Mesalamine Gastro-resistant tablet

What is this medicine?

MESALAMINE (me SAL a meen) is used to treat the pain and inflammation caused by ulcerative colitis.

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

What should I tell my health care provider before I take this medicine?

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

• kidney disease

• liver disease

• pyloric stenosis

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not cut, crush, or chew the tablets or capsules. Some products should be taken with food. Ask your health care provider how to take this medicine, and follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

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 medicine?

• digoxin

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 medicine?

Tell your doctor or health care professional if your symptoms do not start to get better after several days. There is usually an improvement in 3 to 21 days. You may need about 6 weeks of treatment to get good results.

Do not change the brand of this medicine that you are taking without talking to your doctor or health care professional. All brands do not have the same dose.

You may notice the empty shell from this medicine in your stool. If this happens frequently, you should contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

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

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

• bloody diarrhea

• chest pain

• difficulty breathing, wheezing

• fever

• pain or difficulty passing urine

• unusually weak or tired

• yellowing of the eyes or skin

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

• headache

• nausea, vomiting

• stomach gas

• stomach pain or cramps

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 medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Mesalamine Oral capsule, biphasic release

What is this medicine?

MESALAMINE (me SAL a meen) is used to maintain remission of ulcerative colitis.

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

What should I tell my health care provider before I take this medicine?

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

• kidney disease

• liver disease

• phenylketonuria

• pyloric stenosis

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it 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 medicine?

• antacids

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 medicine?

Tell your doctor or healthcare professional if your symptoms get worse.

Do not change the brand of this medicine that you are taking without talking to your doctor or health care professional. All brands do not have the same dose.

What side effects may I notice from receiving this medicine?

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

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

• bloody diarrhea

• chest pain

• difficulty breathing, wheezing

• fever

• pain or difficulty passing urine

• unusually weak or tired

• yellowing of the eyes or skin

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

• headache

• nausea, vomiting

• stomach gas

• stomach pain or cramps

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 medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Mesalamine Oral capsule, extended-release

What is this medicine?

MESALAMINE (me SAL a meen) is used to treat the pain and inflammation caused by ulcerative colitis.

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

What should I tell my health care provider before I take this medicine?

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

• kidney disease

• liver disease

• pyloric stenosis

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not cut, crush, or chew the tablets or capsules. Some products should be taken with food. Ask your health care provider how to take this medicine, and follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

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 medicine?

• digoxin

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 medicine?

Tell your doctor or health care professional if your symptoms do not start to get better after several days. There is usually an improvement in 3 to 21 days. You may need about 6 weeks of treatment to get good results.

Do not change the brand of this medicine that you are taking without talking to your doctor or health care professional. All brands do not have the same dose.

You may notice the empty shell from this medicine in your stool. If this happens frequently, you should contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

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

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

• bloody diarrhea

• chest pain

• difficulty breathing, wheezing

• fever

• pain or difficulty passing urine

• unusually weak or tired

• yellowing of the eyes or skin

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

• headache

• nausea, vomiting

• stomach gas

• stomach pain or cramps

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 medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Mesalamine Oral capsule, gastro-resistant

What is this medicine?

MESALAMINE (me SAL a meen) is used to treat the pain and inflammation caused by ulcerative colitis.

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

What should I tell my health care provider before I take this medicine?

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

• kidney disease

• liver disease

• pyloric stenosis

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not cut, crush, or chew the tablets or capsules. Some products should be taken with food. Ask your health care provider how to take this medicine, and follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

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 medicine?

• digoxin

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 medicine?

Tell your doctor or health care professional if your symptoms do not start to get better after several days. There is usually an improvement in 3 to 21 days. You may need about 6 weeks of treatment to get good results.

Do not change the brand of this medicine that you are taking without talking to your doctor or health care professional. All brands do not have the same dose.

