FULL CMI

Telnasal Allergy Spray^®

Active ingredient: Mometasone furoate monohydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Telnasal Allergy Spray. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Telnasal Allergy Spray.

Where to find information in this leaflet:

1. Why am I using Telnasal Allergy Spray?
2. What should I know before I use Telnasal Allergy Spray?
3. What if I am taking other medicines?
4. How do I use Telnasal Allergy Spray?
5. What should I know while using Telnasal Allergy Spray?
6. Are there any side effects?
7. Product details

1. Why am I using Telnasal Allergy Spray?

Telnasal Allergy Spray contains the active ingredient mometasone furoate monohydrate. Telnasal Allergy Spray belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation.

Allergic Rhinitis (hayfever): Telnasal Allergy Spray is sprayed into the nose to help relieve symptoms that may occur with hayfever or other year round allergies, including stuffiness (congestion) in the nose, discharge, itching and sneezing. This medicine may also be used to help prevent these symptoms two to four weeks before the beginning of the pollen season.

There is no evidence that this medicine is addictive.

2. What should I know before I use Telnasal Allergy Spray?

Warnings

Do not use Telnasal Allergy Spray if:

• you are allergic to mometasone furoate monohydrate, or any of the ingredients listed at the end of this leaflet
• you have a tendency to bleed or recurrent nose bleeding
• you have severe nose infection, especially fungal infection
• you have had recent nose injury or nose surgery; you may wait until healing has occurred before using this medicine
• you have active or inactive tuberculous infections of the respiratory tract, bacterial, systemic viral infections or in herpes simplex.
• the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering

Always check the ingredients to make sure you can use this medicine.

Check with your doctor or pharmacist if you:

• have any other medical conditions especially the following ones:
  - infection of the nose, sinus, mouth, throat, lungs or eye
  - sores in the nose
  - recent injury or surgery to your nose
  - open sores in your nose
• take any medicines for any other condition including CYP3A inhibitors (medicines for metabolic conditions) including cobicistat-containing products
• taking other corticosteroid medicines, either by mouth, as eye drops, as an asthma inhaler or by injection
• have allergies to:
  - any other medicines
  - any other substances, such as foods, preservatives or dyes
• have or recently suffered from any bacterial or viral infection, avoid coming into contact with anyone who has measles or chickenpox especially while you are using cortisone-type medicines. Tell your doctor if you do.

If you suddenly discontinue use of this medicine then reoccurrence of the underling condition, adrenocortical insufficiency or steroid withdrawal syndrome may occur. The risk may vary as per the potency of the steroid.

Typical signs and symptoms can be either systemic such as muscle or joint pain, tremors, weight loss and anxiety or nasal bleeding and nasal drip.

Following the use of intranasal corticosteroids, instances of increased eye pressure have occurred.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Your doctor or pharmacist will discuss the possible risks and benefits of using this medicine during pregnancy. Breastfeeding is not recommended during treatment with this medicine.

Use in Children

Do not use in children under 12 years of age.

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed and discussed with your doctor or pharmacist.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Telnasal Allergy Spray.

4. How do I use Telnasal Allergy Spray?

How much to use

Hayfever and allergies in adults (including the elderly) and children 12 years of age and older:

• Two sprays into each nostril once daily.
• It may take 1-2 days for full effect.
• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.
• Consult your pharmacist or doctor if symptoms are not relieved within 7 days.
• Once symptoms are controlled, reducing the dose to one spray in each nostril may be effective for maintenance.
• Do not use for more than 6 months without the advice of your pharmacist or doctor.
• Do not give to children under 12 years of age.

When to use Telnasal Allergy Spray

• Telnasal Allergy Spray should be used once daily.

How to use Telnasal Allergy Spray

Your 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.

Do not pierce the nasal applicator.

If you are using the spray for the first time prime the pump by pumping the spray 10 times until a fine mist is produced.

If you have not used the pump for 14 days or more reprime by pumping 2 times.

1. Shake the bottle gently and remove the dust cap.
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.
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 the mouth.
8. Repeat steps 3 to 7 for the other nostril. After using the spray, wipe the nozzle carefully with a clean tissue and replace the dust cap.

If you use too much Telnasal Allergy Spray

If you think that you have used too much Telnasal Allergy Spray, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Telnasal Allergy Spray?

