.
• 7. Repeat the steps described in points 3 to 6 to administer the spray to the other nostril.

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

• It is important to regularly clean the nasal spray, as otherwise, it may not work properly.
• Remove the protective cap and gently pull off the tip of the dispenser.
• Wash the tip of the dispenser and protective cap in warm water, then rinse under running water.
• Do notunblock the tip of the dispenser by piercing 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 medicine.
• Leave the protective cap and 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 Mometazon Doppelherz 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 high doses, they may rarely have an adverse effect on your hormones.

Missing a dose of Mometazon Doppelherz

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 Mometazon Doppelherz

In some patients, improvement occurs 12 hours after administration of the first dose of Mometazon Doppelherz, but the full benefits of treatment may only be visible after 2 days of treatment. It is very important that you 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 Mometazon Doppelherz 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 Mometazon Doppelherz or another corticosteroid nasal spray:
Common side effects (may occur in less than 1 in 10 people):

• headache
• sneezing
• nasal bleeding [occurred very frequently (may occur in more than 1 in 10 people) in patients with nasal polyps who used two doses of mometasone furoate in 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 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 leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 Mometazon Doppelherz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: "Expiry Date" or "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
The shelf life after opening the bottle is 2 months. Only open one bottle of medicine 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 packaging and other information

What Mometazon Doppelherz 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, sodium carmellose, citric acid monohydrate, sodium citrate, purified water.

What Mometazon Doppelherz looks like and what the pack contains

Mometazon Doppelherz is a nasal spray, suspension.
Each bottle contains 60 doses (10 g), 120 doses (16 g), or 140 doses (18 g) of the medicine.
Bottles containing 60 and 120 doses are available in packs of 1 bottle.
Bottles containing 140 doses are available in packs of 1, 2, or 3 bottles.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Doppelherz Pharma GmbH
Schleswiger Straße 74
24941 Flensburg
Germany
Manufacturer:
FARMEA
10 rue Bouché ThomasZAC d’Orgemont
49000 Angers
France
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
Queisser Pharma Poland Sp. z o.o.
Domaniewska Street 39
02-672 Warsaw, Poland
Tel.: (22) 487 52 54
Email: [email protected]

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

Germany:
ALLERGO-MOMELIND 50 micrograms/spray nasal spray, suspension
Poland:
Mometazon Doppelherz
Detailed and up-to-date information about this medicine is available after scanning the QR code on the outer packaging using a smartphone. The same information is also available on the website: www.doppelherz.pl/zdrowie/alergia

Date of last revision of the leaflet: