® Ask your doctor if you have Before you start to take it PENTASA any questions about why Mesalazine this medicine has been Tell your doctor if you have prescribed for you. Your allergies to any other Prolonged release tablets doctor may have prescribed it medicines, foods, for another reason. preservatives or dyes.
Consumer Medicine There is no evidence that Tell your doctor if you have Information PENTASA® is addictive. or have had any of the following medical What is in this leaflet It is available only with a conditions: doctor’s prescription. a known allergy to This leaflet answers some It is not expected to affect your PENTASA®, common questions about ability to drive a car or operate sulphasalazine or aspirin- ® PENTASA . machinery. like medicines, or any of It does not contain all the the ingredients listed at the available information. It does Before you take end of this leaflet not take the place of talking to ® a kidney or liver problem your doctor or pharmacist. PENTASA a bleeding disorder a history of asthma Please read this leaflet before When you must not take it ® you start using PENTASA . Tell your doctor if you are Do not take PENTASA® if pregnant or plan to become All medicines have risks and you have an allergy to: pregnant or are breast- benefits. Your doctor has feeding. weighed the risks of you using any medicine containing ® Your doctor can discuss with PENTASA against the mesalazine or aspirin-like you the risks and benefits benefits they expect it will have medicines involved. PENTASA® should for you. any of the ingredients be used with caution during listed at the end of this pregnancy and lactation and If you have any concerns leaflet. only if the potential benefits about using this medicine, outweigh the possible risks in ask your doctor or Some of the symptoms of an the opinion of the doctor. pharmacist. allergic reaction may include: If you have not told your Keep this leaflet with the shortness of breath, doctor about any of the medicine. You may need to wheezing or difficulty above, tell him/her before read it again. breathing you start using PENTASA®. swelling of the face, lips, What PENTASA® is tongue or other parts of the Taking other medicines used for body rash, itching or hives on the Tell your doctor or skin. pharmacist if you are using This medicine is used to treat any other medicines, ® Crohn’s disease and ulcerative Do not take PENTASA if including any that you get colitis, diseases associated you have a severe kidney or without a prescription from with inflammation, ulcers and liver problem. your pharmacy, supermarket sores in the bowel causing or health food shop. ® bleeding, stomach pain, and Do not take PENTASA after diarrhoea. the expiry date printed on There is no information the pack or if the packaging available on interactions The active ingredient in is torn or shows signs of ® ® between PENTASA and other PENTASA is mesalazine. It is tampering. medicines. However, an anti-inflammatory agent, If it has expired or is damaged, mesalazine belongs to a group similar to aspirin, and is return it to your pharmacist for of medicines called salicylates thought to work by reducing disposal. that may interfere with some inflammation in the bowel. medicines:
Medicines that may have effectiveness of the For maintenance (during their effects increased if medicine. remission) of ulcerative colitis, used with PENTASA include: rifampicin, used to treat take up to 2g PENTASA® once tuberculosis. When a day or in divided doses. anti-coagulants, used to PENTASA is used with thin blood or stop blood this medicine it may Crohn’s Disease clots (e.g. warfarin). When decrease the effectiveness PENTASA is used with of the medicine. For active Crohn’s disease these medicines, it may (flare-up of symptoms), take up increase the medicine’s Medicines that may have a to 4g PENTASA® daily in effects on thinning your greater likelihood of divided doses. blood. reducing bone marrow glucocorticoids, used to activity if used with For maintenance (during treat inflammation, PENTASA include: remission) of Crohn’s disease, swelling or allergies (e.g. azathioprine, used to take up to 4g PENTASA® daily prednisolone). When suppress the immune in divided doses. PENTASA is used with system these medicines, it may mercaptopurine, used to For some conditions, your increase the undesirable treat leukaemia doctor may prescribe a effects caused by these different dose. medicines. Ask your doctor or pharmacist sulphonylureas, used to if you are unsure about taking Children: lower blood sugar and any of these medicines. A child’s dose will be treat diabetes (e.g. individualised based on their glibenclamide, glipizide). Your doctor and pharmacist body weight. When PENTASA is used have more information on with these medicines, it medicines to be careful with or How to take it may increase the avoid while taking this medicine’s effect on medicine. Swallow the tablets whole lowering your blood without chewing or crushing. glucose. How to take You can also place the tablets methotrexate, used to treat ® in 50mL of cold water, stir some kinds of cancers and PENTASA rapidly and drink immediately. arthritis. When PENTASA is used with this medicine, Follow all directions given to Do not cut, crush or chew the it may increase the you by your doctor or tablets. possibility of the medicine pharmacist carefully. producing toxic effects on They may differ from the When to take it your body. information contained in this leaflet. Take your medicine the same Medicines that may have time each day. This will help their effects decreased if If you do not understand the you remember when to take it. used with PENTASA include: instructions on the probenicid or packaging, ask your doctor You can take Pentasa with or sulfinpyrazone, used to or pharmacist for help. without food. treat gout or other conditions. When How long to take it PENTASA is used with these medicines it may How much to take Continue using your decrease the effectiveness medicine for as long as your of the medicine. Adults: doctor tells you. spirinolactone or This medicine helps to control frusemide, used to Ulcerative Colitis your condition, but does not increase the amount of cure it. It is important to keep urine produced, and to For active ulcerative colitis using your medicine even if lower blood pressure. (flare-up of