Ryaltris Mono Nasal Spray 120 Metered Doses (18.0 G)

RYALTRIS MONO NASAL SPRAY 120 METERED DOSES (18.0 G) by GLENMARK PHARMACEUTICALS LTD.

Name: Ryaltris-Mono Nasal Spray (Brand Name)

Composition: Mometasone Furoate (0.05% w/w, typically delivering 50 micrograms per spray).

Uses: Ryaltris-Mono Nasal Spray is a corticosteroid medication primarily prescribed to prevent and treat symptoms associated with seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including sneezing, runny nose, nasal congestion, and itching. It is also used in adults for the management of nasal polyps.

Dosage and Administration:

• Ryaltris-Mono Nasal Spray should be used as advised by a healthcare professional.
• For allergic rhinitis, it is recommended for children aged 3 years and above. For nasal polyps, it is used in adults aged 18 years and above.
• Before initial use, prime the pump by releasing 6 sprays into the air until a fine mist appears. If the spray has not been used for 14 or more days, re-prime with 2 sprays.
• Shake the bottle well before each use.
• Gently blow your nose to clear nostrils. Close one nostril, insert the spray tip into the other, and sniff gently while pressing down on the pump. Repeat for the other nostril. Avoid spraying into the eyes or mouth.
• Discard the bottle after 120 sprays or two months after first opening, whichever comes first, even if some medicine remains.

Side Effects:

• Common: Nasal irritation, sore throat, nosebleeds (epistaxis), headache, unpleasant taste, upper respiratory tract infection, viral infection, vomiting, and wheezing.
• Serious (less common): Fungal infection in the nose/throat (Candida), slow wound healing, nasal septal perforation (a hole in the wall between the nostrils), eye problems such as glaucoma or cataracts, and allergic reactions (e.g., wheezing, rash, swelling of face/mouth/tongue). Immune system problems and adrenal suppression may also occur.

Precautions:

• Do not use if allergic to Mometasone Furoate or any other ingredients.
• Inform your doctor if you have a current infection, injury, or have had recent nasal surgery, as corticosteroids can delay wound healing.
• Regular eye examinations are recommended due to the risk of glaucoma or cataracts with corticosteroid use.
• Use with caution if you have a lower resistance to infection or have been exposed to diseases like measles or chickenpox.
• Growth in children should be monitored regularly during long-term use.
• Consult a doctor if pregnant or breastfeeding.
• Avoid concomitant use with other corticosteroids, ritonavir, or cobicistat without consulting your doctor.
• Do not share the nasal spray bottle with others.

Storage:

• Store Ryaltris-Mono Nasal Spray upright with the dust cap on, at room temperature (between 20°C and 25°C).
• Do not freeze or refrigerate.
• Keep out of the sight and reach of children.

Here are frequently asked questions about RYALTRIS MONO NASAL SPRAY, along with concise, accurate answers.

What is RYALTRIS MONO NASAL SPRAY used for?

RYALTRIS MONO NASAL SPRAY is used for the symptomatic treatment of seasonal or perennial allergic rhinitis and its associated eye symptoms in adults and children aged 6 years and older. It helps relieve symptoms such as stuffy nose, runny nose, itchy nose, sneezing, and watery, itchy, or red eyes. It can also be used for the treatment of nasal polyps.

How does RYALTRIS MONO NASAL SPRAY work?

RYALTRIS is a combination nasal spray containing two active ingredients: olopatadine hydrochloride and mometasone furoate. Olopatadine is an antihistamine that blocks histamine, a natural chemical in the body responsible for allergy symptoms. Mometasone furoate is a corticosteroid that reduces inflammation in the nasal passages, thereby easing allergy symptoms and inflammation. These two ingredients work together to provide synergistic relief. Relief from nasal allergic symptoms can be observed within 10 minutes of administration, but the full effect relies on regular use.

What is the usual dosage for RYALTRIS MONO NASAL SPRAY?

