Pentasa Enema - Consumer Medicine Information
|Condition:||Crohn's Disease, Maintenance, 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|
Rectal Suspension, 1 g and 4 g/100mL (Enema) (5-aminosalicylicacid)
About This Medication
What the Medication is Used For
Your doctor has prescribed Pentasa (5-aminosalicylic acid also known as5-ASA or mesalazine) enemas for treatment of acute distal Ulcerative Colitis extending to the splenic flexure and for long- term maintenance therapy in order to maintain remission and prevent relapse of active disease. Ulcerative Colitis occurs in the large bowel. Distal Ulcerative Colitis occurs in the last part of the bowel, from the rectum up to the splenic flexure shown by the light shaded area.
Currently there is no cure for Ulcerative Colitis, 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. Best results are obtained when the entire enema contents are used, so that complete coverage of the grey shaded area can occur.
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
Sodium acetate, sodium edetate, sodium metabisulfite, purified water, with hydrochloric acid to adjust the pH to 4.8.
Pentasa is phthalate free.
What Dosage Forms it Comes In
Enema: 1g per 100 mL and 4g per 100 mL
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) ulcersYou 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 mesalazine 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 components of the container
Interactions With This Medication
The simulateneous 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, simulataneous use of mesalazine 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
BEST RESULTS ARE ACHIEVED IF THE BOWEL IS EMPTIED IMMEDIATELY BEFORE THE ENEMA IS GIVEN. ONE ENEMA SHOULD BE USED AT BEDTIME FOR A PERIOD DIRECTED BY YOUR DOCTOR. RETAIN THE ENEMA OVERNIGHT FOR BEST RESULTS.
Removing the Bottle
Remove the bottle from the protective foil pouch by using scissors as shown below. Be careful not to puncture the bottle inside.
Preparing the medication for use
- Begin by holding the bottle for a few minutes. Doing this raises the temperature of the medication closer to your body temperature reducing the temperature shock you might experience and making it easier to retain the enema.
- Shake the bottle well until the medicine is evenly distributed in the liquid.
- To break the seal, twist the nozzle clockwise one full turn (the nozzle should then be in the same direction as before turning).
- Lubricate top part of rectal applicator including the tip with petroleum jelly (or other lubricant).
- For sanitary and disposal purposes, a plastic bag is provided. Insert your hand into the bag and grasp the enema bottle.
- Hold the container as shown in the picture.
Administrating the Enema
- To administer the lubricated enema, lie on your left side with the left leg straight and the right leg bent forward for balance. This is called the administration position.
- Carefully insert the applicator tip into the rectum. Maintain sufficient steady hand pressure while dispersing the bottle content. The bottle content should be applied within max. 30-40 seconds.
Disposal of the Enema Bottle
- Once the bottle is empty, withdraw the tip with the bottle still compressed.
- Pull up the plastic bag to encase the empty enema bottle.
- The enema should be retained in the bowel. Remain relaxed in theadministration position for 5-10 minutes or until the urge to pass the enema has disappeared.
- Try to retain the enema overnight.
- Discard the empty bagged enema bottle and wash your hands.
If you have any questions do not hesitate to discuss them with your doctor or pharmacist.
|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 dose before bedtime, take the medication as soon as you remember IF you will be able to retain the enema. 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 mesalazine. 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
PENTASA (5-ASA) rectal suspension (enema) and PENTASA (5-ASA) suppositories should be stored at controlled room temperature, preferably below 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<
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.