PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Mometasone Furoate 50 micrograms/dose Nasal Spray, suspension

mometasone furoate

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Mometasone Furoate Nasal Spray is and what it is used for

2.    What you need to know before you use Mometasone Furoate Nasal Spray

3.    How to use Mometasone Furoate Nasal Spray

4.    Possible side effects

5.    How to store Mometasone Furoate Nasal Spray

6.    Contents of the pack and other information

What Mometasone Furoate 1 Nasal Spray is and what it is used for

Mometasone Furoate Nasal Spray contains mometasone furoate, one of a group of medicines called corticosteroids. It should not be confused with “anabolic” steroids misused by some athletes and taken as tablets or injections.

This medicine is used to treat symptoms of allergic rhinitis caused by allergy to pollen from grass or trees (seasonal allergic rhinitis, also called hayfever) or caused by allergy, for example, to animals, house-dust mites or moulds (perennial allergic rhinitis). When tiny amounts of active substance are sprayed into the nose, it can help to relieve inflammation, sneezing, itching and a blocked or runny nose.

In case of allergic rhinitis Mometasone Furoate nasal spray is for use in adults and children aged 6 years and over.

This medicine is also used for symptomatic treatment of nasal polyps (small growths inside the nose) in adults 18 years of age and older. By reducing inflammation it causes nasal polyps to shrink gradually.

Driving and using machines

Mometasone Furoate is unlikely to affect your ability to drive and use machines.

Mometasone Furoate contains benzalkonium chloride

This medicine contains preservative benzalkonium chloride, which may be an irritant and may cause skin reactions. If used for a longer period, benzalkonium chloride may cause nasal mucosa swelling.

How to use Mometasone Furoate Nasal Spray

What you need to know 2 before you use Mometasone Furoate Nasal Spray

Do not use Mometasone Furoate if you:

•    are allergic to mometasone furoate or any of the other ingredients of this medicine.

•    have an infection in your nose. You should wait until the infection is resolved before you start using the nasal spray.

•    have recently had an operation on your nose or you have injured your nose.

You should wait until it has healed before you start using the nasal spray.

Warnings and precautions

Talk to your doctor or pharmacist before using Mometasone Furoate if you:

•    have or have ever had tuberculosis

•    have herpes simplex (virus) infection of the eye

•    have any other type of infection

•    are taking other corticosteroid medicines, either by mouth or by injection

•    have cystic fibrosis.

While using this medicine, avoid coming into contact with anyone who has measles or chickenpox. You should tell your doctor if you do come into contact with anyone who has these infections.

Mometasone Furoate is intended for nasal use only.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not use a larger dose or use the spray more often or for longer than your doctor tells you to.

Hayfever and perennial rhinitis The usual dose is 2 sprays into each nostril once a day. Once your symptoms are under control, your doctor may advise you to spray once only into each nostril once a day.

If you do not start to feel any better, you should see your doctor who may tell you to increase the dose to the maximum daily amount of 4 sprays into each nostril once a day. Once your symptoms are controlled your doctor may advise you to reduce the dose to 2 sprays into each nostril once daily.

Use in children and adolescents

Children over 12 years of age The usual dose is 2 sprays into each nostril once a day. Once symptoms are under control, a doctor may advise to spray once only into each nostril once a day.

Children aged 6 to 11 years

The usual dose is one spray into each

nostril once daily.

Severe hayfever

If you suffer badly from hayfever, your doctor may tell you to start using Mometasone Furoate 2 to 4 weeks before the start of the pollen season, as this will help to prevent your hayfever symptoms. Your doctor may recommend that you use other treatments with this medicine, particularly if your eyes are itching or irritated. At the end of the pollen season your hayfever symptoms should improve and treatment may no longer be needed.

Nasal Polyps

The usual starting dose is 2 sprays into each nostril once daily.

The use of this nasal spray may produce positive results in doping tests.

Children and adolescents

Long term use of nasal steroids at high doses may cause slowing of growth in children. Your doctor may check your child’s height at intervals during treatment and reduce the dose if any effects are seen.

Other medicines and Mometasone Furoate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking other corticosteroid medicines for allergy, either by mouth or injection, your doctor may advise you to stop taking them when you begin using this medicine. A few people may find that when they discontinue oral or injected corticosteroids they have some side effects, such as joint or muscular pain, weakness and depression. If these occur, you should inform your doctor who will advise about continuing use of your nasal spray. You may also develop other allergies, such as itchy, watering eyes or patches of red and itchy skin. If this happens and you are worried, you should see your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not use this medicine if you are pregnant unless your doctor has told you to. You should not breast feed when you are using this medicine.

If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to 2 sprays in each nostril twice daily. Once symptoms are under control, your doctor will reduce your dose.

If no improvement in symptoms is seen after 5 to 6 weeks of twice daily use, you should contact your doctor to discuss different treatments.

