Clarinaze Hayfever Relief, 0.05% nasal spray – patient leaflet, side effects, dosage

1. What Clarinaze Hayfever Relief is and what it is used for

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1. 2. What you need to know before you use Clarinaze Hayfever Relief
2. 3. How to use Clarinaze Hayfever Relief
3. 4. Possible side effects
4. 5. How to store Clarinaze Hayfever Relief
5. 6.
   1. 1. What Clarinaze Hayfever Relief is and what it is used for

What is Clarinaze Hayfever Relief?

Clarinaze Hayfever Relief nasal spray contains mometasone furoate, one of a group of medicines 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 up or runny nose and associated sinus discomfort.

What is Clarinaze Hayfever Relief used for?

Clarinaze Hayfever Relief is used to treat the symptoms of hayfever (also called seasonal allergic rhinitis) in adults aged 18 years and older.

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. Clarinaze Hayfever Relief reduces the swelling and irritation in your nose thereby relieving sneezing, itching and a blocked-up or runny nose and associated sinus discomfort caused by hayfever.

2. What you need to know before you

use Clarinaze Hayfever Relief

Do not use Clarinaze Hayfever Relief

• if you are allergic (hypersensitive) 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. Use of Clarinaze Hayfever Relief during an untreated infection in your nose, such as herpes, can worsen the infection. 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 not use the nasal spray until your nose has healed.
• if you are under 18 years of age.
• if you are pregnant or breastfeeding without talking to your doctor first.
• for more than 1 month without consulting your doctor.
• if you are taking medicines for HIV.

Warnings and precautions

Talk to your doctor or pharmacist before using Clarinaze Hayfever Relief

• if you have or have ever had tuberculosis.
• if you have any other infection.
• if you are taking other corticosteroid medicines, either by mouth or by injection.
• if you have cystic fibrosis.

While you are using Clarinaze Hayfever Relief, talk to your doctor or pharmacist

• if your immune system is not functioning well (you have difficulty 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 have persistent irritation to the nose or throat.
• if you experience blurred vision or other visual disturbances.

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 medicines and Clarinaze Hayfever Relief

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines whilst using Clarinaze Hayfever Relief, including medicines obtained without a prescription.

Do not use this medicine if you are taking medicines for HIV.

Talk to your pharmacist before using this medicine if you are taking any prescribed corticosteroid medicines (including eczema creams, asthma inhalers, injections, nasal sprays and eye or nose drops). 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. 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, you should contact your doctor or pharmacist.

Pregnancy and breastfeeding

Talk to your doctor or pharmacist before using Clarinaze Hayfever Relief if you are pregnant, trying to become pregnant or are breastfeeding.

Driving and using machines

There is no known information on the effect of Clarinaze Hayfever Relief on the ability to drive or use machinery.

Clarinaze Hayfever Relief contains benzalkonium chloride

Clarinaze Hayfever Relief contains 0.02mg benzalkonium chloride per spray which is equivalent to 0.2mg/g. This ingredient may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Clarinaze Hayfever Relief

Always use Clarinaze Hayfever Relief according to the instructions in this leaflet. 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 instructed.

Treatment of Symptoms of Hayfever

Adults (aged 18 years and over)

The usual dose is two sprays into each nostril once a day.

• Once your nasal symptoms are under control, you may reduce the dose to one spray into each nostril once a day.
• Use the lowest possible dose to control your symptoms.
• Do not use more than four sprays in a day.
• Do not use more than the recommended dose.

If your symptoms have not improved within 7 days, you should see your doctor or pharmacist.

In some patients Clarinaze Hayfever Relief begins to relieve nasal 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 the full benefit of treatment.

Children or adolescents under 18 years

Do not use in children and adolescents under 18 years.

Preparing your nasal spray for use

Your Clarinaze Hayfever Relief 0.05% w/w 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:

1. 1. Gently shake the bottle.
2. 2. Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle. Do Not pierce the nasal applicator.
3. 3. 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.

How to use your nasal spray

1. 1. Shake the bottle gently and remove the dust cap. (Figure 1)
2. 2. Gently blow your nose.
3. 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.

4. 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. 5.

   Breathe out through your mouth. Repeat step 4 to inhale a second

   spray in the same nostril if applicable.

6. 6.

   Remove the nozzle from this nostril and breathe out through the

   mouth.

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

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

Bayer Ref No:

BAY593614

Trident Reference No:

TR3069354

Brand:

Claritin-D

Range:

Clarinase

Product:

Tablets

Pack Type:

Leaflet

Pack Size:

60 dose

Action:

B

20/12/2023

Country:

UK

Finished Goods Code:

89490200

Synaps Request Code:

Packaging Site:

Organon International Services GmbH [BE] IN100GV_130x630-SK02_V3 AW.CSA/MUP-65357-01

000000000

N/A

Multi Packaging Solutions (Bornem, Belgium)

Substrate:

White Paper

Barcode 1 Type:

Barcode 1 Mag:

Code 2 Of 5 Interleaved 26.3852%

Barcode 2 Type:

N/A

Barcode 2 Mag:

N/A

N/A

Height (based on lower case x): 1.7mm Barcode 3 Type:

N/A

Barcode 3 Mag:

1

2

LTH

LTH

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England.

T: +44 (0) 1482 828100

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Main Text (body copy): 9.0pt

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 the dust cap and nozzle to dry in a warm place.
• Push the nozzle back onto the bottle and replace the dust cap.
• The spray will need to be primed again with 2 sprays when first used after cleaning.

If you use more Clarinaze Hayfever Relief than you should

Tell your doctor or pharmacist if you accidentally use more than this leaflet recommends.

If you use steroids for a long time or in large amounts they may, rarely, affect some of your hormones.

If you forget to use Clarinaze Hayfever Relief

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 Clarinaze Hayfever Relief

In some patients Clarinaze Hayfever Relief 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. If you stop treatment before the end of the allergy season your symptoms may reoccur.

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

4. Possible side effects

Like all medicines, this medicine 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 Clarinaze Hayfever Relief and get immediate medical help if you experience symptoms such as:

• swollen face, tongue or pharynx
• trouble swallowing
• hives
• wheezing or trouble breathing

Stop taking the medicine and tell your doctor if you experience:

• eye problems such as pain or blurred vision.
• nasal problems such as pain and/or persistent bleeding.

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. The following side effects may occur:

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 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
• blurred vision

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clarinaze Hayfever Relief

• Do not store the nasal spray above 25°C. Do not freeze it.
• The bottle should be used within 2 months of first opening.
• 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 bottle and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Clarinaze Hayfever Relief contains

• The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate, as the monohydrate.
• The other ingredients are dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.

What Clarinaze Hayfever Relief looks like and contents of the pack

Clarinaze Hayfever Relief is a nasal spray suspension.

000000000 630

Each 10g bottle contains 60 sprays.

Marketing Authorisation Holder and Manufacturer

The holder of the Marketing Authorisation is: The manufacturer is: Bayer plc, Organon Heist BV, 400 South Oak Way, Heist-op-den Berg, Belgium Reading, RG2 6AD, UK

This leaflet was last revised in December 2023.