NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
PENTASA® (MESALAZINE) SUPPOSITORIES
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about PENTASA.
It does not contain all the available information.It does not take the place of talking to your doctor or pharmacist.
Please read this leaflet before you start using PENTASA.
All medicines have risks and benefits. Your doctor has weighed the risks of you using PENTASA against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.You may need to read it again.
What PENTASA is used for
This medicine is used to treat ulcerative proctitis, a disease with inflammation, ulcers and sores in the rectum (back passage) causing bleeding, stomach pain, and diarrhoea.
The active ingredient in this medicine is mesalazine. It is an anti-inflammatory agent, similar to aspirin and is thought to reduce inflammation in the rectum.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
There is no evidence that PENTASA is addictive.
It is available only with a doctor’s prescription.
It is not expected to affect your ability to drive a car or operate machinery.
Before you use PENTASA
When you must not use it
Do not use PENTASA if you have an allergy to:
any medicine containing mesalazine or aspirin-like medicines
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take PENTASA if you have a severe kidney or liver problem.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Do not give PENTASA to a child 12 years old or under.
The safety and effectiveness of PENTASA in this age group have not been established.
Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
a known allergy to PENTASA, sulfasalazine or aspirin-like medicines, or any of the ingredients listed at the end of this leaflet
a kidney or liver problem
a bleeding disorder
a history of asthma.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.PENTASA should be used with caution during pregnancy and lactation and only if the potential benefits outweigh the possible hazards in the opinion of the doctor. The underlying condition itself (inflammatory bowel disease) may increase risks for the pregnancy outcome.
If you have not told your doctor about any of the above, tell him/her before you start using PENTASA.
Using other medicines
Tell your doctor or pharmacist if you are using any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
There is no information available on interactions between PENTASA and other medicines. However, mesalazine belongs to a group of medicines called salicylates that may interfere with the following types of medicines:
anti-coagulants, used to thin blood or stop blood clots (eg warfarin)
glucocorticoids, used to treat inflammation, swelling or allergies (eg prednisolone)
sulphonylureas, used to lower blood sugar and treat diabetes (eg glibenclamide, glipizide)
methotrexate, used to treat some kinds of cancers and arthritis
probenicid or sulfinpyrazone, used to treat gout
spirinolactone or frusemide, used to increase the amount of urine produced, and to lower blood pressure
rifampicin, used to treat tuberculosis
azathioprine, used to suppress the immune system
mercaptopurine and thioguanine, used to treat leukaemia.
Ask your doctor or pharmacist if you are unsure about taking any of these medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
How to use PENTASA
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If possible, go to the toilet and empty your bowels before using a suppository. The suppository will work better if the bowel has been emptied.
Insert the suppository in the rectum (back passage).
Detailed instructions for use are available in the pack.
Do not swallow the suppository.
Use the suppository only once daily, usually at night/bedtime.
If you do not understand the instructions on the packaging, ask your doctor or pharmacist for help.
How much to use
Use as directed by your doctor.
Usual dose: Insert one suppository into rectum at bedtime.
How long to use it
Continue using your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep using your medicine even if you feel well.
If you forget to use it
If it is almost time for your next suppository, skip the one you missed and use your next suppository when you are meant to.
Otherwise, use it as soon as you remember, and then go back to using your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some hints.
If you use too much (overdose) or swallow the medicine
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much PENTASA, particularly if the medicine has been taken by mouth.Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using PENTASA
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking PENTASA.
Have all blood tests recommended by your doctor.
PENTASA may cause kidney, liver or blood problems in a few people. You should have regular blood tests to check your kidney and liver function.
Kidney stones may develop while taking PENTASA. Symptoms may include pain in the sides of the abdomen and blood in the urine.
Take care to drink plenty of fluids while you are being treated with PENTASA.
Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.
It may affect other medicines used during surgery.
If you become pregnant while using this medicine, tell your doctor immediately.
Things you must not do
Do not use PENTASA to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop using your medicine or lower the dosage without checking with your doctor.
If you stop using it suddenly, your condition may worsen.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using PENTASA.
This medicine helps most people but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
abdominal or stomach pain
flatulence (stomach discomfort or fullness, relieved by passing wind)
nausea (feeling sick)
mild skin rash
discomfort, pain or itching in the anus or rectum, or feeling that you need to have a bowel movement, during or after inserting the medicine.
The above list includes the more common side effects of your medicine (affecting between 1 in 10 and 1 in 100 patients). They are usually mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
bruising easily, unusual bleeding (e.g. nosebleeds), or signs of infection such as fever, chills, sore throat and mouth ulcers
muscle aches and pains
painful or swollen joints
severe upper stomach pain, nausea and vomiting
changes in kidney function/kidney disease, and or urine discolouration
numbness, tingling or weakness of the arms and legs
yellowing of the skin or eyes, dark coloured urine
hair loss (this is reversible)
worsening of your condition.
Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).
The above list includes serious side effects which may require medical attention. Serious side effects are usually rare or very rare (affecting less than 1 in 1,000 patients).
If you notice any of the following, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
sudden signs of allergic reactions such as rash, itching or hives on the skin, shortness of breath, wheezing, coughing, or swelling of limbs, face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing
severe stomach cramps and/or pain, bloody diarrhoea, fever, severe headache and skin rash
rash with severe blisters and bleeding of the eyes, mouth, lips, nose and genitals e.g. erythema multiforme or Stevens-Johnson Syndrome (SJS)
lupus erythematosus-like reactions (a disease affecting the skin, joints and kidneys with symptoms such as joint pain, fever and skin rash)
chest pain and/or pain behind the breast bone sometimes spreading to the neck and shoulders, or with fever.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are usually rare or very rare(affecting less than 1 in 1,000 patients).
Other very rare side effects that have been reported with PENTASA include:
changes in kidney function
changes in liver function e.g. raised liver enzymes
changes in the blood e.g. a decrease in the number of red/white blood cells, and/or platelets
low sperm count (this is reversible).
As a precaution, your doctor may do blood tests to check if there are any changes in your blood, kidney or liver function.
Very rare side effects occur in less than 1 in 10,000 patients.
Kidney stones may develop while taking PENTASA. Symptoms may include pain in the sides of the abdomen and blood in the urine.
The frequency of this side effect is not known.
Other side effects not listed above may also occur in some people.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After using PENTASA
Keep your suppositories in the packaging until it is time to use them.
If you take the suppository out of the packaging it may not keep well.
Keep your suppositories in a cool dry place where the temperature stays below 25°C.
Do not store PENTASA or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep PENTASA where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
PENTASA Suppositories are white to tan spotted, oblong shaped. Each suppository is protected in an aluminium foil blister.
PENTASA Suppositories may be supplied in packs of 5, 10, 28 and 30. Not all pack sizes are being distributed in Australia.
PENTASA Suppositories contain 1 g mesalazine as the active ingredient, as well as the following inactive ingredients:
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
PENTASA Suppositories are supplied in Australia by:
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble, NSW 2073, Australia.
AUST R 98034 – PENTASA mesalazine 1 g suppository blister pack
This leaflet was prepared in
PENTASA® is a registered trademark of Ferring B.V.
® = Registered trademark
By scanning the QR code with your smart phone or tablet, you can access a video on how to administer PENTASA® Suppositories. Alternative access via www.myibd.com.au Access available only within Australia.
Source: Read Full Article