Dymista

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Dymista. If you are concerned about side effects, discuss the risks and benefits of Dymista with your doctor.

The following side effects have been reported by at least 1% of people taking Dymista. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• change in sense of taste or smell
• crusting in the nose
• drowsiness
• dry or soreness inside the nose
• headache
• nose bleeds
• runny nose
• symptoms of upper respiratory tract infection (e.g., sore throat, Fever, cough, stuffy nose, chills, feeling tired)
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bone or joint pain
• signs of nasal ulcers (pain, burning or irritation)
• signs of too much corticosteroid (e.g., rapid weight gain, sweating, thinning skin, dry skin, muscle weakness)
• slowed growth (in adolescents)
• symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)
• symptoms of Cataracts (e.g., visual glare, reduced vision)
• symptoms of nasal perforation (constant whistling sound when you breathe from your nose)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Dymista.

Each metered spray/actuation of white, homogeneous, redispersible suspension intended for intranasal administration delivers an average volume of 0.137 mL containing 137 µg of azelastine hydrochloride and 50 µg of fluticasone propionate. Nonmedicinal ingredients: disodium edetate, glycerol, microcrystalline cellulose, carmellose sodium, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

Do not use Dymista if you:

• are allergic to fluticasone, azelastine or any ingredients of the medication
• have an untreated infection of the respiratory tract (fungal, bacterial or Tuberculosis infection)

There may be an interaction between fluticasone-azelastine and any of the following:

• aclidinium
• alcohol
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• atropine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• Benztropine
• brimonidine
• Buspirone
• chloral hydrate
• clarithromycin
• Clonidine
• Cobicistat
• conivaptan
• Desmopressin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• ipratropium
• ketotifen
• Mirtazapine
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nefazodone
• seizure medications (e.g., Carbamazepine, Clobazam, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• tolcapone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Tramadol
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Dymista. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Dymista.

Drowsiness/reduced alertness: The antihistamine, azelastine, in Dymista may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Dymista affects you.

Growth in adolescents: Corticosteroids such as the fluticasone in Dymista may slow down the growth of adolescents. Your doctor will monitor for this. Talk to your doctor if you have any concerns.

Infection: Corticosteroids such as the fluticasone in Dymista can mask the signs of infection. You can also develop other infections such as a fungal throat infection or eye infection. Talk to your doctor as soon as possible if you develop any new symptoms.

Infections such as Chickenpox and Measles can be more serious in people taking medications such as fluticasone. If you are exposed to someone who has chickenpox or measles, contact your doctor.

Liver function: Liver disease or reduced liver function may cause Dymista to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Dymista may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Dymista, and whether any special monitoring is needed.

Vision problems: Corticosteroids such as fluticasone may cause Glaucoma or cataracts. Report any vision changes to your doctor immediately.

Wound healing: Corticosteroids such as fluticasone can impair the ability of wounds to heal. If you have ulcers in your nose, have had nasal surgery, or have had nasal trauma, talk to your doctor about how Dymista will affect these conditions. Your doctor may recommend waiting until wounds have completely healed.

Pregnancy: Dymista should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Dymista, contact your doctor immediately.

Breast-feeding: Fluticasone passes into breast milk. It is not known if azelastine passes into breast milk. If you are a breast-feeding mother and are taking Dymista, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Dymista have not been established for children less than 12 years of age.