PENTASA ® (enemas)
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Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

Why am I using PENTASA?

PENTASA contains the active ingredient mesalazine. PENTASA enema is used to treat ulcerative proctosigmoiditis and/or left-sided ulcerative colitis. These are conditions with inflammation, ulcers and sores in the rectum (back passage) and in the large bowel next to the rectum causing bleeding, stomach pain, and diarrhoea.
For more information, see Section 1. Why am I using PENTASA? in the full CMI, starting from page 2.

What should I know before I use PENTASA?

Do not use if you have ever had an allergic reaction to PENTASA or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use PENTASA? in the full CMI, starting from page 2.

What if I am taking other medicines?

Care may be needed when using PENTASA with some other medicines.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI, starting from page 2.

How do I use PENTASA?

Use as directed by your doctor
The contents of one enema (1 g) inserted into the rectum at bedtime
More instructions can be found in Section 4. How do I use PENTASA? in the full CMI, starting from page 2, and in the detailed instructions in the pack.

What should I know while using PENTASA?

Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using PENTASA
Have all blood tests recommended by your doctor
If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine
If you become pregnant while using this medicine, tell your doctor immediately.
Things you should not do
Do not stop using this medicine or lower the dosage suddenly without checking with your doctor
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.
Driving or using machines
PENTASA is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Keep your PENTASA in a cool dry place where the temperature stays below 25°C.
For more information, see Section 5. What should I know while using PENTASA? in the full CMI, starting from page 2.

Are there any side effects?

All medicines can have side effects. Side effects reported from PENTASA can be minor and temporary. However, some side effects may need medical attention.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI, starting from page 2.
PENTASA ® (enemas)
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Active ingredient(s): [mesalazine]
Consumer Medicine Information (CMI)
This leaflet provides important information about using PENTASA. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PENTASA.
Where to find information in this leaflet:

Why am I using PENTASA?

PENTASA contains the active ingredient mesalazine. PENTASA is an anti-inflammatory agent, similar to aspirin and is thought to work by helping to reduce inflammation in the large bowel and rectum.
PENTASA is used to treat ulcerative proctosigmoiditis and/or left-sided ulcerative colitis. These are conditions with inflammation, ulcers and sores in the rectum (back passage) and in the large bowel next to the rectum causing bleeding, stomach pain, and diarrhoea.

What should I know before I use PENTASA?

Warnings

Do not use PENTASA if:

you are allergic to mesalazine, or any of the ingredients listed at the end of this leaflet always check the ingredients to make sure you can use this medicine
have a severe kidney or liver problem.

Check with your doctor if you:

have a known allergy to PENTASA, sulfasalazine or aspirin-like medicines, or any of the ingredients listed at the end of this leaflet
take any medicines for any other condition
have a kidney or liver problem
have a bleeding disorder
have a history of asthma.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss with you the risks and benefits involved. PENTASA should be used with caution during pregnancy and breast-feeding and only if the potential benefits outweigh the possible risks in the opinion of the doctor. The underlying condition itself (inflammatory bowel disease) may increase risks for the pregnancy outcome.

Children

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.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy 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 some medicines.
Medicines that may have their effects increased if used with PENTASA include:
anti-coagulants which are used to thin blood or stop blood clots (e.g. warfarin). When PENTASA is used with these medicines, it may increase the medicine’s effects on thinning your blood.
sulphonylureas which are used to lower blood sugar and treat diabetes (e.g. glibenclamide, glipizide). When PENTASA is used with these medicines, it may increase the medicine’s effect on lowering your blood glucose.
methotrexate which is used to treat some kinds of cancers, some skin conditions, and rheumatoid arthritis. When PENTASA is used with this medicine, it may increase the possibility of the medicine producing toxic effects on your body.
glucocorticoids which are used to treat inflammation, swelling or allergies (e.g. prednisolone). When PENTASA is used with these medicines, it may increase the undesirable gastric effects caused by these medicines.
Medicines that may have their effects decreased if used with PENTASA include:
probenicid or sulfinpyrazone which are used to treat gout. When PENTASA is used with these medicines it may decrease the effectiveness of the medicine.
spirinolactone or frusemide, which are used to increase the amount of urine produced and to lower blood pressure. When PENTASA is used with these medicines it may decrease the effectiveness of the medicine
rifampicin which is used to treat tuberculosis. When PENTASA is used with this medicine it may decrease the effectiveness of the medicine.
Medicines that may have a greater likelihood of reducing bone marrow activity if used with PENTASA include:
azathioprine which is used to suppress the immune system
mercaptopurine and thioguanine, used to treat leukaemia.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PENTASA.

How do I use PENTASA?

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.

How much to use

The recommended dose is the contents of one enema (1 g) inserted into the rectum, once daily at bedtime
Your doctor will prescribe a dosage regimen based on your individual needs, and this may differ from this recommendation.
Follow the instructions provided and use PENTASA until your doctor tells you to stop.

When to use PENTASA

PENTASA should be used at bedtime.

