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PENTASA SLOW RELEASE 500MG TABLETS

Active substance(s): MESALAZINE

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Pentasa® Slow Release 500mg Tablets
(mesalazine)

Patient Information Leaflet
This product is available as the above name but will be
referred to as Pentasa throughout the remainder of this
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 Slow 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 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

5.

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).

How to store Pentasa

Store your tablets below 25°C, protected from light.
Keep out of the sight and reach of children.
Do not use after the expiry date as stated on the carton.
The expiry date refers to the last day of that month.
If the tablets become discoloured or show any other signs
of deterioration, you should seek the advice of your
pharmacist.

If you experience any of the above side effects you
should contact your doctor or go to the nearest hospital
emergency department immediately.

If your doctor decides to stop your treatment, return any
leftover medicine to your pharmacist for safe disposal.
Only keep the tablets if your doctor tells you to.
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.

Common side effects (affecting less than 1 in 10
people) include:

6.

• 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)

• tingling or

numbness in the
hands and feet

• inflammation of

the heart or area
surrounding the
heart
• inflammation of
the liver and liver
failure

• lupus

erythematosis (an
auto-immune
disorder effecting
the skin)
• allergic lung
reactions (including
breathing
problems)
• changes in kidney
function or kidney
failure
• inflammation of the

pancreas

Very rare side effects (affecting less than 1 in 10,000
patients) include:
• raised liver

• muscle pain

enzymes
• hair loss

(reversible)
• joint pain
• allergic reactions



fever

• skin rash or blisters

e.g. Erythema
Multiforme or
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.

Further information

What Pentasa contains
Each tablet contains 500mg of the active ingredient
mesalazine in a slow release formulation. Your tablets
also contain the following ingredients: povidone,
ethylcellulose, microcrystalline cellulose, magnesium
stearate and talc.
What Pentasa looks like and the contents of the pack
Pentasa Slow Release 500mg tablets are round, off white
mottled tablets with a breakline and are marked ‘500’ and
‘mg’ on the front face and ‘Pentasa’ on the reverse.
Your tablets are available in blister packs containing 60
tablets.
Manufactured by: Ferring A/S, Vanlose, Denmark and are
procured from within the EU by the Product Licence
holder: Caseview (PL) Ltd., 20 Alliance Court, Alliance
Road, London W3 0RB and repackaged by OPD
Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts
WD24 4PR.
PL 13826/1542

POM

Pentasa Slow Release 500mg Tablets
Leaflet revision date (ref): 30/07/2015.
Pentasa is a registered trademark of Ferring BV, The
Netherlands.
To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.

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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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