Pentasa Sachets - Consumer Medicine Information
|Condition:||Crohn's Disease, Maintenance, Crohn's Disease, Diarrhea, Stomach Ulcer (Gastric Ulcer), Ulcerative Colitis, Ulcerative Colitis, Active|
|Ingredients:||mesalazine, ethylcellulose, povidone|
What Pentasa is Used For
This medicine is used to treat Crohn'sdisease and ulcerative colitis,diseases associated withinflammation, ulcers and sores in thebowel causing bleeding, stomachpain, and diarrhoea.
The active ingredient in Pentasa is mesalazine. It is an anti-inflammatory agent, similar to aspirin, and is thought to work by reducing inflammation in the bowel.
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 yourability to drive a car or operatemachinery.
Before You TakePentasa
When Tou Must Not Take It
Do not take Pentasa if you have anallergy to:
- any medicine containingmesalazine or aspirin-likemedicines
- any of the ingredients listed atthe end of this leaflet.
Some of the symptoms of an allergicreaction may include:
- shortness of breath, wheezing ordifficulty breathing
- swelling of the face, lips, tongueor other parts of the body
- rash, itching or hives on the skin.
Do not take Pentasa if you have asevere kidney or liver problem.
Do not take Pentasa after theexpiry date printed on the pack orif the packaging is torn or showssigns of tampering.
If it has expired or is damaged, returnit to your pharmacist for disposal.
Do not give Pentasa to a child 12 years old or under.
The safety and effectiveness ofPentasa in this age group have notbeen established.
Before You Start to Take It
Tell your doctor if you haveallergies to any other medicines,foods, preservatives or dyes.
Tell your doctor if you have orhave had any of the followingmedical conditions:
- a known allergy to Pentasa,sulfasalazine or aspirin-likemedicines, or any of theingredients listed at the end ofthis leaflet
- a kidney or liver problem
- a bleeding disorder
- a history of asthma.
Tell your doctor if you arepregnant or plan to becomepregnant or are breast-feeding.
Your doctor can discuss with you therisks and benefits involved. Pentasashould be used with caution duringpregnancy and breast-feeding andonly if the potential benefitsoutweigh the possible risks in theopinion of the doctor.
If you have not told your doctorabout any of the above, tell him/her before you start using Pentasa.
Taking Other Medicines
Tell your doctor or pharmacist ifyou are using any other medicines,including any that you get withouta prescription from yourpharmacy, supermarket or healthfood shop.
There is no information available oninteractions between Pentasa and other medicines. However,mesalazine belongs to a group ofmedicines called salicylates that mayinterfere with the following types ofmedicines:
- anti-coagulants, used to thinblood or stop blood clots (e.g.warfarin)
- glucocorticoids, used to treatinflammation, swelling orallergies (e.g. prednisolone)
- sulphonylureas, used to lowerblood sugar and treat diabetes(e.g. glibenclamide, glipizide)
- methotrexate, used to treat somekinds of cancers and arthritis
- probenicid or sulfinpyrazone,used to treat gout
- spirinolactone or frusemide, usedto increase the amount of urineproduced, and to lower bloodpressure
- rifampicin, used to treattuberculosis
- azathioprine, used to suppress theimmune system
- mercaptopurine and thioguanine,used to treat leukaemia
Ask your doctor or pharmacist if youare unsure about taking any of thesemedicines
Your doctor and pharmacist havemore information on medicines to becareful with or avoid while takingthis medicine.
How to Take Pentasa
Follow all directions given to youby your doctor or pharmacistcarefully.
They may differ from theinformation contained in this leaflet.
If you do not understand theinstructions on the packaging, askyour doctor or pharmacist forhelp.
How Much to Take
For active ulcerative colitis, take upto 4g Pentasa once a day or individed doses.
For long term treatment of ulcerativecolitis, take 2g Pentasa once a day orin divided doses.
For active Crohn's disease, take up to4g Pentasa daily in divided doses
For long term treatment of Crohn'sdisease, take up to 4g Pentasa dailyin divided doses.
For some conditions, your doctormay prescribe a different dose.
How to Take It
Tear or cut to open the sachet alongthe dotted line.Empty the contents (granules) of thesachet onto the tongue and washdown with water or juice.
Empty the contents (granules) of thesachet onto the tongue and washdown with water or juice.
Swallow the Pentasa granules wholewithout chewing or crushing.
When to Take It
Take your medicine the same timeeach day. This will help youremember when to take it.
You can take Pentasa with or withoutfood.
How Long to Take It
Continue Using Your Medicine foras Long as Your Doctor Tells You
This medicine helps to control yourcondition, but does not cure it. It isimportant to keep using yourmedicine even if you feel well.
If You Forget to Take It
If it is almost time for your nextdose, skip the dose you missed andtake your next dose when you aremeant to.
Otherwise, take it as soon as youremember, and then go back totaking Pentasa as you wouldnormally.
If you are not sure what to do, askyour doctor or pharmacist.
If you have trouble remembering totake Pentasa, ask your pharmacist forsome hints.
