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PENTASA 500 MG SLOW RELEASE TABLETS

Active substance(s): MESALAZINE

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Pentasa® 500 mg Slow Release
Tablets

2785
19.01.16[2]

(mesalazine)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
− Keep this leaflet. You may need to read it again
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
− If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
This medicine is available using above name but will be referred to as
Pentasa throughout this leaflet. Also available in other strength.
In this leaflet:
1. What Pentasa is and what it is used for
2. Before you take Pentasa
3. How to take Pentasa
4. Possible side effects
5. How to store Pentasa
6. Further Information
1. WHAT PENTASA IS AND WHAT IT IS USED FOR
The name of this medicine is Pentasa Slow Release Tablets.
Each tablet contains mesalazine 500 mg as the active ingredient.
Mesalazine belongs to a group of medicines called salicylates.
Pentasa is used to treat mild to moderate inflammation of the gut caused by
a condition called ulcerative colitis. It can also be used to control the
condition and prevent it from coming back.
The tablets release the active ingredient slowly which then acts locally to
reduce the inflammation and help relieve or stop the pain.
2. BEFORE YOU TAKE PENTASA
Do Not take Pentasa if you:
− are allergic to mesalazine or any of the other ingredients in Pentasa.
− are allergic to any other salicylates e.g. aspirin
− have severe liver or kidney problems
− are under the age of 15 years
Take special care with Pentasa
You should consult your doctor before taking these tablets if:
− you experience any unexplained bleeding, bruising, skin rashes, fever or
sore throat while using this medicine, stop using this medicine and seek
medical advice as soon as possible.
− If you experience any chest pain, an increased heartbeat and excess
tiredness while using this medicine, stop using this medicine and seek
medical advice as soon as possible.
− you currently have, or have previously had liver or kidney disease
− you are on any medication that may affect kidney function e.g.
azathioprine
− you have ever had an allergy to a medication called sulphasalazine
If you suffer from kidney problems you will require regular check ups by your
doctor.
You should make sure that you don’t become dehydrated, while you are
taking this medicine. This can occur after severe or prolonged attacks of
vomiting and/or diarrhoea, high fever or heavy sweating. If this does occur,
you should speak to a doctor or pharmacist for advice as soon as possible.
Taking with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
This is especially important if you are taking any of the following:
− Non-steroidal anti-inflammatories (NSAIDS)
− Azathioprine or 6-mercaptopurine
Pregnancy and Breastfeeding
If you are pregnant, are planning to become pregnant or are breastfeeding
you should speak to your doctor or pharmacist before taking this medicine,
as they will need to decide if this medicine is suitable for you.
3. HOW TO TAKE PENTASA
Always take Pentasa exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
The tablets should be taken by mouth either whole or broken up, they
should not be crushed or chewed. If you have difficulty swallowing the
tablets you can disperse them in a small quantity of cold water
(approximately 50ml) then stir and drink immediately.

To treat an attack of colitis, your doctor will usually prescribe a dose of up
to 4g mesalazine, to be taken as eight tablets once a day or in two or three
divided doses.
To help prevent further attacks, your doctor will usually prescribe a dose
of 2g mesalazine, to be taken as four 500mg tablets once a day.
If you take more Pentasa than you should
If you accidentally take too many tablets, you should go to your nearest
emergency department or contact your doctor immediately. Take the pack
and any remaining tablets with you.
If you forget to take Pentasa
If you forget to take a dose, take the next dose as soon as you remember,
unless it is less than 3 hours until your next dose. Do not take a double dose
to make up for the forgotten one.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pentasa can cause side effects, although not everyone
gets them.
STOP taking Pentasa if you notice:
− itching, skin rashes, swelling of the face, lips or throat, difficulty in
breathing or wheeziness (signs of an allergic reaction).
− unexplained bleeding, bruising, skin rashes, fever or sore throat (signs of
a blood disorder).
− a change in the colour or amount of urine produced (signs of kidney
problems).
If you experience any of the above side effects you should contact your
doctor or go to the nearest hospital emergency department immediately.
Common side effects (affecting less than 1 in 10 people) include:
− vomiting
− stomach pain
− nausea
− diarrhoea
− rash with or without itching
− headache
Rare side effects (affecting less than 1 in 1,000 patients) include:
− blood disorders (e.g. low levels
− lupus erythematosis (an autoof red blood cells)
immune disorder effecting the
skin)
− tingling or numbness in the
− allergic lung reactions
hands and feet
(including breathing problems)
− inflammation of the heart or area
− changes in kidney function or
surrounding the heart
kidney failure
− inflammation of the liver and
− inflammation of the pancreas
liver failure
Very rare side effects (affecting less than 1 in 10,000 patients) include:
− raised liver enzymes
− muscle pain
− hair loss (reversible)
− fever
− joint pain
− skin rash or blisters e.g.
Erythema Multiforme or
− allergic reactions
Steven-Johnson syndrome
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. HOW TO STORE PENTASA
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package. Protect from light.
Do not take after the expiry date stated on the carton and on the blister.
Do not remove the tablets from the blister pack until you are ready to take
the medicine.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Pentasa contains
− Each slow release tablet contains 500 mg of the active ingredient,
mesalazine (also known as 5-aminosalicylic acid or 5-ASA)
− Other ingredients are povidone, ethylcellulose, microcrystalline cellulose,
magnesium stearate and talc.
What Pentasa looks like and the contents of the pack
− The tablets are white grey to pale brown, speckled, round tablets, scored
and marked ‘500 mg’ on one side and ‘PENTASA’ on the reverse.
− Available in blister strip packs of 100 tablets.
Manufacturer and Product Licence holder
Manufactured by: Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2785

Leaflet revision and issue date (Ref): 19.01.16[2]
Pentasa is a trademark of Ferring BV.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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