
Allegra FX 56 Tablets [Class 2 OTC Drug]
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Product Description
Product Information
It really works: Allegra, taken 2 times a day
About the Sale of Medicines
●Precautions for Use
■■Things You Must Not Do■■ (Not observing these may worsen current symptoms or make side effects and accidents more likely.)
1. The following persons must not take this medicine.
(1) Persons who have had allergic symptoms caused by this medicine or its ingredients
(2) Children under 15 years
2. While taking this medicine, do not use any of the following medicines.
Other allergy medicines (including medicines for skin diseases and oral medicines for nasal inflammation (rhinitis)), oral medicines containing antihistamines (cold medicines, antitussive and expectorant medicines, motion sickness medicines, hypnotic sedatives, etc.), preparations containing aluminum hydroxide/magnesium hydroxide (antacids), erythromycin (an antibiotic), apalutamide (a prostate cancer treatment)
3. Do not drink alcohol before or after taking this medicine.
4. Persons who are breastfeeding should not take this medicine, or should avoid breastfeeding if they take this medicine.
(Transfer into breast milk has been observed in animal studies.)
■■Things To Consult On■■
1. The following persons should consult a doctor, pharmacist, or registered salesclerk before taking this medicine.
(1) Persons receiving treatment from a doctor
(2) Persons who are not sure whether their symptoms are due to allergic rhinitis or to another cause such as a cold
(3) Persons who have been diagnosed with other allergic diseases such as bronchial asthma or atopic dermatitis
(4) Persons with severe nasal congestion
(5) Persons who are pregnant or who think they may be pregnant
(6) Elderly persons
(7) Persons who have had allergic symptoms caused by medicines, etc.
2. If any of the following symptoms appear after taking this medicine, they may be side effects. Stop taking it immediately and consult a doctor, pharmacist, or registered salesclerk, bringing this document with you.
Relevant Area – Symptoms
Skin – Swelling of the throat, eyelids, lips, etc., rash, itching, hives, reddening of the skin
Digestive system – Nausea, vomiting, abdominal pain, indigestion
Psychiatric/nervous system – Numbness, headache, fatigue, malaise, dizziness, insomnia, nervousness, nightmares,
sleep disorders
Urinary system – Frequent urination, difficulty urinating
Other – Palpitations, taste disturbance, edema, chest pain, difficulty breathing, increased blood pressure, menstrual irregularities
The following serious symptoms may occur rarely.
In that case, see a doctor immediately.
Symptom Name – Symptoms
Shock (anaphylaxis) – Immediately after taking the medicine, itching of the skin, hives,
hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, clouding of consciousness, etc. appear.
Liver dysfunction – Fever, itching, rash, jaundice (yellowing of the skin and the whites of the eyes), brown urine,
general fatigue, loss of appetite, etc. appear.
Agranulocytosis, leukopenia, neutropenia – Sudden high fever, chills, sore throat, etc.
appear.
3. The following symptoms may appear after taking this medicine. If they persist or worsen, stop taking it and consult a doctor, pharmacist, or registered salesclerk.
Dry mouth, constipation, diarrhea, drowsiness
●Indications
Relief of the following nasal allergy symptoms caused by pollen, house dust (indoor dust), etc.:
sneezing, runny nose, nasal congestion
●Dosage and Administration
Adults (15 years and older): take 1 tablet per dose, 2 times a day, in the morning and evening.
Age – Single dose – Times per day
Adults (15 years and older) – 1 tablet – 2 times a day, morning and evening
Under 15 years – Do not take.
<Precautions related to dosage and administration>
(1) Strictly follow the specified dosage and administration.
(2) When using this medicine for seasonal allergic rhinitis symptoms caused by pollen, etc., it is effective to start taking it from the forecast date of pollen dispersal, or early, as soon as symptoms begin to appear.
(3) The effect is obtained by taking it continuously.
(4) If no improvement in symptoms is seen after taking this medicine for 1 week, consult a doctor, pharmacist, or registered salesclerk. Also, even if symptoms improve, consult a doctor, pharmacist, or registered salesclerk if you take it for more than 2 weeks.
(5) How to remove the tablets
Press the raised part of the sheet containing the tablet firmly with your fingertip to break the film on the back, take out the tablet, and take it. (If you accidentally swallow the sheet, it may pierce the mucous membrane of the esophagus or cause other unexpected accidents.)
●Ingredients and Amounts
Daily dose: in 2 tablets
Fexofenadine hydrochloride – 120 mg
Additives: crystalline cellulose, partially pregelatinized starch, croscarmellose sodium, magnesium stearate, light anhydrous silicic acid, hypromellose, povidone, titanium oxide, macrogol 400, red ferric oxide, yellow ferric oxide
●Precautions for Storage and Handling
(1) Store in a cool place with low humidity, away from direct sunlight.
(2) Store out of the reach of children.
(3) Do not transfer to another container.
(This may cause misuse or change the quality.)
(4) Do not use the product after the expiration date.
●Contact Information
For inquiries about this product, please contact the pharmacy or drugstore where you purchased it, or the "Customer Consultation Office" shown on the right.
Hisamitsu Pharmaceutical Co., Inc. Customer Consultation Office
TEL. 0120-133250
<Hours> 9:00 to 17:50 (excluding Saturdays, Sundays, public holidays, and company holidays)
Distributor
Hisamitsu Pharmaceutical Co., Inc.
〒841-0017 鳥栖市田代大官町408番地
Manufacturer and Distributor
Sanofi K.K. SANOFI
〒163-1488東京都新宿区西新宿三丁目20番2号
Contact for the Relief System for Sufferers from Adverse Drug Reactions: Pharmaceuticals and Medical Devices Agency (PMDA), Phone: 0120-249-931 (toll-free)
Translation Notice
- This product is manufactured and labeled for sale and use in Japan in accordance with Japanese laws and regulations.
- This English product information is a translation of the original Japanese product information and is provided for reference only. It does not guarantee that the product or this information conforms to the laws and regulations of any country other than Japan.
- The translation may contain errors or omissions and may be revised without notice. If there is any discrepancy between this translation and the original Japanese text, the original Japanese text takes precedence. The original is available on the Japanese version of this page.