125 micrograms + 50 micrograms / spray nasal spray suspension 
azelastine / fluticasone propionate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

This leaflet contains information about: 
1. What Dymista is and what it is used for 
2. What you need to know before using Dymista 
3. How to use Dymista 
4. Possible side effects 
5. How to store Dymista 
6. Contents of the packaging and other information 

1. What Dymista is and what it is used for

Dymista contains two active substances: azelastine and fluticasone propionate.

  • Azelastine belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine which are formed during an allergic reaction. Azelastine thereby reduces the symptoms of allergic rhinitis ( rhinitis ).
  • Fluticasone propionate belongs to a group of medicines called corticosteroids(which in everyday speech are called cortisone ) which reduce inflammation.

Dymista is used in adults over 18 years of age to relieve symptoms of moderate to severe allergic rhinitis if the use of either nasal spray with antihistamine or corticosteroid alone is not sufficient.

Allergic rhinitis is caused by e.g. pollen (hay fever), house mites, mold, dust, or pets.

Dymista relieves allergy symptoms, e.g. runny/dripping nose, sneezing, itchy nose, and/or nasal congestion.

Azelastine and fluticasone propionate contained in Dymista may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Dymista

Do not use Dymista

  • If you are allergic to azelastine or fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Dymista if:

  • you have recently had nose surgery
  • you have a nose infection. Infection of the nasal airways should be treated with drugs against bacteria or fungi. If you get drugs for an infection in your nose, you can continue using Dymista to treat allergies are
  • you have tuberculosis or an untreated infection
  • you have a vision change or if you have had increased eye pressure, glaucoma ( glaucoma ), and/or cataract (cataract). If this applies to you, you should check carefully when using Dymista
  • you have impaired adrenal function. Caution should be exercised when switching from treatment with corticosteroids taken by the body (eg cortisone tablets) to Dymista
  • you have serious liver disease. The risk of systemic side effects increases.

In these cases, your doctor will decide if you can use Dymista.

You must take the dose listed in section 3 below or the dose prescribed by your doctor. Treatment with higher than recommended doses of corticosteroids given by the nose can lead to impaired adrenal function, which can lead to weight loss, fatigue, muscle weakness, low blood sugar, salt cravings, joint pain, depression, and darkening of the skin. If this happens, your doctor may recommend another medicine during periods of stress or planned surgery.

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

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Dymista.

Children and young people

Please note that Dymista should only be given to children on the prescription of a doctor.

Other medicines and Dymista

Tell your doctor or pharmacist if you are taking, have recently taken, nor might take any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Dymista and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat, and medicines to treat fungal infections: ketoconazole ).

Dymista with alcohol

In very rare cases, you may experience fatigue or dizziness due to the disease itself or when using Dymista. Be aware that alcohol consumption can amplify these effects.

Pregnancy and breastfeeding

Dymista should only be used during pregnancy and breast-feeding if prescribed by a doctor. 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

Dymista has little influence on the ability to drive and use machines. In very rare cases, you may experience fatigue or dizziness due to the disease itself or when using Dymista. In these cases, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dymista contains benzalkonium chloride

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

3. How to use Dymista

It is important to use Dymista regularly to get the full effect of the treatment.

Eye contact should be avoided.

Adults from 18 years.

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

For use in the nose.

Read the following instructions carefully and only use the medicine according to the instructions.

INSTRUCTIONS FOR USE

Prepare the spray

1. Gently shake the bottle for five seconds by turning it upside down a few times. Then remove the protective cover (see figure 1).

Figure 1

Figure 1

2. The first time you use the nasal spray, you must activate the pump by spraying it in the air.

3. Activate the pump by placing one finger on each side of the spray pump and thumb against the bottom of the bottle.

4. Press down and release the pump six times until you see a fine spray cloud (see Figure 2).

5. The pump is now activated and ready for use.

Figure 2

Figure 2

6. If it has been more than seven days since you used the spray, reactivate the pump by pressing and releasing it once.

Use the spray

1. Gently shake the bottle for five seconds by turning it upside down a few times.

Then remove the protective cover (see figure 1).

