MOMETAHEXAL

MOMETAHEXAL Hay Fever Spray 50μg/Spray 140 Sprays

Important notes (mandatory information)

MometaHexal Hay Fever Spray 50 micrograms/spray 140 sprays. Active ingredient: Mometasone furoate (Ph. Eur.). Areas of application: for adults to treat the symptoms of hay fever (seasonal allergic rhinitis), provided that the initial diagnosis of hay fever has been made by a doctor.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

MometaHexal Hay Fever Spray 50 micrograms/spray nasal spray, suspension for use in adults
Active ingredient: Mometasone furoate (Ph. Eur.)

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, talk to your doctor.

What this package leaflet contains

1. WHAT IS MOMETAHEXAL HAY FEVER SPRAY AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOMETAHEXAL HAY FEVER SPRAY?
3. HOW TO USE MOMETAHEXAL HAY FEVER SPRAY?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MOMETAHEXAL HAY FEVER SPRAY?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MOMETAHEXAL HAY FEVER SPRAY AND WHAT IS IT USED FOR?

What is MometaHexal Hay Fever Spray?
MometaHexal Hay Fever Spray contains mometasone furoate, a substance from the group of so-called corticosteroids. When mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and irritation of the nose), sneezing, itching and a blocked or runny nose.

What is MometaHexal Hay Fever Spray used for?
MometaHexal Hay Fever Spray is used in adults to treat the symptoms of hay fever (seasonal allergic rhinitis), provided that the initial diagnosis of hay fever has been made by a doctor. Hay fever, which occurs at certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses and also mould and fungal spores. MometaHexal Hay Fever Spray reduces the swelling and irritation in your nose and thereby relieves sneezing, itching and a blocked or runny nose caused by hay fever.

If you do not feel better or if you feel worse after 7 days, talk to your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOMETAHEXAL HAY FEVER SPRAY?

MometaHexal Hay Fever Spray must not be used:

• 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 infection in your nose. Using MometaHexal Hay Fever Spray during an untreated infection in your nose, such as herpes, can worsen the infection. You should wait until the infection has cleared up before you start using the nasal spray.
• if you have recently had an operation on your nose or if you have injured your nose. You should not start using the nasal spray until your nose has healed.

Warnings and precautions

Please talk to your doctor or pharmacist before using MometaHexal Hay Fever Spray:

• if you have or have ever had tuberculosis.
• if you have any other infection.
• if you are using other corticosteroid medicines, both those taken by mouth and those given by injection.
• if you suffer from cystic fibrosis (mucoviscidosis).

Please talk to your doctor or pharmacist while using MometaHexal Hay Fever Spray:

• if your immune system is not working well (if you have difficulty fighting off infections) and you come into contact with people who have measles or chickenpox. You should avoid contact with people who have these infections.
• if you have an infection of your nose or throat.
• if you are using the medicine for several months or longer.
• if you have persistent irritation of your nose or throat.

If you experience blurred vision or other visual disturbances, contact your doctor. If corticosteroid nasal sprays are used in high doses over long periods of time, side effects may occur due to the medicine being absorbed into the body. If your eyes are itchy or irritated, your doctor may recommend other treatments to use together with MometaHexal Hay Fever Spray.

Children and adolescents

MometaHexal Hay Fever Spray must not be used in children and adolescents under 18 years of age.

Using MometaHexal Hay Fever Spray with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or do intend to take/use any other medicines, including medicines that are available without a prescription. Some medicines may increase the effects of MometaHexal Hay Fever Spray and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If you are using other corticosteroid medicines for an allergy, either those taken by mouth or those given by injection, your doctor may advise you to stop using these medicines once you start using MometaHexal Hay Fever Spray. Some patients may have the impression that they are suffering from side effects such as joint or muscle pain, weakness or depression once they stop using corticosteroids taken by mouth or by injection. You may also develop other allergies such as itchy, watery eyes or red, itchy patches of skin. If you experience such symptoms, you should contact your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is almost no information on the use of mometasone furoate in pregnant women. It is not known whether mometasone furoate passes into breast milk.

Driving and using machines

There is no known information on the effect of MometaHexal Hay Fever Spray on the ability to drive or operate machines.

MometaHexal Hay Fever Spray contains benzalkonium chloride

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

3. HOW TO USE MOMETAHEXAL HAY FEVER SPRAY?

Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

2 sprays into each nostril once a day. Once your symptoms are under control, you may be able to reduce the number of sprays to 1 spray into each nostril once a day. If your symptoms become severe again, increase the dose to 2 sprays into each nostril once a day. In some patients, relief of symptoms may occur as early as 12 hours after the first dose of MometaHexal Hay Fever Spray; however, full therapeutic benefit may not be achieved until after the first 2 days. If you suffer badly from hay fever, treatment should start a few days before the start of the pollen season. At the end of the pollen season, your hay fever symptoms should improve, so treatment should no longer be necessary.

Preparing your nasal spray for use

Your MometaHexal Hay Fever Spray has a protective cap that keeps the nozzle clean and protected. Remember to take it off before using the spray and to put it back on afterwards. Shake the bottle before each use. Do not pierce the nasal applicator (nozzle) with a needle or any other sharp object.

