DYMISTA 137 MICROGRAMS/50 MICROGRAMS Назальный спрей, суспензия

Содержание инструкции

1. Dymista
   1. What is Dymista and what is it 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. Package contents and other information

Dymista

137 micrograms/50 micrograms per actuation
Nasal spray, suspension
Azelastine hydrochloride / fluticasone propionate

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Dymista is and what it is used for
• 2. What you need to know before you use Dymista
• 3. How to use Dymista
• 4. Possible side effects
• 5. How to store Dymista
• 6. Contents of the pack and other information

1. What is Dymista and what is it used for

Dymista contains two active ingredients: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to the pharmacotherapeutic category of antihistamines. Antihistamines work by blocking the effects of substances such as histamine, which the body produces following an allergic reaction, thereby reducing the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to the pharmacotherapeutic category of corticosteroids, which reduce inflammation.

Dymista is used to relieve the symptoms of seasonal and perennial allergic rhinitis, from moderate to severe,
when the use of antihistamine alone or corticosteroid alone via the intranasal route is not considered
sufficient.
Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), dust mites, molds, dust or pets.
Dymista relieves allergy symptoms, such as excessive nasal mucus production, runny
nose, sneezing, itchy nose or stuffy nose.

2. What you need to know before using Dymista

Do not use Dymista:

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

Warnings and precautions
Talk to your doctor or pharmacist before using Dymista:

• if you have recently had nasal surgery
• if you have had a nasal infection. Nasal airway infections must be treated with an antibacterial or antifungal medicine. If you have been given a medicine for a nasal infection, you can continue to use Dymista to treat your allergies
• if you have tuberculosis or an untreated infection
• if you have had vision disorders or a history of increased eye pressure, glaucoma and/or cataracts. If you have these conditions, you will be carefully monitored during the use of Dymista
• if you suffer from adrenal insufficiency. Extreme caution is required when switching from systemic corticosteroid treatment to Dymista
• if you suffer from a severe liver disease. Your risk of experiencing undesirable systemic effects is greater.

In these cases, your doctor will decide whether or not you can use Dymista.
It is important that you take your dose, as indicated in the following section 3 or
as recommended by your doctor. Treatment with doses of inhaled corticosteroids higher than those
recommended can cause adrenal suppression, a condition that can cause weight loss, fatigue, muscle weakness, reduced blood sugar levels, craving for
salty foods, joint pain, depression and darkening of the skin. If these conditions occur, your doctor may recommend another medicine during periods of
stress or in case of elective surgery.
To avoid adrenal suppression, your doctor will advise you to take the lowest dose that can
effectively control your rhinitis symptoms.
If taken for long periods, inhaled corticosteroids (such as Dymista) can cause a
slowing of growth in children and adolescents. Your doctor will regularly check your child's height and ensure that they take the lowest effective dose possible.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are not sure whether the conditions mentioned above apply to you, talk to your doctor or
pharmacist before using Dymista.

Children
The use of this medicine is not recommended in children under 12 years of age.

Other medicines and Dymista
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 can increase the effects of Dymista and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the

treatment of HIV: ritonavir, cobicistat and medicines for the treatment of fungal infections:
ketoconazole).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking Dymista.

Driving and using machines
Dymista negligibly alters the ability to drive vehicles and operate machines.
Very rarely, fatigue or dizziness may occur due to the disease itself or
the use of Dymista. In these cases, avoid driving or operating machinery. You should be aware that consuming alcohol can increase these effects.

Dymista contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per actuation, equivalent to

• 0.014 mg/0.14 g. Benzalkonium chloride can cause irritation and swelling inside the nose, especially if used for long periods. Ask your doctor or pharmacist for advice if you feel unwell while using the spray.

3. How to use Dymista

Use Dymista always following exactly the instructions of your doctor. If you have any doubts consult your doctor or the
pharmacist.
It is essential to use Dymista regularly, to obtain the full therapeutic benefit.
Avoid contact with the eyes.

Adults and adolescents (from 12 years of age)

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

Use in children under 12 years of age

• The use of this medicine is not recommended in children under 12 years of age.

Use in patients with renal and hepatic impairment

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

Method of administration
For inhalation use.
Read what is reported in this leaflet and follow the instructions.

INSTRUCTIONS FOR USE
Preparation of the spray

• 1. Gently shake the bottle for 5 seconds, tilting it up and down, then remove the protective cap (see figure 1).

Figure 1

• 2. The first time you use the nasal spray, you must prime the pump by spraying the product into the air.
• 3. Prime the pump by placing two fingers on both sides of the spray pump and place your thumb on the base of the bottle.
• 4. Press down and release the pump 6 times, until a fine mist comes out (see figure 2).
• 5. Now the pump is primed and ready for use.

Figure 2

• 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 and releasing the pump itself.

Using the spray

• 1. Gently shake the bottle for about 5 seconds, tilting it up and down 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 feet. Do not tilt your head back.
• 4. Hold the bottle upright and gently insert the tip of the spray into one nostril.
• 5. Close the other nostril with one finger, press down quickly once and, at the same time, gently inhale (see figure 3).
• 6. Exhale through your mouth.

