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PENTASA SLOW RELEASE TABLETS 500MG

Active substance(s): MESALAZINE

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(mesalazine)

Patient Information
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

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

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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 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.

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1.

• 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.

To treat an attack of colitis, your doctor will usually prescribe a
dose of up to 4g masalazine, 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.

SMP Leaflet 200x200mm

PENTASA® Slow Release Tablets 500mg

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).
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:
• 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

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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.

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
disposal.

6.

Further information

What Pentasa contains
Each tablet contains 500mg 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 Penasa looks like and the contents of the pack
The tablets are white/grey to pale brown, specked, round tablets,
scored and marked ‘500mg’ on one side and ‘PENTASA’ on the
other side. Each carton contains 100 tablets presented in blister
strips of 10 tablets per strip
Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.,
Drayton Hall,
Church Road,
West Drayton
UB7 7PS, (UK).
Manufactured by:
Ferring GmbH,
Wittland 11,
D-24109 Kiel,
Germany.

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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 500mg - PL 03194/0044.
This leaflet was last revised in February 2014 .
PENTASA is a registered trademark.

SMP Leaflet 200x200mm

4.

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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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