Azelast Plus 125 / 50 mcg 

Trade Name:

Azelast Plus 125 / 50 mcg 

Nasal Spray  

25 ml

Composition:

Azelastine 125 mcg

Fluticasone propionate 50 mcg

Properties:

Azelast Plus contains 2 active substances. Azelastine is an antihistamine that works by blocking certain natural substances called histamines that are responsible for allergic symptoms. 

Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

Indications:

Seasonal allergy symptoms of the nose such as stuffy/runny nose, itching, sneezing and post-nasal drip. 

Directions for use:

• Gently blow your nose before using this product. Shake the container before using. 
• Use this medication in the nose as directed by your doctor, usually twice a day in both nostrils. 
• Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.
• Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
• Clean the applicator regularly. Keep track of the number of sprays used from the container. Discard the container after you have used the number of sprays specified on the manufacturer’s package.
• You may feel the product start to work as soon as 30 minutes after the first dose, but it may take several days before you get the full benefit of this product.

Side Effects:

-Drowsiness, nasal dryness/irritation, mild nosebleeds, or a change in the sense of taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

-Tell your doctor right away if you have any serious side effects, including: severe nosebleeds, pain in your nose, a whistling sound when you breathe, eye pain, signs of infection (such as sore throat that doesn’t go away, white patches in your nose/back of your throat, fever, chills).

-Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

-A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

-This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Warnings and precautions:

• Do not spray it in your eyes or mouth. If this medication gets in your eyes, rinse them thoroughly with water.
• Before using this product, tell your doctor or pharmacist if you are allergic to azelastine or fluticasone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
• Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent nose problems (such as injury, ulcers, surgery), current/past infections (including tuberculosis, herpes eye infection), certain eye problems (glaucoma, cataracts).
• This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
• Avoid contact with people who have infections that may spread to others (such as chickenpox, measles). Consult your doctor if you have been exposed to an infection or for more details.
• Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.
• Though it is unlikely, this medication may temporarily slow down a child’s growth if used for a long time. See the doctor regularly so your child’s height can be checked.
• During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
• It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
• Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. •Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
• Some products that may interact with this drug include: HIV protease inhibitors (such as lopinavir, ritonavir).
• Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).
• Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
• If you use this medication for a long time, lab and/or medical tests (such as nose exams, height measurement in children) may be done while you are using this medication. Keep all medical and lab appointments.
• Ask your doctor for ways to reduce your exposure to substances (such as pollen, pet dander, dust mites, mold, smoke) that can worsen allergy symptoms.
• If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage:

Store the container upright at room temperature away from light.

Package:

Carton box holds the container 25 ml with the spray cap and paper instructions.