What Pentasa Suppositories is used for and how to use it
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Pentasa Suppositories - Consumer Medicine Information

Manufacture: Ferring Pharmaceuticals
Country: Canada
Condition: Crohn's Disease, Maintenance, Inflammatory Bowel Disease, Ulcerative Colitis, Ulcerative Colitis, Active, Ulcerative Proctitis
Class: 5-aminosalicylates
Form: Rectal, Tablets
Ingredients: mesalazine (also known as mesalamine, 5-ASA or 5-aminosalicylic acid), microcrystalline cellulose, ethylcellulose, magnesium stearate, povidone, talc

Suppository, 1 g (5-aminosalicylicacid)

About This Medication

What the Medication is Used For

Your doctor has prescribed Pentasa (5-aminosalicylic acid also known as 5-ASA or mesalazine) suppositories for your acute Ulcerative Proctitis and for long-term maintenance therapy in order to maintain remission and prevent relapse of active disease.

Acute ulcerative proctitis is an inflammation of the lining of the rectum (rectum is the last 6 inches of the large intestine).

Currently there is no cure for Ulcerative Proctitis but medical therapy can bring the bleeding, diarrhea, and/ or cramping under control. Medications such as Pentasa are used to calm the inflamed tissue. To do this, the medication must cover the diseased area.

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 acts 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

magnesium stearate, polyethylene glycol, povidone, talc

Pentasa is phthalate free.

What Dosage Forms it Comes In

Suppository contains 1 g of 5-ASA

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)
  • You think you might be pregnant or are breast-feeding, since 5-ASAcrosses 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 components 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 and azathioprine, may increase the risk of renal reactions.

In patients receiving azathioprine or 6-mercaptopurine, simultaneous use of 5-ASA can increase the possibility of having abnormal blood components.

Tell your doctor if you are taking anticoagulants (e.g. coumarin), probenecid, sulfinpyrazone, spironolactone, furosemide, rifampicin and methotrexate.

Proper Use of This Medication

Directions for Adult Use: One Suppository at Bedtime for a Period Determined by Your Doctor

SUPPOSITORIES ARE NOT TO BE TAKEN BY MOUTH

  1. We recommend that the bowel be emptied, if possible, prior to the suppository being administered.
  2. Push the suppository through the foil blister.
  3. You may lubricate the suppository with a water based lubricant to aid in the insertion of the suppository.
  4. Using a rubber finger protector on your index finger, insert the suppository, either end first, into the rectum.

    NOTE: the inserting of the suppository can be done while in a standing position or laying down with one leg bent. The suppository should be inserted as far into the rectum as possible.

  5. For best results, retain the suppository as long as possible.

    NOTE: If the suppository is discharged within the first 10 minutes, a new one can be inserted.

  6. Discard the rubber finger protector.

Overdose

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.

Missed Dose

If you forget to take your dose before bedtime, take the medication as soon as you remember IF you will be able to retain the suppository. If this is not possible administer the next bedtime dose, the next evening.

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 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/effectTalk with your doctor or pharmacistStop taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
Uncommon Blood problems and
symptoms such as
unexplained bruising,
unusual bleeding (for
example, nose bleeds),
anemia (feeling weak),
fever, sore throat
Pancreatis (inflamed or
swollen pancreas) and
symptoms such as
abdominal pain and
feeling sick.
   
Acute Intolerance
Syndrome – symptoms
include cramping, acute
stomach pain, blood and
excessive stools
(diarrhea), fever,
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
symptoms include
swelling of the mouth,
throat, difficulty in
breathing and rash.
Hepatitis including
liver failure
(inflammation of the
liver) – symptoms
include jaundice
(yellowing of the skin
and eyes) and flu-like
symptoms.
   

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

PENTASA (5-ASA) rectal suspension (enema) should be stored at controlled room temperature, preferably below 25 C. PENTASA (5-ASA) suppositories should be stored at 15 – 25 °C. They should be dispensed in their respective containers.

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<
                   Health Canada
                   Postal Locator 0701D
                   Ottawa, Ontario
                   K1A 0K9

    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.

More Information

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.