When using the spray for the first time, you need to prepare the bottle by pressing the spray 10 times until a fine mist is produced

1. Shake the bottle well.
2. Remove the protective cap.
3. Place your index finger and middle finger on either side of the nozzle and your thumb underneath the bottle. Do not pierce the nozzle.
4. Point the nozzle away from you and press down with your fingers to press the spray 10 times until a fine mist is produced.

If you have not used the nasal spray for 14 days or more, you need to prime the nasal spray again by pressing the spray 2 times until a fine mist is produced.

How to use the nasal spray

1. Shake the bottle well and remove the protective cap.
2. Gently blow your nose to clear your nostrils.
3. Close one nostril and insert the nozzle into the other nostril. Tilt your head forward slightly and hold the bottle upright.
4. Start to breathe in gently through your nose and, as you breathe in, spray one spray of fine mist into your nose by pressing down ONCE with your fingers (Fig. 3).
5. Breathe out through your mouth. If necessary, repeat step 4 to give a 2nd spray into the same nostril.
6. Remove the nozzle from this nostril and breathe out through your mouth.
7. Repeat steps 3–6 for the other nostril.

After use, carefully wipe the nozzle with a clean tissue and replace the protective cap.

Cleaning your nasal spray:

• It is important to clean your nasal spray regularly, otherwise it may not work properly.
• To do this, remove the protective cap and gently pull off the nozzle.
• Wash the nozzle and cap in warm water and then rinse under running water.
• Do not try to enlarge the opening of the nozzle with a needle or sharp object as this will damage the nozzle and you will not get the correct dose of medicine.
• Leave the cap and nozzle to dry in a warm place.
• Push the nozzle back onto the bottle and replace the protective cap.
• The nasal spray must be primed again with 2 sprays before first use after cleaning.

If you use more MometaHexal Hay Fever Spray than you should

It is important to use the dose that is stated in the package leaflet or that has been prescribed by your doctor. Using more or less may worsen your symptoms. Tell your doctor if you have accidentally used more than you should. If you use steroids for a long time or in large amounts, they can in rare cases affect some of your hormones.

If you forget to use MometaHexal Hay Fever Spray

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

If you stop using MometaHexal Hay Fever Spray

In some patients, MometaHexal Hay Fever Spray may start to relieve symptoms as early as 12 hours after the first dose; however, the full benefit of treatment may not be felt until after 2 days. It is very important to use your nasal spray regularly. Do not stop using it even if you are feeling better, unless your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Immediate hypersensitivity reactions (allergic reactions) may occur after using this product. These reactions can be severe. You should stop using Mometa-Hexal Hay Fever Spray and seek immediate medical attention if you experience symptoms such as:

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

If corticosteroid nasal sprays are used in high doses or over long periods of time, side effects may occur due to the medicine being absorbed into the body.

Other side effects

Most people do not have any problems after using the nasal spray. However, some people may experience the following after using MometaHexal Hay Fever Spray or other corticosteroid nasal sprays

Common (may affect up to 1 in 10 people):

• headache
• sneezing
• nosebleeds
• sore nose or throat
• sores in the nose
• respiratory tract infection

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

• increased pressure in the eye (glaucoma) and/or cataract with impaired vision
• blurred vision
• damage to the nasal septum
• changes in taste and smell
• difficulty breathing and/or wheezing

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE MOMETAHEXAL HAY FEVER SPRAY?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container after "use by" or "exp.". The expiry date refers to the last day of the month indicated. Do not freeze. Use within 2 months of opening the bottle. Only open one bottle at a time. Do not dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of medicines you no longer use. You help to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What MometaHexal Hay Fever Spray contains

The active substance is mometasone furoate (Ph. Eur.). Each actuation of the pump delivers a metered dose of 50 micrograms of mometasone furoate (as monohydrate). The other ingredients are microcrystalline cellulose, carmellose sodium (Ph. Eur.), glycerol, citric acid monohydrate, sodium citrate (Ph. Eur.), polysorbate 80 [vegetable], benzalkonium chloride, water for injections.

What MometaHexal Hay Fever Spray looks like and contents of the pack

MometaHexal Hay Fever Spray is a white nasal spray in the form of a suspension, packed in a white plastic bottle with a spray pump and a blue protective cap and inserted into a cardboard box.

Pack sizes:

• 1 bottle with 10 g nasal spray, suspension, corresponding to 60 delivered sprays.
• 1 bottle with 17 g nasal spray, suspension, corresponding to 120 delivered sprays.
• 1 bottle with 18 g nasal spray, suspension, corresponding to 140 delivered sprays.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Hexal AG
Industriestraße 25
83607 Holzkirchen
Phone: (08024) 908-0
Fax: (08024) 908-1290
E-mail: service@Hexal.com

Manufacturer

Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana
Slovenia

This package leaflet was last revised in September 2020.

Source: Information from the package leaflet
Status: 09/2021
Active ingredient: Mometasone furoate (Ph. Eur.). Areas of application: for adults to treat the symptoms of hay fever (seasonal allergic rhinitis) applied, provided that the initial diagnosis