You may notice the empty shell from this medicine in your stool. If this happens frequently, you should contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

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

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

• bloody diarrhea

• chest pain

• difficulty breathing, wheezing

• fever

• pain or difficulty passing urine

• unusually weak or tired

• yellowing of the eyes or skin

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

• headache

• nausea, vomiting

• stomach gas

• stomach pain or cramps

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 medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Mesalamine Rectal enema, suspension

What is this medicine?

MESALAMINE (me SAL a meen) is used to treat the pain and inflammation caused by ulcerative colitis.

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

What should I tell my health care provider before I take this medicine?

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

• kidney disease

• pyloric stenosis

• an unusual or allergic reaction to mesalamine, salicylates, other medicines, sulfites, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for rectal use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Shake well before using. Lie on your left side, extend the left leg and pull the right leg up towards your chest or pull both knees toward the chest. Take off the applicator tip cover and place the applicator tip gently into the rectum. Pointing the tip toward your stomach, squeeze the bottle steadily. Stay in position for at least 30 minutes to allow the medication to spread inside. For best results, use this medicine before bedtime and after you have had a bowel movement. Try keeping the suspension in the rectum for 8 hours. Take your medicine at regular intervals. 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 medicine?

Interactions are not expected.

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 medicine?

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse. There is usually an improvement in 3 to 21 days. You may need about 6 weeks of treatment to get good results.

This medicine may stain clothing and other fabrics, flooring, painted surfaces, marble, granite, plastics, and enamel.

What side effects may I notice from receiving this medicine?

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

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

• black, tarry stools

• bloody diarrhea

• breathing problems

• chest pain

• fever

• nausea, vomiting

• pain or trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

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

• headache

• rectal discomfort

• stomach gas

• stomach pain or cramps

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 medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Once the foil-wrapped unit of seven bottles is opened, all enemas should be used within a short period of time. The suspension may darken after opening foil pouch. Slight darkening is okay; however, throw away enemas with dark brown contents. Throw away any unused medicine after the expiration date.

Mesalamine Rectal suppository

What is this medicine?

MESALAMINE (me SAL a meen) is used to treat the pain and inflammation caused by ulcerative colitis.

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

What should I tell my health care provider before I take this medicine?

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

• history of pancreatitis

• kidney disease

• pyloric stenosis

• an unusual or allergic reaction to mesalamine, salicylates like aspirin, other medicines, foods like saturated vegetable oils, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for rectal use only. Do not take by mouth. Wash your hands before and after use. Take off the wrapping. Try to handle the suppository as little as you can, so that it does not melt before use. A small amount of lubricating gel may be used on the tip of the suppository. Lie on your side with your lower leg straightened out and your upper leg bent forward toward your stomach. Lift upper buttock to expose the rectal area. Apply gentle pressure to insert the suppository completely into the rectum, pointed end first. Hold buttocks together for a few seconds. For best results, use this medicine after you have had a bowel movement, and try to keep in place for 1 to 3 hours or longer. Do not use more often than directed.

Take your medicine at regular intervals. Follow the directions on the prescription label. 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 medicine?

Interactions are not expected.

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 medicine?

Tell your doctor or health care professional if your symptoms do not start to get better after several days. There is usually an improvement in 3 to 21 days. You may need about 6 weeks of treatment to get good results.

This medicine can cause stains on things it touches. Therefore keep it away from clothing and other fabrics, flooring, painted surfaces, marble, granite, plastics, and enamel. Be careful to avoid stains.

What side effects may I notice from receiving this medicine?

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

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

• bloody diarrhea

• chest pain

• difficulty breathing, wheezing

• fever

• pain or difficulty passing urine

• unusually weak or tired

• yellowing of the eyes or skin

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

• dizziness

• headache

• nausea, vomiting

• rectal pain

• stomach gas

• stomach pain or cramps

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 medicine?

Keep out of the reach of children.

Store below 25 degrees C (77 degrees F). Do not freeze. Keep away from direct heat, light or humidity. Throw away any unused medicine after the expiration date.