DYMISTA 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION NASAL SPRAY SUSPENSION - patient leaflet, side effects, dosage

Patient leaflet - DYMISTA 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION NASAL SPRAY SUSPENSION

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

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

3. How to use Dymista Nasal Spray

4. Possible side effects

5. How to store Dymista Nasal Spray

6. Contents of the pack and other information

|1. What Dymista Nasal Spray is and what it is used fo

Dymista Nasal Spray contains two active substances: azelastine hydrochloride and fluticasone propionate.

■ Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects 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 inflammation.

Dymista 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 sufficient.

Seasonal and perennial allergic rhinitis are allergic reactions to substances such as pollen (hayfever), house mites, moulds, dust or pets.

Dymista 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 Dymista Nasal Spray|

Do not use Dymista Nasal Spray:

■ If you are allergic to azelastine hydrochloride or fluticasone 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 Dymista 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 Dymista 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 Dymista Nasal Spray.
■ You suffer from impaired adrenal function. Care must be taken when transferring from systemic steroid treatment to Dymista Nasal Spray.
■ You suffer from a severe liver disease. Your risk of suffering from systemic side effects is increased.

In these cases your doctor will decide whether you can use Dymista 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 effective control of your symptoms of rhinitis is maintained.

Taking nasal corticosteroids (such as Dymista) 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 effective 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 Dymista Nasal Spray.

Children

This medicine is not recommended for children under 12 years.

Other medicines and Dymista 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 effects of Dymista 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 Dymista Nasal Spray.

Driving and using machines

Dymista Nasal Spray has minor influence on the ability to drive and use machines.

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

Dymista Nasal Spray contains benzalkonium chloride

This medicine contains 14 micrograms benzalkonium chloride in each spray. 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.

3. How to use Dymista Nasal Spra

Always use Dymista Nasal Spray exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure.

It is essential to use Dymista Nasal Spray regularly to gain the full therapeutic benefit.

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.

INSTRUCTIONS FOR USE

Preparing the spray

1. Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap (see figure 1).
2. The first time the nasal spray is used, you must prime the pump by squirting it into the air.
3. Prime the pump by putting two fingers on either side of the spray pump and place your thumb on the bottom of the bottle.
4. Press down and release the pump 6 times until a fine mist appears (see figure 2).
5. Now your pump is primed and ready to use.
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. Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap (see figure 1).
2. Blow your nose to clear your nostrils.
3. Keep your head tilted downwards towards your toes. Do not tilt head backwards.
4. Hold the bottle upright and carefully insert the spray tip into one nostril.
5. Close other nostril with your finger, rapidly press down once and sniff gently at the same time (see figure 3).
6. Breathe out through your mouth.
7. Repeat in your other nostril.

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 figure 4).

9. After each use wipe the spray tip with a clean tissue or cloth and then replace the protective cap.

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

Dymista 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 Dymista 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 Dymista Nasal Spray, contact your doctor or nearest hospital casualty department as soon as possible.

If you forget to use Dymista 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 Dymista Nasal Spray

Do not stop using Dymista 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 effects

Like all medicines Dymista Nasal Spray can cause side effects, although not everybody gets them.

Very common side effects (These may affect more than 1 in 10 people):

■ Nosebleed

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

■ Dry mouth

Very rare side effects (These may affect 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 effects have been reported following prolonged treatment with fluticasone 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)

Seek immediate medical help if you have any of the following symptoms:

■ Swelling of face, lips, tongue or throat which may cause difficulty 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.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

■ Blurred vision
■ Sores in the nose

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

Nasal corticosteroids can affect the normal production of hormones in your body, particularly if you use high doses for a long time. In children and adolescents this side effect 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 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 at: 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.

|6. Contents of the pack and other information!

What Dymista Nasal Spray contains

The active substances are: azelastine hydrochloride and fluticasone propionate.

Each gram of suspension contains 1000 micrograms azelastine hydrochloride and 365 micrograms fluticasone propionate.

Each actuation (0.14 g) delivers 137 micrograms azelastine hydrochloride and 50 micrograms fluticasone propionate.

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

What Dymista Nasal Spray looks like and contents of the pack

Dymista Nasal Spray is a white, homogenous suspension in an amber coloured glass bottle fitted with a spray pump, nasal plastic applicator (actuator) and a protective dust cap.

Pack size: 1 bottle with 23 g nasal spray, suspension (at least 120 actuations)

PL: 15814/1439 POM

Manufactured by MEDA Pharma GmbH & Co. KG, Benzstr. 1, 61352 Bad Homburg, Germany OR Haupt Pharma Amareg GmbH, Donaustaufer Str. 378, 93055

Regensburg, Germany.

Procured from within the EU and repackaged by the Product Licence holder: O.P.D.

Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (Ref.): 05.03.2021.

Dymista is a registered trademark of Meda AB.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

5. how to store dymista 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 outer carton after “exp”. the expiry date refers to the last day of that month.

■ Do not refrigerate or freeze.
■ Shelf life after first opening: Dispose of any unused medicine 6 months after you first 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.
■ If your medicine shows any signs of deterioration, consult your pharmacist who will tell you what to do.