1. What Tabunex is and what it is used for

Tabunex Nasal Spray contains mometasone furoate, one of a group of medicines called corticosteroids. Mometasone furoate should not be confused with “anabolic” steroids misused by some athletes and taken as tablets or injections. When tiny amounts of mometasone furoate are sprayed into the nose, it can help to relieve inflammation, sneezing, itching and a blocked up or runny nose. Tabunex is used in adults and children aged 6 and older to treat the symptoms of hayfever (also called seasonal allergic rhinitis) and perennial rhinitis. In adults aged 18 and over, Tabunex is also used to treat nasal polyps.

What is hayfever and perennial rhinitis?

Hayfever, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds and also moulds and fungal spores. Perennial rhinitis occurs throughout the year and symptoms can be caused by a sensitivity to a variety of things including house dust mite, animal hair (or dander), feathers and certain foods. These allergies cause a runny nose and sneezing and make the lining of the nose swell, causing a stuffy blocked-up feeling. Tabunex reduces the swelling and irritation in your nose and so relieves sneezing, itching and a blocked-up or runny nose.

What are nasal polyps?

Nasal polyps are small growths on the lining of the nose and usually affect both nostrils. The main symptom is a blocked feeling in the nose which may affect breathing through the nose. Watering from the nose, a feeling of something running down the back of the throat and loss of taste and smell may also occur. Tabunex reduces the inflammation in the nose, causing the polyps to gradually shrink.

2. Before you use Tabunex

Do not use Tabunex

If you are allergic (hypersensitive) to mometasone furoate or any of

the other ingredients of Tabunex.

If you have an infection in your nose. You should wait until the

infection is resolved before you start using the nasal spray.

If you 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 Tabunex

- If you have or have ever had tuberculosis.

- If you have herpes simplex (virus) infection of the eye.

- If you have any other type of infection.

- If you are taking other corticosteroid medicines, either by mouth or by injection.

- If you have cystic fibrosis.

While you are using Tabunex, talk to your doctor:

- If your immune system is not functioning well (if you have difficulty in

fighting infection) and you come into contact with anyone with

measles or chickenpox. You should avoid coming into contact with

anyone who has these infections.

- If you have an infection of the nose or throat.

- If you are using the medicine for several months or longer.

- If you have persistent irritation to the nose or throat.

When corticosteroid nasal sprays are used at high doses for long

periods of time, side effects may occur due to the drug being absorbed

in the body.

If your eyes are itching or irritated, your doctor may recommend that

you use other treatments with Tabunex.

Children

When used at high doses for long periods of time, corticosteroid nasal

sprays may cause certain side-effects, such as slowed growth rate in

children.

It is recommended that the height of children receiving long-term

treatment with nasal corticosteroids is regularly monitored and if any

changes are noted, their doctor should be notified.

Using other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines, including medicines obtained without a

prescription.

If you are taking other corticosteroid medicines for allergy, either by

mouth or injection, your doctor may advise you to stop taking them

once you begin using Tabunex. A few people may find that once they

discontinue oral or injected corticosteroids they suffer from some

undesirable 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 seem to

develop other allergies, such as itchy, watering eyes or patches of red

and itchy skin. If you develop any of these effects and you are worried,

you should see your doctor.

Some medicines may increase the effects of Tabunex and your doctor

may wish to monitor you carefully if you are taking these medicines

(including some medicines for HIV: ritonavir, cobicistat).

Pregnancy and breast-feeding

There is little or no information on the use of Tabunex in pregnant

women. It is not known if mometasone furoate is found in breast milk.

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.

Driving and using machines

There is no known information on the effect of Tabunex on the ability to

drive or use machinery.

Important information about some of the ingredients of Tabunex

Tabunex contains benzalkonium chloride which may cause nasal

irritation.