How to use PENTASA

If possible, go to the toilet and empty your bowels before using an enema. The enema will work better if the bowel has been emptied
Shake the enema container well. The enema should be used not more than 5 minutes after being shaken.
Insert the contents of the enema in the rectum (back passage). Keep lying down for 5 to 10 minutes
Detailed instructions for use are available in the pack
Do not swallow the enema
You may experience a little discomfort and a feeling of urgency to empty your bowels immediately after inserting the enema. This is normal and expected due to the inflammation present within the bowel. Try to resist this urge to empty your bowels for as long as possible. This feeling will subside as treatment continues and the inflammation decreases
Even if you retain just a portion of the enema, it is a step in the right direction.

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If you forget to use PENTASA

PENTASA should be used regularly at the same time each day.
If it is almost time for your next enema, skip the dose you missed and use your next enema when you are meant to.
Do not use a double dose to make up for the dose you missed.

If you use too much PENTASA or swallow the medicine:

If you think that you have used too much PENTASA, or if the medicine has been taken by mouth, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
( by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.

What should I know while using PENTASA?

Things you should do

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 function
Kidney stones may develop while using 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.

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.
Remind any doctor, dentist or pharmacist you visit that you are using PENTASA.

Things you should not do

Do not stop using this medicine or lower the dosage suddenly without checking with your doctor. If you stop taking it suddenly, your condition may worsen
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.

Things you should be careful of

PENTASA enemas may stain clothing, fabrics or other surfaces.

Driving or using machines

PENTASA is not expected to affect your ability to drive a car or operate machinery.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.
Keep your PENTASA in the packaging until it is time to use your next dose
If you take PENTASA out of the packaging it may not keep well
Keep your PENTASA in a cool dry place (temperature stays below 25°C), away from moisture, heat or sunlight.
Do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.

Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects
What to do
Nervous system related:
headache
Stomach and intestine related:
diarrhoea
abdominal or stomach pain
flatulence (stomach discomfort or fullness, relieved by passing wind)
nausea (feeling sick)
vomiting
General and administration site related:
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.
Skin related:
mild skin rash
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects
What to do
Nervous system related:
dizziness
numbness, tingling or weakness of the arms and legs
Blood and lymph system related:
bruising easily, unusual bleeding (e.g. nosebleeds), signs of infection such as fever, chills, sore throat and mouth ulcers
Bone, muscle and tissue related:
muscle aches and pains
painful or swollen joints
Stomach and intestine related:
severe upper stomach pain, nausea and vomiting
Kidney and urinary related:
changes in kidney function/kidney disease, and or urine discolouration
Liver and gallbladder related:
yellowing of the skin or eyes, dark coloured urine
 
 
Skin related:
hair loss (this is reversible)
Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)
Condition related:
worsening of your condition
Call your doctor straight away, if you notice any of these serious side effects.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Call your doctor straight away, if you notice any of these serious side effects.
Immune system related:
sudden signs of allergic reactions such as rash, itching or hives, shortness of breath, wheezing, coughing, or swelling of limbs, face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing
nausea, severe stomach cramps and/or pain, bloody diarrhoea, fever, severe headache and skin rash with severe blisters and bleeding of the eyes, mouth, lips, nose and genitals e.g. erythema multiforme or Stevens-Johnson Syndrome (SJS)/ Toxic epidermal necrolysis (TEN)
Bone, muscle and tissue related:
lupus erythematosus-like reactions (a disease affecting the skin, joints and kidneys with symptoms such as joint pain, fever and skin rash)
Breathing and chest related:
chest pain and/or pain behind the breast bone sometimes spreading to the neck and shoulders, or with fever
Go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Kidney and urinary related:
changes in kidney function
kidney stones may develop while using PENTASA. Symptoms may include pain in the sides of the abdomen and blood in the urine.
Liver and gallbladder related:
changes in liver function e.g. raised liver enzymes
Blood and lymph system related:
changes in the blood e.g. a decrease in the number of red/white blood cells, and/or platelets
Reproductive system related:
low sperm count (this is reversible)
Your doctor may do blood tests, or other tests, to check if there are any changes in your blood, kidney, liver or reproductive system function
 
 
 
 
 
Your doctor may do blood tests, or other tests, to check if there are any changes in your blood, kidney, liver or reproductive system function
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side affects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop using any of your medicines.

Product details

This medicine is only available with a doctor's prescription.

What PENTASA contains

Active ingredient
(main ingredient)
mesalazine
Other ingredients
(inactive ingredients)
disodium edetate
sodium acetate
hydrochloric acid
sodium metabisulfite
purified water
Potential allergens
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Do not use this medicine if you are allergic to any of these ingredients.

What PENTASA looks like

PENTASA enema is in the form of a transparent plastic bottle containing a white to slightly yellow suspension. Each bottle is protected by an aluminium foil bag. The aluminium foil bag protects the contents of the enema from light. They are supplied in packs of 7. (AUST R 98033)

Who distributes PENTASA

PENTASA Enema is supplied in Australia by:
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble, NSW 2073, Australia.
PENTASA ® is a registered trademark of Ferring B.V.
® = Registered trademark
This leaflet was prepared in June 2021.
DOCS#5476v11A

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