If You Take too Much(Overdose)
Immediately telephone your doctoror the Poisons Information Centre(telephone 13 11 26) for advice, orgo to Accident and Emergency atthe nearest hospital, if you thinkthat you or anyone else may haveused too much Pentasa. Do thiseven if there are no signs ofdiscomfort or poisoning.
You may need urgent medicalattention.
While You are TakingPentasa
Things You Must Do
If you are about to be started onany new medicine, remind yourdoctor and pharmacist that youare taking Pentasa.
Have all blood tests recommendedby your doctor.
Pentasa may cause kidney, liver orblood problems in a few people. Youshould have regular blood tests tocheck your kidney function.
Tell any other doctors, dentists,and pharmacists who treat youthat you are using this medicine.
If you are going to have surgery,tell the surgeon or anaesthetist thatyou are using this medicine.
If you are going to have surgery,tell the surgeon or anaesthetist thatyou are using this medicine.
If you become pregnant whileusing this medicine, tell yourdoctor immediately.
Things You Must not Do
Do not take Pentasa to treat anyother complaints unless yourdoctor tells you to.
Do not give your medicine toanyone else, even if they have thesame condition as you.
Do not stop using your medicine orlower the dosage without checkingwith your doctor.
If you stop taking it suddenly, yourcondition may worsen.
Tell your doctor or pharmacist assoon as possible if you do not feelwell while you are taking Pentasa.
This medicine helps most people butit may have unwanted side effects ina few people. All medicines can haveside effects. Sometimes they areserious, most of the time they are not.You may need medical attention ifyou experience some of the sideeffects.
Do not be alarmed by the followinglists of side effects. You may notexperience any of them.
Ask your doctor or pharmacist toanswer any questions you mayhave.
Tell your doctor or pharmacist ifyou notice any of the following andthey worry you:
- abdominal or stomach pain
- nausea (feeling sick)
The above list includes the morecommon side effects of yourmedicine. They are usually mild andshort-lived.
Tell your doctor as soon as possibleif you notice any of the following:
- bruising easily, unusual bleeding(e.g. nosebleeds), signs ofinfection such as fever, chills,sore throat and mouth ulcers
- muscle aches and pains
- painful joints
- severe upper stomach pain,nausea and vomiting
- chest pain, sometimes spreadingto the neck and shoulders, or withfever
- mild skin rash, hives or itching
- numbness, tingling or weaknessof the arms and legs
- yellowing of the skin or eyes,dark coloured urine
- worsening of your condition.
The above list includes serious sideeffects which may require medicalattention. Serious side effects arerare
If you notice any of the following,tell your doctor immediately or goto Accident and Emergency atyour nearest hospital:
- sudden signs of allergic reactionssuch as rash, itching or hives,shortness of breath, wheezing,coughing, or swelling of limbs,face, lips, mouth, tongue or throatwhich may cause difficultyswallowing or breathing
- severe stomach cramps and/orpain, bloody diarrhoea, fever,severe headache and skin rash
- rash with severe blisters andbleeding of the eyes, mouth, lips,nose and genitals.
The above list includes very seriousside effects, which may need urgentmedical attention or hospitalisation.These side effects are very rare.
Other rare side effects that havebeen reported with Pentasainclude:
- changes in kidney function
- changes in liver function
- changes in the blood
- hair loss.
As a precaution, your doctor may doblood tests to check if there are anychanges in your blood, kidney orliver function.
Other side effects not listed abovemay also occur in some people.
Tell your doctor or pharmacist ifyou notice anything that is makingyou feel unwell.
After Taking Pentasa
Keep your Pentasa in thepackaging until it is time to takeyour next dose.
If you take Pentasa out of thepackaging it may not keep well.
Keep your Pentasa in a cool dryplace where the temperature staysbelow 25°C.
Do not store Pentasa or any othermedicine in the bathroom or near asink. Do not leave it on a windowsill or in the car.
Heat and dampness can damagesome medicines.
Keep Pentasa where childrencannot reach it.
A locked cupboard at least one-anda-halfmetres above the ground is agood place to store medicines.
If your doctor tells you to stoptaking Pentasa or the expiry datehas passed, ask your pharmacistwhat to do with any granules thatare left over.
What it Looks Like
Pentasa Sachets contain short andcylindrical (or tube) shaped granulesthat are white-grey to pale whitebrown in colour.
Pentasa 1g Sachets are supplied inpacks of 30 and 120.
Pentasa 2g Sachets are supplied inpacks of 15 and 60.
Pentasa 4g Sachets are supplied inpacks of 8 and 30.
Not all pack sizes are beingdistributed in Australia.
Pentasa Sachets contain 1g , 2g or 4gof mesalazine as the active ingredient, as well as the followinginactive ingredients:
This medicine does not containsucrose, gluten, tartrazine or anyother azo dyes.
Pentasa Sachets are supplied in
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble, NSW 2073
Australian Register Number
AUST R 161063 Pentasa 1g Sachets
AUST R 161064 Pentasa 2g Sachets
AUST R 216259 Pentasa 4g Sachets