3. How to use Tabunex
Always use Tabunex exactly as your doctor has told you. You should 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
Adults and children over 12 years old
The usual dose is two sprays into each nostril once a day for adults 
(including the elderly) and children over the age of 12 years.
- Once your symptoms are under control, your doctor may advise you to only spray once into each nostril once a day.
- If you do not start to feel any better, you should see your doctor and he may tell you to increase the dose to the maximum daily dose of four sprays into each nostril once a day. Once your symptoms are controlled your doctor may advise you to reduce the dose to two sprays into each nostril once daily.
Children aged 3 to 11 years
The usual dose is one spray into each nostril once daily.
In some patients Tabunex begins to relieve symptoms within 12 hours after the first dose; however full benefit of treatment may not be seen in the first two days. Therefore, you should continue regular use to achieve full benefit of treatment.
If you or your child suffer badly from hayfever, your doctor may tell you to start using Tabunex some days before the start of the pollen season, as this will help to prevent your hayfever symptoms from occurring. Nasal Polyps
The usual starting dose for adults aged 18 and over is two sprays into each nostril once daily.
- If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to two sprays in each nostril twice daily. Once symptoms are under control, your doctor may advise you to decrease your dose. - If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, you should contact your doctor.
Preparing your nasal spray for use
Your Tabunex Nasal Spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray and to 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:
Gently shake the bottle.
Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle. Do Not pierce the nasal applicator. - Point the nozzle away from you and then press down with your fingers to pump the spray 10 times until a fine mist is produced.
If you have not used the spray for 14 days or more, you need to “re-prime” the bottle by pumping the spray 2 times until a fine mist is produced. 

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 to 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. 
Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine. 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 Tabunex than you should
Tell your doctor if you accidentally use more than you were told. 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 Tabunex
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 Tabunex
In some patients Tabunex should begin to relieve symptoms 12 hours after the first dose; however full benefit of treatment may not be seen for up to two 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 product, ask your doctor or pharmacist.

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

Figure 1

2. Gently blow your nose.

3. Close one nostril and put the nozzle into the other nostril as shown. (Figure 2).

Tilt your head forward slightly, keeping the bottle upright.

Figure 2

4. 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.

5. Breathe out through your mouth. Repeat step 4 to inhale a second spray in the same nostril.

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

7. Repeat steps 3 to 6 for the other nostril (Figure 3). 

Figure 3

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 to 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. 
Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine. 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 Tabunex than you should
Tell your doctor if you accidentally use more than you were told. 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 Tabunex
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 Tabunex
In some patients Tabunex should begin to relieve symptoms 12 hours after the first dose; however full benefit of treatment may not be seen for up to two 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tabunex can cause side effects, although not

everybody gets them.

Immediate hypersensitivity (allergic) reactions may occur after use of

this product. These reactions may be severe. You should stop taking

Tabunex and get immediate medical help if you experience symptoms

such as:

- Swollen face, tongue or pharynx.

- Trouble swallowing.

- Hives.

- Wheezing or trouble breathing.

When corticosteroid nasal sprays are used at high doses for long

periods of time, side effects may occur due to the drug being absorbed

in the body.

Other side effects

Most people do not have any problems after using the nasal spray.

However, some people, after using Tabunex or other corticosteroid

nasal sprays, may find that they suffer from:

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

- Headache.

- Sneezing.

- Nose bleeds (occurred very commonly (may affect more than 1 in 10 people) in people with nasal polyps receiving Tabunex two sprays in  each nostril twice a day).

- Sore nose or throat

- Ulcers in the nose.

- Respiratory tract infection.

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

- Increase in pressure in the eye (glaucoma) and/or cataracts causing

- Visual disturbances,

- Damage to the partition in the nose which separates the nostrils.

- Changes in taste and smell.

- Difficulty in breathing and/or wheezing.

5. How to store Tabunex

Keep out of reach of children.

Store below 30°C.

Do not freeze.

The spray should be used within 2 months of first use.

Do not use beyond the expiry date or if the product shows any signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use.

These measures will help to protect the environment.