2. Blow your nose to clear your nostrils.

3. Bend your head down towards your toes. Do not bend your head back.

4. Hold the bottle upright and gently insert the syringe tip into a nostril.

5. Close the other nostril with your finger, press down quickly once, and inhale through the nose at the same time (see figure 3).

6. Exhale through your mouth.

Figure 3

Figure 3

7. Repeat in the other nostril.

8. Inhale gently and do not bend your head back after spraying. This prevents the drug from flowing down the throat and gives an unpleasant taste (see Figure 4).

Figure 4

Figure 4

9. Wipe the spray tip with a clean handkerchief after each use. Then replace the protective cover.

10. Do not poke with a needle or other sharp object in the spray tip if there is no spray. Clean the spray tip with water.

Length of treatment

Treatment should last as long as you are exposed to the allergen (what you are allergic to). If you have not improved after 14 days of regular use, consult a doctor.

Also, consult a doctor if the medicine needs to be used daily for more than 3 months.

Feel free to try to end the treatment if you think that the pollen season for you is over or

if there are very low levels of pollen in the air.

Please note that Dymista should only be given to children on the prescription of a doctor.

If you use more Dymista then you should  

You are not likely to have any problems if you spray too much medicine in your nose. If you are concerned, or if you have used a higher dose than recommended for a long period of time, consult a doctor. If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or poison information center for risk assessment and advice.

If you forget to use Dymista

Take the 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

It is important to use Dymista regularly to get the full effect of the treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Very common  (affects more than 1 user in 10):

  • Nasal blood

Common (affects more than 1 user in 100):

  • Headache
  • A bitter taste in the mouth, especially if you bend your head back when using the nasal spray. This should disappear if you drink something a few minutes after using the medicine
  • Unpleasant odor of the drug

Uncommon (affects less than 1 user in 100):

  • Slight irritation on the inside of the nose. This can lead to slight burning, itching or sneezing
  • Dry nose and throat, throat irritation and cough

Rare (affects less than 1 user in 1,000): 

  • Dry mouth

Very rare (affects less than 1 user in 10,000):

  • Dizziness or drowsiness
  • Glaucoma ( glaucoma ), cataract (cataract) or increased pressure in the eye that can lead to vision loss and / or red and painful eyes. These side effects have been reported after long-term treatment with fluticasone propionate nasal spray.
  • Damage to the skin and mucous membranes of the nose
  • Feeling sick, tired, exhausted or weak
  • Rash, itching or hives
  • Bronchospasm (spasm of the trachea)

Seek medical attention immediately if you experience any of the following symptoms:

  • Swelling of the face, lips, tongue or throat that can lead to difficulty swallowing / breathing and sudden skin rash. This may be a sign of a severe allergic reaction . Note! This is very rare.

Has been reported (occurs in an unknown number of users):

  • Dimsyn
  • Sores in the nose

Side effects that affect the whole body can occur if this medicine is used in high doses for a long time. These effects are much less likely if you use a corticosteroid as a nasal spray than if you take corticosteroids as tablets. These effects may vary in individual patients and between different corticosteroid medicinal products (see section 2).

Corticosteroids taken by the nose can affect the normal production of hormones in the body, especially if you use high doses for a long time. In children and adolescents, this side effect can lead to them growing more slowly than others.

In rare cases, decreased bone density ( osteoporosis ) has been observed if corticosteroids taken through the nose have been used for a long time.

5. How to store Dymista

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 outer carton after “EXP. dat ”or“ EXP ”. The expiration date is the last day of the specified month.

Store in a cold place.

Shelf life after first opening: Use within 6 months, then discard the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are: azelastine and fluticasone propionate.

Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride equivalent to 913 micrograms of azelastine and 365 micrograms of fluticasone propionate.

Each spray (0.14 grams) gives 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.

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

What the medicine looks like and contents of the pack

Dymista is a white, homogeneous solution.

Dymista is delivered in a colored glass bottle with a spray pump, an applicator and a protective cap.

The 25 ml bottle contains 23 grams of nasal spray, suspension (at least 120 sprays).

Dymista is available in:

Packs of 1 bottle with 23 grams of nasal spray, suspension

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Tel. 08- 630 19 00

Email: Info@meda.se

Manufacturer

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

D-61352 Bad Homburg

Germany

Muhammad Nadeem

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