Patient Medication Information: uses, side effects, how to take - Asacol 800
What is Asacol 800 used for?
To treat symptoms related to ulcerative colitis when the condition of the disease is moderate. Ulcerative colitis is where the large bowel (colon) and back passage (rectum) becomes red and swollen (inflamed).
How does Asacol 800 work?
Asacol 800 is an anti-inflammatory drug for the bowel. Asacol 800 is believed to stop the production of certain substances in your body that cause swelling (inflammation). Asacol 800 tablets are designed to prevent the medicine from being released early.
What are the ingredients in Asacol 800?
Medicinal ingredients: mesalamine, otherwise known as 5-aminosalicylic acid or 5-ASA
Non-medicinal ingredients: colloidal silicon dioxide, dibutyl phthalate, edible black ink (ammonium hydroxide, n-butyl alcohol, shellac glaze [modified] in SD-45, propylene glycol, synthetic black iron oxide), Eudragit®-L {methacrylic acid copolymer Type A (USP)}, Eudragit®-S {methacrylic acid copolymer Type B (USP)}, iron oxide red, iron oxide yellow, lactose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate and talc.
Asacol 800 comes in the following dosage form:
800 mg tablet
Serious Warnings and Precautions
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Do not use Asacol 800 if:
- You are allergic to mesalamine (5-ASA) or any of the ingredients in Asacol 800.
- You have a history of sensitivity to salicylates, for example acetylsalicylic acid (i.e. Aspirin®).
- You have severe liver problems.
- You have severe kidney problems.
- You have an ulcer in the stomach or intestines.
- You have a blocked urinary tract.
- You are unable to swallow the whole tablet.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Asacol 800. Talk about any health conditions or problems you may have, including if you:
- have higher than normal blood urea nitrogen (BUN) levels (renal function test)
- have a history of kidney problems
- have pyloric stenosis. Pyloric Stenosis is a condition in where the passage from the stomach to the small intestine is narrow or blocked. Pyloric stenosis may keep the Asacol 800 tablet from reaching the colon as quickly as it normally would.
- are taking other ulcerative colitis drugs that contain Mesalamine. Speak to your doctor before switching your treatment to Asacol 800
- had an allergic reaction to sulfasalazine. Stop taking Asacol 800 and speak to your doctor if you experience a rash or a fever.
Other warnings you should know about:
Treatment with Asacol 800 can increase your risk of certain side effects, including:
- Liver problems: You may develop liver function problems, including liver failure.
Kidney Stones: You may develop kidney stones when using Asacol 800. Be sure to drink enough liquids while you are taking Asacol 800. Speak to your doctor about how much water or other liquids you should be drinking. Symptoms of kidney stones may include:
- blood in urine
- urinating more often
- pain in back, side, stomach and groin
Acute Intolerance Syndrome: Mesalamine, the medicinal ingredient in Asacol 800, can cause Acute Intolerance Syndrome. Your doctor may monitor your kidney function if you have kidney disease while on treatment. Speak to your doctor immediately if you experience any of the following symptoms:
- cramping
- sudden abdominal pain
- bloody diarrhea
- fever
- headache
- rash
Colitis (inflamed colon): Asacol 800 can cause the symptoms of colitis to worsen. Speak to your doctor immediately if you suddenly experience any of the following symptoms:
- cramping
- abdominal pain
- bloody diarrhea
- fever
- headache
- rash or itchy skin
- eye infection
Pregnancy and breastfeeding: If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your doctor.
- Tell your doctor right away if you become pregnant or think you are pregnant during treatment with Asacol 800.
Taking Mesalamine during pregnancy have been reported to cause:
- early Labor
- stillbirth (death of baby)
- low birth weight of baby
- If you breastfeed your baby while taking Asacol 800, your baby could develop / start to have diarrhea. It is important to monitor your baby’s stool and contact your doctor right away if they have diarrhea. Your doctor may advise you to stop breastfeeding your baby.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Asacol 800:
- Aminosalicylates. Taking Asacol 800 with aminosalicylates may increase your risk of developing a blood clot.
- Azathioprine, 6-mercaptopurine. Taking Asacol 800 with these drugs may increase your risk of developing a blood disorder.
- Nonsteroidal anti-inflammatory drugs (NSAID). Taking Asacol 800 with these drugs may increase your risk of side effects to your kidneys.
How to take Asacol 800:
- Take Asacol 800 exactly as your doctor tells you to take it. Do NOT take more of it than prescribed. Speak to your doctor or pharmacist if you are not sure.
- Take the exact dose your doctor tells you to take during remission. Following your doctor’s instructions can reduce the risk of your symptoms returning.
- Do NOT stop using Asacol 800 abruptly.
- Swallow tablets whole. Do NOT crush or chew the tablet.
- The whole tablet or a part of it may occasionally appear in your stool. Speak to your doctor if this occurs frequently.
Usual Adult Dose:
Treatment of moderate ulcerative colitis:
Take six 800 mg tablets daily in divided doses.
Overdose:
| If you think you have taken too much Asacol 800, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take double the dose.
What are possible side effects from using Asacol 800?
These are not all the possible side effects you may feel when taking Asacol 800. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- anxiety, confusion or nervousness
- bloated stomach
- diarrhea
- difficulty sleeping
- headache or migraine
- increased appetite
- menstrual (period) pain
- nausea
- rash
- pain in groin, joints, neck or back
- sore throat
- vomiting
Your doctor may run tests, including a blood test, to check your liver function and blood cell counts.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Worsening of your ulcerative colitis symptoms | ✓ | ||
| UNCOMMON | |||
Kidney stones (hard little pebbles that form in your kidneys) blood in urine, urinating more often, pain in your back, side, belly or groin | ✓ | ||
| Chest pain | ✓ | ||
| Stomach pain | ✓ | ||
| RARE | |||
| Ear Problems: pain, contestation, noise, ringing in ear or vertigo (a sense of spinning dizziness) | ✓ | ||
| Eye problems: blurred vision, eye pain, or pink eye (infection) | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Fever (higher than normal body temperature) | ✓ | ||
| Fast heartbeat: pounding, fluttering, racing, skipping beats, chest discomfort or shortness of breath | ✓ | ||
Allergic (hypersensitivity) reactions itching, rash, swelling of face or hands, tightness in chest, trouble breathing | ✓ | ||
| Lung Problems (thickening and scaring of lung tissues): Shortness of breath, fast, shallow breathing, dry cough | ✓ | ||
Kidney problems changes in urine output, cloudy or tea-coloured urine, blood in the urine, weight gain (from retaining fluid), confusion, swelling of the eyes, hands, legs, and feet Additional less specific symptoms may include: drowsiness, fatigue, nausea, vomiting, rash, persistent itching, and back pain | ✓ | ||
Liver problems severe abdominal pain or distension, nausea, vomiting, drop in appetite, bloating, together with yellowing of the skin and eyes, and abnormal liver function tests | ✓ | ||
| Acute intolerance syndrome cramping, stomach pain, bloody and excessive stools, fever, headache and rash | ✓ | ||
| Stevens-Johnson syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Asacol 800 should be stored at controlled room temperature (15 ̊C – 30 ̊C).
Keep out of reach and sight of children.
If you want more information about Asacol 800:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.allergan.ca, or by calling 1-800-668-6424.
ASACOL™ is a trademark of Medeva Pharma Suisse SA, used under license by Allergan Inc.