For adults and adolescents 12 years of age and older, the recommended dose is two sprays in each nostril twice daily (morning and evening). For children aged 6 to 11 years, the recommended dose is one spray in each nostril twice daily (morning and evening). RYALTRIS is not recommended for children under 6 years of age. Always shake the bottle well before each use.

How should I use RYALTRIS MONO NASAL SPRAY?

Before the first use, or if the spray has not been used for 14 days or more, you will need to prime the pump by releasing a few sprays into the air until a fine mist appears (6 sprays initially, 2 sprays if re-priming). Gently blow your nose to clear your nostrils. Hold one nostril closed, insert the spray tip into the other nostril, aiming slightly away from the nasal septum (the wall between your nostrils). Press down firmly to activate the pump while gently inhaling through your nose. After spraying, avoid blowing your nose for at least 15 minutes to allow the medicine to work.

What are the possible side effects of RYALTRIS MONO NASAL SPRAY?

Common side effects may include an unpleasant taste, nosebleeds, nasal discomfort, nasal irritation, sore throat, or headache. More serious, though less common, side effects can include sores or crusting in the nose, a hole in the cartilage between your nostrils (nasal septal perforation) which may cause a whistling sound when breathing, slow wound healing, or a fungal infection (thrush) in your nose or throat. Eye problems such as glaucoma or cataracts, increased risk of infections, and, rarely, problems with adrenal gland function can also occur with prolonged use. This medication can also cause sleepiness or drowsiness. In children, there is a potential for slowed or delayed growth, so regular growth monitoring is advised.

Is RYALTRIS MONO NASAL SPRAY safe during pregnancy or breastfeeding?

If you are pregnant or plan to become pregnant, consult your healthcare provider. It is not known if RYALTRIS will harm an unborn baby. While one of its components, mometasone, has limited evidence of harm in human pregnancy, animal studies have shown adverse effects at high doses. There is less available safety data for olopatadine during pregnancy.

If you are breastfeeding or plan to breastfeed, discuss this with your healthcare provider. It is not known if RYALTRIS passes into breast milk. Breastfeeding is generally not recommended during treatment with this medicine.

Can RYALTRIS MONO NASAL SPRAY be taken with other medications?

You should avoid consuming alcohol or taking other central nervous system depressants while using RYALTRIS, as this can increase the risk of drowsiness and impaired mental alertness. Certain medications, such as some antifungals (e.g., ketoconazole, itraconazole), antibiotics (e.g., clarithromycin), and HIV medicines (e.g., ritonavir, cobicistat-containing products), can affect the metabolism of mometasone, potentially increasing its levels in the body and the risk of side effects. Always inform your healthcare provider about all prescription, over-the-counter, vitamin, and herbal supplements you are taking.

What precautions should be taken while using RYALTRIS MONO NASAL SPRAY?

Use RYALTRIS only as directed for nasal use and avoid spraying it into your eyes or mouth. Due to the potential for drowsiness, do not drive or operate machinery until you know how this medication affects you. Inform your doctor if you have any existing medical conditions such as tuberculosis, recurrent nosebleeds, a severe nose infection (especially fungal), herpes infection, sores in your nose, recent nasal injury or surgery, or eye problems like cataracts or glaucoma. Regular eye exams may be recommended for individuals with a history of eye pressure issues. Corticosteroids can impair wound healing, so avoid using the spray until your nose has healed if you have any nasal sores, injury, or have had recent nasal surgery.

What happens if a dose of RYALTRIS MONO NASAL SPRAY is missed?

If you miss a dose, take your next dose when it is regularly due. Do not take a double or extra dose to compensate for the missed one.

How should RYALTRIS MONO NASAL SPRAY be stored?

Store RYALTRIS MONO NASAL SPRAY upright with the dust cap on, at room temperature between 68°F and 77°F (20°C and 25°C). Do not freeze or refrigerate the medication. Keep it in a cool, dry place and out of reach of children. The bottle should be discarded after the labeled number of sprays has been used or within two months after the first opening, whichever comes first.