Flomister 137 micrograms / 50 micrograms per actuation nasal spray, suspension – patient leaflet, side effects, dosage

1. What Flomister Nasal Spray is and what it is used for

Flomister Nasal Spray contains two active substances: azelastine hydrochloride and fl uticasone propionate. • Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by

preventing the eff ects of substances such as histamine that the body produces as part of an allergic reaction – thus reducing symptoms of allergic rhinitis.

• Fluticasone propionate belongs to a group of medicines called corticosteroids which reduces infl ammation. Flomister Nasal Spray is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis if the use of either intranasal antihistamine or corticosteroid alone is not considered suffi cient. Seasonal and perennial allergic rhinitis are allergic reactions to substances such as pollen (hayfever), house mites, moulds, dust or pets.

Flomister Nasal Spray relieves the symptoms of allergies, for example: runny nose, post nasal drip, sneezing and itchy or blocked nose.

2. What you need to know before you use Flomister Nasal Spray

Do not use Flomister Spray:

• If you are allergic to azelastine hydrochloride or fl uticasone propionate or any of the other ingredients of this

  medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Flomister Nasal Spray if:

• You had a recent operation on your nose.

• You have an infection in your nose. Infections of the nasal airways should be treated with antibacterial or

  antifungal medication. If you are given medication for an infection in your nose you can continue to use Flomister Nasal Spray to treat your allergies.

• You have tuberculosis or an untreated infection.

• You have a change in vision or a history of increased ocular pressure, glaucoma and/or cataracts. If this applies to

  you, you will be closely monitored whilst using Flomister Nasal Spray.

• You suff er from impaired adrenal function. Care must be taken when transferring from systemic steroid treatment

  to Flomister Nasal Spray.

• You suff er from a severe liver disease. Your risk of suff ering from systemic side eff ects is increased. In these cases your doctor will decide whether you can use Flomister Nasal Spray.

It is important that you take your dose as stated in section 3 below or as advised by your doctor. Treatment with higher than recommended doses of nasal corticosteroids may result in adrenal suppression, a condition that may produce weight loss, fatigue, muscle weakness, low blood sugar, salt cravings, joint pains, depression and darkening of the skin. If this happens your doctor may recommend another medicine during periods of stress or elective surgery. To avoid adrenal suppression your doctor will advise you to take the lowest dose at which eff ective control of your symptoms of rhinitis is maintained.

Taking nasal corticosteroids (such as Flomister) may when taken for a long time cause children and adolescents to grow more slowly. The doctor will check your child’s height regularly, and make sure he or she is taking the lowest possible eff ective dose.

Contact your doctor, if you experience blurred vision or other visual disturbances.

If you are unsure whether the above applies to you, talk to your doctor or pharmacist before using Flomister Nasal Spray.

Children

This medicine is not recommended for children under 12 years.

Other medicines and Flomister Nasal Spray

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

Some medicines may increase the eff ects of Flomister Nasal Spray and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat and medicines for the treatment of fungal infections: ketoconazole).

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 using this medicine.

Driving and using machines

Flomister Nasal Spray has minor infl uence on the ability to drive and use machines.

Very rarely, you may experience fatigue or dizziness due to the disease itself or when using Flomister Nasal Spray. In these cases, do not drive or operate machinery. Please be aware that drinking alcohol may enhance these eff ects. Flomister Nasal Spray contains benzalkonium chloride

This medicine contains 14 micrograms benzalkonium chloride in each actuation, which is equivalent to 0.014 mg / 0.14 g. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. Tell your doctor or pharmacist if you feel discomfort when using the spray.

Flomister Nasal Spray contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per actuation that is to say essentially ‘sodium free’.

3. How to use Flomister Nasal Spray

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

It is essential to use Flomister Nasal Spray regularly to gain the full therapeutic benefi t. Contact with the eyes should be avoided.

Adults and adolescents (12 years and above)

• The recommended dose is one spray into each nostril in the morning and evening.

Use in children under 12 years

• This medicine is not recommended for children under 12 years.

Use in renal and hepatic impairment

• There are no data in patients with renal and hepatic impairment.

Method of administration

For nasal use.

Read the following instructions carefully and use only as directed.

INSTRUCTION FOR USE

Preparing the spray

1. 1.

   Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap (see

   fi gure 1).

Figure 1

1. 2. The fi rst time the nasal spray is used, you must prime the pump by squirting it into the air.
2. 3.

   Prime the pump by putting two fi ngers on either side of the spray pump and place your thumb on the bottom of the

   bottle.

3. 4. Press down and release the pump 6 times until a fi ne mist appears (see fi gure 2).
4. 5. Now your pump is primed and ready to use.

Figure 2

1. 6.

   If the nasal spray has not been used for more than 7 days, you will need to re-prime the pump once by pressing

   down and releasing the pump.

Using the spray

1. 1.

   Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap (see

   fi gure 1).

2. 2. Blow your nose to clear your nostrils.
3. 3. Keep your head tilted downwards towards your toes. Do not tilt head backwards.
4. 4. Hold the bottle upright and carefully insert the spray tip into one nostril.
5. 5. Close other nostril with your fi nger, rapidly press down once and sniff gently at the same time (see fi gure 3).
6. 6. Breathe out through your mouth.

