ADV - Care Pharmacy
195 Riviera Dr. Unit #2,Markham,Ontario
Tel: (905)948-1991

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Brand Name
Galexos
Common Name
5-aminosalicylic acid (mesalamine, mesalazine)
How does this medication work? What will it do for me?

5-aminosalicylic acid (5-ASA or mesalamine) belongs to the group of medications known as anti-inflammatories. It is used to treat mild to moderate ulcerative colitis and mild to moderate Crohn's disease. 5-ASA acts by reducing inflammation in the bowel.

Different brands of 5-ASA are designed to act on different places in the gastrointestinal tract (the digestion tube that runs from the mouth to the anus). Ulcerative colitis affects the colon and rectum only, while Crohn's disease affects the whole gastrointestinal tract. For this reason, some brands are used to treat only ulcerative colitis, while others can be used to treat both Crohn's disease and ulcerative colitis.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended dose of simeprevir is 150 mg taken once daily with food. The capsule should be swallowed whole with fluids and not crushed or chewed. Ideally, simeprevir should be taken at the same time each day.

Simeprevir must be taken in combination with peginterferon-alfa and ribavirin. It is usually taken for 12 weeks, when the effectiveness of the combination of medications is determined by your doctor with blood tests. At this time, your doctor will determine how much longer you will need to continue to take peginterferon alfa and ribavirin.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor and not reduced. Reducing the dose may cause the medication to fail. If you miss a dose, and it is within 12 hours of the missed dose, take it as soon as possible with food and continue with your regular schedule. If it is more than 12 hours past the time of your missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature in its original package, protect it from light and moisture, and keep it out of the reach of children.

What form(s) does this medication come in?

Each white capsule, marked with "TMC435 150" in black ink contains 154.4 mg of simeprevir sodium salt, which is equivalent to 150 mg simeprevir. Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate and sodium lauryl sulphate; capsule: gelatin and titanium dioxide (E171); ink: iron oxide black (E172) and shellac (E904).

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to 5-aminosalicylic acid or any ingredients of the medication
  • are allergic to other salicylates (e.g., ASA)
  • are not able to swallow tablets whole
  • have a gastric (stomach) or duodenal (intestinal) ulcer
  • have a urinary tract obstruction

Do not give this medication to children under 2 years of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal or stomach cramps or pain (mild)
  • back or joint pain
  • diarrhea (mild)
  • dizziness
  • fatigue
  • flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
  • gas
  • headache (mild)
  • heartburn or indigestion
  • increased frequency of bowel movements
  • loss of appetite
  • loss of hair
  • nausea or vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • anxiety
  • fast heartbeat
  • mood swings
  • severe back or stomach pain
  • severe headache
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • skin rash and itching
  • unusual tiredness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of acute intolerance syndrome (e.g., abdominal or stomach cramps or pain [severe], bloody diarrhea, chills, fever)
  • signs of heart attack (e.g., chest pain, possibly moving to the left arm, neck, or shoulder)
  • signs of inflammation around the heart (e.g., fatigue, fever, difficulty breathing, cough)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Acute intolerance syndrome: This medication has been known to cause symptoms similar to those of worsening Crohn's disease or ulcerative colitis. If you experience the sudden onset of symptoms such as cramping, acute abdominal pain and bloody diarrhea, headache, rash, and possibly fever, contact your doctor immediately.

Allergy: Some people who are allergic to sulfasalazine or acetylsalicylic acid (ASA) also experience allergic reactions to mesalamine (5-ASA). Before you take 5-ASA, inform your doctor about any previous adverse reactions you have had to medications, especially sulfasalazine or ASA.

Contact your doctor at once if you experience signs of an allergic reaction such as skin rash, itching, difficulty breathing or swelling of the face and throat.

Heart problems: People with heart problems may be at an increased risk of side effects of 5-ASA. If you have heart problems or a history of heart problems, including heart infections, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: This medication is removed from the body by the kidneys. 5-ASA may not be removed from the body as quickly as expected if your kidneys are not working properly. This increases the likelihood of experiencing side effects.

If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: The use of this medication by people with reduced liver function has not been well studied. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor as soon as possible.

Slow stomach emptying: The tablet form of 5-ASA may not work as well for people with a condition known as pyloric stenosis. If you have pyloric stenosis or have a history of slow emptying of the stomach, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Tablets in stool: Infrequently, what looks to be intact or partially intact tablets may appear in the stool. If this occurs repeatedly, consult your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking 5-aminosalicylic acid, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication for use by children have not been established.

What other drugs could interact with this medication?

There may be an interaction between 5-aminosalicylic acid and any of the following:

  • 6-mercaptopurine
  • antacids (e.g., aluminum hydroxide, calcium carbonate, sodium bicarbonate)
  • azathioprine
  • digoxin
  • furosemide
  • H2 antagonists (e.g., cimetidine, famotidine, ranitidine)
  • lactulose
  • methotrexate
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ibuprofen)
  • probenecid
  • proton pump inhibitors (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole)
  • spironolactone
  • sulfinpyrazone
  • sulfonylureas (e.g., glyburide, gliclazide)
  • thioguanine
  • varicella (chicken pox) vaccine
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.





The contents of this site are for informational purposes only. Always seek the advice of your physician or other qualified healthcare provider regarding any questions you may have about a medical condition.
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