Saline Enema Enema [Galentic Pharma Recall

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Side Effects & Adverse Reactions

For rectal use only

Dosage Warning: Using more than one enema in 24 hours can be harmful.

• a sodium-restricted diet
• abdominal pain, nausea or vomiting
• kidney disease, heart problems, or are dehydrated
• notice a sudden change in bowel habits that persists over a period of 2 weeks

• If pregnant or breast feeding, ask a health professional before use.

Ask a doctor or pharmacist before use if you are

• taking any other drug
• take this product two or more hours before or after other drugs

Laxatives may affect how other drugs work.

• If you have rectal bleeding
• you have no bowel movement after use of a laxative. This may indicate a serious condition

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

• For relief of occasional constipation

When using this product

• Do not exceed recommended dose unless directed by a doctor. Serious side effects may occur from excess dosage.
• Do not use more than three days.

Use of this product:

CAUTION: REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

Positioning

Left-side position: Lie on left side with knees bent and arms at rest. (see diagram on box)

Knee-chest position: Kneel, then lower headand chest forward until left side of face is resting on surface. Position arms comfortably. (see diagram on box)

Administering Enema

• With steady pressure, gently insert enema with tip pointing toward navel.
• Squeeze bottle until recommended dose is expelled ( it is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
• Remove tip from rectum.
• Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
• Maintain position until urge to evacuate is strong (usually 1 to 5 minutes).
• If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

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History

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Other Information

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Sources