Allegra FX Premium

Allegra FX Premium

アレグラFXプレミアム

Allergy
Pharmacist-Guidance Drug — Sold only by a pharmacist
Abuse-Prevention Designated · 指定濫用防止医薬品
Drug Type

Allergy-only rhinitis medicine (fexofenadine + pseudoephedrine)

Form

Tablets with an extended-release part

Indication

Relief of the following nasal allergy symptoms caused by pollen, house dust (indoor dust), etc.: sneezing, runny nose, and nasal congestion.

Active Ingredients (per 4 tablets (daily dose))

Fexofenadine hydrochloride 120 mg
Pseudoephedrine hydrochloride 240 mg

Inactive Ingredients

Carnauba wax, stearic acid, light anhydrous silicic acid, crystalline cellulose, croscarmellose sodium, partially pregelatinized starch, magnesium stearate, polyvinyl alcohol (partially saponified), titanium oxide, macrogol 4000, talc, yellow ferric oxide, red ferric oxide

Instructions for Use

  • ✓Take on an empty stomach, in the morning and evening. The tablets contain an extended-release part, so do not chew or crush them. Swallow them whole with water.
Age Dose per use Times per day
Adults (15 years and older) 2 tablets 2 times daily, morning and evening, on an empty stomach
Under 15 years Do not use —
  • ✓Follow the recommended dosage strictly.
  • ✓Use this product if nasal congestion is especially troublesome among your allergic rhinitis symptoms.
  • ✓Take it only for the shortest time, while nasal congestion is severe. Once your nasal congestion eases, switch promptly to a medicine with an antihistamine alone or a similar option.
  • ✓If symptoms do not improve after 1 week, consult a doctor or pharmacist. Even if symptoms improve, consult a doctor or pharmacist before taking it for more than 2 weeks.
  • ✓The empty tablet shell may appear in your stool. It is what remains after the ingredients are absorbed. The ingredients are fully absorbed and the effect is not affected.
  • ✓To remove a tablet from the PTP sheet, press firmly on the raised side of the sheet with your fingertip to break the film on the back, then take out the tablet. Do not swallow the PTP sheet, as it may puncture the esophageal lining and cause serious injury.
  • ✕Do not use this product if you:
  • (1) Have ever had an allergic reaction to this product or any of its ingredients.
  • (2) Are under 15 years of age.
  • (3) Have urinary retention, or difficulty urinating due to an enlarged prostate.
  • (4) Have been diagnosed with high blood pressure, heart disease, thyroid disease, diabetes, or glaucoma.
  • (5) Have experienced insomnia, dizziness, weakness, trembling, or palpitations after taking a cold medicine, cough/phlegm medicine, or rhinitis medicine.
  • ✕Do not use any of the following medicines while taking this product: other allergy medicines (including medicines for skin conditions and oral rhinitis medicines); oral medicines containing antihistamines (such as cold medicines, cough and phlegm medicines, motion sickness medicines, and hypnotic sedatives); erythromycin (an antibiotic); antacids containing aluminum hydroxide and magnesium hydroxide; methyldopa or reserpine (blood pressure medicines); oral medicines containing pseudoephedrine hydrochloride or pseudoephedrine sulfate; monoamine oxidase inhibitors such as selegiline hydrochloride; or apalutamide (a prostate cancer medicine).
  • ✕Do not drink alcohol before or after taking this product.
  • ✕Do not take this product while breastfeeding. If you must take it, avoid breastfeeding. (It has been found to pass into breast milk.)
  • ✓Seek immediate medical attention if any of the following serious symptoms appear:
  • • Shock (anaphylaxis): Itching of skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, or clouded consciousness immediately after use.
  • • Convulsions: Sudden, involuntary contractions of the muscles.
  • • Liver disorder: Fever, itching, rash, jaundice (yellowing of the skin or whites of the eyes), dark urine, general fatigue, or loss of appetite.
  • • Agranulocytosis, leukopenia, neutropenia: Sudden high fever, chills, or sore throat.
  • • Acute generalized exanthematous pustulosis: High fever, widespread rash or redness on skin, small blisters (pustules) on reddened skin, general fatigue, or loss of appetite that persists or rapidly worsens.
  • ⚠Consult a doctor or pharmacist before use if you:
  • (1) Are under medical treatment.
  • (2) Are not sure whether your symptoms come from allergic rhinitis or from another cause, such as a cold.
  • (3) Have been diagnosed with another allergic disease, such as bronchial asthma or atopic dermatitis.
  • (4) Are pregnant or possibly pregnant.
  • (5) Are elderly.
  • (6) Have ever had an allergic reaction to a medicine.
  • (7) Have been diagnosed with kidney disease.
  • ✓Stop use immediately and consult a doctor or pharmacist — bringing this package insert with you — if any of the following symptoms appear after taking this product, as they may be side effects:
  • Skin: Rash; swelling of the throat, eyelids, lips, etc.; itching; hives; or reddening of the skin
  • Gastrointestinal: Nausea, vomiting, abdominal pain, indigestion, or bloody stool
  • Nervous system: Headache, tiredness, numbness, general fatigue, dizziness, insomnia, nervousness, nightmares, sleep problems, emotional excitement, restlessness, weakness, fear, anxiety, tension, trembling, or hallucinations
  • Urinary: Frequent urination, difficulty urinating, or urinary retention
  • Cardiovascular: Rapid heartbeat, palpitations, rise in blood pressure, high blood pressure, irregular heartbeat, or shock (circulatory collapse)
  • Other: Taste disorder, swelling, chest pain, difficulty breathing, loss of appetite, pale complexion, or menstrual problems
  • ✓Stop use and consult a doctor or pharmacist if the following symptoms persist or worsen: dry mouth, constipation, diarrhea, or drowsiness.
  • ✓Store in a cool, dry place away from direct sunlight. Keep out of reach of children. Do not transfer to another container (this can cause mistaken use or affect quality). Do not use after the expiry date.

Abuse-Prevention Designated Medicine 指定濫用防止医薬品

  • Purchase is limited to 1 unit per person per transaction, both in-store and online
  • A pharmacist or registered salesperson must confirm appropriate use before the sale is completed
  • Additional restrictions apply for buyers under 18
  • Do not exceed the prescribed dose — taking more than directed may cause serious adverse effects

Additional Information

Combines a second-generation antihistamine (fexofenadine hydrochloride) with pseudoephedrine hydrochloride, which reduces congestion and swelling of the nasal lining. It is the first OTC medicine to contain pseudoephedrine hydrochloride in the same amount as the prescription medicine.
Less likely to cause drowsiness, or the hard-to-notice drop in concentration, judgment, and work efficiency known as impaired performance.

Sources & Documents

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For informational purposes only. Always consult a doctor or pharmacist before taking any medication.