Caution: The following texts are translated from the Japanese original. We cannot take responsibility for ambiguity in the translation.

Designated Category 2 OTC medicine

ナザールαAR0.1%C NAZALαAR0.1%C

Product features

● Beclometasone dipropionate works to alleviate congestion and inflammation and help open up the nasal passage.
● A spray that dispenses a set amount of liquid medication. Once sprayed, the liquid does not flow back into the container, making it hygienic.
● A cool type nasal spray with a very refreshing feeling.

Indication

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

Dosage and administration

In ordinary cases, spray the following quantities into both the left and the right nasal passage.

<Age: Dosage: Doses per Day>
Adults (over 18): 1 spray each in the left and the right nasal passage: twice a day (morning/evening)
Under 18: Do not use this product

May be used up to a maximum of 4 times a day (8 sprays), but make sure to keep at least 3 hours between applications.
● Reduce applications as symptoms improve. Number of applications can be increased should symptoms worsen.
● Do not use for more than three months in a year.

Precautions of Dosage and Administration

(1) This medicine contains beclomethasone dipropionate (steroid). If you overdose or misuse the medicine, you may easily experience side effects. Strictly follow the prescribed dosing schedule.
(2) The medicine should be used only for nasal application.
(3) If you have a taste in your mouth when taking the medicine, rinse with water.

Ingredient and amount

In 100g
Beclomethasone dipropionate :0.1g

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 by the following persons
(1) Persons diagnosed as having the following
systemic mycoses, tuberculous disease ,hypertension, diabetes, recurrent bleeding from the nose, asthma, glaucoma, infection
(2) Individuals with nasal suppuration (infection of hairy roots causes pus as well as pain and swelling).
(3) Individuals who have experienced an allergic reaction to this medicine or beclomethasone dipropionate.
(4) Persons under 18 years old.
(5) Pregnant women or women suspected of being pregnant.
(6) Individuals treated with steroid nasal sprays for at least 3 months in the last year.
2.Do not use this medicine for more than 3 months within a year including the period when other steroid nasal sprays were used.
3.Do not use steroid nasal sprays after using this medicine. However, if it is prescribed by your doctor, follow his/her instructions.

■ Consultation
1.The following persons should consult with a doctor, pharmacist or registered salesperson before using this medicine.
(1) Patients undergoing medical treatment from a physician.
(2) Individuals receiving allergy treatment including hyposensitization therapy.
(3) Individuals who suffer from pain in the head, forehead or cheeks and with yellow or green nasal discharge (sinus infection).
(4) Nursing women
(5) Patients who have experienced allergic symptoms associated with drugs, etc.
(6) Individuals who cannot assure the reason of their symptoms as seasonal allergy.
(7) The elderly
(8) Individuals with hypertrophic rhinitis*1 or nasal polyps*2
*1:Heavy feelings around the nose and small amount of nasal discharge of mucous, yellow or green.
*2:Nasal congestion, nasal speech or foreign object sensation in the depth of the nose. "
(9) Individuals receiving long-term or high-dose systemic steroid therapy.

2.If the following symptoms are observed after using this drug, these may be adverse reactions, so immediately discontinue the use, and show this document to your physician, pharmacist, or registered salesperson for a consultation.
【Related parts :Symptoms 】
 Nose bleeds,scabs in the nose,irritation,itching,dry sensation,discomfort,sneezing, dysosmia,purulence(Pus is accumulated due to infection of hair roots, accompanied by pain or swelling.)
Throat: irritation, foreign body sensation, suppuration symptoms (infection causes whitish pus to accumulate in the back of the throat, with pain and swelling)
Skin:rash・redness、itching, swelling
Neuropsychiatric system: headache, dizziness
Gastrointestinal system:nausea and vomiting , diarrhea, loss of appetite
Other: onset of asthma,eye pain,blurred vision,palpitations,elevated blood pressure

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 take.

3.If pain in the head, forehead or cheek occurs, or if unusual symptoms along with yellow or green nasal discharge appear after taking this drug, immediately discontinue the use of this drug, and show this document to your physician, pharmacist, or registered salesperson for a consultation. (Other diseases may develop.)

4.When symptoms do not improve even after using the medicine about 1 week(up to 4 times (8 sprays) per day), stop taking this medicine and consult a physician, pharmacist or registered salesperson, being sure to take this instruction leaflet with you.

Additive

Cellulose, sodium carmellose sodium, propylene glycol, glycerin, polysorbate 80, benzalkonium chloride, citric acid, fragrances (including alcohol, I-menthol)

Precautions for storage and handling

(1) Store 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.

Other

<how to use>
1.Do not use when nostrils are suppurating.
2.Gently blow your nose before use. Do not blow your nose too hard.
3.Shake the container gently, remove the cap, and hold it as diagram shown in the figure. (When using for the first time, press several times until the liquid medication dispenses as mist)
4.Place the tip of the nozzle gently into the nasal cavity and spray the medication once. Repeat the same action for the other nasal cavity.
5.After use, wipe the portion that touches the nose and close the cap to keep the container clean.

<Notes on use>
1.Blow your nose before use to clear the nasal passages.
2.Shake the container gently before use and remove the cap.
3.Medication will not turn to mist when dispenser is held horizontally, so be sure to use it holding vertically.
4.Be aware that medicine may become contaminated should the tip of the container come into contact with nasal discharge.
5.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
6.After use wipe the nozzle area with tissue paper to keep it clean.
7.Pricking the nozzle with a needle is extremely dangerous when broken. Do not do this under any circumstances.

Disclaimer on Multilingual Product Information

・This product is a pharmaceutical product approved under a Japanese law, the Law for Ensuring the Quality, Efficacy and Safety of Drugs and Medical Devices, with a view to its sale and use in Japan.

・Multilingual product information is a translation of the product labeling written in Japanese and provided for your information only. It does not warrant that its contents and the product itself conforms to laws and regulations in countries other than Japan.

・Multilingual product information is a tentative translation by Our Company, and may be modified or altered without notice.

・Our Company assumes no responsibility for any occurred problem attributable to the contents of the multilingual product information.