Things you should do

If you become pregnant while you are using this medicine tell your doctor or pharmacist.

Tell any other doctors, dentists and pharmacists who are treating you that you are using this medicine.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are using this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.

See your doctor immediately if you notice the symptoms of severe bacterial infection. These symptoms may include fever, persistent face/tooth pain on one side of the face, swelling around the eye area, or worsening of symptoms after an initial improvement.

How long to use it

You can stop taking Telnasal Allergy Spray when you obtain relief from the symptoms. It can be restarted if the symptoms reoccur.

See your doctor or pharmacist if your symptoms are not relieved within 7 days.

Do not use for more than 6 months without the advice of your pharmacist or doctor.

Things you should not do

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use it to treat any other complaints unless your doctor tells you to.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use it as soon as you remember, and then go back to use your medicines as you would normally.

Do not use a double dose to make up for the dose you missed.

Driving or using machines

This medicine generally does not cause any problems with your ability to drive a car or operate machinery.

Drug testing for sport events:

This product is a corticosteroid for intranasal administration; it is not a restricted drug for sports.

Corticosteroid may be detected in blood and in the urine during drug testing; thus prior written permission for its use may be required by some sport agencies.

Looking after your medicine

It is important to clean the nozzle 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 the nozzle to dry. Push the nozzle back onto the bottle and replace the dust cap. The pump will need to be reprimed when first used after cleaning.

Follow the instructions in the carton on how to take care of your medicine properly.

• Store below 25°C.
• Do not freeze.
• The bottle should be discarded after the labelled number of actuations or within 2 months of first use.

Store in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date or if the packaging is torn or shows signs of tampering.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

If you are over 65 years of age you may have an increased chance of getting side effects.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

More serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Long-term use of corticosteroid sprays may be associated with other side effects. Your doctor or pharmacist will monitor your health if you are using Telnasal Allergy Spray for extended periods of time.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What Telnasal Allergy Spray contains

Do not take this medicine if you are allergic to any of these ingredients.

What Telnasal Allergy Spray looks like

Telnasal Allergy Spray is a white to off-white suspension contained in HDPE bottles with a metered-dose, manual spray pump for intranasal administration. Available packs of 1 x 140 metered doses and in a twin pack of 2 x 140 metered doses.

Australian Registration Number: AUST R 330202

Who distributes Telnasal Allergy Spray

Sanofi Consumer Healthcare
87 Yarraman Place
Virginia, 4014, Australia
Freecall No: 1800 818 806

This leaflet was prepared in April 2022.

Tel-nas-ccdsv1-cmiv4-20apr22

Published by MIMS September 2022

1 Name of Medicine

Mometasone furoate monohydrate.

2 Qualitative and Quantitative Composition

Telnasal Allergy Spray is a metered-dose, manual pump spray unit containing a suspension of mometasone furoate. Each actuation delivers approximately 100 mg of mometasone furoate monohydrate suspension, containing mometasone furoate monohydrate equivalent to mometasone furoate 50 microgram.
Telnasal Allergy Spray contains mometasone furoate 0.5 mg/g (as the monohydrate).
Mometasone also contains benzalkonium chloride 0.2 mg/g as preservative.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Aqueous nasal spray.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

4.2 Dose and Method of Administration

Do not exceed the recommended dosage.
The effect of mometasone aqueous nasal spray 0.05% is not immediate. Full therapeutic benefit takes a few days to develop. Dosage should be administered as directed and not to be taken by the patients at will for symptomatic relief.

Allergic rhinitis.

Adults and children 12 years of age and over.

Instructions to patients.

Cleaning your nasal spray.

Do not use.

4.3 Contraindications

Patients with known hypersensitivity to mometasone furoate or any of the excipients.
Severe nasal infection, especially candidiasis.
Persons with haemorrhagic diathesis or with a history of recurrent nasal bleeding.
Use in children under 12 years of age.
Use for longer than six months without the advice of a doctor or pharmacist.

