Mometasone doppelherz

Package leaflet: Information for the patient

Mometazon Doppelherz, 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 outer packaging with a smartphone,
or at the website: www.doppelherz.pl/zdrowie/alergia (see also section 6 of the patient leaflet).

Please read this 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 for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days of treatment, or if symptoms worsen, contact your doctor.

Table of contents

1. What Mometazon Doppelherz is and what it is 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 pack and other information

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

What is Mometazon Doppelherz?
Mometazon Doppelherz 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.

What is Mometazon Doppelherz used for?
Mometazon Doppelherz is used in adults for the treatment of symptoms of hay fever (also known as seasonal allergic rhinitis), after prior diagnosis 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 mould and fungal spores.
Mometazon Doppelherz reduces swelling and irritation of the nasal mucosa and thereby relieves symptoms caused by hay fever, such as sneezing, itching, nasal congestion, and decreased nasal discharge.

If there is no improvement after 14 days of treatment, or if symptoms worsen, consult your doctor.

2. Important information before using Mometazon Doppelherz

When not to use Mometazon Doppelherz

• 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 Mometazon Doppelherz during an untreated nasal infection, such as herpes, may worsen the symptoms of infection. Nasal spray should not be used until the infection has resolved.
• if the patient has recently undergone nasal surgery or nasal injury. The nasal spray should not be used until wounds have healed.

Warnings and precautions
Before starting treatment with Mometazon Doppelherz, discuss with a 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, bacterial, viral,
• if the patient is taking other corticosteroids orally or by injection,
• if the patient has cystic fibrosis.

While using Mometazon Doppelherz, discuss with a doctor:

• if the patient’s immune system does not function properly (difficulty fighting infections) and the patient has been in contact with someone who has measles or chickenpox. Contact with people who have these infections should be avoided,
• 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 irritation of the nose or throat,
• the patient should contact a doctor if blurred vision or other visual disturbances occur.

If nasal corticosteroid sprays are used in 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 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 the 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.
Some medicines may enhance the effect of Mometazon Doppelherz. The doctor may then closely
monitor the patient taking such medicines (including certain HIV medications: ritonavir,
cobicistat).
If the patient is being treated for allergies with other corticosteroids taken orally or by injection, the treating doctor may advise the patient to discontinue their use when starting
treatment with Mometazon Doppelherz. In some patients, after stopping oral or injectable
corticosteroids, adverse symptoms may occur 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. The patient should contact a
doctor if any of these symptoms occur.
Pregnancy, breastfeeding and fertility
There are no data or only limited data on the use of Mometazon Doppelherz 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 child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
There are no data on the effect of Mometazon Doppelherz on the ability to drive
and operate machinery.
Mometazon Doppelherz contains benzalkonium chloride
Mometazon Doppelherz contains benzalkonium chloride, which may cause irritation or
swelling inside the nose, especially if used for a prolonged period.
This medicine contains 0.02 milligrams of benzalkonium chloride per one gram of spray.

3. How to use Mometazon Doppelherz

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.
Treatment of hay fever
Use in adults
The usual dose is two sprays into each nostril once daily.

• Once symptoms have improved, your doctor may recommend reducing the dose to one spray into each nostril once daily.
• If you do not experience improvement, contact your doctor.

In some patients, relief of symptoms may occur within 12 hours after the first dose of Mometazon Doppelherz, but full benefit from treatment may not be evident during the first two days of treatment. Therefore, it is important to continue regular use to achieve the full therapeutic effect.
If you have severe hay fever symptoms, your doctor may recommend starting treatment with Mometazon Doppelherz before the pollen season begins. This may help prevent the onset of hay fever symptoms.
Preparing the nasal spray for use

Mometazon Doppelherz comes with a protective cap that covers the spray nozzle, protecting it from contamination. Remember to remove the cap before using the spray and replace it after each use.
Before first use, prime the spray by pressing the pump 10 times or 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 nozzle.
3. Pointing the nozzle away from you, press down with your fingers to release the spray.

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

1. Gently shake the bottle and remove the protective cap.
2. Gently blow your nose.
3. Close one nostril and insert the spray nozzle into the other nostril. Tilt your head slightly forward and hold the bottle upright.
4. Begin a gentle and slow inhalation through the nose, while pressing down once on the pump to release the nasal spray (as a fine mist).
5. Breathe out 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 breathe out through your mouth.
7. Repeat steps 3 to 6 to administer the spray into the other nostril.

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 nasal spray

• Regular cleaning of the nasal spray is important, as blockage may prevent proper functioning.
• Remove the protective cap and gently pull off the spray nozzle.
• Wash the spray nozzle and the protective cap with warm water, then rinse thoroughly 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.
• Allow the protective cap and spray nozzle to dry in a warm place.
• Reattach the spray nozzle to the bottle, then replace the protective cap.
• After cleaning, check that the spray is working properly by releasing two sprays.

Use of more than the recommended dose of Mometazon Doppelherz
If you accidentally use more medicine than recommended, consult your doctor.
If steroids are used for a long time or in high doses, they may rarely affect the patient's hormone system.
If you forget to use Mometazon Doppelherz
If you forget to use the nasal spray at your usual time, use it as soon as you remember, then continue with your regular dosing schedule.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Mometazon Doppelherz
In some patients, improvement may occur within 12 hours after the first dose of Mometazon Doppelherz, but full benefit from treatment may not be evident until after two days of use. It is very important to use 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience
them.
After using this medicine, immediate hypersensitivity (allergic) reactions may occur with unknown frequency. These reactions can be severe. You should stop using Mometazon Doppelherz and seek immediate medical help if any of the following symptoms occur:

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

If nasal corticosteroid sprays are used at high doses for prolonged periods, adverse reactions may occur due to systemic absorption of the medicine.

Other adverse reactions
Most people do not report any adverse reactions after using a nasal spray. However, in some individuals, the following adverse reactions have been reported after using Mometazon Doppelherz or another corticosteroid nasal spray:

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

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

Frequency not known (frequency 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 of taste and smell
• breathing difficulties and/or wheezing
• blurred vision

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Mometazon Doppelherz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after:
"Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicine.
The shelf life after first opening the bottle is 2 months. Only one bottle of the medicine should be opened at any one time.
Medicines must not be disposed of via the sewage system 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 pack 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 carboxymethylcellulose, citric acid monohydrate, sodium citrate, purified water.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Doppelherz Pharma GmbH
Schleswiger Straße 74
24941 Flensburg
Germany

Manufacturer:
FARMEA
10 rue Bouché Thomas ZAC d’Orgemont
49000 Angers
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Queisser Pharma Poland Sp. z o.o.
ul. Domaniewska 39
02-672 Warsaw, Poland
Tel.: (22) 487 52 54
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: ALLERGO-MOMELIND 50 Micrograms/Spray Nasal Spray, Suspension
Poland: Mometazon Doppelherz

Detailed and up-to-date information about this medicinal product is available by scanning with a smartphone the QR code located on the outer packaging. The same information is also available on the website: www.doppelherz.pl/zdrowie/alergia