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PENTASA 1G SLOW RELEASE TABLETS

Active substance(s): MESALAZINE

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Pentasa® 1g slow release tablets



(mesalazine)



This medicine is available as the above name but will be
referred as Pentasa throughout the following leaflet.

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

1. 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 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.
• 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
sulfasalazine

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 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.
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.

4. Possible side effects

5. How to store Pentasa

Like all medicines, Pentasa can cause side effects,
although not everyone gets them.

Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package
in order to protect from light.
Do not take after the expiry date on the packaging. The
expiry date refers to the last day of that month.
If the tablets have 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.

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.

6. Further information

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

What Pentasa contains
Each slow release tablet contains 1g mesalazine.
Also contains povidone, ethylcellulose, microcrystalline
cellulose, magnesium stearate and talc.

• vomiting

• stomach pain

• nausea

• diarrhoea

• rash with or without
itching

• headache

Rare side effects (affecting less than 1 in 1,000
patients):

What Pentasa looks like and the contents of the
pack
Pentasa is a white/grey to pale brown, speckled, oval
shaped slow release tablet embossed with “PENTASA”
on both sides.
Pentasa is available in blister pack of 60 slow release
tablets.
PL: 15814/1174

• blood disorders (e.g. low • lupus erythematosis
(an auto-immune
levels of red blood cells)
disorder affecting the
skin)
• tingling or numbness in • allergic lung reactions
the hands and feet
(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):
• raised liver enzymes

• muscle pain

• hair loss (reversible)

• fever

• joint pain

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

POM

Manufactured by Ferring GmbH, Wittland, Kiel,
Germany.
Procured from within the EU and repackaged by the
Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 12.05.2016
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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