DYMISTA nasal spray 13750 mcg. 23 g
DYMISTA nasal spray 137/50 mcg. 23 g
What Dymista and what it is used
Dymista nasal spray contains two active ingredients: azelastinov fluticasone propionate hydrochloride .
Azelastinov hydrochloride belongs to a group of medicines called antihistamines . Antihistamines act to prevent the effects of substances such as histamine , which is separated in the body, as part of an allergic reaction, and thus , the symptoms of allergic rhinitis.
Fluticasone propionate belongs to a class of drugs known as corticosteroids, which reduce inflammation .
Dymista Nasal Spray is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis alone when using glucocorticoid or antihistamine nasal is not enough.
Seasonal and perennial allergic rhinitis, allergic reactions to substances such as pollen (hay fever) , house dust mites , molds , dust or pets .
Nasal spray Dimista relieve allergy symptoms such as runny nose , drip of mucus in the nasal passage , sneezing and itchy or stuffy nose .
2 . What you should know before using Dymista
Do not use Dymista :
if you are allergic to azelastinov hydrochloride and 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 :
if you have had recent surgery of the nose ;
if you have an infection in the nose. The infections of the nose should be treated with an antibacterial or antifungal drug . If you have a medicine for infection of the nose , you can continue to use the nasal spray Dimista for treating allergies;
if you suffer from tuberculosis or untreated infection;
if you have any change in vision or a history of increased intraocular pressure, glaucoma and / or cataracts. If this applies to you , you will be closely monitored while using the nasal spray Dimista ;
if you suffer from impaired adrenal function . You need to be especially careful when changing from systemic steroids to treat nasal spray Dymista ;
if you suffer from severe liver disease. The risk of systemic side effects is increased.
In these cases, your doctor will decide whether you can use nasal spray Dimista .
It is important to take the dose as indicated in paragraph 3 below or as your doctor prescribes . Treatment with corticosteroid nasal doses higher than recommended may lead to suppression of adrenal function , a condition leading to weight loss , fatigue, muscle weakness, low blood sugar, desire for salt intake , pain joints, depression and darkening of the skin. If this happens , your doctor may recommend another medication for periods of stress or surgery .
To avoid suppression of adrenal function , your doctor will advise you to take the lowest dose that provides maintenance of effective control of symptoms of rhinitis.
Prolonged corticosteroid nasal ( as Dimista ) can cause stunted growth in children and adolescents. The doctor will regularly check your child's growth and ensure that it accepts the lowest possible effective dose.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using nasal spray Dimista .
This medicine is not recommended for children under 12 years.
Other medicines and Dymista
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.
Tell your doctor or pharmacist :
if you are taking medicines to treat HIV, such as ritonavir ;
if you are taking medicines to treat fungal infections such as ketoconazole.
Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant, or ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Nasal spray Dimista has negligible effect on the ability to drive and use machines.
Very rarely , you may experience fatigue or dizziness due to the disease itself or the use of nasal spray Dimista . Do not drive or operate machines in these cases. Keep in mind that alcohol consumption may increase these effects.
Dymista contains benzalkonium chloride
The substance may cause irritation of the nose and bronchospasm . Tell your doctor or pharmacist if you experience discomfort when using the spray.
3 . How to use Dymista
Always use this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
It is important to use a regular nasal spray Dimista to get the full therapeutic effect.
Avoid contact with eyes.
Use in adults and adolescents ( over 12 years):
The recommended dose is one spray in 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 or hepatic impairment:
There are no data in patients with severe renal or hepatic impairment.
Method of administration
For nasal administration .
Read carefully the instructions below and use according to directions .
INSTRUCTIONS FOR USE
Getting the drift
1. Shake the bottle gently for 5 seconds by tilting up and down , and then remove the protective cap .
2 . The first time you use the nasal spray must prepare bulb by spraying into the air.
3 . Prepare bulb by placing two fingers on either side and thumb on the bottom of the vial.
4 . Press down and release the bulb 6 times until fine spray.
5 . Bulb is already prepared and ready for use.
6 . If the nasal spray is not used more than 7 days , you have to prepare once the bulb by pushing down and relax .
1. Shake the bottle gently for 5 seconds as turn it up and down , then remove the cap .
2 . Blow your nose to clear your nostrils .
3 . Keep your head tilted down toward your toes. Do not tilt your head back .
