Pentasa Tablets - Consumer Medicine Information
|Condition:||Crohn's Disease, Maintenance, Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis, Ulcerative Colitis, Active, Ulcerative Proctitis|
|Ingredients:||mesalazine (also known as mesalamine, 5-ASA or 5-aminosalicylic acid), microcrystalline cellulose, ethylcellulose, magnesium stearate, povidone, talc|
Extended Release Tablets, 500 mg and 1g (5-aminosalicylic acid)
About This Medication
What the Medication is Used For
PENTASA tablets contain extended release granules of 5-aminosalicylic acid (also known as 5-ASA, mesalamine or mesalazine), which is an anti-inflammatory drug for the treatment of and/or to help maintain remission and prevention of relapse in patients with Ulcerative Colitis or Crohn’s Disease.
Ulcerative Colitis is a disease of the large bowel (colon) and back passage (rectum), where the lining of the gut becomes red and swollen (inflamed) resulting in symptoms of frequent and bloody stools together with stomach cramps.
Crohn's disease is a form of inflammatory bowel disease (IBD). It usually affects the intestines, but may occur anywhere from the mouth to the end of the rectum (anus).
What it Does
It is believed that PENTASA blocks the production and action of certain substances (cyclo-oxygenase, prostaglandins and others) involved in producing inflammation. PENTASA passes throughout the colon and rectum to treat this inflammation and reduces symptoms, such as bloody stools and diarrhea
When it Should not be Used
- If you are allergic to this drug or its ingredients or parts of the container (see What the nonmedicinal ingredients are)
- If you are allergic to a family of drugs known as salicylates (which includes acetylsalicylic acid (i.e. Aspirin †)
- If you have severe liver problems If you have severe kidney problems
- If you have a stomach or intestinal ulcer If you have a urinary tract obstruction
- If the patient is an infant under 2 years of age
What the Medicinal Ingredient Is
Mesalazine (also known as mesalamine, 5-ASA or 5-aminosalicylic acid).
What the Important Nonmedicinal Ingredients Are
Microcrystalline cellulose, ethylcellulose, magnesium stearate, povidone and talc.
PENTASA tablets do not contain gluten, lactose or phthalates.
What Dosage Forms it Comes In
PENTASA 500 mg Extended Release Tablets are round, white-grey to pale brown speckled tablets embossed “500 mg” with a scoreline on one side and embossed PENTASA on the other.
PENTASA 1g Extended Release Tablets are oblong, white-grey to pale brown speckled tablets embossed PENTASA on both sides.
Warnings and Precautions
BEFORE you use PENTASA, talk to your doctor or pharmacist if:
- You have pyloric stenosis (a narrowing of the outlet from the stomach that causes contents of the stomach to remain there for a longer period of time)
- You have any kidney or liver problems
- You have digestive (peptic) ulcers
- You have had previously inflammation of the heart (which may be the result of an infection of the heart)
- You have chronic lung problems (e.g. asthma, bronchitis etc.)
- You think you might be pregnant or are breast-feeding, since mesalamine crosses the placenta in pregnancy and is excreted in breast milk in small quantities. You should ask your doctor for advice about taking PENTASA in these circumstances.
- You have had previous allergy (hypersensitivity reaction) to sulfasalazine (an ingredient in other medicines used to treat ulcerative colitis)
- You have had any allergies to this drug or its ingredients or parts of the container
Interactions With This Medication
The simultaneous use of 5-ASA with drugs known to affect the kidney, including some anti-inflammatory drugs (NSAIDS) and azathioprine, may increase the risk of renal (kidney) reactions.
In patients receiving azathioprine or 6-mercaptopurine, simultaneous use of 5-ASA can increase the possibility of having abnormal blood cells.
Tell your doctor if you are taking anticoagulants (e.g. coumarin), probenecid, sulfinpyrazone, spironolactone, furosemide, rifampicin and methotrexate.
Proper Use of This Medication
Always take PENTASA as directed by your doctor. Management of mild to moderate active ulcerative colitis and maintenance therapy in adults: 0.5 g four times daily (2 g daily dose). In some cases, your doctor may increase the dose up to 1 g four times daily (4 g daily dose) if required.
Management of mild to moderate Crohn’s disease in adults: 1 g four times daily (4 g daily dose). For patients with Crohn’s Disease in remission, the usual dose is 3 g daily in divided doses.
PENTASA extended-release tablets should not be chewed, broken or crushed but should be swallowed whole with plenty of water.
PENTASA extended-release tablets should be taken with meals.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you forget to take your tablets, then take them as usual the next day. Do not take a double dose to make up for a forgotten tablet.
Side Effects and What to do About Them
Like all medicines, PENTASA can cause side effects, although not everybody gets them. The most common side effects are abdominal pain, vomiting, rash, fatigue, fever, back pain, dizziness, headache, itching skin (pruritis), diarrhea and feeling sick (nausea).
Other less common side effects (seen in less than 1 in 100 patients) are dizziness, feeling sleepy or tired, trembling or shaking, ear or throat pain, racing heartbeat, changes in blood pressure, painful or bloated stomach, hair loss, indigestion, acne, rash, joint aches or pains, back pain, weakness, swollen face, an inflamed pancreas or colon (associated with pain in upper abdomen and back and feeling sick). Rarely, decreased sperm count and motility which may be reversible when treatment is stopped
The following side effects are associated with other medicines containing mesalazine (5-ASA). These are: low blood cell counts; neuropathy (abnormal or damaged nerves giving a sensation of numbness and tingling), inflammation of the heart and lining around the heart; inflammation of the lung, difficulty in breathing; gall stones, hepatitis (inflammation of the liver giving rise to flu-like symptoms and jaundice), allergic swelling of tongue, lips and around eyes, skin redness, muscular pain, kidney problems (such as inflammation and scarring of the kidney).
If any of the side effects become serious or persist, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking|
|Uncommon||Blood problems and |
symptoms such as
unusual bleeding (for
example, nose bleeds),
anemia (feeling weak),
fever, sore throat
Pancreatis (inflamed or
swollen pancreas) and
symptoms such as
abdominal pain and
|Acute Intolerance |
Syndrome – symptoms
include cramping, acute
stomach pain, blood and
headache and rash.
These symptoms could
be a sign of a serious
condition which occurs
rarely but means your
treatment would have to
be stopped immediately.
|Allergic reaction – |
swelling of the mouth,
throat, difficulty in
breathing and rash.
(inflammation of the
liver) – symptoms
(yellowing of the skin
and eyes) and flu-like
This is not a complete list of side effects. For any unexpected effects while taking PENTASA, contact your doctor or pharmacist.
How to Store It
Store at room temperature (15°C to 30°C). Protect from light.
Keep out of reach of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program<
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be provided by contacting the sponsor, Ferring Pharmaceuticals at: 1-866-384-1314.