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PENTASA PROLONGED RELEASE TABLETS 500MG

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PENTASA® PROLONGED-RELEASE
TABLETS 500mg

T04444

(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.
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 Prolonged-release Tablets. Each tablet
contains mesalazine 500mg 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 up to 4g
masalazine, to be taken as eight tablets a day 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.

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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
• nausea
• rash with or without itching

• stomach pain
• diarrhoea
• headache

Rare side effects (affecting less than 1 in 1,000 patients) include:
• blood disorders (e.g. low
levels of red blood cells)

• lupus erythematosis (an
auto-immune disorder
effecting the skin)

• tingling or numbness in the
hands and feet

• allergic lung reactions
(including breathing problems)

• inflammation of the heart or
area surrounding the heart

• changes in kidney
function or kidney failure

• inflammation of the liver
and liver failure

• inflammation of the
pancreas

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
Steven-Johnson syndrome

• allergic reactions

If any of these side effects become severe or if you experience any other side
effects not listed you should contact your doctor or pharmacist as soon as possible.

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.
Do not take the tablets after the expiry date printed on the packaging.
If the tablets become discoloured or show any other signs of deterioration, you
should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6. Further information

What Pentasa contains
• Each tablet contains 500mg of the active ingredient mesalazine, (also known as
5-aminosalicylic acid or 5-ASA) in a prolonged release formulation.
• Other ingredients in Pentasa Prolonged-release Tablets 500mg are: povidone,
ethylcellulose, microcrystalline cellulose, magnesium stearate and talc.
What Penasa looks like and the contents of the pack
Your medicine is called Pentasa Prolonged-release Tablets 500mg.
The tablets should be taken by mouth.
• The tablets are white-grey to pale-brown, specked, round tablets, scored and
marked ‘500mg’ on one side and ‘PENTASA’ on the other side.
• Pentasa Prolonged-release Tablets 500mg are available in pack sizes of 60 and
100 tablets, presented in blister strips of 10 tablets per strip.

Manufacturer and Product Licence Holder

Manufactured by Ferring A/S, Vanlose, Denmark. It is procured from within the EU
by the Product Licence Holder: Swinghope Limited, Brandon House, Marlowe Way,
Croydon, CR0 4XS and repackaged by Interport Limited, Brandon House, Marlowe
Way, Croydon, CR0 4XS.
POM

PL No: 10380/1237

Leaflet revision date: 09/08/2013
Pentasa® is a registered trademark of Ferring B.V., Netherlands.

T04444

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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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