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Category 2 OTC medicines

BORRAGINOL A ZAZAI
ボラギノールA坐剤

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. For better effect, the medicine is designed to act directly on the affected area by using a fat-type base that melts quickly at body temperature.
    • The fat-type base causes little irritation, is easy to insert, protects the affected wound area, and helps in smooth defecation.
    • This medicine is a white to slightly yellowish white suppository wrapped in aluminum foil.

INDICATIONS

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

DOSAGE AND DIRECTIONS

Remove the wrapper and insert the following amount into the anus:

Age One dose Daily dose
Adult (15 years or over) 1 piece Once to twice
Under 15 years Do not take.

Precautions regarding dosage and directions

  1. In case the suppository is soft, cool it for a while before use.
    In case the surface of the suppository gets too hard because of cold season or storage at low temperature, warm with hands to make the surface smooth before use.
  2. For use for the anus only.
  3. Please follow the recommended dosage and directions.
How to take out and insert a suppository
- Insertion after a bowel movement, after taking a bath, or before bed is effective -

Cut off 1 piece from the aluminum sheet.

Using your both hands, peel the wrapper evenly down both sides and take out the suppository.

Hold the bottom part of the suppository and insert it, pointed end first, with your finger until it completely enters into the anus.

Note: Be careful not to injure your hands and fingers with the aluminum container.

Precautions after insertion

  1. Try to avoid strenuous exercise immediately after insertion so that the suppository will not come out.
  2. After insertion, feeling of a foreign body may remain, but it will gradually disappear as the suppository dissolves.
  3. Oil-like matter may come out at the bowel movement after insertion of this medicine. Do not worry because this is a dissolved fat-type base.

INGREDIENTS

In 1 piece (1.75 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:

Hard fat

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 out of the reach of children.
  2. To prevent improper use or loss of quality, do not transfer the medicine to another container.
  3. Do not use this medicine after the expiration date.
  4. Store in a cool place at 1-30°C, away from direct sunlight, () because this medicine is designed to dissolve at body temperature. After opening, store in the outer box with the pointed end of the suppository pointing down, as shown in the figure (right). Store the outer box in a standing position as shown in the symbol ().
  5. Avoid storing this medicine below 0°C because cracking of the suppository may occur when it is stored in a place below 0°C such as in the freezer.

on the outer box

  1. means storage temperature is 1-30°C.
  2. means to store in a standing position with the pointed end of the suppository pointing down. Storing in this direction prevents deformation of the suppositories even in case they melt or get soft at high temperature.
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.