Product features

● Mometasone furoate monohydrate relieves nasal congestion and inflammation, clearing a stuffy nose.
● A spray that dispenses a set amount of liquid medication.

Precautions

■ When not to use the product
(If you do not follow these instructions, the current symptoms may worsen or adverse reactions are more likely to occur. )
1. This product should not be used in the following persons:
　(1) Those who have experienced allergic symptoms to this medication or any of its ingredients.
　(2) Children under 15 years old.
　(3) Pregnant women or women suspected of being pregnant.
　(4) Patients who have nasal suppuration (accumulation of pus accompanied by pain and swelling) , ulcers, or injuries in the nasal cavity. Patients who have had nasal surgery that has not yet fully healed.
　(5) Those who have been diagnosed with the following:
　Systemic mycoses, tuberculous disease, infections, herpes simplex in the eyes, recurrent nosebleeds
　(6) Patients who have used steroid nasal drops for more than 3 months within the past year.
2. Do not use this medicine for more than 3months within a year including period when other steroid nasal drops were used.
(If you need to use this medicine for more than 3months, consult an otolaryngologist, as this may be due to another illness.)
3. Do not use this medicine with other steroid nasal drops. However, if your doctor prescribes them, follow the instructions.
■ Consultation
1. The following persons should contact a physician, or pharmacist for a consultation before use.
　(1) Patients undergoing medical treatment from a physician.
　(2) Nursing women.
　(3) The elderly.
　(4) Patients who have experienced allergic symptoms associated with drugs, etc.
　(5) Persons with the following symptoms:
　Pain in the head, forehead, cheeks, etc., yellow or green nasal discharge (infectious sinusitis), a heaviness around the nose, a small amount of mucus or yellow/green nasal discharge (hypertrophic rhinitis), stuffy nose, nasal voice, a foreign body sensation in the back of the nose, etc. (nasal polyps)
　(6) Patients undergoing allergy treatment such as desensitization therapy.
　(7) Patients undergoing long-term or high-dose systemic steroid therapy.
　(8) Persons who cannot assure the reason of their symptoms as seasonal allergy.
2. If the following symptoms are observed after using this medicine, these may be adverse reactions, so immediately discontinue the use, and show this document to your physician, or pharmacist for a consultation.
　[Related parts: Symptoms]
　○ Nose: irritation, itchiness, dryness, pain, redness, discomfort, nosebleed, runny nose, stuffy nose, sneezing, olfactory disturbance, scabs inside the nose, heat sensation
　○ Throat: irritation, pain, discomfort, dryness, swelling
　○ Skin: rash
　○ Neuropsychiatric system: headache, malaise
　○ Respiratory system: cough
　○ Other: taste disturbance
　Nosebleeds can also occur when you blow your nose too hard, but if you experience frequent nosebleeds or scabs form inside your nose, this may progress to a nasal septum perforation, so stop using the product immediately and consult a doctor.
　◇ Nasal septum perforation: A condition in which a hole appears in the wall inside the nose that separates the left and right nasal cavities.
　The following serious symptoms may occur in rare cases. In such cases, immediately seek medical aid.
　[Symptom name: Symptoms]
　○ Shock (anaphylaxis): Symptoms, such as itching of skin, urticaria, hoarseness, sneezing, itchy throat, breathing difficulties, palpitations, and clouding of consciousness may occur immediately after use.
3. If you experience any of the following symptoms after using this medicine: pain in the head, forehead, cheeks, etc., or a yellow or green nasal discharge, discontinue use immediately and consult a doctor or pharmacist with this leaflet (other illnesses may be occurring at the same time).
4. When symptoms do not improve even after using this medicine for about 1 week, stop taking this medicine and consult a physician, or pharmacist being sure to take this instruction leaflet with you.

Indication

Relief of the following symptoms including seasonal allergy caused by pollens: nasal congestion, runny nose, sneezing.

Caution regarding efficacy

Dosage and administration

Spray the following amount into each nostril.
[Age: Amount per use: Number of uses per day]
Adults (15 years and older: 2 sprays into each nostril): 1 time a day
Under 15 years of age: Do not use.
● Do not use this medicine for more than 3 months per year.

Precautions of Dosage and Administration

[1] This medicine contains mometasone furoate hydrate (a steroid). Excessive or improper use may increase the risk of side effects. Strictly follow the prescribed dosage and administration.
[2] The medicine should be used only for nasal application.
[3] If you feel any taste when using this medicine, rinse your mouth.

Ingredient and amount

In 100g
Mometasone furoate hydrate 52 mg (50 mg as mometasone furoate)

Caution regarding ingredient amounts

Additive

Benzalkonium chloride solution, Polysorbate 80, Crystalline cellulose, Sodium carmellose, Concentrated glycerin, pH adjuster

Precautions for storage and handling

[1] Store with the cap in a cool, low humidity place away from direct sunlight.
[2] Keep out of reach of children.
[3] Do not transfer the medicine to a different container. (It may lead to misuse or alter the quality of the drug. )
[4] Do not share with others.
[5] Do not use the product after its expiration date. Use as soon after opening as possible even if the expiration date is away.

Customer Service Center

For inquiries about this product, please contact the store where you purchased it or the following:
Customer Service Center [Sato Pharmaceutical Co., Ltd. ]
Tel: 03-5412-7393 Reception hours: 9:00-17:00 (excluding Saturdays, Sundays, and holidays)
Telephone inquiries are only available in Japanese as a language.

How to use

[1] Blow your nose before use to clear the nasal passages.
[2] Before use, shake the container well up and down then pull the cap straight up. (Do not twist the cap.)
[3] Hold the container firmly. (When using for the first time, prime the spray by pressing it about 10 times until a fine mist is released .)
[4] Tilt your head slightly forward, insert the tip of the nozzle into your nostrils and spray once into each nostril.
[5] Breathe in through your nose and out through your mouth so that the medicine reaches the back of your nasal cavity.
[6] Again, spray once into each nostril.
[7] Breathe in through your nose and out through your mouth so that the medicine reaches the back of your nasal cavity.
[8] After using the spray, wipe the nozzle to keep it clean and replace the cap.

Notes on use

[1] Before use, shake the container well up and down then pull the cap straight up.
[2] Be aware that medicine may become contaminated should the tip of the container come into contact with nasal discharge.
[3] Insert the nozzle so it is straight and not facing the nasal septum when spraying.
Those who are right-handed must beware of pointing the nozzle toward the right septum,
and those who are left-handed must beware of pointing it toward the left septum.
*Nasal septum: the wall separating the nasal cavities within the nostrils
[4] Pricking the nozzle with a needle is extremely dangerous when broken. Do not do this under any circumstances.

Manufacturing and sales company

Sato Pharmaceutical Co., Ltd.
1-5-27 Motoakasaka, Minato-ku, Tokyo

Dosage form

Spray

Pharmaceutical classification

Pharmaceuticals Requiring Guidance

Version No.

1

Contact details for the Adverse Reaction Relief System

Pharmaceuticals and Medical Devices Agency
https://www.pmda.go.jp/kenkouhigai_camp/index.html
Tel: 0120-149-931 (toll-free)