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

Category 2 OTC medicine 

ストナリニZジェル   STONARHINI Z GEL

Product features

● Stonarhini Z is an oral medicine for nasal allergies containing cetirizine hydrochloride, a second generation antihistamine
● Alleviates allergy symptoms such as sneezing, runny nose, and nasal congestion.
● Take once a day before bedtime for lasting efficacy. When using for rhinitis symptoms stemming from pollen or other seasonal allergies, this product is most effective when taken soon after symptoms appear.
● Made with an easy-to-swallow soft capsule containing liquid.

Indication

Alleviates the following nasal allergy symptoms caused by pollen or house dust: sneezing, runny nose, nasal congestion

Dosage and administration

Take the following dose before bedtime.

[Age: single dose: number of daily doses]
Adult (15 years old and over): 1tablets: 1 times
Under 15 years: Do not take.

Precautions of Dosage and Administration

(1)Strictly follow the prescribed dosage and administration.
(2)When using for symptoms of seasonal allergic rhinitis, such as pollen, this medication is most effective when taken at the onset of symptoms in the beginning of pollen season.
(3) Please take this document and consult with your physician, pharmacist, or registered seller if symptoms do not improve after taking this medication for a week, or when taking for more than two weeks, even when symptoms improve.
(4) How to Dispense Capsules
 Using your finger, push the convex portion of the PTP sheet containing capsules to break the aluminum foil on the back. Please remove the capsule and ingest it.
 (Can lead to unforeseen consequences such as piercing the esophageal mucosa if mistakenly swallowed.)"

Ingredient and amount

In 1 tablets
Cetirizine hydrochloride:10mg: Alleviates pollen or house dust related sneezing, runny nose, and nasal congestion.

Precautions

■When not to use the product
(If you do not follow these instructions, the current symptoms may worsen or adverse reactions/incidents are more likely to occur.)
1.This product should not be taken by the following persons.
(1)Those who have experienced allergic symptoms when taking this drug, its ingredients, or piperazine derivatives (including levocetirizine and hydroxyzine).
(2)Persons diagnosed as having the following
kidney disease
(3)Children under 15 years old.

2.This drug should not be taken together with the following drugs:
Other allergy medication (including medication for skin conditions or oral rhinitis medication), internal medication containing antihistamines (cold medicine, cough suppressant-expectorants, motion sickness drugs, sedatives), and internal medication containing theophylline, ritonavir, or pilsicainide hydrochloride hydrate

3.After taking this drug, do not drive a car or operate machinery (sleepiness may occur).

4.Nursing women should either not take this medicine or stop nursing while taking this medicine.

5.Do not drink alcohol before/after taking this medicine

■Consultation
1.The following persons should contact a physician, pharmacist, or registered salesperson for a consultation before administration.
(1)Patients undergoing medical treatment from a physician
(2)Persons diagnosed as having the following
 liver disease,epilepsy
(3)Those who have experienced seizure.
(4)Pregnant women or women suspected of being pregnant.
(5) The elderly
(6) Patients who have experienced allergic symptoms associated with drugs, etc.
(7)Those who are unsure whether their symptoms are caused by allergies or other inducers.
(8)Those diagnosed with bronchial asthma, atopic dermatitis, or other allergic diseases.

2.If the following symptoms are observed after taking this drug, these may be adverse reactions, so immediately discontinue the use of this drug, and show this document to your physician, pharmacist, or registered salesperson for a consultation.

Neuropsychiatric system:Malaise, headache,heavy‐headedness, dizziness, numbness, anacatesthesia, insomnia,trembling, depression, suicidal thoughts, excitement, aggression, sense of helplessness, dysesthesia, hallucination, motor tics, loss of consciousness, amnesia, nightmares
Gastrointestinal system: nausea and vomiting, loss of appetite, feeling of discomfort in the stomach, indigestion, stomachache, abdominal discomfort, cheilitis, dry lips, dysgeusia, stomatitis,abdominal bloating, increased appetite, tongue swelling
Cardiovascular system:palpitations,increased blood pressure, arrhythmia
Skin: rash/redness, urticaria, edema, rash, itching ,blisters
Eyes: red eye, dimness of vision, abnormal eye movement, eyelid swelling
Respiratory system: breathing difficulties, coughing
Urinary system: Proteinuria, glycosuria, blood in urine, urination difficulty, incontinence
Other:Ear ringing, abnormal menstruation, chest pain, hot flush, joint pain, stiffness of limbs, dysosmia, bleeding nose, hair loss, weight gain, myalgia, fever

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.
Hepatic function failure: Symptoms, such as fever, itching, rash, jaundice (yellowing of skin and white of eyes), brown urine, general malaise, loss of appetite, etc. may occur.
Thrombocytopenia: Symptoms, such as nosebleeds, bleeding from the gums and bruises, caused by reduced counts of platelets which is a component of the blood may occur.

3.The following symptoms may be observed after taking this drug. If these symptoms persist or worsen , discontinue the use of this drug, and show this document to your physician, pharmacist, or registered salesperson for a consultation.
dry mouth, constipation,diarrhea, drowsiness

Additive

Macrogol, hydroxide K, gelatin, succinated gelatin, glycerin, sugar alcohol derived from corn starch, ferric trioxide

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 take the product after its expiration date.

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.