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Active substance(s): MESALAZINE

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Patient Information
Read all of this leaflet carefully before you start taking this
− Keep this leaflet. You may need to read it again
− If you have any further questions, ask your doctor or
− 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
In this leaflet :
What Pentasa is and what it is used for
Before you take Pentasa
How to take Pentasa
Possible side effects
How to store Pentasa
Further Information

What PENTASA is and what it is used for

The name of this medicine is Pentasa Slow Release Tablets.
Each tablet contains mesalazine 1g 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


Before you take PENTASA

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Do Not take Pentasa if you :
• are allergic to mesalazine or any of the other ingredients in
• 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
• 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.

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.


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 as whole, 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.

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• you currently have, or have previously had liver or kidney
• you are on any medication that may affect kidney function
e.g. azathioprine
• you have ever had an allergy to a medication called

To treat an attack of colitis, your doctor will usually prescribe a
dose of up to 4g mesalazine, to be taken as four 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 two 1g 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.

SMP Leaflet 200x200mm

PENTASA® Slow Release Tablets 1g


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
Common side effects (affecting less than 1 in 10 patients):
• vomiting
• nausea
• rash with or without itching

• stomach pain
• diarrhoea
• headache

Rare side effects (affecting less than 1 in 1,000 patients):
• lupus erythematosis (an
auto-immune disorder
affecting the skin)

• tingling or numbness in the
hands and feet

• allergic lung reactions
(including breathing

• 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

Store in original packaging and do not use after the expiry date
detailed on the pack.
Keep out of reach and sight of children.
Return any old or unused medicines to your pharmacist for


Further information

What Pentasa contains
Each tablet contains 1g of the active ingredient, mesalazine
(also known as 5-aminosalicylic acid or 5-ASA) It also contains
the following inactive ingredients: 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, oval shaped,
and embossed with ‘PENTASA’ on both sides of the tablets.
Each carton contains 60 tablets presented in blister strips of 10
tablets per strip.
Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.,
Drayton Hall,
Chruch Road,
West Drayton,
UB7 7PS (UK).
Manufactured by:
Ferring GmbH,
Wittland 11,
D-24109 Kiel,

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• blood disorders (e.g. low
levels of red blood cells)

How to store PENTASA

Do not store above 25ºC.

PENTASA Slow Release Tablets 1g - PL 03194/0108.
• raised liver enzymes

• muscle pain

• hair loss (reversible)

• fever

• joint pain

• skin rash or blisters e.g.
Erythema Multiforme or

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• 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.

This leaflet was last revised in February 2014.
PENTASA is a registered trademark.

SMP Leaflet 200x200mm

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

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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.