Figure 3

1. 7. Repeat in your other nostril.
2. 8.

   Breathe in gently, and do not tilt your head back after dosing. This will stop the medicine going into your throat

   and causing an unpleasant taste (see fi gure 4).

   Figure 4

   1. 9. After each use wipe the spray tip with a clean tissue or cloth and then replace the protective cap.
   2. 10. Do not prick the nozzle in case spray is not obtained. Clean the actuator with water. It is important that you take your dose as advised by your doctor. You should use only as much as your doctor recommends.

Duration of treatment

Flomister Nasal Spray is suitable for long-term use. The duration of treatment should correspond to the period of experiencing allergy symptoms.

If you use more Flomister Nasal Spray than you should

If you spray too much of this medicine into your nose you are unlikely to have any problems. If you are worried or if you have used doses higher than recommended over a long period, contact your doctor. If anyone, especially a child, accidentally drinks Flomister Nasal Spray, contact your doctor or nearest hospital casualty department as soon as possible.

If you forget to use Flomister Nasal Spray

Use your nasal spray as soon as you remember, then take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Flomister Nasal Spray

Do not stop using Flomister Nasal Spray without asking your doctor, because this puts the success of the treatment at risk.

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

4. Possible side eff ects

Like all medicines this medicine can cause side eff ects, although not everybody gets them. Seek immediate medical help if you have any of the following symptoms:

• Swelling of face, lips, tongue or throat which may cause diffi culty in swallowing/breathing and a sudden onset of skin rash. This could be signs of a severe allergic reaction. Please note: This is very rare. Very common (may aff ect more than 1 in 10 people):
• Nosebleed

Common (may aff ect up to 1 in 10 people):

• Headache

• A bitter taste in your mouth, especially if you tilt your head backwards when you are using the nasal spray.

  This should go away if you have a soft drink a few minutes after using this medicine.

• Unpleasant smell

Uncommon (may aff ect up to 1 in 100 people):

• Slight irritation of the inside of the nose. This can cause mild stinging, itching or sneezing.
• Nasal dryness, cough, dry throat or throat irritation

Rare (may aff ect up to 1 in 1 000 people):

• Dry mouth

Very rare (may aff ect up to 1 in 10 000 people):

• Dizziness or drowsiness
• Cataract, glaucoma or increased pressure in your eye where you may have a loss of vision and/or red and painful eyes. These side eff ects have been reported following prolonged treatment with fl uticasone propionate nasal sprays.
• Damage of the skin and mucous membrane in the nose
• Feeling sick, weary, exhausted or weak
• Rash, itchy skin or red, raised itchy bumps
• Bronchospasm (the narrowing of the airways in the lungs)

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

• Blurred vision
• Sores in the nose

Systemic side eff ects (side eff ects concerning the whole body) may occur when this medicine is used at high doses for a long time. These eff ects are much less likely to occur if you use a corticosteroid nasal spray than if you take corticosteroids by mouth. These eff ects may vary in individual patients and between diff erent corticosteroid preparations (see section 2).

Nasal corticosteroids can aff ect the normal production of hormones in your body, particularly if you use high doses for a long time. In children and adolescents this side eff ect can cause them to grow more slowly than others. In rare cases a reduction of the bone density (osteoporosis) was observed, if nasal corticosteroids were administered long-term.

Reporting of side eff ects

If you get any side eff ects, talk to your doctor or pharmacist. This includes any possible side eff ects not listed in this leafl et. You can also report side eff ects directly via

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 eff ects you can help provide more information on the safety of this medicine.

5. How to store Flomister Nasal 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 bottle label and the carton after “EXP”. The expiry date refers to the last day of that month.

Do not refrigerate or freeze.

Shelf life after fi rst opening: Dispose of any unused medicine 6 months after you fi rst open the nasal spray. 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 Flomister Nasal Spray contains

The active substances are azelastine hydrochloride and fl uticasone propionate. Each g of suspension contains 1000 micrograms azelastine hydrochloride and 365 micrograms fl uticasone propionate.

Each actuation (0.14 g) delivers 137 micrograms azelastine hydrochloride (= 125 micrograms azelastine) and 50 micrograms fl uticasone propionate.

The other ingredients are glycerol, microcrystalline cellulose, carmellose sodium, disodium edetate, polysorbate 80, benzalkonium chloride, phenylethyl alcohol and purifi ed water.

What Flomister Nasal Spray looks like and contents of the pack

Flomister Nasal Spray is a white, homogenous suspension.

Flomister Nasal Spray comes in an amber coloured glass bottle fi tted with a spray pump, applicator and a protective cap.

The 25 ml bottle contains 23 g nasal spray, suspension (at least 120 actuations).

Flomister Nasal Spray is presented in:

Packs containing 1 bottle with 23 g nasal spray, suspension

Multipacks comprising 3 bottles, each containing 23 g nasal spray, suspension.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Strides Pharma UK Limited

Unit 4, The Metro Centre,

Dwight Road, Watford,

WD18 9SS

United Kingdom

This leafl et was last revised in 12/2023.