Salofalk Suppositories

Salofalk Suppositories

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Disclaimer

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Title

MESALAMINE (5-AMINOSALICYLIC ACID) SUPPOSITORY – RECTAL (mess-AL-uh-meen)

Common Brand Name(s)

COMMON BRAND NAME(S): Pentasa, Salofalk

Uses

Mesalamine (also known as 5-aminosalicylic acid) is used to treat ulcerative proctitis, a type of bowel disease. It does not cure ulcerative proctitis, but it may decrease the number of stools, the amount of mucus/blood in the stools, and the rectal bleeding caused by irritation/swelling of the colon/rectum. Mesalamine is an aminosalicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural chemicals that may cause pain and swelling.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used for Crohn’s disease.

How to Use

Read the Patient Information Leaflet provided by your pharmacist before you start using mesalamine and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Use this medication rectally. If you are using the 1000-milligram strength, insert rectally, usually once daily at bedtime. If you are using a lower strength, then your doctor may direct you to use this medication 1 to 3 times daily. Follow your doctor’s directions carefully. Dosage is based on your medical condition, response to therapy, and the strength of your prescription. This medication works best if you have a bowel movement before using it. Wash your hands before and after using the medication. Unwrap the suppository right before using. Try to handle it as little as possible because heat from your fingers may cause it to melt. Lie down on your left side with right knee bent. Gently insert the suppository, pointed end first, into the rectum with your finger. Use a small amount of lubricating gel on the tip of the suppository if desired. Remain lying down for a few minutes. Try to avoid having a bowel movement for 1 to 3 hours, keeping the suppository in place so the medicine can work. This medication may stain surfaces that it touches (such as clothing, floor, and counter surfaces). Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Tell your doctor if your condition persists or worsens.

Side Effects

Rectal pain, pain when inserting the suppository, headache, gas, stomach pain, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Infrequently, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor right away if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, severe/prolonged headache. Tell your doctor right away if any of these rare but very serious side effects occur: chest pain, shortness of breath, severe stomach/abdominal pain (especially if spreading to the back), yellowing eyes/skin, dark urine, signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications that are broken down into mesalamine (such as balsalazide, sulfasalazine, olsalazine); or to other salicylates (such as aspirin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver disease, pancreas problems (pancreatitis), inflammation of the sac around the heart (pericarditis), skin problems (such as atopic dermatitis, eczema). This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (such as varicella vaccine), without first consulting a doctor about Reye’s syndrome, a rare but serious illness. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. This medication may interfere with certain laboratory tests (including urine normetanephrine levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others. Laboratory and/or medical tests (such as kidney and liver function tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store refrigerated or at room temperature. Do not freeze. Keep away from light, heat, and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.