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Category 2 OTC medicines

BORRAGINOL A CHUNYUNANKO
ボラギノールＡ注入軟膏

CHARACTERISTICS

  1. Four ingredients work to provide an excellent effect on pain, bleeding, swelling, and itching due to hemorrhoids.
    • Prednisolone acetate suppresses bleeding, swelling, and itching, and lidocaine relieves pain and itching.
    • Allantoin helps in recovery of wounds and repairs tissues, and vitamin E acetate improves blood circulation and helps in relieving the symptoms of hemorrhoids.
  2. This is an easy-to-carry medicine for hemorrhoids that can be used for both internal hemorrhoids (inside the anus) and external hemorrhoids (outside the anus).
    • It is possible to insert it hygienically without touching either the affected area or the medicine directly by hand.
  3. Less stimulus and smooth and slippery fat-type base protects injured affected area.
    • The tip of the container (nozzle) has been made rounded in order not to injure the affected area.
    • This medicine is a white to slightly yellowish white ointment.

INDICATIONS

For relief of pain, bleeding, swelling, and itching of hemorrhoids and anal fissure (rectal bleeding)

DOSAGE AND DIRECTIONS

  • Insert the nozzle part into the anus and inject the whole amount slowly (when putting into the anus).
    Age One dose Daily dose
    Adult (15 years or over) 1 piece Once to twice
    Under 15 years Do not use.

    OR

  • –Apply the following amount of medicine on the affected area. Do not use an applicator that has been used for application by injection (when applying to the affected area).
    Age One dose Daily dose
    Adult (15 years or over) Appropriate amount Once to three times
    Under 15 years Do not use.

Precautions regarding dosage and directions

  1. For use for the anus only.
  2. When injecting into the anus, insert only the nozzle part and use.
  3. Please follow the recommended dosage and directions.

How to Use Ointment in Prefilled Disposable Applicators

- Using after a bowel movement, after taking a bath, or before bed is effective -

[When putting into the anus]

Remove the cap and slightly press out the ointment from the tip of the nozzle.

Insert the nozzle part into the anus.

Press the body part of the container and inject slowly, and pull it out while you keep pressing the container.

[When applying to the affected area]

Remove the cap, take out the amount of ointment required to cover the affected area using your clean finger, and apply it directly or spread on gauze, etc. and keep gauze on the affected area.

When the ointment is hard and difficult to push out

In case the ointment gets hard because of cold season or storage at low temperature, hold the tube in hands and warm it to make it soft.

INGREDIENTS

In 1 piece (2 g)

ACTIONS INGREDIENTS CONTENTS
Suppresses inflammation and relieves bleeding, swelling, and itching Prednisolone acetate 1 mg
Relieves local pain and itching Lidocaine 60 mg
Helps in recovery of wounds and repairs tissues Allantoin 20 mg
Improves peripheral blood circulation and helps in improving congestion Vitamin E acetate
(Tocopherol acetate)		 50 mg

Inactive ingredients:

White petrolatum, medium chain triglycerides, glycerin monostearate

  • A small amount of medicine will remain in the container because it is injectable, but the medicine is filled in anticipation of the remaining amount.

PRECAUTIONS FOR USE

What you should NOT do

(If you do not follow the precautions listed below, your current symptoms may worsen and you may be at an increased risk of side effects.)

  1. The following persons should not use this medicine:
    1. Persons who have had allergies to this medicine or ingredients of this medicine
    2. Persons who have an affected area with pus formation
  2. Do not use this medicine regularly for long periods.

Who should seek consultation

  1. The following persons should consult a physician, pharmacist, or registered salesperson** before using this medicine:
    1. Persons under treatment by a physician
    2. Women who are or may be pregnant
    3. Persons who have had allergies to medicines or something
  2. Stop using this medicine immediately and consult a physician, pharmacist, or registered salesperson if the following symptoms appear after using this medicine because they might be side effects of the medicine. Take this leaflet with you.
    Affected area Symptoms
    Skin Rashes, redness, itching, swelling
    Others Irritation, pus formation

    In rare cases, serious symptoms might occur. In such a case, immediately consult a physician.

    Names of symptoms Symptoms
    Shock
    (Anaphylaxis)    		 Symptoms such as itching of the skin, urticaria, hoarseness, sneezing, itching of the throat, breathing difficulties, palpitations, and clouded consciousness will appear immediately after using this medicine.
  3. Stop using this medicine and consult a physician, pharmacist, or registered salesperson if symptoms do not improve after using this medicine for about ten days. Take this leaflet with you.

**Registered salesperson: person who has the license to sell OTC medicines except Category 1.

PRECAUTIONS FOR STORAGE AND HANDLING

  1. Keep the bottle closed and store it in a cool place away from direct sunlight.
  2. Keep out of the reach of children.
  3. To prevent improper use or loss of quality, do not transfer the medicine to another container.
  4. Do not use this medicine after the expiration date.
  5. Do not flush the used container or pouch into toilet.
  6. This medicine is a grease-based ointment. Avoid contact with clothes because it may not come off easily.
Keys to prevent hemorrhoids
- Maintain a healthy lifestyle and prevent hemorrhoids -

Eat balanced meals three times a day to have better bowel movements.

Keep your anal clean at all times. In particular, taking a bath improves blood circulation of the anus.

Do not push forcefully during a bowel movement.

D6