Preparing your nasal spray for use

Your Mometasone Furoate Nasal Spray has a dust cap which protects the nozzle and keeps it clean. Take this off before using the spray and replace it after use.

If you are using the spray for the first time you need to ‘prime’ the bottle by pumping the spray 10 times until a fine mist is produced:

1.    Shake the bottle well.

2.    Put your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle (Figure 1).

3.    Point the nozzle away from you and then press down with your fingers to pump the spray (Figure 1).

If you have not used the spray for 14 days or more, you need to “re-prime” the bottle by pumping the spray twice until a fine mist is produced.

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At the usual dose of 2 sprays into each nostril once daily, this medicine should provide enough doses for 30 days (120 sprays) or 35 days (140 sprays).

How to use your nasal spray

1. Shake the bottle well and remove the dust cap. (Figure 2)

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 leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

2.    Gently blow your nose.

3.    Close one nostril and put the nozzle into the other nostril.

4.    Tilt your head forward slightly, keeping the bottle upright.

5.    Start to breathe in gently or slowly through your nose and whilst you are breathing in squirt a spray of fine mist into your nose by pressing down ONCE with your fingers (Figure 3).

6.    Breathe out through your mouth. Repeat step 5 to inhale a second spray in the same nostril.

7.    Remove the nozzle from this nostril and breathe out through your mouth.

8.    Repeat steps 3 to 7 for the other nostril.

After using the spray, wipe the nozzle carefully with a clean handkerchief or tissue and replace the dust cap.

Cleaning your nasal spray

It is important that you clean your nasal spray regularly, otherwise it may not work properly. Remove the dust cap and gently pull off the nozzle. Wash the nozzle and dust cap in warm water and then rinse under a running tap. Allow to dry in a warm place. Push the nozzle back onto the bottle and replace the dust cap. The spray will need to be re-primed with 2 sprays when first used after cleaning.

If you use more Mometasone Furoate than you should

It is important that you take your dose as stated in this Package Leaflet or as advised by your doctor. Using more or less may make your symptoms worse.

Tell your doctor if you accidentally use more than you should.

If you use steroids for a long time or in large amounts they may, rarely, affect some of your hormones. In children this may affect growth and development.

If you forget to use Mometasone Furoate

If you forget to use your nasal spray at the right time, use it as soon as you remember, then carry on as before.

Do not take a double dose to make up for a forgotten dose.

If you stop using Mometasone Furoate

In some patients this medicine should begin to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be seen for up to 2 days. It is very important that you use your nasal spray regularly. Do not stop your treatment even if you feel better unless told to do so by your doctor.

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

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking this medicine and seek medical help immediately if you have any of the following which may be signs of a rare severe allergic reaction:

•    difficulty breathing or swallowing

•    swelling of the face, lips, tongue or throat

The following side effects can also occur during treatment:

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

•    headache

•    nose bleeds

•    sore nose or throat

Rare side effects (may affect up to 1 in 1,000 people):

•    immediate hypersensitivity (allergic) reactions.

Very rare side effects (may affect up to 1 in 10,000 people):

•    an increase in pressure in the eye (glaucoma), causing visual disturbances and damage to the partition in the nose which separates the nostrils

•    alterations in taste and smell

Additional side effects in children and adolescents

When used at high doses for long periods of time in children, corticosteroid nasal sprays may cause growth reduction. Your child’s height may be monitored regularly.

How to store Mometasone Furoate Nasal Spray

Keep out of the reach and sight of children.

Do not use Mometasone Furoate after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Do not freeze.

Once opened use within 2 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

What Mometasone Furoate contains

•    The active substance is mometasone furoate. Each actuation of the pump delivers a metered dose of

50 micrograms of mometasone furoate (as mometasone furoate monohydrate).

•    The other ingredients are microcrystalline cellulose (E460), carmellose sodium (E468), glycerol (E442), citric acid monohydrate (E330), sodium citrate dihydrate (E331), polysorbate 80 (E433), benzalkonium chloride and water for injection.

What Mometasone Furoate looks like and contents of the pack

Mometasone Furoate is a white nasal spray, suspension packed in white plastic bottle fitted with a spray pump.

1 bottle containing 10.0 g nasal spray suspension, corresponding to 60 delivered doses.

1 bottle containing 17.0 g nasal spray suspension, corresponding to 120 delivered doses.

1 bottle containing 18.0 g nasal spray suspension, corresponding to 140 delivered doses.

3 bottles containing 18.0 g nasal spray suspension, corresponding to 140 delivered doses.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Lek Pharmaceuticals d.d. Verovskova 57,

1526 Ljubljana Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220 Lendava Slovenia

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures Romania

This leaflet was last revised in 03/2015.

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SZ00000LT000

Artwork Proof Box

Ref: V015: SPC update in line with PAR for paediatric studies & QRD