■ Product OverviewManufacturer: Taisho Pharmaceutical Co., Ltd.Product Name: Helpecia Cream 2gPharmaceutical Classification: Class 1 Prescription DrugCategory: OTC DrugPediatric Classification: For All AgesDrug Form: OtherContents: 2gProduct Description: Treatment for recurrent cold soresJAN Code: 4987306062047Product Code: 079509083
■ Initial and Revised Dates of Package Insert, Package Insert Version NumberInitial Creation: 2012/09Revision: -KY2A1
Please read this instruction manual carefully before use.Also, keep it in a safe place where you can read it when needed.
■ Features◆ Helpecia Cream is a treatment for recurrent cold sores containing the antiviral drug acyclovir.◆ It is effective to start treatment early when symptoms such as tingling or prickling appear.
■ Do Not Do(Failure to follow these instructions may worsen current symptoms or increase the risk of side effects.)
(1) Do not use the following people:(1) People who believe they are experiencing their first outbreak, or people with widespread lesions. (If it is the first outbreak, symptoms may worsen, and if the affected area is widespread, it is severe, so please seek medical attention.)(2) People who have had allergic reactions to this product, its ingredients, or valacyclovir preparations. (Reactions may occur again with the use of this product.)(3) Infants and young children under 6 years of age. (In the case of infants and young children, it is highly likely to be the first infection.)
(2) Do not use on the following areas:(1) Eyes and around the eyes. (May cause irritation if it enters the eyes.)(2) Areas other than the lips and their surroundings. (Cold sores occur on and around the lips.)
■ Consult a Doctor or Pharmacist(1) The following people should consult a doctor or pharmacist before use:(1) People receiving medical treatment. (It may affect prescribed medications or you may be using the same medication.)(2) Pregnant or breastfeeding women. (Use medication with caution and seek advice from a specialist.)(3) People who are breastfeeding. (The same ingredient in prescription oral medications has been confirmed to transfer into breast milk.)(4) People who have experienced allergic reactions to medications, etc. (People who have had allergic reactions to medications may also experience them with this product.)(5) People with severe wetness or sores. (If symptoms are severe, consult a specialist for instructions.)(6) People with atopic dermatitis. (Symptoms may worsen, so consult a specialist for instructions.)
(2) If the following symptoms appear after use, discontinue use immediately and consult a doctor or pharmacist with this instruction manual, as it may be a side effect.[Affected Area] [Symptoms]Skin: Rash/redness, swelling, itching, irritation, pain, dryness, burning sensation, scaling (flakes, peeling skin like dandruff), hives(This may be an allergic reaction to the drug or an exaggerated pharmacological effect of the drug. In such cases, continuing to use the same medication may further worsen the symptoms.)
(3) If symptoms do not improve after about 5 days of use, or if they worsen, discontinue use and consult a doctor or pharmacist with this instruction manual.(If symptoms do not improve after about 5 days of use, it should be considered that the symptoms are severe or due to another illness, and you should consult a doctor or pharmacist as soon as possible.)
■ Efficacy and EffectivenessRecurrence of cold sores(Limited to those who have been diagnosed and treated by a doctor in the past)
[Explanation]Cold sores are a disease caused by infection with the herpes virus. Once infected, the virus does not disappear even when the symptoms subside; it remains dormant in nerve cells. When your body's condition deteriorates due to a cold, stress, fatigue, etc., the virus becomes active again, leading to preliminary symptoms (signs of recurrence) such as tingling or prickling, followed by redness, swelling, and blisters. This reactivation of dormant viruses is called recurrence.
■ Dosage and AdministrationApply an appropriate amount to the affected area 3 to 5 times a day.(Apply immediately when you feel discomfort such as tingling or prickling on or around your lips.)
[Explanation]・ Sensations such as tingling or prickling are signs of cold sore recurrence.Use from the early stages of recurrence.・ Recommended usage times are after each meal and before bedtime.・ Please be very careful to prevent family members who may be experiencing their first outbreak from accidentally using the product.