4.4 Special Warnings and Precautions for Use

Improvement should be seen within seven days of starting treatment. Treatment should be reassessed if there is no improvement within seven days of continuous use, or if symptoms have improved but are not adequately controlled after seven days of continuous use.
If signs or symptoms of eye pain and/or visual disturbance develop, discontinuance of mometasone nasal spray use or appropriate treatment may be required.
Mometasone aqueous nasal spray 0.05% should not be used in the presence of untreated localized infection involving the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Following 12 months of treatment with mometasone aqueous nasal spray 0.05%, there was no evidence of atrophy of the nasal mucosa. Mometasone furoate tended to reverse the nasal mucosa closer to a normal histological phenotype. As with any long-term treatment, patients using mometasone aqueous nasal spray 0.05% over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localized fungal infection of the nose or pharynx develops, discontinuance of mometasone aqueous nasal spray 0.05% therapy or appropriate treatment may be required.
Persistence of nasopharyngeal irritation may be an indication for discontinuing mometasone aqueous nasal spray 0.05%.
Mometasone aqueous nasal spray 0.05% should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
Topical corticosteroids may be absorbed in amounts that can have systemic effects. Use of excessive doses may suppress HPA function. Physicians should be alert for evidence of systemic effects, especially in chronically treated patients.
However, there is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with mometasone aqueous nasal spray 0.05%. Patients who are transferred from long-term administration of systemically active corticosteroids to mometasone aqueous nasal spray 0.05% require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA axis function. If these patients exhibit signs and symptoms of adrenal insufficiency, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted.
During transfer from systemic corticosteroids to mometasone aqueous nasal spray 0.05%, some patients may experience symptoms of withdrawal from systemically active corticosteroids (e.g. joint and/or muscular pain, lassitude and depression initially) despite relief from nasal symptoms and will require encouragement to continue mometasone aqueous nasal spray 0.05% therapy. Such transfer may also unmask pre-existing allergic conditions such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g. chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.
Following the use of intranasal aerosolized corticosteroids, instances of nasal septum perforation or increased intraocular pressure have been reported very rarely.

Use in elderly.

Paediatric use.

Effects of laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There have been no formal interaction studies performed.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adult population.

Paediatric population.

Acute rhinosinusitis.

Reporting suspected adverse effects.

4.9 Overdose

Because the systemic bioavailability of mometasone aqueous nasal spray is low and has been estimated as < 1%, overdose is unlikely to require any therapy other than observation. Treatment can be reinitiated at the usual recommended dose.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of hypothalamic-pituitary-adrenal (HPA) axis function.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Allergic rhinitis.

5.2 Pharmacokinetic Properties

Systemic bioavailability of mometasone furoate was investigated in 24 healthy volunteers following intranasal administration of 400 microgram of the suspension. Mometasone was detectable in plasma (at sporadic time points) in only 4 of the 24 subjects, despite the use of a sensitive assay with a limit of quantitation of 50 picogram/mL. Thus, there were no relevant pharmacokinetic data for this dosage form.
Systemic absorption of mometasone furoate suspension administered as aqueous nasal spray, 200 microgram single dose, was measured using a sensitive assay with a lower quantitation limit of 0.25 picogram/mL. Mean C max was 5.77 picogram/mL (CV% 32) and mean AUC (0-12 hr) 29.6 picogram.hr/mL (CV% 37). When compared with dose adjusted PK data for IV mometasone administration from earlier studies with a quantitation limit of 50 picogram/mL and longer sampling duration, the estimated relative systemic (or 'absolute') bioavailability is < 1%. The bioavailability of mometasone following intranasal administration is low.
Systemic effects were not detected in adults, adolescents or children following the administration of mometasone furoate aqueous nasal spray.
Mometasone furoate suspension is very poorly absorbed from the gastrointestinal tract, and the small amount that may be swallowed and absorbed undergoes extensive first-pass metabolism prior to excretion in urine and bile.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cellulose microcrystalline, carmellose sodium, citric acid monohydrate, sodium citrate, glycerol, polysorbate 80 and water purified with benzalkonium chloride 0.2 mg/g as preservative.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store Telnasal Allergy Spray below 25°C. Do not freeze.

6.5 Nature and Contents of Container

Telnasal Allergy Spray is supplied in a HDPE Pump Actuated Metered Dose Aerosol containing mometasone furoate (as the monohydrate) 50 microgram/actuation; 140 metered doses or in a twin pack 140 x 2.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Mometasone furoate is a white to almost white powder and it is practically insoluble in water; soluble in acetone and in methylene chloride, slightly soluble in ethanol 96%, methanol and isopropanol.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Pharmacy medicine (S2).

Summary Table of Changes