4 . Hold the bottle upright and gently insert the nozzle of the spray in one nostril .
5 . Close the other nostril with your finger , press down sharply once and simultaneously smraknete slightly.
6 . Exhale through your mouth.
7 . Repeat with the other nostril .
8 . Inhale gently , do not tilt your head back after dose administration . This will stop the drug to go into the throat and cause an unpleasant taste .
9. After each use , wipe the spray tip with a paper or cloth towel and reattach the protective cap .
It is important to take the dose recommended 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 during which you have allergy symptoms .
If you take more dose Dymista
It is unlikely the injection of too much medicine in the nose lead to problems . If you have concerns or have used larger doses than recommended for a long period of time, contact your doctor. If someone , especially a child accidentally swallows Dimista nasal spray , contact your doctor or nearest emergency as quickly as possible .
If you forget to use Dymista
Use nasal spray as soon as you remember and then take your next dose at the usual time . Do not take a double dose to make up for a missed dose.
If you stop using Dymista
Do not stop using nasal spray Dimista without consulting your doctor , as this jeopardizes the success of the treatment .
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Very common side effects (affects more than 1 in 10 people):
Bleeding from the nose.
Common side effects (affects 1 in 10 people) :
Bitter taste in the mouth , especially if the use of the nasal spray tilt your head back . This should go away if you take a soft drink a few minutes after use of the drug ;
Unpleasant odor .
Uncommon side effects (affects 1 in 100 people) :
Mild irritation inside the nose. This may cause a slight burning , itching, or sneezing ;
Dry nose , cough, dry mouth or throat .
Rare side effects (affects up to 1 in 1000 people):
Dry mouth .
Very rare side effects (affects up to 1 in 10,000 people):
Dizziness or drowsiness;
Cataracts, glaucoma or increased pressure in the eye, which can lead to loss of vision and / or erythema , and pain in eyes . These side effects have been reported after prolonged treatment with nasal spray containing fluticasone propionate ;
Lesions of the skin and mucous membranes of the nose ;
Malaise , weakness , fatigue or weakness ;
Rash, itchy skin or red , itchy bumps ;
Bronchoconstriction (narrowing of the airways in the lungs) .
Seek medical attention immediately if you experience any of the following symptoms:
Swelling of the face, lips , tongue or throat, which may lead to difficulty swallowing / breathing and sudden onset of skin rash . These may be signs of a severe allergic reaction. Please note: This happens very rarely .
For use of the drug in high doses for long periods can generate systemic adverse events ( side effects affecting the whole body ) . The use of a nasal spray of corticosteroid was much less likely to occur such reactions than corticosteroid orally . These reactions differ between patients and between different corticosteroid preparations.
Topical corticosteroids can alter the normal production of hormones in the body, especially if you use high doses for long periods . In children and adolescents these side effects can cause growth retardation in comparison to their peers.
In rare cases where application of glucocorticoids for long periods , there was a reduction in bone density ( osteoporosis) .
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store Dymista
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Shelf life after first opening: Discard any unused medication 6 months after first opening the nasal spray .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Dymista
The active substances are azelastinov hydrochloride and fluticasone propionate . Each gram of the suspension contains 1, 000 micrograms azelastinov hydrochloride and 365 micrograms of fluticasone propionate .
One dose (0,14 g) contains 137 micrograms azelastinov hydrochloride ( = 125 microgram azelastine ) and 50 microgram fluticasone propionate .
The other ingredients are disodium edetate, glycerol, microcrystalline cellulose , croscarmellose sodium, polysorbate 80 , benzalkonium chloride , phenylethyl alcohol , purified water .
Dymista looks like and contents of pack
Dymista white, homogeneous suspension.
Dymista comes in glass bottles with dark , fitted with spray pump applicator and a protective cap .
Bottle with a volume of 10 ml contains 6,4 g suspension nasal spray ( at least 28 doses).
Bottle with a volume of 25 ml contains 23 g suspension nasal spray (at least 120 doses).
Dymista comes in :
packs containing 1 6,4 g nasal spray suspension;
packs containing 1 23 g nasal spray suspension;
Multipack of 10 bottles each containing 6,4 g nasal spray suspension; Multipack of 3 bottles , each containing 23 g nasal spray suspension.
Not all pack sizes may be marketed.