Figure 3

• 7. Repeat the same procedure for the other nostril.
• 8. Gently inhale without tilting your head back after spraying. This will prevent the medicine from going down your throat, causing you to taste an unpleasant flavor (see figure 4).

Figure 4

• 9. After each use, wipe the tip of the spray with a tissue or a clean cloth and then reinsert the protective cap.
• 10. Do not puncture the nozzle if you do not get the spray. Clean the tip of the spray with water.

It is important that you take your dose as recommended by your doctor. Use only the amount recommended
by your doctor.

Duration of treatment
Dymista is indicated for long-term use. The duration of treatment should correspond to the
period in which the symptoms of allergy manifest.

If you use more Dymista than you should
If you spray an excessive dose of this medicine into your nose, it is unlikely that you will have any
problems. If you are concerned or if you have used higher doses than recommended for a long period,
contact your doctor. In case of accidental ingestion of Dymista, especially by a child,
contact your doctor or the nearest hospital emergency room as soon as possible.

If you forget to use Dymista
Use the nasal spray as soon as you remember, then take the next dose as usual. Do not
take a double dose to make up for a missed dose.

If you stop using Dymista
Do not stop using Dymista without asking your doctor, as this puts the
success of the treatment at risk.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• nosebleeds

Common side effects(may affect up to 1 in 10 people):

• headache
• bitter taste in the mouth, especially if you tilt your head back when using the nasal spray. It should disappear quickly if you sip a non-alcoholic beverage for a few minutes after using this medicine
• unpleasant smell

Uncommon side effects(may affect up to 1 in 100 people):

• mild irritation of the inside of the nose. This can cause a slight burning, itching or sneezing
• nasal dryness, cough, dry throat or throat irritation

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

• dry mouth

Very rare side effects(may affect up to 1 in 10,000 people):

• dizziness or drowsiness
• cataract, glaucoma or increased pressure in the eye, resulting in loss of vision and/or red and painful eyes. These side effects have been reported after prolonged treatment with fluticasone propionate-based nasal sprays.
• damage to the skin and mucous membrane of the nose
• feeling of nausea, fatigue, tiredness or weakness
• skin rash, itching or redness of the skin, raised itchy welts
• bronchospasm (narrowing of the airways in the lungs)

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

• blurred vision
• nasal ulcers

Seek immediate medical attention if you notice any of the following symptoms:

• swelling of the face, lips, tongue or throat, which can cause difficulty swallowing/breathingand sudden onset of skin rash.These may be signs of a serious allergic reaction. Note: This is very rare.

It is possible that systemic side effects (side effects involving the whole
body) may occur when this medicine is used at high doses for a long period. These effects
may vary in individual patients and between different corticosteroid preparations (see
section 2).
These effects are much less likely to occur if you use a corticosteroid nasal spray, compared to taking corticosteroids by mouth.
Nasal corticosteroids can affect the normal production of hormones in the body, in
particular if you use high doses for a long period. In children and adolescents, this side
effect can cause a slowing of growth.
In rare cases, a decrease in bone density (osteoporosis) has been observed when inhaled corticosteroids
have been administered for a long period .

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at
http://www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety
of this medicine.

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 that is stated on the label of the bottle and on the
pack 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 the first
opening of the nasal spray.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dymista contains
The active ingredients are: azelastine hydrochloride and fluticasone propionate.
Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride and 365
micrograms of fluticasone propionate.
Each actuation (0.14 g) delivers 137 micrograms of azelastine hydrochloride (= 125
micrograms of azelastine) and 50 micrograms of fluticasone propionate.
The other ingredients are: disodium edetate, glycerol, microcrystalline cellulose, sodium carboxymethylcellulose, polysorbate 80, benzalkonium chloride solution, phenyl ethyl alcohol and purified water.

Description of Dymista and package contents
Dymista is a white, homogeneous suspension.
Dymista is supplied in an amber glass bottle with a spray pump, an
applicator and a protective cap.
The 10 ml bottle contains 6.4 g of nasal spray, suspension (at least 28 actuations). The
25 ml bottle contains 23 g of nasal spray, suspension (at least 120 actuations).
Dymista is available in:
packs containing 1 bottle with 6.4 g of nasal spray, suspension
packs containing 1 bottle with 23 g of nasal spray, suspension
multipacks comprising 10 bottles, each containing 6.4 g of nasal spray,
suspension
multipacks comprising 3 bottles, each containing 23 g of nasal spray, suspension
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN, Ireland

Manufacturer
MEDA Pharma GmbH & Co. KG
Benzstraße 1,
D-61352 Bad Homburg,
Germany
Mylan Hungary Kft
H-2900 Komárom,
Mylan utca 1,
Hungary
Haupt Pharma Amareg GmbH
Donaustaufer Str. 378, 93055 Regensburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations: