Brand Name(s):

Cytotec^®

IMPORTANT WARNING

Do not take misoprostol to prevent ulcers if you are pregnant or plan to become pregnant. Misoprostol may cause miscarriages, premature labor, or birth defects.

If you are a woman of childbearing age, you may take misoprostol to prevent ulcers only if you have had a negative pregnancy test in the past 2 weeks and if you use a reliable method of birth control while taking misoprostol. You must begin taking misoprostol on the second or third day of your menstrual period. If you become pregnant while taking misoprostol, stop taking it and call your doctor immediately.

Before taking misoprostol, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully. Talk to your doctor about the risks of taking misoprostol.

Do not let anyone else take your medication, especially a woman who is or may become pregnant.

WHY is this medicine prescribed?

Misoprostol is used to prevent ulcers in people who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. It protects the stomach lining and decreases stomach acid secretion.

HOW should this medicine be used?

Misoprostol comes as a tablet to take by mouth. It is usually taken 4 times a day, after meals and at bedtime with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take misoprostol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Misoprostol must be taken regularly to be effective. Women should not take their first dose until the second or third day of their menstrual period (to be sure that they are not pregnant). Do not stop taking misoprostol without talking to your doctor.

Are there OTHER USES for this medicine?

Misoprostol is also used sometimes to treat ulcers and to induce labor. Misoprostol is used in combination with mifepristone to end an early pregnancy. Talk to your doctor about the possible risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking misoprostol,

tell your doctor and pharmacist if you are allergic to misoprostol or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antacids, aspirin, arthritis medications, and vitamins.
tell your doctor if you are breast-feeding.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2017.