symptoms), take up you feel well. ® When PENTASA is used to 4g PENTASA once daily or with these medicines, it in divided doses. If you forget to take it may decrease the If it is almost time for your next who treat you that you are Ask your doctor or dose, skip the dose you using this medicine. pharmacist to answer any missed and take your next questions you may have. dose when you are meant to. If you are going to have surgery, tell the surgeon or Tell your doctor or Otherwise, take it as soon as anaesthetist that you are pharmacist if you notice any you remember, and then go using this medicine. of the following and they back to taking PENTASA® as It may affect other medicines worry you: you would normally. used during surgery. headache If you are not sure what to do, If you become pregnant diarrhoea ask your doctor or pharmacist. while using this medicine, abdominal or stomach pain tell your doctor immediately. nausea (feeling sick) If you have trouble vomiting remembering to take Things you must not do PENTASA® , ask your The above list includes the pharmacist for some hints. Do not take PENTASA® to more common side effects of treat any other complaints your medicine. They are If you use too much unless your doctor tells you usually mild and short-lived. (overdose) to. Tell your doctor as soon as Immediately telephone your Do not give your medicine to possible if you notice any of doctor or the Poisons anyone else, even if they the following: Information Centre have the same condition as (telephone 0800 764 766) for you. bruising easily, unusual advice, or go to Accident bleeding (e.g. nosebleeds), and Emergency at the Do not stop using your or signs of infection such nearest hospital, if you think medicine or lower the as fever, chills, sore throat that you or anyone else may dosage without checking and mouth ulcers have used too much with your doctor. muscle aches and pains PENTASA®. Do this even if If you stop taking it suddenly, painful joints there are no signs of your condition may worsen. severe upper stomach discomfort or poisoning. pain, nausea and vomiting You may need urgent medical Side effects chest pain, sometimes attention. spreading to the neck and
shoulders, or with fever Tell your doctor or mild skin rash, hives or While you are taking pharmacist as soon as ® itching PENTASA possible if you do not feel numbness, tingling or well while you are taking weakness of the arms and PENTASA®. Things you must do legs
yellowing of the skin or This medicine helps most eyes, dark coloured urine If you are about to be started people but it may have on any new medicine, worsening of your condition unwanted side effects in a few remind your doctor and people. All medicines can pharmacist that you are The above list includes serious ® have side effects. Sometimes side effects which may require taking PENTASA . they are serious, most of the medical attention. Serious side time they are not. You may effects are rare. Have all blood tests need medical attention if you recommended by your experience some of the side If you notice any of the doctor. effects. PENTASA® may cause kidney, following, tell your doctor immediately or go to liver or blood problems in a few Do not be alarmed by the people. You should have Accident and Emergency at following lists of side your nearest hospital: regular blood tests to check effects. You may not your kidney function. experience any of them. sudden signs of allergic
Tell any other doctors, reactions such as rash, dentists, and pharmacists itching or hives, shortness of breath, wheezing, and ‘PENTASA’ on the other coughing, or swelling of Tell your doctor or side. They are supplied in limbs, face, lips, mouth, pharmacist if you notice blister packs of 100 tablets. tongue or throat which may anything that is making you Each tablet is protected in an cause difficulty swallowing feel unwell. aluminium foil blister. or breathing severe stomach cramps After taking and/or pain, bloody ® Ingredients diarrhoea, fever, severe PENTASA headache and skin rash PENTASA® tablets contain rash with severe blisters Storage 500mg mesalazine as the and bleeding of the eyes, active ingredient, as well as the mouth, lips, nose and Keep your PENTASA® in the following inactive ingredients: genitals e.g. erythema packaging until it is time to multiforme or Stevens- take your next dose. magnesium stearate Johnson Syndrome (SJS)/ If you take PENTASA® out of talc Toxic epidermal necrolysis the packaging it may not keep povidone (TEN) well. ethylcellulose microcrystalline cellulose The above list includes very Keep your PENTASA® in a serious side effects, which may cool dry place where the This medicine does not contain need urgent medical attention temperature stays below sucrose, gluten, tartrazine or or hospitalisation. These side 25C, away from moisture, any other azo dyes. effects are very rare. heat or sunlight Distributor Other rare side effects that Do not store PENTASA® or have been reported with ® any other medicine in the Pharmaco (NZ) Ltd PENTASA include: bathroom or near a sink. Do 4 Fisher Crescent not leave it on a window sill Mt Wellington changes in kidney function or in the car. Auckland 1060 changes in liver function Heat and dampness can e.g. raised liver enzymes damage some medicines. This leaflet was prepared in changes in the blood July 2021 hair loss Keep PENTASA® where (CCDS v 17) Increased sensitivity of children cannot reach it. your skin to sun and A locked cupboard at least ultraviolet light one-and-a-half metres above (photosensitivity) the ground is a good place to Kidney stones may develop store medicines. with use of mesalazine. Symptoms may include Disposal pain in sides of abdomen and blood in urine. Take If your doctor tells you to care to drink sufficient stop taking PENTASA® or amount of liquid during the expiry date has passed, treatment with mesalazine. ask your pharmacist what to Low sperm count ( this is do with any medicine that is reversible) left over.
As a precaution, your doctor Product description may do blood tests to check if there are any changes in your What it looks like blood, kidney, reproductive or liver function. PENTASA® 500mg prolonged release tablets are white-grey Other side effects not listed to pale brown, speckled round above may also occur in some tablets with breakmark and people. marked: ‘500 mg’ on one side,