Ranitidine tablets or capsules

What is this medication?

RANITIDINE (ra NYE te deen) is a type of antihistamine that blocks the release of stomach acid. It is used to treat stomach or intestinal ulcers. It can relieve ulcer pain and discomfort, and the heartburn from acid reflux.

Ranitidine has been withdrawn from the market due to safety concerns. The FDA recommends that you stop taking any tablets or capsules you currently have, dispose of them properly, and not buy more. Talk to your health care provider if you need advice about treatments.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Acid Reducer, Ranitidine, Taladine, Wal-Zan, Zantac, Zantac 150, Zantac 75, Zantac Maximum Strength

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

•kidney disease

•liver disease

•porphyria

•an unusual or allergic reaction to ranitidine, other medicines, foods, dyes, or preservatives

•pregnant or trying to get pregnant

•breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. If you only take this medicine once a day, take it at bedtime. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

•atazanavir

•delavirdine

•gefitinib

•glipizide

•ketoconazole

•midazolam

•procainamide

•propantheline

•triazolam

•warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care professional if your condition does not start to get better or gets worse. You may need to take this medicine for several days as prescribed before your symptoms get better. Finish the full course of tablets prescribed, even if you feel better.

Do not smoke cigarettes or drink alcohol. These increase irritation in your stomach and can lengthen the time it will take for ulcers to heal. Cigarettes and alcohol can also make acid reflux or heartburn worse.

If you get black, tarry stools or vomit up what looks like coffee grounds, call your doctor or health care professional at once. You may have a bleeding ulcer.

This medicine may cause a decrease in vitamin B12. You should make sure that you get enough vitamin B12 while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care professional.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

•agitation, nervousness, depression, hallucinations

•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

•breast enlargement in both males and females

•breathing problems

•redness, blistering, peeling or loosening of the skin, including inside the mouth

•unusual bleeding or bruising

•unusually weak or tired

•vomiting

•yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

•constipation or diarrhea

•dizziness

•headache

•nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.